Express Pharma (Vol.13, No.3) December 1-15, 2017 by Indian Express

VOL. 13 NO. 3 PAGES 208

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CONTENTS Vol.13 No.3 December 1-15, 2017 Chairman of the Board Viveck Goenka

44-57

Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty

As we near the end of yet another year, a retrospective coverage of our stories that reflected the trends, strategies, policies, challenges and aspirations of the pharma industry | pg 58-74

BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja, Swati Rana New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Rajesh Bhatkal Ambuj Kumar Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar

Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at 2nd floor, Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

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December 1-15, 2017

EDITOR’S NOTE

Time for a new strategy?

ccording to a recently released CII report, “Indian Roots, American Soil,” the life sciences, pharmaceuticals, and healthcare sector is the second largest group of Indian companies in the US, in terms of FDI, jobs created and saved, R&D, skills training and local CSR initiatives. While IT and IT-es tops at 28 per cent, lifesciences, pharma, and healthcare is a close second at 25 per cent. Obviously targeted to play to US President Trump's call to action, To Make America Great Again, the biannual “Indian Roots, American Soil” survey showed that 100 companies with origins in India are responsible for creating more than 100,000 jobs and $17.9 billion in investments across the US. The average investment received from Indian companies per state/territory is $187 million. President Trump will be pleased to know that 85 per cent of these companies plan to make more investments in the US while 87 per cent plan to hire more employees locally in the next five years. How do we interpret investment flow to the US at a time when the first anniversary of demonetisation saw fiery TV debates blaming the government for continuing jobless growth? In fact, four Indian pharma companies with sizeable investments in the US (Dr Reddy’s Laboratories, Glenmark Pharma, Sun Pharma and Emcure Pharma), are reportedly among the 18 companies accused by a consortia of US states of colluding to fix prices of generic medicines. Secondly, most of India's pharma majors investing in the US continue to be in the cross hairs of the US FDA for not following mandated cGMP norms at their manufacturing plants. Most recently, in a Warning Letter 320-18-06 dated November 6, the US FDA warned Lupin that ''repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate''. The WL stated that the US FDA had reviewed Lupin’s response to concerns highlighted during previous inspections at the company’s Goa and Indore plants but deemed the response inadequate and not addressing all the issues raised in sufficient detail. Over analyst calls, Lupin officials expressed surprise over the US FDA's stance, not expecting the regulator to reject their response and pick holes in the remedial actions outlined in its response. Clearly, the US regulator is not letting companies off the hook until it is satisfied that the root causes have been sufficiently addressed. Just a couple of days later, on November 13, Sun Pharma's Baska plant reportedly had a surprise visit from US FDA inspectors. Given that the plant is close to its Halol facility, which still has ongoing unresolved issues as there has been a delay in reinspection, this news is particularly significant.

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Are continued investments in the US market justified, given that the opportunities seem to be drying up?

Thus, are continued investments in the US market justified, given that the opportunities seem to be drying up? Of course, these companies cannot ignore the largest pharma market in the world, but maybe it is time for moderation and re-thinking strategy. The good news is that the domestic market is showing signs of revival from the effects of GST. AIOCD PharmaTrac data for October shows that four months after the roll out of GST, growth during October was 6.5 per cent, compared to just 2.4 per cent in August. Pharma pundits are assuming that this upward trend will continue and the industry will achieve double digit growth again, in the next few months. In contrast, pharma exports dropped in October. In fact, the country's overall exports contracted for the first time in 13 months in October. As per a CARE Ratings report, pharma/drugs is one of the top five industries, dominating India's exports basket, which together contribute a little over 60 per cent of total exports. Of these five sectors, two i.e. gems and jewellery (14.5 per cent share of the total exports pie) and pharma (5.7 per cent share) showed a decline which contributed to the overall fall in exports in October. As per data from the Ministry of Commerce, pharma/drugs share of the total exports pie was $9.8 billion in 2016, which registered a negative growth of -2.1 per cent in 2017. Though the slip is small, it is a cause for concern. One hopes that this is an aberration and the graph turns upward again over the next few months. In the final 18 months of his term, Prime Minister Modi finds himself with so much to do, and so little time. Of course, there have been gains, like the country moving up 30 places in the World Bank's Ease of Doing Business Index. More recently, Moody's Investors Service upgraded the Government of India's local and foreign currency issuer ratings to Baa2 from Baa3 and changed the outlook on the rating to stable from positive. Let us hope that as the country moves into election mode, health and associated policies once again become a key part of the political debate. It is against this backdrop that we bring to you our annual CPhI India and P-mec India special issue. Do read the in-depth coverage of our first Pharma CXO Summit, focussed on leveraging serialisation and traceability for business growth. All experts at the Pharma CXO Summit agreed that investment in such technologies is crucial to future global growth of the sector and CXOs will have to strategise to achieve long term sustainability rather than quarter to quarter P&L goals. Hopefully, the interactions at CPhI India and P-mec India 2017 will inject new vigour into India Pharma Inc’s growth trajectory. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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PHARMA CXO SUMMIT

DAY 1 - NOVEMBER 9, 2017

INAUGURAL CEREMONY

L-R: Dr Ajit Dangi, CEO, Danssen Consulting; Bejon Misra, Founder, PSM India; Daara Patel, Secretary, IDMA; Ravi Uday Bhaskar, Director General – Pharmexcil; Shaunak J Dave, CEO & MD, OPTEL Group India, VP (Asia), OPTEL Group and Viveka Roychowdhury, Editor, Express Pharma

AGENDA ◗ Lamplighting Ceremony ◗ Welcome Address by Express Pharma ◗ Welcome Address by Optel ◗ Putting the Patient First ◗ Serialisation and traceability based on

GS1 standards ◗ PANEL DISCUSSION: Leveraging Global Traceability for Sustainable Business & Growth

OPTEL FACILITY VISIT

AWARDS NITE ◗ Video Address from OPTEL ◗ Welcome Address by Express Pharma ◗ Launch of Pharma Export Excellence Handbook ◗ Express Pharma Exports Excellence Awards ◗ PANEL DISCUSSION: CEO Think Tank: Strategies

for the next decade ◗ Gala Dinner

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Viveka Roychowdhury, Editor, Express Pharma giving the Welcome Address

he event got off to an auspicious start with the lamp lighting ceremony followed by a Welcome Address, wherein Viveka Roychowdhury, Editor, Express Pharma addressed all the delegates at the event. She extended her heartfelt thanks to the esteemed delegates for making time in their

busy schedules to attend the Summit. She also elaborated on the vision of the event and pointed out how pertinent it was to discuss on this year’s theme, given that countries across the globe are already implementing or set to enforce track & trace and serialization mandates by 2018.

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PHARMA CXO SUMMIT

Welcome Address by Optel

haunak J Dave, CEO & MD, OPTEL Group India, VP (Asia), OPTEL Group , welcomed the audience on behalf of the OPTEL Group. He threw more light on the current scenario in the pharma industry and the challenges faced by it, especially in exports. He pointed out that the pharma industry accounts for 20 per cent in terms of volume but only 1.4 per cent of value, in the global market. By 2020, it is estimated to reach $55 billion, where one third of the revenue will come from exports. He also drew attention to the growth opportunities in regu-

Shaunak J Dave, C EO & MD, OPTEL Group India, VP (Asia), OPTEL Group

Putting the Patient First

ejon Misra, Founder, PSM India set the context for the whole summit by pointing out the need to keep the patients first on all initiatives by the lifesciences industry. Misra spoke on the need to assure quality and safety of drugs for patients’ benefits and the role of technology in doing so. Rooting for traceability adoption he said, “There is a need for traceability and the Ministry of Commerce needs to mandate traceability for atleast exported medicines.” He said that this move will

protect Indian brands and medicines are protected. He informed, “We are on the final stage of drafting a regulation for sale of medicines within the country and there is a large element of tracking and traceability in that.” He also urged the regulators to offer more clarity on the laws to ensure easy implementation and compliance. Misra also recommended collaborations between the industry stakeholders to come up with affordable traceability solutions to enable their wide-spread adoption.

KEY TAKEAWAYS ◗ Traceability in the pharma supply chain is a right step towards ensuring wellbeing of the most important stakeholder in this sector – the patient ◗ Technology will empower organisations to build their capacity and compete at the market place on quality and efficacy ◗ There is a need for acceptance of tracebility solutions within the industry to drive progress. Collaborations can help come up with affordable solutions to enable wide-spread adoption Bejon Misra, Founder, Partnership for Safe Medicines (PSM) India

46 EXPRESS PHARMA December 1-15, 2017

lated markets like the US where India has 30 per cent of the market share in volumes and 10 per cent in value. In 2018 branded drugs worth $50 billion will become off patent, which is a tremendous opportunity. He said, “We need to become more innovative and do more investment in research. We need to establish Brand India as a leading destination for quality medicine at affordable prices.” Dave also highlighted the importance of traceability in achieving sustainable business and growth and how OPTEL can partner companies in this intitative.

PHARMA CXO SUMMIT

Serialisation and traceability based on GS1 standards

ubrato Dey, Head, Western Regional Office, GS1 India addressed the audience and informed them about GS1 standards and elaborated on serialisation and traceability based on them. Emphasising on the need for global standards in healthcare supply chain, he explained how these standards help ensure efficiency, safety, collaboration and sustainability. He said, “GS1 provides the platform on which a solution can be built to address challenges of medication errors, counterfeiting and traceability. Global standards eliminate inefficiencies in the supply chain and it reduces

the risk of counterfeiting and lost business opportunities. Another reason for the need of global standards in healthcare is because of diverging regulatory requirements of each country. Different countries have different encoding requirement.” He also informed that GS1 is working towards harmonising regulatory requirements across multiple countries. He further stated, “Traceability is the need of the day and that's why we want to engage with the industry and bring out the best practices which can be used by the industry and develop the solution.”

KEY TAKEAWAYS ◗ Unique identification is the first step towards building serialization ◗ Data communication is important in sharing and moving the data in the entire supply chain ◗ harmonisation with global standards is a must for progress. Subrato Dey, Head, Western Regional Office, GS1 India

Glimpses of Pharma CXO Summit 2017

An enrapt audience

Industry veterans in deep discussion

Browsing through Pharma Exports Excellence Handbook

Interactive sessions galore at the inaugural edition of Pharma CXO Summit

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EXPRESS PHARMA

December 1-15, 2017

PHARMA CXO SUMMIT

Panel Discussion: Leveraging Global Traceability for Sustainable Business & Growth

(L-R): Viveka Roychowdhury, Editor, Express Pharma (Moderator); Ravi Uday Bhaskar, Director General, Pharmexcil; Dr H G Koshia, Commissioner, Food & Drugs Control Administration, Gujarat; Daara Patel, Secretary General, Indian Drug Manufacturers Association; Shaunak J Dave, CEO & MD, OPTEL Group India, VP (Asia), OPTEL Group

he next session was a panel discussion on the theme of the event, ‘Leveraging Global Traceability for Sustainable Business & Growth’. Moderated by Viveka Roychowdhury, Editor, Express Pharma, the eminent panel comprised Ravi Uday Bhaskar, Director General, Pharmexcil; Dr H G Koshia, Commissioner, Food & Drugs Control Administration, Gujarat; Daara Patel, Secretary General, IDMA; Shaunak J Dave, CEO & MD, OPTEL Group India, Vice President (Asia), OPTEL Group. The panelists debated and deliberated on different aspects of serialisation, in-

48 EXPRESS PHARMA December 1-15, 2017

KEY TAKEAWAYS ◗ Technology can be of help in not only tracking wrong doings but also in preventing them ◗ There is a need for affordable solutions to encourage serialisation in India ◗ There is a need to educate the SMEs in pharma to improve and accelerate adoption of serialisation in India

cluding the need for it in the first place, implementation strategies if it becomes mandatory in all global markets, the various opportunities and challenges it unfolds, dealing with cost concerns, technology’s role in making

serialisation effective and efficient etc., during the course of the discussion. The panelists were divided in their opinions. Patel was opposed to making serialisation compulsory as SMEs do not have the funds needed to

implement it. He also argued that India’s drug quality is very superior and the fact that a big part of the world looks at it to supply medicines is an evidence of this fact. Dr Koshia was in favour of measures to constantly improve the standards of India Pharma Inc and highlighted the various initiatives implemented in his state to improve quality and safety of drug. Bhaskar also reiterated that there is a need for the industry to constantly evolve and urged the companies to take steps towards progress, of which one is serialisation. At the same time, he also urged the providers to make

these solutions more cost-effective. Dave emphasised that thought these is cost involved in adopting serialisation, the move will prove to be very beneficial in the long course of time. He also highlighted that the OPTEL Group can help companies smoothen their serialisation journey and make it more affordable as well as effective. Roychowdhury summed up the discussion very well and pointed out that like it or hate it, serialisation is here to stay. She also said that it is time all stakeholders came together to make this journey simpler and efficient, thereby enabling the sector to embark on the next phase of growth.

PHARMA CXO SUMMIT

AWARDS

Export excellence awarded at Pharma CXO Summit 2017 The maiden Express Pharma Export Excellence Awards recognise and honour the resounding successes of Indian pharma companies and their untiring efforts in establishing India as a leading export destination

xpress Pharma Export Excellence Awards 2017 was one of the key highlights of the Pharma CXO Summit, organised by Express Pharma and OPTEL Group. Held on the eve of the first day of the Summit, it sought to acknowledge and celebrate the resounding successes of Indian pharma companies, and the vital roles they have played in establishing India as a leading export destination. It commenced with a Welcome Address by Viveka Roychowdhury, Editor, Express Pharma. She explained the vision and mission of the endeavour and explained the methodology of the awards. She also thanked the Presenting Partner, OPTEL Group and the Knowledge Partner, Pharmexcil for their support and guidance in building this platform and choosing the deserving winners. Next, Louis Roy, President, OPTEL Group gave a video message wherein he expressed his best wishes for the Summit and the Awards. He also gave the audience a very thorough understanding of OPTEL Group’s operations across the world, and conveyed its vision and mission to the audience. The Guest of Honour, Sidharth Sripad Kuncalienker, the present MLA of Goa State and Chairman of Economic Development Corporation of Goa was the next speaker. In his

Winners of Express Pharma Export Excellence Awards 2017

informative and insightful address, he informed the delegates about the conducive business climate in Goa and pointed out that the state is already a thriving pharma hub with over 78 companies. He also appreciated Express Pharma and OPTEL Group for organising the Pharma CXO Summit to discuss pivotal issues in the industry. He recommended meaningful collaborations as the way forward to drive progress. After his address, Kuncalienkar joined Roychowdhury, Editor, Express Pharma; Ravi Uday Bhaskar, Director General

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– Pharmexcil; and Shaunak J Dave, CEO & MD, OPTEL Group India, VP (Asia), OPTEL Group to launch the Pharma Export Excellence Handbook. It sought to encourage Indian pharma companies to evolve their export strategies to stay at the top of the game and acknowledge the players who are already expanding India Pharma Inc’s reach to all corners of the world. Therefore, it featured company profiles and insights from pharma professionals in key roles, who have steered companies to global leadership positions.

Next, Express Pharma Export Excellence Awards were given away by Kuncalienkar, Roychowdhury, Bhaskar, Dave and Dr HG Koshia, FDA Commissioner, Gujarat. (Check the award winners in the consecutive pages. ) The final part of the evening was a panel discussion called, ‘CEO Think Tank: Strategies for the next decade’. Utkarsh Palnitkar, Partner & National Head - Infrastructure, Government & Healthcare, National Head - Life Sciences Practice, KPMG India; Dr Ajit Dangi, CEO, Danssen Consulting; KG Ananthakrishnan, Former VP &

MD, MSD India; and Hitesh Sharma, Partner & National Leader - Life Sciences, EY were the panelists. The session was aimed at giving CEOs in the audience - past, present and future cause for introspection on their blueprint to confront a world filled with unprecedented challenges and opportunities. Thus, the first day of Pharma CXO Summit gave ample opportunities for both, celebration and contemplation. After a lot of food for thought, the delegates ended the evening with a gala dinner. lakshmipriya.nair@expressindia.com

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PHARMA CXO SUMMIT

WINNERS OF EXPRESS PHARMA EXPORT EXCELLENCE AWARDS 2017

Glenmark Pharmaceuticals in Formulations - Large Enterprise Category

Cipla in Formulations - Large Enterprise Category

Eisai Pharmaceuticals, India in Formulations – Mid-sized Enterprise Category

Indoco Remedies in Formulations – Mid-sized Enterprise Category

50 EXPRESS PHARMA December 1-15, 2017

PHARMA CXO SUMMIT

WINNERS OF EXPRESS PHARMA EXPORT EXCELLENCE AWARDS 2017

ZIM Laboratories in Formulations – Emerging Enterprise Category

Rusan Pharma in Formulations – Emerging Enterprise Category

Shantha Biotechnics in Vaccines Category

Launch of Pharma Export Excellence Handbook

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PHARMA CXO SUMMIT

Panel Discussion: CEO ThinkTank: Strategies for the next decade

Utkarsh Palnitkar,Partner & National Head â&#x20AC;&#x201C; Infrastructure, Government & Healthcare, National Head - Life Sciences Practice, KPMG India; Dr Ajit Dangi, CEO, Danssen Consulting; KG Ananthakrishnan, Former Vice - President & Managing Director, MSD India; and Hitesh Sharma,Partner & National Leader - Life Sciences, EY

he final part of the 1st day of the Pharma CXO Summit evening saw an interesting panel discussion titled, â&#x20AC;&#x2DC;CEO Think Tank: Strategies for the next decadeâ&#x20AC;&#x2122;. Moderated by Utkarsh Palnitkar, Partner & National Head - Infrastructure, Government & Healthcare, National Head - Life Sciences Practice, KPMG India, an eminent panel comprising Dr Ajit Dangi, CEO, Danssen Consulting; K G Ananthakrishnan, Former VP & MD, MSD India; and Hitesh Sharma, Partner & National Leader - Life Sciences, EY, this session was aimed at giving CEOs in the audience - past, present and future - cause for introspection on their blueprint to confront a world filled

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with unprecedented challenges and opportunities. Palnitkar set the context for the discussion by giving an understanding on the current scenario in the pharma sector and its growth story over the past couple of decades. Then he spoke that the panel will discuss and deliberate on what the future beholds for this sector and the strategies it needs to look at to ensure continuous growth. In the course of the discussion, he touched upon several pivotal issues ranging from the existing business models in the sector, strategies to create and protect intellectual property, Dr Dangi pointed out that all these years, India's competitive advantage has been cost but in times to come, this

will not be sustainable. He advised that we will have to move up the value chain to continue its growth momentum. He recommended moving from cost arbitrage to intellectual arbitrage. Dr Dangi also said that the intellectual pool in India is deep and we just need to make optimal use of it to change the game in pharma from volumes to value. Ananthakrishnan highlighted that there are challenges but the opportunities too are huge. He emphasised on the need to identify and leverage newer and unexplored growth opportunities. He also advised the domestic and MNC pharma companies to get into strategic partnerships to pool their skills, expe-

rience and strengths to create a win-win situation. Sharma said that the pharma industry is brimming with potential. Funding is not the challenge but strategic vision. The sector should be more focussed on its growth path and invest wisely to enable its progress. Newer technologies, untried ideas etc are the need of the hour for India Pharma Inc's progress. He spoke on how tech companies are partnering with pharma companies to embark on the next phase of growth. The panelists were unanimous in their view that India Pharma Inc should invest in innovation to accelerate its progress. Ananthakrishnan recommended creating an ecosystem that encourages in-

novation. Dr Dangi spoke on the need for skill building in the sector to gear up for the future. Palnitkar emphasised on the necessity of de-stigmatising failures to nurture innovation while Sharma advised everyone to not be afraid of experimenting as innovation is often born from the lessons learnt from failures. The other suggestions were creating a BIRAC-like institution for the pharma industry and utilising IT effectively to enable and inspire originality and out-of-the-box ideas. The discussion concluded with the panelists reiterating that investing in innovation is a long-time strategy and this would be key to success in the next decade.

PHARMA CXO SUMMIT

DAY 2 - NOVEMBER 10, 2017

AGENDA ◗ Networking Breakfast ◗ Welcome Address ◗ Video Address: Critical

Importance of Global Traceability in the Experience Economy ◗ OPEN Serialization

Standard Released: Why it’s needed and why you should join? ◗ Serialization: 2017 &

Video Address: Critical Importance of Global Traceability in the Experience Economy

he first session of the second day at Pharma CXO Summit 2017 was on 'Critical Importance of Global Traceability in the Experience Economy'. A global pharma expert, Dr Ajaz S Hussain, Founder Insight, Advice & Solutions, LLC and former Deputy Director of Pharmaceutical Science, US FDA, spoke to the audience at the event through a video address. He emphasised that we are in an age of experience and meeting patients’ expectations is going to be paramount. He explained that the need for experience is growing exponentially but our ability to provide assurance is not growing at the same pace. Dr Hussain also gave insights on how serialisation will help improve patient experience in times of outcomebased pricing and help the industry avail manifold benefits and accelerated growth.

KEY TAKEAWAYS ◗ Assurance, be it of quality, safety or outcomes, is a growing need and the pharma industry should work towards enhancing its ability to deliver it ◗ Value-based pricing will be the trend of the future. Soon pay-for-performance may be the norm in healthcare Dr Ajaz S Hussain, Founder Insight, Advice & Solutions, LLC and former Deputy Director of Pharmaceutical Science, US FDA

He advised the pharma industry veterans to have an open mind towards serialisation and devise their strategies for its adoption with care.

◗ Pharma players need to move beyond compliance when it comes to serialisation and look for ways to improve their systems and become future-ready

Beyond ◗ Networking Tea Break ◗ Panel discussion: The

Serialization Journey in India ◗ Valedictory Address: Make

in India, Export to the World ◗ Vote of thanks

OPEN Serialization Standard Released: Why it’s needed and why you should join?

arcel de Grutter, Executive Director, OPEN-SCS and Liaison Regulatory & Government Affairs, Abbott, an OPEN-SCS expert, gave an understanding on the vision and scope of these standards and explained how they offer manifold benefits to streamline and improve the supply chain, aid in GAMP-compliant change and lifecycle management, spur innovation, improve quality and performance etc. He also informed how global companies are already part of this initiative and urged the rest of them to follow suit to increase their competitiveness in the global arena. He strongly recommended serialisation for countries like India and opined that it will help improve quality processes. He also advised training people to use electronic systems to ensure easy implementation. He mentioned that quality will be a huige determinant of success in times to come and Indian pharma companies could use serialisation as an oppurtunity to increase exports. In his presentation, he also explained the criticality of a standard data exchange specification for healthcare packaging serialisation. He also shared achievements and mile-

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Marcel de Grutter, Executive Director, OPEN-SCS and Liaison Regulatory & Government Affairs, Abbott

stones of various packaging serialisation specification 1.0 use cases which his company has already implemented such as PSS 1.0 and 2.0 deliverables and agile

GMAP development process of PSS. He said that with implementation of serialisation, companies can also train their people to apply GAMP.

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PHARMA CXO SUMMIT

Serialisation: 2017 & Beyond

ean Pierre Allard, CTO, OPTEL Group made a presentation on the impact of serialisation in the pharma industry. He revealed that recorded incidences of counterfeiting in 2014 stood at 2177. Cautioning that counterfeiting is not a myth but a reality, he also said that this number does not represent the real number of counterfeit and this could be tip of the iceberg! He informed that in the world, 15,000 packaging lines need serialisation and stressed on the point that unless we do something on a urgent basis, an unprecedented dilemma is on its way. On the plus side, he said that India is one of the country which has started its serialisation journey. He also spoke on how serialisation mandates are being adopted in countries across the world and gave an overview on the laws in different developed markets such as the US and the EU. He also laid emphasis on the need to comply with these laws. He also spoke on the global regulations already implemented in India, China, South Korea, Turkey and Argentina. He also said that serialisation is here to stay and each company needs to create to blueprint for embracing serialisation. He also spoke on OPTEL’s readiness and ability to be a great partner to pharma companies in their efforts to adopt serialisation processes.

Jean Pierre Allard, CTO, OPTEL Group

ValedictoryAddress: Made in India, Export to the World

r Sanjit Singh Lamba, MD, Eisai Pharmaceuticals India, in his valedictory address, spoke on Make in India, Export to the World. He also briefed the audience on the journey of Eisai Pharma and shared the key learnings of the company while dealing with different markets globally. He said that after the success of Eisai in India we have seen a number of investments coming from major Japanese pharma companies coming to India. He also highlighted the various challenges faced by the Indian pharma companies. He pointed out that on one side we talk about being the ‘Pharmacy of the World’ and on the other side we are faced with issues of infrastructure, compliance and regulation. However, he also said that with technology adoption, the industry is undergoing a huge change since the in past 10 years. Speaking on exports, he said, “The major challenge is the quality issue that is affecting the reliability. We are doing a lot more on that, for instance, serialisation to ensure that we have full control on our supply chain.” He also advised, “We need to have continuous investment in technologies and people.” Thus it was a very befitting conclusion to two days of knowledge sharing at Pharma CXO Summit 2017.

Dr Sanjit Singh Lamba, MD, Eisai Pharmaceuticals India

54 EXPRESS PHARMA December 1-15, 2017

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PHARMA CXO SUMMIT

Panel Discussion: The Serialisation Journey in India

he last panel discussion at Pharma CXO Summit 2017 was on The Serialization Journey in India. The panel discussion was moderated by SM Mudda, Director – Global Strategy (Technical), Micro Labs. Prabir Das, VP, Mylan Laboratories; Shivaji Chakraborty, Assistant General Manager, Packaging Development, Fresenius Kabi Oncology; and Vardhaman Jain, Marksans Pharma were the panelists. The discussion began with a very important question: Why there has been a reluctance to accept serialisation? Lack of understanding about technology and its potential, high initial cost of implementation were some of the major reasons which emerged as the answer to the question. The discussion also touched upon varied topics ranging from India’s standing in the global pharma industry, rising threat of counterfeit medicines, and global track and trace regulations, to India’s regulations for the export market, as well as serialisation compliance and challenges and more. Das informed that serialisation is the most discussed topic in the pharma industry these days. He also spoke on the basic challenges faced in packaging. One of them is accommodating the additional barcode which is relatively smaller to our conventional barcode. He said that at various levels of packaging, we face different challenges. Elaborating on them he said, there are no harmonised standards across the globe which can be easily integrated in a common system. It is a challenge for the packaging industry to keep evolving complying with the new regulations coming up in different countries. Speaking on operational challenges faced in serialisation, Chakraborty said, “Serialisation looks simple but its not that simple. The few challenges which is very common in the industry is integration with the existing packaging line. It is really difficult keeping in mind the Indian scenario. Most of the lines are

56 EXPRESS PHARMA December 1-15, 2017

(L-R) SM Mudda, Director – Global Strategy (Technical), Micro Labs; Prabir Das, VP, Mylan Laboratories; Shivaji Chakraborty, Assistant GM, Packaging Development, Fresenius Kabi Oncology; and Vardhaman Jain, Marksans Pharma

KEY TAKEAWAYS ◗ There is need to work with the government to find solutions for SMEs to reduce the cost burden of serialisation implementation ◗ The government should document a common standard for the industry for the better implementation of serialisation ◗ Lack of understanding about technology and its potential, high initial cost of implementation are some of the major reasons for the slow adoption of serialisation

old and their speed is very low and changing to updated machinery involves cost. In India, we have unskilled, untrained manpower in the packaging line so handling the new equipment is a big challenge for them. Accommodating text on small cartons is a challenge for automation. We are still working on to deal with challenges.” Jain elaborated on how the barcodes need to be integrated in the quality system. He said, “The complexity is very high. However, today, people understand that track and trace is not required only for the DAVA portal but also falls under the FDA enforcement, US as well as EU.” Concluding the panel discussion, Mudda said, “It is a difficult journey and there is a long way to go before we standardise the requirements globally to find workable solutions. We should be looking forward to better solutions and compliance.”

PHARMA CXO SUMMIT

Glimpses of Pharma CXO Summit 2017

EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

As we near the end of yet another year, a retrospective coverage of our stories that reflected the trends, strategies, policies, challenges and aspirations of the pharma industry

EXPRESS PHARMA (JANUARY 16-31, 2017) EXPANDING ACCESS

cover ) here is no doubt that the pharmaceutical industry has a social commitment to public health. Many pharma companies do take this commitment seriously enough to invest considerable resources to reduce disease burden by increasing access to doctors, diagnostics, medication and a host of interventions. Their access strategies most often take the form of patient outreach programmes and health awareness campaigns through which they identify a health need and try to address gaps in current healthcare systems. Pharma companies have been part of global and national campaigns aimed at achieving public health goals, be it eradicating infectious diseases like polio, TB or HIV, or managing NCDs like diabetes. But how effective are such interventions? Can they be replicated? Are they sustainable? And above all, are they above the needle of suspicion that they are but a means to access and penetrate new markets? Since 2008, the Netherlands-based Access to Medicine Foundation's Access to Medicine Index has evolved into a barometer of effectiveness of these access programmes, at least for the 20 research-based pharma companies tracked by the Index. The Index analyses these companies on how they make medicines, vaccines and diagnostics more accessible in low- and middle-income countries. It also highlights best and innovative practices, and areas where progress has been made and where action is still required. Published every two years, the latest report released in December 2016 received financial support from the UK Government, the Bill & Melinda Gates Foundation and the Dutch COMPANIES Ministry of Foreign Affairs. GSK, ABBVIE, J&J, GSK leads the 2016 InSANOFI, NOVARTIS dex, for the fifth time, ahead AND MERCK of Johnson & Johnson ACCOUNT FOR NEARLY (which improved its ranking by one place), Novartis (also up one rank) and Merck (up two places). Companies which showed maximum improvement in their rankings OF PROJECTS were AstraZeneca (up eight TARGETING places from 15 to 7) and HIGH-PRIORITY, Takeda Pharmaceutical (up LOW-INCENTIVE five places from 20 to 15). GAPS Novo Nordisk slipped eight places from second to 10th rank while Roche slipped seven places from 12 to 19. But many would consider GSK's top rank ironic since the company was pulled up by the Chinese government for ethical breaches. In fact, many big names in the pharma firmament have faulted on the ethics side. Which is probably why for the first time, the 2016 edition of the Index analysed pharma companies’ compliance performances alongside their systems and strategies for improving access to medicine. Jayasree K Iyer, Executive Director, Access to Medicine Foundation acknowledges this “central tension” saying, “The social contract that companies have with the people is that the companies have the responsibility to provide quality, affordable and effective health products to people, who are ultimately their customers. However, there is a central tension between shareholder profits and stakeholder needs, exacerbated by poverty, inequality, and such.” Explaining the methodology followed by the ranking she

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T H E

M A I N

FO CUS

BY VIVEKA ROYCHOWDHURY

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January 16-31, 2017

xpress Pharma has always taken a keen interest in India’s progress in the public welfare.Ascertaining that commitment to public health, this story covered a crucial issue — Access to health. It examined an often overlooked aspect, the efficacy of pharma companies’access strategies to identify a health need and address gaps in current healthcare systems. It highlighted the challenges and recommended that the industry will have to evolve its access strategies, specifically for India, and in some cases, state by state. The measures in the article , if implemented, will enable better access to medicines and also help pharma companies in their endeavour to tap rural markets.

CPhI & P-MEC INDIA 2017 SPECIAL

INTERVIEWS WITH INDUSTRY LEADERS AND GAME CHANGERS

n the first interview, GSK’s AVaidheesh talks about increasing access to medicines through meaningful collaborations and digital technologies.The second one features the founder of a promising start-up, Locus Technologies which is transforming the logistics space.The third interview with KPMG is on the changing business dynamics of the pharma industry in increasingly volatile conditions.

cover ) I N T E R V I E W

Increasing access to medicines via collaboration and digitisation A Vaidheesh, VP, South Asia and MD, India, GlaxoSmithKline Pharmaceuticals, in an exclusive interaction with Prathiba Raju mentions that in 2017 and beyond, the pharmaceutical sector will witness partnerships with governments to increase access to a broad range of innovative medicines, vaccines and foresees a transformational role of digital in the next few years

What will be the most dominant business trends in 2017 in the Indian pharmaceutical industry? I foresee a trend of collaboration between government and pharma companies to further increase access to medicines and vaccines in the coming years. The evolution of digital technologies will further aid this development. In fact, GSK India is already making big investments on the digital front, to deliver growth while remaining committed to serve patients with futuristic quality standards. Apart from partnerships, digitisation will see a major leap in the sector. Digital disruption is transforming every industry globally. At GSK, we believe that the time has come for the pharma industry to leverage technology to improve realtime flow of information and ride the digital revolution to fast forward the future. With increased Internet penetration in India and more digital-savvy healthcare professionals (HCP’s) GSK is leading this transformation with a vision of an integrated solution that will increase the quality of in-clinic interactions. In fact, in a single quarter in 2016, GSK reached over 400,000 HCPs through the digital route. GSK is also investing in communications with the doctors and leveraging

the power of emerging new technologies. We have digitised our entire field force of over 3000 sales reps with iPads for instant detailing and real-time reporting. We have invested in Veeva a CRM tool for our sales force with an integration of all the digital channels such as websites, emails, webinars, tele-detailing so that they can communicate easily with doctors and offer real-time information. This ensures a seamless and transformational customer experience and makes GSK future ready. Titans of the pharma

industry are adjusting their sails to adapt to an increasingly VUCA world where volatility, uncertainty, complexity and ambiguity are the only constants. So, what defines the leadership in a VUCA pharma scenario? It is not just the pharma industry but the entire world that is in VUCA right now. First and foremost, we need to recognise the fact that we are in a volatile ever-changing environment and one of the key factors that are likely to face more scrutiny in the pharma industry is the increasing role of regulators and policy

makers. For example, in a critical ecosystem of healthcare, industry is made up of 6Ps – Patients, Payers, Providers, Policy makers, Physicians and Play makers. In every country, VUCA is created by any one of them in some form or the other. For example, in India, this whole focus towards accessible and affordable medicine has created volatility. Now talking of volatility, I believe that the government is very much justified in stepping up and trying to find a way to reach healthcare to over 1.2 billion people in this country. The pharma industry should also play a huge role as one unified voice and discuss with policy makers ways and means to drive the agenda of accessible and affordable medicine. Though the government and private players strategies might differ, a coalition is necessary. Even industry associations such as OPPI (Organisation of Pharmaceutical Producers of India) are working towards the same goal. Moreover, we as sensible business leaders, must recognise our own responsibility of ensuring the affordability and accessibility of medicines. For example, at GSK India, we have made our vaccines and medicines more accessible by voluntarily reducing the prices of our key

products such as pneumococcal conjugate vaccine (PCV) Synflorix vaccines and Seretide, our leading respiratory offering. We do believe that a large number of people need to get these vaccines and medicines from the private market. If you want to play for the long term then you need to start looking at price volume equations. There are some categories where you may not have volume headroom and that is where you need to seek government intervention. So, we need to develop an innovative method of engaging with the government on ways and means to subsidise our price decrease otherwise business becomes non-viable. VUCA is all about how we engage with the entire ecosystem proactively. How have pharma leaders and corporations in the established markets like the US, EU etc. changed their strategies? From a GSK perspective, we have always been focussed on access to medicines to patients at large. We differentiate IP and pricing. IP has to get protected and pricing is a function of affordability of that particular country. As far as the US is concerned, we know a new president has been elected. He,

22 EXPRESS PHARMA January 1-15, 2017

LOGISTICS SPECIAL I N T E R V I E W

‘Locus aims to be a market leader in the healthcare services domain’ Locus, a machine learning start-up, is helping companies across sectors automate their intra-city scheduled and on-demand delivery, thereby ushering a new paradigm in logistics solutions. Nishith Rastogi, Co-Founder and CEO, Locus, talks about the differentiators that his company offers, the challenges it seeks to address and changing trends in pharma logistics, in an interview with Lakshmipriya Nair Excerpts

What are the most pressing challenges that you seek to overcome in the logistics arena through your solutions? Let’s categorise these challenges to decipher them better. Productivity vs time is a major challenge that needs

to be addressed in logistics. The key current issue is underutilisation of space and resources. Dependency on human resources makes the entire operation sub-optimal. Inefficient logistics leads to increase in overhead and resource costs, which is an alarming sign. The product margins get squeezed and this can make organisations noncompetitive in the market. We must aim to impress the consumers during the last mile delivery to help create customer loyalty. Customer experience is a key lever for Locus. There is a huge reliance on humans for decision making (the question that the operations head always asks is - Manoj kahaan hai?) and hence issues with consistency are very big. Analytics and reporting day-to-day operations remain unanswered. Locus helps in addressing these challenges. Why is automation the need of the hour in logistics? Let's take the planning process as an example. Even now, a large number of traditional companies use excel sheets and paper-pen to plan their routes. Also, in order to keep up with customer requirements, the approach they use is to deploy an over-supply of resources. One small change in the direction of automation holds

the potential to reduce costs and dependence on labour as well as make operations quick and accurate, regardless of the volume being processed. The era of ‘one size fits all’ type of service has ended. Nowadays, logistics solutions must be tailored to suit each customer. Full transparency of orders, visibility from raw material stage to final goods sale, and reverse logistics have almost become standards in this space.

One small change in the direction of automation holds the potential to reduce costs and dependence on labour

How are you geared to serve the healthcare sector which has very peculiar demands when it comes to logistics? When it’s healthcare, time is the most critical factor that is stressed upon by the industry. In services like diagnostic sample collections and delivery of medicines at patients’ doorstep, time sensitivity play a vital role. The underlying prescription for today's advanced healthcare supply chain approaches—regardless of the healthcare organisation's scope and scale—is technology, with a strong dose of data and analytics. We enhance these service levels and ensure that the customer is catered to on-demand and on-the-go. At Locus, we help our customers increase the serviceability quotient by increasing the utilisation of

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As a logistics solutions company, how are you different from your counterparts? What are the three major differentiators that you have brought to the table? Locus is a highly intelligent platform that focusses on decision making. We are not just a software developer but a squad with an ability of solving complicated operational challenges on ground. It is the first automatic dispatch engine to work on the ground and scale as per the industry's wants. Our routing technology is easily adaptable to several verticals and use cases, right from moving people to packages. From cement to FMCG and the pharma industry where time is of essence, our platform can easily be scaled for crossindustry disruption. Locus’ planning engine concocts highly optimised routing while it envisages constraints like time, volume, etc., taking into account several variables, including real-time gridlock conditions.

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current resources on ground and continuously tapping their ability to provide additional offerings to their end customers. You have recently signed a deal with 1mg, an online pharma player. Can you share more details about it? Are there any more deals in the pipeline as far as the pharma sector is concerned? Locus helps 1mg in delivering medicines to the patient's doorstep. Primarily, we help them optimise their deliveries by enabling efficient automation and optimisation using our route planning engine. The average distance travelled per rider for every task completed was reduced by 50 per cent by following the routes planned by Locus’ optimisation engine. We are at various stages of discussions and pilots with some of India's largest diagnostics labs and other medicine delivery companies. What are your growth plans for the sector this year? The healthcare industry has realised that it's time to bridge the gap between technology, data, and analytics to truly transform supply chain into a strategic business asset. Various companies have now Continued on Page 32

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MARKET I N T E R V I E W

‘Differentiation through quality needs to be the success mantra’ Utkarsh Palnitkar, Partner, KPMG in India, National Head – Infrastructure, Government & Healthcare; and National Head – Life Sciences and Christopher Stirling, Global Chair, KPMG Life Sciences, KPMG International speak on trends driving the pharma sector in India and globally, emerging revenue and business models in volatile market conditions, growing role of R&D in Indian pharma and more, in an interaction with Viveka Roychowdhury. Excerpts How will President Trump impact India’s pharma sector? Palnitkar: The US is the single largest export destination for India; out of the total $15.2 billion pharma exports from India, the US share was $4.2 billion (27.9 per cent). From FY13 to FY15, exports to the US has increased by 15 per cent. The Indian pharma industry is aligned with President Trump’s vision of containing drug costs and making healthcare affordable. India is expected to remain a preferred source of safe, effective and affordable medicines to millions in the US, notwithstanding the recent comments of Trump’s administration on high drug prices and a new proposed process for bidding which could indicate a challenging environment for all generic players exporting to the US, including India. These are however early days to comment on how the new US administration will impact the sector. Comment on PM Modi's approach to healthcare initiatives like UHC. Palnitkar: Evident challenges around high out-of-pocket spending, inequality of services and fragmented social and regulatory standards are forcing stakeholders back to the policy drawing board. Further, with the voice for UHC gaining traction, it is becoming imperative for the government

companies have slowly begun to deploy technology to engage more with patients. Sooner than later, a ‘patient-centric healthcare’ approach is expected to shape up as the driver of the life sciences industry where quality and affordability of care remain fundamental.

Utkarsh Palnitkar

Christopher Stirling

and other stakeholders to reassess and redesign the current healthcare system. While the government has always had positive intentions for healthcare in India, the missing pieces around implementation; effective oversight; competent policy framework and pertinent regulations to meet our national health goals and build UHC, need to be tackled without further delay. Stirling: The Netherlands model of mandatory health insurance has demonstrated that providing guaranteed quality and affordable healthcare is possible – an effort which has been praised around the globe. This model can stimulate Indian policymakers to embrace a health security model that aspires to deliver healthcare without having to suffer any fiscal hardship. How is the patient impacting

the life sciences business model, globally and in India? Stirling: Considering that the new patient pool is well-informed about treatments and medicines, in developed countries such as the US and the EU – payers (insurance companies) are looking forward to ink different healthcare plans with an outcome/value-based pricing model, especially for highpriced and specialty drugs — oncology drugs, Hepatitis C treatment, etc. Enhancing the patient experience via better efficacy of drugs drives valuebased pricing instead of volume-based pricing. These market dynamics have led global life sciences companies to think of transformative ways that could replace traditional blockbuster drugs, incremental innovation and physician-preferred models to patient-centric models. In India, life sciences

How do quality and pricing issues impact the revenue and business models of life sciences companies? What should be the top five focus areas of growth for life sciences CEOs ? Stirling: The pharma sector is at crossroads. In a heavily disrupted marketplace, characterised by shifting payer attitudes and patient empowerment, neither incremental adjustments nor steady evolution are likely to halt the decline of the traditional pharma business model. With rising demand for healthcare and falling budgets, governments and payers are exerting pressure to drive down prices. One bold example involves the Netherlands; not content with striking volume deals with the major pharma players, it is looking to utilise the power of the EU to create even greater economies of scale. At the moment, several member states are pooling together into a single procurement machine with much greater bargaining power. This initiative, in its early stages, is also being

looked at by other EU states seeking to cut their drug expenditure. Going forward, life sciences companies need to focus on new drugs to shore up growth, embrace technology to increase efficiency and compliance, emphasise on collaboration and partnerships, and focus on patient-centric business models. Life sciences companies that manage to embrace the evolving regulatory environment, and master disruption, will likely have the greatest chance to deliver real value. Many of the bigger Indian life sciences companies have invested in R&D. Are these viable bets? Palnitkar: The top 25 Indian companies increased their R&D expenditure from 7.1 per cent in 2014-2015 to almost 7.8 per cent of their consolidated net sales in 2015-16, however this is still low compared to global life sciences companies who spend over 17 per cent of their net sales on R&D. With enablers such as access to skilled manpower, presence of quality technical institutes, and exposure to global multinationals, the journey from generic to innovator has only just begun in India. This journey is expected to help Indian companies in an environment where there is high competition in generics, tighter scrutiny by drug regulators, higher usage of biologics drugs, and budget

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EXPRESS PHARMA (FEBRUARY 1-15, 2017) RISE OF PHARMA HUBS

cover )

(

THE MAIN FOCUS

RESURRECTING

BRAND AP Visakhapatnam and Nellore to play pivotal roles in rebuilding Andhra Pradesh's reputation as a leading pharma hub BY PRATHIBA RAJU

ndhra Pradesh, gearing to enter a new orbit of growth, is set to revive its IT and pharma sectors which took a hit post bifurcation. A major chunk of the pharma industry’s base remained in Hyderabad and its surrounding districts of Ranga Reddy, Mahabubnagar, Medak and Nalgonda which became a part of Telangana. The state has plans to become to regain its position as a major pharma hub and is beckoning investors Now,

the Andhra Pradesh government is contemplating to set up two big pharma clusters, one in Visakhapatnam and the second one in Nellore district of the state. These upcoming new clusters are expected to be crucial connecting points for the East and Far Eastern countries. Located in the middle of coastal Andhra with well-developed infrastructure, an international airport and good rail connectivity, among other advantages, Visakhapatnam is well positioned to take on a pivotal role in

further progress in the pharma sector. Lured by the incentives offered by Chief Minister of Andhra Pradesh, Nara Chandra Babu Naidu, multinationals such as Mylan, Eisai, Johnson & Johnson, Hospira have set to make significants investments in the state. Major domestic players such as Dr Reddy’s Laboratories, Aurobindo Pharma, Hetero Drugs, Divis Laboratories, SMS Pharmaceuticals, Cipla, Ranbaxy, Laurus Labs, Lee Pharma, Sionc Pharma, Pharmazell, Raks Pharma, Natco, Granules, Neuland

20 EXPRESS PHARMA

Laboratories have also made inroads in the state. Thus, the industry too is keen to leverage the opportunities being offered by Andhra Pradesh.

Teeming with opportunities The US-India Business Council, during a meeting with the Chief Minister, had discussed investment plans worth around $5 billion by Mylan,

which has four facilities in Visakhapatnam. Citing that the sunrise industry has a bright future in AP, SV Krishna Prasad, CEO and Director, Cito Healthcare says, “The Andhra Pradesh government is taking proactive steps to develop the pharma industry in the state. In the recent bifurcation, the state had lost a major chunk of pharma industry to Telangana. So, the state government has taken

measures to expand the pharma industry’s base in AP. As of today, the North Andhra region of pharma industry is worth nearly $2 billion.” Adding to the state's advantage is the Jawaharlal Nehru Pharma City (JNPC) built over 2,200 acres at Parawada near Visakhapatnam, has 600 acres under SEZ. This has attracted major investments from Hospira, Mylan, Eisai, Reddy’s Lab and Aurobindo Pharma. Apart

from these, major companies such as Hetero Drugs which has a huge plant near Nakkapalli and Divis Pharma also have their expansion plans charted out for the state. Also, Lupin Pharma has plans to invest nearly `500 crores while Biocon also plans to revive its Parawada facility. Johnson & Johnson has shown interest in setting up a greenfield project, So, these indicate that Andhra Pradesh is

striving to be a preferred destination for the pharma sector.” “In the coming years, exports are expected to have a quantum jump, as the state government is adding another cluster in the JNPC region. This would give a double boost to the new investors as most of the ancillary units required will be in the same vicinity. With this, VisakHAPAtnam will have two pharma clusters, one at Parawada and the other

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February 1-15, 2017

xpress Pharma has been chronicling the happenings of the pharma industry for over two decades.This story trained its focus on how Andhra Pradesh is rebuilding itself as a pharma hub post-bifurcation. Visakhapatnam will be the nucleus of this new hub, given its advantages of being a flourishing port. It also examined the opportunities that the state offers to entice major pharma players to the state. Challenges and bottlenecks that could hinder the rise of the state as a pharma was also analysed to find solutions.The pharma industry received a thorough understanding of this burgeoning market and hopefully will be able to leverage it to expedite their progress.

February 1-15, 2017

EXPRESS PHARMA (FEBRUARY 16-28, 2017) COMPANY WATCH MANAGEMENT

BETTING on

BEAT Bouyed up with promising research results, Glenmark seems to be revving up for some major out-licensing deals. Do they finally have a blockbuster waiting in the wings? Will their bets pay off? By Viveka Roychowdhury

ast December, Glenmark Pharma unveiled its strategic blueprint for the next decade. In the 16 years since its IPO in 2000, the Mumbai-headquartered company has achieved many milestones. It has grown into a global entity, from two formulation facilities in 2000 to 17 facilities across four continents, seven of which are approved by the US FDA. International revenues have grown from eight per cent to 70 per cent of total revenues. Consolidated revenue went from $31 million in 2000 to $1.2 billion in 2016. But more importantly, the management realised that the generics game was not sustain-

able as a sole business and hence took the first steps into new molecular entity (NME) research in 2000. The announcement in December was a reaffirmation of this stance, even though the company today is a leading player in the generic dermatology space in the US and has filed approximately 200 drug master files (DMFs) in various markets in the API business segment. Its three business segments clocked healthy CAGRs over the past five years, with APIs at 21 per cent, followed by generic formulations (20 per cent) and branded formulations (19 per cent). There have been seven

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February 16-28, 2017

60 EXPRESS PHARMA December 1-15, 2017

Products derived from the BEAT platform have the highest potential Dr Kurt Stoeckli President and CSO, Glenmark Pharmaceuticals

out-licensing deals since 2004, with the likes of global majors like Forest Laboratories and Teijin (2004-05) , Eli Lilly and Merck (2006-2007), and Sanofi (2010-11). In fact for 2011, a year after the IPO, the company won two awards from the Londonbased SCRIP as the 'Best Company in Emerging Markets' and 'Best Overall Pipeline'. Even though all three out-licensed molecules ultimately suffered setbacks before the Sanofi deal too fell through, Glenmark had clocked cumulative revenues of over $20 million.

R&D roulette Pharma R&D has always been a high risk-high reward game, a

Russian roulette at best. And Glenmark has been one of many hopefuls, chasing dreams of a blockbuster, only to have them turn to dust. In October 2008, Eli Lilly stopped clinical trials of Glenmark's pain drug molecule after adverse findings. In August 2009, Glenmark's first outlicensed molecule, oglemilast, was terminated by Forest as Phase IIb dose range studies on the COPD molecule were not successful enough. Glenmark's deal on oglemilast with Teijin Pharma for the Japan market also met the same fate. Not all of the out-licensing deals were terminated because the molecule was snuffed out due to unimpressive data. For

instance, in October 2006, Glenmark had out-licensed melogliptin for type-2 diabetes to Merck. But less than two years later, in February 2008, the MNC decided to refocus its portfolio and stop further investments in diabetes R&D. This, in turn, led to R&D on Glenmark's molecule being terminated. Coming after these disappointments, the Sanofi deal in 2011 for one of Glenmark's first monoclonal antibodies, vatelizumab (GBR 500) was seen as a major positive for Glenmark, but Sanofi too decided to return the molecule in 2016. But Glenmark has not given up. It is very clear from the strategic blueprint released in December that going forward, the engine of the next level of transformation will clearly be the R&D pipeline, which seems to have three main areas of focus: oncology (the company has four NOEs from preclinical to Phase 1), dermatology (one NME in Phase 2) and respiratory (four NOEs, in preclinical to Phase 3). The 10th molecule is for pain and is in the Phase 2. Any one of these 10 NOEs are potential candidates for outlicensing deals in addition to four NOEs which have been classified as non-core assets. The market is already sniffing out the molecules with promise. The HDFC Securities report says that the company believes that GBR8383 (which is in preclinical phase) is going to be a groundbreaking product and is showing better efficacy than current treatments. Glenmark's earliest NDA/BLA filings, as per currently planned studies, is in 2019, for two respiratory molecules in the speciality area, GSP301, currently in phase 3 and GSP304 currently in phase 2. With a mission statement to "transition into an innovationled global pharmaceutical organisation over the next decade, the identified focus 'growth catalysts' besides NOEs, are filing as many as nine new drug application (NDA)/biologic license application (BLAs) in the next 10 years and targeting 30 per cent of total revenues from specialty and innovation segments over

EXPRESS PHARMA

February 16-28, 2017

the next decade. The change in the distribution of ANDAs across segments also give a hint of Glenmark's chosen path. In FY12-16, the “ANDAs were distributed across just four segments: the bulk of 46 per cent in oral solids, followed by topicals (21 per cent),

onco injectables (18 per cent) and oral hormones (15 per cent). Contrast this with the projected picture for FY17-21, when oral solids will shrink to 22 per cent, topicals grow to 35 per cent, onco injectables reduce to 12 per cent, hormones reduce to eight per cent with two new

segments, drug-device combinations (16 per cent) and controlled substances (seven per cent) are sure to play a significant role.

Muted market reaction But Glenmark's R&D play in the last 16 years, has taken a toll on the balance sheet, as had cur-

rency fluctuations. The market is cautious about Glenmark's strategic blueprint. With a Neutral rating, an HDFC Securities Institutional Research report in response to Glenmark's strategy says, "Although we believe Glenmark's strategy to invest in three lucrative therapies

xpress Pharma the pharma industry and its progress very closely. So obviously, when Glenmark Pharma, a leading pharma major unveiled its strategic blueprint for the next decade, it couldn’t have gone uncovered. Bouyed up with promising research results, Glenmark seems to be revving up for some major out-licensing deals. Do they finally have a blockbuster waiting in the wings? Will their bets pay off? These were some of the major pegs covered in the story. It also covered their growth strategy in detail and traced its progress in the 16 years since its IPO in 2000. It also featured the market’s predictions on Glenmark’s blueprint and the possibility of its success.

CPhI & P-MEC INDIA 2017 SPECIAL

he three interviews in this page deal with varied issue. The first one is on the ensuring data security through encryption. The second interview with Cipla’s Chief Medical officer is on the growing incidence of respiratory disease and tackling it with a multi-pronged strategy involving patient compliance, monitoring and raising awareness. The third interview is on Wockhardt Pharma’s endeavour to tackle AMR with novel antibacterial therapies.

PHARMA TECHNOLOGY REVIEW I N T E R V I E W

‘Pharma industry is heavily regulated and HIPAA compliance mandates that the industry encrypts its data’ Rahul Kumar, Country Manager,WinMagic throws light on the importance of data security solutions and the need to adopt encryption by the pharma industry, in a tête-à-tête with Mansha Gagneja

which creates a lot of IP and it is imperative that the customer is able to ensure that their IP is secure and with them. How widely is the pharma sector adopting these solutions as it is often labelled as a technology laggard? The industry is fairly good in adopting the technology primarily because of compliance. However, what we have seen in the market is that pharma customers have troubles with encryption. Once they are aware about solutions available for managing encryption, it will be hassle-free. That is what we bring to the table and customers are very happy about it.

What are the different data security options available and why is encryption of data becoming a more favoured option? Securing data is the priority for Chief Information Security Officer of an organisation. The only way to

secure data is by encrypting it. This ensures that the data is not accessible to unauthorised users. What will be the application of encryption in the pharma sector? Pharma industry is heavily

regulated and HIPAA compliance mandates that the industry encrypts its data. The compliance is aimed at securing the data at rest, thereby ensuring that the research data is secure and can’t be compromised. This is one of the industries

What are the encryption challenges that exist in the changing tech world? The challenges have really been the same for a couple of decades. User experience is one of the biggest challenge when it comes to end-point encryption. Encryption industry has not seen a lot of innovations in the space and we are the only company that focuses on this area and we bring a seamless user experience for the customer. How are your solutions helping pharma companies secure their data? How are they different from the existing solutions?

Pharma companies like the fact that we bring in a solution which helps them manage encryption, a perpetual pain area, better. The users are now happy using this technology as it is simple and does not interfere with their working. The bottom line is – encryption was a word which used to push customers away and now – customers know that a better world exists. What is your market share? Tell us about your major clientele. We have some of the key enterprise customers in India. Our clientele includes four big consulting houses, three top pharma companies, three insurance companies and three retail companies. We have more than 110 customers in India now and we are reaching a stage where customers, when they think about encryption, think about us. Are there any other solutions or upgrades in the pipeline for the pharma industry? We have recently come up with a solution to help customers secure their cloud infrastructure. We are seeing a lot of traction for this as customers have been wary about the security of their virtualised environments.

Quality. Speed. Simplicity.

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28 EXPRESS PHARMA February 16-28, 2017

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RESEARCH I N T E R V I E W

‘India has at least 60 million to 80 million people with chronic respiratory disease’ As we mark World Asthma Day on May 2, Dr Jaideep A Gogtay, Chief Medical Officer, Cipla explains to Viveka Roychowdhury why unlike the rest of the world, 70 per cent of COPD patients in India are non-smokers and why increasing patient compliance, monitoring and awareness are key to tackling chronic respiratory disease. Excerpts from the interaction Why do we see an increase in patients with chronic respiratory diseases (CRD)? Globally, CRD are believed to affect one billion people. Asthma and chronic obstructive pulmonary disease (COPD) are the two main CRD, while there are several others, like allergic rhinitis for example. Asthma affects just over 300 million, and for the first time, this year, estimates for COPD crossed asthma. (One reason for the increase could be that) we are now able to diagnose more COPD cases in the last five to 10 years and with this better data, COPD incidence is today around 330 million, up from the previous estimate of 210 million. These figures are as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 guidelines. So, while there is a focus on cardiovascular diseases (CVDs), diabetes and cancer, CRD has now also been recognised as a big issue. In fact, COPD is included by the Government of India in the list of non-communicable diseases (NCDs). The challenge with some of the CRD is that in most countries, the ratio of patients diagnosed to undiagnosed is 1:8 or 1:9. So, COPD is vastly underdiagnosed. For example, there was a study in Latin America, which showed that 90 per cent patients were undiagnosed, as diagnosis requires a spirometry or a lung function test. Where does India stand? In India, again, the estimates

are guesstimates. Asthma patients make up roughly 2-2.5 per cent of the population, which is 30 million people of India’s 1.2 billion total population. An equal number could have COPD. There are some who believe it may be more than 2.3 per cent. Our guesstimate is that there are at least 60 million to 80 million people with CRD in India. The unique part of COPD in India is that 70 per cent, that’s almost two thirds of the COPD patients are non-smokers, whereas in most Western countries 90 per cent of COPD patients are smokers. The reason is that we have a huge contribution (to COPD figures) from biomass fuel, which women use for cooking in the rural communities. That is why we see the push to move to LPG for cooking. Biomass is also used for heating in the winter, which adds to the COPD burden among non-smokers in India. Of late, we realised that Africa, parts of Latin America too have high numbers of nonsmoker COPD patients. Besides COPD, allergic rhinitis in India is quite high, estimated at around 15 per cent, meaning it is several times more common than asthma. India also has a fairly large population of smokers, estimated around 15-18 per cent. What’s worrying is that while smokers in their 40s are giving up smoking, youngsters seem to be picking it up earlier than before. Also, more young women seem to be picking up (smoking) of late. And beedis do

be amplified.

not seem to have lost their appeal. So, we need to track these changes on the smoking front very carefully. Air pollution too adds to the CRD burden. The Lancet has recently carried an article on the impact of air pollution in various cities and India ranks second in terms of PM2.5, following Bangladesh. This data tells us that air pollution is a big looming problem that will add to our lung health incidence. We don’t as yet know what is the exact contribution of pollution to CRD but there is an interesting hypothesis put forward around a decade back, that when air pollution, like diesel exhaust, combines with allergies/allergens like dust mites, cockroach allergies, etc, the lungs amplify the allergic response. So while air pollution may not directly cause asthma, when combined with allergens, the symptoms of asthma may

How will these factors impact treatment? You would see more severe asthma attacks, more difficult patients to deal with, etc. Increasing urbanisation too will add to air pollution levels, with increasing number of vehicles, leading to increased incidence of CRDs. The recent Supreme Court ban on BS III vehicles is a welcome step to reduce vehicular pollution. Another source of air pollution is dust from roads, construction site activities, industrial pollution. So all these factors are unfortunately very conducive to creating more respiratory problems for us. Another hypothesis, called the hygiene hypothesis, is that as countries become more prosperous, and the number of infections and exposure to bacteria starts decreasing, the immune system develops a stronger allergic response. Thus, the highest prevalence of asthma is in New Zealand and Australia. We don’t understand everything right now because the immunology (related to CRD) is quite complex. What are the basic asthma treatment protocols? Asthma treatment protocols are quite clear. It was very well established in the early 90s that inflammation is the real problem to deal with in asthma. And if you can control the inflammation, you can control the symptoms of bronchospasm, coughs,

wheezes, breathlessness attacks, etc. The best drugs for controlling inflammation are corticosteroids. Steroids given by the oral route will always have problems, because they have systemic side effects. But if you give them by the inhaled route, used in the standard therapeutic doses, they have virtually no side effects in most patients. This is supported by data of almost 13-15 years of use of inhaled corticosteroids, even in children aged five to six years. In many patients, you would need to add a long acting bronchodilator. So this combination is the standard treatment of choice. There may be 5 per cent patients who may need more medication. But 8890 per cent patients will do well on this treatment protocol, with no symptoms, no nocturnal attacks and no loss of activities, as long as they follow the doctor’s orders and take their treatment regularly. What are the major challenges when addressing chronic long term respiratory conditions like asthma, COPD? Patient compliance is a huge challenge in treatment of asthma. There is a huge drop of around six months of the year, especially during the summer when it’s so hot that the chances of asthma attacks goes down. Most patients stop treatment, for a variety of reasons. Some feel well, the symptoms disappear so they stop taking their medication.

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Wockhardt intends to acquire global leadership in the field of antibiotics Dr Murtaza Khorakiwala, MD, Wockhardt, shares the challenges faced with regards to AMR and his vision to create a continual stream of novel antibacterial therapies in a conversation with Mansha Gagneja

requires highly specialised skill sets and considerable insights in this therapeutic area, which is developed through longterm commitment. Looking at

DEATHS ATTRIBUTABLE TO AMR EVERY YEAR

What are the challenges faced in formulation of antibiotics and anti-parasitic drugs? As antibiotics have a wide range of uses besides treating infections, including pre and post-surgical propylaxis for a range of surgical procedures, organ transplant, and hip/knee/joint replacement, it is important that the formulations developed are compatible with a wide range of clinical conditions. Development of injectable formulations throws up a significant challenge in managing injection site tolerability. Similarly, oral formulations need to have good GI tolerability and rapid absorption for quick onset of antibacterial action. How much share is allotted to research for AMR in Wockhardt? Wockhardt has been engaged in drug discovery research for the last 20 years and invested significantly during this period. Last year, our spend on R&D itself was approximately 15 per cent of our sales of which our drug discovery portfolio is a critical component.

Source: The Review on Antimicrobial Résistance, Jim O'Neill, 2016

Wockhardt has recently received an approval for phase III clinical trial from the US FDA, could you brief us about the new superdrug? WCK 5222 is a novel class of

superdrug that introduces the first entirely new class of Gram-negative antibiotic treatment in 35 years. WCK5222 is expected to be a life-saving destination therapy for serious hospital acquired infections (HAIs) such as hospital acquired bacterial pneumonia, ventilator associated pneumonia and blood stream pneumonia and blood stream infections. It would be the first antibiotic moving ahead in Phase III for five gram negative superbugs Enterobacteriaceae, Acinetobacter, ESBLs, Salmonella, Pseudomonas. Wockhardt has five drugs which have entered phase II and phase III clinical trials. What is the progress on these drugs? Our NCEs WCK 771, WCK 2349 and WCK 4873, are against multi-drug resistant gram positive infections, while WCK 4282 and WCK 5222 are against multi-drug resistant gram negative infections. In addition to WCK5222, WCK 771 and WCK 2349 drugs have received QIDP status. Presently, this combination is entering phase III clinical trials in India, post successful completion of its global phase I and India-based phase II trials. It would cater to Indian and emerging markets. Further, WCK 4873 is positioned against multi-drug resistant gram positive superbug and has successfully completed its global phase I trials and would be entering global phase II trials. WCK 4282 is a combination

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such challenges it is no wonder that in the past four to five years several Indian companies that were engaged in this field have also given up discovery efforts.

e Spe

Why is research for new tools to combat drug resistance declining? The research on new antibacterial agents is declining due to its economic unattractiveness. Antibiotics which are prescribed for shorter courses of one or two weeks do not generate sufficient return on investments to recoup the cost of research. Therefore, big pharma companies have vacated the field to focus on more lucrative lifestyle diseases requiring long-term therapies. This is paradoxical since majority of such therapies do not cure the disease but it helps companies

earn good profits. On the other hand, antibiotics which actually cure the disease are priced much lower. In order to preserve the effectiveness of antibiotics used in critical care, they are required to be used judiciously for several years, thereby further curtailing their sales growth. This is unlikely for lifestyle disease products as their sales keep expanding on yearly basis. As a result of Big Pharma exodus from antibiotic discovery, internationally the skill sets required for antibiotic discovery have also sharply declined. On the other hand, scientific challenges involved in discovering novel antibiotics targeted towards multi-drug resistant pathogens have multiplied in view of a superbugs’ ability to deploy multiple resistance mechanisms. Such a scenario demands discovery of new agents that can tackle a broad range of pathogens and resistance mechanisms. This

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May 16-31, 2017

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Why is antimicrobial resistance a global concern? Today, global mortality due to anti-microbial resistance (AMR) is more than seven lakhs, which is slated to increase up to 10 million by 2050. Due to AMR, the additional healthcare cost per year is more than $4 billion globally. Moreover, there has been collateral damage to healthcare settings across the globe, with compromised ability to manage various surgeries, organ transplants, deliveries etc. AMR through various multi-drug resistant superbugs as Enterobacteriaceae, Acinetobacter, ESBLs, Salmonella, Pseudomonas, Staphylococcus and Streptococcus, is leading to loss of lives at a great extent due to the uncontrolled deadly infections. Thus putting the entire healthcare industry under threat.

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THE MAIN FOCUS

ERA OF ELECTROCEUTICALS COMING SOON? Electroceuticals, hailed as the next frontier in medicine, is garnering considerable interest from medical researchers and entrepreneurs on the lookout for the next class of therapies BY LAKSHMIPRIYA NAIR

ince time immemorial, the idea of a miracle cure to rid all the ailments afflicting the human body have held tremendous fascination for scientists, medical researchers, alternative medicine practitioners and even faith healers. Could it be that the panacea the world’s looking for is nothing but electricity? The concept might not have had too many takers a few decades earlier, but today ‘electroceuticals’ a term used to describe miniature devices which can alter electrical signals diffused by nerves throughout the body

S 28 EXPRESS PHARMA

to treat a wide range of illnesses, is being touted as the next great frontier in medicine.

Gaining ground Also known as bioelectric medicine, it is has generated considerable interest globally among medical researchers and entrepreneurs. Leading medical device manufacturers like Medtronics, Boston Scientific Corporation, Cochlear and even pharma majors like GlaxoSmithKline (GSK) are making significant investments for research in this arena. Even organisations like the Defense Advanced

Research Projects Agency (DARPA) and National Institutes of Health (NIH) in the US have shown immense interest in the field of electroceuticals. DARPA, an agency of the US Department of Defense in charge of the development of emerging technologies for military use, has initiated a $79 million project called Electrical Prescriptions (ElectRx), in this field. NIH's Stimulating Peripheral Activity to Relieve Conditions (SPARC) programme is another initiative that seeks to expand our current knowledge of nerve-organ interactions and propel progress in the field of

neuromodulation. In October 2016, NIH also announced $20 million in funding for the field. The endeavour’s goal is to understand more about the body’s electrical circuit – the peripheral nervous system.

Catalysts of change A MarketsandMarkets report predicts that the global electroceuticals/ bioelectric medicine market will reach $25.20 billion by 2021 from $17.20 billion in 2016, growing at a CAGR of 7.9 per cent from 2016 to 2021. The reports also reveal that North

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March 1-15, 2017

NEW TECHNOLOGIES

his article analysed electroceuticals, a new branch of medicine, which is generating considerable interest globally among medical researchers and entrepreneurs like GSK. It explored the potential of electroceuticals to treat a wide range of illnesses by altering electrical signals diffused by nerves throughout the body. The article also covered the research done on this field and reflected whether it could replace pharmaceuticals completely some day? The story is an example of how Express Pharma captures the pulse of the lifesciences industry. It is always on the look out for technological and therapeutic innovations and disruptions to serve the sector and keep it abreast of the latest and future trends in the industry.

March 1-15, 2017

EXPRESS PHARMA (APRIL 1-15, 2017)

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DISEASE MANAGEMENT STRATEGIES THE MAIN FOCUS

he story covered the Union Health Ministry’s efforts to eliminate and control congenital rubella syndrome (CRS) by 2020. It particularly focussed on a concerted, nation-wide measles-rubella vaccination (MR-VAC) campaign for children aged between nine months and 15 years. It also highlighted that the government needed to quash fears about safety of the rubella vaccine and establish its efficacy to achieve its goal of eliminating the disease by 2020. The objective of the article was to review a public health campaign and its effectiveness in dealing with a disease which afflicts many children in the country.

ROOTING OUT RUBELLA: MAKING IT MISSION POSSIBLE The government needs to quash fears about safety of the rubella vaccine and establish its efficacy to achieve its goal of eliminating the disease by 2020 BY PRATHIBA RAJU

22 EXPRESS PHARMA April 1-15, 2017

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April 1-15, 2017

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his page features three more interviews which cover various other aspects of the industry. The first interview with Dr GN Singh and Dr V Kalaiselvan, reflected on the progress of PvPI in India and its activities to strengthen pharmacovigilance in the country. The second interview with Merck, covered the company’s plans for India in the next 18 months and its intent to reach out customers directly through their consumer healthcare and bio-pharma segments. The interview with Dr B Suresh from PCI reflected the state of pharmacy education in the country and the steps initiated by PCI to bridge the industry-academia gap. (

THE MAIN FOCUS

I N T E R V I E W

Long-term goal of PvPI is to develop e-reporting and reporting culture among HCPs Dr GN Singh, DCG(I) and Secretarycum-Scientific Director, IPC and Dr V Kalaiselvan, Principal Scientific Officer, IPC, in an interview with Swati Rana speak on PvPI’s progress, various skill development programmes and steps taken to spread awareness in rural areas on ADR reporting

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Pharmacovigilance Programme of India (PvPI) was initiated in July 2010 with an aim to monitor and report ADR across the country. Brief us on the current status of PvPI and PvPI's short term as well long goals? A robust and stable system of PvPI has been established under the aegis of Indian Pharmacopoeia Commission (IPC) to monitor, report, collate and analyse adverse drug reactions. In order to ensure a stable PvPI system, the guidance and support from MoH&FW, commitment and support from DCG(I) and CDSCO officials is

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July 16-31, 2017

Express Pharma (July 16-31, 2017)

cover ) overwhelming. Hence, the current pharmacovigilance system in India has reached an advanced stage. Our short-term goals are to develop and implement pharmacovigilance system in India, recognising MCIapproved medical colleges as ADRs monitoring centres and encourage healthcare professionals (HCPs) in reporting adverse events associated wit the use of pharma products. Long-term goals are to expand the PvPI to all hospitals and centres of public health programmes located across the country, to develop electronic reporting system and develop reporting culture among the HCPs. It's being seven years since PvPI was launched in India. How was the journey so far and what were the challenges? Yes. PvPI is seven-year-old and has become a flagship programme in the country. When we took charge as NCC, we realised that there is a huge need of capacity building at NCC and also AMC. Therefore, efforts were taken to develop infrastructure, appointing manpower etc., both national and regional level - we succeed! Also, there was a great need of training and education needed on pharmacovigilance for those working in PvPI. In addition to this, to impart pharmacovigilance education and training, 10 zonal training centres have been identified, which are functioning under the umbrella of PvPI. PvPI also integrates with various public health programmes to monitor the safety of drugs and vaccines used in their respective programmes. NCC has introduced various tools for ADR reporting by the HCPs and patients such as reporting form in vernacular languages, mobile app and helpline (tool free). The biggest achievement, is the amendment in Schedule Y of

At present there are around 250 Adverse drug Monitoring Centre (AMC) across the country. Explain the functioning of AMC and tell us about the number of upcoming AMCs in 20172018. The AMCs are responsible in monitoring and reporting ADRs. They are routinely engaged in motivating HCPs to monitor adverse events. AMCs are the backbone of PvPI in providing clinicaloriented and India-specific ADRs so that the meaningful information shall be used for protecting the safety of the population. In the upcoming year 2017-18, NCC plans to recognise 50 more hospitals as AMCs.

PvPI data is effectively utilised by the CDSCO for taking regulatory decisions Dr GN Singh DCG(I) and Secretary-cum-ScientificDirector, IPC

D&C Rules 1945 for establishment of pharmacovigilance system at marketing authorisation holders.This provides a huge opportunity to the industry to participate in PvPI. Since quality management system has been put in place to manage the PvPI activities, the completeness score of the date generated from Indian patients is ahead of other countries. SMS facility (drug alert) is being well received among the HCPs. Interestingly, the PvPI data is effectively utilised by the CDSCO for taking appropriate regulatory decisions.

monitor the safety of medicines used in private sectors. Any further collaboration or MoU that will be signed globally? IPC, NCC-PvPI is going to be declared as WHO collaborative centre for pharmacovigilance in national health programmes and regulatory capacity-building for pharmacovigilance in public health programmes and regulatory services in the WHO South-East Asia Region.

What are the plans to expand pharmacovigilance programme to govt as well as private hospitals? At present, how many hospitals report on ADR? IPC, NCC-PvPI is planning to enrol all government and private hospitals to participate in PvPI. A circular from MoH&FW has been sent to states and UTs to adopt pharmacovigilance in the practice of HCPs. In January 2017, IPC signed an MoU with National Accreditation Board for Hospitals (NABH). Tell us more on this initiative. What are the numbers of ADR reported from NABH hospitals till date? After having an MoU with NABH, series of training programme for the NABH hospitals in reporting ADRs is conducted across the country. In order to promote ease of doing pharmacovigilance by the hospitals, reporting of ADRs to PvPI will only be accountable during the NABH accreditation or renewal (no need of duplicate reporting). Now NABH accredited hospitals begin reporting to their nearby or preferred AMCs. This arrangement will boost to

IPC, NCC-PvPI plans to recognise 50 more hospitals as AMCs Dr V Kalaiselvan Principal Scientific Officer, IPC

How PvPI is planning to expand its scope of activities to widen its reach to other healthcare professionals? The current system of PvPI, engages with HCPs such as

doctors and clinical pharmacists. Since nurses and community pharmacists are important stakeholders of pharmacovigilance, steps are being taken to motivate/empower them in reporting ADRs. What kind of training and skill development programmes are organised under PvPI? As we mentioned, NCC and AMCs are jointly conducting CMEs (pharmacovigilance) programme, orientation/induction-cum training programme etc. for better pharmacovigilance and harmonised pharmacovigilance practices. In addition to this, to provide an opportunity to the HCPs and students across the country, a nationwide 10-day skill development programme is conducted by the IPC. So far, four skill development programmes have been successfully conducted where 220 participants were benefited. What steps have been taken to spread awareness on ADR reporting in rural areas? AMCs in association with NCC are taking keen interest to promote PvPI in rural areas. To make public aware about the benefits of PvPI, the concept and importance of ADRs reporting is covered in regional newspapers and also transmitted through radio. IPC is working with Doordarshan to spread the message of pharmacovigilance, which will go a long way to educate the public particularly in rural areas. Road ahead for PvPI a.Expansion of PvPI outreach to district and below level hospitals b.Self sustainability of the programme c.IPC to become a centre of excellence in pharmacovigilance swati.rana@expressindia.com

26 EXPRESS PHARMA July 16-31, 2017

Express Pharma (July 16-31, 2017)

cover ) I N T E R V I E W

‘A contemporary and relevant pharmacy curriculum is the need’ Dr B Suresh, President, Pharmacy Council of India, speaks on various issues related to pharma education in India and elaborates on the initiative taken by Pharmacy Council of India (PCI) to bridge the gap between industry and academia, in an interview with Swati Rana

Brief us on the current scenario of pharma education in India. The pharmacy education in India is presently in a very challenging phase. Due to an increase in the growth of the pharma industry, there is a growing need for qualified and highly knowledgeable human resource. As a result, there is now a sudden spurt of interest from the students to pursue pharmacy programme in India. Further, job opportunities for engineeringbased programmes are on the downslide, making it less attractive for students to pursue engineering as a first choice of career option. The sudden influx of interest and consequent increase of demand has resulted in the rush to start new pharmacy colleges in India in an already overcrowded space. This sudden growth has precipitated issues relating to the quality of education being delivered at these institutions. The Pharmacy Council of India (PCI) has addressed this challenge of quality in pharmacy education through a strategy involving three domains of action: quality assurance, academic and institutional capacity building and more emphasis on experiential education and competency building. What are the issues faced by PCI? PCI faces a major challenge with regards to dual regulation

attempt by PCI to bring complete pharma education under its roof. What is the status? I would like to reiterate that dual regulation is greatly impacting the pharmacy education system. Efforts to overcome this by the PCI are ongoing and has to be considered by the government as changes require amendment to various acts.

PCI has made it mandatory that pharma teachers need to undergo continuing education programmes and quality improvement programmes and get themselves updated both with the pedagogy of teaching as well as the advances that has happened in the relevant fields of pharmacy education, i.e. by the PCI and All India Council for Technical Education (AICTE). This dual regulation has led to institutions exploiting structural and procedural mechanisms of regulation to their advantage, resulting in a number of litigations. Though the PCI and AICTE have worked out

strategies to harmonise their regulations it still does precipitate regulatory challenges that result in not being able to bring about quality advancement. Besides this, the major challenge for pharmacy education in the country relates to the availability of qualified and competent pharmacy teachers

that can carry forward the vision of PCI in preparing a pharmacist workforce that is competent, current and relevant. Pharma education is regulated by two bodies, PCI and AICTE in India. How is it impacting the education system? There was also an

The gap between academia and industry is a major concern. How is PCI bridging the gap? There has been a steady change in the pharma sector approach to drug discovery and development. A contemporary and relevant pharmacy curriculum is the need to address this gap. Emerging and growing scientific areas in pharma sciences such as modelling and simulation training, clinical and translational science as well as nano technology should become available for both basic and advanced training. The faculty should be developed and supported to lead and contribute to fields such as cell and system biology, genomics, proteomics and nano technology. PCI has brought out five regulations and a national curriculum to usher a paradigm shift in pharma education, training and research. This will not only provide much needed direction, growth and leadership for the cusrriculum

30 EXPRESS PHARMA

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eviews, predictions and feedback on the policies of the government and laws of the regulatory bodies are frequently covered in Express Pharma.Then how could it have not covered the government’s intent to push genericisation? A fiery debate on ‘Genericisation: Panacea or Pandora’s Box?’ensued at the third edition of Vantage Point, Express Pharma‘s platform to discuss and deliberate on Indian pharma sector’s most pressing and controversial topics, covered this issue in detail with the industry experts. An eminent panel deliberated on the implications and possibilities of the Centre’s push towards genericisation of pharma brands, in a very interesting and insightful session.

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Genericisation evokes fierce debate at third edition of Vantage Point Panelists divided on the impact of the push for generics, many laud the intent but remain sceptical of consequences

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Lakshmipriya Nair & Mansha Gagneja Mumbai A FIERY debate on ‘Genericisation: Panacea or Pandora’s Box?’ ensued at the third edition of Vantage Point, Express Pharma‘s platform to discuss and deliberate on Indian pharma sector’s most pressing and controversial topics. Partnered by Wellness Forever, the event was held at Sofitel in Mumbai. An eminent panel deliberated on the implications and possibilities of the Centre’s push towards genericisation of pharma brands, in a very interesting and insightful session, moderated by Dr Milind Antani, Head, Pharma and Life Sciences, Nishith Desai Associates. The panel comprised Dr Amar Jesani, Editor, IJME; Dr Jayesh Lele, National Secretary – IMA Board of India; Milind Mangle, Internationally Certified Coach and Consultant, Angle Consultancy & Services; Vaijanath Eknath Jagushte, Treasurer, Chairman of Legal Affairs Committee —AIOCD & MSCDA and Treasurer of MSCDA; Priti Mohile, Managing Director, MediaMedic Communications; Dr KS Sharma, PG Committee Member, Medical Council of India MCI and Director Academic Tata

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Drew out the panelists to share their views candidly and discuss the ramifications of a mandate to prescribe only generic names of drugs Dr Milind Antani Head, Pharma and Life Sciences, Nishith Desai Associates

He said that if there was political will and collaboration between stakeholders, then genericisation could indeed be a panacea and create significant positive impact for patients

Dr Jayesh Lele National Secretary – IMA Board of India

Dr Amar Jesani Editor, IJME

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He opined that quality can be a concern in such a scenario as the industry and medical fraternity is illequipped to deal with genericisation

He stated that though the intention was to introduce a panacea to many problems faced by healthcare industry today, inadvertently opened a Pandora’s Box

She threw light on how marketing and PR would change in times of genericisation and its effect on patients Priti Mohile Managing Director, MediaMedic Communications

Milind Mangle Internationally Certified Coach and Consultant, Angle Consultancy & Services

EXPRESS PHARMA

June 1-15, 2017

EXPRESS PHARMA (JUNE 16 - 30, 2017) ENCOURAGING AYUSH

cover )

(

{

SANJEEVANI FOR

AYUSH

AYUSH could be the answer to India's unmet medical needs but only if it is backed by scientific validation and credible evidence BY LAKSHMIPRIYA NAIR

his Sanskrit prayer is also a goal that India has been striving to ensure for its citizens and enabling universal healthcare access (UHC) is a pivotal step towards achieving this noble objective. Yet, it remains a distant dream due to unequal health access, threat of existing and emerging diseases, lack of trained medical professionals and rising costs of healthcare. The patient-centric approach of India’s alternative and traditional systems of medicines that comprise Ayurveda, Yoga & Naturopathy, Unani, Siddha & Sowa-Rigpa and Homoeopathy (AYUSH), has led the government to look at them as a panacea to India’s public health challenges. Spurred by the belief in the potential of AYUSH to alleviate the crises within Indian healthcare, the government has been trying to promote and popularise alternative systems of medicine with an aim to integrate it with modern systems of medicine. However, despite myriad actions to promote and popularise AYUSH, it hasn’t taken off the way it was expected to. A health survey conducted by National Sample Survey Office (NSSO) in 2015 revealed that ‘inclination towards allopathic treatment was prevalent (around 90 per cent in both the sectors). Only five to seven percent usage of ‘other’ including AYUSH was reported both in rural and urban area.’

Clarion call for evidence

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June 16-30, 2017

64 EXPRESS PHARMA December 1-15, 2017

}

May all become happy, may all be healthy (free from illness), may all see what is auspicious, may no one suffer in any way.

So,

Om Sarve Bhavantu Sukhinah Sarve Santu Nir-Aamayaah | Sarve Bhadraanni Pashyantu Maa Kashcid-Duhkha-Bhaag-Bhavet |

THE MAIN FOCUS

what’s

hindering

the

growth of AYUSH and preventing its widespread acceptance? In answer to this question, experts and industry veterans cite various reasons on all fronts: education, research, clinical practice, industry, and regulation. But, all of these are interconnected and seems to be linked to one mammoth hurdle: lack of scientific validation and evidence. This has often led to the rampant misuse of herbal and traditional medicines and thereby the negative outcomes are often reported. Though traditional medicines have been in use for a long time, there has been limited quality control and negligible documented evidence of their safety and effectiveness. This, in turn, has negatively impacted the development of regulations and legislation in this arena. Hence, building trust in the traditional medicine systems through validated data and irrefutable evidence has emerged as an urgent need to leverage the true potential of these systems.

Are clinical trials the answer? Fortunately, paying heed to the increasing clamour for evidence-based AYUSH, regulators and the government have been mulling over measures, systems, policies and processes to ensure better documentation and validate the drugs and practices of these alternative systems of medicine. Clinical trials for AYUSH drugs is one of them. In 2016, Indian Council of Medical Research (ICMR) released guidelines for conducting testing medicines from AYUSH to provide more clarity on testing ayurvedic formulations and other traditional medicines. While there is unanimous accord on the good intent of the government, the industry is divided on its impact. Many believe that it would undoubtedly lead to better safety and efficacy of AYUSH drugs, but there are many dissenting voices who argue that such a step, if implemented with proper thought and planning, would not only curb the growth of the industry but also do it

unforetold harm. Dr Ali Mehdi, Fellow & Project Leader, Health Policy Initiative from Indian Council for Research on International Economic Relations (ICRIER), a leading policy research institution supports the intent to mandate clinical trials for AYUSH drugs and states, “The AYUSH industry cannot sustainably thrive on faith! It has to be based on sound scientific and management principles.” Opining that clinical trials are in the best interests of the AYUSH industry, he believes that it would empower the practitioners to feel more confident - and probably incentivised - to prescribe AYUSH medicines once they are convinced of their scientific value. He says, “Right now, they are unable to take ownership and leave it to the patients to take them at their own risk.” However, he believes that the move will meet with resistance from at least some segments of the AYUSH industry and recommends the government to engage with the industry and clearly explain the

Paying heed to the increasing clamour for evidence-based AYUSH, regulators and the government have been mulling over measures, systems, policies and processes to ensure better document and validate the drugs and practices of these alternative systems of medicine. Clinical trials for AYUSH drugs is one of them

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merits of the move. VK Dhawan, CEO, Planet Herb Lifesciences also speaks in support of clinical trials. He says, “It will certainly help to build trust and authenticity amongst doctors and patients for herbal medicines. Today, many doctors, mainly practicing in Western medicines doubts and do not trust on herbal medicines due to lack of clinical studies done on these products. Once thorough studies are carried out it will help to support clinical claims about the brand/products. It will certainly encourage those organisations that are sincerely involved in research-based manufacturing activities and ready to spend good amount on R&D activities to develop quality product.” He further states, “It will help in manufacturing quality medicines and to make clinical claims for these products. Only those manufacturers/brand owners will stay in the field who really have good research based formulations available. Quality and efficacy of herbal medicines will go high and reliability of herbal medicines over allopathic medicines will improve a lot. Additionally, companies who really want to stay in the market shall be forced to set up their own R&D set up to deliver research based products. Copying of branded formulation will stop.” However, he is also aware of the challenges that need to be tackled. He outlines, “Clinical trials are quite expensive, they require huge investment. Only those companies who are really sincere about conducting

EXPRESS PHARMA

June 16-30, 2017

he patient-centric approach of India’s traditional systems of medicines has led the government to look at AYUSH as a panacea to India’s public health challenges.This story covered the several measures have been initiated by the government to drive access to affordable, reliable and easily accessible medical facilities to the masses through AYUSH. It also reflected on the ways and means to promote and popularise alternative systems of medicine. It also covers examining the several factors hindering the growth of AYUSH and preventing its widespread acceptance, the story reveals how building trust in the traditional medicine systems through validated data and irrefutable evidence has emerged as an urgent need to leverage the true potential of these systems.

CPhI & P-MEC INDIA 2017 SPECIAL

EXCLUSIVE ARTICLES FROM INDUSTRY EXPERTS

n this retrospective issue, we bring to you some of the articles shared by domain experts on various pertinent issues of the industry.Three experts from Khaitan and Co share their views on the FDC ban in the first article of this page. The second one is from a representative of MSF Access Campaign who strongly supports India’s strategy of providing affordable generics to the world. The third one reflected on the need for a stringent regulatory authority to procure anti-TB medicines. cover ) INSIGHT

Fixed dose combination drugs – to be banned or not to be banned Ajay Bhargava, Vanita Bhargava and Aseem Chaturvedi explain how the FDC ban notification has adversely affected the pharma industry

ith the advancement of science and technology, the pharmaceutical Industry has also grown and evolved. Various ailments, which could not be treated before, are easily diagnosed and medication is available for its treatment. There are boons and banes to every field and science certainly is no exception . Earlier, the only medication that was given as a cure for fever, cold, cough etc. was paracetamol. Paracetamol, till date, is considered a safe option for treating fever and flu. However, with the advancement of science, various other medicines were developed for combating cold, flu, fever etc. The pharma companies developed combination drugs also known as Fixed Dose Combination Drugs (FDC). FDCs are combinations of two or more active pharma ingredients in fixed ratios, given in the form of a single dose. For example, a patient suffering from fever, cold, cough etc. would ideally have to take 3 medicines i.e. for fever, the patient is usually administered 500 mg of paracetamol and for cold and cough the patient is usually administered 10 mg of Phenylephrine Hydrochloride. However, Phenylephrine Hydrochloride is known to cause drowsiness. In order to get rid of the side-effect of drowsiness, caffeine is added which is known to keep people awake. Thus, when the companies added 500 mg of paracetamol + 10 mg of phenylephrine hydrochloride + 32 mg of anhy-

The petitions were heard by Justice Rajiv Sahai Endlaw, over a period of nearly three months, with several days of back to back hearings.

Ajay Bhargava, Partner, Khaitan & Co

Vanita Bhargava, Partner, Khaitan & Co.

Aseem Chaturvedi, Principal Associate , Khaitan & Co.

drous caffeine, they formulated an FDC to treat common cold, cough, throat pain and fever, which in the common market is known and available as D-Cold Total. Similar combinations are available in the market under different trade names such as Ascoril-D, Wickoryl etc. manufactured by different companies. Some other popular examples of FDCs are Pfizer’s Corex, Piramal Healthcare’s Saridon, Merck India’s Nasivion, Glenmark’s Ascoril and Candibiotic, Lupin’s Gluconorm etc. The Government of India, however, sought to ban this mushroom growth of FDCs. Exercising its powers under Section 26A of the Drugs & Cosmetics Act, 1940 (the Act), the Central Government, through its Department of Health & Family Welfare; issued a notification dated 10 March 2016, whereby 344 Fixed Dose Combination (FDC) Drugs were banned

with immediate effect. The notification purported to ban the FDCs for the reason that they involved risk to human beings and that safer alternatives to the same were available. Further, the notification was also purported to be based on the findings and recommendations of an Expert Committee appointed by the Central Government, which stated that the FDCs in question were found to have no ‘therapeutic justification’. Lastly, the notification was, of course, touted as an exercise in ‘public interest’. Hundreds of pharma companies were in for a shock when this notification was published. Needless to say, the said notification adversely affected almost the entire pharma industry of the country; and had the notification gone unchallenged – it would have amounted to a loss of revenue of approximately `3,000 Crores, annually.

The pharma industry immediately proceeded to challenge the notification on various grounds. Although, several writ petitions were filed before various High Courts of the country – the Delhi High Court, having passed the first interim order dated 14 March 2016 concerning the notification in WP (C) No. 2212 of 2016, directing that no coercive action will be taken by the government in furtherance of the notification, till further orders – became the hot-bed of the present litigation. Soon, various other companies followed and flooded the court room with petitions challenging the ban; and a total of 455 writ petitions were filed before the Delhi High Court. To maintain decorum in such a circumstance the High Court, in an unprecedented measure, directed that only 1 lawyer per matter be allowed to enter the court room.

The companies challenged the ban on, inter-alia, the following grounds: ◗ Violation of Article 14 of the Constitution of India, in as much as the notification was issued in an arbitrary manner; in violation of the principles of natural justice; was unreasonable, harsh and unscientific. ◗ Violation of Article 19(1)g, in as much as the notification was an unreasonable restriction upon the business and trade of the petitioners. ◗ Violation of the procedure prescribed under the Act, for exercise of powers under Section 26A, in as much as the Notification was issued without the mandatory consultation with the Drugs Technical Advisory Board (DTAB) and the Drugs Consultative Committee (DCC), as constituted by virtue of sections 5 and 7 of the Act, respectively. ◗ The primary ground of challenge in most of the petitions was that there was a violation of the principles of natural justice, more particularly the principle of audi alteram partem – in as much as no Show-Cause Notice was issued to the petitioners, enabling them to empirically justify their production/ sale of the banned FDCs. It may be noted that a Show-Cause Notice was, in fact, duly issued to some of the petitioners; and the said petitioners, nonetheless, went

34 EXPRESS PHARMA January 1-15, 2017

Express Pharma (January 1-15, 2017)

MANAGEMENT INSIGHT

Don’t shut down the pharmacy of the developing world Shailly Gupta, Deputy Head, MSFAccess Campaign (India) emphaises the need to ensure availability of affordable medicines within public health programmes, which is the need of the hour

ne of the fastest-growing economies in the world, our country is known globally as the homeland of the famed Taj Mahal and for its strong cultural heritage. However, and more significantly, India has had a farreaching positive global impact through its supply of vast quantities of low-cost, good-quality generic medicines, which have saved or prolonged the lives of millions of people. Amongst a handful of developing countries with a huge production capacity to manufacture quality-assured generic medicines, India did not grant patents on medicines till 2005 and thus, its generic companies produce some of the cheapest life-saving drugs in the world. Known as the ‘pharmacy of the developing world’, the country played a major role in scaling up treatment to 17 million people across the world by lowering the price of antiretrovirals (HIV medicines) from $10,000 per patient per year in 2001 to less than $300. As a medical treatment provider, Doctors Without Borders/Médecins Sans Frontières (MSF) relies on affordable, quality generic medicines to treat a number of diseases. In fact, 97 per cent of the medicines used by MSF to treat HIV are generics sourced from India. When the country amended its patent law to comply with international trade rules in 2005 and started granting patents for pharmaceuticals, Indian parliamentarians ensured the inclusion of public health safeguards by granting patent monopoly rights only to genuine inventions. India’s patent law strives to strike an

even handed balance between providing patent protection on innovative medicines and the necessity to protect public health needs. India’s public health safeguards have guaranteed fewer patents in India, more generic competition and thus, more affordable medicines for people and governments in developing countries. In contrast, countries like the US have patent laws that blindly favour pharma companies over generic competition,

Source: MSF Access Campaign (India)

allowing multiple and extended monopolies on the same medicine, which, in turn, lead to exorbitant prices for lengthy periods of time. Multinational pharma corporations view robust, affordable generic medicines produced and marketed by Indian suppliers as an enormous threat to their profits. Pressured by these corporations, foreign governments have utilised various platforms—including diplomatic talks, bilateral and regional trade deals— to coerce the Indian government to amend its patent policies to offer more

patent protections and restrict generic competition. One such trade deal is the Regional Comprehensive Economic Partnership (RCEP). Big Pharma is attempting to restrict access to low-cost, lifesaving medicines and jeopardise public- health via the RCEP negotiations that were initiated in 2012 between 10 ASEAN countries and six trading partners – India, China, Australia, New Zealand, Japan and South Korea. Like several other free trade agreements, the RCEP, too, is being negotiated behind closed doors with no inputs from pub-

lic health stakeholders. An online leaked draft text of this trade deal reveals that Japan and South Korea have proposed several provisions that go far beyond the World Trade Organisation (WTO) requirements and seek to extend patent monopolies of pharma corporations. This includes provision for extending patent terms for an additional five years beyond the present 20year limit. Another proposed harmful provision is introduction of data exclusivity to defer the registration or marketing approval of generic versions of medicines by several years which will effectively provide a backdoor monopoly status to pharma corporations – even for older medicines that do not deserve a patent. If accepted, both provisions will delay the entry of affordable versions of medicines in the market and eventually, in the absence of generic competition, keep prices high for longer periods of time. In India, where people pay nearly 70 per cent of health expenses out of pocket and rarely have health insurance, high prices of lifesaving medicines will keep them out of reach of the most vulnerable sections of society. With emerging public health challenges and the increasing burden of tuberculosis, hepatitis, and cancer in our country, the need to ensure the availability of affordable medicines within the public health programme is certainly the need of the hour. In the current economic landscape, the RCEP trade deal has been lauded as it will bring in huge investments, infrastructure and jobs to India.

However, what is largely being ignored is that corporations are utilising such trade deals to disguise their attack on public welfare sectors such as healthcare and access to essential medicines. This attempt to surreptitiously convert public healthcare into a commercial enterprise will allow medicine to be treated as any other profitable commodity, subject to monopolies and elevated product pricing. Consequentially, India’s revolutionary low-cost generic industry that stems from its public health-oriented patent policies will be shut down to make space for profit-focussed multinational corporations. Elevated levels of intellectual property rules in RCEP can dismantle the public health system of many developing countries and restrict governments’ capacities to protect public health in not only India but in other developing and least-developed nations of Asia and Africa. So far, India has stood firm against the inclusion of these harmful patent provisions. With the next round of RCEP negotiations set to take place in Japan in March, MSF, as a treatment provider that relies on affordable medicines sourced from India, hopes that India, along with other ASEAN countries, does not agree to a final text unless all provisions that go beyond international trade rules are removed. In its place, the trade deal negotiating text should ensure the protection of existing public health safeguards and enable developing countries like India to effectively balance its patent system with public health needs.

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MANAGEMENT INSIGHT

Strict or stringent national regulatory authority for procurement of anti-tuberculosis medicines ? John F Loeber,Chief Procurement Officer,UN Stabilisation Mission in Haiti (MINUSTAH) Port-au-Prince,Haiti,in this article examines the requirement of strict or stringent National Regulatory Authority (NRA) environments for procurement of anti-tuberculosis (TB) medicines,with specific focus on the World Health Organisation,United Nations Office for project services,Stop TB Partnership/Global Drug Facility and The Global Fund to Fight Aids,TB and Malaria

he Global Drug Facility (GDF) operates as the procurement arm of the Stop TB Partnership (TBP) Secretariat, hosted at the World Health Organisation (WHO), Geneva, Switzerland, from 2001 until 2014 and forthwith at the United Nations Office for Project Services (UNOPS). The Stop TB Partnership is a network of some 1,300 governments, donors, industry, NGOs, academia and other partners, joined in the common fight against tuberculosis (TB)2. The TBP i.a. provides access for countries to quality assured, affordable anti-TB medicines via GDF. As of 2014 GDF has delivered medicines for 24 mn TB patients to 133 countries3 in 13 years of operation, financed by bilateral and multilateral donors such as USAID, The Global Fund to Fight Aids, TB and Malaria (GFATM) and UNITAID. GDF’s annual purchases of TB medicines amounted to about $200 mn in 20134, and the GFATM disbursed approximately $500 mn for TB in 20155.

Stringent NRA requirement A condition for procurement of anti-TB medicines by the GDF or its facilitation of direct procurement is that medicines are approved under the WHO Prequalification Programme6 or licensed for marketing by stringent National Regulatory Authorities (NRAs). This is established in the GDF Quality

TABLE 1 ANTI-TB MEDICINES SOURCING ACCORDING TO GDF AND GFATM QA POLICIES Anti-TB Medicines Sourcing

WHO PQ Programme

Assurance Policy7. The same standard is applied by the GFATM8 as well as other financing institutions and procurement entities such as UNITAID9 and UNDP10. On further examination, GDF and the GFATM define the term “stringent” as being a member, observer or associate of the International Council for Harmonisation (ICH)11. The ICH, founded in 1990, is an association which helps in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration12. Current ICH regulatory members or associates are Brazil, Canada, the EU, Japan, South Korea, Switzerland and the US13. In regard to ICH members having newly acceded to the EU such as Cyprus, Lithuania, Malta, Poland and Latvia, the GDF Quality Assurance Policy principles additionally provide that “GDF will consult with relevant WHO experts on the progress

Stringent NRA

ERP Process

Member, Observer or Associate of the International Council for Harmonisation (ICH) in adjusting their pharma legislation to EU laws before recognising the approval by the national health authorities”14. From 2015, a range of Regulatory Authorities joined the ICH as observers, namely Australia, Chinese Taipei, Cuba, India, Kazakhstan, Mexico, Russia, Singapore and South Africa 15. Both GDF’s and the GFATM’s Quality Assurance Policies, which antedate 2015, limit recognition to “an ICH Observer, being the European Free Trade Association (EFTA) as represented by Swiss Medic, Health Canada and World Health Organisation (WHO) (as may be updated from time to time)”16. Despite the closing adjustment clause, given the significant development in ICH Observers and the generally restrictive nature of both organisations’ policies, including the specific formulation of this provision, referring mainly to associations and only

to one individual authority, moreover now an ICH “Standing regulatory member”17, it cannot be deduced that the nine new ICH observers are currently recognised as representing stringent regulatory environments. The conclusion must also be drawn in view of issuance of tenders for firstand second-line anti-TB medicines in October and February 2016 with reference to the unchanged GDF Quality Assurance Policy18. Hence apparent lack of sourcing from those countries on the basis of ICH observer status, as well as the absence of media releases to the contrary or other forms of clarification by the two organisations since 2015 on these significant developments at ICH. As a further qualifying option, according to the GDF Policy it will be sufficient that products are “approved or subject to a positive opinion under the Canada S.C. 2004, c. 23 (Bill

C-9) procedure, or Art. 58 of European Union Regulation (EC9 No. 726/2004) or US FDA tentative approval”19, i.e. interim approvals have been given by this set of countries/intergovernmental organisation. A next to identical regulation is found in the GFATM’s Quality Assurance Policy20. In the event that none of the above requirements are met, GDF’s Quality Assurance policy then allows that “Products shall be found acceptable to the GDF through a quality risk/benefit assessment process involving an Expert Review Panel (ERP)”21. While this specific, exceptional process was managed by the GDF itself until 2009/2010, the ERP assessment was forthwith handled by the GFATM, in cooperation with GDF. The GFATM respectively refers to this process on its website and linked material22. Under this backup process, for which approvals are limited to a 12month period23, product submissions must be pending with either the WHO Prequalification Programme or a stringent NRA. Also, the product must have been produced at a manufacturing site that was inspected and found acceptable by either the WHO Prequalification Programme, a stringent NRA or a regulatory authority participating in the Pharmaceutical Inspection Cooperation Scheme (PIC/S)24. PIC/S was established in 1995 as an extension to the

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EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

EXPRESS PHARMA (JULY 1-15, 2017)

cover )

(

FORMULATION DEVELOPMENT THE MAIN FOCUS

FDD Conclave 2017

A congregation of R&D leaders In an endeavour to encourage research and innovation in the rapidly evolving field of formulation development and drug delivery, Express Pharma and The Indian Express Group hosted the inaugural edition of FDD Conclave at Novotel Airport, Hyderabad. Held on 16-17 June, 2017, it saw attendance from over 100 leading scientists and R&D heads representing prominent pharma organisation and top biotech companies

28 EXPRESS PHARMA

EXPRESS PHARMA

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July 1-15, 2017

xperts predict an increase in formulation R&D spend, as players try to differentiate themselves by investing heavily in R&D efforts and the development of new drugs. Companies are looking at tapping new patient segments, creating branding strategies around innovative drug delivery approaches and meeting evolving regulations.They have realised the need for executable strategies and leading-edge technologies. Therefore, in an endeavour to encourage research and innovation in the rapidly evolving field of formulation development and drug delivery, Express Pharma hosted the inaugural edition of FDD Conclave in Hyderabad. It saw attendance from over 100 leading scientists and R&D heads of pharma companies.This issue featured exclusive coverage of the event.

July 1-15, 2017

EXPRESS PHARMA (JULY 16-31, 2017) PROGRESS OF PVPI

cover )

n 2010, Dr Surinder Singh, Former DCG(I), launched the Pharmacovigilance Programme of India (PvPI) with the objective of studying the adverse effects of drugs, to strengthen the number of drug inspectors and to maintain quality parameters in countries from where India imported drugs. In observance of Pharmacovigilance Day, let’s examine the progress of the PvPI programme so far.

Improved ADR reporting Commenting on the progress so far, Dr Renuka Munshi, Coordinator, AMC, TN Medical College & BYL Nair Hospital says, “In the last seven years, the programme has been progressing in leaps and bounds. Recently, PvPI has also taken the responsibility of reporting adverse events due to medical devices and has initiated the process of reporting adverse events due to drugs used for vector-borne diseases like Kala-azar. We have more than 250 ADR monitoring centres, which have been involved in the activity. Programmes like Revised National Tuberculosis Control Program (RNTCP) and ART and their respective centres have been roped in to report ADRs.”

(

THE MAIN FOCUS

NEED FOR CONSTANT VIGILANCE An analysis on the progress of India’s pharmacovigilance programme By Usha Sharma

Enhanced Data Collection PvPI has contributed numerous data to the WHO-Uppsala Monitoring Centre (UMC) and Central Drugs Standard Control Organization (CDSCO). Quality checks of the submitted ADRs is done by National Coordinating Centre (NCC) and queries sent to respective ADR Monitoring Centre (AMC). There has been a positive impact on the quality of Indian

20 EXPRESS PHARMA July 16-31, 2017

66 EXPRESS PHARMA December 1-15, 2017

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EXPRESS PHARMA

July 16-31, 2017

n observance of Pharmacovigilance Day, the story examined the progress of the PvPI programme so far. It empahsised on the growing role of PvPI in India and pointed out that though PV is well practiced in developed countries, multinational pharma companies operating in India have realised that they too need better understanding in this arena. It also highlighted that both the industry as well as regulatory bodies are working towards instrumenting a system which will work effectively. It reviewed the steps taken to strengthen pharmacovigilance in the country as well. Thus, Express Pharma acts as a watchdog of the industry with such stories.

CPhI & P-MEC INDIA 2017 SPECIAL

ntellectual property and patents are very crucial topics in the pharma industry.The first two articles on this page address this issue, with two renowned IP experts,Ashish Prasad and Dr Gopakumar Nair, sharing their views. Both deal with encouraging innovation and creation of IP.The first deals with evolving an effective IPR policy while the second one gives insights on how effective IP systems can create a conducive environment to attract investments.The third article on this page deals with how the pharma industry can drive innovation beyond core areas to minimise environmental impact.Thus, we do not only cover issues which impact the pharma industry but also looks at how the sector impacts our world. cover ) Abalancing act Ashish Prasad, Partner, Economic Laws Practice Delhi, analyses IPR in India, elaborates on the need to evolve an effective IPR policy to encourage innovation without compromising public interest

Patent system only way to... Continued from Page 19

nnovation is integral to the lives of individuals as it has over the years turned complications into progress, thereby improving standards. It has found a cure to diseases to which no cure was available, made tasks easier, found simpler solutions to problems, improved our knowledge, made our lives healthier, safer and more comfortable by improving availability of crops, drugs, medical procedures, appliances etc. To put it generally, innovation is developing a novel idea or concept to cause an improvement over existing knowledge or product to resolve problems faced by humans. The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) which came into force on January 1, 1995 sets the minimum standards for Intellectual Property Rights protection for all members of the World Trade Organisation (WTO). It provides a framework for granting legal protection to new creations, innovations and technological advancements, thus incentivising innovators to invest in research and development of new products and processes. The National IPR policy of India by promoting amongst others, innovation, licensing, technology transfers, patent pooling, cross sector partnerships, reducing API imports by incentivising manufacture of API in India etc. follows the TRIPS framework and attempts to provide for an enabling structure for new innovations. At the same time, over the years there have been considerable debates amongst econ-

Ashish Prasad, Partner, Economic Laws Practice Delhi

omists and policymakers regarding the development of the Intellectual Property Rights (IPRs) regime in order to balance public interest and the rewards to be accorded to the innovator. The pharma industry illustrates this conflict the best; need for the state to ensure that medicines are available and affordable by all and the interest of the pharma industry in engaging in continuous research and development for the invention of new drugs and medicines. In India, this conflict of interest is manifested in the tussle between innovated drug manufacturers and manufacturers of generic/follow on products. Indian law and policy is designed to encourage generic drug manufacturers to develop and market follow-on drugs so that fruits of innovation are available to the masses at lower costs. It is but natural therefore, that developed countries are calling for stricter implementation of tougher and more restrictive conditions in the

patent laws of the developing economies in the form of TRIPS-Plus provisions to curb the manufacture of generic drugs. One of the most prominent examples is pushing for protection under Article 39.3 on data exclusivity which disallows clinical trial data that is generated by the innovator company to be used by another company for obtaining approvals to market the generic versions of the drug for which the trial had been conducted. Acceding to this provision can considerably delay the market approval as well as availability of generic versions of medicines for many years since this would require generic manufacturers to conduct clinical trials afresh. This would increase the cost of production of generic medicines leading to a higher price burden on the consumers. As the tussle continues, multinational innovator companies have often knocked the doors of the judiciary seeking protection of their IPRs. The judiciary has in turn taken a nuanced stand and walked the fine line between the interest of the innovator and public interest. Recently, the Delhi High Court, while dealing with the first case on bio-similar approvals in India, between Roche and The Drug Controller General of India and well known Indian drug manufacturers (Mylan & Biocon) in its decision disallowed the right to question the approval granted by the DCGI in an appeal before division bench. The interim decision by the single judge had earlier denied the Indian manufacturers to market their product as a bio-similar to the drug innovated by

Roche. With another battle for bevacizumab already in courts, it appears that we are about to see the same pattern that was seen during the rise of the generic manufacturers. This decision has a far reaching impact on the pharma industry of India as the generic drug/biosimilar manufacturers would be encouraged to innovate and develop substitutable products in the interest of public. On March 8, 2017 in the case of Bayer v. Union of India the Delhi High Court held that export of drugs for the purposes of clinical trial was covered under the exemption as provided under Section 107 A of the Patents Act, 1970. The Indian judiciary has by far been able to set a well-reasoned standard, maintain equilibrium of obligations under the TRIPS, Patents Act and the social interest of the country. It is now well known that the innovator pharma companies, in the interest of protecting their legitimate IP rights, adopt various strategies including delaying of the introduction of bio-similar/generic versions though litigation tactics. They have now realised the opportunity vesting with the generic market and have now sought to enter the generics’ market. President Trump’s decisions to withdraw the TPP may have temporarily jolted the existing negotiations undertaken during President Obama’s regime. However, it may not be long before when India will be asked the same question again i.e. to give its consent to incorporate the TRIPS-plus provisions which would then affect the Indian pharma industry, especially the generic segment.

open and closed IP policies by being able to sustain revenues within the total consumption bundle of platforms and complementary goods and services. In his view, the markets reward generosity where ‘to win a platform race, the clever host must leave a substantial portion of total revenues to third parties that provide complementary goods. Conversely, the market punishes the selfish host that keeps too large a portion of market revenues for itself.’ Clearly, calibrating firm’s IP policies depending on the nature of the market to self-maximise is actually an efficient marketbased outcome. How far these conclusions support the pitch for substantial ‘reforms’ in the patent system in an attempt to ‘fix it’ by analogising it with some imaginative ‘regulatory’ mechanism is anybody’s guess! Of course, this is not to suggest that the patent system is perfect. In fact, it has miserably failed to facilitate R&D in neglected diseases that disproportionately affect the developing world. We do need government interventions on a massive scale to support R&D in such cases. Perhaps we shouldn’t stop trying non-market based alternatives to the patent system like prizes, subsidies etc... Again, whether the state-supported R&D will replicate the success of the market in innovation without recourse to patents and market exchange is a difficult question. However, it is important to note that these alternative measures can only be in addition to the patent system and not by undermining it! (Views are personal)

20 EXPRESS PHARMA April 16-30, 2017

Express Pharma (April 16-30, 2017)

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THE MAIN FOCUS

Techniques to enhance IP valuations Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates, gives an insight on why IP systems must support innovations by creating a conducive environment to attract investments, and must reward inventions with IP protection in return for disclosures

allikattu’ controversy can wait, IPR appears to be the new arena for the “bulls and bears.” Intellectual property right (IPR) has come a long way since Paris Convention and other early treaties and conventions. The fundamental ratio, unanimously accepted, has always been a fine balance of rights (to inventors) and obligations (to users and the state). In recent years, post 1980s in particular, there has been intensive efforts and initiatives to exploit IPR to the hilt in favour of inventors (or assignees) often to the detriment of users. Uruguay Round was conceived by the developed nations as an extension of this bull run, to use IPR as a trade barrier to rein in the trade growth potential of the third world countries. The transformation of General Agreement on Tariffs and

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‘J

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Pharmalab’s Pure Steam Generator are designed to deliver high quality, sterile steam, free of condensate, Pyrogens or Endotoxins. These units are suitable to generate highest quality of steam according to the latest international Pharacopeia and rules (FDA, cGMP, etc), and is also validated to meet the most exacting standards of EN285 & HTM 2010 for any pharmaceutical applications such as: • Sterilization of storage tanks & solution tanks • Sterilization of distribution loops • Sterilization of other pharmaceutical equipment or filter assemblies • Heating of autoclaves / sterilizers The unit is equipped with degasifying column for eﬀective elimination of non-condensable gases to meet the exacting standards of USP. Fully automotic with programmable control system.

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April 16-30, 2017

Express Pharma (April 16-30, 2017)

cover ) INSIGHT

Thinking beyond medicines and products Vivek P Adhia, Strategy Head – Climate, WRI India, Tanvi Bongale, Sr Project Associate, Climate, WRI India, Shruti Karkhedkar, Air Quality Intern, WRI India, elaborate on how the pharma industry can drive innovation beyond core areas to minimise environmental impact especially on air quality, and in turn support improved human health

VIVEK P ADHIA, Strategy Head – Climate, WRI India

TANVI BONGALE, Sr Project Associate, Climate, WRI India

SHRUTI KARKHEDKAR, Air Quality Intern, WRI India

ir pollution is increasingly being recognised as a serious human health issue for India, and with exponential growth in industrialisation, cities and infrastructure – this warrants immediate cohesive national action. As a

background, local air pollutants are those substances when emitted in the atmosphere – that continue to exist over and above the natural physical diffusion, chemical elimination and biological purification to have a direct or in-

direct effect on human health. Typically, four major pollutants are said to have maximum impact viz. sulphur dioxide (SOx), nitrogen oxides (NOx) and particulate matter (PM10 and PM2.5). Health related standards providing guidelines on

safe concentration levels of these pollutants have been established based on various public health studies, meant to provide a means to benchmark and ascertain environmental impact on the local air quality front. Consistently across the

last few years, it is found that more than 85 per cent of the global population lives in areas exceeding these safe guidelines – which results in acute public health and livelihood impacts. For emerging economies, low and middle income countries and other groups that include India and China – about 99 per cent of the population lives in vulnerable areas. Further, as per the outdoor air pollution in cities database of World Health Organization (WHO), 10 of the 20 most polluted cities (in terms of PM2.5) are in India, with most regions across the Indo-Gangetic plains topping the list as can be seen from the adjoining chart. Multiple causes, contributing to deteriorating air quality including mobile sources (transport), area sources (waste burning, cook stoves, suspended dust of construction and industrial activity) and stationary sources such as power plants, and diesel generators have resulted in severe and acute health impacts. Air pollution related deaths have in a short time jumped into the topfive causes within the country (as seen in the chart titled, Acting now is inevitable). This also reflects the broader situation globally, with both indoor and

34 EXPRESS PHARMA June 1-15, 2017

Express Pharma (June 1-15, 2017)

EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

EXPRESS PHARMA (AUGUST 1-15, 2017) CELEBRATING 70 YEARS OF INDEPENDENCE

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EVOLUTION OFTHE INDIAN PHARMA INDUSTRY 50 19 s

✦ Dominated by western MNCs. Controlled 80 90% of market, mainly through importation.

70 19 s

60 19 s

✦ Foreign companies held the patent for 99% of all pharma products under patent in India. ✦ Domestic Indian drug prices were among the highest in the world.

✦ Import-dependent until government policies stressed self-reliance through local production. ✦ Five state-owned pharma companies were set up to grow the domestic market

THE GROWTH SAGA

80 19 s

✦ Indian Patents Act 1970 and Drug Price Control Order of 1970 gave a big fillip to Indian manufacturers. ✦ A generation of scientist-entrepreneurs took this opportunity to set up companies which have emerged as pharma giants

90 19 s

✦ Indian pharma companies developed R&D base and moved up the value chain. ✦The indigenous sector gained considerable portion of the market. ✦ In late 1980s, Indian pharma firms started eyeing overseas markets.

✦ Production and formulations of bulk drugs grew substantially. ✦The Trade Related Intellectual Property Rights (TRIPs) agreement brought India's patent regime in harmony with the WTO regulations. ✦ Free imports, foreign investment and technological superiority became the buzzwords

00 20 s

✦ The pharma sector started attracting high FDI inflows. ✦ India became a major manufacturer of branded, generic and branded generic medicines with a strong export pipeline. ✦Enactment of the Patent (Amendment) Act, 2005 changed the protection regime in India.

TURNOVER OFTHE INDIAN PHARMA INDUSTRY

Established in 1954, Hindustan Antibiotics Ltd (HAL) was the first public sector pharma company in India. It was set up with help from WHO, UNICEF

India had entered independence with the patent system of the British colonial masters, enacted in 1911

Among fastest growing industries The country’s pharmaceutical industry is expected to expand at a CAGR of 12.89 % over 2015–20 to reach $55 billion

2015 $30 BILLION

The pharma industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, pharma formulations, chemicals, tablets, capsules, orals and injectables

DID YOU KNOW?

1952 `32 CRORES

Roche was the first company in India to receive a patent under the product patent regime. It was granted for Pegasys (peginterferon alfa-2a), used in the treatment of hepatitis C, in March 2006

Ranked 5th in terms of attracting FDI Pharma sector in India attracted 5 % of the total FDIs into India from April 2000 to September 2016 Cumulative FDI inflows worth $14.49 billion were made during April 2000 to September 2016

Source: BEF Report 2017 www.ibef.org

Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 Regulates import, manufacture, distribution and sales of drugs in India. Ensures drugs and cosmetics sold in India are safe for consumption and conform to standards set by Government

Indian Patent Act, 1970 Encourages the indigenous pharma industry in India and to ensure that the citizens could afford the drugs. Only process patents were allowed until amendment in 2005 to implement product patent regime in India

1990 $1 BILLION

The first pharma company in India, Bengal Chemicals was founded by Acharya Prafulla Chandra Ray, the Father of Indian Chemistry, in 1901

Growing generics market The generics market stood at $26.1 billion in 2016 from $21 billion in 2015. India’sgenerics market has immense potential for growth

One of the highest exports India accounts for 20% of global exports in generics. In FY16, India exported pharmaceutical products worth $16.89 billion, with the number expected to reach $40 billion by 2020

✦ Indian pharma companies take the M&A route to increase product portfolios and market footprint. ✦ 100 % FDI in medical devices and New Drug Pricing Control Order

Rapidly growing healthcare sector Indian healthcare sector, one of the fastest growing sectors, is expected to advance at a CAGR of 17% to reach $ 250 billion over 2008–20

Leading pharma producer Indian pharmaceutical sector accounts for about 2.4% of the global pharma industry in value terms and 10% in volume terms

10 20 s

LAWS OF THE LAND

1947

THE MAIN FOCUS

Drugs and Magic Remedies (Objectionable Advertisements) Act in 1954 Ensures adequate control over the advertising of drugs in India. Prohibits advertisements of drugs that claim to have magical properties. Narcotic Drugs and Psychotropic Substances Act, 1985 Provides stringent provisions to control and regulate operations of narcotics drug or psychotropic substance. Prevents and combats abuse of illicit traffic in narcotic drugs. Drug (Prices Control) Order, 2013 Empowers the National Pharmaceutical Pricing Authority (NPPA) to regulate the prices of essential drugs

Pharmacy Act, 1948 Regulates the profession and practice of pharmacy within the country. Provides provisions to constitute a Central Pharmacy Council of India and State Pharmacy Councils

1970 `445 CRORES 1947 `10 CRORES

xpress Pharma, in its Independence Special issues, chronicled the role of the pharma sector, which evolved from being an insignificant nonentity during the time we gained our independence to the present day power house that produces and supplies high quality generic drugs to markets across the world, in driving the progress of the nation. It showcased the struggle and triumphs which led to India’s rise as the ‘Pharmacy of the world.’It acknowledged people, companies and institutions that have been part of India’s journey throughout its existence as an independent nation through profiles, photo features and guest articles.

Sources: http://www.jpsbr.org/ https://www.ibef.org https://www.in.kpmg.com http://pharmaceuticals.gov.in/document/annual-report-2016-17

24 EXPRESS PHARMA

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August 1-15, 2017

EXPRESS PHARMA (AUG 16-31, 2017) MAKING SENSE OF SERIALISATION

PHARMA TECHNOLOGY REVIEW

Making sense of serialisation With more than 40 countries already implementing or set to enforce their serialisation mandates by 2018, are pharma exporters from India geared up to face this challenge? Viveka Roychowdhury

magine a world where all medicines, from strips of tablets to syrups to vaccines, in every chemist shop in the world, from Africa to America to India, has a unique serial number with information on the origin, shelf life and batch number. If all these numbers can be stored, tracking a substandard or counterfeit medicine to the exact location where it was produced becomes much easier. Actually, serialisation, or the process of marking products with unique identifiers, is already a reality in most countries for a variety of products, from FMCG to toys to medicines. The next logical level of security is to use these serial numbers, which in most cases is a unique number of alphanumeric code, most commonly encoded into a barcode, to track each pharma product as it moves through the supply chain, from the time it leaves the manufacturer's gate, to the stockist/distributor and finally to the chemist shelf. A further level of security is to be able to trace back the journey of each pharma product. Serialisation, combined with track and trace mechanisms, are being seen as one important solution to ensure that substandard or counterfeit medicines are discovered before they do too much harm so that they can be recalled from global markets.

The case for serialisation The pharma sector thrives on exports and more so the companies from India, resulting in the country being often referred to as the 'pharmacy of the world'. According to India Brand Equity Foundation

It is always advisable to stick to the existing plan and implement it as soon as possible. This will allow the organisation to conduct some trials and testing to avoid market complaint. Every country has their own regulations which creates difficulty for the manufacturers Shivaji Chakraborty Asst GM, Packaging Development, Fresenius Kabi Oncology

With more than 40 countries already implementing or set to enforce their serialisation mandates, most important export destinations will require some level of serialisation/ traceability in place by 2018. How prepared are pharma exporters from India to face this challenge? Will they lose out on their competitive advantage to exporters from other countries? As usual, there are the early birds and the laggards. Shaunak Dave, VP, Asia and CEO and MD, India, Optel Group, points out that outside the US, the maximum number of US FDA plants are located in India and these plants do not have any choice but to comply with US DSCSA regulations. He reveals that the Optel Group started serialisation projects in India around 2011-12 and most big and medium size pharma exporters are today equipped with serialisation at the secondary and tertiary packaging levels to meet India's export regulations. “Many companies exporting to the US are ready with serialisation but aggregation is still a work in progress as it is not a mandatory requirement as of now. However, it is the requirement from their master distributors and business partners.”

Multiple standards, multiple complications …

India has no choice but to be part of the global mandate for serialisation, followed by track and trace systems

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August 16-31, 2017

68 EXPRESS PHARMA December 1-15, 2017

(IBEF), India is the largest supplier of generic medicines globally, accounting for 20 per cent of the global export volume. Pharma exports from India stood at $16.4 billion in 2016-17, and is expected to reach $20 billion by 2020, as per estimates from the Pharmaceutical Export Promotion Council (Pharmexcil). India thus has no choice but to be part of the global mandate for serialisation, followed by track and trace systems. India's serialisation initiative for pharma products

started in January 2011, when the Directorate General of Foreign Trade (DGFT), launched the country's track and trace system for all pharma products exported from India. The US, the biggest pharma market of the world, has its serialisation mandate, known as the Drug Supply Chain Security Act (DSCSA), which was signed into law on November 27, 2013. Though it is set to be implemented by November 27 this year, enforcement of the product identifier requirement was

postponed by a year. The European Union (EU), another important destination for pharma exports, has the Falsified Medicines Directive (FMD), under which new track and trace regulations come into force from February 2019. Countries like Belgium, Greece and Italy have reportedly already made serialisation mandatory. Turkey is often cited as an early bird example of having one of the longest standing track and trace systems in place for all pharma products.

I personally believe this is a little bit far fetched but technically speaking, yes, the risk exists Jean-Pierre Allard CTO, Optel Group

Serialisation has been successfully implemented in many other sectors, but pharma serialisation has turned out to be more complicated. Comparing the mandates of various countries, Pradeep Dhargalkar, Head of Packaging Development, Unichem Laboratories says, “The four basic data to be serialised remains the same across mandates: i.e. batch number, expiry, GTIN, and serial number. In the EU, apart from serialisation, the pack also needs to be tamper evident.” But regulators of countries have not been able to agree on which standard to

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follow. Even when they do decide on a global standard, (GS1 seems to be the most common choice), there are differences in the interpretations, which has turning out to be a nightmare for manufacturers. “Since there is no single global standard, every country has adopted their own regulations, which has made it difficult for manufacturers,” says Shivaji Chakraborty, Asst. GM, Packaging Development, Fresenius Kabi Oncology. He also points out that the Indian guideline is for products which are exported from India, not for products which are being sold in the domestic market. By this logic, manufacturers would need to have different packaging lines for export and domestic markets, adding to the capital expenditure by way of labour costs, separate storage areas, etc. Explaining further, Dave says,“India's serialisation guidelines are based on the GS1 standard which is adopted by a majority of countries who have announced this compliance. A few countries like China mandated different standards. Considering the implementation issues, the regulations are under review in China and industry experts believe that it will also be aligned with GS1 global standard.” Differences in interpretation snowball into implementation challenges across the supply chain. For example, Dave points out that while the Indian regulatory authority's standards are based purely on the definition of packaging (primary, secondary and tertiary) and therefore considers primary packaging as the first level of serialisation (although this is on hold), this view is not aligned with global mandates from various countries. As per US DSCSA, EU FMD regulation, serialisation begins with the unit saleable pack, says Dave. He reckons that this is one of the biggest challenges as far as technical

ICRIER-RXGPS RECOMMENDATIONS TO CDSCO ON SERIALISATION ◗ Recommendation 1: CDSCO and DGFT should delegate an independent body to undertake (i) an economic impact assessment for domestic serialisation and traceability requirements under consideration, and (ii) a regulatory impact assessment of existing requirements for serialisation and traceability of exports. ◗ Recommendation 2: With regard to product exported to a country that has its own serialisation requirements, the “tertiary package” should be considered the highest level of shipping container for export. For example, the pallet will typically be the tertiary package for exports to the United States or the European Union.The homogenous case would be the tertiary package for markets where the case is the highest level of container exported.All levels of packaging below the tertiary package (as defined here) should then be exempt from unique identifier and labelling requirements under the India serialisation and traceability regulations. ◗ Recommendation 3: DGFT should grant exemptions on a country-by-country basis, not a manufacturer-by-manufacturer or product-by-product basis. ◗ Recommendation 4: Regulators should not define the GTIN indicator digit; it should be set by the manufacturer, as provided in the GS1 GTIN General Specifications. ◗ Recommendation 5: NIC should revise the DAVA database and portal to: ❏ Segregate the portal interface for exports and domestic product. ❏ Eliminate the primary package serial number field, or at a minimum, permit the field to be left blank. ❏ Eliminate the pricing information field, or at a minimum, permit the field to be left blank. ❏ Eliminate the requirement to upload product photos. ❏ Permit a single manufacturer to repeat serial numbers for different GTINs. ❏ Provide the option and interface for automatic upload of data via web service. ❏ Prevent a company’s data from being visible to other companies. ◗ Recommendation 6: NIC should maintain development and simulation environments to support revisions to the DAVA portal. ◗ Recommendation 7: NIC should establish a clear, predictable process for communicating revisions to the DAVA portal. ◗ Recommendation 8: In the initial phase of requirements for domestic product, CDSCO should require serialisation of the saleable unit. ◗ Recommendation 9: CDSCO should not require manufacturers to capture, maintain, or report any information related to the movement of products by downstream trading partners. ◗ Recommendation 10: CDSCO should adopt a four-year, phased implementation timeframe for domestic requirements. ◗ Recommendation 11: CDSCO and DGFT should consider alternative approaches that limit data volumes. ◗ Recommendation 12: There should be a process for accrediting, certifying, or otherwise auditing serialisation vendors.

EXPRESS PHARMA

August 16-31, 2017

s serialisation mandates are getting adopted in various countries, this article revealed how important it is to increase tracebility in pharma and enhance the quality and safety of drugs. It revealed that the process of marking products with unique identifiers, is already a reality in most countries for a variety of products, from FMCG to toys to medicines. It also pointed out that though serialisation has been successfully implemented in many other sectors, pharma serialisation has turned out to be more complicated. It concluded that all stakeholders will need to work with, rather against, each other, to set common standards and achieve the common goal of increased patient safety through more secure pharma supply chains.

CPhI & P-MEC INDIA 2017 SPECIAL

his page features a very diverse mix of articles. The first one is a very strongly worded article from Bharathi Ghanashyam of Journalists against TB, who talks about the story of MDR – TB control in India, which seems to be stuck at the foreword and asks when does it move forward.The other article in this page is from ACG’s CEO,Ajit Singh who traced the progress of the pharma industry over the past seven decades. The third one is a very interesting piece on blending traditional medicine and modern science to develop a holistic approach for cardiovascular healthcare.Thus, the readers of Express Pharma are spoilt for choice in terms of information and content. MANAGEMENT INSIGHT

Let’s move this story forward Bharathi Ghanashyam, Founder &Editor, Journalists against TB, talks about the story of (multidrug-resistant tuberculosis) MDR – TB control in India, which seems to be stuck at the foreword and asks when does it move forward

or the first time in over 125 years we have new diagnostics, we have two new drugs — bedaquiline, manufactured by Janssen Pharmaceutica NV, and delaminid, manufactured by Otsuka Pharmaceuticals, after a wait of 50 years (this article will talk only about bedaquiline). We finally have strong tools with which to fight a disease that has been defeating us down the centuries. And it seems like we are frittering away the opportunities, stuck as we are in red-tape and seemingly needless delays in effectively using these tools. MDR – TB is a lethal form of TB. As defined by World Health Organisation (WHO), it does not respond to at least isoniazid and rifampicin, the two most powerful anti-TB drugs. It currently requires the patient to be on treatment for 24 months or more, with six other drugs, including injectibles for an intensive phase of six months and a continuation phase with four drugs for 18 months or more. These drugs are toxic and induce severe side-effects.

nearly half of whom were in China, India, and the Russian Federation. Worldwide, only 52 per cent of MDR-TB patients and 28 per cent of XDR-TB are currently successfully treated. More alarming was the fact that about 9.5 per cent of MDR-TB cases had extremely drug-resistant TB (XDR-TB). As per the TB India 2017 report of the Central TB Division, India is home to the highest burden of MDR - TB. An estimated 1.3 lakh MDR - TB patients emerge annually in India. Despite the grim situation, instead of waging a full-scale war, we are still making our first weak battle cries. Let’s look at the history of what has been done.

The history of inaction January 2015: The Government of India approved the use of bedaquiline (BDQ) for about 500 patients under the national TB control programme.

However, no plans were announced to make the drug available to the private sector, when in India, traditionally, more than half of those afflicted with TB, including MDR – TB seek treatment from the private sector. No data is available for how many patients actually received BDQ that year. March 2016: On the eve of World Tuberculosis Day, Health Minister JP Nadda launched BDQ as part of the national programme for MDR

The numbers are growing Dr Jennifer Furin, an infectious diseases specialist in Harvard Medical School has observed in one of her papers that “…unless the management of MDR TB changes radically, it will be one of the main drivers of antimicrobial resistance, which could kill more persons than cancer by 2050…” According to WHO, about 480 000 people worldwide developed MDR-TB in 2015;

– TB and XDR – TB patients. The drug was to be introduced at six tertiary care centres across India, which had advanced facilities for laboratory testing and intensive care for patients. It was to also be introduced in 104 districts across five states. There is no data available on how many patients received BDQ during the year. A year had passed with little or no progress. March 2017: The Government of India announced that it would expand access to BDQ and make it available in 140 government-run centres by November. The Annual Status Report of RNTCP reported that till December 2016, more than 207 drug resistant TB patients had been initiated on BDQ containing treatment (BDQ is given in combination with other drugs). Dr Sunil D Kharpade, Deputy Director General, Head, Central TB Division,Project Director RNTCP, responding to questions by e-mail responded, “The yearly estimated number of BDQ eligible patients in the public sector as per existing criteria is around 7000 – 8000.” He also revealed that 443 patients have been enrolled into the programme across the sites. Juxtaposed against the number of people requiring the drug, what has been achieved does not even do justice to a pilot-programme. These numbers also do not take into account patients in the private sector who are eligible for the drug. A press note uploaded on the website of the Central TB

Division of the Government of India on 25 May 2017 cautiously mentions, “For patients being treated outside the government system, the manufacturers are providing this drug under Compassionate Use Programme free of cost to the doctors, provided they follow the recommended guidelines for starting the drug and its close monitoring.”

A lot of time has gone by Implementation of the plans outlined by the Central TB Division for the use of BDQ has been something of a nonstarter. There has been no resolution to concerns on whether the drug stands the danger of being misused; whether it would end up being available over the counter without prescriptions and most of all whether patients would become resistant to the only really powerful weapon available for TB. These fears might be unfounded. Prof Furin says, “While it is certainly true that many antibiotics can be purchased without prescriptions, it is highly unlikely that newer agents like BDQ and delamanid would be purchased on the open market. They have no indications for use other than in the treatment of serious mycobacterial disease, such as TB. So the risk of them being sought after for broad use is very low.” That patients in need of the new drug are running out of patience is evident from the case that was recently filed by the father of an 18-year old patient of XDR –TB in the Delhi High Court. He demanded that

EXPRESS PHARMA

June 16-30, 2017

Express Pharma (June 16-30, 2017)

cover )

Agrowth saga Ajit Singh, Chairman, ACG Worldwide, speaks on the journey traversed by the Indian pharma industry and predicts a bright future for it in the times to come

he amazing growth, sophistication and international reach of the Indian pharma industry in the last few decades has few parallels. It is now promoted as the ‘Pharmacy to the World’. I prefer to use the words ‘World’s Pharma Hub’ which would be more correct, also in its grammar. Our group, ACG Worldwide (formerly, the Associated Capsules Group), started its production of empty capsules in the 1960s, along many of the present leading companies of the Indian pharma industry. We grew side-by-side with the Indian pharma industry. Let me illustrate the performance of this industry based on ACG’s actual experience as a leading supplier of equipment and consumables. By the second year of our production by when the output had reasonably stabilised, we were producing about 50 million capsules per year. We are now producing about a 100 billion capsules a year. This exponential growth is an indication of the growth of the pharma industry in India. As the World’s Pharma Hub, India makes thousands of formulations to meet all illnesses and doctors’ prescriptions. Some people say that, in spite of its other advancements, India has been largely unable to develop any new pharma molecules that have become blockbusters. This may be so, but should India’s strategy be any different from what it is. The Government of India has played a strong supportive role even as it burdened the industry with a number of controls. For example, in an almost uncanny fashion it gave protec-

companies are generally headed with persons from Finance or Marketing or similar backgrounds. The resilience of this industry in India is demonstrated by its success and growth even though it has the strictest price controls in the world. Like a champion weight-lifter challenged with heavier and heavier weights, every successive round of price control the industry has not succumbed, but has only strengthened. And, interestingly, several heads of pharma companies are among the richest in the country. Alongside, Indian pharma, its ancillary industry has also developed the capabilities, the technology and competence to compete globally. For example, in the sophisticated, high technology gelatin capsule industry, ACG is the second largest in the world and growing much faster than others. Several types of pharma machines designed and made in India lead the world in volume of production and in the value-for-money they offer to pharma customers worldwide. Major global pharma producers and even MNCs, recognising the strong competition they face from Indian pharma manufacturers, have started importing and using Indian-made machinery and ancillaries, as historically done by Indian competitors, so that their costs become more competitive. At the present time, various units of the Indian pharma industry are facing rough weather with inspection of their plants by some overseas FDA agencies. Somewhat damaging is the focussed attention such

ACG's factory at Shirwal, near Pune - One of India's largest factory making pharma machinery parts

tion to the industry when it was most needed. And left them to compete with the rest of the world at the appropriate time, when it was felt to be strong enough. Pharmexcil, the export promotion council has also played an important role in assisting the globalisation of this industry, particularly in the last few years. India has developed the capacity to manufacture huge quantities of formulations, of world quality standard, at the

world’s cheapest prices and it still makes a profit. This is itself an indication of high technology and competence, surely more important than inventing a couple of new molecules. No other country in the world has been able to match this performance, and India’s leadership increases year-by-year. Though the IT industry has received greater recognition and its size is much bigger, the pharma industry should really be recognised as the pride

of India. It’s a high-tech, high value-added industry not relying on cheap labour, and operating with ingenuity and high productivity. Due to its affordable prices, the industry saves millions of lives globally each year. One of the noteworthy aspects of the Indian pharma industry is that many of the largest companies in India are headed by pharmacists or technocrats. This is not so in advanced countries where large

30 EXPRESS PHARMA August 16-31, 2017

Express Pharma (August 16-31, 2017)

MANAGEMENT INSIGHT

Integrative cardiology: Where can Ayurveda contribute? Dr M Vijayakumar, Clinical Professor,Adult Cardiology,Amrita Institute of Medical Sciences, Kochi, Kerala and Dr P Ram Manohar, Research Director, Amrita Centre for Advanced Research in Ayurveda,Amrita School of Ayurveda, Kollam, Kerala, share insights on blending traditional medicine and modern science to develop a holistic approach for cardiovascular healthcare

Dr M Vijayakumar, Clinical Professor, Adult Cardiology at Amrita Institute of Medical Sciences, Kochi, Kerala

here is no question about the miraculous impact of advanced medical knowledge in saving millions of human lives. Specially so, when it comes to diseases that afflict a vital organ like the heart, which can create life and death situations demanding complex interventions. New pharmaceutical drugs, bypass surgery, angioplasty, heart transplantation, pacemakers and the list is endless when it comes to discussing about the path breaking developments that have revolutionised medical interventions in the field of

cardiology. Cardiology has become increasingly technology intensive and while these advances are life saving in many situations, there is growing concern that such interventions are sometimes being used out of context and become the cause of economic burden to the public. Worldwide, there is growing dissatisfaction with conventional treatments as they can at times be not effective or cause side effects or be prohibitively expensive. People are searching for less invasive, cost effective and safer solutions where it is

warranted. While the advancements in modern cardiology cannot be undermined in any way, complementing it with alternative approaches can perhaps reduce drug dependence, minimise surgical procedures and improve quality of life where it is reasonably possible to do so. In many parts of the first world, Integrative Cardiology has emerged as a clinical discipline that attempts to integrate the best of both worlds in the bid to provide the best care for the patient. Many cardiologists are

beginning to consider alternatives to conventional treatment for management of a wide range of conditions including angina, arrhythmia and congestive heart failure. Apart from surgery and pharmaceutical drugs, Integrative Cardiologists are keen to prescribe diet and lifestyle modifications along with standard care. Integrative Cardiology is developing around the world by incorporating many practices from complementary and clternative Medicine. However, the role that Ayurveda can play in Integrative Cardiology is yet to

Dr P Ram Manohar, Research Director, Amrita Centre for Advanced Research in Ayurveda, Amrita School of Ayurveda, Kollam, Kerala

be widely recognised. Ayurveda uses at least 1200 medicinal plants and about 25,000 herbal formulations. Many of these plants and formulations have been found to be potentially beneficial in the management of cardiovascular diseases in preclinical and clinical studies. However, sufficient translational work has not been done to integrate Ayurveda into mainstream clinical practice for management of cardiovascular diseases.

26 EXPRESS PHARMA October 1-15, 2017

Express Pharma (October 1-15, 2017)

EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

EXPRESS PHARMA (SEPTEMBER 1-15, 2017)

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ENHANCING PHARMA EDUCATION THE MAIN FOCUS

Pharma education: In need of a revamp An analysis of the current state of pharma education in India, its successes and shortcomings, as well as measures needed to bridge the gap between the industry and academia By Swati Rana

he pharmacy profession in India began in the early 20th century and since then, has undergone several transformations. These changes have had an impact on pharmaceutical education as well.

Tracing the beginnings

INSIDE

PHARMA EDUCATION: IN NEED OFA REVAMP

'REVIVAL OF PHARMACY EDUCATION IN INDIA IS THE NEED OFTHE HOUR'

‘A CONTEMPORARY AND RELEVANT PHARMACY CURRICULUM IS THE NEED’

HOMAGE TO THE GURUS

24 EXPRESS PHARMA September 1-15, 2017

The systematic implementation of pharma education in India commenced from 1948, with the enforcement of Pharmacy Act-1948, to set standards and regulate pharmacy education, profession and practice in India. Provisions of the Pharmacy Act are implemented through the Pharmacy Council of India (PCI), a statutory body established in 1949. Thus, formal pharma education in India has been prevalent for several decades. Since the late 1980s, due to rapid industrialisation in the pharma sector, privatisation, and economic growth, pharmacy education has been developing faster in India than anywhere in the world. Yet,

EXPRESS PHARMA

September 1-15, 2017

his story highlighted the current state of pharma education and traced the evolution of pharma education. Industry experts share their insights on the way forward to revamp the pharma education system within the country.A multi-pronged strategy involving three domains of action: quality assurance, academic and institutional capacity building and more emphasis on experiential education and competency building was also discussed. Industry veterans also shared their views on the upcoming trends in pharmacy education.The article highlighted the urgent need to strengthen industry-academia collaborations in terms of education, training and research, through continuous interaction with the pharma industry leaders and involving them in the framing of the pharmacy curriculum.

EXPRESS PHARMA (SEPTEMBER 16-30, 2017) MAKE IN INDIA REVIEW

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THE MAIN FOCUS

INSIDE

22 EXPRESS PHARMA September 16-30, 2017

EXPRESS PHARMA

December 1-15, 2017

THE LION AT CROSSROADS

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MAKE IN NORTH EAST INDIA

MAKE IN INDIA ACHIEVEMENT REPORT

EXPRESS PHARMA

September 16-30, 2017

s India observed the third anniversary of the ‘Make in India’initiative, Express Pharma reviewed its achievements and shortcomings within the pharma sector. It reflected on the vision of the initiative to raise the manufacturing sector’s contribution to the GDP. However, it also disclosed India’s disproportionate dependency on Chinese APIs which could seriously derail the endeavour’s progress. The article recommended the industry to tap the true potential of pharma PSUs to rev up API production.The article drew attention towards the need for significant investment and efforts to make PSUs selfsustainable and profitable.Thus, it is an example of how Express Pharma periodically reviews policies of the government.

CPhI & P-MEC INDIA 2017 SPECIAL

A FORUM FOR KEY OPINION LEADERS

xpress Pharma has always been the vehicle for the industry to convey its views and insights on several topical issues. For instance, the first one is a post-budget analysis on the allocation for the pharma sector.The next one is on the GST roll out.Though many were optimistic that it would prevent the cascading effect of taxes, most of them had expressed concern on its effective implementation.A very valid one, considering that it does seem to have adversely effected the sector’s growth. cover )

All bluster and no lustre? With little or no financial incentives in Union Budget 2017, the pharmaceutical industry remains deprived of a cure for its ailments

‘The budget has not specifically addressed imminent challenges directly affecting the sector’ he life sciences sector had great expectations from the Budget not only from a fiscal incentives perspective but also from a regulatory angle; more so, given the government’s vision of making India one of the top-three pharma markets by 2020. However, this year, too, no specific impetus was given to the sector. While the move to eradicate certain diseases; the proposal to set up two new AIIMS; additional post-graduate medical seats; proposed amendments in the Drugs and Cosmetics Rules; and new

UTKARSH PALNITKAR NATIONAL HEAD – LIFE SCIENCES PRACTICE, KPMG INDIA

rules for medical devices are welcome, the Budget has not specifically addressed imminent challenges directly affecting the sector. In order to stay competitive in the overseas market and given the uncertain global climate, it was expected that specific impetus or incentives would be given to innovation in the form of weighted deduction on R&D, incentives for patents, exemptions of certain duties and taxes, etc. These demands remained largely unaddressed, giving no specific reason to cheer for the sector as a whole in 2017–18.

‘The budget provides the necessary impetus to sustain GDP growth at over seven per cent’ verall, the Union Budget 2017 that was presented earlier today is a step in the right direction. While it has focussed on economic reforms and liberalisation of the economy, it has also allocated funds to bring more irrigation, roads, electricity and sanitation to rural India. Even though the economic survey paints a sober picture for 16-17 primarily due to a weaker second half, the budget provides the necessary impetus to sustain GDP growth at over seven per cent. Lowering tax on MSME’s is a welcome step that would provide a much needed fillip – by creation of jobs and putting more money in their pockets in all sectors includ-

GLENN SALDANHA CHAIRMAN AND MD, GLENMARK PHARMA

ing pharma. The government has shown its clear intent towards fast-tracking inflow of FDI, and the scrapping of FIPB is a notable step that would go a long way in supporting the objective of ease of doing business. Additionally government’s impetus to reduce the borrowing cost and increase access to credit will surely help businesses to grow. We see the biggest ever allocation to the infrastructure sector which would benefit all sectors, including the fast growing pharmas. The FM reiterates his commitment to keep current account deficit and fiscal deficit under control GST implementation as soon as possible.

‘The budget initiative of STRIVE would be of great help for the Indian pharma industry’ he budget has increased its allocation to `3016 crores, up by 67 per cent and 39 per cent over the budgeted estimate and revised estimate of the last budget. From a pharma industry perspective, the budget initiative of Skill Strengthening for Industrial Value Enhancement (STRIVE) to be launched in 2017-18 at a cost of `2,200 crores would be of great help for the Indian pharma industry, which has already gone global both in regulated and non-regulated markets.

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INSTRUMENT TABLE

‘We hoped for some reform announcements on the regulatory front’

KANCHANA TK DIRECTOR GENERAL, OPPI PPI welcomes the commitment of the Government to - reduce infant and maternal mortality rates; eliminate certain diseases like TB, leprosy, measles and filaria and make structural reforms in medical practice and education. The Government’s intention of

transforming 1.5 lakh health sub-centres is encouraging. We also appreciate the Government’s intent to amend the Drugs and Cosmetics Act which will be a step towards ensuring patient safety. We had some expectations from the Union Budget 2017-18, given the Government’s past stated intentions of improving access to healthcare. Yesterday’s World Economic Forum said that that India’s public spending on healthcare is much lower than the global average. It is unclear whether the allocations will adequately address current healthcare challenges. We also hoped for some reform announcements on the regulatory front in the form of weighted deduction on R&D, incentives for patents, exemptions of certain duties and taxes, etc.

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GST: Ushering new rules to the game

WALL TABLE

Goods and service tax (GST), to be rolled-out from July 1 this year, is expected to help bring in better efficiencies in the pharmaceutical industry’s supply chain management and reduce the cost of manufacturing pharmac products. A few industry players and service providers share their views on the impact of GST and getting ready for its roll-out By USHA SHARMA

'GSTwill act as a bridge to create a seamless connection between manufacturers, distributors, regulators and customers'

ST will have a positive impact on the pharmaceutical industry. It will lead to an increase in compliance and thereby enhanced transparency and better supply chain management which will not only be beneficial for the pharma industry but also for all the intermediaries in supply chain management and the customers.

RAVI KANT SHARMA FOUNDER AND CEO, SASTASUNDAR

Enhanced transparency in pharma distribution There may be issues during the initial phase of implementation of GST, the reason being in most of the states, medicines are currently being charged with VAT on MRP, i.e., single point taxation. It means the intermediaries involved in the distribution of medicines are not required to pay any VAT. In the current regime, maximum of intermediaries are not required to take any registration or pay VAT or file returns. But in the GST arena, there will be no concept of taxation on MRP. Rather, all the intermediaries will be required to take GST registration, pay monthly taxes and file three returns per month and in total, 37 returns annually. It will enhance compliance levels across the supply

chain management by bringing in enhanced transparency to the system with complete tracking of movement of the product. It will be beneficial for all in the longer term. The country will have a major relief from the threat of fake or counterfeit medicines. We believe that GST will act as a bridge to create a seamless connection between the manufacturers, distributors, regulators and customers.

Innovative business models will come up The pharma distribution system will undergo a major transformation. There will be

no incentive for pharma companies to keep multiple warehouses across the country. The movement of goods from one state to the other will not attract any differential taxation and the pharma companies will rework on their distribution strategies. Eventually, it will result in the application of newer technologies in the supply chain management domain with better inventory planning and in turn, result in huge savings in the warehousing and logistics cost. We may see the emergence of innovative business models in near future in the pharma supply chain management domain.

We may see the emergence of innovative business models in near future in the pharma supply chain management domain

Shortage of medicines GST on most medicines have been kept at five per cent or 12 per cent and there will be no major impact on the price variation at all. However, due to concerns regarding the input tax credit of 40 per cent (allowed under the GST transition regime), realignment of production strategy by pharma companies due to changes in tax rates and other factors, there are fears related to medicine shortages during the tran-

ISLAND TABLE

sition phase. Recognising this threat and also our responsibility, we at SastaSundar have decided to rework on our procurement strategy so that during this transition phase, we can ensure the consistent availability of medicines.

Preparedness Regarding the preparedness for GST at Sastasundar, we have an efficient supply chain management model empowered with technology. We have already redesigned our system in compliance with GST and tested it as well. For a majority of the intermediaries in the pharma distribution, the GST regime will be a kind of transformation for their business models with enhanced compliance load but with the adoption of readily available technology, we believe that it can be managed. We understand that like us, all those associated with the supply chain management are also geared up for GST. GST is one of the biggest reforms in the country and we believe that the government's mission to ensure affordable healthcare to all Indians will get a major boost by the GST regime.

'We need to embrace the new reality and move away from banal considerations'

ST is finally upon us. Enough has been spoken, and comprehensively so, about GST’s form, structure, benefits and pitfalls by consultants, specialists, analysts and pundits. However, the unanimous sentiment is that GST is an absolute game changer,

criticise or are negative about the developments and reforms pertaining to GST. While it’s true that these reforms have been designed by administrators and bureaucrats and not by businessmen, hence the flavour is more of compliance and regulation and not business friendliness,

GULSHAN BAKHTIANI DIRECTOR, WELLNESS FOREVER, WELLNESS

The undisputed consensus is that this is a move in the right direction for realising the vision of better governance not just for the pharma industry but for the country and its commerce as a whole. The undisputed consensus is that this is a move in the right direction for realising the vision of better governance. As responsible citizens and business leaders, it is not only expected of us but it’s also our responsibility to be active enablers for smooth implementation of the new GST reforms. Digitisation, automation and the resultant transparency is going to be a way of life rather than mere change management. Therefore, we need to embrace the new reality and move away from banal considerations such as impact on profit, deployment of additional resources for bookkeeping, document filing compliance. In fact, the focus should be on reshaping the organisation to become more compliant, efficient and, as a result, more scalable. I often meet leaders of small, medium and large businesses who partially owing to ‘change inertia’ and fear of the unknown and partially due to hearsay and incomplete information, indiscriminately

however, the bottom-line remains that legal compliance is the fundamental pre-requisite and should not be slotted as aspirational conformance. ‘What is inevitable, needs to be embraced’. With the roll-out of GST, two things will happen for sure: a) The manner in which business will be conducted will witness a paradigm shift from how it was conducted in the past. b) Boys will be separated from men Confusion with regards to GST taxation for online businesses will continue to prevail. The industry itself has given birth to myriad business models and it’s imperative that clear distinctions are made as to what constitutes online commerce. This in turn will lead to better clarity with respect to GST taxation for online businesses. Personally, I would like to believe that GST is a procedural, simple, tax-passing mechanism which is purely between businesses; the customer is merely the consumer of tax.

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July 1-15, 2017

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EXPRESS PHARMA (OCTOBER 1-15, 2017) A MAJOR NEED

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THE MAIN FOCUS

Holistic and multi-disciplinary healthcare approaches are an urgent need to tackle complex challenges posed by an increasing elderly population and ensure effective social and economic development

EXPRESS PHARMA

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October 1-15, 2017

report released by the Ministry of Statistics reveals that the number of citizens over the age of 60 jumped 35.5 per cent â&#x20AC;&#x201D; from 7.6 crores in 2001 to 10.3 crores in 2011.Though many pharma companies are operating in the global geriatric medicines market for older group of population, there is still a void when it comes to providing specific treatment options suitable for geriatrics. In this issue Express Pharma focussed on the unique social, economic, and clinical challenges of geriatric care in India and the solutions to tackle them. It focussed on tackling their medication needs for complex health issues require special attention to safeguard their golden years and offer them more independence and mobility.Thus, it attempted to identify and fulfil a growing need in the country, which could become a huge problem, if left untackled.

October 1-15, 2017

EXPRESS PHARMA (OCTOBER 16-31, 2017) PROPELLING GROWTH

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THE MAIN FOCUS

The global push for traceability to quell counterfeiting and raise quality standards have opened up myriad growth avenues for Indiaâ&#x20AC;&#x2122;s pharma packaging equipment industry By Swati Rana

INSIDE

28 26 EXPRESS PHARMA

EXPRESS PHARMA

December 1-15, 2017

PACKED WITH POTENTIAL

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OPPORTUNITIES CALLING

INTV: PRAKASH CHANDRAJOSHI, SECRETARY GENERAL, PACE

EXPRESS PHARMA

his article highlighted a growth opportunity for the pharma packaging equipment market with the global emphasis on the implementation of traceability solutions to reduce counterfeiting of pharma products. Serialisation mandates in many countries in turn have created opportunities as well as challenges for the pharma packaging industry. This article analysed how pharma packaging equipment manufacturers are upping the game to help the packaging sector. This story emphasised why it is essential for the players in this industry to spot opportunities and take timely steps to leverage them effectively to stay at the top of the game.

CPhI & P-MEC INDIA 2017 SPECIAL

e bring you three more instances of how Express Pharma acts as a forum for the industry to share their observations.The first one on this page covered the debate over gelatin capsules vs plantbased capsules. The next one was a special features where pharma experts expressed their respect and gratitude towards their teachers.The last one discussed the impact that extended tax incentives to industries in the North Eastern and Himalayan states till March 2027 albeit as a refund.Thus, we come to an end of this compilation. We assure our readers that we will continue to offer timely, relevant and informative content for our readers and subscribers. MANAGEMENT

QUESTION POSED TO MOHFW IN THE LOK SABHA Unstarred question no: 2081, Answered on: 28.07.2017, Jayadev Galla-TDP-Teleana

Will the Minister of Health and Family Minister be pleased to state: (a) whether the types of cellulose capsules that are presently available in the market are different from animal based gelatin capsules, if so, the details thereof; (b) whether switching over to vegetarian cellulose capsules will hit the Rs 5000 crores gelatin capsule industry; (c) if so, the details thereof; and (d) the action taken by the Government to address the problem?

Answered by Faggan Singh Kulaste, the Minister of State in MoH&FW (a): Yes. Presently, cellulose capsules are prepared from HydroxyPropylMethyl Cellulose (HPMC), which is synthetic in origin, whereas Gelatin Capsules are pre-

pared from gelatin which is a purified protein obtained by partial hydrolysis of animal collagen (b) to (d): The Government has not received any such report that switching over to vegetarian cellulose capsules will hit the ` 5000 crore gelatin capsules industry. However, some industry associations have raised certain issues including technical issues and economic viability for replacing gelatin capsules with cellulose capsules. The government has, after examination of all pertinent issues relating to use of gelatin capsules and its replacement by cellulose based capsules, already constituted a Committee to consider all pertinent issues and make recommendations to the Government.

'CONSUMPTION OF MEDICINE IS MORE CURATIVE THAN OUT OF PERSONAL CHOICE'

he debate over gelatin capsules vs plant-based capsules (Cellulose) has garnered a lot of attention from all stakeholders of the lifesciences industry. The discussion began almost a year back when Maneka Gandhi, Union Minister for Women and Child Development made a ‘representation' to the Health Ministry on completely replacing gelatin capsules with plant-based capsules following a request received from the Jain community to create an option so that consumers can not be forced to use capsules made from animal tissues. JP Nadda, Union Minister of Health and Family Welfare discussed the matter with the Drug Controller General of India (DCG(I)), Dr GN Singh and and then Health Secretary, Bhanu Pratap Sharma to look into the matter on a priority basis. However, the matter wasn’t taken up at the Drug Technical Advisory Board (DTAB) and failed at the initial proposal itself. However, lately the debate has regained steam and now an expert committee set up by the Health Ministry has asked all stakeholders to share their views on the matter. However, it is an issue with wide-ranging implications. Some of the major questions that the situation throws up include: ◗ Gelatin-based capsules have been in use for over 185 years. How easy and feasible would it be to replace them? ◗ Is the issue about benefits or are we tinkering with long-established, scientifically-proven practices to pander to religious sentiments? ◗ Cellulose-based capsules are likely to be more expensive. Is it morally right to make medicines more expensive in a country struggling to ensure healthcare access? ◗ What are the proven benefits, if we switch over from gelatin-based capsules to cellulose-based capsules? ◗ How will the industry be affected by the switchover, if cellulose-based capsules become the new reality? Industry leaders and veterans share their views on these issues and highlight the different aspects of such a switchover.

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MANAGEMENT

Veg meds: Yay or nay?

elatin capsules are consumed by people at large as carriers of important medicines used to cure many terminal and lifestyle diseases. The consumption of medicine is more curative than out of personal choice. Looking at fundamentals, it is not prudent to enter the vegetarian and non-vegetarian debate in this matter. It may further be noted, that gelatin used in the manufacture of empty capsules are derived from an extraction process wherein no animals are harmed or killed for this specific purpose. Only the leftover bones having hydroxide and collagen, which is a protein widely found in animal bones (and is not more than two per cent of the total value of the dead animal) is extracted through sophisticated machineries in a WHO-GMP approved extraction and manufacturing plants. Accordingly it is misplaced to have any notion that gelatin capsules are non-vegetarian in origin. The Supreme Court, in its order dated March 07, 2013, Case No. 641, had ordered that there is no need for non-veg or veg labels on drugs or

EXPRESS PHARMA

August 16-31, 2017

cosmetics and hence even the red dots which are printed on non-veg products was not implemented for medicines. In the meanwhile, soft gelatin capsules have been given a go-ahead, therefore there is no prima facie issue with the raw material and hence the replacement of hard gelatin capsules because it is non-vegetarian is totally misplaced and uncalled for. Across the globe, over 95 per cent of capsule formulations are gelatin capsules and even among the rest five per cent, Hydroxypropylmethyl cellulose (HPMC) is primarily used for nutraceutical formulations. In India, only around two per cent capsules are HPMC-based and almost all of them are neutraceuticals. No cellulose capsules are used for products such as antibiotics, oncology, anti-infectious, painkiller and other medicinal categories. Nor have any tests been carried out by the DCGI in India whether such medicinal products would retain their stability, bio-availability, bio-equivalence and other properties if filled in cellulose capsules.

Ajit Singh Chairman, ACG Worldwide

Dr Mahesh Burande Director, Institute of Pharma Education and Research (IPER)

◗ The safety and efficacy of cellulose capsules cannot be guaranteed. Members are concerned that even after approvals, few long term studies may show adverse reports and they may not want to take the responsibility for that. ◗ Today we manufacture 120 billion gelatin capsules compared to only two billion cellulose capsules. ◗ Cellulose capsules are two to three times expensive compared to gelatin capsules.This would increase the cost of drugs to the patients.

◗ Several newspaper reports are harming the Industry’s reputation and needs to be countered.

had some amazing teachers who taught me and some of these teachers went on to teach at universities in US. As naming one teacher will be bias on my part, I will take the some names of teachers who impacted my future and career — Dr VN Sonar, Dr RH Udupi, my PhD supervisor Dr KN Thimmaiah and Dr GJ Peters. One teacher who did not teach me but inspired was Dr Yellapragada Subbarow, a pioneer who discovered medicines like Tetracycline, Folic acid, Methotrexate, Aureomycin and Diethyl Carmabamzepine, we live longer today because of these medicines. Our Late President Dr Abdul Kalam’s Wings of Fire was inspiring for me and I brought and read this beautiful book five times. I also got an opportunity recently to be a Visiting Scientist with Dr GJ Peters who is a pioneer in Preclinical studies in cancer at the VU University Medical Center, Amsterdam, Netherlands on a sabbatical for a year to keep abreast the research happening in the field of cancer. It was a rewarding experience and I was a Postdoc with him a few years ago.

◗ We will be totally dependent on imports of raw materials for cellulose capsules.

◗ Huge investment in plant and machinery would be required to adopt cellulose capsules.

y favourite Teacher in Pharmacy is Dr JK Lala who was the Principal K.M.Kundanani College of Pharmacy Ulhasnagar. He was taking our subject Drug Store Management. While taking this subject, without any PPP during that time (1979), he was literally taking our mind to the Drug Store by illustrating suitable examples, live situations, case studies,involving us and taking suggestions from us and I think it was learning by participation and problem-based learning with command over language and humour. I am also inspired by the teaching style of Dr Chandrakant Kokate, the first Pharmacy Teacher who became Vice Chancellor of University. His lectures would be full of information and statistics without any paper in front of him and wonderful quotes to start and end his speech. Currently, I am impressed with my friend Dr B Suresh, President, PCI, for the way he controls the crowd with humour and delivers new thoughts and concepts. Their styles of teaching inspired me to become a teacher and I am trying to teach and talk like them as a teacher ,trainer and consultant who is appreciated today by pharma industries and pharma profession.

unless that person has the authority to say Yes. I had to really ponder over it, to understand this deep, original concept. My other substantial learning was from the late Professor Arnold Beckett who was Professor at Chelsea School of Pharmacy, London, U.K. He visited India to lecture more than once. The presentation of his lectures were far ahead of his time, illustrated with beautifully composed slides and delivered in a powerful tone of voice that engaged attention of and enthused the audience. He was like an actor on the stage, and I learnt how active body movements and a varied modulation and tone of voice creates excitement in what could otherwise be a drab scientific lecture. During one of his visits, Prof Arnold Beckett inaugurated a Scientific Pharmacy Museum that SciTech Centre/Associated Capsules set up at the Principal K.M. Kundnani College of Pharmacy, Mumbai.

Dr Mayur Yergeri Associate Dean and Professor, SPPSPTM

salute my great teacher, Dr G P Srivasatav. He motivated all students, mentored and largely was responsible for his students being gainfully engaged in the pharma industry. His letter of recommendations in 1970s were enough to fetch jobs in any place, in any industry, in any city, even abroad. Dr G P Srivastav was a popular teacher and always smiling, interacting with students in laboratories, class rooms. Under his mentorship, his students achieved great positions in national and international institutions in the pharma industry. We were fortunate to learn a lot of talents and technologies relevant to the pharma industry in those days. He helped us to dispose the dog from the laboratory after pharmacological experiment when technician was not available and the laboratory was stinking. He gave us a lesson and educated us that even if the technician is not available, we can go ahead with our experiment and research. Even during strikes and student unrest, he was the one allowing the students like me to come and enter from the backdoor to work in the laboratory and use the library. We will not get such great teachers these days. However, he passed away in Varanasi in the year 1976 when I had just completed my M Pharm. I cannot forget my teacher of pharmacy, Dr Srivasatav who is responsible for making me and shaping me as a pharmacy teacher and researcher.

Dr N Udupa Professor and Research Director (Health Sciences), Manipal University, Manipal

n Teachers’ Day I always talk about my favourite teacher, Anne Warrior. She was a fascinating person who taught me to think for myself, to excel in everything I do and to do things differently and creatively in order to make a difference. Once, she got us to creatively spruce up a wilting garden patch in school into a designer cactus garden over a weekend to win our class ‘The Garden Patch of the Year’ award! Now when I look back, I realize that her unconventionality rubbed off on me and led me later in life to break convention and do many of the things that were considered pioneering for young women in the 1970s.

O Dr Dinesh Dua Vice Chairman, Pharmexcil, Chairman,Higher Education, CII North India n Teacher’s Day on, I very fondly recall my Dronacharya Guru, Dr Ahmed, HoD Pharmacology. Early on in 1972, he saw a spark in me from the chemistry perspective besides potential in extracurricular activities and sports. With his continuous mentoring for five years of my academic career, I excelled in pharmacology. He encouraged me to prepare and qualify for MBA from the Indian Institute of Management, Ahmedabad during 1977-79 which gave a great fillip to my career. Dr Ahmed strongly ingrained in me a huge significance for culture and a value system which I’m very proud of. Whatever I’m today, a huge credit goes to Dr Ahmed's mentoring.

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◗ Gelatin capsules have been in use for over 100 years. It has been found to be very safe for human consumption and accordingly it has been accepted by regulators all over the world.

◗ There have been no adverse reports of gelatin capsules. ◗ We are totally self-sufficient with the raw materials for gelatin capsules.

person whose wisdom changed my life, in its own way, was the late Nobel Laureate, Sir James Black, the Research Scientist at GSK, UK whose work led to the development of Propranolol and Cimetidine. I learnt that a recognition by the Nobel Prize Committee is not given only for expertise and new frontiers development in the narrow area of specialisation of the award winner. It is also for a broad and humanitarian view of our planet. I learnt that one could talk to Sir James on almost every subject. For example, we even discussed about marriage and divorce, right down to how to avoid bureaucracy creeping into a growing organisation. He said that his recipe for attacking bureaucracy would not be found in any book on Management. It was simply that, within an organisation, authority should never be given to a person to say No to any proposal

Secretary-General, IDMA

e have taken up the matter with the Health Ministry and DCGI. We also had a meeting with Nripendra Misra, Principal Secretary to PMO on July 18, 2017 in New Delhi and explained to him that change over from gelatin capsules to cellulose capsules in no way would benefit our Indian population. He asked us as to how much time industry would require to change over, to which we put forth our logical arguments as mentioned below. Finally, he was of the opinion that both types of capsules should co-exist. We therefore request the government to continue to allow the use of gelatin capsules to ensure availability of safe, efficacious and affordable drugs to the patients.

(

HOMAGE TO THE GURUS

DAARA B. PATEL

◗ Thousands of crores have been spent on establishing the quality, viability and economics of gelatin capsules.

VIVEK SEIGELL Director, PHD House

'IDMAWOULD NOT RECOMMEND CHANGE FROM GELATIN TO CELLULOSE'

Kiran Mazumdar Shaw

cover )

Dr Arun Garg General Secretary – IPGA, Prof. & Dean, School of Medical & Allied Sciences KR Mangalam University, Gurgaon rof B Suresh, the Honourable Vice-Chancellor of JSS University, Mysore, was my Ph.D supervisor and is my ideal teacher! Prof Suresh has been actively involved in uplifting the quality and standards of pharmacy education and profession in India for the past 30 years. It was Prof B Suresh who gave me the opportunity and encouraged me to indulge myself in pharma research especially on drug utilisation to ensure and improve the safety and quality of the life of diabetic patients. It was this humanitarian concern of my teacher that has made me become fully committed to indulge in the issues and problems of diabetic patients around. On the very first day in JSS College of Pharmacy, Ooty, Prof Suresh introduced Dr David Kosh from Adelaide, Australia, to me and encouraged me to interact with him. With utmost care, Dr Kosh went through my concepts and improved my understanding of the drug utilisation studies. It is this generous and selfless attitude of my teacher that enabled me to have a wider circle of pharmacy related academicians. Prof Suresh’s nurturing and encouragement has helped me a lot to enrich my professional career. Last, but not the least, I would like to share with you that Prof Suresh as a human being is very supportive and always gives right guidance and suggestion with clear objectives and aims.

The government is making all efforts to uphold GST and Make in India campaign as their progressive steps. This September, the Make in India campaign will be turning three and the government has given many lucrative schemes to encourage industries to work in line with the campaign. The government is trying to attract investors and encourage them to setup their manufacturing facilities in the North Eastern region and Himalayan states. Last year in May, PM Narendra Modi had said that he will consider the North Eastern Region as the Gateway to South-East Asia. And recently Arun Jaitley, Finance Minister announced that under the GST regime, the government has extended tax incentives to industries in the North Eastern and Himalayan states till March 2027 albeit as a refund. Under the new GST regime, there is no provision for exemption but there is one section under the Act which permits refunds. The industry experts are saying that the later move of the government is to implement indirect taxation structure and give exemption to business enterprises from paying sales tax.These businesses will be eligible to

DR AJIT DANGI

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September 1-15, 2017

claim the refund later. To bring a new tax regime based on exemption, the Department of Industrial Policy and Promotion (DIPP) is working on preparing a scheme which will replace the current system. However, the new GST regime is critical for several industries like automobile, pharma and consumer goods and companies must start units in backward areas, where the economic condition of the state is poor just by availing the advantage of area-basedprogramme. This is a major reason why the government is extending tax incentives since 2003 to these regions. On January 7, 2003, the new industrial policy and other concessions for these states were announced for 10 years. However, companies started looking to exit the state as the concession period ends. To retain companies, the government further extended the concession till March 2017. To those who set up their facilities before march 2017, now it has been further extended for 10 years which will help companies to contribute to PM Modi's vision of Make in India. By Usha Sharma

Apart from taxincentives,there is a need for dedicated pharma parks

CMD, Biocon

he most important priority for ‘Make in India’ campaign from the pharma industry perspective should be domestic manufacturing of APIs, as we are over dependent on China and other countries for supply of APIs as well as drug intermediates. Any disruption in supply chain due to any geopolitical reasons could drastically impact our formulation industry. The new draft pharma policy has taken cognizance of this problem and has proposed that for-

mulations manufactured using domestically produced APIs be exempted from price control for a period of five years as well as be given preference for government procurement. The finance minister’s announcement of tax incentives under GST for companies setting up manufacturing facilities in North Eastern and Himalayan states till March 2027 is a positive move and certainly encourage industry to set up their manufacturing plants in this region. Already more than a

30 EXPRESS PHARMA September 16-30, 2017

dozen large pharma companies have made plans for the same. Apart from tax incentives, there is a need for dedicated pharma parks with subsidised water, electricity, common effluent plant etc. Assistance in land acquisition will help in attracting industry. A proactive drug control administration and skill training centre in the these zones and good logistic as well as digital infrastructure will provide necessary ecosystem for efficient running of such manufac-

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Continuityof taxincentives will not onlyboost the industrybut also human health

MAKE IN NORTH EASTINDIA

President & CEO, Danssen Consulting

32 EXPRESS PHARMA

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turing plants. As regards to GST, while the government is periodically issuing clarifications on 'frequently asked questions', many SMEs will require guidance on interpretation on matters such as clearance of physicians samples not for sale, treatment of loan licence units, supplies made from erstwhile tax free zones etc. A GST Guidance Cell, in collaboration with industry associations, in these zones will help clear many such doubts.

DR SANJIT SINGH LAMBA MD, Eisai Pharmaceuticals

he pharma sector is the caretaker of national human resources of any country. Being a nation which has more concern and care for human beings and which has a huge population with hand to mouth means of earning, does necessarily require affordable pricing of medicines to all. In pursuit of that, providing tax incentives to pharma companies, irrespective of the zone or region is always a step in the right direction to provide affordable price of medicines to all. So, the continuity of tax incentives to pharma companies will not only boost the industry but also keep the well-being of human health. ‘Make in India’ is a major national initiative designed to facilitate investment, foster innovation and build best in class infrastructure that will further boost the economy and bring in more foreign investment in India. It should not be restricted as a concept and should be propagated to the world that Make in India as a philosophy is a reality and this can happen when the government is serious in giving incentives and tax breaks to companies. This will boost indigenous innovation and also compete with countries like China for API manufacturing.

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36 EXPRESS PHARMA August 16-31, 2017

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Pharmaceutical Grade Crystalline, Spray Dried, Anhydrous, and Inhalation Lactose • For more than 70 years, we have delivered the industry's most extensive Lactose portfolio

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CPhI & P-MEC INDIA 2017 SPECIAL

EXPRESS PHARMA (NOVEMBER 1-15, 2017) THE TECH EFFECT

cover )

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ndia Pharma Inc has emerged as a noteworthy competitor and a significant partner in the global pharma arena. However, with thinning product pipelines, lessening blockbuster drugs, increasing regulatory scrutiny, pricing pressures, quality concerns, increasing duration of clinical trials, shifting disease profiles and patterns etc., challenges and barriers to success too are mounting.

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til recently. As an Accenture report, released a few years ago, stated, “The net effect is that real, enduring success has become tougher for life sciences companies to attain. More than ever, sustainable and profitable growth requires a solid foundation built on longer term fundamentals. Interestingly, very few companies in this industry consider supply chain excellence to be one of those fundamentals. Life sciences

Emerging new technologies are creating strategic opportunities for organisations to build competitive advantages in various functional areas of management including logistics and supply chain management Anjani Mandal, Co-founder and CEO, 4TiGO

Technology can be used to integrate functions across the network, increase visibility of products across the value chain and automate processes to improve the supply chain’s responsiveness and reliability Nishith Rastogi, Founder, Locus.Sh

Automated storage and distribution centres will add to just-in-time delivery model, reducing inventory and financial losses due to expiry of medicines Dinesh Agarwal, Executive Director, Khaitan & Co

We would see a lot new businesses flourishing with a focus on pharma logistics which has very different needs when compared to the FMCG sector Pradyumn Singh, Co-founder and CEO, Pharmarack

This, in turn, has led to pharma companies expanding their horizons to emerging markets, exploring untried strategies and revamping their product mix. In this scenario, the role of an effective supply chain to become a major differentiator in the value chain, as companies seek the next phase of growth, cannot be undermined. Yet, the supply chain has often rated very low in the priority list of life sciences companies un-

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companies typically spend more time and effort on the commercial and research sides of the business and, conversely, place a lower priority on supply chain improvement.” Thankfully, the pharma companies are gradually waking up to the revenue building, cost-reducing potential of supply chain excellence. They have also recognised that revamping the supply chain, of which logistics is a major part, will enable pharma players to capitalise

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November 1-15, 2017

igital technology plays a key role in transforming a business enterprise and an industry at large.The pharma sector is no exception. Every segment of the pharma sector has been touched by technology and pharma logistics too is undergoing a metamorphosis, fuelled by digital technology. This article showcases various pharma logistic companies’ strategies to leverage digital technology in their business. Promising start-ups such as Locus, PharmaRack, 4TiGO, etc., share their vision to user better efficiencies in the logistics sector through technology and their efforts in this direction.The article also highlights the significance of digital technology in enhancing the supply chain within the pharma sector and examines future trends.future.

November 1-15, 2017

EXPRESS PHARMA (NOVEMBER 16-30, 2017) VIGILANCE FOR QUALITY

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THE MAIN FOCUS

Quality Assurance (QA) in pharma has been discussed and deliberated several times within the industry. Express Pharma has been a part of this debate for a very long time.We have brought to light many loopholes within the sector and presented many strategies to overcome challenges.This article reiterated the need for QA in pharma and pharmacovigilance’s role in ensuring it. Moreover, the article gives an update on the measures taken by the government and the private sector to put an effective QA system in place for India. Finally, it urged the industry to look at measures that need to be taken to strengthen QA in Indian pharma.We are constantly vigilant about the needs of the pharma industry.

By Swati Rana

24 EXPRESS PHARMA November 16-30, 2017

EXPRESS PHARMA

December 1-15, 2017

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November 16-30, 2017

CPhI & P-MEC INDIA 2017 SPECIAL DEALTRACKER

Pharma industry witnesses 68 deals in October 2017 Deal value decreases to $7.1 billion when compared five months average of $10.6 billion THE pharmaceutical and healthcare industry reported an increase in volume terms recording 68 deals in October 2017 when compared to five months average, which stood at 56 deals per month. However, deal value decreased to $7.1 billion when compared five months average of $10.6 billion. Novartis’ acquisition of Advanced Accelerator Applications, a pharma group specialised in the field of nuclear medicine, for $3.9 billion in cash, is one of the top deals reported in October. The acquisition will enable Novartis to introduce a new technology platform for cancer treatment and strengthen its oncology portfolio. Other major transactions reported in October 2017 include Amgen’s acquisition of remaining 50 per cent stake in Kirin-Amgen, a biotechnology company, for approximately $780 million; and TPG Capital’s acquisition of Exactech, a producer of orthopaedic implant devices and surgical instrumentation, for a price of $42 per share in cash or $625 million. The venture capital market recorded a decrease in the number of deals and deal values in October 2017 with 59 deals worth $1.1 billion when compared to five months average of 82 deals worth $1.2 billion. Notable fundings in October include: Cullinan Oncology raising $150 million in series A financing round; KSQ Therapeutics raising $76 million in financing round; and Forty Seven raising $75 million in series B financing round.

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December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Deal Date

Acquirer (s)

Target

Deal value (US$ m)

30-Oct-17

Novartis AG (Switzerland)

Advanced Accelerator Applications SA (France)

3,900.0

30-Oct-17

Amgen Inc (US)

Kirin-Amgen, Inc (US)

780.0

22-Oct-17

TPG Capital LP (US)

Exactech Inc (US)

625.0

5-Oct-17

Fidelity Management & Research Company (US); Valor Equity Partners (US); HBM Healthcare Investments AG (Switzerland); venBio LLC (US); Nan Fung Group (China); Novo Holding AS (Denmark); Vivo Capital (US)

Harmony Biosciences LLC (US)

270.0

25-Oct-17

Ambu A/S (Denmark)

invendo medical GmbH (Germany)

264.6

Deal Date

Acquirer (s)

Target

Deal value (US$ m)

3-Oct-17

F2 Ventures Limited; MPM Capital, Inc

Cullinan Oncology LLC (US)

150.0

2-Oct-17

Polaris Partners LLC; Flagship Pioneering Inc; ARCH Venture Partners LP; Alexandria Equities LLC

KSQ Therapeutics Inc (US)

76.0

17-Oct-17

Wellington Management Company LLP; Clarus Ventures LLC; Sutter Hill Ventures LLC; Lightspeed Venture Partners

Forty Seven Inc (US)

75.0

13-Oct-17

Undisclosed

Personal Genome Diagnostics Inc (US)

65.4

3-Oct-17

AME Cloud Ventures; Felicis Ventures; Two Sigma Investments LP; Epic Ventures; Advantage Capital Partners; Lux Capital Management, LLC; Charles River Ventures; Menlo Ventures; Data Collective Venture Capital LLC; Obvious Ventures; Mubadala Investment Company Limited; Undisclosed

Recursion Pharmaceuticals Inc (US)

60.0

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December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

New diabetes therapeutics to steal ground from insulin therapies: GBI Research Increased market diversification is expected due to patent expiries for major insulin products THE INCIDENCE of diabetes mellitus (DM), and most notably type II diabetes mellitus (T2DM), which accounts for 90–95 per cent of all DM cases, is growing rapidly on a global scale, according to business intelligence provider GBI Research. The company’s latest report, ‘Global Diabetes Drugs Market to 2023 - A Diversifying Treatment Landscape as GLP-1 Receptor Agonists and SGLT-2 Inhibitors Gain Ground Following Landmark Cardiac Outcomes’ reveals that the US is expected to experience the greatest rise in T2DM prevalence, and incidence rates are also expected to increase from 2.5 per cent in 2016 to four per cent by 2023. DM is a generalised term used to define multiple diseases with different etiologies that are characterised by chronic hyperglycemia (high blood glucose levels) resulting from insufficient synthesis, secretion or signalling of insulin – a hormone produced by the pancreas. The main role of insulin is to facilitate the absorption of glucose into skeletal muscle and fat cells following food digestion, which provides these cells with a source of energy for metabolism, and also reduces the concentration of glucose in the blood. Insulin signalling also has important roles in many processes including growth, development and controlling inflammation. The DM market has undergone a dynamic shift over the past decade, primarily due to the entry of three new non-insulin drug classes for T2DM: glucagon-like peptide-1 (GLP1) receptor agonists, dipeptidyl peptidase 4 (DPP-4) inhibitors and sodium–glucose linked transporter 2 (SGLT-2) inhibitors. EP News Bureau

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CPhI & P-MEC INDIA 2017 SPECIAL

Crohn’s Disease diagnosed incident cases set to increase in the 7MM to 2026 The burden of diagnosed Crohn’s Disease (CD) is expected to grow between 2016 and 2026 in the seven major markets

pidemiologists from GlobalData, a leading data and analysis company, forecast an increase in the number of diagnosed incident cases, most notably in the US and Japan. The company’s latest report ‘EpiCast Report: Crohn’s Disease – Epidemiology Forecast to 2026 and the EpiCast Model: Crohn’s Disease – Epidemiology Forecast to 2026,’ confirms that diagnosed incident cases of CD in the 7MM will increase from 70,985 cases in 2016 to 74,712 cases in 2026, at an Annual Growth Rate (AGR) of 0.53 per cent. In 2016, the US accounted for 63.23 per cent of the diagnosed incident cases of CD. The US is expected to have the highest number of diagnosed incident cases of CD among the 7MM throughout the forecast

period, while Italy will have the lowest. A spokesperson from the GlobalData Pharma Analysts team commented, “The

data is based on a base forecast that used literature values where there was lack of temporal data to trend for certain

markets. However, we believe the lack of temporal data is a data gap, and that in reality, incidence would be likely to increase based on findings from primary research and from analysis of global trends.” Therefore, an alternate forecast of diagnosed incident cases of CD is also provided for the US and the 5EU markets to estimate the patient size if trending was applied. The increase in incident cases in the alternate forecast is even greater than the main forecast for each market included. GlobalData epidemiologists estimate the US would see an increase of CD incident cases to 65,023 cases in 2026, and the 5EU will see an increase to 35,992 cases in 2026. CD is an inflammatory bowel disease (IBD) characterised by chronic inflammation of the

gastrointestinal tract. While any part of the gastrointestinal tract can be affected, inflammation is most commonly found at the end of the small intestine (ileum), and the start of the large intestine (colon). The disease course of CD is characterised by periods of remission followed by periods of relapse, the length and severity of which differ from case to case. Inflammation in CD can result in severe scarring and narrowing of parts of the bowel. There is no cure for CD, and treatment aims to control symptoms and sustain remission; it is estimated that up to three quarters of those with CD require surgery. The disease can lead to premature mortality, disability, and decreased quality of life. EP News Bureau

Flexion’s Zilretta poised to shakeup knee osteoarthritis marketplace The company anticipates a steady stream of novel therapies to enter the OA marketplace over the next 10 years FLEXION THERAPEUTICS recently announced the FDA approval of Zilretta, (triamcinolone acetonide [TA] extended-release injectable suspension) for the treatment of pain associated with moderateto-severe knee osteoarthritis (OA). This is a segment of the patient population that GlobalData, a leading data and analytics company, expects to significantly drive the value of the market over the next 10 years. The company anticipates a steady stream of novel therapies to enter the OA marketplace over the next 10 years including anti-nerve growth factor (antiNGFs) antibodies such as Pfizer’s tanezumab and Regen-

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December 1-15, 2017

eron’s fasinumab, as well as DMOADs such as Samumed’s SM04690 and TissueGene’s Invossa. Zilretta will face competition upon launch of these therapies; however, its significantly lower cost is likely to position the therapy earlier in the treatment algorithm, ensuring a large patient share and peak sales of over $345m by 2026. Maria Sudul, Healthcare Analyst, Globaldata commented, ‘‘The OA space is largely genericised, so the entry of Zilretta at a hypothetical cost of $500 per injection is likely to shift the treatment algorithm, with Flexion’s extended-release injection replacing the conventional intraarticular (IA) TA injection as

the preferred treatment option in the US.” Zilretta is a sustained-release IA injection of TA delivered in a poly lactic-co-glycolic acid matrix (PLGA), which releases the drug’s active ingredient in the joint and is subsequently metabolized into carbon dioxide and water. The significance of Flexion’s proprietary microsphere technology is twofold. Localised and sustained release of Zilretta in the joint space offers pain relief for over 12 weeks, which is up to four times longer than conventional TA IA injections. In addition, Zilretta’s product label includes positive data from a double-blind, ran-

domised, parallel-group trial examining blood glucose concentrations in patients with type II diabetes, with peak plasma concentration of Zilretta decreased 40-fold relative to immediate-release TA. This is particularly important for comorbid OA patients with type II diabetes, as conventional IA corticosteroid injections can elevate blood glucose levels, causing significant distress for these patients and potentially negatively impacting compliance. The OA space has been stagnant for several decades, largely due to the elusive nature of OA pathophysiology and consequent lack of suitable therapy targets. Recent advancements

in OA biomarker research have led to the identification of potential targets, which is reflected in the current OA pipeline. The FDA approval of Zilretta offers an important alternative therapy option to OA patients and marks an important milestone for the OA space. Sudhul added, ‘‘Even with the entry of Zilretta to the market, the unmet need for improved therapies remains largely unfulfilled, with an abundance of opportunities existing for the development of novel analgesics and disease-modifying OA drugs (DMOADs) with improved modes of action.” EP News Bureau

CPhI & P-MEC INDIA 2017 SPECIAL

Affluent market,medical tourism to steer best-in line drug delivery devices in India Trends indicate that medical tourism will also bolster the demand for sophisticated devices AS THE GDP per capita increases, India’s affluent market will drive demand for best-in line drug delivery devices and reward innovations in the years to come, says GlobalData. According to the company’s latest report, ‘India Drug Delivery Devices Market Outlook to 2023, – Central Venous Catheters, Infusion Systems, Needle Free Injections and Metered Dose Inhaler Devices,’ the market, which was worth $411 million in 2016, is on course to touch $510 million by 2023, clocking a CAGR of 3.1 per cent from 2016 to 2023. Trends indicate that medical tourism will also bolster the demand for sophisticated devices and emerge as an important source of revenue for the Indian medical industry. Relatively affluent patients from more developed countries are opting India to get a standard of care at a fraction of the cost compared to their home country. As healthcare prices in the developed world continue to increase, so too will the interest in medical tourism in India. Even as the demand for sophisticated products is set to grow, Indian government is ready and willing to take strong measures to control the prices of devices. This calls for devices sold within its borders to be effective as well as cost efficient. Aging population, prevalence of chronic diseases, increasing health awareness are among the other key factors driving this market. According to GlobalData, the country’s aging population will take care of volume growth in future, if not necessarily the quality of products. Currently, 1.9 per cent of the population of India is 75 or above. James Spencer, Medical Devices Analyst, GlobalData, says, “India is the ‘diabetes capital’ of the world, and the number of people suffering from diabetes is only expected to increase. As more knowledge and awareness is spread about diabetes, the de-

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December 1-15, 2017

mand for insulin delivery systems will only grow as time pro-

gresses.” Interestingly, the overall drug delivery devices space is

almost swept by overseas players, with only one domestic firm

figuring in the top 10 list. EP News Bureau

CPhI & P-MEC INDIA 2017 SPECIAL UPDATES

FDAapproves Roche drugs for rare types of blood,lung cancers The drug is already approved for patients who have been treated with Pfizer's lung cancer drug Xalkori ROCHE HOLDING won US approval to market its skin cancer drug Zelboraf for certain patients with Erdheim-Chester Disease, a rare type of blood cancer, and to market its drug Alecensa as a first choice of treatment for a subset of patients with non-small cell lung cancer. The Food and Drug Administration approved Zelboraf to treat patients with ErdheimChester Disease whose cancer cells have a genetic mutation known as BRAF V600. It is the first FDA-approved treatment for the disease.

Zelboraf is already approved to treat melanoma, the most serious type of skin cancer, in patients whose cancer cells also contain a BRAF V600 mutation. Only 600 to 700 patients world-wide suffer from Erdheim-Chester Disease, and about 54 per cent of those have the BRAF V600 mutation, the FDA said. Separately, the FDA approved Roche’s drug Alecensa as initial treatment for patients with a rare form of non-small cell lung cancer caused by a mutation to a gene known as ALK.

The drug is already approved for patients who have been treated with Pfizer's lung cancer drug Xalkori whose disease had nonetheless progressed. Now patients can be given Alecensa without first being treated with Xalkori. Patients with ALK-positive non-small cell lung cancer account for about 5 per cent of patients with the condition. Non-small cell lung cancer accounts for about 85 per cent of the more than 220,000 lung cancer cases diagnosed in the United States each year. Reuters

Novartis seeks European approval for cell therapy Kymriah The immunotherapy Kymriah is a key element of Novartis’s efforts to bolster its portfolio of oncology drugs SWISS DRUGMAKER Novartis has submitted its cell therapy Kymriah for European approval in two forms of blood cancer, seeking to expand the use of a new treatment it hopes will eventually become a $1 billion-a-year seller. Novartis has applied to the European Medicines Agency (EMA) for Kymriah to be used in children and young adults with acute lymphoblastic leukemia (ALL) and adult patients with diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant, the company said. The therapy has been approved in the US in paediatric ALL and was submitted in the world’s largest drug market for

80 EXPRESS PHARMA December 1-15, 2017

adults with DLBCL last week. The immunotherapy Kymriah is a key element of Novartis’s efforts to bolster its portfolio of oncology drugs. It has been hit by the patent expiry of its once top-selling blood cancer medicine Gleevec, whose market is quickly being eroded by generic rivals. “The submission to the EMA is a major step toward our goal of delivering it to more critically ill cancer patients around the world,” said Vas Narasimhan, Novartis’s drug development chief who will take over as chief executive from Joe Jimenez on Feb. 1. Kymriah is a chimeric antigen receptor T cell (CAR-T) therapy in which patients’ immune cells are taken from their

bodies, genetically re-engineered to fight their cancer and then reinfused. While Kymriah’s landmark approval in August in the US signalled a new era in cancer treatment, the drug now faces rivals in the DLBCL setting. Last month, the US Food and Drug Administration approved Gilead’s Yescarta for patients with the disease who had failed other treatments. Novartis set the price for Kymriah at $475,000 per treatment for young patients with ALL that respond to the treatment, but the Basel-based company has yet to announce the price for additional indications and geographies. Reuters

CPhI & P-MEC INDIA 2017 SPECIAL

GSK gets boost for early cancer hopes with breakthrough status The decision by the Food and Drug Administration paves the way for a speedy regulatory review of the BCMA drug for multiple myeloma GLAXOSMITHKLINE received a boost for its oncology research when an experimental drug for blood cancer received a 'breakthrough' designation from US regulators. The decision by the Food and Drug Administration paves the way for a speedy regulatory review of the BCMA drug for multiple myeloma. Although GSK sold its marketed cancer drugs to Novartis in 2015, it continues to invest in early-stage research

GSK planned a rapid programme of clinical trials with the new drug, both alone and in combination with other therapies and has said oncology could become another pillar of its pharmaceuticals business, alongside HIV and respiratory medicine. The actions by the US and European regulators are based on promising Phase I clinical trial results, details of which will be announced on December 11 at the annual meeting of the American Society of Hematology meeting in Atlanta. GSK planned a rapid programme of clinical trials with the new drug, both alone and in combination with other therapies. Reuters

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CPhI & P-MEC INDIA 2017 SPECIAL

Biotech firms race to recruit good bugs in war on cancer Certain bacteria seem to help in cancer by priming immune cells and smoothing the path for immunotherapy drugs known as PD-1 drugs BIOTECH COMPANIES are competing to develop medicines using 'bugs as drugs' to fight cancer, building on the latest scientific findings that patients with high levels of good gut bacteria are more likely to respond to modern immunotherapy. Certain bacteria seem to help in cancer by priming immune cells and smoothing the path for immunotherapy drugs known as PD-1 drugs that work by taking the brakes off the immune system. Seres Therapeutics hopes to become the first company to leverage this discovery through a collaboration with the MD Anderson Cancer Center in Texas and the Parker Institute for Cancer Immunotherapy that will see its microbe medicine tested in a clinical trial. The Cambridge, Massachusetts-based firm has an exclu-

sive option to license patent rights under the deal announced recently. MD Anderson scientists were among two groups of cancer researchers who reported on the benefits of good gut microbes in the journal Science earlier this month. The work underscores the importance of the microbiome - the vast community of microbes living inside us - which has been linked to everything from digestive disorders to depression. Roger Pomerantz, CEO, Seres told Reuters the aim was to start the randomised, placebo-controlled clinical trial in metastatic melanoma in 2018, evaluating the impact of giving a newly developed Seres microbiome drug alongside a PD-1 therapy. There are currently two approved PD-1 drugs, Merck &

Co’s Keytruda or Bristol-Myers Squibb’s Opdivo, but Pomerantz declined to say which would be used. Seres, which is backed by Swiss food giant Nestle, became the first microbiome drug developer to go public in June 2015 but it suffered a setback last year when its leading drug candidate failed in a trial against C. difficile, a debilitating gut infection. Other companies are competing hard. Like Seres, some are also eyeing the new opportunity in cancer, as microbiome science moves beyond the initial focus on gastrointestinal conditions like C difficile, ulcerative colitis and inflammatory bowel disease. Vedanta Biosciences, another US biotech firm that is an affiliate of PureTech Health, plans to file for approval to start a clinical trial in immuno-

oncology in 2018, while Synlogic is also working on experimental cancer therapies. French biotech company Enterome, meanwhile, is working with Bristol-Myers on microbiome-derived diagnostic tests and potential drugs to use with the US drugmaker’s immunotherapy medicines. “This shift makes sense,” said Bernat Olle, CEO,Vedanta of the latest focus on cancer. “About 80 per cent of your immune system cells are in the intestine ... but cells that are educated in the gut don’t stay there. Every day they cycle several times throughout the body and some of them will go to tumours.” Advocates argue that microbiome medicine offers a smart way to both tone down the immune system response useful for conditions like rheumatoid arthritis and aller-

gies - or ramp it up, which is needed for the body to fight back against cancer. The first wave of microbiome drugs rely on faecal microbiota transplantation (FMT), or samples of microbes distilled from human faeces, delivered either as a capsule or by enema. But companies are also working on synthetically fermented versions. Seres boss Pomerantz believes microbiome science will open up a major new treatment field, like monoclonal antibodies did when they were pioneered by Centocor, now part of Johnson & Johnson, three decades ago. “Just as Centocor started monoclonals back in the 1980s, we think we are the Centocor of the microbiome - but of course there will be other companies.” Reuters

Merck's drug gets US FDAapproval Sandoz says new The drug is expected to be available from December, was approved both as a tablet and an injection MERCK'S DRUG to prevent serious infection in patients who undergo a type of stem cell transplant was approved by the US Food and Drug Administration, the drugmaker said recently. Merck said the drug, which is expected to be available from December, was approved both as a tablet and an injection. The list price for the tablets is $195 per day, while it is $270 a day for the injection. The recommended dosing for the drug is once everyday for 100 days after the stem cell transplant, bringing the effective list price to $19,500 for the tablets and $27,000 for the injections. The list price of a drug is not necessarily what patients actually pay. ‘Out-of-pocket’ costs

82 EXPRESS PHARMA December 1-15, 2017

While there are other drugs that treat CMV once it occurs, attempts to find a safe drug that can prevent it had failed vary based on the duration of the treatment and individual healthcare plans. Merck’s drug, Prevymis, was approved to prevent cytomegalovirus (CMV) infection a complication associated with bone marrow transplants that treat acute leukemias, other cancers and diseases of the bone marrow. CMV can occur in pa-

tients who have undergone a transplant of hematopoietic stem cells, which are located in the bone marrow and derived from a donor. While there are other drugs that treat CMV once it occurs, attempts to find a safe drug that can prevent it had failed. Reuters

clinical data support two biosimilars The trials shows the efficacy and safety of biosimilar adalimumab NOVARTIS’ GENERICS division, Sandoz, said new immunology data from four clinical studies supported its proposed biosimilars adalimumab for treating psoriasis and cancer drug rituximab. Adalimumab is a copy of AbbVie’s Humira, while rituximab copies MabThera/Rituxan by Roche and Biogen. The trials showed the efficacy and safety of biosimilar adalimumab and the safety of biosimilar rituximab matched their reference medicines in studies of multiple-switching and retreatment, Sandoz said. Biosimilar adalimumab is under European regulatory review, while biosimilar rituximab has already been approved in Europe and is under review by the U.S. Food and Drug Administration. Reuters

CPhI & P-MEC INDIA 2017 SPECIAL

Novartis posts eye drug data amid play for Eylea’s turf The Basel-based drugmaker hopes this latest analysis lends RTH258 additional muscle when matched head-to-head with Eylea NOVARTIS’S BID to move in on Bayer’s and Regeneron’s eyedrug turf was buoyed by data showing patients on the Swiss drugmaker’s new RTH258 drug showed less disease activity than those on its rivals’ drug Eylea. Active disease was observed in 23.5 per cent of RTH258 patients versus 33.5 percent of Eylea patients at 16 weeks, Novartis said, of its investigational treatment for wet age-related macular degeneration (AMD), where abnormal, leaky blood vessels can cause blindness. A second, similar study found active disease in 21.9 per cent of RTH258 patients versus 31.4 per cent of those on Eylea for the condition affecting 20-25 million people worldwide. Novartis in June touted initial data showing its drug may require fewer injections directly into the eye than Eylea, while matching it on vision and safety measures. The Basel-based drugmaker hopes this latest analysis lends RTH258 additional muscle when matched head-to-head with Eylea as well as Lucentis, which Roche sells in the United States. “When you take all of that together ... we believe we have a very compelling proposition,” Vas Narasimhan, Chief Drug Developer, Novartis who will become CEO in 2018, said on a conference call. Novartis, which released the data at the American Academy of Opthalmology conference in New Orleans, predicts RTH258 annual sales will top $1 billion and aims to file for US approval in late 2018. Making it a success is by no means clear sailing. For one, Novartis owns Lucentis rights in Europe where it has contractual obligations to continue marketing that drug. Analysts say cannibalisation from RTH258 will be a challenge. Competition abounds, too: Eylea, with $5 billion in annual sales, has made inroads against the $3.2 billion-per-year Lucen-

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December 1-15, 2017

tis, whose 2020 US patent expiration will expose it to cheaper copies.

Moreover, Roche’s cancer drug Avastin is effective in off-label AMD use and has won favour

because it costs a fraction of Lucentis and Eylea. In Britain, Novartis and Bayer are fighting

doctor groups aiming to switch to Avastin. Reuters

CPhI & P-MEC INDIA 2017 SPECIAL

J&J’s Stelara shows promise against lupus in study J&J said the results were strong enough to advance Stelara into larger Phase III testing JOHNSON & Johnson’s blockbuster psoriasis drug Stelara led to a significant reduction in disease activity in patients with systemic lupus compared with a placebo in a midstage clinical trial. Stelara, a biotech drug known chemically as ustekinumab, is already approved for psoriasis, psoriatic arthritis and Crohn’s disease and had thirdquarter sales of $1.12 billion. In the trial of 102 patients with active lupus despite being on standard therapy, 60 per cent of those who received Stelara experienced improvement on a scale that measures disease activity after 24 weeks of treatment. That compared with improvement in 31 per cent of

patients who received a placebo on top of standard medicines, such as steroids or immunosuppressive drugs, the company reported. Dr Ronald van Vollenhoven, the study’s lead investigator, called the results 'pretty exciting and encouraging,' adding that Stelara’s known safety profile provided added comfort. J&J said the results were strong enough to advance Stelara into larger Phase III testing. There has only been one new drug approved for lupus in the last 50 years, GSK’s Benlysta. “Any new treatment for lupus is going to be very welcomed by patients and physicians,” said van Vollenhoven, who was scheduled to present the data at a

rheumatology meeting in San Diego. Lupus is a debilitating and sometimes fatal chronic inflammatory autoimmune disorder that can affect the joints, skin, heart, lungs, kidneys and brain.

An estimated 1.5 million Americans and five million people worldwide have the disease which disproportionately affects women. On some secondary measures of disease activity, such as Physician Global Assess-

ment, Stelara failed to achieve statistical significance over placebo but showed a trend in the right direction, researchers reported. Stelara did lead to significantly fewer disease flareups. Van Vollenhoven said trials for potential new lupus treatments were notoriously difficult because of the way disease activity tends to come and go and because Stelara can affect patients differently. The J&J drug was given intravenously at the start of the trial and then by subcutaneous injections every eight weeks. It works by blocking two proteins believed to play an important role in the immune system’s inflammatory process. Reuters

Time limit for stroke treatment may be longer in selected patients The patients, all of whom had an occlusion of the intracranial internal carotid or proximal middle cerebral artery, were treated at 26 centres in the US, Europe, Canada and Australia REMOVING A stroke-causing clot from a large blood vessel in the brain can improve outcomes in some patients, even when extraction occurs six to 24 hours after symptoms develop, according to results of a large new test of the technique. Until now, studies have suggested that the extraction needs to be performed within six hours of the stroke. The old time limit may still provide the best outcome, but the new findings of the DAWN trial open the door to clot removal for other patients, particularly people who don’t discover their symptoms until they wake up, making the precise time of onset unknown. The study was financed by Michigan-based Stryker Neurovascular, which made the clotremoval device used in the trial, maintained the database for the study, and analysed the data. “The stroke community is going to embrace these results very easily because many be-

84 EXPRESS PHARMA December 1-15, 2017

lieve you can benefit beyond 6 hours,” coauthor Dr Tudor Jovin, University of Pittsburgh Medical Center Stroke Institute told Reuters Health. But the results, presented at the Society of Vascular and Interventional Neurology’s annual meeting in Boston and online by the New England Journal of Medicine, are not going to apply to all stroke patients. The DAWN study only considered testing the technique, known as thrombectomy, on people with a blockage in a large blood vessel of the brain that had produced symptoms six to 24 hours earlier. In about one third of those cases, symptoms were far more severe than a CT scan or an MRI of the brain might suggest, and that mismatch made them candidates for clot extraction, said Dr Jovin. That meant some degree of blood was still getting to the affected areas of the brain. Those criteria would apply

to only about 2 per cent to 3 per cent of the roughly 800,000 strokes in the US each year, according to Dr Jovin. The results of the study are 'strikingly positive,' said Dr Werner Hacke, a neurologist at the University of Heidelberg in a Journal editorial. At 90 days, 49 per cent of the 107 patients who received a thrombectomy along with standard care were functionally independent versus 13 per cent of the 99 who received standard care alone. The rate of neurological deterioration was 14% in the clotextraction group versus 26% with standard care. “For every 2.8 patients who underwent thrombectomy, one additional patient had functional independence at 90 days,” the researchers concluded. The benefits were seen regardless of age, stroke severity, time to treatment, the site of the blockage and whether the stroke happened when the person was

awake or asleep. Delayed removal did not, however, reduce mortality, which occurred at rates of 19 per cent with clot extraction and 18 per cent without. The patients, all of whom had an occlusion of the intracranial internal carotid or proximal middle cerebral artery, were treated at 26 centres in the US, Europe, Canada and Australia. The trial was stopped after the first interim analysis because the benefit was so dramatic. The median time between inclusion in the trial and when the patient was last known to be free of new stroke symptoms was 12.2 hours in the thrombectomy group and 13.3 hours in the control group. It typically took another 1.4 hours to remove the clot and restore blood flow to the brain. But the key element in deciding whether to go ahead with clot removal once more than six hours has expired is whether there is a sizable “area of re-

versible damage that’s severely undersupplied with blood and not functioning well, but still alive,” said Dr Jovin. “It’s not the time; it’s that mismatch.” If the clot isn’t removed, “the area that’s threatened but not dead will eventually become dead,” he explained. Dr Hacke cautioned that the findings do not mean doctors can relax the six-hour treatment window. “Reducing the time from the onset of stroke to treatment remains essential and results in the best outcomes,” he said. “It is likely that a limited proportion of patients with occlusion of a large vessel who present late after the onset of stroke will have a small infarct core and a large volume of tissue at risk, as did the patients in the DAWN trial. For those patients, late thrombectomy works — but as of now, as far as we know, it works only for them.” Reuters

CPhI & P-MEC INDIA 2017 SPECIAL

Trial data suggests new typhoid shot could halve infection rate The vaccine developed by Bharat Biotech could also be used safely in babies A NEW typhoid vaccine developed by privately-held Bharat Biotech proved safe and highly immunogenic in a study and could be used to prevent millions of infections if it succeeds in final-stage clinical trials, researchers said. Typhoid fever affects between 12 and 20 million people worldwide in regions where the quality of water and sanitation is low, particularly in south Asia and sub-Saharan Africa. Around one in 100 cases is deadly, and about 3 per cent of those infected become chronic carriers of the disease. Results of a mid-stage trial of the vaccine, a so-called Viconjugate shot which, its developers say, could also be used safely in babies, showed it was able to prevent half of those vaccinated from developing typhoid when they were exposed to it. “Our study provides further evidence to support the development of Vi-conjugate vaccines as a control measure to reduce the burden of typhoid fever,” said Andrew Pollard of Oxford University’s vaccine group, who co-led the trial. Experts say that while children are particularly susceptible to typhoid, no vaccine has yet been licensed for worldwide use in babies under 24 months old. This study, published in The Lancet medical journal, was conducted in 112 adult volunteers and used a ‘controlled human infection model.’ Volunteers are randomly assigned to be given either the experimental vaccine or a control one, and then deliberately exposed to the pathogen. Participants are closely monitored and treated for infection afterwards. Studies like this have been used in the development of various vaccines, including shots against cholera, since they are a fast and clear way to assess whether a vaccine works. Nicholas Feasted, an expert at the Liverpool School of Tropical Medicine in Britain, and Myron Levine of the University of Maryland in the US,

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December 1-15, 2017

said in The Lancet that the trial’s results had been “awaited with much anticipation” by global health experts keen to tackle typhoid in en-

demic areas. The World Health Organization’s expert panel on vaccines is due next month to consider whether to recommend Vi-con-

jugate vaccines to prevent typhoid. Once the WHO’s recommendations have been made, the Global Alliance for Vaccines and Immunisation, which helps

fund vaccines at lower prices for poor countries, will decide whether or not it can finance the shots. Reuters

CPhI & P-MEC INDIA 2017 SPECIAL

‘We received an excellent reaction from the European market’ Suresh Pareek, MD, Ideal Cures, in an interaction with Express Pharma, talks about the uniqueness of INSTACOAT 4G, which was recently displayed at CPhI Worldwide What are the major advantages of INSTACOAT 4G over other coating technologies? INSTACOAT 4G stands today as one of those rare coating formulations that can maximise the potential of advanced continuous and batch coaters. Our team has also presented papers on this innovation at AAPS 2017, held in San Diego this year. Some of the major features of INSTACOAT 4G include but are not limited to: ◗ High production output with approximately 60 per cent reduction in the coating process time compared to HPMC-based film coating systems ◗ Reduced energy consumption by virtue of reduced coating time results in reduced carbon emissions and carbon footprint making INSTACOAT 4G a best-in-class eco-friendly coating system ◗ There is an approximate reduction of 80 per cent in carbon emissions/ year with INSTACOAT 4G compared to traditional coating systems (11 per cent) ◗ *Batch size = 300 kg, ◗ ** 2 batches of 300 kg/day in a year (300 working days in a year) ◗ *** With respect to 11 per cent reconstitution levels ◗ # 0.5377(CO2 conversion factor used for calculations, Ref: Carbon Trust, “Conversion factors: Energy and Carbon Conversions” 2011) Assumptions: All the parameters are based on assumptions. These assumptions were used to quantify both the aforementioned energy consumption and the production capacity of a single coater. These numbers may obviously vary from equipment

86 EXPRESS PHARMA December 1-15, 2017

to equipment, from company to company and by geographic location. Typical values are used and it is used as a representative analysis. Under the assumptions provided in this article, using INSTACOAT

system). ◗ INSTACOAT 4G allows for high solids reconstitution level of 35 per cent at low viscosity values and increased spray rates ◗ INSTACOAT 4G trials have

4G may reduce energy consumption since it has shorter coating process time and may in turn reduce equivalent CO2 emissions by 79.2 per cent per year (compared to HPMC coating

NSTACOAT 4G - CO2 EMISSION Reconstitution levels

Energy consumption (KWhr/batch*)

Equivalent CO2 emission (kg/batch)#

CO2 emission (kg/year)**

CO2 saving per year (%)***

Reference (11 per cent)

Approx. 610 (1)

328

1,97,000

Reference (20 per cent)

Approx. 340

183.3

1,09,000

44.7

INSTACOAT 4G (35 per cent)

Approx. 126

67.8

41000

79.2

Batch Coater (60 inch pan) Parameters

Traditional HPMC Based Aqueous System

PVA Based System

Batch size (kg)

INSTACOAT 4G

300

% Solids

Target Weight Gain ( % )

No. of Guns

Spray Rate (g/min)

200

Process Time (Hr.)

6.8

3.8

2.10

% Time Reduction

60% w.r.t HPMC, 40% w.r.t PVA

Parameters

Traditional HPMC Based Aqueous System

PVA Based System

INSTACOAT 4G

Process Time (Hr.) for 1 batch of 300 kg

6.8

3.8

2.10

Process Time (Hr.) / Year (Assuming 2 batches of 300kg for 300 working days)

4080

2280

1260

Time Saving

(Table 3)

Parameters

Approx. 60 per cent time saving w.r.t HPMC and 40 per cent w.r.t PVA Reference (11 per cent) Reference (20 per cent)

shown to maximise the potential of batch and continuous coating machines – A poster detailing the INSTACOAT 4G trial conducted on continuous coaters, was presented at AAPS 2016 as well as AAPS 2017 ◗ AAPS 2017 Posters include: T5047: Coating Performance Evaluation of INSTACOAT 4G in a Bectochem Lodige Coater T5050: Evaluation of INSTACOAT 4G High Productivity Coating System using O’Hara Technologies Continuous Coater T5051: Coating Performance Study of INSTACOAT 4G using various spray guns and nozzles W1031: Evaluation of Coating Performance of INSTACOAT 4G in the Bectochem Perforated Pan ◗ Innate moisture barrier properties as the Polymer is PVA and the absence of plasticizers like PEG There is no gun blockage, tablet sticking and picking, giving the end product a smooth finish with excellent uniformity ◗ Cost saving Cost-savings by virtue of high production output, reduced energy consumption, shorter process times, decreased labour cost and reduced machine-free time. More than 60 per cent INSTACOAT 4G

Energy Consumption (KWhr/batch*) Batch size – 300kg

610

340

126

Energy Consumption (KWhr/year) Assuming 2 batches of 300 kg, 300 working days

3,66,000

2,04,000

75600

Cost spent on energy (Rs 7.07/ unit of KWhr, Palgarh District)

` 25,87,620

` 14,42,280

` 5,34,492

Cost-saving w.r.t traditional systems

Approx. 80 per cent cost saving w.r.t 11 per cent and 60 per cent w.r.t 20 per cent solids

CPhI & P-MEC INDIA 2017 SPECIAL reduction in process time is seen with respect to (w.r.t) traditional HPMC-based film coating systems. Reduced energy consumption (Kwhr) allows for approx. 70 per cent reduction in costs: How was your experience at CPhI Worldwide? Did you launch any new products? An avid participant of this prestigious exhibition, our booth was well received and saw continuous interaction. Some great opportunities presented themselves and we were eager to showcase our new innovation – InstaSpheres. We received an excellent reaction from the European market and are assured that InstaSpheres will be welcomed in India as well. To give a little introduction, InstaSpheres is our take on seal coated spheres, available in MCC, Sucrose, Tartaric Acid and Silicon Dioxide at various commercial sizes. These ready-to-drug layer next generations spheres are coated with either Hypromellose or Ethyl Cellulose. We do it for you so that you do not waste your time doing it. Being available for immediate drug layering they eliminate initial coating time. Reduction in overall processing time brings about massive time and cost saving. These spheres are robust with zero friability and negligible dust generation. Product consistency is maintained with uniform drug loading. There is tight particle size distribution with batch to batch consistency. We are very excited about these 'Next Generation' spheres and look forward to introducing our customers to them at CPhI India. Tell us more about the Sikkim facility. What was the reason behind choosing the state? A state-of-the-art, +7500 sq mt facility with an average capacity of 75 MT/month, our newly commissioned Sikkim facility opened doors in March 2017. The main idea behind setting up manufacturing at a remote location was to provide ease of business for our customers. There are around

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Products launched (Type and size Range (#)) MCC Spheres #20 - #30, #30 - #40 and #40 - #60 Sucrose Spheres #20 - #30 Tartaric Acid #20 - #30 and #30 - #40 Silicon Dioxide Spheres #30 - #40 and #40 - #60 40 pharmaceutical manufacturing plants in NorthEast out of which 32 are in Sikkim. With our new facility, we are the first excipient provider in the vicinity. Being centrally located to our

customers and close to the new airport, we are in a position to deliver our coating materials within the shortest time possible, sometimes even on the same day post manufacturing. This will

greatly reduce transportation time, cost and labour. The second phase of our facility will be commissioned soon, allowing for the production of coloured coating material. Manufacturing of white coating material has already begun and will continue with exponential speed. We have specifically recruited locals for this facility and have ensured that they

have received at least six months of training at our Vasai or Jammu facility. We take pride in being preferred suppliers for excipients and this new facility is another floret added to our blossoming bouquet of services. We are assured that our clients will welcome this new venture and will continue to give us opportunities to serve them! EP News Bureau

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CPhI & P-MEC INDIA 2017 SPECIAL

Risk-based monitoring: Gaining ground Risk-based monitoring (RBM) adoption is building momentum as pharma companies and CROs are shifting focus and are developing strategies to develop processes. An insight by Dr Bina Naik, Chief Operations Officer, CBCC Global Research

linical trial sponsor’s regulatory obligation is to ensure proper monitoring of investigation at each enrolling site. In order to fulfill this requirement, frequent onsite monitoring visits, i.e., 100 per cent source data verification (SDV) with regularly scheduled monitoring visits has been industry’s long standing practice. These monitoring activities include ensuring that rights and well being of trial subjects are protected, compliance with protocol, proper IP handling and management and verification of accuracy of data entered into the database against the primary source of the data. This thinking was changed in August 2013, when the FDA introduced the final guidance for a risk-based approach to monitoring in clinical investigations. This guidance supports selective monitoring, provided that the selective approach is justified in a riskbased monitoring plan linked to sponsor’s assessment of operational and patient safety risks. The FDA believes that targeted risk-based monitoring ( RBM) that focus on critical data elements will result in more effective monitoring and help to overcome many of the limitations of on-site monitoring. There is a growing consensus that risk-based approach is more likely to ensure subject protection and overall study quality while improving efficiency. ICH GCP E6 R2 is an important milestone in driving adoption of Quality-by-Design (QbD) and quality risk management principles and methodologies in clinical development. The revision promotes implementation of efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure hu-

88 EXPRESS PHARMA December 1-15, 2017

man subject protection and data integrity. The new GCP takes evolution of technology into consideration and encourages sponsors to pursue innovative approaches for conducting clinical trials. QbD and risk-based quality management are now recommended as approaches of choice to sponsors of clinical trials. Beyond the regulatory guidance, the TransCelerate BioPharma consortium (a non-profit organisation focussed on advancing innovation in research and development) has published a position paper with operational analysis, best practices, and practical tools for implementing risk-based monitoring. TransCelerate’s methodology focusses on building quality and risk management approaches into the scientific design and operational conduct of clinical trials to mitigate risk and detect issues early. While FDA guidelines and new Good Clinical Practice (GCP) guidance provide the foundation to RBM processes and methodologies, RBM adoption is gradually building momentum as pharma companies and CROs are shifting focus and are developing strategies to develop 2 processes and deploy appropriate technology to adopt risk-based monitoring of clinical trials to improve data quality, trial efficiency and patient safety.

Why adopt risk-based monitoring? Clinical trials are becoming more complex and costly. Various studies have estimated monitoring costs at around 30 per cent of the total study budget. The traditional approach, heavily reliant on exhaustive on site source data verification has proven to be

not only resource-intensive, but limited in its ability to identify and prevent issues proactively. The TransCelerate BioPharma consortium member companies conducted a retrospective analysis to assess queries identified via SDV to find the percentage of SDVgenerated queries in critical data. The total was only 2.4 per cent, suggesting that SDV has little impact on the quality of the data. Risk-based monitoring aims to more efficiently deploy resources across studies based on their specific levels of risk, with the goal of reducing total monitoring resource requirements while maintaining patient safety and data quality.

Some of the benefits are: ◗ Cost efficiency: Out of the total cost of bringing drug to market, approximately 30 per cent of the cost is site monitoring cost. RBM is the way to improve clinical trial quality and increase efficiencies by reducing low value on site monitoring ◗ Better quality: As compared to on-site monitoring, ongoing remote monitoring identifies issues earlier, enabling quick resolution and creating strategies to prevent recurrence thereby providing improved quality of analysis. With all data flowing into a

central repository it is easier to identify outliers and trends in the data. Access to the centralised data also makes is possible to compare data between sites to assess performance and identify potentially fraudulent data. Centralised data analysis enables cross functional team approach with coordination between monitors, data managers, statisticians, medical monitors, and site staff. ◗ RBM provides greater compliance with GCP and relevant regulatory requirements3

Integrating QbD and RBM QbD concept is based on the premise that quality should be part of the project planning process. In clinical research the protocol identifies the quality requirements and detailed plans and activities complement what is in the protocol. Key factors to QbD methodologies include a welldesigned protocol, proper execution of the protocol, steps to assure protocol compliance, corrective and preventative action methodologies, clear and concise communication strategies, a well designed case report form (CRF) to capture critical data accurately and to ensure uniform data collection across investigator sites. A good way to integrate improved protocol quality is to have initial cross-functional discussions to incorporate QbD, review of protocol for clinical trial quality, risk identification, risk mitigation and prioritisation. TransCelerate methodology for risk-based monitoring includes risk assessment, determination of critical data and processes and mitigation of the risks through integrated quality and monitoring plan. The sponsors are encouraged to carry out early and ongoing risk assessment

which involves identifying risks, analysing risks and determining whether risk can be modified by implementing control. Assessments of parameters to identify risks that could affect the collection of critical data or the performance of critical processes is of utmost importance ,to list a few – site characteristics, site performance metrics, (e.g., high screen failure or withdrawal rates, high frequency of eligibility violations, delays in reporting data), complexity of the study design, types of study endpoints, and clinical complexity of the study population; geography, and other factors such as the experience of partners working with each other, use of electronic data capture systems, the stage of the trial .This assessment assists in appropriate resource allocation to areas of greatest need. No single approach to monitoring is apt or necessary for every clinical trial. FDA recommends that each sponsor design a monitoring plan that is tailored to the subject protection and data integrity risks of the trial. RBM, by building quality and risk management approaches into clinical trial design and management integrates early and ongoing risk identification and mitigates risks early or even prevents them entirely.

The monitoring process with RBM ◗ Data collection and submission. A centralised approach requires a steady and reliable flow of data from each study site to the central monitoring system. This will take place through entry of relevant data into an electronic database. ◗ Back office /centralised monitoring Centralised monitoring

CPhI & P-MEC INDIA 2017 SPECIAL processes provide additional monitoring capabilities that can complement and reduce the extent and/or frequency of on-site monitoring and help distinguish between reliable data and potentially unreliable data. ◗ Identify missing data, inconsistent data, data outliers, unexpected lack of variability and protocol deviations. ◗ Examine data trends such as the range, consistency, and variability of data within and across sites. ◗ Evaluate for systematic or significant errors in data collection and reporting at a site or across sites; or potential data manipulation or data integrity problems. ◗ Analyse site characteristics and performance metrics. ◗ Select sites and/or processes for targeted on-site monitoring. ◗ Targeted on-site investigation Centralised monitoring and further analysis will recommend further requirements of monitoring, recommending traditional onsite visits for source data verification in certain cases.

Challenges to implementation of RBM Some of the challenges that have prevented companies from moving to RBM include the level of change management required to adopt an RBM approach, lack of experience with and ability to feel confident in data quality if not performing 100 per cent SDV, and lack of industry experience with approval of new drug applications that moved away from the old 100 per cent SDV model. The sponsors will have to take a systematic approach and plan steps towards implementation of quality management framework ensuring overall risk management.

safety measures. However it is some time before industry to adopt RBM and for the onsite visits to decrease. ICH GCP E6 (R2) will propel the adoption of RBM.

References 1. Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice (R2) Current

Step 4 version dated 9 November 2016 2. FDA, August 2013. Guidance for Industry - Oversight of Clinical Investigations - A RiskBased Approach to Monitoring 3.European Medical Agency. (2015) Guideline for good clinical practice E6(R2) 4 - Step 2b

4. EMA, 2013. Reflection Paper on Risk Based Quality Management in Clinical Trials (EMA/INS/GCP/394194/2011) 5. Position Paper: Risk-Based Monitoring Methodology, 2013 TransCelerate Biopharm Inc 6. Andrianov A, Wilder B, Proupin-Perez M. ICH GCP Goes Risk Based. Applied Clinical

Trials, Oct 20, 2015. 7. FDA Guidance for Industry: Q9 QRM, June 2006. 8. Quality by Design: Concepts for ANDAs ,Robert A. Lionberger, Sau Lawrence Lee, LaiMing Lee, Andre Raw, and Lawrence X. Yu, AAPS J. 2008 Jun; 10(2): 268–276.Published online 2008 May 9.

PHARMACEUTICAL

S o l ut i o ns

Lubrizol LifeSciences is your pharmaceutical solution partner. We provide support from idea to execution. How we do it: • Polymers: high performance pharmaceutical ingredients for applications including sustained release oral solids, semisolid and liquid, transdermal applications and drug eluting devices • Formulation: advanced drug delivery solutions, including drug-eluting devices • Manufacturing: contract manufacturing for complex pharmaceutical drug delivery systems To learn more, visit www.lubrizol.com/lifesciences or email LifeSciencesIndia@lubrizol.com

Conclusion Compared to earlier monitoring methods, like 100 per cent source data verification, RBM clearly demonstrates advantages. Beyond cost saving the obvious benefits of RBM are better quality data, improved timelines and robust patient

© 2017 The Lubrizol Corporation, all rights reserved. All marks are the property of The Lubrizol Corporation. The Lubrizol Corporation is a Berkshire Hathaway company. 17-80600 Lubrizol Advanced Materials India Pv.t Ltd., 5th, 6th & 7th Floor, Jaswant Landmark, LBS Marg, Vikhroli (W), Mumbai- 400079, India Ph.: +91 22 6607800 Email id : LifeSciencesIndia@lubrizol.com

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CPhI & P-MEC INDIA 2017 SPECIAL

Beyond just a filler – application of calcium phosphates in direct compression formulations Daniel Zakowiecki, Marek Lachmann and Tobias Heß Chemische Fabrik Budenheim, in this article outlines the most important properties of various grades of calcium salts of orthophosphoric acid CALCIUM PHOSPHATES have been used in the pharmaceutical technology for many years. They have many physical and chemical properties that make them ideal candidates for the production of solid oral dosage forms. They are mainly used as fillers in order to bulk up formulations [1] however, the function of calcium phosphates goes far beyond mere filler and the adequate utilisation of their full functionality can support achieving the intended formulation goals. Calcium phosphates are inorganic substances of mineral origin and therefore are characterised by exceptional chemical stability. For the same reason, they are compatible with most of known drug substances. The few exceptions include indomethacin and tetracycline antibiotics which form with the calcium ions hardly absorbable complexes. Tribasic calcium phosphate (USP) shows incompatibility with the tocopheryl acetate which is related to the large number of hydroxyl groups on the surface of the substance. [1,2] Calcium salts of orthophosphoric acid do not interact with water and therefore can be successfully used in any technological operations involving water as a completely inert densifier. Due to the very high content of calcium and phosphorus they are very often used in dietary supplements. Especially hydroxyapatite finds wide spread use due to its calcium to phosphorous ratio which is identical to the one present in human bones. Calcium phosphate based excipients possess many functional properties making them ideal candidates for direct compres-

90 EXPRESS PHARMA December 1-15, 2017

Daniel Zakowiecki

Marek Lachmann

are hard, inorganic compounds which during compression undergo mainly brittle fracture. Because of that property they show very good compaction properties allowing preparation of hard tablets. In addition to that tablets made with calcium phosphates do not expand in volume upon ejection from the die. A phenomenon commonly observed after decompression of elastic or plastic-elastic materials. Another essential feature of calcium phosphates is their low lubricant sensitivity. Increased

well as fine materials for granulation processes. This article outlines the most important properties of various DC grades of calcium salts of orthophosphoric acid: ◗ dibasic calcium phosphate anhydrous: DI-CAFOS® A150 and DI-CAFOS® A60 ◗ dibasic calcium phosphate dihydrate: DI-CAFOS® D160 ◗ tribasic calcium phosphate: TRI-CAFOS 500 manufactured by the German company Chemische Fabrik Budenheim (called further Budenheim) and intended for direct compression processes. Furthermore, it presents the properties of tablets obtained from these products showing how many different formulation purposes they help to achieve.

Functional properties of calcium phosphates

sion process. Due to their favourable particle size and shape calcium phosphates exhibit excellent flowability. Furthermore, they enable to govern the flow pattern of poorly flowable powders, which allows for relatively easy preparation of tableting mixtures without the

granulation. Very high density of calcium salts of orthophosphoric acid allows either using of larger amounts of excipients without increasing the size of the dosage form or decreasing it when the same quantity of excipient is used. Dibasic calcium phosphates

amounts of lubricants or longer mixing time do not significantly affect the compaction properties of powder mixtures containing calcium phosphates. There are many different types of calcium phosphates available in the pharma market including coarse DC grades as

Grains of dibasic calcium phosphate (DI-CAFOS® A150, DI-CAFOS® A60 and DICAFOS® D160) are aggregates of fine primary particles of various shapes and sizes. The SEM pictures show the almost spherical shape of the calcium phosphate particles (Fig 1 - 3). At the same time the surface is uneven and well-developed which facilitates uniform blending with other ingredients. The surface of tribasic calcium phosphate (TRI-CAFOS® 500) is vast and its structure resembles a sponge (Fig. 4). Owing to this very special structure during mixing fine particles of other substances, including API, can easily adhere to the larger particles of phosphates and improve the efficiency of mixing processes. Calcium phosphates are characterised by very high

CPhI & P-MEC INDIA 2017 SPECIAL volumetric mass density which, in conjunction with the favourable shape of the particles, provides excellent flow properties. On top of that, the elevated density allows a significant reduction of tablet or capsule size without changing their weight. Alternatively it allows using larger quantities of the substance without increasing the size of the dosage form. This is of significant importance when working with drug substances characterised by poor flowability or/and compactibility and allows overcoming these challenges. A very important aspect is the behaviour of calcium phosphates in aqueous environment since it can impact on drug efficacy. Generally, these substances are insoluble in aqueous media at neutral or alkaline pH. However they are soluble in diluted acids, e.g. 0.1 M hydrochloric acid. That means that in acidic environment prevailing in the stomach they dissolve completely without causing the danger of retaining the drug in the tablet matrix. Consequently there is no perturbation in dissolution behaviour and absorption from the gastrointestinal tract. Furthermore, in contact with water or aqueous solutions calcium phosphates do not swell or form hydrogels. They do not disintegrate easily themselves, however, the application of small amounts of commonly used disintegrants (eg. croscarmellose sodium or cross-linked polyvinylpyrrolidone) allows producing tablets with a very short disintegration time (Fig.6). Dibasic calcium phosphates are not hygroscopic and under conditions normally prevailing in laboratory or manufacturing area are chemically and physically stable. [1,4] Tablets containing these substances do not tend to undergo changes in tablet hardness if properly stored. [6] The tendency of the anhydrous organic excipients to form hydrates in contact even with small amounts of water vapour being present in the air is well known. Such negative effect is not observed in the case of calcium phosphates. It should also be mentioned that the anhydrous dibasic calcium phosphate (DI-CAFOS® A60 and DICAFOS® A150) does not form

EXPRESS PHARMA

December 1-15, 2017

hydrates even if mixed with water for a long time.

Tableting properties of calcium phosphate DC excipients Dibasic calcium phosphates undergo fragmentation by brittle fracture. Due to this deformation mechanism the specific surface area of the particles is increased

and thus the amount of potential binding sites between powder particles is elevated. Enhanced bonding capacity allows production of tablets of high hardness even at relatively low compression forces. [3,4] Tribasic calcium phosphate (TRI-CAFOS® 500) behaves differently and during compression undergoes mainly plastic deformations. Its high

binding capacity results from the extensive specific surface area and consequently a large number of potential binding sites. [3,5] Fig 5 - 7 show a comparison of some physical properties of the tablets obtained using four DC calcium phosphates which are manufactured by Budenheim tablet hardness (breaking force),

porosity and size expressed as tablet volume. The tablets contained 99.5 per cent of the selected calcium phosphate and 0.5 per cent lubricant (magnesium stearate). Powder mixtures were compressed into tablets using the Fette 102i rotary tablet press (Fette Compacting , Schwarzenbek, Germany) at three compaction forces: 10 kN,

CPhI & P-MEC INDIA 2017 SPECIAL 20 kN and 30 kN. The results shown in Fig 5 indicate that both dibasic calcium phosphate anhydrous (DI-CAFOS® A150) and dihydrate (DI-CAFOS® D160) have very good tableting properties. Even at relatively low compaction forces tablets of high hardness (breaking force) can be obtained. It should be also noted that in the case of Di-CAFOS® A150 the compaction force has a very significant impact on tablet hardness. DI-CAFOS® A60 is a material of exceptionally high density and very low porosity. These properties can be employed to obtain tablets or capsules of reduced size (Fig 6). Dosage forms of smaller size increase the comfort of intake and thereby enhance patient compliance, especially for pediatric or geriatric applications. Moreover, DICAFOS® A60 can be used to design dosage forms with high density, greater than a density of gastric fluid, which settle in the lower part of the antrum and thus affect gastric retention time. On the other hand, it should be kept in mind that the low specific surface area of DICAFOS® A60 necessitates higher compaction forces to be employed to yield tablets of sufficient hardness. TRI-CAFOS® 500 is mostly not used as the sole filler in DC mixtures but can be successfully used as additive to commonly used filler materials. When used in tablet formulations in a concentration of 10 – 30 per cent its large specific surface area increases the bonding capacity of the powder mixtures and facilitates an increase of tablet hardness and porosity at the same time (Fig. 8 - 9). Apart from calcium phosphates (DI-CAFOS® A150 and TRI-CAFOS® 500) the tablets contained 2 per cent of croscarmellose sodium as a disintegrant and 0.5 per cent of a lubricant (magnesium stearate). It should also be noted that apart from increasing the tablet hardness, admixture of TRI-CAFOS® 500 can increase tablet matrix porosity and consequently significantly shorten disintegration time (Fig 10).

Summary Many properties of calcium phosphates such as excellent flowability or high compactibil-

92 EXPRESS PHARMA December 1-15, 2017

ity make them ideal candidates for direct compression processes. Since the main deformation mechanism that occurs during compression of calcium phosphates is brittle fracture, these materials are less sensitive to differences in production equipment, speed of tableting or lubricant addition. Such robustness can prove to be helpful during scaling-up of technological processes. Although this article focuses on the functional properties of phosphate for direct compression it should not be forgotten that the coarse grades of calcium phosphates can also be

successfully applied in the processes of wet or dry granulation. The advantage of using them is ease of handling. In addition to high bulk density, they contain a smaller fraction of fine particles. Therefore dust generated during weighing and sieving is minimal. Until recently, the excipients were considered solely as inactive ingredients used only in order to bulk-up powders and facilitate their further processing. Nowadays however it is well known that they may also have a crucial impact on a long-term stability of drugs as well as their efficacy.

References 1. Rowe CR, Sheskey PJ, Quinn ME. Handbook of Pharmaceutical Excipients (6th ed.). Pharmaceutical Press, London 2009 2. Khan MA, Reddy IK. Calcium phosphate in pharmaceutical product development. Calcium phosphates in biological and industrial systems (ed. Zahid Amjad). Kluwer Academic Publishers, Boston 1998, pp. 303–323 3. Bolhuis GK, Chowhan ZT. Materials for direct compaction. Pharmaceutical Powder Compaction Technology (ed. Alderborn G, Nyström C). Marcel Dekker Inc., New York 1996, pp. 419–478

4. Zebrowska W, Sawicki W. Excipients. The applied pharmacy (ed. Janicki S, Fiebig A, Sznitowska M). PZWL, Warsaw 2008, pp. 652 - 693 5. 5. Patel NK, Patel BR, Plakogiannis FM, Reier GE. An evaluation of tricalcium phosphate excipients particularly using instrumented rotary and single station tablet presses. Drug Dev. Ind. Pharm. 1987; 13: 2693-2718 6. Ahlneck C, Alderborn G. Moisture absorption and tableting II. The effect on tensile strength and air permeability of the relative humidity during storage of tablets of 3 crystalline materials. Int J Pharm 1989; 56: 143-150

CPhI & P-MEC INDIA 2017 SPECIAL

Coating performance evaluation of INSTACOAT 4G using various spray guns Suresh Pareek, MD, Ideal Cures and Sanjay Negi, DGM Film Coatings, Ideal Cures, give an insight the coating performance of IDEAL CURES revolutionary product INSTACOAT 4G with high solids capability, in combination with different spray guns THE PHARMACEUTICAL industry is witnessing a transformation from conventional batch to automated continuous processing in response to changing requirements. There have also been many improvements in the design of spray guns with the aims of improving coating process efficiency and the quality of appearance of the finished product. With similar aims, there have been parallel developments in the coating formulations that enhance the coating efficiency

Suresh Pareek, MD, Ideal Cures

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Sanjay Negi, DGM Film Coatings, Ideal Cures

and product quality. The present study evaluates the coating performance of IDEAL CURES revolutionary product INSTACOAT 4G with high solids capability (35 per cent solids), in combination with different spray guns (Gansons GHPN-III, Spraying Systems, RAU & Schlick 930 ABC). High Solids and low viscosity capability of INSTACOAT 4G makes it the preferred choice for all types of spray guns and coating equipment.

In a coating process it is very important that the coating suspension must be distributed evenly on the tablet bed. Spraying guns are used to achieve the desired distribution. Most often these are atomisers that use compressed air to atomise the coating suspension. There are three common gun types: 2-port, 3-port and 4-port. The simple 2port spray gun has one port for the liquid coating suspension and the other is for the atomising air. In a 3-port spray gun, the atomi-

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December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL sation and spray activation pressures can be controlled independently which allows the spray width to be controlled. In a 4-port spray gun, three ports are for air and one for liquid, and these allow for the independent control of activation pressure, atomisation pressure and spray width.

Process summary INSTACOAT 4G was reconstituted at 35 per cent solids and applied at a target weight gain of 2.5 per cent w/w. High Solids and low viscosity capability of INSTACOAT 4G allows quick drying of the tablets without any gun

blockage issues. Coating trials were performed using optimised coating conditions at the Ideal Cures laboratory facility in a Gansons Autocoater Model GAC-600 fitted with a 24-inch diameter pan. Refer Table No. 1 for process Parameters. Spray Guns from Schlick, Spray Systems (RAU) and Gansons (GHPN-III) were used for the experiments. Spray patterns were visualised on paper surfaces using each nozzle at a distance of approximately 12 to 15 cm inches’ distance from the gun. Fine spray mist could be achieved with INSTACOAT 4G

due to its low viscosity capabilities. (Ref. Figure No. 2).

TABLE NO. 1: COATING PROCESS PARAMETERS Batch Size (kg.)

Evaluation of coating process An approximate 60 per cent reduction in the coating process time was seen, in comparison to traditional coating formulations. This time saving advantage can be attributed to the ability of INSTACOAT 4G of reconstituting at a high solid level of 35 per cent, while maintaining low viscosity value. (Ref. Figure No. 1) Coating suspension was agglomerate free and easily sprayable. No gun blockage was observed

FIGURE NO. 1: COATING PROCESS TIME COMPARISON

Inlet Air Temperature (°C)

60-70

65-70

Product Bed Temperature (°C)

42-45

Inlet CFM

350

Atomizing Air Pressure (kg/cm2)

2.2

Fan Air Pressure (kg/cm2)

1.8

Pan Differential Pressure (bar)

5-6

Pan Speed (rpm)

11-13

Spray Rate (g/min.)

23.62

22.76

27.7

Spray Time (min.)

Weight gain (%)

during the entire coating process. There were no coating defects, no color uniformity concerns (DE<1.5) and coated tablets exhibited good surface smoothness and logo clarity. (100 coated tablets samples were evaluated).

Conclusion

FIGURE NO. 2: SPRAY PATTERNS OF DIFFERENT SPRAY NOZZLES 1) Gansons GHPN-III

2) Spraying Systems RAU

Coating trials were carried out successfully in a 24 inch Gansons Autocoater 600 using predetermined coating parameters with three spray gun/nozzle combinations at Ideal Cures Goregaon Laboratory using INSTACOAT 4G. It was found that the INSTACOAT 4G – a high solid, low viscosity coating formulation could be rapidly applied at 35 per cent solids. The coating process time was significantly lowered and the suspension exhibited low viscosity in spite of very high solids (35 per cent). Fine spray mist was achieved during spraying with different gun designs. The coated tablets had a smooth surface at the end of the coating process.

About Ideal Cures

3) Schlick 930 ABC

94 EXPRESS PHARMA December 1-15, 2017

Ideal Cures (IC) is one of India’s leading manufacturer and exporter of pharma excipients and ready-to-use coating systems for solid oral dosage forms. IC provides tailor-made solutions and products for the pharma and allied industries, through a network of customers and partners across more than 40 countries around the world. Leveraging over three decades of coating experience, technical know-how and expertise Ideal Cures’ pro-

vides precise, simplified solutions uniquely shaped to meet a customer’s requirements. IC provides its customers with a complete range of coating products and excipients complemented by technical and regulatory services. IC’s product portfolio includes INSTACOAT ready-to-use film coating systems, ECOPOL range of Pharma Acrylic Polymer’s, ECOCOOL brand of cooling compounds, ESPHERES range of microcrystalline cellulose, silicon dioxide, calcium carbonate, tartaric acid spheres, new generation of sugar spheres and INSTANUTE coating technology for nutraceuticals and dietary supplements. IC is the first film coating company to have all its cGMP compliant manufacturing plants EXCiPACT certified. IC’s latest manufacturing facility in Sikkim will be certified in due course. An ISO 9001:2015 certified company with a US DMF for all its manufacturing facilities, IC is one of the most innovative film-coating companies. IC has 11 granted patents and 8 pending grants for its film-coating products, specialised excipients and R&D coating machines. The above study was successfully presented at AAPS (American Associates of Pharmaceutical Scientists) 2017, Nov 12-15, San Diego Experiment protocol designed by: Sanjay Negi Experiments executed by: Sanjay Negi Contact details Email: info@ idealcures.co.in

CPhI & P-MEC INDIA 2017 SPECIAL

‘We are able to make many advances in XRPD to address industry needs’ Dr Michael Caves, India Business Development Manager, Malvern Instruments, in an interaction with Express Pharma, talks about the benefits of XRPD systems and its usage for multiple applications

Why is X-ray powder diffraction (XRPD) so important to the pharmaceutical industry? XRPD is a powerful tool in the pharma industry because of its capability to help researchers identify crystalline structure of materials, identify phases that are present, distinguish between polymorphs, and even elucidate structure in amorphous materials.

Proving that a new chemical entity (NCE) is indeed a novel structure is critical to patent positioning. Additionally, powder diffraction measurements can be made under non-ambient conditions (temperature, humidity, etc) such that material stability can be tested under extreme conditions. And most applications of XRPD are nondestructive in nature, leaving

the sample intact for further investigation by other techniques. What advances in XRPD in recent times have been most significant for pharma analysis? In the past five years, new optics, stages and detectors have allowed more application capability to be added to a multi-purpose diffraction system, as well as

improved the performance for even routine types of measurements. For example, new XRPD optics, such as PANalytical’s BraggBrentanoHD optic delivers 40 per cent improved sensitivity for ultra low-level polymorph screening. New applications possible on an XRPD system include small angle X-ray scattering (SAXS) for nano-sized materials, which can

Acc. to ISO, ASTM and other standards; inspection certificate available

Test Sieves for perfect quality control The well-proven RETSCH sieves consist of a solid stainless steel sieve frame of high stability for reliable sieving results. RETSCH test sieves are available in many sizes and varieties, primarily in the four frame sizes most widely used in laboratory analytics: n 200 x 50 mm, 200 x 25 mm n 8“x 2“ (203 x 50 mm), 8“x 1“ (203 x 25 mm) P R EM I U M Q UA L I T Y M ADE IN GERMANY

To subscribe: bpd.subscription@expressindia.com

marketing@verder-scientific.co.in www.verder-scientific.co.in

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CPhI & P-MEC INDIA 2017 SPECIAL determine size distribution and shape of materials including micelles, proteins, and nano-particles for drug delivery; with new detector technology and easy conversion of an XRPD system to hard radiation (such as Silver X-ray tube anodes), pair distribution function (PDF) for investigating the structure of nano- and amorphous materials has brought this traditionally synchrotron beam-line application to a laboratory system; and these same advanced detectors for hard radiation lend themselves nicely to computed tomography (CT) on an XRPD system, to analyze non-destructively the inner structures of coatings on tablets, evaluate porosity and distribution of components within tablets, and even investigate tablets within packaging.

beam path SAXS chambers has also allowed for bioSAXS experiments on a multipurpose XRPD platform, to study for example the overall size, compactness and aggregation behaviour of protein molecules in their native state (crystallisation not required), and even to determine the 3D envelope structure at a resolution of 1-2 nm. And a very new addition to capabilities on an XRPD system is in situ protein crystallisation with our new computer-controlled transmission humidity chamber.

What are the recent trends in XRPD that you have seen from the pharma industry? We are seeing a trend toward centralised research labs when mergers have occurred. This in turn has caused an increased interest in XRPD systems that can be used for multiple applications versus dedicated systems for a specific application. So systems combining combinatorial screening, environmental chambers (heat and humidity), SAXS, and transmission capability are routinely being supplied to this industry. What other techniques complement XRPD? XRPD analysis for polymorph identification, structural analysis, and nano-particle size and shape is complementary to many techniques available in todayâ&#x20AC;&#x2122;s analytical laboratories, not only for the information provided but also because it is non-destructive. Solid state NMR, spectroscopies such as near infrared (NIR) and Raman, and single crystal diffraction all provide molecular and crystalline structure information that compliments

96 EXPRESS PHARMA December 1-15, 2017

XRPD data. X-ray Fluorescence (XRF) spectroscopy determines elemental composition, and data can be used in an automated fashion within XRPD phase analysis to restrict the search to only phases chemically possible.

How can a powder X-ray diffraction system assist researchers doing protein crystallography? The two main applications that come to mind are powder diffraction for screening samples that will be taken to a beamline for structure determination, and SAXS of

proteins for size and shape determination. Screening samples headed for a beamline can show the quality of the sample, whether it is a single phase, and can also allow indexing to determine lattice type and lattice parameters of the material. The advent of evacuated

What are up and coming XRPD techniques or applications that would be of interest to pharma? One application that we see significant interest from pharma researchers is pair distribution function (PDF) analysis, which can be used to discriminate between different amorphous or crystalline pharmaceutical structures. Protein screening and indexing for researchers in the area of protein crystallography, which is typically done on single crystal instruments or at beam lines, is another area we see as a growth area for XRPD. Finally, we have advanced software capability now, which includes using a method known as partial least squares regression (PLSR) to analyse XRPD data for things like % crystallinity without the use of an internal standard, keeping the method non-destructive. More developments are in the works, and it is through close collaboration with pharma companies that we are able to make many advances in XRPD to address the needs of the industry. Contact details Malvern Aimil Instruments Naimex House, A-8 Mohan Co-operative Industrial Estate, Mathura Road New Delhi â&#x20AC;&#x201C; 110044 Tel : 011-3081024 Fax : 011-26950011 Email : delhi@aimil.com EP News Bureau

CPhI & P-MEC INDIA 2017 SPECIAL

Coating performance evaluation of INSTACOAT4G in a batch coater Suresh Pareek,MD,Ideal Cures and Sanjay Negi,DGM Film Coatings,Ideal Cures,evaluates coating uniformity and appearance of tablets coated with Ideal Cures’revolutionary product INSTACOAT4G,a high solids aqueous coating system of 35 per cent solids capability,in a batch coater THE PHARMACEUTICAL industry is continuously improving manufacturing efficiency and product quality by adopting innovative technologies. Coating systems with high solids are used to significantly save both process time and overall energy consumption. Ideal Cures understands the needs of pharma companies and has developed a revolutionary coating formulation having high solids capabil-

Suresh Pareek

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Sanjay Negi

ity – INSTACOAT 4G. Achieving good colour uniformity at higher reconstitution levels is a big challenge at commercial scale and it has been evaluated in our trial conducted using a batch coater. The present study evaluates the coating uniformity and appearance of tablets coated with Ideal Cures’ revolutionary product INSTACOAT 4G, a high solids aqueous coating system

of 35 per cent solids capability, in a batch coater.

Process summary INSTACOAT 4G was reconstituted at 35 per cent solids concentration in water and applied at a target weight gain of 3 per cent. The coating dispersion was evaluated for appearance and viscosity. Coating trials were performed in a batch coater using

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December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL predetermined optimised coating conditions. Round shaped placebo tablets were used for the coating trials. The viscosity of the coating suspension was found to be 209 cps which is too low and very spray able considering 35 per cent solid. Coating process evaluation was carried out in terms of coating process time, finished tablet appearance, coating defects and disintegration time. Refer Table 1. for coating process parameters. Coated tablet samples were collected from the coating pan at different time intervals (15 minutes) until the completion of the coating process. Colour difference of the coated tablets was measured using a reflectance spectrophotometer. Coated tablets achieved very low colour difference values after 120 minutes of coating. (Figure No.1) which is remarkable. Evaluation of coating process: Massive reduction in coating time with ability to triple production output! Coating process could be completed very quickly as compared to traditional coating formulations (Ref. Figure No. 2) due to high solids and low viscosity capabilities of INSTACOAT 4G. Coating of a batch (300 Kg) in a 60-inch pan generally takes around four hours and hence in one entire shift, an approximate of 1.5 batches is possible. INSTACOAT 4G due to its high solids capabilities will reduce the process time by more than 60 per cent. It allows coating of three batches instead of 1.5 batches and almost triples production output. Further, coating suspension was agglomerate free and easily sprayable. No gun blockage was observed during the entire coating process. There were no coating defects and colour uniformity concerns. (DE<1.5) Coated tablets exhibited good surface smoothness and logo clarity (100 coated tablets samples were evaluated)

Reduce carbon emission, gain carbon credits Reduced energy consumption by virtue of reduced coating time results in reduced carbon emissions and carbon footprint

98 EXPRESS PHARMA December 1-15, 2017

TABLE NO. 1 COATING PROCESS PARAMETERS Desired Weight Gain (%)

Batch Size (kg)

600

Product Bed Temp (?C)

40-45

Gun to tablet bed distance (cm)

20-22

Atomising air pressure (kg/cm2)

Pan speed (rpm)

2-7

Spray rate (g/min)

90-100

Actual Spraying Time taken (mins.)

140

making INSTACOAT 4G a bestin-class eco-friendly coating system There is an approximate reduction of 80 per cent in carbon emissions/ year with INSTACOAT 4G compared to traditional coating systems (11 per cent) ◗ *Batch size = 300 kg, ◗ ** 2 batches of 300 kg/day in a year (300 working days in a year) ◗ *** With respect to 11 per cent reconstitution levels ◗ # 0.5377(CO2 conversion factor used for calculations, Ref: Carbon Trust, “Conversion fac-

FIGURE NO.1: COLOUR DEVELOPMENT AT DIFFERENT COATING PROCESS TIME POINTS

tors: Energy and Carbon Conversions”2011)

Assumptions All the parameters are based on assumptions. These assumptions were used to quantify both the aforementioned energy consumption and the production capacity of a single coater. These numbers may obviously vary from equipment to equipment, from company to company and by geographic location. Typical values are used and it is used as a representative analysis. Under the assumptions provided in this article, using INSTACOAT™ 4G may reduce energy consumption since it has shorter coating process time and may in turn reduce equivalent CO2 emissions by 79.2 per cent per year (compared to HPMC coating system).

Conclusion

FIGURENO.2:COATINGPROCESSTIMECOMPARISONWITHTRADITIONALCOATINGFORMULATIONS

A need for innovative technologies to improve product quality and process efficiency with retention or enhancement of product safety within commercially acceptable cost constraints was identified, leading to the development of the most advanced aqueous coating formulation – INSTACOAT 4G. INSTACOAT 4G, innovated by Ideal Cures is the most advanced immediate release film coating system, designed for rapid film coating. It brings about large-scale reduction in the overall coating process time, reduces total cost of coating operations and most importantly, will save energy and help reduce carbon footprints. It offers excellent film adhesion properties, smooth product finish along with moisture barrier properties. Launched globally in 2016, this one-of-a-kind firm coating system offers 35 per cent reconstitution – seen in no other coating formulation. The coating trial of INSTACOAT 4G was successfully performed in a 60-inch Batch Coater and coated tablets were evaluated for appearance, colour difference, coating defects and disintegration time at various intervals of the coating process. INSTACOAT 4G achieved acceptable results. The product under test was successfully applied and achieved

CPhI & P-MEC INDIA 2017 SPECIAL good colour uniformity within a short coating process time. Over 60 per cent coating process time savings can be achieved by using INSTACOAT 4G as compared with traditional film coating formulations. INSTACOAT 4G is well suited for all coating equipment i.e. conventional, batch coaters to the most advanced continuous coaters being used in the pharma industry worldwide.

Ref: (1) Coating Economics – How very low viscosity coatings reduce the total cost of ownership of coating operations, DOW WOLFF Celulosics About Ideal Cures Ideal Cures (IC) is one of India’s leading manufacturer and exporter of pharmaceutical excipients and ready-to-use coating systems for solid oral dosage

INSTACOAT 4G - CO2 EMISSION Reconstitution Levels

Energy Consumption (KWhr/batch*)

Equivalent CO2 Emission (kg/batch)#

CO2 Emission (kg/year)**

CO2 Saving per year (%)***

Reference (11%)

Approx. 610 (1)

328

1,97,000

Reference (20%)

Approx. 340

183.3

1,09,000

44.7

INSTACOAT 4G (35%)

Approx. 126

67.8

41,000

79.2

forms. IC provides tailor-made solutions and products for the pharma and allied industries, through a network of customers and partners across more than 40 countries around the world. Leveraging over three decades of coating experience, technical know-how and expertise Ideal Cures’ provides precise, simplified solutions uniquely shaped to meet a customer’s requirements. IC provides its customers with a complete range of coating products and excipients complemented by technical and

regulatory services. IC’s product portfolio includes INSTACOAT ready-to-use film coating systems, ECOPOL range of Pharma Acrylic Polymer’s, ECOCOOL brand of cooling compounds, ESPHERES range of microcrystalline cellulose, silicon dioxide, calcium carbonate, tartaric acid spheres, new generation of sugar spheres and INSTANUTE coating technology for nutraceuticals and dietary supplements. IC is the first film coating company to have all its cGMP com-

pliant manufacturing plants EXCiPACT certified. IC’s latest manufacturing facility in Sikkim will be certified in due course. An ISO 9001:2015 certified company with a US DMF for all its manufacturing facilities, IC is one of the most innovative film-coating companies. IC has 11 granted patents and eight pending grants for its film-coating products, specialised excipients and R&D coating machines. The above study was successfully presented at AAPS (American Associates of Pharmaceu-

tical Scientists) 2017, Nov 12-15, San Diego. Experiment Protocol Designed by: Sanjay Negi Experiments Executed by: Sanjay Negi (Note: All figures/graphs derived are based on the assumptions given in this article. The actual performance in a manufacturing operation may vary depending on various factors, but the fundamental efficiency advantage of using INSTACOAT 4G coating still holds)

We from Optima Pharma are convinced: A demanding customer should never have to settle for mediocre solutions and - above all - not when it comes to safety and hygiene. This is why we plan, develop and design filling lines that keep all the options open – regardless where your machine will produce.

p-mec India | November 28–30, 2017 | Mumbai | India Hall 6 | Booth # F 34 We will present pharmaceutical turnkey projects in 3D.

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December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

India is an important market for Shin-Etsu in the global business Hiroshi Watanabe, GM, Shin-Etsu Chemical Company, Japan, Shungo Fujii, Sales Manager, Shin-Etsu Chemical Company, Japan and Nitin Bhusane, Director, Shin-Etsu Chemcial Tylose India, in an interaction with Express Pharma, inform about the companyâ&#x20AC;&#x2122;s growth prospects in India

How has Shin-Etsu Chemical evolved over the years? Where are your facilities located? Shin-Etsu Chemical began producing cellulose derivatives in 1962. Since then, thanks to feedback from our customers, we have been improved our quality and manufacturing system. We are confident in our quality control which is in accordance with IPEC/PQG GMP guideline,. Shin-Etsu Chemicalâ&#x20AC;&#x2122;s cellulose excipients can make a valuable contribution in various areas of pharmaceutical technology. Currently, Shin-Etsu has two production plants for pharma excipients. One plant is located in Naoetsu Japan and the other in Wiesbaden Germany. Shin-Etsu is continuously expanding its global presence. Shin-Etsu understands the importance of continuous technical support to pharma customers. Therefore, ShinEtsu has developed global network of application laboratories. We have application labs in Naoetsu, Yokohama, Japan; Wiesbaden, Germany and New Jersey, US. We have also opened a new application lab in Thane near Mumbai, India What is your say about the Indian pharma market? India is a very important market for Shin-Etsu in the

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HIROSHI WATANABE, GM, Shin-Etsu Chemical Company, Japan

SHUNGO FUJII, Sales Manager, Shin-Etsu Chemical Company, Japan

NITIN BHUSANE, Director, Shin-Etsu Chemcial Tylose India

global business. Indian pharma companies mainly target generic business for regulated markets like the US and Europe, who require good quality excipients to make high quality pharma products. Shin-Etsu is well known in the industry for high quality excipients, which gives a valuable contribution between Indian pharma companies and Shin-Etsu. It has been observed that the domestic Indian market has become more and more quality conscious, and majority of the branded generic products maintain high quality standards. Shin-Etsu cellulose excipients are used for

applications like binder, disintegrant, film coating, enteric coating, solid dispersion etc., which are well known in the pharma industry. Sometime customers require special guidance related to use of these products. Therefore our new application lab will play a very crucial role to provide technical support to Indian pharma scientists.

name Shin-Etsu Chemical Tylose India. This is another extension of Shin-Etsu application lab global network. Shin-Etsu Chemical Tylose India lab will focus on providing support to pharma customers and coordinate with other ShinEtsu labs worldwide to generate more application data using Shin-Etsu products for pharma customers worldwide. This application lab is being set up for solid oral dosage formulation developments. The offerings from the India lab will involve preformulation and formulation development studies, workshops and

You have recently launched Thane facility. Throw some light on the same. Shin-Etsu is proud to announce the opening of a new pharma application lab in the Thane area, Mumbai, India, under the company

technical seminars, and providing problem based solutions to pharma customers. As per current R&D trends in Indian pharma companies, beside conventional projects of immediate release tablets ,sustained release tablets or delayed release tablets, more focus has been given on solubility enhancement of poorly soluble drugs. Generally, Shin-Etsu AQOAT (HPMC AS) is well known for its application in solid dispersion and enteric coating. Shin-Etsu lab in Thane will explore ShinEtsu AQOAT and other Shin-Etsu products like LHPC, METOLOSE, PHARMACOAT, HPMCP in their formulation. Shin-Etsu believes in continuous research and development of its products, so that it can launch new products in the market, which meets customer requirements. Recently Shin-Etsu has added Smart Ex, HME Cleaner Plus and Polyvinyl Alcohol (PVA) to its portfolio. Smart Ex can be used as directly compressible grade for orally disintegrating tablets or for MUPS application. HME Cleaner Plus is a unique cleaner, which can be used to clean the screw of hot melt extruder. PVA can be used in moisture barrier coating and has an advantage to use as a binder. EP News Bureau

CPhI & P-MEC INDIA 2017 SPECIAL

NEOMACHINE MFG CO: Aleader in automatic coating technology KOLKATA-BASED NEOMACHINE MFG CO was started in 1973 with an objective of manufacturing quality pharmaceutical machinery. For a decade, the company catered to the requirements of the Indian pharma companies in injectable, liquid, tablet, capsule and ointment sections machinery. While catering to this market segment, NEOMACHINE happened to come across a Kolkata-based pharmaceutical producer, who were envisaging problems in solvent-based film coating of tablets. Till then, the tablets were being coated in conventional pans, which were not only causing health hazards to the coating personnel, but was also a time consumingprocess.

During the last three decades, NEOMACHINE manufactured and marketed more than 600 machines, out of which 100 machines were exported to the different countries like the US, Australia, China, Jordan, Yemen, UAE, Uganda, Kenya, Sudan, Cyprus, Saudi Arabia, Austria, Brazil, Bangladesh and Bolivia, Nepal, Myanmar, Nigeria etc. NEOMACHINE, a professionally managed organisation now has two manufacturing During the last three decades, NEOMACHINE manufactured and marketed more than 600 machines units in Kolkata, which are equipped with stateof-the-art equipment like fabrication, machining, assembling, finishing and other related jobs. The company has been

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During the last three decades, Neomachine manufactured and marketed more than 600 machines strictly following all the quality control guidelines during manufacturing. The boughtout items are inspected at the manufacturersâ&#x20AC;&#x2122; works periodically. The company has a dedicated team of engineers for providing erection and commissioning and prompt aftersales

service to the clients. The in-house R&D facility is abreast with latest technology upgradation and developments in â&#x20AC;&#x2DC;coating technology. This helps in continuous improvement of the product. NEOMACHINE also provides DQ/IQ /OQ/ documents for automatic coating system and are in the process of getting CE certification. Neomachine being a single product company manufacturing only automatic coating system for coating of Pharma Tablets, Pellets & Gems Products has gained vast experiences in latest coating technology as well as validation and qualification of coating equipment to qualify for audit of various national and international agencies. The latest models of NEOCOTA are having all the

constructional features for validation and qualification. The equipment are supplied with all the necessary documents for proper validation during installation and commissioning as well as trial production. Inspired by this opportunity, NEOMACHINE started the process of developing an Automatic Coating Machine for tablets. After, two years of research and development, the first NEOCOTA Automatic Coating System was manufactured in 1984. Over the years, the company has gained vast experiences in manufacturing 'Automatic Coating System' by interacting with various Indian & multinational pharma and confectionery units based in India and abroad.

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Growth will be driven by targeting non-traditional markets Mitul Shah, CEO, LabGuard India, in an interaction with Express Pharma talks about LabGuard’s future growth prospects Labguard India is in the market since the last 30+ years. How has the journey been so far? Prakash Sansare took voluntary retirement from Mazagon Docks to fulfill his dream of addressing the engineering industry's most challenging problems. The journey has been nothing short of an adventure. What started as an opportunity to design and make import substitute has now become an industry in itself. Prakash Sansare was joined by his elder son Salil after graduation (VJTI Production) and contributed towards establishing market reach as well as customer interface. The younger son Swapnil, an electronics engineer soon joined with the focus on automation and product design. Soon thereafter, Ajay Kanekar joined to lead the overall operations as the business was growing. Salil and Swapnil eventually moved on to pursue their own career aspirations in respective areas of interests. The current leadership team has been with the organisation in thick and thin for almost a decade. I joined eight months back as the CEO after spending 13 years with organisations like Aditya Birla Group and Prince Piping System. It was a home coming for me as I had started my professional career as the Production Engineer at this organisation after passing out from VJTI and then moved on to pursue higher studies (MBA from JBIMS). Sans family has been my local guardian during engineering and MBA days. Today, LabGuard has metamorphosed into a force to

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reckon with and has built an enviable national and global reputation. Prakash Sansare has been the driving force behind the tremendous equity for product quality and LabGuard's reputation built over the years. Tell us about your new product launches. How are the products unique from your competitors? Research and development is always a work in process for ever evolving target audience that we cater to. Continuous engagement with research fraternity, end users and others in the ecosystem gives us insights into product design. It is our endeavour to offer new designs and work concepts to the end user keeping safety, functionality and productivity in mind all the time. During the last two years, we have successfully launched and scaled up some key products. 1. Adventa helps optimise space and aids ease of maintenance of the fume hood. 2. PP storage cabinets not only add to performance but increase aesthetics of the workspace. 3. Custom made furniture to suit individual lab and end user culture has been our specialisation and therefore, each solution is unique in itself. Customers today want one stop shop for their needs and we have successfully completed lab sets ups for prestigious clients. We are always on the lookout for adopting technological advances to meet latent customer needs; adopting auto fireextinguishers, auto work area in fume hood closures as well as maximising flexibility in

We are looking at forging collaborations and tie-ups with local representatives in target markets furniture with available and easy to maintain technology has been our contribution for the Indian industry. Who are your major pharma clients? Difficult to choose a few in this limited space. Suffice to say that all major pharma companies have been our clients. Not just pharma companies, we also service industries such as chemical (petroleum, speciality, agro, etc), FMCG, Flavours & fragrances, paints and dyestuff, engineering, energy, manufacturing, mines and minerals, healthcare (hospitals). We also provide

service to leading research institutes, educational institutes, standards and certification agencies. What will be your growth strategy in the next three years? Growth will be driven by targeting non-traditional markets/ end user applications and embedding more technology in our products for safer and more productive work environments. Investment would be in sourcing technology and augmenting manufacturing capability. Investment is not just about creating physical assets; ◗ We are targeting to create brand loyalty through actively engaging with key stakeholders to offer solutions for day-to-day problems through product design, servicing and offering one-stop solution for establishing labs like civil interior, MEP and design and consulting services. ◗ We are investing in our future users by conducting free sessions at various universities, schools for good lab practices. ◗ Investing in human capital by skill building and employee engagement are our focus areas. It is noteworthy that

workmen that we employ at our factory are from local farming community who have been trained in their respective trades ◗ Investment does not stop at internal stakeholders alone. We go extra mile to support community around us and have set up labs in schools in Aadivasi cluster through social organisations as part of our social responsibility. We take pride in supporting clients for their social commitments in their respective neighbourhoods for setting up labs for schools and colleges. Do you plan to launch new facilities? We have already commissioned new assembly shops and are working on enhancing sheet metal processing capacity at existing facility. We have launched modern trainingcum-conference facility at our factory for our staff as well as customers. For further facility expansion, we are going for hybrid model in the short term; wherein we have tied up with partners for optimising supply chain and improving lead time as we scale up operations across geographies. Are there any plans to venture into foreign shores? We are already present across geographies and our products have been our brand ambassadors as most orders have been through referrals. However, we are looking at forging collaborations and tieups with local representatives in target markets. We are very conscious about compatibility of culture while exploring such collaborations. EP News Bureau

CPhI & P-MEC INDIA 2017 SPECIAL

Save time and protect data integrity with fingerprint authentication

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TEKNOPAK

Engineered Solutions for Airborne Contamination Control

Sterilizing & Depyrogenating Tunnels for Glass Vials and Ampoules

Aditya Marfatia, Director, Electrolab and Dr Neelam Sayed, Application Scientist, Electrolab give an insight about how Electrolab with a technological collaboration has introduced a convenient 21 CFR part 11 compliant operating system, integrOS Unidirectional Air Flow Systems (LAFs)

Mobile Unidirectional Air Flow Systems Reverse Air Flow Containment Stations for Dispensing & Sampling

Pass Boxes Dr Neelam Sayed

Aditya Marfatia

EACH CONSUMER expects the drugs they consume to be safe and effective. To ensure safety, efficacy and quality of drugs, regulatory bodies such as US FDA, UK MHRA and Indian FDA have set regulatory standards, typically referred to as Good Manufacturing Practices (GMP). GMP assures proper design, monitoring and control of manufacturing processes and facilities for various systems. This is supported by underlying data records to trace manufacturing processes, which can prove evidence that the drugs have been manufactured as per agreed protocols. Data integrity affirms that complete, consistent and accurate data records

are attributable, legible, contemporaneously recorded, original or a true copy and accurate (ALCOA). It refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, including the usage of any system which stores, processes, or retrieves data. Ensuring data integrity means protecting original data from accidental or intentional modification, falsification, malicious intent (fraud), or even deletion (data loss). Considering that raw data acts as an evidence that drugs are safe, efficacious and manufactured as per appropriate quality standards required, violation of data integrity is considered to be grave by

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Garment Storage Cabinets

CLEANROOM EQUIPMENT & ACCESSORIES STERILIZING & DEPYROGENATING TUNNELS Our Specialization

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CPhI & P-MEC INDIA 2017 SPECIAL leading regulators such as the US FDA, UK MHRA, Health Canada, Therapeutic Drugs Administration (TGA) and Indian FDA, all of which mandate data integrity. In recent years, FDA has increasingly observed CGMP violations involving data integrity during inspections. FDA inspections cite a range of serious deficiencies in how employees handle important data records and documents. FDA cites reports of records found in trash bins, data that do not match test results, unauthorised manipulation of electronic raw data, sample retesting to achieve desired results, deletion of undesirable results, practice of performing trial injections for HPLC analyses prior to running the release and stability tests etc. Some of the key root causes for these violations are lack of awareness, shortage of manpower, quantity over quality approach and ineffective training. These data integrityrelated CGMP violations have

led to numerous regulatory actions, including warning letters, drug recalls, import alerts and consent decrees. These regulatory actions not only impact the existing revenue stream of the company, but also affect the drug maker’s ability to get approval for new drug applications. In addition, it also causes reputational damage, competitive disadvantage and lengthy remediation process that tend to consume time, money and often loss of talent. Data integrity is critical to regulatory compliance and hence the fundamental reason for formation of Code of Federal Regulations (CFR). A company’s SOP describes how processes are to be performed while manufacturing a particular drug or formulation. During implementation of these processes, the US FDA registered company needs to comply with Title 21 of CFR – Part 11, commonly known as '21 CFR 11'. 21 CFR Part 11 establishes the criteria under which electronic records and signa-

FIG.1: THE KEY PILLARS OF 21 CFR PART 11 COMPLIANCE

FIG.2: INTEGRATION OF INSTRUMENTS WITH KLOUDFACE WITH INTEGROS

FINGERPRINT SCAN

KLOUDFACE WITH BIOMETRICS

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CPhI & P-MEC INDIA 2017 SPECIAL FDAWarning Letter Excerpt, 2015 states “Access to production equipment used in parenteral manufacturing and solid (b)(4) dosage forms used a password shared by four or five individuals to gain access to each individual piece of equipment and access level. During our inspection, your Executive Production and QA manager confirmed that the password was shared. Neither your operators nor your supervisors had individual passwords.” Why is FDA concerned with the use of shared login accounts for computer systems? US FDA in its draft guidance states “You must exercise appropriate controls to assure that only authorised personnel make changes to computerized MPCRs (master production and control records), or other records, or input laboratory data into computerised records and you must implement documentation controls that ensure actions are attributable to a specific individual.When login credentials are shared, a unique individual cannot be identified through the login and the system would thus not conform to the CGMP requirements in parts 211 and 212. FDA requires that systems controls, including documentation controls, be designed to follow CGMP to assure product quality”.

tures are stored and is considered trustworthy, reliable and equivalent to paper records by the US FDA. Part 11 has a total of 19 requirements, some of them are specific to Part 11 and others are more generic requirements of some or all FDA regulations. The key pillars of 21 CFR part 11 compliance is depicted in Fig.1. It is crucial to pay particular attention to all these requirements when addressing data integrity. Due to lack of thorough understanding of 21 CFR aspects, pharmacists and even instrument manufacturers may believe a system is 21 CFR part 11 compliant however; gaps may still exist which when highlighted by auditors can lead to detrimental effects. Some of the commonly observed issues that lead to breaches in data integrity include no correct administrator rights for laboratory system (72 per cent users in QC department have IT administration rights), sharing of login IDs and passwords for laboratory systems (33 per cent), audit or reviews not being conducted to assess potential gaps in assurance of data integrity (33 per cent), unawareness about 21 CFR Part 11 compliance requirements (25 per cent), disabled audit trails on lab equipment (21 per cent) and no clearly documented SOP on backup and deletion of laboratory data (13 per cent) (Analysing the state of data integrity compliance in the Indian pharmaceutical industry, EY). Amongst all the above concerns, sharing of login credentials for laboratory systems is a common issue cited by FDA in its observations. Primarily, sharing of login credentials are done to streamline remembering multiple passwords for multiple instruments and for cost saving reasons when softwares are licensed on a named user model. In a convenience focussed world, making compliance convenient would minimise deviations from good laboratory practices. Users, especially in regulated industries need solutions that

minimise the time personnel are spending on compliance activities while ensuring that they are still in compliance. To ensure complete 21 CFR part 11 compliance and to overcome all the hassles listed above while also better securing the organisation, Electrolab with a technological collaboration has introduced a convenient 21 CFR part 11 compliant operating system, integrOS. integrOS has a secure authentication method that utilises fingerprint authentication to register a user on the system. Biometrics is usually a quicker process than entering a username and password and far more secure than using login credentials. Biometric technology eliminates employee downtime due to forgotten passwords and also reduces the amount of IT support required to reset accounts. An audit trail with classification of events based on user, date, creation/modification status in integrOS aids with compliance and assures that no alterations have been made post approval. Managing paper and complying with regulatory policies can be tedious, while integrOS allows more efficient use of time in the lab or on the plant floor. kloudface is an interface which allows existing installed base of instruments to use integrOS and achieve convenient compliance, hence optimising capital investment. Instruments that can be integrated with kloudface with integrOS are depicted in Fig.2. Data integrity software integrOS, fulfills CFR requirements in terms of multi-level security, unlimited users, user defined privileges, audit trails, accurate and complete copies of records, authority and device checks, linking of electronic signatures etc. Utilising integrOS with biometrics in the manufacturing process and laboratories can help to remain compliant, operate more efficiently and receive faster approvals. Contact details: Electrolab Email: sales@electrolabgroup.com Website: www.electrolabgroup.com Tel: +91–22–4041 3131/ +91–22–41613122

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CPhI & P-MEC INDIA 2017 SPECIAL

‘We are known for quick, prompt and reliable service in the market’ Dr Kiran Badgujar, Founder and Director, Mack Pharmatech, talks about Mack Pharmatech’s services to the pharma industry and its growth prospects in an interaction with Express Pharma How has Mack contributed to the growth of the Indian pharma industry? Mack Pharmatech is and always has been an 'innovator' of novel technologies which helps the user of our chamber to concentrate more on his/her core work rather than looking at and/or attending the equipment. Mack Pharmatech has pioneered and launched the European certified 'CE' approved environmental chambers first time in India. It has received a grand welcome by the Indian pharmaceutical industry and pharma fraternity in general. Also, Mack Pharmatech pioneered and launched a 'PLC'-based control system in India. We have developed a 'software' which is 21CFR Part 11 compliant and certified and one of the best in industry, as the PLC & Software: D.A.A.S., performs all the important functions- automation, controlling, communication and database, giving user complete freedom. After the advent of the PLCbased machines our users are facing the audits more confidently and completing them even more successfully. This has gone down in history books that all our peers and contemporaries followed our footsteps. We launched a new HMI last year (Make: ASEM from Italy), wherein the HMI itself has a inbuilt memory of 4GB: so it can store roughly about five years of data in itself, more over the user can take print outs directly from HMI by connecting a printer to it. We also have successfully designed and launched our

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competitors? Being a very young player in the market, we are giving the leaders a good run for their money as we are committed to manufacture and supply the best and latest equipment and services. We are known for quick, prompt and reliable service in the market, which sets us in a different league altogether.

'Fire Proof Chambers' recently. We are in a constant process of developing and upgrading our state-of-the-art and pioneer software DAAS with- newer features making it more user friendly. Recently, we have launched our DAAS 3.0 edition & its been welcomed by the industry. We, MPPL, DO NOT charge any fees (license &/or up gradation) to our client if they want to upgrade their software from an earlier version to the latest one, and there are no hidden costs whatsoever. What are the different types of products you manufacture? Mack Pharmatech manufactures all types of environmental chambers, such as Humidity Chambers (Stability Chambers), Cold Chambers, BOD Incubators- all the three. We have our

We are in a constant process of developing and upgrading our pioneer software DAAS with- newer features making it more user friendly standard models as well as we can 'customise' them as per the need of our customers- StandAlone or Walk-in type. Apart from these, we also manufacture deep freezers

(upto -40 Deg. Cel.), bacteriological incubator, photo stability chamber, hot air oven, vacuum oven, duel zone chamber, seed germinator etc. Our state-of-the-art machines are carefully handcrafted with utmost care in our fully equipped plant in Malegaon, Sinnar plant in Nashik district of Maharashtra, India. Which are your pharma specific products? Do you cater to any other industry as we well? All the products are specific to the pharma sector. However, these are also used in food, cosmetic, chemical, health industry. Also, used in colleges and universities for educational purpose. What are the advantages of your products? How good are they in comparison with your

How much revenue did your company generate in the last fiscal? What percentage of your revenue came from the Indian market? MPPL has consistently been showing a double digit growth in the last few fiscals. This year was no exception where we clocked an impressive more than 30 per cent growth beating the industry growth rate by a huge margin. We are confident that we will continue to do so this year and years to come, thanks to our innovative products and top notch after sales service. Whom do you consider your major client and why? We have a strong presence in the West & South markets. Most of the big names in the industry are our valued and regular clients. Tell us more about your expansion plans? Recently, Mack has acquired a second plant dedicated for our 'Walk in Chambers.' We have shifted our R&D department in the same plant giving them more room and freedom to experiment on the novel ideas and technologies. EP News Bureau

CPhI & P-MEC INDIA 2017 SPECIAL

‘Our products are widely accepted and used across India’

Dissolution Tester

Sunil Saraf, Director, REMI Group, in an interaction with Express Pharma, talks about the company’s offerings for the pharma sector and its growth plans Brief us about your company. REMI, founded in 1960, is a reputed and huge group of multiple manufacturing units. We at REMI LAB are primarily into manufacturing of laboratory and blood bank equipment catering to the medical and healthcare industries. Over the last six decades, we have established ourselves as market leaders in India for centrifuges and other laboratory and blood bank products. Along with all major hospitals, medical colleges, path labs diagnostic centres in India, our clientele spans across 50 plus other countries. We have a strong sales and support team network spreading across 14 different cities in India. What is your company’s USP? We are market leaders in centrifuges. Our products are widely accepted and

Technological upgradation and global market expansion will constantly sophisticate our existing range of products used across India and various other European, African, Asian and Middle Eastern markets. We are known to bring the latest in technology of centrifuges from time to time for our customers with our new models and variants to suit their changing and increasing demand for various purposes of centrifugation. The master technology in centrifugation can be attributed to the company's history of developing motors way back in 1960 as their first product. The

COMPLIANCE MEETS CONVENIENCE

Hardness Tester

Fingerprint Authentication

Disintegration Tester

Electromagnetic Sieve Shaker

Tap Density Tester

Friability Tester

creation of this motor which revolved in circular motion further gave birth to different manufacturing units which used this motor technology as their primary product to create products like fans, mixies, centrifuges, stirrers etc, which now function as independent business units respectively. Which products will be showcased at CPHI/P-MEC 2017? For P-MEC 2017, we will showcase some of our best products. There will be a wide range of centrifuges accompanied with stirrers, shakers, mixers, incubators, freezer and walk in chamber. What is the company's road map for next five years? We at REMI, are focussing on a twopronged approach for the next five years. Technological upgradation and global market expansion will constantly sophisticate our existing range of products for our home market customers. Market expansion will ensure a global reach to strengthen and grow our market in the world and optimise on the rich technology exchange in order to serve our home market and extended market with the best products. EP News Bureau

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Weighing Balance

Introducing

integrOSTM Data Integrity Operating System

Paper instrument log book

Limited System Access

21 CFR

Audit Trail Authority and Device Checks Metadata Storage Electronic Signatures

ELECTROLAB (INDIA) PVT. LTD. E-mail : sales@electrolabgroup.com l Website : www.electrolabgroup.com Tel : +91-22-4041 3131 / +91 - 22-4161 3122

CPhI & P-MEC INDIA 2017 SPECIAL

HiMedia in collaboration with premier academic institutes is exploring key projects with BIRAC Dr GM Warke, Founder, CMD, HiMedia Laboratories, in an exclusive interview with Swati Rana, spoke about the companyâ&#x20AC;&#x2122;s journey and its upcoming project with DBT HiMedia is almost four decades old. How has the journey been so far? The journey of Make in India biosciences products was started by us about 42 years ago. The expedition was very challenging, inspiring and satisfying as well. We have our state-of-art R&D set up; strong, enthusiastic research team with innovative ideas and high-end technology. The company, which was started with barely five to six products in microbiology, now has diversified and flourished with other wings of biosciences, animal cell culture, plant tissue culture, molecular biology, agro industry and so on. HiMedia currently has a strong portfolio of 4500 supplying products to many industries such as pharmaceutical, agriculture, clinical and health sector, brewery and fermentation, environmental and sanitary, textile, petroleum, cosmetics, food, dairy, veterinary and biotechnology segments of biosciences. HiMedia has consistently provided exemplary services to all the biosciences segments at reasonable prices. How do you assure the quality, sustainability and affordability of your product in the Indian market? Over the past four decades, we faced intense competition from more than 40 companies. However, we have been able to sustain due to the unchallenged quality of our products, prompt technical services and moreover, wide range of products including microbiology, cell culture and molecular biology. To provide quick solution to our esteemed customers, if they feel they are facing certain challenges in our products, we try our best

108 EXPRESS PHARMA December 1-15, 2017

to immediately provide replacement instead of wasting time in sequential analysis. Of course simultaneously, we begin root cause analysis of the issues faced by the customers. HiMedia is always focussed on the common man needs and on how they can benefit from our knowledge and experience. Tell us about your manufacturing capacity and capabilities. At present, we have six WHOGMP certified manufacturing facilities in Maharashtra spread across Nashik, Ambernath and Dombivali, where in hi-tech and advanced machines have been installed. We have invested around

`120 crores in the past five years for such cutting-edge equipment facility. We are constantly updating and upgrading our manufacturing units so as to satisfy the needs of global demand. To achieve this, we are increasing our per day manufacturing capacity of ready prepared cultured media plates by about five folds by 2018. For this, our new production unit for ready prepared cultured media plates is being set up near Mumbai. Apart from this, we are expanding and upgrading our Nashik plant with new technology to produce 10-12 fold greater amount of dry powder over our existing capacity. What are the challenges

faced by the company? In pursuit of the Make in India dream, obtaining a license and recognition of our products in the domestic and global market was a very difficult task in the beginning, as these products were imported from other countries such as the US and the UK. Very few manufacturing units were present in India at that time.They were unable to compete with the foreign companies then especially in terms of quality and cost of the products. Urge for costeffective quality products and market scenario were the major motivations for us, which led to the foundation of indigenous manufacturing unit of HiMedia in India in 1976. Keeping the promise of

'Excellent Quality', HiMedia presently caters esteemed patrons globally with a comprehensive range of sophisticated, word-class quality products at competitive prices, for excellent and accurate results. Today, HiMedia is a leading biosciences company and have a 90 per cent market share in India.Which countries do you export to and how much does export contributes to your annual turnover? We are an aggressively growing industry and at present, we are exporting to more than 150 countries, including Japan, the US, European countries, Russia, other Asian Countries, Brazil and Argentina. We have our own warehouses in the US and Germany to quickly deliver the products to the US, Canada, Europe and other neighbouring countries. We also have our presence in strategically located centre, Dubai, which can cater to the Middle East and African countries. There is a massive demand for HiMedia products worldwide. Understanding this global demand, we would like to open our warehouses in Thailand and Philippines to cater to the nearby countries. Currently, HiMedia is generating sales revenue of over ` 500 crore of which 35 per cent revenue is generated through exports According to you, what steps should the government take to ease exports? We truly appreciate the efforts taken by Government of India for encouraging, Make in India concept and its development. Moreover, there is further scope to encourage indigenous companies, to export more Make in India products by reconsidering certain rules so as to speed up the delivery of

CPhI & P-MEC INDIA 2017 SPECIAL the products. This will help us to increase foreign revenues. Concerned officials perhaps need to work more closely with medium to large Indian origin companies to understand these challenges which would definitely increase the export, generating more foreign currency. Tell us about the USP of HiMedia. Urge for innovative products, supplying excellent quality and exclusive products at reasonable price has been the main USP of HiMedia, ever since its inception. Our R&D team is always on the toes and is driven for constant innovations and quality enhancement. Hence, we have successfully invented many unique products which are not available with our competitors. We are the first manufacturer of certain unique products such as HiVeg, having highest purity. What is the annual turnover of the company and how much do you invest in R & D? As R&D is our core strength, approximately 10 per cent of

Strength of HiMedia is R&D, due to which the company could flourish and possess broad series of products in all the segments of biosciences. Henceforth, we will keep launching numerous new products persistently in the future our sales revenue is devoted to R&D. We also plan to surge it beyond that, to upgrade our technology for inventing novel products. We have gone to the next level with respect to innovations. We have invented many synthetic media wherein raw materials from vegetable or animal sources are not used, which is supporting to the green revolution. Tell us about your project with DBT. It has been revealed by several experts that innovation in biosciences can make it a bigger industry and also it’s envisaged that without basic research the country will always remain knowledge deficient. Therefore, the

Department of Biotechnology (DBT) has developed very strong benches for basic and applied research in modern biology. Moreover, several biotech parks and incubation centres have been established by DBT and are fully operational. DBT is really a back-bone for scientists/industrial R&D’s like ours and others in India who are willing to develop new technologies for the mankind. HiMedia in collaboration with a couple of premier academic institutes have been exploring certain key projects with Biotechnology Industry Research Assistance Council (BIRAC), which is a not-forprofit set up by Department of Biotechnology (DBT), Government of India. The

proposed projects are under the scheme of affordable product development. Which products are in the pipeline? Strength of HiMedia is R&D, due to which the company could flourish and possess broad series of products in all the segments of biosciences. Henceforth, we will keep launching numerous new products persistently in the future. As India is the second hub for FDA approved products, we understand enormous opportunities in pharmaceutical/healthcare industry. As pharma industry is expanding at almost 18-20 per cent CAGR, we are also expanding our portfolio in this segment, especially the supply

of varieties of ready prepared media. Recently, HiMedia has ventured into hydroponics business and working aggressively in this sector. What is the company's road map for the next three years? With the mission of “BioSciences in the service of Humankind” and vision “Quality First” HiMedia is working dedicatedly to provide unique, cost-effective, unchallenged quality products and excellent service to our customers worldwide. At present, HiMedia is one of the leading brands in the world. My directors, fellow scientists, marketing team and other colleagues are striving strategically to make HiMedia the top brand in the world within a span of 5 years. To attain this goal, enhancing quality of products, inventing unique products and supplying these at reasonable prices is always going to be our first priority. swati.rana@expressindia.com

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Emerging trends in pharmaceutical industry Manu Grover, Product Manager â&#x20AC;&#x201C; Pharma, Waters India, gives an insight about the concepts of reverse innovation in LC Detector Technology drawing instances from a case study THE PHARMACEUTICAL industryâ&#x20AC;&#x2122;s steady growth curve is beginning to taper in 2017, thanks to a few unique challenges that have unfolded recently. Pharma R&D productivity has also diminished and the pharma landscape is changing. The US is the largest pharma market globally and for India too, hence the performance of the US market is crucial for the industry. Single-digit spending growth is forecast for the US market. The US market growth rate declined from 12 per cent in 2015 to 7 per cent to 8 per cent in 2016 with a 6 per cent to 9 per cent growth forecasted through 2021. Despite the slowing growth, the US will account for 53 per cent of forecasted global pharma industry growth of $367 billion through 2021. In these times of rapid changes, it is not enough for pharma companies to focus solely on selling drugs and medications. Today, the industry aims for more holistic approach with integrated services. There are upcoming trends in the industry to which pharma companies have to respond to. One such innovative trend is 'reverse innovation or reverse engineering.' Reverse innovation is any innovation, which is likely to be adopted first in the developing world. Upon adoption of the reverse innovation in emerging world, the product gets distributed globally. Reverse innovation is a response to numerous challenges, which the industry is facing now, such as a slowdown in successful new drug launch, increasing research costs, decreasing revenues due to patent expirations and huge expense to bring a drug to the market as a result of enhanced regulatory hurdles. There are different levels of reverse innovation, for e.g. in first level, we identify the

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FIGURE-1: COMPARISON OF PEAKS IN MULTIPLE BRANDS/DIFFERENT FORMULATIONS

major ingredients/impurities. This is often used to verify label claims or give guidance to the formulation/analytical chemist, and in next level we need to identify and quantify all impurities, process markers etc. in the system which is needed to ensure that the ANDA will meet approval with consideration to ICH Q3B (R2), impurities in NDA. There are analytical tools available in the industry today which can help in innovator/generic drug screening like liquid chromatography equipped with Acquity QDa, Evaporative Light Scattering Detectors, Refractive Index Detectors & UV/PDA detectors. Other than conventional liquid chromatography techniques, we have technologies available like FTIR, DSC/TGA, SEM, Microscopy, XRD, LC-MS etc. Let us explore here through a case study the advantage of Waters 'Acquity QDa' w.r.t reverse innovation process. Acquity QDa is an orthogonal mass detector, that complements UV/PDA detector and gives mass information about the peak of interest. This detector has been designed for chromatographers who lack mass spectrometer (LC-MS) handling expertise. In this case study, to study

CPhI & P-MEC INDIA 2017 SPECIAL the concepts of reverse innovation we procured multiple formulations of API called as 'Metoclopramide. Metoclopramide is used to prevent nausea and vomiting. The samples used in case study were Metoclopramide HCl 10mg Tablets from two different brands (Brand X and Y) and Metoclopramide HCl injection 5mg/ml from Brand Y. All the samples were prepared in a uniform way and were run under identical conditions using liquid chromatography coupled with PDA and Acquity QDa. After analysis, we processed the data using Empower CDS software and compared the

data as depicted in the table in Figure-1. A representative image of how PDA-Acquity QDa gives the spectra and mass no. simultaneously on Empower Software is shown in Figure2. This data clearly reflects the advantage of an easy to use mass detector Acquity QDa. Based on the data generated using Acquity QDa detector coupled with PDA detector, it was found that USP specified impurity, 4-Amino5-chloro-N-(2-(diethylamino) ethyl)-2-hydroxybenzamide was found in tablets of brand X and injectable of brand Y only, but no other USP-specified impurities have been found in any samples. We also

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Acquity QDa along with its ease of use, makes this detector a real universal detector for most of the pharma applications and a must investment for R&D and QC labs observed formulation-specific impurities/excipient peaks and they were identified by their mass number. Hence to conclude, Acquity QDa is going to be 'must to have' detector for all R&Ds and QC labs working on generics, complex generics, nutraceuticals etc. It's a

fast screening tool in R&D's to compare analytical samples like multiple source of API's, different grades of API, API versus formulation and stressed samples versus unstressed samples. It is useful in QC labs w.r.t cleaning sample analysis/validations, low level genotoxic impurity

quantification, unknown peak identifications and OOS/OOT studies. Acquity QDa is a tool for conducting orthogonal peak purity studies, wherein homogeneity of the peak can be verified or confirmed by selecting the purity tab from Empower Software. Here, we get mass number at start, apex and end of the peak. This unique feature of Acquity QDa along with its ease of use, makes this detector a real universal detector for most of the pharma applications and a must investment for R&D and QC labs. Contact details manu_grover@waters.com

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Detection methods in HP-TLC (Part I) TB Thite, Sr Manager (Lab),Anchrom Enterprises India,gives an insight about the features of HP-TLC TRADITIONALLY, qualitative and quantitative detection and evaluation in High Performance Thin Layer Chromatography (HP-TLC) is done by evaluating the chromatographed plate under UV (absorbance) or fluorescence (emission). Visible light was used to evaluate coloured fractions, usually after postchromatography derivatisation (PCD). In Part I of the series, the above technique will be described while in Part II discussions will be held on HPTLC/MS-IR-NMR and Effect Directed Analysis. At the outset, it must be noted that in HP-TLC, after separation, the 'chromatogram' remains on the plate and does not go to waste. Only in HP-TLC, the term 'chromatogram' can have three meanings viz. a) separated samples embedded on the plate b) its photographic image(s) c) its 'scans.' Therefore, HP-TLC 'chromatogram' can be evaluated by the eye as well as by instrumental means. The ‘scan’ data is similar to GC-LC output, in form of peaks. Two things to unlearn here are that one has to 'forget practice of TLC' because it is not instrumental and has no universally agreed methodology. LC users must get used to parallel processing of multiple and different samples and 'stored' chromatograms. The ‘plate’ i.e. separating medium in HP-TLC is 20 x 10cm in size, coated with a 0.2mm thick layer of 5µm adsorbent on a flat support. Silica gel with fluorescent indicator F254 is the adsorbent of choice, unless proved unsuitable. Once the chromatographic development is over and the plate dried, the HP-TLC 'chromatogram' on plate is visually evaluated under UV 366nm for native fluorescence and then UV 254nm for substances absorbing around that region against a fluorescent green background. Next, the 'chromatogram' is image documented in a table top dark room, again under UV 254nm and 366nm and also

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‘CHROMATOGRAM’TYPE 1 PLATE WITH SEPARATED SAMPLES

white light. This documentation under GLP, when handled through HP-TLC software, enables comparative evaluation of reference and sample, qualitatively (identification) and semiquantitatively (dilution), as per regulatory requirements. Next the same ‘plate chromatogram’ is scanned in a scanner, where a monochromatic beam of chosen wavelength (between 190-800nm) travels over each sample track, detecting absorbance and, generating ‘scan chromatograms.’ UV absorbance spectra of selected or all peaks are also recorded. Then the 'plate chromatogram' is scanned similarly for fluorescence with 366nm as incident light and a visible light transmitting filter placed before the photomultiplier detector. In HP-TLC scanner, since the photomultiplier detector is an angle to the light source the emission can be selectively measured, without interference from the light source. No separate fluorescence detector is required. A big advantage! All the above are non-destructive methods of detection that leave the ‘chromatograms’ intact! Another big advantage!! A chromatographed sample (on multiple tracks) can be derivatised i.e. reacted on the plate with one or more derivatisation reagents in-situ to get a treasure of additional specific and high sensitivity information about the sample; PCD is very simple, applicable to every sample and needs no special accessories in

‘CHROMATOGRAM’TYPE 2 IMAGE OF SAMPLES ON PLATE

‘CHROMATOGRAM TYPE 3 PLATE SCAN OFSAMPLES ON PLATE

HP-TLC. Modern PCD reagent spraying machines require only 2-4ml reagent and generate an uniform mist, leading to high quality derivatisation. PCD gen-

erates more chromatograms! Where a HP-TLC scanner is available, visualisation may not be necessary unless the fraction(s) of interest do not absorb

UV down to 190nm. In research labs, it is common to apply same sample on same plate on multiple 'tracks' and then evaluate all tracks with same detection technique as well as each 'track' by a different detection mode!! All this without repeating chromatography! No wonder HP-TLC is called the Cindrella of Chromatography. HP-TLC proves to be a simple technique with many unique advantages, particularly with respect to data obtainable from samples, high throughput and low cost of analysis. Further information can be obtained from the same plate, using MS, IR, NMR and Effect Directed Analysis, which will be described in Part II.

HP-TLC

THE DATA-INTENSIVE TECHNIQUE! HP-TLC “chromatograms” remain on the plate, unlike GC-LC. Several non-destructive detection methods can therefore be used and followed by destructive ones on the same plate. Each detection mode gives different information. Given below is the data obtainable from one “plate”. HP-TLC plate with 15 samples (UV 254nm)

Data Set 1

Data Set 3

From Imager

Images Documentation 254nm, 366nm, visible light

Data Set 6

From Scanner

Fluorescence scan - incident 366nm, emit 400-800nm

Effect Directed Analysis

Anti-oxidant (DPPH)

Toxic Fractions Detection

Data Set 4

From PCD + Imager

Post Chromatography Derivatisation (PCD) Anti-bacterial fractions detection

Data Set 2

From Scanner

UV, Vis. Absorbance Before

After

Data Set 5 Quantitative scanning

HP-TLC/MS Hyphenation & IR, NMR

Undesired estrogenic substances

Data Set 7 2D Chromatography UV Abs. spectra

3-D plot - multiwavel. scans

HP-TLC Specialist!

IR, NMR

Simple. With same or different mobile phases

For live demo, details & free training: hptlc@anchrom.in 9833830899/9833830898

CPhI & P-MEC INDIA 2017 SPECIAL

Louis Roy,President,OPTEL GROUP bags Quebec Entrepreneur Of The Year Award The awards recognise aspects such as integrity, leadership, entrepreneurship, vision, as well as the financial performance LOUIS ROY, President, OPTEL GROUP, was presented with two Entrepreneur of the Year Awards by EY, the first in the Business Products and Services category, and the second covering the entire province of Quebec. These awards recognise aspects such as integrity, leadership, entrepreneurship, vision, as well as the financial performance. “If I received these awards today, it’s thanks to the team behind me, who supports my vision and works relentlessly to meet our common goal. The awards are proof that we’re not the only ones who believe in our mission and that the business community supports

and encourages us to do what we do best: work towards a more sustainable world for future generations,” declares Roy. “This cause has always meant a lot to me and it’s the reason I created OPTEL. I wanted to be a socially responsible entrepreneur working for the good of the planet. At OPTEL, our main goal is to solve problems rather than create them. Our personalised solutions are developed in line with these values and they aim to meet customer needs while protecting consumers as well as the environment,” adds Roy. EP News Bureau

OPTELGroup bags loan worth CAD $68 m from Desjardins Group The loan will allow OPTEL Group to extend its traceability service offer as well as diversify its activities in the healthcare, medical devices and R&D fields as well as in other various field OPTEL GROUP, a leading global provider of traceability systems, announced that Desjardins Group is providing the company with CAD $68 million in loans in order to support its growth and expansion plans. Such financial support will allow OPTEL to extend its traceability service offer as well as diversify its activities in the healthcare, medical devices and research and development fields as well as in other various fields, such as food and natural resources. This assistance also aims to improve OPTEL’s predominance and influence in one of

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its usual markets – pharmaceuticals. OPTEL already owns 25 per cent of the global market share for the healthcare Track & Trace hardware systems market and keeps exhibiting its proficiency in securing the medical products’ supply chain. “OPTEL is always looking to push limits and rise to nextlevel, more difficult challenges. These issues that humanity is facing, they require innovative solutions. This support from Desjardins will allow us to go even further in our growth, by entering new, crucial markets to create a more sustainable

world,” says Louis Roy, President, OPTEL Group. “Desjardins is pleased to grant these loans, because we trust the OPTEL brand completely. The financial situation of the company is excellent and it was very important to us to support their expansion and growth,” adds Robert Bastien, VP, Business Services at Desjardins Group. OPTEL is constantly committing to attain new objectives, on a bigger scale, and Desjardins Group is a critical ally to make them a reality. Indeed, not only are

OPTEL is constantly committing to attain new objectives, on a bigger scale, and Desjardins Group is a critical ally to make them a reality

they the leading cooperative financial group in Canada, but Desjardins also stands out with its commitment, financial strength and contribution to sustainable prosperity. Since Desjardins’ and OPTEL’s values are perfectly aligned, this collaboration between two leaders in their respective field is entirely logical and will help OPTEL maintain its present momentum, by continuing developing solutions perfectly adapted to its customers’ needs and able to solve real issues. EP News Bureau

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CPhI & P-MEC INDIA 2017 SPECIAL

CPhI Worldwide report highlights unpredictability in CDMO growth over next five years Flow chemistry, fermentation, repatriation of overseas funds, oncology and API/product integration to grow, but the rate of change remains unclear CPHI WORLDWIDE, which was recently held in Frankfurt announced the findings of part i of the 5th edition of the CPhI Annual Report, which focusses on the immediate and longterm trends in pharmaceutical outsourcing. The exhibition, as the world’s largest pharma event, is a key bellwether of global trends and the industry’s overall strength. This first part of the report features the contributions of four industry experts — Gil Roth President, PBOA; Vivek Sharma, CEO, Piramal Pharma Solutions; BSV Prasad, Sr VP & Head, Small Molecules Business, Biocon and Sam Tadayon, Executive Director and Dr Minzhang Chen, CEO, STA Pharmaceutical. The overall findings reveal that the trend towards the integration of pharma outsourcing continues, with single source providers in terms of development increasingly sought. However, acquisitions in the future will not be dominated by big deals and large mergers, but rather smaller commentary services and niche technologies to fill specific technology asset gaps. Furthermore, the industry is anticipating a large increase in the use of flow chemistry and fermentation technologies – but resistance to change may slow adoption significantly. The new US Government administration, the longerterm implications of drug pricing, and big pharma income repartitions are highlighted as the key unknowns and risks for CDMO sector. Gil Roth, President, Pharma and Biopharma Outsourcing Association, suggests that the consolidation expected of the CMO/CDMO sector to improve the efficiency of outsourcing has not yet panned out in 2017 [this was written prior to Catalent’s

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purchase of Cook Pharmica]. The only large merger with the intention of creating a more integrated outsourcing model was the Lonza acquisition of Capsugel. However, Roth predicts that smaller scale buys to expand their current capabilities are far more likely by CDMOs, whilst ‘exUS CDMOs’ may try to boost their US presence by acquiring an existing provider or an available pharma facility. Roth explained at length the relative unpredictability of the current pharma climate, considering the unclear plans of the current US administration. For instance, there has been a keen political desire in the US to reduce drug prices, but with very little indication of policy, leaving pharma companies and ‘CDMOs in the dark as to decisions that may very well disrupt their entire business model’. Another knock-on industry effect could result from a ‘tax holiday’ in which big pharma reinvests large amounts of repatriated capital in its own domestic facilities, particularly biologics sites, with negative connotations for the growing CDMO industry. He added, “Given the focus on reducing legal immigration in the US, there is additionally the strong possibility of a shift in the talent pool of pharma employees to other more welcoming nations, which may impact the domestic wages.” Vivek Sharma, CEO, Piramal Pharma Solutions, forecasts that the long heralded one-stop-shop CDMO is now coming to fruition in the industry, with biotechs a clear beneficiary of this trend. Echoing Roth’s perspective, he argues that over the next few years we will see ‘CDMOs in niche areas forward and back integrate’, offering more integrated value chains to customers. In fact, by

simplifying the supply chain CDMOs enable VCs to have a longer runway for investments, and the potential for faster returns, whilst also reducing risk. “From pharma’s perspective, this enables them to concentrate on broadening the number of drug discovery programmes they work on simultaneously and should expedite new drugs to market. In fact,

The overall findings reveal that the trend towards the integration of pharma outsourcing continues, with single source providers in terms of development increasingly sought over the next two to five years, we will increasingly see more symbiotic relationships between pharma and CDMOs – with even capital and risk sharing deals,” added Sharma. He concluded that in terms of specific products classes, in the immediate future, oncology continues to grow quickly as pharma and biotech see medium-term potential success. It is therefore likely that CDMO’s will invest in parallel areas such as high potency API manufacture,

lyophilised/injectable products and antibody drug conjugation as the sector arms itself for the next wave of drug candidates. Sam Tadayon, Executive Director and Dr Minzhang Chen, CEO, STA Pharmaceutical, state that flow chemistry has the potential to revolutionise and modernise pharma processes, but cautions that overall, the industry is still a full 50-years behind the bulk chemicals industry on the implementation of this technology. They note that implementing changes at the commercial stage can be limited by regulatory challenges. However, those companies that invest early in this technology will benefit from more environmentally friendly production, and potentially double digit cost savings at commercial scale. To expedite the process and advance the technology more quickly, an increased number of specialised chemical engineering teams will be needed. Initial development of flow chemistry production occurred at big pharma facilities, but increasingly, we will see these outsourced by the pioneers to their strategic CDMO partners. “The message here is clear: for flow chemistry to deliver on its huge promise, pharma and CDMOs need to build the platform into the early phase process R&D of innovative API programmes,” commented Dr Tadayon. “In the next five years, however, more advanced flow technologies will be developed and more companies will be developing continuous processes, while the existing scientists will build up more experience in this area. As a result, we should expect a wider range of reactions to be processed through flow, and a lower bar to be established for selecting a process to be operated in flow. During this time,

we expect to see more multistep flow processes performed,” Dr Chen added. The report also pointed to the increased role fermentation is set to have in bringing newer types of drugs through the development pipeline. Biocon’s, Prasad highlighted the role it will have in helping to commercialise new vaccines, biologics and even problematic areas like the creation of new antibiotics that overcome antimicrobial resistance. In particular, the technology holds the key to fully leveraging the advances in recombinant DNA and will be beneficial to drug discovery programmes involving stem cells and even gene therapy vectors. The resurgence of interest in antibiotic development and therapeutic vaccines is also forecast to drive increased demand over the medium term. Andreas Mavrommatis, Global Marketing Director, UBM EMEA, said, “In the last five years, CPhI has grown its attendee base enormously, but during the same period, the event has established itself as a vital channel for industry research, analysis and trends. This year our Annual Report experts have highlighted flow chemistry, integrated CDMOs, and potential threats to outsourcing from a changing business environment. I would encourage all attendees to read a copy of the findings and also use CPhI Worldwide as a sounding board to explore how they might be able to work more efficiently, grow revenues and explore the latest development and manufacturing technologies. As well as an opportunity to meet existing customers, CPhI provides a steer on tomorrow’s developments and helps you explore the right partners to maximise the value in your business.” EP News Bureau

CPhI & P-MEC INDIA 2017 SPECIAL

CPhI Worldwide report forewarns of intense battle between innovators and biogeneric companies for next three years Experts state pharma regulation will shift due to increased data dependence, warn regulatory oversight is slowing six sigma adoption, and forecast increased generic options 2025 onwards CPHI WORLDWIDE, organised by UBM, announced the findings of final section (part iii) of the 5th edition of the CPhI Annual Report, which focusses on the immediate and longterm trends in pharmaceutical data, regulation, generics and biosimilars. The full report was published live from CPhI Worldwide in Frankfurt amongst more than 42,000 executives, with four experts in data, regulation, generics and biosimilars — Dilip G Shah, Alan Sheppard, Bikash Chatterjee, and Ajaz S Hussain – giving their views on near- and longterm trends across the industry. The overall findings warn that the FDA’s approach to achieving six sigma is currently failing, encouraging regulatory oversight, rather than the selfadoption of continuous quality systems by industry. A positive impact, however, was identified in the regulatory approach to data standards and analysis, which will see drug discovery and patient treatment revolutionised over the next decade. For example, investments in handling big data will allow the industry to mine lost nuggets of insight into historical performance, whilst also enabling insight from e-clinical and postmarket vigilance initiatives more effectively. The report also noted that, despite what one expert describes as the ‘abusive’ and ‘unethical’ antics of innovator companies, the development of biogenerics is continuing apace. Furthermore, with the anticipated harmonisation of biosimilar regulatory guidelines – a common dossier for use both in the US and Europe is currently under discussion – and an overall increase in players in the market, the dynamics of the biosimilar market are shifting towards congruence with the generics and adoption

should now accelerate. Dilip G Shah, CEO, Vision Consulting Group, discusses how the intense battle between innovators and biogeneric companies is likely to play out over the next three years, explaining the tide is now gradually turning in favour of generic companies thanks to pressure from patients on governments to act. Shah states that innovators are known to impede the progress of biogeneric companies in generic and biosimilar production through morally dubious prac-

suggests in his article that there are still good opportunities for biosimilars in the industry. In the past, he claims, biosimilars were often viewed as a ‘risky venture’ for pharma companies, but now could be the ideal time to invest. He added, “uptake of the latest biosimilars in Europe is extremely positive and is starting to track the dynamics of small molecule products.” Sheppard emphasises that it is even not too late for pharma companies that have yet to get involved in the

the PIC/S by 50 regulatory entities (with a further 70 expected to join by 2020). There have also been important legislation changes, for example the 21st Century Cures Act in late 2016 authorised new drug and device manufacturers to utilise real-life data to establish drug safety and efficacy for FDA approval. As a consequence of new high-throughput technology, notably next generation sequencing, Chatterjee says that the role of data in illustrating performance and compliance

The overall findings warn that the FDA’s approach to achieving six sigma is currently failing, encouraging regulatory oversight, rather than the self-adoption of continuous quality systems by industry tices, yet he does not believe these methods will be fruitful in slowing down the progress of biogenerics. He explains, “The innovator companies will face increasing pressure to ensure access to medicines at affordable prices. But now the regulators and the governments will take on the innovators and force them to facilitate development of biogeneric versions over the next two to three years.” Shah added, “FDA Commissioner’s recent statement will encourage biogeneric companies to be more aggressive than they have been so far. The FTC has already conveyed that it is contemplating launching a formal investigation. Thus, both drug regulator and the competition authorities will be on the same side.” Alan Sheppard, Principal of Global Generics, IMS Health,

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biosimilar market: “As with small chemical molecules there now exists biosimilar developers who are seeking partners for marketing and distribution and contract manufacturing organisations with biosimilar capabilities. If that is not an option then portfolio growth from small chemical molecules will still offer opportunities. The recent increase in launches of small chemical products forecasted to be potential blockbuster molecules will offer significant generic opportunities in the years beyond 2025.” Bikash Chatterjee, President and Chief Science Officer, Pharmatech Associates, argues that the emergence of a global marketplace with shared regulatory compliance is one of many factors driving change in pharma regulation. A key element to this is the adoption of

will continue to increase over the next decade. Improvements in big data analytics will be crucial in highlighting the most suitable candidate drugs more quickly from e-clinical, lifestyle diagnostics and digital health initiatives. However, Chatterjee highlighted cyber security as a potential risk factor, especially as the industry increases dependence on patient data for drug development. He added, “The industry’s ability to manage the constantly evolving threats to data management and integrity will define how we develop new drug therapies in the future.” Ajaz S Hussain, Founder of Insight, Advice & Solutions, explores why a perpetual gap between what we know and what we can practice and implement – more than a decade after the launch of FDA’s 21st century ini-

tiative – remains. Utilising the constructive development theory of adult human development, he explores how Amgen (as a case study) reached six sigma with an error rate of just 3.4 defects per million opportunities. Ajaz stresses that much of the sector is held at a development stage – “socialised mind.” Systems orientation begins at the ‘self-authored’ stage of development. The Amgen case illustrates how this can be achieved. However, in the synthetic drug product sector, the legacy practices – such as the use of compendial test methods for batch release testing – and the inherent uncertainty in measurement systems for physical attributes, such as dissolution tests, can serve as a 'self-imposed' 2-3 sigma barrier. This barrier contributes to high OOS rates and high rates of invalidated OOS, which is a metric that the FDA is currently seeking from industry. Often this is not appreciated, and it serves as a blind spot. Chris Kilbee, Group Director, Pharma Portfolio, UBM EMEA said, “Now in its fifth year, the CPhI Annual Report delivers detailed perspectives on the most advanced pharma practices, analyses and future predictions. CPhI Worldwide is pharma’s one true global event, with a reputation as the place to do business and learn the developments of tomorrow. This report, like the event, provides insight on all parts of the pharma supply chain. In part iii, experts identified exciting developments in high-throughput sequencing, potential new methods to achieve regulatory excellence and changing dynamics across the biosimilars marketplace. I would encourage all of our attendees at CPhI Worldwide and the wider industry to study the report’s full findings closely.” EP News Bureau

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CPhI & P-MEC INDIA 2017 SPECIAL

LANXESS expands its CSR outreach in Nagda Signs MoU with Nagda Municipal Corporation for support, undertakes maintenance of overhead water tank in Mehatwas, supports development and maintenance of municipal garden in Nagda LANXESS INDIA, a leading speciality chemicals company has taken another major step towards creating a sustainable environment in and around Nagda by undertaking three projects as part of its corporate social responsibility. The company signed a memorandum of understanding with the Nagda Municipal corporation wherein it committed to undertake the maintenance of overhead water tank in Mehatwas, development and maintenance of Nagda municipal garden and installation of solar street lights in Mehatwas and Durgapura. This announcement follows the company’s CSR outreach projects launched last month wherein LANXESS committed its support to the Nagda government college by way of elearning tools and support of a sonography machine to the Nagda Civil hospital. The three-year long MoU was signed in a ceremony held at the Nagda community hall in the presence of Ashok Malviya Chairperson Municipal Council and Dilip Singh Shekhawat Member of Legislative Assembly Khachrod-Nagda Con-

stituency, Neelanjan Banerjee, Senior Executive Director, LANXESS India, Sanjay Singh, Site Head, Nagda, LANXESS India and other esteemed dignitaries from the state and local administration. These projects are in line with LANXESS’ vision for sustainable development and a better quality of life for the people of the region. As part of the maintenance and development of the Nagda mu-

nicipal garden, LANXESS India will ensure structuring of the fencing, grass beautification and planting of saplings. With an aim to ensure better infrastructure for distribution of the current water supply system in the town, LANXESS will support in the repair and renovation of the pipeline distribution and strengthening of column structure of the overhead water tank in Mehatwas.

This is expected to directly benefit a population of over 2400 in the region.Contributing towards making the planet greener, LANXESS India will be undertaking the installation of solar street lights in Mehatwas and Durgapura wherein, the company will support the municipal corporation with installation of 25 solar street lights. The installation will include pole installation, battery,

LANXESS LEADS IN CLIMATE PROTECTION SCORING ◗ Group among the top five per cent of the companies rated worldwide ◗ Inclusion in the Climate A List of the non-profit organisation CDP ◗ Broad contribution to UN sustainable development goals At the United Nations World Development Information Day, the international climate protection initiative CDP (formerly Carbon Disclosure Project) honoured speciality chemicals company LANXESS. The Cologne-based company once again achieved the highest score in this year’s evaluation and is therefore listed in the CDP’s Climate A List. With this list, CDP recognises companies’ efforts to cut emissions, mitigate climate risks and develop the low-carbon economy. As part of the Climate A List, LANXESS is among the top five per cent of several thousand companies sur-

veyed by the initiative. Commenting on the achievement, Neelanjan Banerjee, Senior Executive Director, LANXESS India said, “It is a matter of pride for us at LANXESS to be included in the Climate A list. As this listing reiterates our commitment to doing business across the globe in a sustainable manner and gives us the confidence that we are on the right path in addressing our sustainability goals and targets.” Even beyond climate protection, LANXESS’s business activities, products and corporate initiatives contribute effectively to each of the 17 sustainable development goals, which the United Nations draws attention to every year on October 24. They include clean watersolutions as well as an educational initiative that has already supported hundreds of thousands of children, young people and young adults around the world.

solar panels, solar bulbs and maintenance for a period of three years. On this occasion, Banerjee said, “LANXESS takes its social responsibility projects in true spirit and has been relentless in its efforts of making a positive and meaningful change in the lives of the people in and around Nagda. In the current fiscal year itself, the company has supported the region through five different CSR projects worth around `50 lakhs. The three new projects launched today assert our commitment towards the region’s welfare and the company’s vision of a sustainable environment.” Commenting on the projects, Singh said, “LANXESS India has taken these initiatives as a step forward to sustainability in the region of Nagda. With the current environmental conditions, sustainable development is the solution for a healthier lifestyle. Through these projects, we hope to improve the quality of living for the people of Nagda. I also thank the Municipal Corporation of Nagda for seeing merit in our efforts and supporting us.” EP News Bureau

DKSH to promote pharma portfolio at CPhI India 2017 DKSH will showcase an exciting portfolio of pharma ingredients, innovative solutions and concepts, together with its renowned key clients DKSH’S BUSINESS Unit Performance Materials, a leading ingredients and speciality chemicals distributor and provider of market expansion services, will exhibit at CPhI India 2017 in Mumbai, India, from November 28-30. The event is South Asia’s leading platform for pharma ingredient product manufacturers, suppliers as well as buyers and provides a unique environment for pharma

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experts to meet, learn, share ideas and drive business throughout the year. DKSH will exhibit at stand A15 in hall 1 at the Bombay Exhibition Centre, where senior executives from DKSH and its valued business partners will be present throughout the show to promote their extensive pharma ingredients portfolios, which include: ◗ Ashland: Various grades of

Plasdone, Klucel, Benecel, Blanose, Aqualon Ethly cellulose, Aquarius coatings systems and Natrosol ◗ Crest: Various grades of Cellucrest (MCC) and Crestcross, Crestadd, Gelmac, Lubricrest and Rapigel ◗ Symega: Pharmaceutical flavour (liquid form) and functional flavour ◗ Stepan: Stepanol WA 100 ◗ Mondo Minerals: Microtalc

Pharma 8/30/50 ◗ JMC: Sodium Saccharin 6 per cent and 15 per cent ◗ Precheza: Pretiox AV 01 PhG ◗ Daicel: Granfiller (coprocessed excipient) GNFD211/GNF D215 ◗ Wacker: Cavamax W8, Cavacurcumin and HTEssence ◗ Horphag: Pycnogenol and Robuvit ◗ Other sources: Active Pharmaceutical Ingredients (APIs)

and Intermediates for pharmaceutical synthesis “Exhibiting again at CPhI India, together with our valued business partners, will allow us to attract new business and continue to contribute to the world of innovative pharmaceutical ingredients. We look forward to another successful show this year,” commented Atul Nagarkar, MD, DKSH India. EP News Bureau

CPhI & P-MEC INDIA 2017 SPECIAL

LANXESS Urethane Systems to enhance research on next generation materials Collaborates with Polymer Science and Engineering department of University of Massachusetts Amherst THE URETHANE Systems business unit of speciality chemicals company LANXESS decided to join the Center for UMass/Industry Research on Polymers (CUMIRP) at the University of Massachusetts Amherst, USA, in order to enhance its scientific research on next generation materials. CUMIRP acts as a crossroads where university research and education meet with industrial partners in polymer materials, engineering and processing to leverage resources and foster collaboration. LANXESS will join Flammability Cluster (Cluster F) and Mechanical Properties & Additive Manufacturing Cluster (Cluster M). This collaboration targets the development of novelurethane materials, it focusses on in-depth understating of structure-

In the long run, LANXESS expects cost savings through sophisticated, highly efficient solutions as well as benefits in business competition by using progressive technologies and the recruiting of qualified specialists property relationships to develop new process methods and new chemistries. The collaboration will come into effect on October 2017. In the long run, LANXESS expects cost savings through sophisticated, highly efficient solutions as well as benefits in business competition by using progressive technologies and the recruiting of qualified specialists. Furthermore, access to other companies who could be potential partners and/or customers will be provided.

Dr Polina Ware, Head of Global Research and Development, LANXESS Urethane Systems business unit, “The research clusters are targeted towards specific research areas and allow small team dynamics and interactions as well as collaboration between industrial members, faculty and students. This team-oriented approach fosters cross-industry collaboration as well as gives us access to top experts in polymer science as consultants. As members of Cluster M and F, we expect to

gain potential cost savings and business growth though new product innovation.” The Polymer Science and Engineering Department at the University of Massachusetts Amherst is the leading institute on polymer science in the US and one of the largest academic centres for polymer research in the world, with currently more than 200 scientists, $24 million in instrumentation and over 600 doctoral degrees awarded. A key figure in the aca-

demic collaboration for Urethane Systems is scientist Alan Lesser from the University of Massachusetts Amherst, who is a world expert in deformation and fracture of polymers and composites. His research focusses on strength, durability, and micromechanics of polymer blends and composites, nano and molecular composites, constructive modelling of polymers in complex stress states as well as unique processing methods and multifunctional additives. As of 2016, the group is focussing on next-generation additive manufacturing formulations. Furthermore, Lesser is editor-inchief for the technical media Polymer Engineering and Science Journal, Polymer Composites, and Journal of Vinyl & Additives Technology. EP News Bureau

Clariant packaging solutions extend shelf life of oxygen and moisture-sensitive probiotics Solutions include ‘active’ scavengers and ‘passive’ barriers CLARIANT, A world leader in speciality chemicals, with its healthcare packaging business unit, announces a combination of packaging solutions that protect the potency and extend the shelf life of probiotics in nutraceutical products by inhibiting their exposure to damaging oxygen, moisture and light. “As probiotics are living ‘good’ microorganisms, it is essential to protect them from exposure to elements – oxygen, moisture, and UV light – that can damage or kill the probi-

otics along with their effectiveness,” explained Stephane Rault, Product Manager, Clariant Healthcare Packaging. “The optimal way to protect the most sensitive probiotics often involves a combination of ‘active’ and ‘passive’ solutions.” Passive solutions are the first line of defense for probiotics. These can include packages with strong barrier properties, such as Clariant’s Oxy-Guard bottles. According to Rault, the unique structure of these six-layer, extrusion

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blow-molded containers offers several times the oxygenbarrier protection of standard, single-layer polyethylene bottles, plus enhanced protection against the permeation of moisture and UV light. Oxy-Guard bottles are compliant with US FDA and EU regulations for use in pharmaceutical and nutraceutical applications and are covered by a Drug Master File (DMF). Oxy-Guard bottles are available in a range of standard sizes, with neck fin-

ishes that accept pharmaceutical screw caps produced according to SP400. Oxygen scavengers, typically in the form of canisters, packets, or cap inserts, provide active protection against oxygen exposure, including residual headspace oxygen present during packaging or any fugitive oxygen molecules that make ingress to the package during its shelf life. Scavengers are inserted directly into the package or bottle where they actively absorb oxygen. Clari-

ant offers PharmaKeep oxygen scavengers, which are humidity-neutral and combined with a desiccant that simultaneously adsorbs moisture. Clariant also manufactures a full line of silica gel and molecular sieve desiccant canisters and packets that adsorb water vapor to protect packaged pharmaceuticals, nutraceuticals, and other products from damage due to excess moisture. EP News Bureau

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Translational Research Institute,Australia leads way with Livecyte in APAC Livecyte enables quantitative, label free, live cell imaging and analysis of single and multiple cell types in heterogeneous cell populations using ptychographic quantitative phase imaging THE TRANSLATIONAL Research Institute (TRI), Brisbane has become the first centre in Australia and the Asia Pacific region to adopt the Livecyte Cell Imaging and Analysis system. TRI was formed to enhance collaboration between science, healthcare and industry with the purpose of accelerating the application of innovative scientific research to improve healthcare outcomes. The Institute, derived from a partnership between Queensland Health; Princess Alexandra Hospital, University of Queensland, Queensland University of Technology, Mater Research and its health partner DSM biologics, provides both laboratory facilities and resources to aid the research community in developing solutions which address key

After installation a Livecyte system at TRI, Phasefocus Biological Applications Specialist, Richard Kasprowicz runs through its operation with Alex Stevenson from the TRI Melanoma Research Group

clinical issues. Developed by UK-based company Phasefocus, Livecyte enables quantitative, label free,

live cell imaging and analysis of single and multiple cell types in heterogeneous cell populations using ptychographic quantita-

tive phase imaging (QPI). Requiring only low-level illumination, Livecyte provides a gentle experimental environment which mimics the behaviour of cells in 'real life' making it suitable for more clinically and physiologically relevant primary and stem cell populations, alongside traditional cell assays. Prof Brian Gabrielli, who leads the Melanoma Research team, Mater Research saw the capabilities of Livecyte firsthand, during a visit to the University of York, UK and immediately recognised its potential to gain a better understanding of cell cycle defects associated with melanoma. Following a review of the system’s functionality, funding was then successfully sought to procure Livecyte for the Mi-

croscopy core facility at TRI. Senior microscopy scientist Dr Sandrine Roy, who manages the facility commented, “The label-free imaging potential for primary cell studies is very exciting in tracking cell behaviour with minimal interference and we are all really excited to have such a powerful automated system to help with the data analysis.” Tracey Zimmermann, Phasefocus VP Global Sales added, “We are delighted by TRI’s decision to purchase Livecyte for their microscopy facility. This is a significant result for Phasefocus and we have great expectations for Livecyte in the Asia Pacific region, supported by the achievements of the researchers in Brisbane.” EP News Bureau

Noramco introduces turnkey approach to cannabinoid APIs at CPhI Worldwide The company has obtained patents for chemical synthesis of Dronabinol, Cannabidiol and derivatives in high yield and high stereospecificity NORAMCO IS moving forward with a broad offering of clinical- to commercial-scale cannabinoid APIs for branded and generic pharmaceuticals. The comprehensive offering includes everything a drug manufacturer requires to advance cannabinoid-based APIs to finished dosage forms. More than 100 active clinical trials are in progress involving cannabinoids, most focussing on Dronabinol (THC) and Cannabidiol (CBD). “Therapeutic benefits are established for several cannabinoid compounds, and

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today pharmaceutical companies require a robust partner to ensure regulatory approval and commercial supply,” said Bill Grubb, Vice President Global Strategy and Innovation, Noramco. “To help clinicians and drug development companies progress potentially lifechanging drug development, we are leveraging assets, expertise, and intellectual property to provide customers a sound solution, seamlessly.” Earlier this year, Noramco announced that it obtained patents for chemical synthesis

of Dronabinol, Cannabidiol, and derivatives in high yield and high stereospecificity. These patents allow production of high-purity, stable synthetic material. “Pharma companies that choose to work with us in cannabinoids can expect superior quality and secure supplies, starting with a full portfolio of API impurity and reference standards, and continuing with samples, clinical material, and commercialscale supply from facilities in Europe and the US,” Grubb said.

Dronabinol in sesame oil and ethanol Noramco maintains a Drug Master File (DMF) for high-purity synthetic Dronabinol API in a solution of 20 per cent sesame oil. The API is produced in Switzerland today via a novel synthesis process, and work is underway to make the product available from Noramco’s US-based production facilities. Going forward, Noramco also will make Dronabinol available in a 20 per cent ethanol solution, with initial synthesis already in progress in Athens, GA. Full GMP mate-

rial for clinical trials from the US will be available in the first quarter of 2018.

Cannabidiol Leveraging eight years of global supply chain expertise in Dronabinol, Noramco is running a global supply programme for Cannabidiol. Included in the programme is a plan to produce high-purity material via a patent-protected synthetic route, utilising assets in the US. Currently, Noramco supplies GMP samples from Europe. EP News Bureau

CPhI & P-MEC INDIA 2017 SPECIAL

Noramco introduces controlled substance development solutions at CPhI Worldwide The speciality API producer introduced a comprehensive development-to-manufacturing platform to provide its customers more technically sound solutions NORAMCO IS integrating its API development offering to include all of the technologies and services that generic and branded pharmaceutical producers require to advance solutions to market. The speciality API producer introduced a comprehensive development-to-manufacturing platform to provide its customers more technically sound solutions, under one roof, with less complexity. “Noramco has fine-tuned its business to serve as a solutions provider” said Jim Mish, CEO and President. “We now provide all of the expertise and assets that customers require to rapidly advance novel controlled API solutions from clinical to ready-to-implement commercial products,” Mish said. “We are here at CPhI Worldwide to showcase the pillars of our business that afford our customers the option to accelerate the development of their products in a flexible customer friendly manner,” said Bill Grubb, VP Global Strategy and Innovation. “The announcements we are making

needs of its global customers. These include the amphetamine salts, methylphenidate hydrochloride and tapentadol hydrochloride as well as Cannabidiol, Dronabinol, and other related cannabinoids. “One of the leading producers of specialty APIs, Noramco holds both the development and regulatory expertise required to bring virtually any controlled API to market, anywhere in the world,” Grubb said. “As we further expand our technology portfolio, our customers may come to us for APIs that address a greater diversity of medical conditions.” today provide the framework for Noramco as a one-stop resource for novel API development and unique dosage form solutions.”

Custom synthesis of controlled APIs Most recently, Noramco upgraded its small-volume manufacturing suites in the US. The flexible high-containment suites have controls in place to produce compounds of OEL<500 µg/m3. Special adaptions in-suite design, equip-

ment design, operations and process safety afford developers a one-stop location to produce parenteral and high-potency controlled substances supported by a rapid response team to execute against client needs for clinical-to-commercial APIs.

New Controlled APIs Noramco, a global controlledAPI supplier with 40 years of experience, also continues to expand its portfolio of technologies to better serve the

Distribution partnership for Europe Earlier this year, Noramco announced a strategic framework to unlock the full potential of its business by expanding its portfolio and geographic reach to better align with market needs. To ensure generic and branded pharma product makers have access to the company’s expanding portfolio and solutions services throughout Europe, Noramco has signed a letter of intent

with Azelis, a value-adding distributor with expertise in controlled APIs. Azelis maintains application laboratories and warehouses throughout Noramco’s European service area and is capable of accelerating product and reference standards delivery. Azelis joins existing distribution partners, Midas and IMCD.

Reference standards portfolio now available online Noramco offers well-characterised, highly purified analytical reference standards for routine analysis, method validation and development, commercial investigations, stability studies and other product development activities. Companies that hold a DEA license may now order impurity reference standards from Noramco directly online from a new highly secure website. This new website provides analysts, formulators, and developers rapid access to more than 175 reference standards products to accelerate their product development programmes. EP News Bureau

Noramco, SPI Pharma sign letter of intent To develop formulation solution packages NORAMCO AND SPI Pharma, a global leader in the manufacture and supply of functional excipient platforms and drug development services, signed a letter of intent to develop and license formulation packages, specifically for implementation by their customers. The companies intend to deliver 'ready-to-implement' patient-friendly drug formula-

tions that provide convenience, compliance, and efficacy for such therapeutic indications as intense pain, opioid addiction, and central nervous system conditions (epilepsy, migraine, etc.). Noramco has previously pledged to help its customers around the world accelerate pharmaceutical development with technical solutions pack-

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ages. “Partnering with SPI Pharma enables Noramco to bring together API and functional excipient science to deliver innovative, patientfriendly solutions to formulators of finished dosage forms,” said Bill Grubb, VP Global Strategy and Innovation. Grubb went on to say that going to generic and branded

pharmaceutical customers with formulation packages allows Noramco and SPI Pharma to directly support speed-tomarket, a reduction in trialand-error, product differentiation, life-cycle management, and technical/regulatory support. “Our customers will have the ability to work in a fee-forservice or royalty arrange-

ment, and implement the technology at the facility they choose,” added Grubb. Following a definitive agreement, which is expected in the next 30 days, testing of a select group of cannabinoid and addiction treatment APIs in unique dosage forms will commence to establish proof of concept (POC). EP News Bureau

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CPhI & P-MEC INDIA 2017 SPECIAL

Honeywell Connected Plant Takes center stage at annual users conference Honeywell users group EMEA to feature customer presentations, new products and technology demonstrations HONEYWELL PROCESS Solutions and its customers, who represent some of the biggest brands in the industrial space, recently met at The Hague for the company’s 29th annual EMEA Honeywell Users Group (HUG). A major portion of the event focussed on Honeywell Connected Plant, which is the company’s programme that helps manufacturers operate their plants more safely, more efficiently and more reliably by leveraging the power of the Industrial Internet of Things (IIoT). More than 850 delegates from across the oil and gas, chemical, pulp and paper, and metals and mining sectors attended HUG. The event features numerous displays of the newest technologies, along with

dozens of Honeywell- and customer-led sessions and technical discussions. “The main challenges facing manufacturers and plant operators today continue to be safety, efficiency, reliability, productivity and security,” said Vimal Kapur, President, HPS. “The power of digitisation and our Honeywell Connected Plant programme allows us to address these challenges in new ways by leveraging the incredible amount of data being produced by our customers’ facilities.” Honeywell showcased examples of where Honeywell Connected Plant has been implemented and some of the results that customers are seeing. Attendees at HUG experienced a range of new technologies and solutions that can help them en-

able the quick and effective adoption of IioT. Some of the technologies on display at HUG included: ◗ Process reliability advisor is part of Honeywell Connected Plant and uses Honeywell UOP process models for ongoing monitoring, early event detection and mitigation of performance issues before they become costly. ◗ Maintenance training simulator is a hands-on demonstration of the next generation of mixed reality worker training, which can enhance skills and reduce classroom time. ◗ Enterprise ICS Cyber Security Solution combines the ICS Shield platform with Risk Manager and other Honeywell cyber security technologies to provide

multi-vendor, multi-site cyber security that’s scalable to meet customer needs. ◗ Safety manager SC provides an 'out of the box' SIL certified safety platform that can be easily configured to meet SIL2 and SIL3 applications across the plant ranging from small packaged systems to large distributed architectures. ◗ Experion Local Control Network (LCN) enables customers to use their TPS/TDC investment as the foundation for incremental process automation upgrades for a secure, seamless integration with Experion PKS. ◗ Experion Batch combines Experion’s distributed control, batch automation, and patent pending visualisation technology for a solution optimised for pharmaceutical, speciality chemical,

and food and beverage applications. ◗ ControlEdge, when combined with Experion, dramatically reduces integration costs for ancillary plant operations, minimises downtime through unified support, decreases risk with embedded cyber security, and lowers total cost of ownership through extended system lifecycle. ◗ The conference agenda also included presentations and panel discussions from several Honeywell customers including British Sugar, Saudi Aramco, Shell, Qatar Fuel Additives Company, Sarlux Refining & Power, VTTI, Gazprom Neft, Linde, and others. These presentations covered a range of topics critical to industrial automation. EP News Bureau

New unrivalled capabilities take GC-MS to next level of performance Enhancements to Thermo Scientific Orbitrap GC-MS Systems offer users unprecedented depth for comprehensive compound characterisation UPDATED WITH new capabilities in high resolution accurate mass (HRAM) GC-MS, the Thermo Scientific Orbitrap GCMS systems now give users across metabolomics, food safety, environmental, pharma and toxicology applications high levels of accuracy in their data. Building on the existing reputation and success of the Thermo Scientific Q Exactive GC Orbitrap and the Exactive GC Orbitrap, enhancements include the addition of Variable electron Voltage (VeV) technology, the Orbitrap GC-MS HRAM Metabolomics Library and the TraceFinder Automated Compound Identification. These new capabilities are designed to provide highly sensitive, selective and accurate compound identification of complex samples for

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both research and routine laboratories performing gas chromatography mass spectrometry (GC-MS). “The power of the multi-award winning Orbitrap GC-MS technology has facilitated numerous scientific advances and enabled our customers to break new ground and gain a deeper understanding of samples through the use of HRAM technology,” said Fausto Pigozzo, Director of Marketing, GC GC-MS, Thermo Fisher. “Our R&D teams are dedicated to advancing this technology and with these newest capabilities offer systems that continue to provide customers with information rich analysis.” “Orbitrap GC-MS technology provides a remarkable opportunity to explore the metabolome, and alongside other technology

is helping us build up an understanding of disease phenotypes in more detail,” said JeanFrançois Focant, professor and director of the organic and biological analytical chemistry laboratory (OBiAChem), University of Liege, Belgium. “One of the primary challenges in metabolomics is to identify significant metabolites during non-targeted studies. The addition of the new Orbitrap GC-MS HRAM Metabolomics Library is helping us move in the right direction with respect to obtaining putative metabolite identifications quickly, and as such, allowing a fast route to begin the work of understanding the biological meaning of our observations.” The new capabilities included on the Q Exactive GC Orbitrap

and the Exactive GC Orbitrap, include: ◗ VeV technology that enables low electron voltage settings to be used during electron ionisation (EI) protocols, promoting high mass signals and providing high sensitivity for compounds prone to extensive fragmentation. ◗ The Orbitrap HRAM Metabolomics Library for electron ionization (EI), metabolite identification is efficiently streamlined. The library includes more than 800 metabolites and the spectra is refined and curated with the elemental composition of each EI fragment verified. ◗ New TraceFinder software features a specialised spectral deconvolution library and automated compound identification

to enable identification of challenging compounds. With the addition of Kovats retention index to the scoring index of unknowns, user confidence in compound identification is improved, especially in relation to isomeric compounds. ◗ The Q Exactive GC Orbitrap is a relatively easy-to-use GC-MS system that provides high quality data for compound discovery, identification and quantitation for comprehensive analyses. The Exactive GC Orbitrap GC delivers sensitive, routine grade performance in both targeted and non-targeted screening protocols. Both systems provide excellent resolving power, mass accuracy, linear dynamic range and sensitivity of leading Orbitrap technology. EP News Bureau

CPhI & P-MEC INDIA 2017 SPECIAL

Industrial filtration equipment to improve production and product quality of emulsions Installation of Russell Finex's high-performance self-cleaning filters double the production of water-based emulsion for Visen VISEN IS widely known as one of the top producers of waterbased emulsion. With its products being sold to numerous long-established paint manufacturers across the world, and with manufacturing facilities in several locations across India, Visen produces over 120,000 metric tonne of latex emulsion every year. In 2011, to meet increased customer demand, Visen invested in new manufacturing facilities. Built in India, it was anticipated that the new plant would virtually double their production capacity to 220,000 metric tonnes per year. To ensure the new plant was equipped with the latest technologies, the company undertook a review of all their existing processes. As a result of the review, it was identified that the existing quality control procedure in place for check-screening the latex emulsion prior to packing needed to be improved. The current procedure was carried out

using a simple filter cloth system, which would catch any contamination in the paint as it is fed into the packing containers. Although fit for purpose, improvements were identified, which if implemented would provide significant increases in production efficiency. Being an open system meant the cloths and paint were exposed to atmospheric influences which increased the possibility of skins forming in the latex emulsion. This could cause the industrial filtration equipment to block or end up contaminating the final product. As a result, machine operators were required to continually watch the line, which increased their exposure to the latex emulsion. In addition, the filter cloths needed to be changed between each new batch, and with several filling lines in operation, up to ten filter cloths could be used in any one day. As the cloths were not reusable, the company also incurred high disposal and re-

placement costs. Whilst they recognised its importance they also acknowledged the inefficiencies of this existing system. In search for a new filtration system, Visen attended the Middle East Coatings Show in Dubai to talk to potential suppliers. Intrigued by the filtration system on display at the Russell Finex stand, Visen approached stand representatives to learn more about the machine. With an in-depth consultation provided, an onsite trial was arranged for the Self Cleaning Russell Eco Filter. With the filter installed into their own production line, the trial enabled Visen to undertake personal monitoring of the machine's effectiveness. "It was important for us to be able to trial the filter at our plant prior to purchase, not only to ensure that product quality would not be compromised, but also to ensure operators would be safeguarded from the potentially harmful fumes," states VM Salunkhe,

Manufacturing Manager, Visen's plant in India. Following the success of the trials, Visen recognised the potential savings that would be gained prompting them to purchase ten Self-Cleaning Russell Eco Filters. The installation of the industrial self-cleaning filtration system has enabled Visen to eliminate the problems associated with the previous system. With its reusable filter element, the Self-Cleaning Russell Eco Filters have minimised production downtime as stoppages to change filter cloths are no longer required. Substantial cost savings have also been gained as the removable element can be easily cleaned and used repeatedly, removing the high disposal and replacement costs, which Visen experienced with the filter cloth system. A key requirement was for the new system to operate without constant supervision. Being a fully enclosed system, the product is unaffected by atmospheric

elements and therefore minimises the possibility of skins forming in the latex emulsion, which would subsequently form blockages. In addition, with the installation of the Russell Filter Management System which is designed to continuously monitor the filtration process, the filter is able to run efficiently without operator involvement. This not only safeguards operators from excessive exposure to the latex emulsion, but also releases the operators to perform other tasks around the factory. Salunkhe states, "Compared to our previous manual filtration system, the enclosed Eco Filters have allowed us to achieve good housekeeping and reduce labour costs." The installation of the Russell Eco Filters has improved Visen's manufacturing efficiencies whilst also enhancing their already meticulous quality control procedures. EP News Bureau

Pall Corporation partners with BioFactory Competence Center Launches practical continuous bioprocessing courses featuring pall Life Sciences’Cadence Technologies PALL CORPORATION, a global leader in filtration, purification and separation has partnered with the BioFactory Competence Center (BCC) in Fribourg, Switzerland to launch new training courses in early 2018 focussed on continuous bioprocessing advances. The courses will detail the state of the industry and the advantages and practical implications of transitioning from batch to semi- or fully-continuous bioprocess methodologies. Pall Life Sciences’ Cadence platform technologies will be featured for hands-on training.

Registration for standard sessions will be available through the BCC beginning in December and custom sessions are available upon request. “The BCC launched in January 2016 to deliver theoretical and practical biopharmaceutical industry training on everything from basic aseptic techniques to more detailed applications focussed training from upstream to downstream processing, covering cell culture, cell separation, chromatography and concentration, comparing single-use vs. traditional approaches,” stated Ian

To subscribe: bpd.subscription@expressindia.com

Marison, CEO and co-founder, BCC. “As industry interest grows in the advantages of continuous bioprocessing, we felt it necessary to introduce specialised training for successfully navigating this next-generation of drug making.” The upcoming courses will highlight key advantages of integrated continuous bioprocessing, and how best to leverage semi- or fully- continuous manufacturing technologies based on current resources and future goals. The practical sessions will feature Pall Life Sciences’ process development

scale technologies, including the Cadence Acoustic Separator for continuous clarification and separation, the Cadence BioSMB PD system for multicolumn chromatography, and the Cadence Inline Concentrator for continuous concentration at various process steps. “As drug manufacturers look to shift from batch to continuous processing for both small and large molecule drugs, information-sharing and continued education have become key drivers of advancement,” said Peter Levison, Senior Marketing Director of Down-

stream Processing, Pall Corporation. “These unique training courses have been designed around real-life situations, with hands-on access to enabling technologies, and we are proud to support them.” In addition to the new courses, plans exist to build a dedicated continuous bioprocessing facility in Fribourg for education on, and application of continuous bioprocessing technologies. The facility will also feature Pall Cadence platform technologies. EP News Bureau

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CPhI & P-MEC INDIA 2017 SPECIAL

Werum ITSolutions and Chinese-based Neotrident in partnership Customers benefit from additional resources during PAS-X MES implementation WERUM IT Solutions further expands its PAS-X Service Partner network. The world’s leading supplier of manufacturing execution systems (MES) signed a partnership agreement with Neotrident. Based in Beijing with several local offices in China, Neotrident is a leading IT solutions provider to the Chinese life sciences industry. As a certified 'PAS-X Endorsed Service Partner Local', Neotrident will support Werum customers in the People’s Republic of China during the onsite implementation of Werum’s PAS-X MES. For instance, Neotrident will provide resources for project management, MBR design, system

configuration, installation, training and the integration of automation and equipment. “We selected Neotrident among many candidates based on long-time experience in the life sciences industry and because of their complementary capabilities in terms of ISA-

Level 3 systems,” says Olivier Néron, Senior VP China Operations at Werum IT Solutions. “Neotrident has an excellent reputation in China and successfully managed a wide range of services from single site projects up to large roll-outs. Furthermore, the Neotrident

management has been working with foreign companies for decades which enables them to overcome cultural differences. Therefore, Neotrident will provide our pharma and biotech customers with high-quality services and support for the years to come.” Lingxiao Cao, CEO, Neotrident, “Neotrident’s long experience in offering IT solutions to the pharma market makes us a stable and reliable partner for Werum and its customers during the implementation of PAS-X MES. With our deep understanding of the daily operations in the industry we can perform the transition from a paper-based to a digital-based quality control system more

efficiently and in high quality.” “PAS-X Endorsed Service Partners” meet all requirements of Werum’s PAS-X Service Partner Program. The main objective is to offer the same quality and competence of services to Werum customers all over the world – through reliable, experienced and certified partners. The Service Partners need to have comprehensive PAS-X knowledge, participate at PAS-X trainings on a regular basis, possess experience in the regulated industry and use a quality management system. The certification has to be renewed on a regular basis. EP News Bureau

Aptar Pharma receives Excellence in Pharma: Sustainability Initiative of the Year award at CPhI Worldwide 2017 The company was awarded for its Landfill Free Certification programme APTARGROUP, A leading global supplier of a broad range of innovative dispensing and sealing solutions for the beauty, personal care, home care, prescription drug, consumer healthcare, injectables, food and beverage markets, was awarded the inaugural Excellence in Pharma: Sustainability Initiative of the Year at CPhI Worldwide 2017. The award was presented as part of the CPhI Pharma Awards Gala, which took place in Frankfurt, Germany. Aptar was awarded the Excellence in Pharma: Sustainability Award for its Landfill Free Certification programme, a global internal certification programme which promotes the efficiencies and conservation of natural resources in a manufacturing setting. Facilities that achieve at least a 90

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per cent reuse and/or recycling threshold are eligible to receive internal Landfill Free Certification. With more than 40 per cent of Aptar’s manufacturing sites already certified through this programme, Aptar has achieved significant accomplishments in waste re-

duction, cost savings and employee engagement. The programme is incorporated as a measurable aspect of Aptar‘s global sustainability strategy and Aptar anticipates more facilities will achieve certification in years to come. Data from Aptar’s recent

customer satisfaction surveys demonstrated the growing importance of sustainability to customers and supply partners. Therefore, Aptar’s internal programme further reinforces that Aptar is prioritising the needs of its customers in line with its own company mis-

sion and corporate social responsibility. Yann Ghafourzadeh, VP, Sales & Operations Europe Prescription Division, Aptar Pharma comments, “We are delighted to have been awarded the Sustainability Initiative of the Year at the CPhI Pharma Awards. It is great to be recognised for the progression of Aptar’s Landfill Free Certification programme, which has been significant within our global sustainability strategy. We have aligned our programme with our customers‘ requirements and we are dedicated to responding to what sustainability considerations are important to them. We look forward to further Aptar facilities obtaining the internal Landfill Free Certification in the future.” EP News Bureau

CPhI & P-MEC INDIA 2017 SPECIAL

EKF Diagnostics’Procalcitonin Assay gets FDAclearance User defined application available on Beckman AU clinical chemistry analysers for LiquiColor Procalcitonin (PCT) assay enabling quick and effective sepsis identification EKF DIAGNOSTICS, the global in vitro diagnostics company, announced that its Stanbio Chemistry Procalcitonin (PCT) LiquiColor assay has been FDA cleared and validated for use on Beckman AU 480, 680 and 5800 clinical chemistry analysers. EKF is pleased to confirm the immediate availability of a user defined application (UDA) for running this 10 minute test for bacterial infection and sepsis on these Beckman AU analysers. PCT is a widely accepted marker for use in conjunction with other tests to quickly identify sepsis and monitor progression/severity over time. EKF’s PCT test is designed to be used on an open channel of most main brand clinical chemistry analysers, including Roche Cobas, Abbott Architect and Hitachi systems. Therefore, the availability of the User Defined Application (UDA) on Beckman AU analysers further

increases the breadth of application of the LiquiColor PCT assay. Trevor McCarthy, Sales Manager, EKF Central Laboratory Products, EMEA/APAC said, “The news regarding the FDA clearance and Beckman AU analyser validated application for the PCT LiquiColor assay will bolster trust in the quality and reliability of our product. Having EKF’s PCT assay validated on Beckman AU chemistry analysers allows us to provide a competitive alternative product for hospital labs and should open up new markets and opportunities for us to support improved and early detection of sepsis.” The cost-effective, immunoturbidimetric assay, which features the use of monoclonal antibodies coated to latex particles, can determine PCT from just 20µL of serum and plasma specimens. Conveniently, the reagent set requires

no reagent preparation and is designed to be used on open chemistry systems. It is available in a liquid-stable format, meaning that it can remain onboard a clinical chemistry

analyser for up to four weeks. PCT is a quick and effective adjunct marker in sepsis diagnosis which helps to differentiate between viral and bacterial infections, so enabling early ad-

ministration of antimicrobial therapy. It is an important test, as the Surviving Sepsis Campaign (SSC) estimates that the incidence of sepsis is 3 per 1,000 worldwide. There has been a steady rise in the number of patients with sepsis; globally there are now over 18 million cases per year. In addition to improving sepsis survival rates and improving antibiotic stewardship, studies have also shown that PCT testing reduces hospital costs and length of stay. For example, a recent large cohort study examined whether PCT testing helps to more effectively manage sepsis care. The study found that use of PCT testing on day one of admission into the ICU lead to an average of 1.2 fewer hospital days than patients who were not screened and saved an average of $2,759 on their total hospital costs. EP News Bureau

Almirall opts for Werum’s PAS-X MES Rollout in German plant in Reinbek near Hamburg IN THE context of a tendering process, the Spanish pharmaceutical company Almirall opted for Werum’s PAS-X Manufacturing Execution System to be installed in the German plant in Reinbek near Hamburg. Almirall is the market leader for skin medicine in Germany and e.g. produces the Balneum skin care products. PAS-X will be rolled out as a full-scope MES for the entire manufacturing process – including weighing, mass production and packaging. It will replace the legacy production management system. The new review and release workflows will lead to more effective processes as well as compliance with regulatory requirements.

To subscribe: bpd.subscription@expressindia.com

PAS-X will be implemented out of the box and according to Werum’s unique implementation method 'Ready', 'Fit', 'Build' and 'Run'. The benefit for Almirall: short project term and significant cost efficiency. “We are already thrilled about the Fit Phase,” says Maik Weber, Head of Production, Almirall. “Together with the Werum consultants, we matched our business processes in the Reinbek production site with the bestpractice-based PAS-X workflows. Both the approach and the expertise of the consultants and the results of this phase were really convincing.” EP News Bureau

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Aptar Pharma to showcase products at CPHI India,Mumbai The company will present a pharma talk focussed on connected healthcare solutions, one such growing megatrend APTAR PHARMA, a leading drug delivery systems provider, will showcase Aptar Pharma’s wide product portfolio covering various routes of administration, including connected device systems for better patient adherence and compliance. The products will be displayed at CPhI India 2017 stand No H77, Hall 1, which will be held at the Bombay Exhibition Centre (BEC),

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Mumbai, from November 28 – 30, 2017 A dedicated innovation area will feature the megatrends that are currently influencing the drug delivery industry. Further to exhibiting at CPhI India, Aptar Pharma will present a pharma talk focussed on connected healthcare solutions, one such growing megatrend.

Sai Shankar

Presented by Sai Shankar, Director Business Development - Connected Devices, Aptar Pharma’s Exhibitor Showcase will reveal the findings of a recent study on its integrated connected pMDI. He will also present the company’s connected health devices portfolio that supports respiratory treatment for patients. Using a patient-centric de-

sign approach, Aptar Pharma supports Pharma companies worldwide with custom-made solutions, including connected technologies, for the treatment of respiratory diseases including asthma and COPD. Sai Shankar’s Exhibitor Showcase will take place on November 28 from 13:00 – 13.45 at Hall 7A, Goregaon. EP News Bureau

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Excellence far beyond

An ISO 9001 : 2015 Certiﬁed Company

TURNKEY CLEANROOM SOLUTIONS

CLEANROOM PANELS

CLEANROOM DOORS

CLEANROOM HVAC

Static Pass box

Dynamic Pass box

Sampling Booth

Horizontal LAF

Laminar Air Flow

Bio-Safety Cabinet

Air Showers

Mobile LAF

CLEANROOM EQUIPMENT 108,Swastik Regalia, Waghbil, Oﬀ Ghodbunder Road, Thane West, Mumbai

+91-22-2597 1641 / 42

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+91-809 777 9747 / 992 032 4980

sales@pharmintech.net

www.pharmintech.net

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Stockists & Marketing Professionals

600

UCT

D PRO

Nursing Homes, Private Hospitals, Big Multi-Specialities Hospitals, Polyclinics, Institutions, Trauma Centers and Doctors.

Highlights Manufacturing of all Products in our own state of art Plants Manufacturing of injectables (Beta Lactam and non Beta lactam), Tablets, Capsules, Ointment, Lotion, Liquid orals, Eye/Ear Drops etc. Very Competitive Price with high margin of profit Stock Available round with Clock-timely service & on time suppliers Elegant Packing with unmatched Quality. Long lasting Relationship, Committed Dealings

Inquiries for stockistship and superstockistship are solicited. Experienced Pharma Personnels can also contact for excellent opportunity.

Export and 3rd Party inquiries are solicited. OUR MARKETING DIVISIONS

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AGRON REMEDIES PVT LTD. Sarverkhera, Moradabad Road,

CARDIRON HORON YC

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For Dynamic Enthusiastic and

CONTACT US: Email:- agronremedies@gmail.com Phone No. : 09358650929, 09359489829, 08859001367, 05947275279 FAX:- 05947274929 website: agronremedies.com

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US $4 Billion well diversiďŹ ed Group

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Leading Nirtogen Plant manufacturer for more than 30 years

Turnkey supplies to Pharma Sector and other industrial segments such as Chemical, Power, Metallurgical and Food - where we have sustained majority market share consistently and established ourselves as market leaders and amongst the largest and best-of-breed air and gas treatment systems company around the world.

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ADVANTAGES OF PRE-PREPARED TROLLEY System over BUCKET TROLLEY System Today´s Cleaning Innovative Pre-prepared

3 No Heavy buckets 3 No Cross-contamination 3 > 50% less consumption of water and chemicals 3 High on ergonomics 3 Sustainable 3 Microfiber technologie 3 Small footprint of trolley´s

The pre-prepared method is exactly what it says – every mop and cloth required for that days’ cleaning is prepared in advance with the correct amount of water and customers validated disinfectant.

another pre-prepared mop is placed on the frame for use in the next room/area/surface. The used mop is then placed into a

B902 / 903 / 904, O2 Galleria, Minerava Industrial Estate, Mulund (West), Mumbai - 400 080 Tel : +912261716666 l Cell : +91-8976610332 Website: www.vileda-professional.com l Email: prasad.crg@fhp-ww.com

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REAL-TIME CONTROL In-process solutions for particle size analysis Micron and Sub-Micron Particle Sizer suitable for dry powders, emulsions, suspensions and slurries.

INSITEC PARTICLE SIZE ANALYZER • Size range: 0.1 – 2500μm • URS / FAT / SAT supported • 21CFR part11 compliant • SOP Configurable and Customizable

• Intrinsic Safety to Class I, Div 1 (Zone 0) • Plant communication integration (OPC, Modbus, Profibus, Discrete I/O)

• ARTMiS Automated RealTime Milling SystemContinuous Particle Size Control in RealTime

P-MEC 2017 Venue : BC&EC, Date : 28–30 Hall No. 5 Stall No. N18 November, 2017 Goregaon, Mumbai

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WE ARE CERTIFIED FOR ISO 15378:2011, WHICH INCLUDES BOTH ISO 9001 AND GMP

PACKAGING PRODUCTS FOR HEALTH CARE

RUBBER S TOPPERS

RUBBER DISCS & PLU NGER FOR DENTAL CARTRI DGES

TABLET & GEL APPLICATOR

EYE / EAR DROP BOTTLES (CONTROLLED DROP S YSTEM)

30ML, 60 ML & 100ML DRY S YRUP BOTTLE WITH CAP & MEASURING CUP

DROPPER ASSE MBLY

RUBBER DISCS WITH EUROHEAD CAPS AND FLASH BLUB

DIAGNOSTIC PACKAGING DIFFERENT SIZE CAPS

PLASTIC MEASURING CUPS/SPOONS (for LIQUIDS & Dry Powders)/ PLASTIC CAPS (ROPP)

SYRUP SPOON

DOSING S YRINGE WITH ADAPTOR

SCOOPS

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BEAK TYPE DROPPER, OPVD DROPPER & BUILT IN DROPPER

LIDS F OR TIN CONTAINERS

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BHARAT RUBBER WORKS PVT LTD. B-46, Girikunj Industrial Estate, Off. Mahakali Caves Road, Andheri (East), Mumbai - 400 093. INDIA. Tel.: +91-22-2687 5361 - 64  Fax: +91-22-2687 5221 / 22 Email: marketing@brworksindia.com  Website: www.bharatrubberworks.com

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Your Partner in Healthcare

STERILIZING & DEPYROGENATION TUNNELS SUITABLE FOR AMPOULES / VIALS / CARTRIDGES

MAIL US YOUR REQUIREMENTS : venerabiotech@gmail.com venera@vsnl.com

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Venera Biotech Systems Pvt. Ltd. D - 2 / 1, RHODIA COMPOUND, AMP GATE ROAD, MIDC INDUSTRIAL AREA, AMBERNATH (W), DIST. - THANE, MAHARASHTRA - 421501. INDIA. VOICE CONTACT : 0251 - 6946900.

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For almost 40 years, Domino has been a leading global producer of innovative printing, coding and marking solutions for the Pharmaceutical and healthcare industries.This equates to extensive experience in serialization support. Our technology enables manufacturers and CMOâ&#x20AC;&#x2122;s to comply with the validation requirements of Good Manufacturing Practice (GMP) and emerging global legislative standards, such as the DQSA, helping to secure the supply chain from Product to Pallet.

Trust the experts. Contact Domino to discuss your serialization

Domino Printech India LLP Corporate office- Plot No. 167, HSIDC, Udyog Vihar, Phase I, Gurgaon122016, Haryana, India Tel: +91 124 488 6100, marketing@dominoindia.com

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28-30 Nov 2017, BEC, Mumbai Visit us : Booth No.: R36, Hall No.: 7A

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VISIT US @ Multiple Products Under One Roof HALL #5, STALL #N‐36 TH TH 28 ‐ 30 NOV, 2017

07 ‐ 12 FEB, 2018

BOMBAY EXHIBITION CENTER, MUMBAI, INDIA.

Imavac™ - Silicone Hose reinforced with SS 316 helical wire

for Food & Bio-Pharma Industries

GANDHINAGAR, AHMEDABAD, GUJARAT. INDIA

Imawrap - Silicone Hose reinforced with Polyester Fabric & SS 316 helical wire

Imaprene™ - Thermoplastic Elastomer Tube (TPE)

We are specialized in manufacturing Platinum Cured Silicone Tubes, Braided Hoses, Inflatable Seals / Gaskets and customized polymer solution for food, medical and pharmaceutical industries application.

Imavacfit - Silicone hose reinforced with Polyester Braiding and SS 316 helical wire

Silicone Inflatable Seals & Gaskets

Ami Polymer Pvt. Ltd.

www.amipolymer.com

“Sealing Expert in Silicone” An ISO 9001:2008/14001:2004/18001:2007 & Clean Room Certified Co. DMF #26201 accredited by USFDA

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Balsam

Life sciences & Technologies Healthcare Consultants

Balsam Ultimate Solution For Your Requirement of

API & Intermediate

Balsam

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Balsam Ultimate Solution For Your Requirement of Pharma Machinery & Equipment

Our services include API manufacturing under strict cGMP product release & process validation. All are delivered as per European, US & Japanese standards.

LYMECYCLINE

Fluid Bed Processor

Fluid Bed Dryer Rapid Mixer Granulator

Active Pharmaceutical Ingredients

Coating Pan

Liquid Syrup Manufacturing

Balsam Life Sciences and Technologies Pvt. Limited.

C/O Indcon Corporation, Bharti Industries, Opp: State Bank of India,Vicco Naka, Off Kalyan Shil Road, MIDC Phase I Dombivali (East) Thane - 421201 Maharashtra India

+91 251 6516564 +91 9920104145 / 9967975365 / 9920745365 / 99222260666 info@balsamlifesciences.com www.balsamlifesciences.com Skype - balsamlifesciences

Cold Chamber

Various size & capacity of chambers available on request.

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Guaranteed safety & reliability of your life saving products.

WFI Stills and Pure Steam Generators

Machinfabrik Industries Pvt. Ltd.

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R - 89 / 90, Rabale, MIDC., Thane Belapur Road, Navi Mumbai - 400701, India www.machinfabrik.com | sales@machinfabrik.com | 91-22-6736 8200

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BUSINESS AVENUES With high performance comes design freedom. A choice of 9 RAL colors to go with your brand image.

You demand. We fulfill. Bangalore I Delhi I Guwahati I Hyderabad I Jammu I Kolkata I Mumbai I Vadodara I Sales@labguard.biz I www.labguard.biz Call National Hotline - 022 65650606

9 RAL colors available

The Reagent Racks featuring in this image is not a standard LabGuard product.

S. P. PRODUCTS

PHARMA EQUIPMENTS AT IT'S BEST

S.S. MULTIPURPOSE TROLLEY

S.S. VIAL / AMPOULE BOX

S.S. CAGE TROLLEY

S.S. TROLLEY FOR STD WEIGHT / STORAGE

S.S. CONTAINER (5LTR - 500LTR)

S.S. STEP OVER BENCH WITH SHOE RACK

S.S. HELMET STAND

S.S. CHEMIST TABLE.

S.S. STERILE CABINET WITH UV LIGHT

S.S. SIEVES FOR SIFTER / MULTIMILL / CADMILL

S.S. CROSS OVER BENCH 'L TYPE & 'C TYPE

SS INPROCESS CONTAINER

S.S. DRAIN TRAP (SINGLE / DOUBLE SEAL)

S.S. PADDLE / TILTING DUSTBIN

S.S. KEY BOX

S.S. SIEVES TROLLEY

S.S. TRAY

S.S. SPOON / MEASURING JAR / SCOOPS

S.S. STERILLIUM STAND

S.S. STEP LADDER

S.S. PERFORATED / PLAIN TABLE

S.S. PASS BOX

S.S. CABINET FOR FBD BAGS STORAGE

S.S. TROLLEY FOR HAND DISINFECTANT / HAND GLOVES / MASK /ROLLER

S.S. STREET SHOE RACK

S.S. PALLET

S.S. ANTIVIBRATION TABLE S.S. FIX / REV STOOL / CHAIR TM

S.S. CABINET FOR BLISTER S.S. LOCKER S.S. VISITOR CHANGE PART / STRIP CH PART / FOR KEEPING APPRON CABINET POLYBAG STREET GARMENT

• All products are custom made & available in 304, 316 & 316L Quality with optional Matt & Mirror finish. • We undertake the side work of Cladding of Machinery & others.

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S.S. CABINET FOR MULTIMILL SIEVES

S.S. WRITING DESK WITH DRAWERS

S.S. II CHANGE CROSS OVER BENCH

Contact: Mr. Kiran Shah / Mr. Chirag Shah

S.S. DIES & PUNCHES CABINET

OFFICE: F-823, VEENA SANTOOR BLDG., NEAR PAWANDHAM, BEHIND 'D' MART, MAHAVIR NAGAR EXTN. ROAD, BORIVALI (W), MUMBAI-400092. TELEFAX: 28197068 / 3082 MOBILE: 98200 54453. Email: info@pharmaequipments.com URL: www.pharmaequipments.com WORKS: W6, OM SAI COMMERCIAL COMPLEX, GODDEO ROAD, NEAR EKVIRA GAS GODOWN, BHAYENDER (EAST), THANE - 401 105 TEL: 2819 3082

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“TECHNOPTIONS”group

… emerging .. beyond technology ...

PHARMACEUTICAL METAL DETECTION SYSTEM

MOISTURE & Bulk DENSITY / WEIGHT Measuring - Monitoring - Control

for .. TABLET / CAPLETS / SOFT and HARD GELATIN CAPSULES / POWDER / GRANULES etc.

(Hand-Held / Laboratory / At-Line / In-Process) RECORD & CONTROL the “Product Moisture” during

FLUID BED DRYER process … ON-LINE .. REAL-TIME

PHARMA TECHNOLOGY PHARMA FLEX

Visit us at:

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28-30 November 2017 HALL 5 / STALL N1

PHARMA Series – WIP & WOL Series Containment levels: - “DT” Dust Tight Series <OEB3 - “C” Containment Series ≤OEB3 - “HC” HIGH Containment Series ≤OEB-5 SS 316 SPIRAL

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MODULAR Segment SPIRAL

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LABORATORY EQUIPMENTS G G G G G G G G G G G G

Walk in stability Chamber/Cold Room -86 0C Ultra-low Temperature Freezer Humidity Chamber/Stability Chamber Cooling Incubator Bench Top and Refrigerated Centrifuge Deep Freezer/Laboratory Refrigerator Cold Cabinet Orbital Shaking Incubator Rotary Shaker Laboratory/Magnetic Stirrer Vortex Mixer Healthcare Equipments Walk in Chamber

Roller Tube Mixer

Micro Mini Centrifuge

Dry Hot Air Oven Microplate Shaker

Magnetic Stirrers

Magnetic Coupling

Single Door Refrigerator

Upright Freezer

Multi Vortexer Laboratory Centrifuges

Laboratory Stirrers

Bench Top Orbital Shaking Incubator

Neya Centrifuges

Heating Incubator

Humidity Chamber with TFT Display

Medico Plus

REMI SALES & ENGINEERING LTD. Remi House, 3rd Floor, 11, Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai-400 063. India Tel: +91 22 4058 9888 / 2685 1998  Fax: +91 22 4058 9890  E-mail: sales@remilabworld.com  Website: www.remilabworld.com

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Silicone Rubber Profile, Gasket, Cords & Tube. (-40 to + 220 Deg. C) Rubber Cords Gasket, ‘O’ Ring & Sheet in NEOPRENE, EPDM, NITRILE, VITON, FLUORO SILICONE for Pharma, Food Chemical & Medical Industries. Single & Multi Core Cables. (1.1 KV to 11 KV. Grade) Welding, thermocouple, FRLS & TRS Cables. High Temp, ResistanCe Cables (-60 to + 1200 Deg. C) RoHS Certified 1,2 & 9, Jay Vailankanni Indl. Est., B/h, Tirupati Gas Godown, United Rubber compound, Bhayander (East), Dist. : Thane - 401 105 Phone: + 91 - 22-28147776 Mob.: 9987228484 9869804701 centurycables@yahoo.co.in

www.centurycablesindia.com / www.centuryrubbercables.net

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International standarts:  FDA compliant  ISO2000-9001  ISO14001  OHSAS18001  ISO15378  HACCP

Aluminum Tubes Since 1967, LAGEENTUBES has been offering tailor-made, cutting edge aluminum packaging tube solutions for the leading pharmaceutical companies in over 30 countries across the globe. As a western best quality aluminum tubes manufacturer, LAGEENTUBES caters to the Indian pharmaceutical up-market industry who seeks to grow their business in the western world. Our aluminum tubes are produced through an impact extrusion process, and include application of internal and external lacquers, decorations & capping.

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Salient Features

Please Contact: Mr. Sandip Lagad

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Mr. Rajkumar Hange

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TECHNIC PHARMA EQUIPMENTS Mfg. of: Pharmaceuticals, Food, Cosmetic & Chemicals Machinery

Liquid - Syrup Manufacturing Plant

Rapid Mixer Granulator

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CONTACT : Fact.: Gala No. 16, Building, No. B-11, Sagar Industrial Estate, Dhumal Nagar, Waliv, Vasai (E), Dist. Palghar-401208. Raj Yadav : 07798007538, 08888911581 Mohan Sahani : 09730252310, 08080802767 Email: rajtpe1979@gmail.com, mohan.tpe@gmail.com Visit us: www.technicpharmaequipments.com

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To widen our offerings and horizons through innovation & technology, we have extended our hands for Technical Collaboration for mutual benefits to enable us spearhead in Turnkey, Single window Solution to Customers. We are associated with companies like - Loedige GmbH, Fitzpatrick USA, MPE USA, CSP ireland, RML Engineerinf, New Zealand.

Agency Division Bectochem Consultants and Engineers Pvt. Ltd.

CONTAINED CHILSONATOR SYSTEM CCS Series Roll Compactor Also, Suitable for product which need process Isolation/ Containment

A Traditional of innovation in Particle Forming Technology for Pharmaceuticals, API, Food & Cosmetics Contained Chilsonator System CCS 220 Lab Model Ideal for R&D, Pilot plant and Small • Ultimate GMP and Process flexibility • Wide range of capacities from 50 grams to 20 kgs/hr • Fully instrumented with automated controls • Scales up to larger roll compaction • Low profiles/minimal headroom required • Process flexibility with VariousRoll Surfaces, Size reduction Rotor • Automated Controls for Consistent Product

Contained Chilsonator System CCS 1025 Model • Sealed technical area • "Free-Standing" or "In-Wall" Installation • Integrated roll process housing and milling system minimizes headroom requirement • Utilities enter technical area from the back of machine • Ease of disassembly is considered in the design of ALL components • Wash-In-Place (WIP) option • Automated controls allow ALL adjustments to be made from the control panel • Fully instrumented with convenient display and logging of variables • 21 CFR part 11 complaint capable • Multiple layers of password security Advantages of the Product Containment System • Minimal product exposure to operator and environment • Prevents product contamination • Minimal product loss

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Modern Process Equipment (MPE), USA - Chainvey

FitzPatricks, USA, Contained Chilsonator System (CSS)

GL Filtration Limited - World Leader in Solid- Liquid Seperation

Efficient Agitator System Metal Detector from Viscojet, Germany and Separator

Industrial & Chemical Compactor

Contained Tablet Press

Bectochem Consultants and Engineers Pvt. Ltd. Building 5C/204, Mittal Estate, Andheri-Kurla Road. Andheri(E), Mumbai-400059, India Tel: (91) 22-39277900/ 28500008/ 657018999 Fax: (91) 22-28506785 Email: fitz@bectochem.com Website:www.bectochem.com

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CIN: U51503MH2001PTC132921

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ISO 9001 - 2015 Certified

Photon Cleantech Inc.

Manufacturer and Supplier of Cleanroom Turnkey Projects & Cleanroom Equipments

Ceiling Suspended LAF Lupin

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Dispensing Booth

Doors

Air Shower

PB Lupin

Bio Safty Cabinet

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Fore more info contact:

Photon Cleantech Inc. Survey No. 106 A/3, Office No. A-6, Surya Lok Nagari, Pune - 411028, India. l l / Website: www.photoncleantech.com Mobile: +91 8805060111 / Email: photoncleantech@gmail.com ISO 9001:2015

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OSMOMETER 3250

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

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Wiper Type Sight Glass

DIN 100 Light Glass LED

Swastik Associates Shed No. 1, 2 & 3, Sr. No. 30/7, Behind Dran Company, Dhayari-Pune 411041 Phone : 020 24690268 / 24690041, 9923124949 / 9028716622, 9028716222 Email : sale1swastik@gmail.com swastikpune1@gmail.com

Our other product details u

SS Fittings

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SS Powder Blender

SS Steam & Water Mixing Station

Drain Trap

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YOUR PARTNERS FOR STERILE FLUID TRANSFER

Contact Details: Wadala Shree Ram Indl. Estate, Unit No. C-32, 3rd Floor, G. D. Ambekar Marg, Wadala, Mumbai - 400 031, Maharashtra India. Phone: +91 22 4356 0400 Fax: +91 22 4356 0425 Email: pharma@shahbros.com

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Pharmaceutical Applications NASAL

ORAL

TOPICAL

The One Point Source for Tamper Evident Sprayers

IVTEC, PUNE. Complete Solution To Pharma Business Services Offered: • Gap Analysis as per Different GMP guidelines • GMP Audit Services for API Facilities, Vendors and Plants • GMP Trainings for Pharma companies and Pharma students • GMP and GLP Quality Documentations • Qualifications and Validations services • ISO 9001:2015 Certification with Documentation • Due diligence for Acquisitions • Productivity Improvement • Cost Reduction • Microbiological / Biological Tests & Validations

Email id: suhas@ivtec.in

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FEATURES u

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Tablet Applicators

Accurate dosage delivery

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Available in different dosages

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SANTAPET POLYMERS LIMITED Office: 8 Sheriff Devji Street, 1st Floor, Mumbai - 400 003. India Tel.: +91-22-23420381 l 66151691 Fax: +91-22-23441578 Email: suraj@santapetpolymers.com l Website: www.santapetpolymers.com

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KILITCH HEALTHCARE INDIA LTD. Avoid the

Harmful Side Effects of Preservatives

India’s first ever Preservative Free Ophthalmic Manufacturing Facility Widely accepted by Ophthalmologist

Patented Pure Flow Technology For contract manufacturing contact: Kilitch Healthcare India Ltd. 902/B Godrej Colesium, Behind Everad Nagar, Near Priyadarshani Cirlce, Sion (East), Mumbai – 400022. Tel. : 022 6137 2222 Mr. Divya Mehta : +91 9819724957 www.kilitchhealthcare.com info@kilitchhealthcare.com

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BUSINESS AVENUES Laboratory Glass Syringes

Chromatography Consumables

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CONTROL GLASS SYRINGE • 2ml, 5ml & 10ml • 3 Ring offers better grip while use in Laboratory especially for Filteration High Recovery Storage Vial

Range: • HPLC Vials (1.5ml / 1.8ml / 2ml) - 9mm, 8-425, 11mm (crimp & snap) • 4ml - 13mm • GC Vial, 20mm - 10ml / 20ml • Vial Inserts, Shell Vials • EPA Vials - 20ml - 60ml • Storage Vials 2ml -60ml

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• 2ml, 5ml,10ml, 20ml, 30ml, 50ml & 100ml • Tested upto 43.50 PSI • Very Smooth (Loss of Resistance) • Graduation starting from 0.02ml SELF REFILLING SYRINGE • 0.5ml, 1ml, 2ml & 5ml • Repititive Dispensing Of Preset Volumes • Feed Tube Set, Vial Holder Set • Fully Autoclavable • SS Piston, Glass Barrel, No O-ring REUSABLE NEEDLES

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www.kesarcontrol.com

Humidity Chamber

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Service Network all over INDIA Mfg. Unit : B/8, Karma Industrial Estate, Nr. Trikampura Patiya, Vatva, Ahmedabad - 382445. Gujarat, INDIA. Tele : 079 - 25890727

Mobile : 09427613646 Email : service@kesarcontrol.com

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No. 1, Ravi Prakash, Nagwekar Marg, Prabhadevi, Mumbai 400 025. INDIA Tel: +91 22 2422 8562 / 1849, Fax: +91 22 2422 1849 Email: diecraftengg@gmail.com / sales@diecraftmachines.com Website: www.diecraftmachines.com

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BUSINESS AVENUES Experiment With The Truth Certified ISO 9001: 2008

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B-44, New Empire Industrial Premises, Kondivita, J. B. Nagar, Andheri (East), Mumbai - 400 059. India Tel.: +91-22-28320880 / 28390487 E-mail: info@osworldindia.com

Goggles & Writing Accessories For Cleanroom

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28-30 Nov 2017, BEC, Mumbai Visit us : Booth No.: N52, Hall No.: 5

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Federation of Pharma Entrepreneurs

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The Council of EU Chambers of Commerce in India

HELIOS CONCREW PVT. LTD.

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Philosophy Engineered--to--Order

"Together Thinking Enginering Out Of The Box" SINGLE POINT PROCESS ENGINEERING SOLUTION

DESCRIPTION: ACE MILL (INTEGRATED SYSTEM) We have experienced that your entire process problem comes from use of a Multimill in Pharmaceutical API & Bulk drug industries. Old Multimill were not complying cGMP and any other pharma standards. A Pharmaceutical Powder Pulverizer (innovative conceptual design) is really another kind of technology, extremely sophisticated. which will meet , FDA, USFDA, FDA 21 CFR Part 11 standards. This Ace Mill will give proven ideas to involves re-defining the internal Geometry to achieve a perfect milling without dusting in production area with maximum through put.

FEED VESSEL WITH SCREW The feed rate to the mill is an important factor to determine PSD (Particle Size Distribution) & output, the result is depends upon residence time in the milling chamber, the feeder is an important tool in controlling residence time. However, as with any process, the product flow & it's characteristics will often determine the best feed method.

FEED RATE As with all feeders, this rate range is dependent upon the type of screw configuration chosen as well as the drive type and available turn down ratio.

VARIABLE FEED SCREW (VFS) SYSTEM Overfeeding can cause unpredictable results starving can produce a wider-than-desired range of particle sizes. The ACE-Mill can be built with a (VFS) option to assure precisely controlled feed rate. A variable feed screw (VFS) helps minimize waste, eliminates operator variables, and achieves particle uniformity.

Plot No.36, “Shramsafalya” Bungalow,Veer Savarkar Nagar, Thane (W)-400606,Maharashtra, INDIA. E mail:-ace.syn_sdb@hotmail.com/ ace.syn_sales@hotmail.com Mr.S. D. Botre(Technical Director ), Ms Jhanvi. Botre(CEO) Mobile: +91 -98201 03114 / 9167122060 / 9167122709

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AIR PERMEABLE DUST RETAINER Using a dust retainer to connect the mill discharge to the product container will contain the material being processed and vent the process air created by the rotor.

SCOPE OF SUPPLY : ► Powder Pulverizing (Milling) unit. ► Feedvesselwith Screw feeder.(Volumetric) ► Powder collection portable vessel. ► Specially designed Cyclone Separator with air flushing

arrangement. ► Exhaust Blower. ► Control Panel for system. ► Can be supplied Scrubber. ► Gravity material feed unit with load cell weighing

arrangement can be provided.

INNOVATIVE PROCESS EQUIPMENT: ► Ace Airo-Jet Micronizer- Size 1 to 36 inch ► Ace Fluid Bed Dryer- Cap 2 kg to 800 kg. ► Ace Fluid Bed Coater/Processor- Cap 1 kg to 200 kg ► Ace Comills for Dry and Wet Milling Application ► Trial Equipment is available.

ASSOCIATES: Mr.S. D. Botre/ Mr.Sameer Kotwal Mobile:+91-9820103114/09320413888 paan.sdb@rediffmail.com/ paan.sales@rediffmail.com

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25 Y E

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Anniversary www.chromline.in

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For further details contact Exclusive Distributor:

CHROMLINE EQUIPMENT COMPANY Unit No. 17, Udyog Bhavan, Sonawala Road, Goregaon (East), Mumbai 400 063, India. Tel.: 022 2686 0816 / 61887317 Website: www.chromline.in E-mail: mail@chromline.in

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CPhI & P-MEC INDIA 2017 SPECIAL

Biopharmax: Enable operational excellence and competitive advantage Atul Pabalkar, Sr GM Engineering and Projects, extends the views expressed by the CEO Biopuremax Shlomo Sackstein about holistic measures which should be taken to ensure that all system function as one entity MORE AND more businesses these days are beginning to understand the importance of holistic approach, or in other words, total system analysis. Especially in complex systems such as pharmaceutical manufacturing facilities, looking at the big picture and knowing that all the systems have to function as one entity, is crucial for success. Biopharmax has had this approach from the start, insisting on a turnkey method, focussing on the way all the system components interrelate and how they work within the context of the larger system.

costs of: maintenance, new parts and much more reliable than all the other solutions in the market.

I identified the bottle-neck, now I can solve the problem Not necessarily. Solving one bottleneck can create a new bottleneck.

Existing state and client reported problem ◗ Distillation process for hot WFI production, storing the water at 90OC and cooling it before use. Water cooling process is too slow, creating a holdup in the production schedule.

Holistic approach ◗ Viewing and treating a complex systems as one entity. ◗ Looking at the big picture, considering the entire process rather than specific components Thinking 'outside of the box,' not being afraid to make substantial changes ◗ Develop entirely new mindsets and solutions to problems ◗ Dramatic improvements to take optimise functionality ◗ Making sure the system reaches its full potential as a whole, rather than having strong areas and weak areas

Turnkey projects ◗ One of the biggest advantages of turnkey projects is being able to integrate subsystems into the total system ◗ Old fashioned way: Execute each part of the project separately, which limits the options needed to optimise the system as a whole ◗ Turnkey: Streamlines the entire process of fitting all the components together for ideal integration ◗ Responsibility for project success by meeting present criterion ◗ Allows flexibility and cus-

190 EXPRESS PHARMA December 1-15, 2017

What is the real problem? tomisation to client needs

Biopharmax Water System ◗ The development of Biopuremax process is a perfect example of holistic approach ◗ Rather than accepting the current drawbacks of water purification systems, the former CEO of Biopharmax invented a first-of-its-kind solution which includes an ESR (Electrolytic Scale Reducer) and a HOD (Hydro Optic DeChlorination), which in combination, maximise all water performance criteria: high reliability, low maintenance, low bacteria, low operational costs, no regenerations, no chemicals, no organic media. ◗ Resulting in substantial low life cycle costs and low environmental foot print.

Open-minded clients ◗ It is not enough for the contractor to have an holistic approach, as few clients are able to approach a problem 'open minded'

◗ In many cases, the client requests to repair or replace a specific component that creates a bottle-neck only resulting in a new bottle-neck in a different part of the system. ◗ Therefore, it is crucial to find the root of the problem and look at the system as a whole, often improving the entire process and saving costs of future maintenance and repairs.

Constant maintenance, is it really inevitable? It can be avoided! A client owning an existing vaccination production facility has contacted Biopharmax reporting unreliable final product.

before sanitisation.

Why is this not good enough? ◗ Inefficient commonly used water purification systems create microbial build up and microorganism proliferation in softeners. These microbes were fed directly to the reverse osmosis membranes and caused surface contamination and fouling of those membranes with impact on product water and operational parameters. ◗ As a result, constant maintenance was required, having to stop the system for rigorous cleaning and possibly having to replace the system components at some point.

Identified problem Even though the final product seems to be clean according to standards, the reality was that the entire process was contaminated. Only thanks to the RO, the final product was clean enough. There was a bacterial breakthrough and the system was taken off line

Solution offered ◗ Holistic view of the problem, looking at the big picture and identifying the true problem: contamination throughout the entire process. ◗ Biopuremax system, including ESR and HOD ◗ The solution is proven to save

1. After analysing the system as a whole, it was identified that: ◗ Heat exchanger are too small ◗ 93 per cent of WFI is used cold ◗ In addition to insufficient cooling capacity, the WFI storage tank was always at critical low level.

Options for solution? Increasing the size of the cooling system – will solve the cooling bottleneck, but will come up against a new bottle neck in production capacity because of low levels of WFI in the tank. Recommended solution: Split the WFI system into hot and cold systems. The existing system will continue to supply the hot consumers, and a new cold generation with cold storage will supply the cold users. In this way, energy savings are maximised, no new cooling or heating utilities are needed, and the system pays itself back with a year due to infrastructure and ongoing energy savings.

CPhI & P-MEC INDIA 2017 SPECIAL

CCIT(Container Closure IntegrityTesting) & HGA(Headspace Gas Analysis) methods METHODS FOR detecting leaks in blister packaging and analysing headspace gas in ampoules and vials have traditionally involved a destructive and non-deterministic process. However, non-destructive and deterministic methods, which do not result in wasted products, have emerged as viable alternatives. Bonfiglioli Engineering and Sepha, both part of TasiTest, are leading specialists in these packaging leak test and inspection solutions. Between them, Sepha and Bonfiglioli have developed a number of innovative deterministic and non-destructive solutions for pharmaceutical container closure integrity requirements.

holes in the tray or lid materials, faulty seals and channel leaks between pockets.

Destructive vs nondestructive testing The current industry standard for testing blister pack integrity is non-deterministic blue dye testing, which consists of placing a selection of packs into blue dye water, sub-

manually deblistered and inspected for dye ingress. This technique has two main problems; it is subjective as it relies on operator judgment and it is destructive to the blister packaging and product as all blisters need to be destroyed after testing in blue dye water. Sepha have developed a number of technologies which are deterministic and non-de-

integrity packaging before the start of clinical trials. This ensures that laboratories and R&D departments can rule out the variable of package integrity during a study.

Sepha VisionScan The Sepha VisionScan is a tool-less, non-destructive leak detection device developed for testing pharmaceutical blister

Blister pack leak testing Demonstrating the integrity of pharmaceutical blister packs is critically important, any defects can affect the shelf life and efficacy of the contents. In addition, it is also an FDA requirement as specified in current Good Manufacturing Practice (cGMP) 21 CFR 211.166 for finished pharmaceuticals. Ensuring a robust, objective and repeatable process (deterministic) for leak testing is key to proving product stability and reducing the risk of product recalls or contamination, in addition to preventing a reduction in drug efficacy. Blister packs typically are composed of a thermoformed polymer or cold formed aluminum tray, with a number of individual pockets to hold the product. After the tablets or capsules are placed in the pockets, the packs are heat sealed with a paper or foil laminate sheet. During these production stages, there is a risk of microbial containment or degradation of the products if any defects are present in the packaging. Such defects can take the form of rips or pin-

jecting the packs to a vacuum of typically 400-600mBar for several minutes and then removing the vacuum, which allows any defective pockets to take up the dye. The packs are

To subscribe: bpd.subscription@expressindia.com

structive in the evaluation of package integrity, enabling all defect free packs to be returned to the production process. Sepha’s technology also enables companies to test

packs. It measures pack deflection using camera and projection technology in response to an applied vacuum. Images of the pack surface before and after the application of two vacuum levels are compared. The lidding material of a good pack will deform when a vacuum is applied due to differences in pressure between the pocket interior and the applied vacuum. Any defect will allow this pressure differential to equalize and change the way in which the pack deflects when the vacuum is applied. The Sepha VisionScan generates accurate, reliable and repeatable results with clear pass or fail information. It can detect defects in individual blister pockets, channel leaks and weak seals equivalent to a 7µm laser drilled pin hole. It has a rapid test time down to 10 seconds for micron holes (<30µm) and as low as six seconds for gross holes

(>30 µm). The system is uses qualified thresholds which allows the detection of faulty packs without operator subjectivity. The system does not require dedicated tooling for each pack type and allows multiple packs to be tested in a single test cycle.

Headspace gas analysis systems for parenteral manufacturing processes Headspace content verification is a solution to ensure parenteral product stability and sterility maintenance. Integrity defects as well as failures in the aseptic manufacturing process, including unexpected variability in the nitrogen flushing or vacuum application, pose a risk to product quality and patient safety. Monitoring the maintenance of container headspace conditions is needed for sterile drugs such as oxygen sensitive liquid products and lyophilised or powdered products; any modification in the headspace pressure, moisture or oxygen level may result in the degradation of the active drug, likewise in the reduction of drug potency and product shelf life. Specific requirements for sterile drugs packaged under full or partial vacuum are covered by EU GMP Annex 1 'Manufacture of Sterile Medicinal Products,' section 123: “Containers sealed under vacuum should be tested for maintenance of that vacuum after an appropriate, pre-determined period.” In addition to that, new regulations are expected to enter into force and are to include measures to demonstrate the maintenance of sterility over time for drug products into controlled headspace gas packaging. In particular the proposed revision of USP <1207> 'Sterile Product – Package Integrity Evaluation“ is expected

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CPhI & P-MEC INDIA 2017 SPECIAL to provide clearer guidance for headspace critical content verification through the entire product life cycle, from stability studies to commercial production stage.

Destructive vs nondestructive Headspace Gas Analysis Even with a well-defined manufacturing process in places, it is still almost impossible to keep up with regulatory and quality requirements without a system ensuring a reliable and repeatable monitoring of

the headspace critical gas content. Most of the headspace gas measurement methods available on the market are destructive, therefore they are generally performed on samples, at regular intervals, during the production cycle. The main disadvantage of these destructive approaches arises when out of specification conditions are detected and the entire batch is to be rejected. Bonfiglioli Engineering has developed different innovative, non-destructive solutions in the field of HGA with signifi-

cant advantages over other existing system including the Bonfig LaserCube.

Bonfig LaserCube The Bonfig LaserCube is a benchtop system that uses a non-destructive and non-invasive laser-based inspection technology for measuring the level of gases including oxygen, moisture content and absolute pressure in the headspace of sterile pharmaceutical containers. It is mainly focussed on the inspection of the closure integrity of pharmaceutical

finished containers and of the maintenance of the proper headspace conditions for products packaged under modified atmosphere or under vacuum. The HGA inspection process is based on the Tunable Diode Laser Absorption Spectroscopy (TDLAS) method which uses a laser beam to detect the target molecules within container head space, ideal for the accurate inspection of translucent containers, head space conditions for products packaged under modified atmosphere and clo-

sure integrity in pharmaceutical finished containers. The Bonfig LaserCube is a compact and lightweight system that is easy to use and set up via an integrated PC or any wireless touchscreen tablet. It is suitable for inspection of a wide range of different sized glass containers including vials, ampoules, bottles and pre-filled syringes. ACE technologies is an official representative of Tasitest in India. Contact details acetechnologies@vsnl.net

Clean room high speed doors a necessity DOES YOUR business plan include the development of an area in your plant for clean manufacturing? Better quality or better yield is the primary reason for investing in a cleanroom space. It goes straight to your bottom line. Numerous manufacturing facilities now require a controlled environment in which you limit the amount of dust and dirt in the area of the manufacturing. Medical instrument manufacturing and packaging, electronics and computer manufacturing, food preparation and some military applications are but a few of the instances that have strict requirements for maintaining a clean environment. Clean rooms have become integral part of pharma manufacturing facilities. One of the most important aspects of cleanrooms are the doors chosen for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside temperature, humidity etc. Opening and closure of door has to quick enough to isolate the outside environment and internal facility. Gandhi Automations provide clean room high speed doors specifically designed for above purpose. The clean room high speed doors are best suited for facilities where controlled environment is required. The opening and clos-

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ing of door is quick enough to separate outside environment and internal facility. High speed clean room doors designed by Gandhi automation are engineered carefully with feature below:◗ Concept of low air permeability in pressurised rooms with positive and negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA. ◗ Control device enclosure in Stainless Steel SS 316 Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300(200 Lines)Fax: +91 22 66720201Email: sales@geapl.co.inWebsite: www.geapl.co.in

CPhI & P-MEC INDIA 2017 SPECIAL

Atlantium innovation takes UVto next generations Atlantium Technologies, founded in 2003, provides water-dependent industries such as dairy, food and beverage, pharmaceutical and aquaculture, as well as municipalities, with UV (ultraviolet) based treatment to meet the growing need for safe water. The company’s cost-effective and environmentallyfriendly hydro-optic solutions deliver unprecedented microbial inactivation, taking water safety to levels never before achieved with other UV systems. Atlantium’s Hydro-Optic system is field proven and validated to the highest regulatory standards including EPA, FDA and PMO. The company has an international customer base with installations all over the world.

Non-Chemical Dechlorination – Safe and Sustainable Atlantium Technologies' Hydro-Optic UV is a clean, green solution that has been engineered for maximum efficiency and economy, using medium pressure polychromatic UV light and Hydro-Optic principles that optimise UV energy to its full potential, reducing carbon footprint. It provides the bio-pharma industry with two sustainable solutions in one system: efficient dechlorination and powerful disinfection barrier, on-demand and with no chemicals. Atlantium systems comply with cGMP standards.

The disadvantages of commonly used methods Commonly used dechlorination process methods include reduction of chlorine compounds by activated carbon or by dosing of SMBS (sodium metabisulphite), which both serve as nutrients for microbial populations, in effect creating an ideal environment for aerobic and anaerobic bacterial growth, requiring increased maintenance and a more complex operation. The active carbon grains’ relatively large surface areas and filter pores make it easy for microorganisms to attach and

become a source of food for various types of bacteria. ◗ The active carbon requires frequently-scheduled maintenance procedures such as hot sanitation and backwash. ◗ SMBS is a source for sulphate bacteria and makes an ideal environment for anaerobic microorganisms, creating slime

Sustainable alternative field proven in global companies Hydro-Optic UV is a clean, green alternative to activated carbon and SMBS that offers the bio-pharma Industry reduced risk, better protection and lower operating expenses. It reduces Free Available-Chlorine (FAC) in production lines to undetectable levels, and provides the following added value: ◗ Protects products from chlorine contamination ◗ Protect RO (reverse osmosis) membranes ◗ Protects EDI (Electro De-Ionization) modules ◗ Protects chlorine-sensitive equipment ◗ Provides high level disinfection to PW water Field studies have proven that feed water treated with medium pressure UV actually lengthens the membrane lifespan, reduces bio-fouling, reduces pressure drop, enhances flux and extends time between chemical CIPs, saving in both CAPEX and OPEX.

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Medium pressure ultra-violet (UV) treatment of the process water prior to the RO membrane easily reduces free available chlorine in production lines to undetectable levels and therefore protects the RO membranes from being damaged. At the same time, UV irradiation inactivates microorganisms and represses their repair mechanism, which inhibits regrowth downstream without requiring additional chemicals or causing harmful chemical by-products that may damage membrane performance. Fully compliant with PW and WFI standards, Atlantium systems provide a powerful enough dose to use as the primary disinfectant in a purified water loop.

Innovative technology drives efficiency and sustainability ◗ Total internal reflection Atlantium UV technology leverages fibre optic and hydraulic principles to harness the full power of UV light using Total Internal Reflection (TIR) – an optical phenomenon where quartz is used to extend the paths light photons take over very long distances. The core of the Hydro-Optic system is a water treatment chamber made of high quality quartz (instead of the traditional metal) surrounded by an

air block. This unique configuration uses fibre-optic principles to trap the UV light photons and repeatedly bounce them along the length of the quartz walls and back into the water chamber at different angles, effectively lengthening their paths, recycling the energy, and creating a uniform UV dose distribution. At the same time, the water is optimally engineered to move in a controlled hydraulic pattern. The result is that the UV dose is uniformly distributed across the entire volume of water, with no 'dead' areas that remain untreated. The user benefits from 'recycled' UV light for maximised efficacy using less energy.

Two sensors per lamp for total accuracy Effective UV water disinfection depends on three parameters: UV intensity, water UV transmittance and water flow rate. Since these parameters are dynamic and fluctuate, they need to be measured continuously. The Atlantium system measures these critical data in real time and uses sophisticated validated algorithms to adjust operations. Integrated sensor calibration makes sure the sensors are reading accurately.

Automatic control and monitoring A user-friendly touch screen provides a real-time status display of critical parameters including actual delivered dose, water flow rate, lamp intensity and water UVT. An alarm is triggered if any of the parame-

ters is not within the required range. The data logging system enables traceability over time to monitor data for analysis and proof of compliance. Reports can be printed out at the touch of a button.

Medium pressure UV lamps Atlantium's medium pressure high intensity UV lamps pack a much stronger dose in a significantly smaller footprint than low pressure or other UV lamps. When a microorganism has been inactivated by low pressure UV it can still repair upstream. Atlantium medium pressure high intensity technology disables the proteins and enzymes needed to enable repair. Atlantium UV lamps, placed perpendicular to the water flow in thick glass tubes, can be replaced quickly without draining the unit in only four minutes. Being much easier to handle than long lamps, they are far less likely to break.

Compliant and user friendly Atlantium cGMP compliant systems are a small-footprint solution that easily integrates with existing plant processes. Equally effective with cold or hot water, they can be installed anywhere along the process line, either horizontally or vertically. Customisable options include remote control, data logging and monitoring. ACE technologies is an official representative of Atlantium in India. Contact details acetechnologies@vsnl.net

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CPhI & P-MEC INDIA 2017 SPECIAL

TE-ring remains firmly attached to dropper bottle in line with FDArequirements THE TE-RING fixed to the type A eye-dropper bottle in accordance with the new FDA regulations is one good example. “It’s often the technical details that add the finishing touches to packaging,” says Niels Düring, Global Executive Vice President, Gerresheimer Plastic Packaging. Production of US dropper bottles with a fixed TEring will be operational in Q3, 2017 and production will besides Poland also be produced out of both India and US. The US Food and Drug Administration (FDA) now stipulate that the TE-ring must be firmly attached to the bottle. This product change was very

easy to make, owing to experience with the type B dropper bottle, which already has a fixed TE-ring. Only minor adjustments were made to the design, while the dimensions, properties, and the materials are the same. The bottle and the dropper are made from LDPE and the cap from HDPE. The existing type A dropper bottles can therefore be used for stability tests. Gerresheimer produces type A dropper bottles holding 2-360 ml under clean-room conditions. Depending on the size of the container, they are produced using the injection blow molding (IBM) or the extrusion blow

molding (EBM) process. Radiation or ETO sterilisation is possible on request. All caps protect the original contents and can also be supplied with a childproof screw cap. Contact details Gerresheimer Klaus-Bungert-Strasse 4 40468 Düsseldorf Germany Jens Kürten Group Senior Director Communication & Marketing Phone +49 211 6181-250 Fax +49 211 6181-241 E-mail j.kuerten@gerresheimer.com Internet www.gerresheimer.com

CryoCube F740 series by Eppendorf makes ULT sample storage future-proof BASED ON the reliable and durable Innova U725/ -G models, the new CryoCube F740 series by Eppendorf makes ULT sample storage futureproof. An increased capacity of 740 L/ 576x boxes, improved energy efficiency without sacrificing temperature accuracy, and a considerable noise reduction create a safe storage environment.

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Options such as air-cooling or water-cooling, righthanded or left-handed doors, and three or five interior compartments set new benchmarks for user demands. The CryoCube F740 is network-compatible and can be monitored through smart Eppendorf VisioNize systems – directly at the device’s touchscreen or flexibly at a computer or tablet in the office.

Contact details M Anthoni Jai Kumar Senior Manager - Marketing Eppendorf India Plot No. 18, 19, 20 (Part), Ambit Park Road Sidco Industrial Estate (South Phase) Ambattur Chennai – 600 058 Direct: +91 44 66 312 207 Board: +91 44 66 312 222 Mobile: +91 938 017 6423

CPhI & P-MEC INDIA 2017 SPECIAL

When inspection needs perfection Sterile injectable products are extensively used in healthcare. Despite all efforts for producing sterile parenteral drugs that are 'essentially free' of particles, achieving such result has proven to be very challenging for the pharmaceutical industry. In many cases the observation of particles or container defects have led to product recall, sometimes causing drug shortage to patients. Process improvement is an expectation of clinicians and patient population while quality standards are becoming more stringent. Each individual container shall, therefore, be inspected to the extent possible for the presence of observable foreign and particulate matter or other type of defects, such as container integrity. With billions of injectable doses administrated annually worldwide, the need of reliable, efficient and technologically advanced automatic inspection machines has increased consistently. Since the late 1950’s, Brevetti CEA has been manufacturing in-

spection machines for injectable pharma products. The company first concentrated on the production of semi-automatic machines until when, thanks to the intuition of the owner, the production shifted its focus on fullyautomated inspection systems, which now represent the core business of Brevetti CEA. The first automatic inspection machine was manufactured in 1980 when the availability of first photodiode sensors made it possible to automatically detect particles that contaminate pharma products. Today, Brevetti CEA boasts of more than 2.000 inspection machines installed worldwide, half of which fully automatic. A continuous commitment to research, development and to parenteral product safety, has brought the company to become an undiscussed leader in inspection. Fully responding to the expectations coming from the most advanced pharma sectors, Brevetti CEA offers a complete range of automatic inspection machines for injectable pharma

products contained in syringes, ampoules, vials, cartridges and bottles. These innovative machines are designed according to the newest and most comprehensive concepts that cover the entire Brevetti CEA product line allowing customers to further enhance the recognised advantages of Brevetti CEA technology. To complete its product portfolio, Brevetti CEA has recently launched the new 'BH-S600' machine. Conceived to satisfy the most demanding production lines, the 'BH-S600' can inspect ampoules, vials and cartridges filled with liquid products at the maximum speed of 36.000 units per hour. Within the range of clear solutions and vaccine products, the combination of cutting-edge cameras with a new dedicated 'Tracking Algorithm' software for defects detection, grants high inspection performances. Ground-breaking technologies, optimised mechanics and remarkable value for money are just some of the strong points which distinguish the new inspec-

tion solution of Brevetti CEA. With its state-of-the-art technology and a total re-designed look, the 'BH-S600' will definitely be the undisputed protagonist of the upcoming P-Mec show which will be held in Mumbai.

Main features 1. Particles, fill level and cosmetic inspection 2. RPV Remote parameterisation and validation 3. 'Fail safe' reject verification system (Optional)

4. 21 CFR part 11 compliance for electronic records (recipes, batches/sub-batches, audit trail) 5. Ethernet connection 6. User-friendly interface 7. Manual loading 8. In-line connection to upstream and downstream equipment ACE technologies is an official representative of Brevetti CEA in India. Contact details acetechnologies@vsnl.net

BH-S600 TECHNICAL DATA-SHEET TECHNICAL SPECIFICATION Inspected containers:

Vials,Ampoules, Cartridges

Products to be inspected

Waterlike, Suspensions, Oily

Container size

Diameter: from 8mm to 32mm Height: up to 135

Machine nominal speed

up to 600 pcs/min (36.000 pcs/h)

Spindle Rotation

54 brushless servo-motors

Rotation speed

Continuous regulation. Up to 4000 rpm

By trays or in line

Unloading Accepted

By trays or in line

Unloading Rejected

By trays SERVICES REQUIRED

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Electric supply

400V ±10%-50/60 Hz-3Ph+N+PE

Power

10kW

Compressed air

6bar, 600 Nl/min

Dimensions (WxDxH)

2500x2300x1990mm

Weight

2100 kg

Loading height

970 mm ± 25 mm

Unloading height

970 mm ± 25 mm

Noise

< 75 dB(A)

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Dividella: The future remains modular Overview Modularity is built into every aspect of Dividella’s packaging and cartoning products and services, from the design of NeoTOP machinery to its wide range of packaging solutions. For Dividella and its clients, the future is modular: providing easy upgrade and expansion paths and a wider range of innovative solutions on materials and packaging. Modular design has always been a core characteristic of Dividella’s NeoTOP cartoners and top loading machinery, enhancing service life, upgradeability and flexibility to minimise Total Cost of Ownership (TCO). Similarly, an integrated range of complementary packaging modules allows clients to adopt more space and cost-effective solutions and a wider range of materials to reduce Total Cost of Package (TCP). Dividella is itself part of a modular ecosystem of related skills and competences within the Medipak Systems group, along with Fargo Automation, Mediseal, Seidenader, Rondo and Werum IT Solutions. These sister companies are each highly expert in their respective core areas, able to collaborate with each other to provide complementary modules of innovation and specialised capability. Each of these modules is becoming increasingly relevant to questions of how the pharma industry can generate sustainable competitive advantages within the Industry 4.0 concept that leverages the very latest information and communications thinking to generate innovation and progress. A modular approach to Industry 4.0 allows Dividella to offer leading edge solutions in smart packaging, smart devices, Condition Monitoring and Predictive Analytics, Plug & Produce Internet of Things (IoT) functionalities and Enterprise Manufacturing Intelligence (EMI).

which itself performs a defined task or purpose, but which can be linked with other modules to form a larger system. The modular approach has three key advantages: ◗ It makes it easier to configure a system to an exactly defined purpose with minimal redundancy of components or capability ◗ It makes it easier to expand or upgrade the system to incorporate new functions, capabilities

or technologies, with minimum material waste ◗ It makes it easier to adopt a systemic overview across facilities and process, allowing faster identification of bottlenecks and priority areas for further investment. However, to maximise these key advantages means overcoming the principal challenges of modularity: interconnection, interoperability and compatibility. For modularity

to work to best effect, it is vital that each module actually connects properly with neighbouring modules, that each module forms its own discrete ‘centre of excellence’ without needlessly duplicating the functions of others and that each module can match the capabilities of the system. Otherwise, there is the damage that the whole system will only perform at the speed of ‘the slowest ship in the convoy’.

Modularity in top loading Modular design and construction allows Dividella’s NeoTOP family of TOPLoader machines to form a continuous upgrade path from manual packaging of small lots up to 100,000 unites per year to fully automated high speed production of more than 24 million packs annually The five machine family ranges from NeoTOPx, designed for semi automated packaging of small batches of blisters, ampoules, vials, syringes, injectors and similar products, through to the flagship NeoTOP 804 designed for fully automated high speed production of very large lots. Across the range, there is consistent sharing of specialised modules that add specific capabilities, such as tailored infeeding. The modular concept allows NeoTOP machines to expand at any time to integrate, for example, different product inserters or a manual insertion stage I the process. The NeoTOP concept is adaptable to accommodate extreme product changes and complex pack arrangements.

Modularity in packaging The modular philosophy The core meaning of ‘module’ is a self-contained unit or item,

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Dividella’s TOPLoading packaging solutions for pharmaceutical products follow a similarly mod-

CPhI & P-MEC INDIA 2017 SPECIAL ular philosophy emphasising a component-based approach to design, assembly and regulatory compliance. These features include provision of flat blanks for cartons and partitions allowing printing on all sides, safe automated erecting of packs and a safer loading process, enabling 100 per cent verification after loading. This approach offers a variety of advantages for pharma companies and their customers, influencing the complete production and logistical process and allowing a wider choice of materials. All these have positive effects on TCO and TCP. It also allows Dividella to incorporate innovative concepts like folding ’wing’ format, extended fifth panel flap, integrated partitioning, external tamper evident wafer seals, use of 100 per cent recyclable material and space-saving designs that minimise footprint and logistics costs. In turn these deliver further cost-saving benefits that include ◗ Distribution improvements: economies in warehouse storage

◗ Cold-chain storage and distribution savings: Reduction in package volume easing logistics burden of refrigerated truck and internal cold-chain storage space ◗ Damage reduction: Specifically tailored partitioned design prevent breakage and reduce risks to container closure integrity ◗ Packing/Processing efficiencies: Easier tamper evident sealing for improved overall equipment effectiveness (OEE). ◗ Material cost savings: Elimination of plastic-based blister trays and lids can result in over 400 per cent reduction in material unit costs.

Pharma 4.0 modularity Dividella is working in tandem with its fellow Medipak Systems companies in their respective core areas to find answers to the question of how the pharma industry can generate sustainable competitive advantages with the aid of Industry 4.0 concepts. They are developing a modular family of advanced solutions that can work in isolation or in combination as part of a Pharma 4.0 approach.

These solutions include:

Smart packaging Smart packaging takes product personalisation and product security to a new level, envisaging packs that communicate with the patient and with the machines in the production process. Using digitally encoded data within the package can revolutionise information and service options for providers and end-users of pharma products, such as: digital patient information leaflets, audio patient information leaflets, digital tamperproof protection, health management, intake reminder and automatic repeat order. In production, smart packaging can instruct the machine to vary settings to the requirements of the individual package and even an individual end user.

Smart devices Smart control devices provide the right information at the right time and place, enabling machine operators or production managers to operate and monitor the machine or system, even remotely. By means of the mobile, 'extended' HMI, the ma-

chine operator gains significant freedom of movement can perform tasks more efficiently, resulting in higher quality and hugely simplified changeover, setup or maintenance.

Condition monitoring and predictive analytics Condition monitoring and predictive analytics can reduce downtimes and optimise deployment of personnel and resources by collecting data in real time but interpreting it more meaningfully to detect critical incidents before they occur and schedule preventative maintenance. Reactive or preventive maintenance is replaced by using data mining, modelling, statistics and machine learning

Plug and produce Plug and produce lays the basis for IoT functionalities by using standardised interfaces to allow vertical integration between MES, automation and control systems. Like connecting an electronic device via a USB interface, it should be possible in the future to link a line, a system or a machine such as a packaging machine to the network,

simply and straightforwardly: Plug & Produce.

Enterprise Manufacturing Intelligence (EMI) EMI can improve product quality (process stability) and productivity (process efficiency) by translating production data into usable information for decision making. The customer can make well-founded decisions that improve process stability and process efficiency, thereby increasing product quality and productivity. Production can be supervised in virtually real time and can be continuously verified.

Target sectors ◗ Pre-clinical research ◗ Drug discovery ◗ Drug delivery ◗ Clinical trials and studies ◗ CRO, CMO, CRAMS & CDMO ◗ Formulation and ingredients ◗ RA & compliance ◗ Manufacturing and production ACE technologies is an official representative of Dividella (KORBER SOLUTIONS) in India. Contact details acetechnologies@vsnl.net

ZhengLi Pharmaceutical Packing: Focus on process innovation ZHENGLI Pharmaceutical Packing was found in 1991 that specialises in vials,cartridges, syringes and other glass containers development, manufacturing and supplying . ZhengLi passed ISO9001:2000 in 2000, FDA DMF in 2017, ISO9001:2008 in 2009 and ISO15378:2011 in 2016. To adapt to constantly developing market, ZhengLi invested more than $ 40 million to design and built top level plant with advanced equipment and clean room from Grade D / C / A base on GMP standard. The annual capacity achieves to two billion pieces of glass containers. With strong R&D team, ZhengLi has certified as hightech enterprise of China, and owns 26 authorised patents and seven invention patents. ZhengLi Products are used in anti-tumour, biotech, vaccine blood products, contact lenses,

cosmetics etc., which can match with products like freeze-dryer, powder injection and hydro acupuncture. And ZhengLi can also provide customers reliable pre-fillable syringes, vials and

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cartridges packed in special nest formats. 500—More than 500 domestic and international outstanding pharmaceutical enterprises choose ZhengLi as supplier.

10 years---- Long-term cooperation with six china national bio-tech research centre. 80 per cent----------80 per cent market share in domestic biological pharmaceuticals. 50 per cent -------- 50 per cent market share in domestic highend pharmaceuticals. 15 per cent -------- 15 per cent products are exported to Europe, the US, the Middle East and other country and areas. ZhengLi ‘s perspective is to be responsible for a health in-

dustry. ZhengLi people always treat its products not just as a container, but as a part of drugs. ZhengLi will always focus on process innovation and providing advanced products. Contact details Robin Sales Director -- India Mob :0091-9108088888 Mail: robin.zuo@nbzhengli.com Zhengli Pharmaceutical Packaging http://www.zlpharmapkg.com

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When seal quality matters – I2VS When you open a bottle of pills you bought at the pharmacy, you assume that the manufacturer has sophisticated processes in place to assure the medicine or vitamins will do the job they’re supposed to. The integrity of the seal and how it could affect the contents of the bottle is something that most users never think of. Surprisingly, after the bottles get sealed there wasn’t any way to test the quality of the seal aside from random sampling -- until the Israeli company DIR Technologies (http://www.dirtechnologies.com/) invented a system that checks every sealed package via thermal imaging. Operators can find and fix the factor causing the faulty seals whenever they occur, without destroying a sample or holding up the production line. DIR’s Induction Integrity Verification System (I2VS) was launched in 2013 and was quickly adopted by some of the largest pharmaceutical and nutraceutical manufacturers worldwide, like Pfizer, Merck, Abbvie, Hetero Pharma and many more. The importance and relevance of product was recognised by the international community when in 2015 won the Innovation Award at the ACHEMA World Forum, (http://www.achema.de/en/ho me.html) an international event for chemical engineering and the process industry. “The packaging of medicine is considered part of the medicine, because it directly affects the medicine’s quality,” says Fabian Schapiro, Marketing VP, DIR. “There is some type of technology to test every part of the packaging process except after the package is sealed. Every so often in a batch, someone takes a package off the line and checks it manually. But you don’t really know the quality of the rest, and if you find one with a problem, you don’t know how many are affected, leading to a significant waste

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every now and then. “And some cases are difficult to discover, like if the company has received damaged raw material and the seal doesn’t sit right, or the liners are defective. It is a big leap from sampling to true process control where you check every single bottle and find out not only if something is good or bad, but also get an indication why it went wrong.” For example, trends might reveal that more seals are found to be defective on a specific work shift, and the management can take steps to correct the situation.

Not only for pharma

of time and effort. It’s not a proper engineering process.” DIR is an Israeli company with a strong background in thermal imaging. DIR’s founders and key managers came from the advanced Israeli defence industry, where they were scientists and developers. “Thermal imaging reads the inherent heat signature from the sealing process that heats through the cap of the bottle and glues the lining to

the bottle,” says Schapiro. “Until now, there was no way to know if that was done properly since the bottle is closed, but our imaging can see through the cap and if there is a problem with a seal you can discover that single one and get rid of it. The system can be adapted to any existing line, and can work at production speeds above 400 bottles per minute.” He explains that sealing problems are bound to occur

To provide a suitable response to non-pharma users, DIR came with I²VS Lite, a simplified version intended for packagers of food, cosmetics, cleaning supplies, automotive and other non-pharma applications. Anything with a heat-applied seal under its lid, from coffee to make-up, “is where we could fit in,” says Schapiro. The Lite version uses the same core technology but it’s more modular and less costly because it doesn’t have to comply with the pharma industry’s heavy set of regulations. “We’re pleased to now be able to offer the same leap

from sampling to 100 per cent to packagers in additional industries.”

We are not alone “One of the best indicators of the market need for the real time inspection of seals, is the number of competitors that started to copy the I2VS” says Schapiro. “In a very short period of time, we started to see similar systems being launched in India and the US. The main difference between the original I2VS and the copies, is the know-how behind it. The I2VS was developed by scientists that truly understand thermal imaging and have been working in this discipline for year. Anyone can buy a thermal camera and put some image processing algorithms in place, but there’s something else needed to achieve a robust and consistent system, and that’s understanding correctly what the camera is detecting and processing the data accordingly. That’s why the I2VS remains the leader of this market. It’s the only system done by the experts.” ACE technologies is an official representative of DIR technologies in India. Contact details acetechnologies@vsnl.net

CPhI & P-MEC INDIA 2017 SPECIAL

Virosil Pharma: ASwiss eco-friendly disinfectant Virosil Pharma effectively protects critical surfaces that come in contact with pharma products SANOSIL BIOTECH, a Mumbai-based company is the first company to pioneer the novel concept of ecofriendly fumigation in sterile areas completely replacing the use of carcinogenic proven formalin. The product Virosil Pharma is based on Hydrogen Peroxide (H2O2) with Silver ions. The combination of these two ingredients gives a synergistic broad spectrum of activity on all kinds of viruses, bacteria, fungi, yeasts, molds, protozoa and algae. It is a clear, colour-

less, odourless, tasteless disinfectant which is non-carcinogenic, non-mutagenic, revolutionary and can be used where other chlorine based disinfectants have been feared. Virosil Pharma is presently being used in organisations and institutions such as Pfizer, Cipla, Dabur, Ranbaxy, J&J, Abbott, Serum Institute, Dr Reddy’s, Lupin Labs, Cadila Healthcare, Wockhardt, Biocon, Astrazeneca, Reliance Life Sciences, etc., as a very effective

How effective is it?

How safe is it ?

Even at low dosages,Virosil Pharma has the power of penetrating bio-film and killing the actual bacteria, thereby providing a long residual level of disinfection

It cannot pollute waste water, because it breaks down into water and oxygen, i.e. it produces no noxious by-products.

VIROSIL PHARMA For bacteria- free surface & Pipelines How does it compare to chlorine?

How does it work ?

Virosil Pharma is superior to chlorine since it imparts no taste or odour to the water and is highly effective at both hot and cold temperatures

H2O2 is a strong oxidising agent (more powerful than chlorine or chlorine dioxide).The oxygen separated from H2O2 destroys the biofilm,enabling the silver to help destroy any bacteria or virus.

fumigant and disinfectant providing an environment with microbial containment and a completely safe and sterile environment Virosil Pharma effectively protects critical surfaces that come in contact with pharma products. Manufacturing, filling, packing and storage areas; Instruments, equipment, water tanks and pipelines – can now be pathogen free. What’s more, there’s no need to re-wash disinfected surfaces or instruments since H2O2-based Virosil Pharma safely decomposes into water and oxygen. The formulation has been tested in various reputed institutions in Switzerland, France, Germany, Australia and India. MIC determination Method based on modified BSEN13704 (sporicidal) Test Organisms: 1) Bacillus subtilis ATCC 6633

RESULTS TABLE 1- Count of standard culture B subtilis used Standard Culture

CFU/ml

Log Value

B subtilis

270000000

8.4313

Disinfecting biofilms using Virosil Pharma

Virosil Pharma not only successfully penetrates biofilms and eliminates bacteria but also maintains a long residual level of disinfection in water tanks and pipelines. Using Virosil Pharma overcomes the disruption problem because it is absolutely safe to leave it in the water. Better still, the longer it’s in the water, the better the results since it will attack the biofilms which harbour most of the bacteria populations. The company also offers a customised disinfection audit on its website; www.sanosilbiotech.com

Contact details Dev Gupta, CEO, Sanosil Biotech Warden House, 1st floor, Sir PM Road, Fort, Bombay 400 001 Tel No. 022 22872295 / 43112700 / +919820016292 email: info@sanosilbiotech.com

RESULTS TABLE2- Microbial Counts Post Disinfectant Exposure in CFU/ml

B subtilis

Microbial Counts in CFU/ml

Microbial Counts in Log Values

Log Reductions

Virosil l0%

5 mins

30 mins

60 mins

5 mins

30 mins

60 mins

5 mins

30 mins

60 mins

5 mins

30 mins

60 mins

4900

2300

310

4.7411

5.0696

5.9400

3.6901

3.36178

2.4913

99.9981

99.9991

99.9998

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CPhI & P-MEC INDIA 2017 SPECIAL

Understanding serialisation challenges: Flexibility matches with performances ACE TECHNOLOGIES offers SEA Vision’s complete Track & Trace solution, whose major benefit relies on the architecture of the solution itself. Thanks to its modular and configurable structure, built and designed on best practice, this is the most flexible and reliable solution on the market to face up actual Track and Trace challenges. The complete software suite covers from level 1 to level 3 and is composed namely: Site Server, HMI Supervisor, Vision systems for serialisation and aggregation. The complete software suite covers from level 1 to level 3 and is composed namely: Site Server, HMI Supervisor, Vision systems for serialisation and aggregation. This solutions - at a software level – can be fully configured in order to match initial client needs and can be upgraded in the future at any time in order to comply with any future regulation or customer expansion.

since the documentation update affects only the new functionality.

Site server

Site server is responsible for

It’s a system based on Windows Server and integrated with SQL database. This architecture consists of multiple modules that allow the Server to communicate with: ◗ IT systems along the Enterprise Level (Level 4) including ERP, regulatory agencies, L4 corporate repository ◗ Line Level vision systems installed on the packaging line (Level 2)

Functionalities extension, low validation impact Aiming at granting the maximum system scalability, additional new licenses can be added in time, in order to: support new T&T markets, be compliant with serialisation regulations; add new features not foreseen in the initial project. Each added licence has no impact on the Server core in terms of validation processes,

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One server, cross-efficiency The site server allows the communication towards all Level 4 players (Serial Numbers Providers and/or governmental Agencies) and Level 2 vision systems on the packaging lines. It is the unique repository, monitoring and coordinating all serialisation and aggregation events across the mentioned levels. Being a centralised platform, it facilitates data redundancy and backup activities for safer processes. Moreover data exchange between the site server and vision systems occurs only during the batch start/end, granting an independent management of all serialisation data during the production processes.

Serial numbers provisioning/Autogeneration, managing complexity

the provisioning or auto generation of unique random serial numbers (and for their posting to Level 4), in order to help Brand owners and CMOs to face serialization and aggregation compliance in a safe and flexible way.

Line manager All the systems installed on the line can be managed by a single centralised client provided with a user-friendly touch screen-interface, that could be located next to the packaging line: SEA Vision Line Manager provides an overall view on the whole line status and on the current batch parameters. SEA Vision Line Manager is a SCADA Client providing several functions to execute easily the main operations on the packaging line.

Serialisation vision systems Developed by SEA Vision, the serialisation vision systems to be equipped on print and check machines is able to manage Level 1 devices, thus performing the physical inspection of codes printed on serialised cartons/bottles.

Aggregation vision systems Thanks to a long-time experience integration on automatic and semi-automatic machines, SEA Vision has developed a system able to inspect the codes cartons in the case and build the parent-child aggregation covering all the aggregation levels. Since 2012 SEA Vision has successfully deployed over 350 pharma serialisation lines worldwide, over 70 per cent of them including full aggregation, with less than three months average delivery time. If you would like to discover, how we can help you on your serialisation journey, contact us at acetechnologies@vsnl.net for more information.

CPhI & P-MEC INDIA 2017 SPECIAL

BEC — small letters,Big Value HIGHLY FLEXIBLE and efficient: these are the strengths common to the global success story of the BEC family. The biography commenced in 1999 with the first Blister Express Center (BEC) and culminates for the time being in 2015 with the introduction of the threelane BEC 700. Reason enough to look behind the scenes and identify the most significant developments. Flashback to the 1990s: signs of a shift in pharmaceutical production are visible around the Globe. Mergers and acquisitions, globalisation, as well as the growing competition from generics manufacturers is leaving a noticeable impact. The market for nonproprietary products is growing and that for original products is on the decline. At the same time, orders ranging from 500 to 15,000 blisters are increasing at a fast pace, but frequently packaged on highperformance lines. The negative effect is twofold: bulk orders are hindered and the smaller ones are not cost effective because of time-consuming format changeovers. In many cases, the OEE fails to reach even 50 percent.

Evolution of new concept Good reasons for Uhlmann to think about developing a completely new machine concept that also takes the logistical environment into account. Result: the ‘Blister Express Center’, in short BEC. Managing Director Siegfried Drost summarised its merits at the time as follows: “Everything about the BEC is minimised: the footprint, number of tools, setup times, and operating effort. Our customers find precisely this idea convincing.” Just how convincing it became was pretty evident at Interpack in 1999. Combining a blister machine, cartoner, and a stretch-banding machine, Uhlmann presented a linked system for the cost-effective handling of short order runs completed in minutes. Crucial

Well-engineered for maximum flexibility: the Blister line BEC 500 An integrated, end-to-end system perfectly combining a blister and a cartoner module in a line approx. ten metres in length

for the productive interaction of the three elements are the 26-synchronised servo-regulated drives, which automatically control all the drive functions, and a central operation and visualisation system controlled via a touchscreen. Another highlight at the trade show was the live format changeover from PVC/Al to Al/Al in just 15 minutes – a minor sensation!

Basic principle: Flexibility Unmanned production, selfmonitoring and self-regulating, and a reliable process owing to

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direct blister transfer: these merits, in addition to fast format changeovers, are the success factors of all the blister lines of the BEC family. The BEC family includes the highperformance BEC 500, which Uhlmann presented at ACHEMA in 2006. Unlike the first BEC, the BEC 500 appeared with the configuration common to all blister lines since then: blister machine plus cartoner. What was the reason for omitting the stretch-banding machine? Additional flexibility when it comes to end-ofline packaging! Whether

stretch-banding machine, overwrapper, case packer, or palletiser, the BEC 500 can be supplemented with end-of-line packaging systems suited to the particular application.

BEC 300: Built to impress. Priced to move Low procurement and running costs, proven Uhlmann quality, and convincing performance data are factors with which the Blister line BEC 300 attracted attention at FachPack 2009 in Nuremberg. The single-lane line processes all common types of solid dose products

and forming materials at an output of 300 blisters and 150 cartons per minute. One person can complete a format changeover in 20 minutes. The BEC 300 also made a mark with its attractive price. Customers receive a single-lane, continuous motion packaging line ready for immediate production.

Simplicity in perfection: The new BEC 500 On account of the radical changes in production structures, the pharmaceutical manufacturers not only have

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CPhI & P-MEC INDIA 2017 SPECIAL to cope with sinking batch sizes, but also find themselves confronted with other challenges such as a shortage of qualified personnel, stricter quality specifications, and less scope for investments. The replacement of an older packaging line is only viable when the new line is more flexible and productive. The Blister line BEC 500 is tailored to meet these needs. Revised in all respects, the two-lane line presented in 2012 is geared to handle batches of 30,000 to 150,000 packs. The line is available with Flat or Rotary sealing. Consequently, a broader range of requirements can be met, e.g., complex product shapes, rigid aluminum pockets, or calendar packs. The modular design allows individual configuration, and guidance through a format changeover is provided by the Smart Control operating system. As is the case with all the models of the BEC family, Track & Trace by Uhlmann can also be integrated to meet the statutory requirements of the relevant countries.

cept of combining a blister and a cartoner module, which dates back to 1999. The footprint, number of tools, setup times and operating effort remain at a minimum, while there is no limit to productivity with the three output Range – BEC 300, BEC 500 & BEC 700.

The BEC journey

Efficient packaging with the BEC Blister Lines. Left: BEC 700. The top performer with high output on account of three-lane operation Maximum output: 700 blisters/min. and 300/500 cartons/min Middle: BEC 500. Proven technology for maximum flexibility combined with low operating costs. Maximum output: 500 blisters/min and 300/500 cartons/min Right: BEC 300. Attractive price and excellent production performance in customary top Uhlmann quality. Maximum output: 300 blisters/min. and150/300 cartons/min

BEC 700: Three lanes for higher output The latest member of the BEC range, introduced in 2015, is the blister line BEC 700. Compact and powerful, it is the right line needed for rapidly expanding markets with high potential. The BEC 700 celebrated its debut in China for this reason. The pharmaceutical market there is developing at a fast pace and the demand for medicines is on the increase. This means that there is also the need for lines capable of handling various forms of packaging and large batches. The top performer BEC 700 is based on the proven concept of the BEC range, but its three-lane operation offers significantly higher output – up to 40 per cent compared to the BEC 500.

Uhlmann India presents the BEC 500 in action during the PMEC at Bombay Exhibition Centre at Booth No J2, Hall No 5 from November 28 to 30, 2017.

BEC — A convincing idea The addition of the new BEC 700 to the BEC family means that the ideal solution is available for every production scenario. The BEC lines are in operation all over the world. They prove and validate round the clock that the innovative con-

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◗ 1999 The Blister Express Center combines a blister machine, cartoner, and stretchbanding machine in a single unit and revolutionises the conventional production structures in the pharmaceutical industry. ◗ 2006 The BEC 500 combines maximum flexibility with high output. ◗ 2009 Built to Impress. Priced to Move. Two strong arguments in favor of the Blister line BEC 300, the flexible system comprising a blister and a cartoner module. ◗ 2012 The new BEC 500. The line for alternating batches of up to 150,000 packs scores with innovative features such as servo-regulated drives, radically simplified format changeovers, the new SmartControl operating system, and two-lane operation. ◗ 2014 BEC 300 containment solution: a special, highly flexible alternative based on the standard blister line. ◗ 2015 The new BEC 300 generation – developed in close cooperation with Uhlmann customers. Suitable for all types of forming materials, product shapes, cartons, and leaflets. ◗ 2016 The efficient packaging of bulk volumes on three lanes without forgoing flexibility: the BEC 700 rounds off the BEC family to a higher output level.

The SmartControl operating system is designed for simple and efficient operation

Contact details Uhlmann India Niranjan Mirje, Head of Sales Phone +91 20 6628 6219 Mobile +91 9146003482 sales@uhlmann.in www.uhlmann.de Please follow us: Facebook and LinkedIn

CPhI & P-MEC INDIA 2017 SPECIAL

Lighthouse USAlaunches lightest,smallest 100 LPM portable particle counter LIGHTHOUSE USA has launched industryâ&#x20AC;&#x2122;s lightest(3.8Kg) and smallest (not only footprint, but also volume) 100 LPM portable airborne particle counter. Built in web browser. With integrated web browser one can access real time data locally or anywhere in the building on iPhone, iPad, Android, Windows Tablet Data View Built-in cleanroom certification reports FS 209E, ISO 14644-1:1999, ISO 14644-1:2015, & EU GMP regulatory pass/fail reports on screen or printer Handle with integrated status lights, an app for remote control and configuration, integrated Wi Fi and Bluetooth Self-diagnostics When you are looking to take your environmental monitor-

cleaning solutions, and much more. Real-time monitoring ApexZ50 can be used as a wireless real time sensor. Rooms and custom sample recipes can help to automate and simplify your monitoring routine. The ApexZ50 gives you various user and security levels, audit trails, and data tags that allow you to record things like batch and lot information, room status, or any other information you want associated with your particle counts.

ing programme to the next level, the ApexZ50 is your solution. The power of the

ApexZ50 starts with the most complete system of self-diagnostics in the industry, an en-

closure that is sealed, easy to wipe-down, and chemically compatible with all major

CONTACT DETAILS Jyoti Gangwani Measuretest Corporation 94 Atlanta,Nariman Point Mumbai - 400021 ph:- 022-22027982 www.measuretest.com

Labchrom Scientific launches Automatic Amino Acid Analyzer THE INNOVATIVE automatic Amino Acid Analyzer S 433 combines the advantages of the classical ion exchange separation method with the modern technique of high performance liquid chromatography. The complete package of sophisticated instrumentation, a wide variety of prepacked and tested separation columns combined with optimised ready-to-use buffer solutions and chemicals, creates the right answer for any routine or research problem in amino acid determination. More than 30 years experience in developing and operating sophisticated amino acid analysers results in unmatched performance. In exchange chromatography with post column Ninhydrin detection is one of the most common methods employed for quantitative amino acid analysis.

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The S433 system includes an autosampler with cooled sample storage and partial loop fill technique without sample loss, as well as a 2-plunger buffer pump, a dual beam photometer, a column oven with active cooling capabilities, a Ninhydrine pump, a 4-channel vacuum de-gaser and a refrigerated reagent organiser with integrated inert gas application system. Multi-step separation, cooled reagent storage, integrated autosampler ( 120 Vials), integrated vacuum degasser, separation column oven, high temperature reactor, integrated reagent dosing pump, complete inert design, safety devices intuitive software control for complete control of gradient programme, column and reactor temperature. programmable sample sequence with individual run times gradient and

temperature profiles, automatic uses control of buffer and reagent solutions, SOS feature in case of pressure errors, manual control of each single unit.

Optional fluorescence detector (for OPA applications) Consumables including ready made buffer solutions, separation columns, ready made Ninhydrine solutions and variety of standard solutions. Application area includes physiological fluids, protein hydrolysates. Contact details LABCHROM SCIENTIFIC 253, Udyog bhavan, Sonawala Road, Goregaon East, Mumbai â&#x20AC;&#x201C; 400063, Maharashtra, India Tel : +91 22 26851182 / 83 Fax : +91 22 26851183 Email : mail@labchrom.com

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Romaco Group to demonstrate single-sided rotary press for bi-layer and effervescent tablets The KTP 590X single-sided rotary press, the newest model in Romaco Kilian’s established KTP series, will be the main highlight at the exhibition stand THE ROMACO Group will demonstrate its extensive knowhow regarding pharmaceutical applications with selected technologies for tableting and secondary packaging. The KTP 590X single-sided rotary press, the newest model in Romaco Kilian’s established KTP series, will be the main highlight at the exhibition stand.

based on compression force or displacement controlled. The ROCO Pack software additionally simulates the operation of granulating mills on request. This extreme versatility is a hallmark of the STYL’ONE Evolution tableting robot. The remarkable precision of the test batches means powder properties can be analysed very realistically, for instance. By the same token, scaleups or test series to optimise ex-

Romaco Kilian KTP 590X single-sided rotary press The KTP 590X is an extremely versatile single-sided rotary press from Romaco Kilian which can be used to manufacture both mono-layer and bi-layer tablet formats. It can be switched between mono-layer and bi-layer mode without any modifications to the compression units. Bilayer tablets can be compressed at any time on the version with three compression rollers. The tablet press is equipped for this purpose with two standard fill shoe modules, which distribute the powder absolutely uniformly in the die. Thanks to the optimised paddle design, even poorly flowing or sticky powders can be processed efficiently and compressed homogeneously. With its three separate compression stations, the Kilian KTP 590X is equally suited for manufacturing effervescent tablets. The powder is simply tamped initially to prevent air pockets and capping, then pre-compressed and finally converted into finished tablets in the main compression unit. The dwell time is significantly longer owing to the use of Kilian 28/41 tooling, meaning harder tablets can be made. All in all, the Romaco Kilian KTP 590X singlesided rotary press boasts a maximum output of up to 510,000 tablets per hour, even in bi-layer mode. Low process temperatures, efficient cleaning and retooling and a mature hygiene concept – the KTP 590X singlesided rotary press, too, conforms

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cGMP compliant balcony architecture affords a better view of the process and reduces the risk of cross-contamination. All line clearance measures can be completed in a very short time. The optimal access to all components and the retractable carton magazine simplify cleaning and enable faster product and format changes. The operator simultaneously profits from the cartoner’s lower noise level and er-

Intermittent motion cartoner series Romaco Promatic P 91

Romaco Kilian KTP 590X single-sided rotary press

to the design principles of Romaco Kilian’s successful KTP series: 'Cool, Fast & Clean.'

Romaco Kilian STYL’ONE Evolution tableting robot

In the newest generation of Romaco Kilian’s STYL’ONE Evolution single-stroke press, the compression cycles have been speeded up by more than 60 per cent and the maximum compression force increased to 50 kN. The technology is thus ideal for simulating high speed presses like the Romaco Kilian KTP 420X at up to 104 revolutions per minute. The compression force profiles of all standard rotary presses are stored in ANALIS, the intelligent PAT software, and can be accessed easily when needed. Furthermore, depending on the test set-up, the compression processes can be either

isting processes or troubleshoot errors can be performed on the laboratory press. The new models also have an interchangeable process worktable, which is an advantage if the products in question are highly abrasive. The STYL’ONE Evolution is capable of compressing up to 1,750 tablets per hour in configurations for mono-layer, multilayer or core tablets.

Romaco Promatic P 91S intermittent motion cartoner In the high-speed version, the Promatic P 91S intermittent motion cartoner achieves a maximum output of 140 cartons a minute. This compact machine has a small footprint which makes it perfect for many pharmaceutical applications and line configurations. The cartoner’s

gonomic working height. The use of servo technology and Venturi vacuum systems not only reduces noise emissions; it also ensures reproducible processes and gentle handling of the products and packaging. What’s more, the intuitive HMI terminal of the P 91S intermittent motion cartoner from Romaco Promatic provides maximum ease of use. On show at P-MEC in Mumbai (India) from November 28 to 30, 2017 (Bombay Exhibition Centre, Stand D40). Contact details Susanne Silva Market Communications The Romaco Group Am Heegwald 11 76227 Karlsruhe Germany T +49 (0)721 4804 0 F +49 (0)721 4804 225 E susanne.silva@romaco.com

CPhI & P-MEC INDIA 2017 SPECIAL

How sweet is your HPLC? SUGAR IS a simple carbohydrate belonging to a class of chemically-related sweet-flavored substances. Since sugars are omnipresent in our life, we need the tools and applications to reliably analyse or purify them. Sugars typically found in foods and beverages are monosaccharides (galactose, glucose, and fructose) and disaccharides (sucrose, lactose, and maltose). Sorbitol, xylitol, mannitol and erythritol are a type of sugar alcohol that because of their relative sweetness, are also used as sweeteners. We were all told as children that too much sugar rots our teeth. However, the adverse effects of sugar according to health organisations can be even more drastic than dental issues. The WHO (World Organization of Health) and American Heart Association urge people to restrict their added sugar intake due to their association with obesity, heart disease and type II diabetes. To keep control of sugar levels, it is helpful to know how much sugar there is in the food and beverages we consume. Nutritional labelling is a great controlling aid, as food products are required to list sugar and total carbohydrate content. The measurement of sugars in food stuffs are typically carried out via HPLC. Another issue facing the food and beverage industry is adulteration. Good examples are wine and honey. The price of natural bee honey is much higher than other sweeteners making it susceptible to adulteration with cheaper sweeteners, primarily sucrose. As well as sucrose, high fructose corn syrup and lactose (high in calories) are added to some foods to increase sweetness at a low cost. Adulteration can often be monitored via HPLC. Sugars and sugar alcohols display almost no ultraviolet absorption, and are therefore typically detected using a differential refractive index detector (RID), evaporative light scattering detector or electro-

chemical detector. The choice of detector depends on the method type (gradient or isocratic) and sensitivity required. Refractive index detection is a so-called universal detection method that can detect almost any sample components that have a different refractive index from the mobile phase. This detection method is the most common for sugars, arguably due to its low cost and robustness. The KNAUER dedicated AZURA Analytical Sugar System is equipped with a differential refractive index detector (AZURA RID 2.1L), an isocratic pump (AZURA P 6.1L), manual

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injection valve and column thermostat (AZURA CT 2.1) and is compatible with a range of separation columns. This simple and low maintenance system offers a price optimised configuration, able to cover a wide range of standard applications. Preparative HPLC can be readily used to purify monosaccharides and their simple derivatives from synthetic or natural matrices. A similar system to the AZURA Analytical Sugar System is the dedicated AZURA Semi-Preparative Sugar System. This system can be operated up to 10 ml/min, and the extended dynamic range of the included refractive

index detector make the system appropriate for analytical and semi-preparative purposes. The extended dynamic range option enables the linear dynamic range of the AZURA RID 2.1L to be broadened in +100 per cent (-1000 μRIU offset) or -100 per cent (+1000 μRIU offset). This prevents the need to dilute samples, which saves time and money and diminish additional errors during sample preparation (e.g. pipetting errors). The analysis and purification of sugars is an essential task for increasing awareness and improving health. Simple KNAUER system solutions are

available for fulfilling the modern challenges facing the food and beverage industries.

Applications ◗ Routine analysis of ingredients in wine ◗ Simplified scale up for sugars ◗ Xylitol HPLC extraction from fermented biomass ◗ Semi-preparative xylitol purification Contact details KNAUER Wissenschaftliche Geräte GmbH Hegauer Weg 38, 14163 Berlin, Germany +49 30 809727-0, +49 30 8015010 (Fax)

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Rommelag to display products at P-MEC Mumbai 2017 ROMMELAG WILL display its products at the P-MEC in Mumbai to be held from November 28-30, 2017. The service areas Rommelag Engineering and Rommelag Flex will be presenting innovations for the pharma industry, such as the aseptic, fully isolated filling process or the fully-automated inspection of BFS containers. As the slogan 'Filling your needs' says, the Rommelag Group is presenting special solutions that make these applications easier, safer and faster to use. If you are looking for information about our service options and the world-

Rommelag Engineering will demonstrate the aseptic Blow-Fill-Seal filling process. The bottelpack bp 434 has a completely sealed parison with just one rotating mould

wide availability of specialists, come to the fair stand J-32 in Hall 5. Rommelag Service, which offers comprehensive maintenance and customer service, has an information point set up specifically for this purpose. Rommelag Engineering will demonstrate the aseptic Blow-Fill-Seal filling process. The bottelpack bp 434 has a completely sealed parison with just one rotating mould. The advantages here are maximum safety when filling high-

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Blow fill process with one mould and sealed parison

There are practically no limits with regards to container design for bottlepack BFS containers

value products and simple format changes. Until recently, several steps with manual interventions were necessary to detect particles and cosmetic defects in containers. The particle inspection machine (PIM) now enables a 100 per cent inline check. BFS containers can now be checked fully automatically for particles and cosmetic defects. Rommelag Flex will demonstrate new application options for transport, storage, transferring and weighing in the field of flexible containment solutions for powders and bulk goods. Including Flecofilm, a film approved for the pharma industry. The antistatic property of this film increases product yields.

Contact details Andreas HĂ¤uĂ&#x;nerDirector Marketing Rommelag Fabrikweg 16 5033 Buchs, Switzerland Andreas. Haeussner@rommelag.com www.rommelag.com

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Pharmaceutical Sciences Conferences 2018 2nd World Congress on Embryology and In Vitro Fertilization March 30-31, 2018 Orlando, USA

5th International Conference on Pain Management and Pain Medicine May 21-22, 2018 New York, USA

15th International Conference on Pharmaceutical Formulations & Drug Delivery September 17-18, 2018 Philadelphia, USA

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International Conference on Biobetters and Regulatory Implications June 27-28, 2018 Vancouver, Canada

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4th World Congress and Exhibition on Antibiotics and Antibiotic Resistance June 14-15, 2018 Barcelona, Spain

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18th Annual Pharmaceutical Chemical Analysis Congress November 05-06, 2018 Madrid, Spain

8th World Congress on Chromatography September 13-14, 2018 Prague, Czech Republic

9th Global Experts Meeting on Neuropharmacology November 15-16, 2018 Frankfurt, Germany

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2nd International Conference and Exhibition on Pharmaceutical Development and Technology May 14-15, 2018 Tokyo, Japan 13th World Congress on Pharmacology and Toxicology May 24-25, 2018 Osaka, Japan 17th Annual Medicinal & Pharmaceutical Sciences Congress July 03-04, 2018 Bangkok, Thailand

International Conference on Medicinal and Pharmaceutical Chemistry July 19-20, 2018 Dubai, UAE

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