Express Pharma (Vol.12, No.6) January 16-31, 2017 by Indian Express

VOL. 12 NO. 6 PAGES 84

www.expresspharmaonline.com

Market

Healthcare Sabha 2017: Co-creating a manifesto for a healthy India

16-31 JANUARY 2017, ` 40

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CONTENTS

Ahelping hand

Vol.12 No.6 JANUARY 16-31, 2017 Chairman of the Board Viveck Goenka

The search for a sustainable, affordable and complaint access strategy is a tough task but the gains outweigh the pains | 20

Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja New Delhi Prathiba Raju

MARKET

HEALTHCARE SABHA 2017: CO-CREATING A MANIFESTO FOR A HEALTHY INDIA

STRESSING ON QUALITY ASSURANCE THROUGH LC-MS BIOANALYTICAL TOOLS

DESIGN

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

P33: REPORT

Dyslipidemia market poised for strong growth, surpassing $29.2 bn by 2025

MANAGEMENT

P37: INTERVIEW

‘We are looking at a compound growth of about 35 per cent in the next three years’ Ettore Cucchetti, CEO, ACG Inspection, ACG Value Links, ACG Pharmagents

RESEARCH

RARING TO GROW

P39: INSIGHT

Drug delivery advancements enabling self-care at home

P41: CASE STUDY

HERON DRUG FOR POST-SURGERY PAIN SUCCEEDS IN MIDSTAGE TRIAL

EVEN AFTER NONCARDIAC SURGERY, HEART ATTACKS AND STROKES MAY BE A RISK

Romaco’s packaging solutions for PADMA

P43: VENDOR NEWS

Alfa Laval India appoints Anantha Padmanabhan as MD

A WAVE OF CHANGE

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.

EDITOR’S NOTE

Giving with a purpose

‘H

e who has health, has hope; and he who has hope, has everything,’ said Thomas Carlyle, social commentator and philosopher. This observation is as true today st in the 21 century as it was in Carlyle’s Victorian era. Thus anyone associated with the health sector, is not just making a pill or drawing a blood sample or performing a heart surgery. They are giving hope to the patient and family members that their products and services will cure their disease and result in a better life. The truth of this statement is starker in India’s rural and semi urban areas. Off the beaten path, with no or poor access to medicines and doctors, the lack of a health infrastructure reduces the chances that the population of these areas will be able to lead better lives than the previous generation. But there is hope. An analysis of corporate social responsibility (CSR) expenditure by firms in India in the December 13, 2014 edition of Economic & Political Weekly (EPW) found that education and health were the top two areas chosen by companies across industries, according to the annual reports of the top 200 firms for the year 2012-13. Within the pharma sector, 30 per cent of CSR spend was on health, closely followed by education (28 per cent), community development/rural development (22 per cent) and environment (20 per cent). Amendments to the Companies Act, 2013 made a two per cent spend on CSR mandatory so the figure is likely to have increased since the EPW analysis. As the cover story in the Jan 16-31, 2017 Express Pharma issue, many pharma companies are lending ‘A Helping Hand’ through their CSR programmes, both in India and abroad. MNC pharma companies of course have a head start in this area as their parent companies have been committed

The seed may have been philanthropy, but the nurturing and investment of access programmes is today more careful and considered

to such activities for a longer time. Of course, there is always the criticism that such programmes hide a not so altruistic motive: to garner goodwill in important segments of the population in existing markets, allow entry and access to new markets and also burnish corporate images in a world where perceptions seem to matter more than action. The reality is that these motives and incentives ensure the long-term sustainability of these initiatives, which is ultimately also good for the populations they cover. Such market access initiatives are today part of a company’s strategic road map. The seed may have been philanthropy, but the nurturing and investment of access programmes is today more careful and considered. The fruits are definitely not confined to the population served but also to the server. As long as there is full disclosure to all stakeholders, the means would seem to justify the ends in most cases. But expecting the private sector to foot our medical bills is not the answer to India’s public health burden. “The health of people is the foundation upon which all their happiness and all their powers as a state depend,” said former UK Prime Minister Benjamin Disraeli. Thus it is obvious that policy makers need to build this foundation, independent but mindful of, global influence and experience. Our upcoming conference Healthcare Sabha 2017 promises to be a forum where some of the best minds in the public healthcare space will meet and debate the way forward to build the nation’s healthcare infrastructure. For more details see our website http://healthcaresabha.financialexpress.com VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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12 EXPRESS PHARMA January 16-31, 2017

MARKET PRE EVENTS

BioAsia 2017 to be held in Hyderabad

Healthcare Sabha 2017: Co-creating a manifesto for a healthy India The event will be held at Visakhapatnam from February 9-12, 2017

ith an aim to drive a revolution and facilitate a dialogue in public health, Express Healthcare, a publication from The Indian Express Group, launched Healthcare Sabha – The National Thought Leadership Forum on Public Healthcare. Healthcare Sabha 2017 will create a blueprint to facilitate evidence-based policy making, augment excellence in healthcare delivery and eliminate barriers to equitable access. Healthcare Sabha 2017 will work toward 'Co-creating a Manifesto for a Healthy India.' The event will be held at Visakhapatnam from February 9-12, 2017.

Key subjects at the forum include: Pillar 1-Tackling talent crunch: Improving capacity and competence ◗ Role of PPPs in training healthcare professionals. ◗ Strategies to attract doctors to public health (especially in rural India). ◗ An assessment of the Skill India Initiative and the way forward. ◗ Creating a large pool of efficient and skilled professionals. ◗ Medical education syllabus in India: In need of a major rehaul.

Pillar 2-Developing sustainable health financing systems ◗ Galvanising healthcare via insurance. ◗ Govt sponsored schemes: Meant for poor, but beyond their reach. ◗ Understanding health economics: A much needed remedy for a healthy India. ◗ Infrastructure essentials: Plan for an affordable healthcare system. Pillar 3-Ushering good governance in public health ◗ Technology for good governance in public hospitals. ◗ Revisiting our disease control strategies: Successes & failures (NCD, Anti-TB programmes etc.) ◗ Strategies to mitigate health infrastructure deficit. ◗ Uprooting corruption from healthcare:

An urgent need. Pillar 4-Ensuring access to quality health services and essential medicines ◗ Analysis of Mohalla clinics (Studying the efficacy of the model and their replicability). ◗ Universal Immunisation Coverage: Making it Mission Possible. ◗ Medicines for all: Roadmap for better accessibility and affordability. ◗ Sanitation: Is the Swachh Bharat campaign taking us closer to a Swasth Bharat? ◗ Eliminating malnutrition: Taking a multi-pronged approach. To be held concurrently with Healthcare Sabha, the Express Public Health Awards will honour Champions, Visionaries and Game Changers in Public Healthcare. The first edition (held from March 4-6, 2016 at Hyderabad Marriott Hotel and Convention Center) brought together significant stakeholders in public health to deliberate on cohesive, unified and innovative ways to achieve the National Health Mission’s Vision pertaining to ‘Universal Access to Equitable, Affordable and Quality Healthcare Services to All’.

NPME 2017 to be held in Lagos, Nigeria The expo will be held from August 30-31 to September 1, 2017 4TH NIGERIA Pharma Manufacturers Expo 2017 (NPME 2017), an international exhibition on pharmaceutical industry, will be held at Lagos, Nigeria from August 30-31 to September 1, 2017. The expo will attract more than 150 exhibiting companies and nearly 3,500 pharma trade professionals from across the region

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January 16-31, 2017

including Nigeria, Ghana, Mali, Chad, Cameroon, EQ Guinea, Central African Republic, Senegal, The Gambia, Ivory Coast, Niger, Burkina Faso, Benin amongst others. NPME 2017 is being jointly organised by the Pharmaceutical Manufacturers Group of Manufacturers’ Association of Nigeria (PMG-MAN) and

GPE EXPO. NPME 2017 will provide an unique platform to showcase pharma processing machineries (tablet/capsule/liquid/injectables/ointment/dry syrup), packaging machineries, packaging materials and consumables, API, bulk drugs, additives, excipients, pharma finished products, formula-

tions lab reagents, glassware and equipment, analytical, R&D equipment and biotech instruments, environment control equipment and services, utilities products and services, turn-key contractors, project consultants etc.

THE FOURTEENTH edition of BioAsia will be held in Hyderabad from February 68, 2017. BioAsia 2017 will be sponsored by Indian Council of Medical Research, OPPI, BIRAC and supported by Department of Pharmaceuticals, Government of India. The event will be organised by Government of Telangana, Pharmexcil and Federation of Asian Biotech Associations. The state partner is Department of Science and Technology, Rajasthan. Corporate sponsors are SHANTHA and UK Trade and Investment. The Technology Conferences of BioAsia is a sciencebusiness bridge, that will aim to bring together a trans-disciplinary environment for driving innovation in the life sciences industry. The tech conferences have been structured in order to leverage technology trends for business relationships. While presenting an opportunity to explore partnerships and channels for extending businesses between industry and academia, BioAsia’s tech conferences will cover contemporary developments in research and will assist in building capabilities to break the technology development resistors for smooth flow of technology and collaborations. The CEO Conclave will discuss opportunities to drive industry’s growth agenda by focussing on key action areas. On February 7, a roundtable will be held on 'Orphan Drugs - Discovery and Development' will be organised under the leadership of Prof Ramaiah Muthyala, Associate Director, Center for Orphan Drug Development, University of Minnesota and President/CEO, Indian Organization for Rare Diseases. EP News Bureau

EP News Bureau

MARKET POST EVENT

Stressing on quality assurance through LC-MS bioanalytical tools

SCIEX with Express Pharma recently conducted a workshop with a vision to stress upon the importance of identification and qualitification of impurities in ensuring quality and safety practices Raelene Kambli Gangtok IDENTIFICATION AND quantification of impurities in drug compounds is an important function when it comes to pharmaceutical process development for quality and safety. According to experts, it is extremely paramount to identify unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during stability testing, or during formulation or upon aging of both APIs and formulated APIs in medicines. The presence of these unwanted chemicals even in small amounts can influence the efficacy and safety of pharma products. Keeping this in mind, Indian regulatory agencies have therefore, put in place guidelines which mandate the identification and profiling of impurities in APIs and formulated drug products. Taking this vision forward and to stress upon the importance of identification and qualitification of impurities in ensuring quality and safety practices, Express Pharma and SCIEX, a global leader in life science analytical technology recently conducted a workshop on ‘LC-MS as an imperative bioanalytical tool in Pharma and Personal care segment’ in Gangtok, Sikkim. The workshop was attended by around 40 plant heads, quality control officers, quality assurance managers, project heads and scientific officers from various pharma companies.

Why Gangtok? As reported earlier by Express Pharma, Sikkim is likely to emerge as a major pharma hub in the North Eastern region by

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January 16-31, 2017

With several pharma companies setting -up manufacturing plant in this pristine hilly state was an obvious choice to conduct the workshop and emphaisis on quality workflows.

The workshop

The workshop was attended by around 40 people from various pharma companies

2018. The state has already attracted an investment of over $400 million (` 2000 crores). As per the Commerce and Industries Department, Government of Sikkim, presently, Sikkim is home to as many as 22 pharma companies, out of which 16 are big firms, one is medium and five

are small scale firms. These include the who’s who of the Indian pharma sector such as Cipla, Sun, Zydus Cadila, Alembic Pharma, IPCA, Alkem, Intas, Torrent, Unichem and Micro Labs from 22 major pharma companies in the last three years.

The session began with a brief introduction to the topic of the workshop by the Express Pharma correspondent followed by a presentation on SCIEX India and its role within the pharma sector. Gurkirat Singh, Marketing Manager, SCIEX India explained how SCIEX is committed to quality solutions and how their solutions enables scientists and laboratory analysts to find answers to the complex analytical challenges they face. He further gave an overview of their global business as well as their market share in India. From thereon, Dr Anoop Kumar, Application Support Manager, Pharma/Non Pharma Support SCIEX, India took over the proceedings for the afternoon. He began the workshop by firstly accentuating on the development of impurity profiling methods using modern analytical technique and the importance of liquid chromatography-mass spectrometry (LC-MS) method for determination of potential genotoxic impurities. Then, he explained on how this method can be useful in the separation of optically active drugs. He said that LC-MS helps in improving the efficiency of drug discovery due to its excellent sensitivity and specificity. The technique can be combined with stable isotope dilution for precise and reproducible assays. He elaborated on the effectiveness of SCIEX solution to

provide a novel workflow for screening and identification of a multitude of targeted analytes. Kumar said, “To ensure patient safety regulatory agencies have put in place guidelines which mandate the identification and profiling of impurities in APIs and formulated drug products and sets thresholds at which these impurities must be reported. A fast, high throughput, robust, and reproducible analytical technology and method is critical for increased confidence in impurity identification, detection, and quantification in pharma research. In every step of the impurity profiling workflow from data acquisition, identification and characterisation of impurities, to batch-to-batch comparison, and quantification of impurities, the SCIEX solution assists scientists.” Moving forward, he also provided information on SCIEX's QTRAP Systems that provide a novel workflow for screening and identification of a multitude of targeted analytes. Dr Kumar's presentation and scientific knowledge kept the audiences engaged. There were many valid questions raised and many doubts cleared. Dr Kumar also provided many case examples that the audiences associated with as they pointed out that in their daily practice they come across such challenges and that this workshop helped them get the insights they require to overcome these challenges. The evening ended with cocktail and snacks wherein the audience networked with each other as well as discussed issues related to quality assurance. raelene.kambli@expressindia.com

EVENT BRIEF JANUARY TO SEPTEMBER-2017 6

BioAsia 2017

BIOASIA 2017 Date: February 6-8, 2017 Venue: Hyderabad International Convention Centre (HICC) Summary: BioAsia 2017 will be supported by Ministry of Science & Technology, Government of India and organised by Federation of Asian Biotech Associations (FABA). There will be participation from 50 countries with 100 speakers, 800 corporates and 1000 partnering meetings. Technology Conferences of BioAsia is a science-business bridge, that aims to bring together a trans-disciplinary environment for driving innovation in the life sciences industry. The tech conferences have been structured in order to

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January 16-31, 2017

India Pharma 2017

leverage technology trends for business relationships and help to put technology in the development relay across the world through codevelopment opportunities. BioAsia’s tech conferences will cover contemporary developments in research and will assist in building capabilities to break the technology development resistors for smooth flow of technology and collaborations. Contact details BioAsia Secretariat 301, Gayathri Nest, Telecom Nagar, Gachibowli, Hyderabad - 500032, Telangana Phone: +91 (40) 23000205/206 Fax: +91 (40) 2300 0207

PharmaTech Expo 2017

Email: info@bioasia.in

INDIA PHARMA 2017 Date: February 9-11, 2017 Venue: Bangalore International Exhibition Centre, Bengaluru Summary: India Pharma 2017, an international exhibition and conference on pharmaceutical industry is a joint initiative of Department of Pharmaceuticals, Government of India and Federation of Indian Chambers of Commerce & Industry (FICCI). It will provide a common platform where all the participants will get an opportunity to enhance their brand value by displaying their product and the capabilities among the conference delegates and

Respiratory Drug Delivery (RDD) Europe 2017

business visitors provided by the event. India Pharma 2017 will cover all the sectors of the pharma industry starting from finished formulations, APIs, bio-pharmaceuticals, fine chemicals and intermediates, natural extracts, excipients and many more. Latest pharma machinery, plants, laboratory equipment, analytical instrument and cleanroom equipment will also be showcased. Contact details Kamal Bhardwaj Deputy Director Mob: 9899392930 Email: kamal.bhardwaj@ ficci.com Federation of Indian Chambers of Commerce & Industry (FICCI) Federation House,

PharmaTech Expo 2017

Tansen Marg, New Delhi 110001

PHARMATECH EXPO 2017 Date: April 11-13, 2017 Venue: Parade Ground, Sector – 17, Chandigarh Summary: The 5th Edition of PharmaTech Expo 2017, an international exhibition on pharma machinery, lab and packaging equipment, will see a common platform for suppliers, manufacturers, industrialists, buyers and consultants. This year the focus will be on nutraceutical, food and cosmeceuticals and ayurveda. The event will be concurrently held with LabTec expo 2017. More than 150 exhibitors from across the country participated in last year’s

event and varied kinds of high tech pharma machinery, lab and packaging equipment were on display. With more than 5000 trade visitors took part in last year's event. Contact details PharmaTechnologyIndex.com A Division of KNS Group 701 - 702, Corporate House, Opp Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

RESPIRATORY DRUG DELIVERY (RDD) EUROPE 2017 Date: April 25-28, 2017 Venue: Palais des Congrès d’Antibes, Nice, France

Summary: RDD Online and Aptar Pharma will organise RDD Europe 2017, an event in the Respiratory Drug Delivery field in Europe. It will bring together pulmonary and nasal drug delivery experts from all around the world to exchange scientific knowledge and expertise, and also provide a dynamic forum for expanded opportunities for business networking. RDD Europe 2017 will feature podium sessions and debates, scientific poster sessions, technology exhibition and workshops sessions. Academics, industrial and regulatory scientists involved in the research, development, investigation will take part in the event.

Contact details Joanne Peart: info@rddonline.com

PHARMATECH EXPO 2017 Date: August 3-5, 2017 Venue: Gujarat University Convention Centre, Ahmedabad, Gujarat Summary: The 6th Edition of PharmaTech Expo 2017 will be Gujarat’s largest pharma expo and will be concurrently held with ‘Labtec’ & ‘Track & Trace’ Expo 2017. This year, the focus will be on pharma machinery and equipment manufacturing sector and pharma packaging. More than 150 exhibitors from across the country participated in last year’s event and varied kinds of high tech pharma

machinery, lab and packaging equipment were on display. Contact details PharmaTechnologyIndex. com A Division of KNS Group 701 - 702, Corporate House, Opp Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

INDIA LAB EXPO 2017/ANALYTICA ANACON INDIA Date: September 21-23, 2017 Venue: Hitex, Hyderabad Summary: India Lab expo, India’s largest exhibition on laboratory, scientific, analytical and biotechnology

sector will see international as well as Indian manufacturers and distributors. Decision makers from sectors like hospitals, diagnostic labs, oil and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science & Technology, Government of India. Contact details MMI India INIZIO 507 & 508, 5th Floor, Cardinal Gracias Road, Opp P&G building, Chakala, Andheri (E), Mumbai - 400099 Tel : +91 22 42554710 Mob: +91 9820668393 Fax: +91 22 42554719 info@mmi-india.in

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January 16-31, 2017

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

20 EXPRESS PHARMA January 16-31, 2017

BY VIVEKA ROYCHOWDHURY

(

To subscribe: bpd.subscription@expressindia.com

THE MAIN FOCUS

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January 16-31, 2017

cover ) says, “The Index is built on a series of indicators; a company like GSK has done badly in the ethics section because of their breach in a country like China. They still top the Index even though they lost points here as they have shown the most engagement in poverty related R&D, and prove that they ensure the most number of products that are affordable (compared to the rest of the industry evaluated) and have shown a host of other programmes that they get credit for (licensing, capacity building, etc.).” The Index also notes that companies are taking steps to address the compliance issues, “as they see misconduct as risky for their reputation and for their sales and for growth,” says Iyer. Citing examples from the Index, she mentions how GSK and now six other

companies (such as AstraZeneca, and Merck) are implementing incentives for their sales agents that are not related to sales targets. Instead, they reward other qualities, such as technical knowledge and level of service. Another example is Gilead (which slipped three ranks from 5 to 8), which has created a Pocket Guide to Regional Business that they use to manage compliance issues. “Keeping high standards and incentivising good ethical behaviour is critical, and must be upheld even when working in less regulated markets,” is Iyer's firm recommendation. Another highly rated criteria for the Index is engagement in R&D for new products even where there is a limited or no paying market. Here too, six companies (GSK, AbbVie, J&J, Sanofi, No-

vartis and Merck) account for nearly 75 per cent of projects targeting high-priority, low-incentive gaps identified by the Index, points out Iyer.

Balancing availability and accessibility Ensuring both availability – the sufficient supply and appropriate quantity of resources, medicines and doctors for example – and accessibility – the equitable distribution of these resources - is a tough task. Global pharma companies run their access programmes across geographies, and each country comes with its own set of challenges. Lokesh Sharma, Head, Public Health (Africa, Middle East, South Asia), QuintilesIMS agrees that the pharma sector recognises the challenges in the public

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 Jayasree K Iyer Executive Director, Access to Medicine Foundation

If public health needs to be strengthened, availability of medicines needs to be strengthened. The public health sector, at times, struggles to buy medicines which are not available in the open market Lokesh Sharma Head, Public Health (Africa, Middle East, South Asia), QuintilesIMS Source: 2016 Access to Medicine Index

22 EXPRESS PHARMA January 16-31, 2017

( health space and has put in effort in filling the gaps, by making healthcare and medicine accessible for public health. However, as he points out, “In India's case, the pharma industry is still not self-reliant as most bulk drugs and Active Pharmaceutical Ingredients (APIs) are imported from China. Spurred by concerns about the pharma industry's dependence on China, the government is said to be making efforts for the revival of the API industry to lessen dependency on import of key starting materials, intermediates and bulk drugs including from China. The challenge is to ensure that raw material is available here. So if public health needs to be strengthened, availability of medicines needs to be strengthened. The public health sector, at times, struggles to buy medicines which are not available in the open market.” Highlighting another pain point, he says, “The pricing policy is another challenge for the industry impacting pharma and public health sectors. There is a need to have a robust and balanced pricing policy as well, which is uniform in nature and allows the public health sector to improve.” As Sharma sums up, “We still have a long way to go, both on the availability as well as the accessibility aspect.” Giving a third perspective, from the academia and health research side, Dr C Ramesh, Dean School of Pharmaceutical Management, IIHMR University calls for collaborative work between pharma companies, hospitals and academia, in order to bring about future remedies and management of health care system in a modern way. “A product of amalgamation of all these three pillars of healthcare would give the future remedy of the health problem of our country.” Jawed Zia, Country President, Novartis India too highlights the role of governments and different stakeholders, saying, “There is no single stakeholder who can achieve any of

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the Sustainable Development Goals (SDGs) in isolation. Education and health are closely interlinked. With education comes more health awareness and the desire to achieve health

goals. Therefore it is up to not just the pharma companies but also the countries to step forward and look at various ways in which they together with other stakeholders come to-

THE MAIN FOCUS

gether to achieve various SDGs including those pertaining to health.”

Selective access? But access programmes do

have their critics. For instance, some pharma companies have come in for criticism as they keep key Middle Income Countries (MICs) out from their licensing agreements for key

cover ) medicines. This is contradictory because the stated rationale of these agreements is to increase access. MICs tend to have a high burden of these diseases and the incidence is generally higher in poorer sections of all countries. As a result, this segment of population in MICs is doubly disadvantaged. As Iyer emphasises, “There is clearly lots to do for pharma and for country governments.” For example, she points out that many MICs such as Brazil, China and Mexico are not covered by any licensing agreement for HIV/AIDS medicines while they are home to more than 1.8 million people living with HIV/AIDS. In the case of Hepatitis C, countries like Armenia, Brazil, China, Colombia, Mexico, Moldova, Kosovo, Peru, Tajikistan, Thailand and Ukraine are not covered by Hep C licenses though they are home to 22.4 million people living with hepatitis. Here too, Iyer cites a few good examples mentioned in the Index, like Novartis’ social business Arogya Parivar (healthy family) programme in rural India and the various licenses that have included countries like India (for e.g. GSK’s Dolutagravir license, which includes India, permits licensees (generic medicine manufacturers) also the ability to supply product outside territories until patent expiry, which is a very important term to improve access worldwide). Specific to India, GSK has identified elimination of lymphatic filariasis (LF) as the lead CSR project in India. Giving a snapshot of the impact of the project, A Vaidheesh, MD, GSK Pharmaceuticals says, “The LF project started in 2000. Over the past 15 years, we have donated more than five billion albendazole tablets across 70 countries, of which over 2.3 billion tablets have been donated in India to help eliminate LF. We have reached over 600 million people – including 200 million children. Researchers estimate the number of people at risk of infection of LF has almost halved since 2000. But the work does not stop here. We have pledged to donate albendazole to the WHO until LF has been eliminated as a public health problem.”

From idea to action But the global pharma industry is much wider than the 20 companies tracked by the Index so of what use will this Index be to them? Iyer refers to the Access to Medicines Index report as a “book of ideas” as the “best practices that we illustrate help other companies to think

24 EXPRESS PHARMA January 16-31, 2017

Usha, LF patient cleaning her leg at Karaikal, Tamil Nadu (Photo courtesy: GSK)

A product of amalgamation of pharma companies, hospitals and academia, the three pillars of health care would give the future remedy of the health problem of our country Dr C Ramesh Dean School of Pharmaceutical Management, IIHMR University

Volunteers carrying out the annual mass drug administration in Puducherry (Photo courtesy: GSK)

about more effective and impactful ways to contribute, and helps governments to become better at negotiating what they need for their people, and prioritising access to medicine.” For instance, several company programmes run in low and middle income countries that ensure that affordable products, and capacity building and infrastructure development go hand in hand when operating in low and middle income countries. In the 2016 Index, Iyer says they identified 57 best and innovative practices, ranging from examples that address affordability of noncommunicable disease products such as the Novartis Access programme, affordability and availability of hypertension treatments such as AstraZeneca’s Healthy Heart Africa programme (both examples running in Africa) and improving overall health, treatments and control such as Eli Lilly’s activities in building local capacity to improve TB

treatment and control in India. And it won’t be long before the Foundation turns its lens on other sections of the pharma industry. While the Index has so far focussed on the researchbased industry, spanning MNCs, there are plans to create a similar index for the generics industry and indigenous companies. “The generics industry is important to engage in access to medicine, as is tracking progress towards goals there. We are still raising funds to launch this project,” says Iyer. “We have spent the last 10 years evaluating big pharma, and we would love to have the opportunity to seek a (multistakeholder) consensus on what the indigenous industry can do more for people and then track progress towards those goals. I’m sure that there are significant programmes in place also for indigenous companies, and by showing what works and why, it becomes a book of more ideas that companies can learn

It is up to not just the pharma companies but also the countries to step forward and look at various ways in which they together with other stakeholders come together to achieve various SDGs including those pertaining to health Jawed Zia Country President, Novartis India

( from as they innovate, address the needs of local people, ensure that products are reaching those regardless of demographic, environmental, literacy or even “ruralness” of communities,” explains Iyer.

is today present in 11 states. Ventures like Novartis' Arogya Parivar fill a very crucial gap in India's healthcare delivery infrastructure, the urbanrural divide. “The healthcare

services in India are skewed in favour of urban areas. Rural India suffers from a lack of health infrastructure and trained healthcare providers including doctors, nurses and

THE MAIN FOCUS

diagnostic centres. Arogya Parivar makes a consistent effort in bringing healthcare to the village level for the rural population through customised training of the rural youth to

provide health awareness and aid patient empowerment. Arogya Parivar has a direct distribution network in Tier IV and V cities helping build the infrastructure to launch affordable

No one size fits all model

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The industry will have to evolve its access strategies, country by country, and in some cases, state by state. As Zia of Novartis puts it, “Health needs and challenges vary greatly from place to place and also within a country the size of India. There is no one size fits all model which is why we follow a mix of approaches that drive access to modern medicine with various novel products launched at prices that are relevant for the Indian setting. Among the various approaches we have full donation programmes through partner organisations including WHO for leprosy drugs and The Max Foundation that administers the full donation Glivec programme for CML and GIST, co-pay programmes for various disease areas where the patient buys x days/weeks of therapy and the balance is free and at cost programmes.” Explaining the company's access strategy for India, Zia says, “Since healthcare is a state subject in India, we endeavour to identify gaps in key states and work with local officials and stakeholders to build capacity of healthcare workers and increase awareness among patients. We have forged partnerships in some states to advance diagnosis of chronic diseases such as diabetes and cardio-vascular diseases.” In a similar vein, the strategy to enhance access in rural India is that Novartis recruits and trains locals in remote villages to become “health educators,” who help inform communities about health, disease prevention and the benefits of seeking timely treatment in the local language. Local teams work with doctors to organise health camps in remote villages – mobile clinics that provide access to screening, diagnosis and therapies. Arogya Parivar

Are you always solving? We are. We are passionate, tenacious solvers who thrive on developing practical, innovative, and elegant solutions to complex problems in drug delivery, always pushing the boundaries of what’s possible, and advancing the competitiveness of our customers. ashland.com/pharma For more information, please contact us: Rohan Rastogi / +91 40 4474 8804 / rrastogi@ashland.com Ninad Kellar / +91 22 6148 4646 / nkelkar@ashland.com

efficacy usability allure integrity proﬁtability™

cover ) products for rural India.” Health awareness can empower people in rural areas to seek quality healthcare and early detection of disease and together with a focus on compliance, this helps bring accountability on the healthcare providers, points out Zia. Likewise, GSK India has partnered with two NGOs, ARTH and CARE, to address the entire continuum of care for newborn survival in the high burden districts in Rajasthan and Madhya Pradesh. The impact of this project can be judged from the numbers. According to Vaidheesh, 82 per cent of neonates have been saved. 70 per cent of sick children are assessed by ASHAs, who refer sick children to the facilities. Female sick newborns are especially tracked for danger signs. Trained ASHA facilitators pay visits at least once a month for all ASHAs. 70 per cent birth attendants are able to demonstrate NSSK skills while 80 per cent ASHAs have HBNC knowledge and skills, he says, citing the latest figures, which points to a gradual up skilling of this key link in the health delivery network. Harking back to Iyer's intention to engage with indigenous pharma companies and track their role in access, many Indian companies have access programmes similar to those of MNCs. For instance, take Glenmark's Project Kavach. Giving the rationale behind their flagship CSR programme, Cheryl Pinto, Director, Corporate Affairs, Glenmark says, “A few years ago, we conducted a detailed research in the field of child health and the key findings of the research directed us to initiate Project ‘Kavach’... the word ‘Kavach’ means a shield and symbolises protection. The aim of ‘Project Kavach’ is to reduce infant and child mortality in children between zero to five years.” Project Kavach was initiated in 2011, and provides ambulatory care to the remotest forest-based villages which do not have accessibility to proper health care. According to Pinto, it runs five days a week to attend to the children with Severe Acute Malnourishment (SAM) condition who are identified and referred to the nutritional rehabilitation centre. “Over the years, we have been able positively impact 6,18,617 lives; 1,22,324 children were reached out through nutrition, immunisation and sanitation interventions; 26,608 malnourished children were treated; healthcare support were provided to 62,981 pregnant and lactating women; and 12,514 children were successfully immunised.”

26 EXPRESS PHARMA January 16-31, 2017

Glenmark organises camp for improving health in the slums of Nairobi, Kenya

Over the years, we have been able to positively impact 6,18,617 lives; 1,22,324 children were reached out through nutrition, immunisation and sanitation interventions; 26,608 malnourished children were treated; healthcare support were provided to 62,981 pregnant and lactating women; and 12,514 children were successfully immunised” Cheryl Pinto Director, Corporate Affairs, Glenmark

A health camp in India (Picture used for representational purpose)

The way ahead Sharma of QuintilesIMS feels that one solution (to plug gaps in current access programs and improve impact) could be better management of information. “There is no pharma monitoring information system (PMIS) which can give a complete holistic picture of what is happening in the pharma industry right from research to pharmacovigilance. At present, the information is scattered. The pharma industry and the government need to come together in establishing a PMIS for timely information which would play a critical role in monitoring the operations at the grassroots, help in informed decision making, and thus allocating adequate resources for the same.” Governments need to find ways to incentivise access to make it more sustainable for corporates to commit resources on a long-term basis. Once again stressing the collaborative approach, Ramesh of IIHMR lists a few existing models and regulations that

ensure accessibility to healthcare services at affordable prices, for instance value based costing, new R&D models to increase access to affordable medicines like new partnerships to access new sources of innovation, open crowdsourcing, public private partnerships, accelerated efforts to enhance availability and quid pro quo-universally legally guaranteed coverage. But these models are not without their weaknesses as management strategies aimed at controlling cost and utilisation create significant barriers to the accountability, affordability, and accessibility, rues Ramesh. Therefore new models of R&D need to be introduced to increase access to affordable (innovative) medicines like for instance, new partnerships to access new sources of innovation etc., reasons Ramesh. Medication is just one part of the healthcare delivery chain. Pharma companies are therefore continuously reviewing their access programmes in

Over the past 15 years, we have donated more than 5 billion albendazole tablets across 70 countries, of which over 2.3 billion tablets have been donated in India to help eliminate LF A Vaidheesh MD, GSK Pharmaceuticals

( response to gaps identified in the existing system. For instance, as Zia of Novartis says, “Our programmes go beyond just the pill to look at compliance and better health outcomes. Given the high patient load per doctor in India, counselling support services are offered to improve health outcomes through enhanced understanding of disease management, reinforced importance of therapy adherence, lifestyle modifications etc. Additionally, customised interventions such as microfinancing, discounted diagnostic support and other value added services are offered for select disease conditions that enable better health outcomes for various chronic diseases. It is generally accepted that whatever is measurable, is easier to replicate. But in this the case of linking pharma companies’ access programmes to health outcomes, Iyer says that key gains are notoriously difficult to quantify, as there is very little reporting of health outcomes and impact and because many pharma programmes are running only for a short time so far. But there is progress because “10 years ago, we did not have this many companies engaging in poverty related disease R&D, starting and maintaining access programmes all over the world and certainly every company we have been evaluating has come some way in the last years.” Sharing some more key takeaways from the Index especially for companies formulating their own access strategies, Iyer comments, “One important thing for anyone to realise is that access to medicine is going beyond philanthropy, and is part of normal corporate strategy in many MNC companies. These ensure more sustainability of programmes and thus are more likely to have a better health impact. When an MNC operates in India, they have to ensure that access to products and contribution to human, infrastructure development go hand in hand, so as to also get

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better health outcomes. As indigenous companies look at their access to medicine strategies, they need to carefully address the user’s needs and develop ways to improve access.

Access based rather than sales based strategies are driving growth in countries like India.” Thus it is evident that though a lot is being done, more can and needs to be done.

THE MAIN FOCUS

Pharma companies cannot rest on their laurels and neither can governments rely solely on corporate funded programmes to secure the health of their citizens. Both sides need to find

common ground and work towards achieving their goals, be it meeting the SDGs or more specific national health targets. viveka.r@expressindia.com

MANAGEMENT

RARING TO GROW Laurus Labs, post a successful IPO, is embarking on the next phase of its growth, armed with the advantage of its core competencies and a strategy to breach new frontiers BY LAKSHMIPRIYA NAIR

ven while political and economic turmoil caused a dip in IPO activity globally last year, India bucked the trend and saw several companies make successful débuts at the stock exchange. As EY Global IPO Trends 2016 4Q report highlights, “India was the standout performer, recording a 38 per cent increase in deal volume and a 79 per cent surge in proceeds raised, driven by stronger economic fundamentals and a pro-business political regime.” IPOs by 21 firms across sectors raised `19,379.10 crores in the first nine months of the year.”

AT A GLANCE ◗ Inception in 2005 ◗ Operates in four business lines: generics – APIs, generics-FDFs, synthesis and ingredients ◗ In FY16, the company sold its APIs in 32 countries ◗ It has commercialised 59 products and filed 37 DMFs ◗ The company has been granted 34 patents and had applied for 152 patents (as of September2016)

A successful debut Laurus Labs, an API manufacturer based in Hyderabad, is the latest pharma company to go down the IPO route. Held from December 6-8, 2016, the total IPO size was `1,331.79 crores. It comprised a mix of offer for sale (OFS) by existing partners Aptuit Asia, Bluewater Investment, FIL Capital Management and Fidelity India Principals as well as as issue of fresh shares for Rs 300 crores, both priced at `426 – 428 per share. The final day of the IPO saw it being subscribed by 4.54 times. While the results of the IPO was modest in comparison to some of the blockbuster ones the industry has witnessed earlier in the year, by no means was it a small feat for a company which has completed justa decade of existence. So, what are the factors which made it an alluring proposition to investors? The market analysts who gave a thumbs up to the company believe that a rapid

28 EXPRESS PHARMA January 16-31, 2017

Satyanarayana Chava, Founder and CEO, Laurus Labs

Key personnel at Laurus Labs

pace of growth, healthy product portfolio alongwith cost advantage, vast experience and expertise of the company’s management, a strong position in high-growth therapeutic areas like anti-retrovirals

(ARVs), Hepatitis C and oncology, its plans to enter into niche formulations business are a few of the reasons which helped the Hyderabad-based pharma company to come across as a favourable investment option and raise a successful IPO despite tumultuous market conditions. The company informs that a majority portion of the IPO proceeds will be utilised for repayment of long-term loans and the balance will be utilised for general corporate purposes. So, what's next for Laurus Labs? Its founders, Dr C Satyanarayana, CEO, Laurus Labs and VV Ravi Kumar, Executive Director, outline their vision for the company's progress in exclusive interviews with Express Pharma. Excerpts...

Fortifying the current position “We are particularly focussed on growing our presence in our key therapeutic areas, comprising ARV, Hepatitis C and Oncology. We have built a leadership position in the manufacturing of APIs in the ARV therapeutic area and believe that there are significant growth opportunities in this area as a result of expected increase in the HIV patient pool as well as the current WHO guidelines recommending initiating early treatment for infected HIV patients, regardless of age and viral load. We believe that our superior process chemistry skills and cost effective process optimisation have led to new synthetic routes and product variants, and have given us market leadership for our key products in the ARV, Oncology and Hepatitis C therapeutic areas. We believe that our

position as a preferred supplier of APIs to several major pharma company participants of the tender driven ARV market insulates us from the wins and losses of our customers and significantly hedges us against revenue volatility,” says Dr Satyanarayana. Ravikumar emphasises that the company is looking at both forward integration and backward integration as a strategy for growth and says that strengthening its current product portfolios is a major goal for the company.

Venturing into new growth paths Ravikumar also expresses his pleasure in the fact that the IPO was oversubscribed despite a volatile market and informs that now the company is looking to grow in new therapeutic areas such as anti-diabetic, cardiovascular, antiasthmatic, gastroenterology therapeutic areas and APIs for the ophthalmic therapeutic area. He speaks on the existing partnership with Natco Pharma to supply Hepatitis C medicines and speaks about expanding in the US market through the partnership. He informs that there are plans to expand in the European market and the emerging markets as well though he refuses to divulge the plans in detail at the moment. Dr Satyanarayana informs, “During the financial year 2015, we established our wholly owned subsidiary in the US, Laurus Synthesis, to directly offer process chemistry services to the US clients. With a view to develop our pipeline for clinical phase manufacturing of new chemical entities and contribute to the supply chain of our customers, we established a presence in Greater Boston, Massachusetts, in 2015 with 12 scientists and four sales personnel who are focused on strengthening our synthesis business. We intend to focus more on the supply of key starting materials and intermediates for new chemical entities as the molecules move to Phase III and to a commercial stage, which would result in significant revenue. We also acquired 100 per cent stake in our subsidiary Sriam Labs. It

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was an associate company but now it has become a wholly owned subsidiary, with effect from November 1, 2016.”

Investing in R&D Dr Satyanarayana highlights that R&D is a major area of focus for the company. He states, “We continually aim to utilise advanced technologies

to bring in cost efficiency in existing API products and processes and enhance our product portfolio through investments in R&D. Many of the APIs in our current ARV portfolio for donor funded markets will bring significant near term opportunities for the US and European markets after the relevant patents

expire in these markets. We intend to continue to leverage our process chemistry skills to expand our API product portfolio.” “We are a research-driven manufacturing company”, informs Ravikumar. He also highlights that five per cent of the company's revenue is invested on R&D. He goes on to

elaborate that they have an R&D facility in Hyderabad which has around 500 employees. He also mentions that they operate a kilo lab at their R&D Centre at Hyderabad for small volume products.

Enhancing manufacturing capabilities “We

believe

that

our

MANAGEMENT KEY PERFORMANCE INDICATORS IN 2015-16

Laurus Labs facility

1,416 million ` 3,866 million

NET PROFIT IN 2015-16 (92 % GROWTH)

EBITDA IN 2015-16 (61 % GROWTH) THE NET SALES GREW FROM

R&D Labs

13,263 million ` 17,808 million

IN 2014-15

IN 2015-16 SHOWING A GROWTH OF 34 PER CENT CAGR OF 41 PER CENTAND 60.6 PER CENT ON REVENUE AND NET PROFIT FRONTS RESPECTIVELY BETWEEN FY12-FY16.

R&D Labs

Source: Laurus labs Annual Report 2015-16

regulatory compliant manufacturing facilities are attracting global generic pharma companies to engage us for the contract manufacturing of generic APIs. We are also developing capabilities for botanical extraction and purification, to capture the growing market of natural ingredients. We are currently in the process of setting up a separate manufacturing facility to add to our existing capacity for botanical extraction and chemical synthesis,” says Dr Satyanarayana. Ravikumar informs that they have three manufacturing facilities in Visakhapatnam through their acquisition of Sriam Labs. “We also have two additional manufacturing facilities, one in Bibinagar, near Hyderabad and the other in Visakhapatnam,” he informs adding that now they are in the process of setting up two additional manufacturing facilities as well.

30 EXPRESS PHARMA January 16-31, 2017

Assuring quality Ravikumar informs that they have plans to make significant investments in technology and human resources as they are important to ensure quality with efficiency, important prerequisites for growth. Ravikumar also emphasises that they ensure products of one quality for all markets and have the same standards at all their facilities .

In future Thus, the management is very gung ho about embarking on the journey to achieve greater heights. It would be interesting to see how the company would withstand the challenges of an increasingly volatile market and sustain its growth without losing momentum. lakshmipriya.nair@expressindia.com

Laurus Labs manufacturing unit

MANAGEMENT INSIGHT

Awave of change Dr Charu Manaktala, Senior Medical Director & Head of Asia Pacific Biosimilars Centre of Excellence, Strategic Drug Development, QuintilesIMS Asia, speaks on biosimilar trends in 2017 European Medicines Agency (EMA) has approved 25 biosimilars and another three have received positive opinion from the CHMP as of December 2016.1,2 US FDA has approved four biosimilars till date via the 351(k) pathway.3-6 In addition, a number of biosimilars have been approved in other highly regulated markets of Japan, Canada, Australia and South Korea. For the years to come, we expect a steady stream of biosimilar approvals to continue, with wave two biosimilars (for biologics with patent expiries between 2015 and 2020) dominating. This is a reflection of the fact that these products have been biopharmaceutical industryâ&#x20AC;&#x2122;s top grossers for the last few years. While we do see signs of development of third wave biosimilars (i.e., for biologicals with patent expiries beyond 2020), however, this is at best sparse, and still quite some time away from regulatory approvals. 2017 could see approval of trastuzumab, rituximab and bevacizumab biosimilars in the EU &/or US.

Evolution of the regulatory framework 2016 marked the 10th anniversary for approval of the first biosimilar in the EU. By this time the basic regulatory framework for biosimilars registration has been established fairly well. A number of regulatory guidelines are in place as well as a good amount of experience has been gained on a number of biosimilars ranging from simple proteins to complex monoclonal antibodies.7,8 Some of the other highly regulated markets such as Japan, South Korea, Canada, Australia among others have adopted EU biosimilar guidelines to a large degree. In addition to the revision of

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MANAGEMENT some of the earlier guidelines, the EMA published guidelines for pharmacovigilance of biologics in 2016.9 The US FDA has published a guidance on the labelling of biosimilars in March 2016.8 The naming of biologicals and interchangability of biosimilars continue to be hotly debated topics. The EMA has approved biosimilars under the same non-proprietary name as for the reference product. In 2015, the US FDA issued draft guidance on the subject of nonproprietary naming of biosimilars.10 This guidance recommends that all biologicals should have non-proprietary names that includes a four-letter suffix to distinguish them from each other. The suffix would be composed of four lowercase letters and not carry any meaning. The proposed approach is intended with a view to clearly identifying biological products to improve pharmacovigilance, and, preventing any unintended substitution. However, a number of industry stakeholders, including the USP have requested for alternative approaches to be considered. While the interchangability guidance from the US FDA is awaited, Sandoz recently reported study findings that show lack of safety and efficacy impact from multiple back and forth switches between the it’s etanercept biosimilar and the originator product.11 Also, we expect to see more products obtaining marketing approval on the basis of lean clinical data packages (especially where validated PD markers are available), supported by strong quality comparability, in vitro biological activity evidence and clinical PK-PD studies.

Market uptake of biosimilars/realisation of biosimilars potential in expanding access and saving healthcare budgets A complex interplay of biosimilars versus originator pricing, stakeholder awareness and attitudes is going to play an important role in shaping the future of biosimilars. The EU experience with biosimilars over the last 10 years has been quite

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positive with a definite cost saving as well as expansion of treatment access (as well shaping a change in treatment paradigms).12 Further the EU experience with the marketed biosimilars has not revealed any unexpected untoward efficacy or safety concerns in the real world use setting. Published studies and systematic analyses provide further evidence supporting the safety and efficacy of biosimilars, including experience in the setting of single and multiple switches between biosimilar and originator (notably NorSwitch and EGALITY studies)11,13. Such emerging data is likely to contribute towards building confidence of the prescribers, patients and payers in the biosimilars, and this is likely to impact the biosimilars uptake positively. In fact we see more and more expert bodies around the world endorsing the use of biosimilars now. Recent surveys reveal that physicians’ knowledge about biosimilars is improving but still there remain knowledge gaps.14 These findings affirm the need for further focus on prescriber and patient education regarding the biosimilars.

Market consolidation 2016 has seen at least two significant players exiting/considering to exit the biosimilars domain in favour of their other priorities. In the months following the Shire-Baxalta merger, Shire returned the rights to two biosimilars that Baxalta was developed jointly with other companies, adalimumab biosimilar with Momenta Pharmaceuticals and etanercept biosimilar with Coherus BioSciences.15 Recently, Merck was also reported to be re-evaluating its biosimilars business.16 It will be no surprise if we see further consolidation in this space in the years to come. The biosimilars development pipelines are crowded and the area is highly competitive. The market may be able to sustain only a limited number of players ultimately. So only those who have the long term focus will remain. Given the nature of biosimilars business, partnerships will continue to play an important role

in this domain.

Spurring innovation Originators have responded to the impending biosimilars challenge with a combination of strategies that prominently include extension of patents, patent litigation, dropping prices, developing newer formulations or obtaining additional indications for existing biologics, developing their own biosimilar assets, or developing bio-better or next generation products. Most importantly, the competition from biosimilars is an important driver for innovation, paving the way for newer therapeutic options and thus influencing patient outcomes positively.

Biosimilars development in Asia Asian manufacturers, especially from South Korea, continue to be significant players in the current biosimilars landscape, with rich product pipelines as well as a number of approved products in both the EU & US. Organisation (CDSCO) guidelines for biosimilars were revised recently.

References 1. European Medicines Agency. Public Assessment Reports. Accessed on 13th December 2016 from http://www.ema.europa.eu/ema /index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_searc h.jsp&mid

=WC0b01ac058001d124&searc hTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status =Authorised&status=Withdrawn&stat us=Suspended&status=Refused&keyword=Enter+keywords&search Type=name&taxonomyPath=&treeNumber=&se archGenericType=biosimilars. 2. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 710 November 2016. Accessed on 14th December from http://www.ema.europa.eu/ema /index.jsp?curl=pages/news_an d_events/news/2016/11/news_de tail_0 02634.jsp&mid=WC0b01ac058 004d5c1 3. Drugs@FDA: FDA Approved Drug Products. Accessed on 13th December from http://www.accessdata.fda.gov/scripts/cder/da f/index.cfm?event=overview.pro cess&ApplNo=125553 4. Drugs@FDA: FDA Approved Drug Products. Accessed on 13th December from http://www.accessdata.fda.gov/scripts/cder/da f/index.cfm?event=overview.pro cess&ApplNo=761024 5. Drugs@FDA: FDA Approved Drug Products. Accessed on 13th December from http://www.accessdata.fda.gov/scripts/cder/da f/index.cfm?event=overview.pro cess&ApplNo=761042 6. Drugs@FDA: FDA Approved Drug Products. Accessed on 13th December from http://www.accessdata.fda.gov/scripts/cder/da f/index.cfm?event=overview.pro cess&ApplNo=125544 7. European Medicines Agency, Scientific Guidelines-Multidisciplinary: Biosimilars. Accessed on 14th December from http://www.ema.europa.eu/ema /index.jsp?curl=pages/regulation/general/general_content_000408.jsp& mid=WC0b01ac058002958c 8. US Food & Drug Administration. Biosimilars Guidances. Accessed on 14th December from http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Gen eral/ucm444891.htm 9. Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations II: Biological medicinal products. EMA/168402/2014. Accessed on 14th December from

http://www.ema.europa.eu/docs /en_GB/document_library/Scientific_guideline/2016/08/WC5 00211728. pdf 10. Notice of Availability: Guidance: Nonproprietary Naming of Biological Products. Accessed on 14th December from https://www.federalregister.gov /documents/2015/08/28/201521383/nonproprietary-namingof-biological-products-draftguidance-for-industry-availabil ity. 11. CEM Griffiths et al. The EGALITY study: A confirmatory, randomised, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, versus the originator product in patients with moderate to severe chronic plaque-type psoriasis. Br J Dermatol. 2016 Oct 27. doi: 10.1111/bjd.15152. [Epub ahead of print]. 12. IMS Institute for Healthcare Informatics. Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets, March 2016 13. Remsima and Inflectra not inferior to Remicade, NORSWITCH study finds. Accessed on 14th December from http://www.biopharma-reporter.com/Markets-Regulations/Remsima-and-Inflectranot-inferior-toRemicade-NOR-SWITCHstudy-finds. 14. Cohen H et al. Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians. Adv Ther (2016) 33:2160–2172. 15. Shire bails out of Baxalta biosimilars, ends Coherus, Momenta deals. Accessed on 14th December from http://www.fiercebiotech.com/bi otech/shire-bails-out-baxaltabiosimilars-ends-coherus-momenta-deals. 16. Merck KGaA could bail on biosims with unit sale: Reuters. Accessed on 14th December from http://www.fiercepharma.com/ pharma/merck-kgaa-could-bailbiosimis-unit-sale-reuters 17. South Korea’s biosimilars industry poised to grow domestically and abroad. Accessed on 14th December from http://www.bigmoleculewatch.c om/2016/06/16/south-koreasbiosimilars-industry-poisedto-grow

MANAGEMENT REPORT

Dyslipidemia market poised for strong growth,surpassing $29.2 bn by 2025 The strong growth will be primarily driven by the launches of three proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors

THE DYSLIPIDEMIA market is set to rise from $11.2 billion in 2015 to $29.2 billion by 2025, representing a compound annual growth rate of 10.1 per cent, according to research and consulting firm GlobalData. The company’s latest report states that such strong growth, which will cover the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, will primarily be driven by the launches of three proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors – Amgen’s Repatha, Sanofi and Regeneron’s Praluent, and Eli Lilly’s LY3015014. Other factors include the launch of several add-on therapies, including Esperion Therapeutics’ ETC-1002 and Merck and Amgen’s cholesteryl ester transfer protein (CETP) inhibitors, and the increase in global prevalence of dyslipidemia. Elizabeth Hamson, Analyst, GlobalData covering cardiovascular and metabolic disorders, explains, “Despite the availability of efficacious and cost-effective lipid-lowering therapies, such as statins, a large proportion of patients with clinical atherosclerotic cardiovascular disease cannot reach guideline recommended levels of low-density lipoprotein cholesterol (LDL-C).” “However, the revolutionary PCSK9 inhibitors Repatha (evolocumab) and Praluent (alirocumab) were launched in 2015, and both truly demonstrated their efficacy in lowering LDL-C in their pivotal Phase III trials. Although uptake

has been slow so far, results of cardiovascular outcomes trials from Repatha and Praluent are due throughout 2017. So far, the major barrier for adoption is the price of these therapies; however, once positive trial data are available, uptake is likely to be significantly accelerated for use in high-risk dyslipidemia patients.” Another exciting drug in the dyslipidemia pipeline is The Medicine Company’s novel PCSK9-targeting small interfering RNA (siRNA), ALNPCSsc, which offers the potential of a triannual or even biannual dosing regimen. Based on the sheer number of patients eligible for treatment with these biologics and gene-based drugs, coupled with the biologics-level prices they can demand, even modest patient shares will correspond to blockbuster sales. Hamson concludes, “The growth of the PCSK9 class, among others in the dyslipidemia pipeline, highlights the current expansion of biologics into the market. However, due to their high prices, there is a significant disconnect between patients who are eligible for treatment based on regulatory approval and those who actually receive treatment. In response to this, there is ample opportunity for more cost-effective therapies targeting the more general dyslipidemia market. Particular areas of unmet need are the mixed dyslipidemia space and the statin intolerant patient pool.”

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January 16-31, 2017

RESEARCH UPDATES

Parental obesity may be tied to developmental delays in kids When both parents were obese, kids were almost three times more likely to struggle with problem-solving

ids born to obese parents may be more likely to experience certain developmental delays early in childhood, a recent study suggests. Based on parents’ reports, children with obese mothers were 67 per cent more likely to have delayed fine motor skill development by age three compared to kids with normal or underweight mothers, even after accounting for the father’s weight, the study found. With obese fathers, children were 71 per cent more likely to have deficits in personal and social skills after taking their mothers' weight into account, the study also found. When both parents were obese, kids were almost three times more likely to struggle with problem-solving. "The immediate take home message is that everyone — male or female, contemplating parenthood or not — should try to achieve a healthy body weight, through appropriate diet and lifestyle," said lead study author Edwina Yeung, a researcher at the National Institutes of Health. The study assessed delays based on questionnaires completed by parents, and so it can't prove that obesity directly causes developmental problems, Yeung added by email. "We don’t have actual diagnoses for the kids," Yeung said. "At this point, we don’t know whether the kids will have problems, or whether they’ll outgrow what we found on the (screening questionnaires)." Yeung and colleagues examined data from questionnaires parents completed for 3,759 singleton babies and 1,062 non-related twins, when the children

34 EXPRESS PHARMA January 16-31, 2017

were four, eight, 12, 18, 24, 30 and 36 months old. Questions screened for developmental delays in five areas: fine motor skills, gross motor skills, communication, personal and social functioning, and problem-solving ability. Researchers examined the odds of developmental delays associated with parental obesity after accounting for other factors that can impact these milestones such as parents' age, race or ethnicity, education and income levels, marital status, health insurance and smoking history. Even though the study didn't examine how parents' obesity might influence child development, it's possible obese mothers might have babies more prone to inflammation, which can in turn impact neurological development in children, the authors note in Pediatrics. Obese fathers might pass certain genetic material on to their children that makes delays more likely, though less is known about how men’s weight impacts children, the researchers point out. Limitations of the study in-

clude the lack of data from follow-up exams to confirm whether children actually had developmental deficits, the researchers wrote. Still, the findings add to a growing body of evidence linking maternal obesity in particular to neuro-developmental problems such as autism spectrum disorders and attention deficit hyperactivity disorder, said Elinor Sullivan, a researcher at the University of Portland and Oregon Health and Science University who wasn't involved in the study. "In an ideal scenario, the parents would be a healthy body weight prior to conception," Sullivan added by email. If parents are overweight or obese upon conception, there are still many things that they can do to benefit their child’s development, Sullivan said. These include following a healthy diet, getting moderate or even mild exercise, and avoiding exposure to cigarette smoke, alcohol, and chemicals found in cleaning and personal hygiene products. Reuters

Scientists link higher dementia risk to living near heavy traffic Scientists said their results could be used to help town and city planners take traffic conditions and air pollution into account as urban areas become more densely populated PEOPLE WHO live near roads laden with heavy traffic face a higher risk of developing dementia than those living further away, possibly because pollutants get into their brains via the blood stream, according to researchers in Canada. A study in The Lancet medical journal found that people who lived within 50 meters (55 yards) of high-traffic roads had a seven per cent higher chance of developing dementia compared to those who lived more than 300 meters away from busy roadways. "Air pollutants can get into the blood stream and lead to inflammation, which is linked with cardiovascular disease and possibly other conditions such as diabetes. This study suggests air pollutants that can get into the brain via the blood stream can lead to neurological problems," said Ray Copes, an environmental and occupational health expert at Public Health Ontario (PHO) who conducted the study with colleagues from Canada's Institute for Clinical Evaluative Sciences. Dementia is caused by brain diseases, most commonly Alzheimer's disease, which result in the loss of brain cells and affect memory, thinking, behaviour, navigational and spatial abilities and the ability to perform everyday activities. Independent experts said the Canadian study had im-

portant implications for public health around the world. Tom Dening of the Center for Old Age and Dementia at Britain's Nottingham University said the findings were ‘interesting and provocative.’ "It is unlikely that Ontario has the worst air quality in the world, so the risks might be even greater in cities that are habitually wrapped in smog," he said. Chen's team analysed records of more than 6.5 million Ontario residents aged 20 to 85 and found 243,611 cases of dementia between 2001 and 2012. Then they mapped residents' proximity to major roadways using postal codes. The increase in the risk of developing dementia went down to four per cent if people lived 50 to 100 metres from major traffic, and to two per cent if they lived within 101 to 200 metres. At more than 200 metres, the elevated risk faded away. The team also explored links between living close to major roads and Parkinson’s disease and multiple sclerosis — two other major neurological disorders — but the findings suggested no increased risk of these from living near heavy traffic. The scientists said their results could be used to help town and city planners take traffic conditions and air pollution into account as urban areas become more densely populated. Reuters

Heron drug for post-surgery pain succeeds in midstage trial HTX-011 also led to statistically significant reductions in the need for opioid medication HERON THERAPEUTICS said its experimental combination drug for post-operative pain led to significant reductions in pain intensity and the need for opioids, according to initial data from a midstage trial. The pain drug, HTX-011, which combines a long-acting version of the anesthetic bupivacaine with the anti-inflammatory meloxicam, produced a statistically significant 36.6 per cent reduction in pain versus placebo through 96 hours following abdominoplasty, a cosmetic procedure commonly known as a tummy tuck.

Heron expects to begin larger Phase III studies this year with an eye toward seeking approval in 2018 Statistically significant reductions in pain were reported between 24 and 48 hours, 48 to 72 hours, and 72 to 96 hours compared with placebo after a single administration of HTX-011, the company said. HTX-011 also led to statistically significant reductions in the need for opioid medication, which could make it an important alternative if approved. Post-surgical use of opioids can cause severe constipation and lead to future abuse of the highly addictive pain drugs. Following discussions with US health regulators, Heron said it expects to begin larger Phase III studies this year with an eye toward seeking approval in 2018.

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Heron said its combination pain therapy could be used following a wide range of sur-

gical procedures involving small to very large incisions, such as with abdominoplasty.

The drug, which is applied directly to the incision site, has previously been tested

in bunionectomy and hernia repair. Reuters

RESEARCH

Even after non-cardiac surgery,heart attacks and strokes may be a risk The research team estimates that about 150,000 heart attacks and strokes occur each year in the US A NEW study is shedding light on the risk of heart attack, stroke and death among patients who are hospitalised for surgery that doesn’t involve the heart. These complications occur in one in 33 — or three per cent — of hospitalisations for non-cardiac surgery in the US, researchers found. “Given that more than 300 million non-cardiac surgeries are performed worldwide each year, this is a situation that physicians encounter commonly,” said study author Sripal Bangalore of the New York University School of Medicine in New York City. “Although the focus is on preventing death (during surgery), this study emphasises the need to think about stroke outcomes,” Bangalore. The risks are higher, he added,

with surgery in the chest or on major blood vessels, or with organ transplants. Bangalore and colleagues analysed data from more than 10 million hospitalisations between 2004 and 2013, looking for heart attacks, strokes and death after surgeries that weren’t heart-related. They saw these complications in more than 317,000 cases, or about three per cent. The rates were highest during hospitalisations for vascular, thoracic and transplant surgeries, at 7.7 per cent, 6.5 per cent and 6.3 per cent, respectively. Patients undergoing obstetric and gynaecologic surgery had the lowest risk, the authors report in JAMA Cardiology. Patients who had one of these complications were generally older, more likely to be

male and more likely to have cardiovascular risk factors such as obesity, tobacco use, alcohol abuse, hypertension, diabetes and kidney disease. In addition, non-Hispanic blacks had the highest rates of stroke and death following surgery. The research team estimates that about 150,000 heart attacks and strokes occur each year in the US following non-cardiac surgery. “Surgery is important, and there’s no doubt that it improves quality of life for those with cancer, joint issues and vascular problems,” said Dr Philip Devereaux, head of cardiology at Juravinski Hospital and Cancer Centre in Ontario, Canada. Devereaux, who researches cardiac complications and surgery, was not involved with this study. The researchers found that

non-cardiac surgery deaths and heart attacks declined between 2004 and 2013 (from 3.1 per cent to 2.6 per cent), but strokes increased slightly (from 0.52 per cent to 0.77 per cent). Devereaux pointed out that in the past two decades, North American hospitals have been discharging patients sooner after surgery. This may partly explain why deaths have decreased in the data, he said. “With this data, we’re unable to follow patients to a common point in time, such as 30 days after surgery,” he said. “That can make it difficult to monitor and estimate.” Hospitals may also miss certain markers of heart destruction following surgery, Devereaux said. Since patients receive pain medicine

during surgery, it can often mask heart attack symptoms. “If we don’t specifically look for biomarkers 24-36 hours after surgery, we miss some heart attacks,” he said. “It’s highly probable that most centres in the US aren’t measuring these biomarkers.” That means one in 33 is probably an underestimate of how many heart attacks and strokes actually occur after non-cardiac surgery, Devereaux added. “This highlights a substantial problem that the public should know about,” Devereaux said. “The medical community needs to bring attention to this issue so patients can have worry-free surgery that doesn’t shorten their life or lead to major complications.” Reuters

Halozyme’s pancreatic cancer drug succeeds in mid-stage trial In 2014, Halozyme halted the trial over concerns of a potential difference in the rate of blood clots found in patients receiving its treatment against those on approved cancer drugs HALOZYME Therapeutics said its lead experimental drug, in tandem with therapies from Celgene Corp and Eli Lilly and Co, succeeded in a mid-stage study involving patients with an advanced form of pancreatic cancer. Halozyme's PEGPH20, in combination with Celgene's Abraxane and Lilly's gemcitabine, provided a statistically significant benefit in helping patients with high levels of hyaluronan (HA) live longer without their cancer worsening. PEGPH20 is an enzyme that

36 EXPRESS PHARMA January 16-31, 2017

targets and degrades HA, a chain of natural sugars found on human tissue that can accumulate in higher concentrations around certain cancer cells and potentially constrict blood vessels and impede other therapies. The data confirmed for the first time that high HA patients will have a meaningfully greater response when PEGPH20 is added to their treatment, said Dr Sunil Hingorani, the study's principal investigator. In Halozyme's trials so far, about 35 to 40 per cent of pan-

creatic cancer patients have elevated HA levels, Helen Torley, CEO, Halozyme Therapeutics told Reuters. PEGPH20 has a checkered past. In 2014, Halozyme halted the trial over concerns of a potential difference in the rate of blood clots found in patients receiving its treatment against those on approved cancer drugs. The clinical hold was eventually lifted after the trial design was amended to exclude patients with high risk of blood clots. The latest data bodes well for a separate late-stage study

in pancreatic cancer examining a similar high-HA population and treatment regimen in a larger group of 420 patients, Piper Jaffray analyst Charles Duncan said in a client note. Duncan raised his target price by $2 to $20. PEGPH20 is also being tested in combination with Merck & Co's Keytruda for gastric cancer and the most common form of lung cancer. It is also being evaluated for use in breast cancer in combination with Eisai Co’s Halaven. Reuters

PACKAGING SPECIAL

I N T E R V I E W

'We are looking at a compound growth of about 35 per cent in the next three years' Ettore Cucchetti, CEO, ACG Inspection, ACG Value Links, ACG Pharmagents, shares the future plans for his divisions, the focus areas for growth, changing market dynamics and more, in an exclusive interview with Lakshmipriya Nair Tell us something about ACG's history. ACG as a group started around 56-57 years ago. We started as empty hard capsules manufacturers in India. Over time, the founders of the company ventured into the pharma machine industry, providing manufacturing, packaging and R&D technologies to pharma, OTC and dietary supplement industry. Realising global serialisation demands, ACG also developed advanced vision inspection systems to help detect faulty blister and carton packaging and a comprehensive range of Track and Trace solutions. Today, ACG Worldwide has a presence in over 100 countries with its products and services, employing approximately 3,500 members that strive to provide world-class technology across multiple domains. However, capsules continue to represent the biggest chunk of our revenues. ACG Worldwide is the second biggest capsule manufacturer in the world producing more than 80 billion capsules annually. Apart from manufacturing facilities in India, we have big capsule manufacturing plants in Europe and Brazil. We have recently built manufacturing facilities in Indonesia and Thailand as well. What are the future plans for each of the divisions you head.

I joined ACG India (ACGI) in 2015 and have been heading the three divisions since then (ACG Inspection Systems, ACG Pharmagents, ACG Value Links). For ACG Inspection, we have two areas of focus. First is inspection for OEM. This is to provide integrated inspection solutions for the machines provided by OEMs. We are already doing it in the Far East, we need to start doing it in Europe as well because there are many machine

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PACKAGING SPECIAL manufacturing companies who could use our services. We are also looking to build further technological relationships as we did with an Italian company for liquid inspection technology for one particular area of solutions based on induction sensors to assure penetration and a strong presence in the rapidly growing market for injectables, or to develop in-house technologies to serve this and other areas in which, for the time being, ACGI is not exposed. The second area we are focussed on is providing track and trace solutions to pharma companies. This area has a huge potential due to changing regulations. We aim to provide track and trace solutions which can be integrated easily with the pharma companies' existing manufacturing lines. Therefore, we are looking at offering track and trace solutions which are fast, accurate, reliable and cost effective. Tell us about the cost advantage offered by ACGI to customers? For us, offering cost advantage does not imply providing cheap or lesser quality products. For example, design is one of the areas where we give a lot of focus. It is a myth that aesthetics add to the cost. Whether you design an ugly machine or a good looking machine, both would entail the same cost. We have a group of designers who put in a lot of

38 EXPRESS PHARMA January 16-31, 2017

We aim to provide track and trace solutions which can be integrated easily with the pharma companies' existing manufacturing lines. Therefore, we are looking at offering track and trace solutions which are fast, accurate, reliable and cost effective effort to create aesthetically appealing products at SciTech Centre. We believe in creating products which are not only efficient but are also good looking. Moreover, we have to continuously ramp up our engineering quality to face the European market. Which are the areas in which you plan to invest, both in terms of geography and well as segments? In terms of investing infrastructure, a lot of our local customers are moving their operations and manufacturing facilities from India and buying companies in areas like North America. We plan to replicate the same model or even create a better one to suit the customersâ&#x20AC;&#x2122; requirements in different markets with different quality standards. We are setting up office in New Jersey, North America and set up a service, engineering and assembly point there. We also plan do the same in the European market. As far as technology is

concerned, we are looking at investing in long-term. We want to build technology that is futuristic, which will be beneficial to us and the industry in the next five to seven years. For instance, if we have to run a capsule blistering machine at 300 blister/min now, we would like to make a machine which will run at 600 blister/min. So, in future, when a need arises, our machine is ready to cater to it. Thus, it is combining R&D with engineering wisdom to prepare for the future. We are, therefore, focussing on R&D considerably. Currently, around 12-15 per cent of our revenue is invested back in R&D. We are planning to increase this investment. What is the growth that ACGI is chasing in the next three years? We are looking at a compound growth of about 35 per cent. It is not without challenges. We need the people, the business and the financial means to sustain it, but I believe we are

geared to achieve it. So, is ACGI confident of achieving its targets even in the current volatile market conditions? It is a good thing that the market is changing. We should prepare the team to be geared for the change. I would actually go on to say that as a technologically-driven company, we should be proactive and provoke the change. We need to drive the market and tell the customers what they need, thereby ushering change. We have the capability to do it, and I am optimistic that we will definitely achieve our targets. What are the challenges that need to be overcome to continue your growth trajectory in the Indian market? Experience is a big factor. The Indian industry needs to learn more about the machinations of the global market. The major difference between European companies and Indian players is experience. Europeans have

over 200 years of industrial and engineering experience, exposure and sophistication in design. Balancing cost and quality would be a crucial challenge. The Japanese, Taiwanese and the Koreans have learnt to do this. The Chinese, to some measure, have followed suit. We need to learn it as well. We have to move from price - sensitive to technology â&#x20AC;&#x201C; sensitive, because if you own the technology, you own the market. We also need to constantly evolve and innovate. ACGI is planning to expand in Europe. Is Brexit going to be a problem to this? Brexit is a challenge but it is also an opportunity. It offers opportunities to improve and we will probably ask someone to help us in dealing with this challenge effectively. So, are you looking at M&As? M&As is definitely one of our strategies. As mentioned earlier, one of them is the tie -up with an Italian company for liquid inspection technology. There are two more in the pipeline but I can't share more details at the moment. But M&As come with their own challenges. The process has to be assessed thoroughly, and the integration has to be handled effectively keeping in mind the cultural differences and other factors. Fortunately, we have a very good team who can handle these things efficiently. lakshmipriya.nair@expressindia.com

PACKAGING SPECIAL

INSIGHT

Drug delivery advancements enabling self-care at home Graham Reynolds, VP and GM, Global Biologics, West Pharmaceutical Services, in this article emphasises that pharma companies and drug delivery system manufacturers must work together to develop a delivery system that meets the needs of both the drug and the patient ACROSS INDIA and around the world, increasing healthcare costs are driving care for many conditions out of the doctor’s office and into the home environment. In particular, treatments for many chronic conditions such as diabetes, multiple sclerosis, rheumatoid arthritis and haemophilia often require patients or caregivers to deliver regular injections of medication themselves. As new home therapies are developed, it is important that drug delivery systems evolve to ensure that injectable medications can be easily, safely and effectively delivered in the home environment.

Considerations for pharma manufacturers Pharma manufacturers must fully understand and incorporate the needs of end users when bringing a self-injected therapy to market. How these medications will be delivered by patients and caregivers at home necessitates careful thought to optimise therapeutic outcomes. Delivery system design is becoming a more essential aspect of drug delivery and, as such, requires consideration in the early stages of drug development. Auto-injectors have quickly become popular choices by drug manufacturers for delivering many therapies for chronic conditions. They are convenient and easy-to-use and can eliminate the need for patients to measure dosages and help prevent the

risk of needlestick injuries. However, as sophisticated new therapies reach the market – for example, high-viscosity injectable biologics and biosimilars – administration challenges have arisen. To address these challenges, pharma companies and drug delivery system manufacturers must work together to develop a delivery system that meets the needs of both the drug and the patient. There are several areas that should be considered at the start of this collaboration.

Patient centricity The World Health Organization

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PACKAGING SPECIAL (WHO) reports that adherence rates for patients with chronic conditions are only approximately 50 per cent in developed countries. This number is much lower in developing countries. It is critical that the healthcare industry find ways to improve patients’ ability and desire to maintain an appropriate selfcare treatment regimen. Administering injectable drugs in the home can be an intimidating task for patients and caregivers. Some patients either don’t want to inject themselves with medications or their conditions make it difficult to do so. However, with many chronic conditions on the rise — and a corresponding increase in self-injectable therapies — it is becoming more important to design selfadministration systems that patients not only can use, but want to use, to aid compliance. The user experience is an extremely important element when designing a drug delivery system. An easy-to-use self-administration system can be key to creating the routines that aid in compliance with care plans. While many products do this reasonably well, a truly successful combination product must also consider the needs of the end user at a variety of stages during the patient journey. For a diabetes patient, for instance, they may transition through a variety of injection systems, from a syringe, to an auto-injector, and ultimately to a wearable pump.

tate a deeper view of the emotional needs and desires of the intended user, and provide perspective on features and visual cues. It can help manufacturers understand the nuances between where a device is used (e.g., a patient’s home) and who is using it (e.g., a patient or caregiver). This research can yield valuable insight into users’ preferences and emotional requirements. Those findings can then translate into feature sets and design elements of the drug delivery system.

Human factors

Compatibility of delivery system components

When creating a delivery system, pharmaceutical companies and their drug delivery system partners must consider patient needs in conjunction with functionality along all stages of the patient journey. Manufacturers stand a better chance of satisfying the needs of the intended user throughout the course of treatment if they bring the relationship between the delivery system design and the patient interface into the center of the development process. Human factors research, testing and analysis can facili-

Equally important to patient centricity and human factors is a consideration of how the various components of a drug delivery system function together. Advanced delivery systems that effectively manage the interrelationship of a drug, its primary container and its administration system can help ensure a delivery system functions accurately, effectively and reliably. Compatibility is of utmost concern for all injectable drugs and particularly with biologics. Many modern biologic formulations may be

40 EXPRESS PHARMA January 16-31, 2017

Compatibility is of utmost concern for all injectable drugs and particularly with biologics sensitive to silicone oil – used as a lubricant in glass syringes – or tungsten and, therefore, may require alternative packaging. Cyclic olefin polymers can be attractive alternatives that can help enable effective drug containment and delivery. Polymers offer particular benefits that are gaining increased attention from manufacturers seeking solutions to growing drug delivery challenges, including: break resistance, dimensional precision, consistent gliding forces, reduced extractables and leachables, and minimised risk of drugcontainer incompatibility due to the impact of silicone oil

and tungsten on drug stability and protein aggregation. Additionally, polymer-based syringes can provide dimensional precision and strength, which can be significant factors when combining a syringe with a spring-based auto injector.

Onboarding While an integrated drug delivery system is being developed, it is essential for pharma and drug delivery companies to consider patient onboarding – how the patient will learn to use the self-injection system. New patients with self-injectors often make errors in administration. One reason for this is many patients do not thoroughly read the required steps outlined in a self-injection system’s Instructions for Use document prior to beginning drug treatment. This can potentially lead to administration errors and may impact a patient’s compliance with a prescribed therapy. Patient-friendly delivery systems must go hand-inhand with comprehensive education around self-injection to improve the patient experience. Multi-sensory, human

factors-based educational and training programmes for drug delivery systems can be helpful to improve patient experience by reducing anxiety and the risk for administration errors.

Conclusion While there are numerous auto-injector devices on the market, pharma companies need forward-thinking drug delivery system partners that anticipate and address the needs of end users and the requirements of new sophisticated therapies for chronic conditions. The overall patient experience can be improved by careful consideration of patient-centric device design, human factors, the integration between a delivery system and its components, and effective training and onboarding. Advanced self-administration systems that incorporate these essential elements can help improve the overall value and effectiveness of drug delivery systems, and may drive down healthcare costs by helping keeping patients on their medication plans and avoid health problems associated with noncompliance.

PACKAGING SPECIAL

CASE STUDY

Romaco’s packaging solutions for PADMA Markus Frey, Product Manager, Romaco Noack, elaborates on how high-tech Romaco built line that includes primary, secondary and final packaging units, has helped Swiss-based PADMA to handle its diverse packaging requirements PADMA IS a Swiss pharmaceutical company which is specialised in the manufacture of Tibetan medicines. The firm trusts in Romaco Noack and Promatic solutions to pack its multicomponent herbal capsules in blisters and folding cartons. All processes are strictly GMP compliant. Tibetan medicine originally spread to Switzerland via Russia. In 1850, the Tibetan physician Sul Tim Badma accepted the Tsar’s invitation to his palace in St. Petersburg. His descendants left the Tsar’s court during the Russian Revolution and set up a practice in Poland. The first contact with Switzerland was established in the mid 50s. It was then that the decision was taken to manufacture Tibetan medicines in accordance with modern, European pharma standards. PADMA was founded in Zurich in 1969, and only 30 years later the first Tibetan medicine was approved for sale by the responsible Swiss agency. The portfolio currently comprises a range of herbal preparations, which can be purchased from retailers as pharmaceuticals or dietary supplements. Around 60 per cent of these products are marketed in Switzerland and two are actually reimbursed under the statutory health insurance scheme. PADMA also serves several other European markets, notably Austria, Denmark, Hungary and Poland.

A successful mix The formulas for Tibetan medicines have been handed down over thousands of years. Their pharmacological action is based on the secondary substances which are found in all plants. These so-called phytochemicals safeguard against ultraviolet light or vermin and are additionally used in

reproduction. The herbal substances have this same special effect on the human organism. Tibetan medicines adhere to the multi-component principle, with up to thirty different dried or powdered plants being processed in each formula. These complex mixtures of substances activate the body’s own immune system and are used to treat diseases of civilisation such as arteriosclerosis, digestive and sleep disorders or chronic inflammations. Tibetan medicine often complements conventional, ‘academic’ medicine. Representatives of integrative medicine claim that the highly specific action of synthetic drugs is more noticeable if the body is holistically stimulated by natural remedies. “Many Swiss patients who are prescribed a PADMA medication by their GP are not even aware that it’s based on a Tibetan formula,” comments Dr Herbert Schwabl, Chairman of the Board, PADMA. “It’s the positive effect that matters – where the formula comes

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PACKAGING SPECIAL from is irrelevant to the therapy’s success.”

grees and places them in the stacking magazine, where they are counted and conveyed directly to the cartoner via the bucket chain. In this configuration the line has a maximum output of four hundred sample blisters or three hundred 20-capsule blisters and 75 boxes per minute. The feed unit is determined by the format selected on the cartoner’s HMI panel plus a mechanical switch at the transfer conveyor between the blister machine and the cartoner. The blisters themselves are manufactured in a three-lane rotary sealing and die-cutting process. Foil waste is thereby considerably reduced. Two people are normally charged with operating the blister line as well as format changes and cleaning the machine. PADMA ships its products in cases, which is why a case packer is attached to the cartoner. The Romaco Promatic PAK 100 is a semi-automatic machine: the folding cartons are grouped, stacked and inserted automatically while the only manual steps are case erection, feeding and closing.

Tradition and modernity PADMA sources its raw materials from all over the world. Some of them are grown in specialised regions, for example India, Nepal, Switzerland and Germany. Geographical origin is not a selection criterion, however, top of the list is premium quality. European medicinal plants such as calendula flowers, Iceland moss or columbine are just as likely to be preferred as Nepalese mombin fruit, aloe extract or cloves. All production processes comply strictly with GMP (Good Manufacturing Practices), GACP (Good Agricultural and Collection Practices) and the European Pharmacopoeia. When it comes to medicinal plants, these regulations also cover inspections of the seeds, cultivation, harvesting and drying. The identity of all herbal raw materials is unequivocally established in the laboratory before they are processed. Furthermore, contamination with pesticides, aflatoxins, heavy metals or microorganisms must be ruled out.

Local support

Automatically packed The raw materials are delivered to PADMA’s headquarters in Wetzikon in powder form and then processed further in manufacturing campaigns. In the first step, the formula is mixed homogeneously and filled into capsules. The finished product is mainly packed in blisters with 20 capsules each, four-capsules blisters are also produced as samples. The products destined for sale can be supplied in packs of 1, 2, 3, 5, 6, 10 or 27. Considerable flexibility is called for to pack the blisters in seven different box sizes.

To meet these complex requirements and satisfy the steady growth in demand, PADMA’s management decided to install a high-tech, Romaco-built line that includes primary, secondary and final packaging units. A Noack 921 blister machine with a Promatic P 91L intermittent motion cartoner and a Promatic PAK 100 case

42 EXPRESS PHARMA January 16-31, 2017

packer were chosen to master this challenge. The line was configured in a U-shape owing to the limited space available. “Romaco went to great pains during the planning phase to accommodate our very specific needs and convinced us with innovative solution strategies,” Schwabl explains. The Romaco blister line was commissioned at the PADMA facility in late 2014. Approximately, two million capsules are processed per batch. PADMA currently employs around 30 staff and generates about ten million Swiss francs in revenues annually.

Flexible feeding The blister line is designed to

The Romaco blister line was commissioned at the PADMA facility in late 2014. Approximately two million capsules are processed per batch

handle extremely diverse stack heights. The cartoner was built with two separate feed units for this reason. The blisters for the size 27 pack are fed via a special bypass with a turn-over starwheel, which turns the stacks vertically 90 degrees. They are then placed in the cartoner’s bucket chain standing up on edge. A counter-slide is used to support the large stacks as they are fed into the open boxes. An output of eight size 27 packs per minute is achieved with this format. For packs with ten blisters or less, the standard feed unit is selected by means of a vertical twist, which turns the blisters horizontally 90 de-

PADMA was supported and assisted during the installation and commissioning phase of the new blister line by Trimaco, Romaco’s Swiss agent. “The support we received from Trimaco was – and still is – vital to a small company like us because the machines have to provide very high flexibility”, Schwabl emphasises. “Trimaco and Romaco are competent partners who can be trusted to help us at any time with user training or technical support.” And if the Dalai Lama pays another visit to PADMA at some time in the future, the official photographs will no longer show him in front of the predecessor Noack DPN 760 but against the backdrop of a fully automatic blister line made by Romaco. The Tibetan formulas used by PADMA may have been handed down over the millennia, but the production process is definitely twentyfirst century.

PACKAGING SPECIAL

VENDOR NEWS

Alfa Laval India appoints Anantha Padmanabhan as MD He will be based in Pune ANANTHA PADMANABHAN has been appointed as the Managing Director, Alfa Laval India and Cluster President for India - Middle East - Africa, with effect from January 1, 2017. Padmanabhan will be based in Pune, headquarters of Alfa Laval India. With over 30 years of experience, Padmanabhan was the Managing Director, Alfa Laval Middle East, heading Middle East business operations before taking up the new role in India. Padmanabhan is a Mechanical Engineer and has undergone management training with Stanford Business School, Ashridge Business School, United King-

dom and Marketing Akademie, Hamburg. He started his career with M/s. Fertilisers and Chemicals Travancore and joined Alfa Laval (India) in 1985. He has been serving in various senior and leadership positions with Alfa Laval, in India, Indonesia and the Middle East and most recently as the Regional Managing Director for Alfa Laval in the Middle East. EP News Bureau

West introduces Verux pharma packaging components in APAC Region Fit-for-purpose stoppers and seals for injectable medicines provide quality packaging solutions for local pharma manufacturers WEST PHARMACEUTICAL Services, a global leader in innovative solutions for injectable drug administration, today introduced the Verux line of pharmaceutical packaging components for the Asia Pacific market. This dedicated brand of fitfor-purpose stoppers and seals for injectable drug products provides quality packaging solutions for local pharmaceutical and biotechnology companies. “By leveraging West’s more than 90 years of expertise in advanced production technologies and global regulatory compliance, and our knowledge base of drug product testing, development, packaging and delivery expertise, we’re able to provide this tailored solution,” said Mike Schaefers, VP, Product Management and Marketing Operations. “Verux components offer an affordable option for customers to help ensure the medicines they make are safely and effectively delivered to patients.”

“Faced with increasing scrutiny from regulatory agencies to ensure consistent drug product quality, Asia Pacific drug manufacturers are seeking cost-effective solutions for safe, effective pharmaceutical packaging that meet regulatory requirements,” said Troy Player, VP and MD, Asia Pacific. “Packaging components play a critical role in ensuring the consistency and quality of injectable drug products. Compromised packaging can lead to a number of adverse consequences, including disruptions in production, resulting in inconsistencies in the final product that can potentially pose risk to patients.” West’s new portfolio of Verux brand pharma packaging components is designed to offer local drug manufacturers fit-for-purpose, quality packaging components that can help reduce variation and non-conformity of end products. EP News Bureau

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January 16-31, 2017

Q A &

PACKAGING SPECIAL

PCI conducts technical seminar on products and technologies for pharma industry

control and R&D labs across the country. It also highlighted the various new products and technologies offered by PCI Analytics for pharma, chemical, food and industrial applications.

It was held to spread awareness about safety and convenience in laboratories Thane. It was held to spread awareness about safety and convenience in laboratories. PCI Analytics is an industry leader in laboratory gas lining and utility work, specialised in pre installation requirements (PIR) for various analytical instruments used in quality

Prachi Rane, Sr Consultant, PCI Analytics introduced the event and gave the opening remarks. Chander Golani, MD, PCI Analytics, gave the Welcome Address and gave an overview on the company. It was followed by a session by Dhirendra Choudhary,

Sr Manager Projects, PCI Analytics on Laboratory Gas Automation, Monitoring & Detection. Sunil Wargantiwar, DGM, PCI Analytics, in two different sessions, spoke on SSI Next Generation Pumps and PCONLab Products. Dilip Pansare, Director, PCI Analytics gave a session dealt with GJC Liquid Flow Meter for HPLC PUMP calibration with 21 CFR Compliance. The participants also got a chance to browse through the various products offerings by PCI Analystics and learn their applications. Delighted with the response they have received from this seminar, the company has plans to conduct similar events in other industrial belts within Maharashtra and in other states. EP News Bureau

SCHOTT GLASS INDIA

What is the shelf-life of glass?

Glass is in use for centuries already. The earliest finding of a glass recipe comes from Syria (700 BC) stating to take 60 parts of sand, 180 of ash from seaweed and 5 parts of chalk, mix it together and you receive glass. Since that time glass vessels are in use and the oldest existing glass vessel is a cup from the Egyptian king from 1450 BC. Clearly from that glass is not decomposing or degrading with uv light. It keeps its properties over the time. As this is also known from church windows such studies to prove this were never really made. The shelf life of glass is generally considered to be infinite.

What is the chemical resistance of glass?

The chemical resistance describes the resistance against chemical attack by defined agents. As glass does not react with organic solutions this can be neglected. The reaction of glass with an aqueous and acidic solution is basically the same. A Hydrogen ion from the solution exchanges with a Sodium ion from the glass. So in the end there is an accumulation of Sodium in the solution which can be measured by titration or flame spectroscopy. This reaction is provoked in the test for hydrolytic resistance according to USP and Ph. Eur. The lower the accumulation of Sodium in the solution the better is the quality of the glass. The reaction with alkaline solutions is completely different. Here the Hydroxide ions directly attack the silicon in the glass structure and erode the surface. This happens more intense at higher pH values, around pH 10 and higher.

Pleased with the response of this seminar, it plans to conduct similar events in other industrial belts within Maharashtra and in other states PCI ANALYTICS, a wellknown name in the field of analytical equipment, accessories and consumables, recently conducted a seminar for industries at TSSIA House, Wagle Industrial Estate,

WITH

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph. Preferably in colour, postcard size and with a good contrast.

44 EXPRESS PHARMA January 16-31, 2017

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The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021. Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 viveka.r@expressindia.com

PACKAGING SPECIAL

PRODUCTS

Dock levellers by Gandhi Automations facilitate fast,smooth and safe transition of logistics GANDHI AUTOMATIONS, India's number one entrance automation and loading bay equipment company is ISO 9001 : 2008 certified, which offers complete logistics solutions by providing dock levellers, dock shelters, sectional overhead doors and dock houses. Electro-hydraulic, mechanical and air-powered dock levellers offered by Gandhi Automations are not only a bridge for connecting a vehicle, but also facilitate fast, smooth and safe transition by compensating the difference in heights between the loading bay and the vehicle. This contributes to minimising energy used and savings on heating and chilling costs resulting in maintaining the quality of the transported goods. Dock levellers offered by Gandhi Automations are designed as per EN 1398 standard for the most demanding loading and unloading operations.

tional overhead door opens, the lip of the dock leveller connects to the truck bed for loading / unloading to take place. At the end of the loading/unloading the dock leveller is put in rest position and the sectional overhead door is closed, without moving the vehicle. The vehicle then departs at the end of the process.

Following are the two types of dock levellers

◗ Radius lip dock levellers Radius lip dock levellers allow the dock to connect with the truck bed, thus making it possible to drive directly on and off with forklift trucks etc. The self-cleaning lip hinging system does not retain rubbish with automatic end-ofrun, so as to keep the 25 mm security distance between the folded lip and structure as per EN 1398 & EN 349. ◗ Telescopic lip dock levellers Telescopic lip dock levellers are ideal for connecting vehicles unable to drive near dock i.e. sea containers, side loading railway wagons etc. These types can be supplied with a lip extending up to 1 m. Gandhi Automation’s dock levellers are equipped with the most secure safety devices and accessories.

Efficient loading and unloading the goods Efficient loading of goods has increased over the years, essentially for two reasons: the lesser availability and the higher cost of manpower. Consequently lesser qualified manpower is being utilised which leads to damage in the goods. The cost of loading and unloading the goods can be calculated precisely and is exactly definable, which allows for a scientific approach to find out the investment that goes into the process. Gandhi Automations has always designed solutions based on such scientific approach and feedback from clients. The dock levellers offered by the company ensure loading and unloading with lesser effort

and minimal cost. It is possible to load and unload your products in a safe way and in the process obtain remarkable energy savings. The loading bay remains with the dock leveller in rest position and the sectional over-

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head door closed, until the vehicle is positioned. The driver drives back centring to the dock shelter and stops the vehicle the moment it gets in contact with the bumpers. The sectional overhead door is then opened only when

the vehicle is positioned, brakes applied and engines shut off. This eliminates the exit of hot air, intake of cold air (or the opposite in hot and inside conditioned places) and intake of exhausting gases in the warehouse. After the sec-

Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300 Fax: +91 22 66720201 Email: sales@geapl.co.in www.geapl.co.in/ dock-levelers.html

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January 16-31, 2017

PACKAGING SPECIAL

Waters gets CE mark for MassTrakVitamin D Solution WATERS CORPORATION'S fully-validated Waters MassTrak Vitamin D Solution is now CE-marked in accordance with IVD Directive 98/79/EC for the quantitative measurement of 25(OH) D2 and D3 (25-OH-VitD) from human plasma and serum. The IVD LC-MS/MS system solution is a complete solution consisting of reagents and consumables, instrumentation, and software and support services for clinical laboratories routinely measuring vitamin D in patient samples. The Vitamin D solution is cur-

rently only available for sale in Europe.

The MassTrak Vitamin D Solution is configured with

the Waters ACQUITY UPLC I-Class/ Xevo TQD IVD System, the MassTrak Vitamin D Kit and MassLynx (IVD) Mass Spectrometry Software. The MassTrak Vitamin D Kit provides metrological traceability to the National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 2972, enabling standardisation and lot- to-lot consistency for an easy comparison of results from multiple laboratories. For high-volume vitamin D testing, the system is designed for use

with an automated liquid handler and custom pipetting script provided with the kit. Contact details Dayamani Santosh Sr Admin Officer Waters India 36A, II Phase Peenya Industrial Area Bengaluru 560 058 [T] 080-49292200-03 [F] 080-49292204 [M] 9632786899 [W] www.waters.com [E] dayamani_santosh@ waters.com

Flowcrete Systems qualify as cleanroom suitable materials TWO OF Flowcrete’s epoxybased floor and wall coating systems are now able to better demonstrate their suitability for use within cleanroom environments having qualified as Cleanroom Suitable Materials (CSM) under the Fraunhofer Institute for Manufacturing Engineering and Automation (IPA). Both Flowshield SL — a colourful, high-gloss, self levelling epoxy floor coating and Flowseal EPW Wall — a pigmented, hygienic epoxy based wall sealer have met the requirements of a number of cleanroom standards set out by the IPA in accordance with the CSM test parameters. Manufacturing under cleanroom or clean conditions is essential for a growing number of industries in order to safeguard process operations and the quality of components. A cleanroom is defined as a controlled environment that has a low level of pollutants including dust, airborne microbes, aerosol particles, and chemical vapours. Cleanrooms are designed in such a way that the number of particles, which have been brought into the room or which have arisen and been de-

46 EXPRESS PHARMA January 16-31, 2017

posited in the room, is as small as possible, and where other parameters relevant to cleanliness, such as temperature, humidity and pressure are also controlled as required. CSM is an industry alliance that was initiated by the Fraunhofer IPA institute in 2003. The CSM alliance develops testing methods based on international standards and is dedicated to assessing and validating the cleanroom suitability of anything that is used

within the design or is entering a cleanroom environment. The CSM qualification defines the suitability of equipment or material against a specific cleanroom class based on its emission of airborne particles, biological resistance, outgassing behaviour, cleanability, electrostatic discharge properties and chemical resistance amongst other factors. CSM status is a critical qualification for decision-makers selecting materials and

equipment in front-end semiconductor manufacturing but also pharmaceutical cleanrooms. Under testing, Flowshield SL exhibited excellent biological resistance (inert and fungi static) in accordance with ISO 846. Emissions of TVOC (Total Volatile Organic Compounds) at 23°C did not exceed the limiting values for ISOACCm Class-8.7 according to ISO 14664-8 and particle release under frictional stress

demonstrated compliance with the air cleanliness requirements of ISO Class 4 cleanrooms according to ISO 14644-1. Flowshield SL is hardwearing and highly abrasion resistant epoxy floor coating system, which is laid in a seamless application to deliver a hygienic, easily cleaned surface. The system is designed for use in dry process areas where the floor is typically subject to medium to heavy-duty foot, trolley, pallet truck and rubber wheeled forklift traffic. Typical uses include laboratories, clean rooms, warehouses, and electronic component manufacturing plants. Flowseal EPW Wall Sealer is a naturally coloured epoxy coating for use on both walls and ceilings, used to ensure a hygienic, easily cleaned and chemical resistant lining within cleanroom environments. Flowseal EPW Wall Sealer when tested for outgassing behaviour registered emissions of TVOC at 23°C not exceeding the limiting values for ISO-ACCm Class>-9.6 according to ISO 14664-8. Contact details Website: www.flowcrete.in

PACKAGING SPECIAL

VALUE ADD

Product D-Value studies: Acritical tool when developing a sterilisation process Kurt McCauley, R&D Lab Manager, Mesa Laboratories, elaborates on D-Value study on sterilisation

◗ Total numbers of organisms present just prior to sterilisation ◗ Identity of organisms present ◗ Number of spore formers present ◗ Resistance of the bioburden ◗ Sampling frequency and statistical analysis

THE OBJECTIVE of a sterilisation process is to kill the naturally occurring microbial contamination (bioburden) present in the product. Two common sterilisation methods used are the Bioburden Based Sterilization (BBS) method and the Overkill Sterilization (OS) method. The BBS method is defined as a sterilisation process with parameters based upon the predetermined type and concentration of bioburden on the material being sterilised. The OS method is defined as a sterilisation process that is based upon an arbitrarily established higher initial concentration and resistance of bioburden than that actually expected on the material being sterilised.

What is the bioburden of the product? The micro-organisms present in product can be viral, bacterial, and fungal and come from three main sources: the manufacturing environment, personnel, and raw materials including water. Some organisms are spore formers, which generally are the most resistant to environmental stresses including sterilisation processes. The product may have little or no bioburden depending on the manufacturing conditions and raw materials, or it may contain high concentrations of multiple organisms. It is essential to learn as much as possible about the bioburden organisms, especially when running minimal sterilisation cycles (due to product sensitivity to the sterilisation process). Information required when characterising the bioburden include:

What effect does the product have on the bioburden prior to sterilisation?

Figure 1. Unclumped spores in ethanol

Figure 2. Clumped spores in product

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It is important to know how the product will influence the behaviour of the organisms present. This is particularly important in liquid products. If the product is capable of promoting growth, then over time, a few organisms could eventually result in high numbers of organisms. This presents a problem if there is a significant time delay between manufacture and sterilisation. High numbers of organisms could result in an increase in sterilisation time. Alternately, the material may be bacteriostatic, bactericidal, sporostatic, or sporicidal. Properties of the material being sterilised (e.g. chemistry of a pharmaceutical product or the physical characteristics of a medical device) can have a significant influence on the resistance of the microorganisms. The product may protect the organisms in numerous ways such as by coating them or causing them to clump, increasing their resistance to the sterilisation process. Alternately, it may make them more susceptible to the sterilisation process. Figure 1 displays single free floating spores, while Figure 2 displays several large clumps, some of them containing

EXPRESS PHARMA

January 16-31, 2017

PACKAGING SPECIAL hundreds of spores.

exposures to replicate units result in both positive and negative units when cultured for growth) 4. In general, a survivor curve establishes the resistance for surviving populations greater than 5 x 101 whereas the fraction negative method establishes the resistance for surviving populations below 5 x 100. There are two advantages to the survivor curve method. One is that it can demonstrate a log linear regression curve when doing product testing, which can be extrapolated to demonstrate the calculated SAL. The other is that the product can be removed through filtration so as to eliminate any potential product inhibition on the injured spores. SGM has years of experience performing these studies on a wide variety of pharma products for R&D and commercial manufacturers. To have a study performed, the manufacturer will need to supply approximately 100 ml of product and a slant containing the bioburden isolate. SGM can supply spores (traceable to American Type Culture Collection) if a bioburden study is not desired. A typical study consists of 1) inoculating the product with the test organism, 2) filling and sealing the spiked product into very small glass ampoules, 3) performing graded exposures on the ampoules in a B.I.E.R. vessel, and 4) assaying the ampoules for surviving spores. The data collected from these exposures is used to calculate a D-value. These D-values can be used to calculate an appropriate SAL for the sterilisation process. SGM can also provide a convenient BI challenge, which complements these studies for routine monitoring of the sterilisation process.

Why is it acceptable to base sterilisation cycles on the resistance of Geobacillus stearothermophilus spores? Geobacillus stearothermophilus (ATCC #7953) spores (which typically have D121-values in the 1.5-2.5 minute range on a paper strip) are more resistant than most wild type organisms. These spores, widely used for monitoring steam sterilisation processes, may be substituted for the bioburden organism during resistance testing. When this substitution occurs, it is assumed that the G. stearothermophilus spores are more resistant than the bioburden organisms or by design significantly out number the bioburden organisms. The kill time for the G. stearothermophilus would then exceed the kill time for the bioburden organisms. The Figure 3 chart illustrates this point.

Exposure Time in Minutes

Is it acceptable to base sterilization cycles on the resistance of other organisms? Other organisms such as Bacillus coagulans (ATCC #7050), B. smithii (formerly B.coagulans ATCC #51232), B. subtilis “5230” (ATCC #35021) and Clostridium sporogenes (ATCC #11437) may be used in certain situations. These organisms are more sensitive to moist heat sterilisation than G. stearothermophilus, but in general, they are still more resistant than the bioburden. It may be desirable to use one of these organisms when the product is sensitive to the sterilisation process, thereby limiting the sterilisation time. However, when working with a heat sensitive product, it is strongly recommended that the bioburden be characterised prior to basing sterilisation parameters on the above mentioned indicator organisms.

Why perform a D-value study? The most direct method for evaluating the resistance of the test organism (a bioburden isolate or G. stearothermophilus spores) is by performing a Dvalue study. When evaluating

48 EXPRESS PHARMA January 16-31, 2017

References the bioburden, it is not necessary to test every organism isolated, only the most resistant (which can be isolated though the use of a heat shock screening procedure).

How are D-value studies performed? Ideally, the D-value study should be performed on the

actual product spiked with the test organism. Biological Indicator Evaluator Resistometers (B.I.E.R.) vessels 1,2, sterilisers capable of running square wave cycles, are commonly used in D-value studies. D-values can be calculated by using one of two methods, survivor curve or fraction negative analysis. A survivor

curve plots the surviving microorganisms against a critical process parameter, usually time. The curve provides an important graphic representation of the kinetics of the microbicidal process 3. Fraction negative analysis, sometimes referred to as “end-point experiments”, focuses on the quantal zone (the area where

1. AAMI Guideline for the use of ethylene oxide and steam biological indicators in industrial sterilization processes. ST34 2 ISO/CD 18472, Sterilization of health care products – Biological and chemical indicators – Test equipment and methods. Draft. 3 ISO 11138-1:1994(E) Annex B. 4 ISO 11138-1:1994 (E) Annex C.

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An important prerequisite for the safety of a drug or medicine is sterility and every year many pharmaceutical products are recalled for a single reason - they fail the Sterility Assurance Test. Our customers are confident that Pharmalab sterilizers will always ensure their products comply with the stringent guidelines of cGMP, EN285 (European), MHRA (UK), FDA (US) and most of the guidelines being followed by the Pharmaceutical & Bio-tech industries. Techniques used for heat sterlization are Dry heat, Super heated water, Air+Steam Mixture and Steam sterilization. Pharmalab covers all the them.

Steam Sterilizer - Designed to operate different sterilization cycles like Gravity cycle, H.P.H.V cycle, Rapid cooling · Pharmalab and air over cycle, Ampoule leak test cycle. Heat Sterilizer - For complete destruction and removal of all micro-organism with dry heat from glass bottles, vials, · Dry ampoules, containers, stainless steel and aluminium containers, powders and specially for hygroscopic products. Sterilizer - For terminal sterilization of large volume parental in plastic pouches, containers whereby the product is · Ventilator removed completely dry after sterilization. · Super Heated Water Spray Sterilizer - For efficiently achieving sterility of the end product in sealed pharmaceutical container. All Pharmalab sterilizers are supported with complete documentation from DQ, IQ, OQ, Operation Manual, Maintenance Manual & Material Quality test certificates.

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Pharmalab India Private Ltd., Registered Office: Kasturi, 3rd, floor, Sanghavi Estate, Govandi Station Rd, Govandi (E), Mumbai 400 088, INDIA. • E-mail: pharmalab@pharmalab.com • Website: www.pharmalab.com CIN No. U29297MH2006PTC163141.

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Shah Brothers introducing BIOPROCESSING SOLUTION: SINGLE USE BAGS BY CHARTER MEDICAL u

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Reduces handling & seed train expansion step for therapeutic production 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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To Advertise in

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■

09821313017 ■

Chennai ■ Bangalore: Mathen Mathew

Ahmedabad: Nirav Mistry 09586424033 ■

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Factory: NBZ Pharma Ltd. R-905, T.T.C. Indl. Area, M.I.D.C, Rabale, Navi Mumbai - 400 701. Tel. : 022 2769 9174, 6516 2146 Mr. Krishnakant Yajurvedi : +91 7710040409

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January 16-31, 2017

PHARMA LIFE APPOINTMENT

Peter Lankau appointed as an Independent Director of Cipla Lankau has over 30 years of management experience in developing and commercialising pharma products

ipla has appointed Peter Lankau as an Independent Director on its board with effect from January 10, 2017. Lankau is currently a principal of Lankau Consulting. He was previously Executive Chairman of the Board for Nautilus Neurosciences, Chairman and CEO, Logical Therapeutics and President and CEO, Endo Pharmaceuticals. Prior to Endo Pharmaceuticals, he was VP, Sales and Mar-

Lankau has graduated with Bachelors of Science in Biology from the State University of New York at Albany, US keting for Alpharma. He began his pharmaceutical career with Rhone-Poulenc Rorer (now

Sanofi). Lankau currently serves on the Board of Directors of ANI Pharmaceuticals

and Phosphagenics and also on the Board of Advisors of Orchard Venture Partners, a life sciences venture capital firm. Lankau has graduated with Bachelors of Science in Biology from the State University of New York at Albany, US. He has over 30 years of management experience in developing and commercialising pharma products. Welcoming his appointment as an independent director, Dr

YK Hamied, Non-Executive Chairman, Cipla said, “Lankau brings with him a deep understanding of the US pharma market that will help us steer the future thinking of our company for this focus market.” Lankau said, “I am delighted to join the Cipla Board, a company that has had such an inspiring history and bold dreams for its future.” EP News Bureau

TO ADVERTISE IN EXPRESS PHARMA, CONTACT:

HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express (P) Ltd. Business Publication Division 2nd Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email id: rajesh.bhatkal@expressindia.com BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express (P) Ltd.

Business Publication Division Express Building, B-1/B Sector 10 Noida 201 301 Dist.Gautam Budh nagar (U.P.) India. Board line: 0120-6651500. Mobile: +91 9999070900 Fax: 0120-4367933 Email id: ambuj.kumar@expressindia.com Our Associate: Dinesh Sharma Mobile: 09810264368 E-mail: 4pdesigno@gmail.com CHENNAI Mathen Mathew The Indian Express (P) Ltd. Business Publication Division New No. 37/C (Old No. 16/C) 2nd Floor, Whites Road, Royapettah, Chennai- 600 014 Board Line: 044- 28543031/2/3 044- 42285522 Mobile: +91 9840826366

Fax: 044- 28543035 Email id: mathen.mathew@expressindia.com BANGALORE Mathen Mathew The Indian Express (P) Ltd. Business Publication Division 502, 5th Floor, Devatha Plaza, Residency road, Bangalore- 560025 Board line: 080- 49681100 Mobile: +91 9840826366 Fax: 080- 22231925 Email id: mathen.mathew@expressindia.com HYDERABAD E.Mujahid The Indian Express (P) Ltd. Business Publication Division 6-3-885/7/B, Ground Floor, VV Mansion, Somaji Guda, Hyderabad – 500 082 Board line- 040- 66631457/ 23418673 Mobile: +91 9849039936, Fax: 040 23418675

Email Id: e.mujahid@expressindia.com KOLKATA Ajanta Sengupta The Indian Express (P) Ltd. Business Publication Division JL No. 29&30, NH-6, Mouza- Prasastha & Ankurhati, Vill & PO- Ankurhati P.S.- Domjur (Nr. Ankurhati Check Bus Stop) Dist. Howrah- 711 409 Mobile: +91 9831182580 Email id: ajanta.sengupta@expressindia.com AHMEDABAD Nirav Mistry The Indian Express (P) Ltd. 3rd Floor, Sambhav House, Near Judges Bunglows, Bodakdev, Ahmedabad - 380 015, Mobile: +91 9586424033 Email Id: nirav.mistry@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express (P) Ltd. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

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