Express Pharma (Vol.11, No.10) March 16-31, 2016

VOL. 11 NO. 10 PAGES 78

www.expresspharmaonline.com

Management NCDs on a rise, India needs a paradigm shift in allocation of funds to health

16-31 MARCH 2016,` 40

CONTENTS MARKET Vol.11 No.10 MARCH 16-31, 2016 Chairman of the Board Viveck Goenka 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 Bengaluru Neelam M Kachhap DESIGN National Art Director Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Harit Mohanty - West & East Marketing Team Rajesh Bhatkal Ambuj Kumar E Mujahid Arun J Debnarayan Dutta Ajanta Sengupta Nirav Mistry PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

12

HEALTHCARE SABHA PAVES WAY FOR PUBLIC HEALTH REVOLUTION IN INDIA Policy makers and stakeholders of public healthcare in India came together to deliberate and discuss on the way forward to revolutionise healthcare delivery in India at the first edition of Healthcare Sabha, held in Hyderabad | P13 P34: INSIGHT Innovations in cleanrooms and environmental monitoring

MANAGEMENT

‘INTEGRATING ROBUST SYSTEMS WOULD HAVE WIDESPREAD INFLUENCE IN GUARDING AGAINST MARKET VOLATILITY’

P LIFE

71

HIRING RIGHT: PIVOTAL TO PROGRESS

P41: NEWS Cleanroom consumables to witness highest growth by 2020 globally

25

GETTING BIGGER & BETTER

P43: INTERVIEW

CLEANROOM SPECIAL

‘Not enough attention has been paid to quality by the Indian regulatory system’

P46: POST EVENT HEL group, UK with Skytech Systems India organise conference and workshop

33

28

NCDS ON A RISE, INDIA NEEDS A PARADIGM SHIFT IN ALLOCATION OF FUNDS TO HEALTH

Express Pharma® Regd. with RNI No. MAHENG/2005/21398,Postal Regd. No. MCS/164/2016 – 18. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2016. 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

Once again, nothing much for pharma

I

n his third budget, Finance Minister Arun Jaitley has taken one more shot at a balancing act between maintaining fiscal discipline and loosening the purse strings to provide a growth impetus.

This time, the health sector did find some cheer, thanks to the announcement of health insurance of up to ` 1 lakh per family, a national dialysis service programme with excise duty waiver for dialysis equipment and the opening of 35,000 medical stores under renamed Pradhan Mantri Jan Aushadhi Yojana. Given the 13 per cent hike in Budget allocation for health, this year is being seen as a windfall year compared to budget announcements in recent past years (http://indianexpress.com/article/cities/delhi/unionbudget-2016-rsby-health-protection-scheme-nationaldialysis-programme/). But these too are being seen as minor, considering the country's health indicators.

Pharmaceutical companies were by and large left disappointed by the lack of any bold reformative steps specific to the pharma sector, though it will benefit from moves like the deferral of the sunset clause for Special Economic Zones (SEZs). This must have pharma manufacturers heaving a sigh of relief for now, even though there were no specific incentives to pharma clusters, inspite of the crucial need to ramp up production of APIs. As part of the ‘Make in India’ vision, the budget also announced that benefits for new units in SEZs will be provided to facilities set up before March 31, 2020. This is being viewed as a clear signal for manufacturing companies to not pull out of SEZs, which have of late, come into question due to lack of infrastructure and uncertainty on the period of tax holidays.

So also, it is hoped that the budget's accent on rural infrastructure and economy will result in increased spending power of the rural consumer and hopefully better access to this segment of the population. But of course, this is a long-term bet as in the short term, the new Krishi Kalyan Cess of 0.5 per cent on all taxable services from June 1 this year will be a drag on balance sheets of all corporates.

While the FM has moved in favour of patients with the thrust to the Pradhan Mantri Jan Aushadhi Yojana, its impact on the pharma industry could be a further erosion of profit margin, and a move towards a value and volumes play. Maintaining quality of generic drugs available at these stores will be a challenge, given the stretched regulatory infrastructure.

10 EXPRESS PHARMA March 16-31, 2016

Is the accent more on incentivising innovation in start ups,rather than established companies,going by the logic that scarce resources should first go to the former, rather than the latter who should now have the means to fund their own R&D?

The main disappointment for the pharma sector is the decrease in R&D weighted deduction to 150 per cent and its phasing out by 2020, which could discourage R&D spends. This seems contrary to the government's stated intention to encourage innovation through the Start Up India plan. Does the government feel that taxation of royalty income at 10 per cent for innovations discovered and registered in India and the ‘Special Patent Regime’ would be enough to spur innovation?

Is the emphasis more on incentivising innovation in start ups, rather than established companies, going by the logic that scarce resources should first go to the former, rather than the latter who should now have the means to fund their own R&D? This could explain why start-up biotech enterprises and new units in Biotechnology Industry Research Assistance Council (BIRAC)-approved biotech incubators will now not be required to pay a service tax on services provided by BIRAC. Analysts surmise that this exemption could have a direct impact of 14 per cent on the bottom-line of such enterprises, which is quite major for start ups.

Again, as start ups established between April 2016 – March 2019 can seek a 100 per cent profits’ deduction for three out of first five years subject to minimum alternate tax, will we see pharma and biotech companies look at hiving off their R&D teams into R&D start-ups? Would these qualify for such tax breaks? For a detailed analysis from industry leaders (See cover story of the March 16-31, 2016 issue: A mixed bag of reactions, pages 18-23).

A few days after the Budget, Express Healthcare organised Healthcare Sabha, a national meeting conclave focused on public health. While the budget did come up for discussion, public health policy experts discussed a lot more (See report, Healthcare Sabha paves way for public health revolution in India, pages 13-16).

While the budget announcement of health insurance of up to ` 1 lakh per family would take the nation one step closer to the goal of having universal health coverage, India is at the beginning of this journey. It will take many more steps in this direction before we achieve this goal.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘Integrating robust systems would have widespread influence in guarding against market volatility’ Mandar Athalekar, Head-Market Development, Global Trade Management, Thomson Reuters, speaks on the current scenario in India’s pharma trade and measures to guard against market volatility, in an interaction with Raelene Kambli Where does the Indian pharma industry stand vis-avis its global counterparts?

The Indian pharma market is the third largest in terms of volume and thirteenth largest in terms of value. Presently, the market size of the pharma industry in India stands at $ 20 billion. The highly fragmented Indian pharma industry is getting consolidated and is estimated to grow at 20 per cent compound annual growth rate (CAGR) over the next five years. It is expected to grow over 15 per cent per annum between 2015 and 2020 and will outperform the global pharma industry, which is set to grow at an annual rate of five per cent in the same period. India's biotechnology industry comprising bio-pharma, bioservices, bio-agriculture, bioindustry and bio-informatics is expected to grow at an average growth rate of around 30 per cent a year and reach $100 billion by 2025. Biopharma, comprising vaccines, therapeutics and diagnostics, is the largest sub-sector contributing nearly 62 per cent of the total revenues at `12,600 crore ($ 1.9 billion).

What are the loopholes in the Indian trade policies that need to be addressed?

Public health concerns demand that the manufacture of pharma products and their subsequent handling within the distribution chain both nationally and internationally must conform to prescribed standards and be rigorously controlled in order to ensure their quality, safety and efficacy.

The need for manufacturers’

12

EXPRESS PHARMA

March 16-31, 2016

compliance with World Health Organization (WHO) guidelines on stringent norms of Good Manufacturing Practices (GMP), to provide all the necessary and important information on products considered for export including registration details and trade for pharma products lead to importers and exporters of pharma products being subjected to additional statutory or regulatory requirements. Regulatory framework of pharma relates to drug pricing, public health implications and accountability of regulatory agencies and procedures utilised by pharma companies for regulatory compliance to address the complex web of regulatory requirements, application processes, quality control and trade authorisations. In this complex web of regulatory requirements and authorities, the biggest loopholes are created by the need to balance the pricing and trade regulation on one hand and to facilitate distribution of the products to end consumers on the other.

These loopholes are further widened by ambiguities in classification of pharma products, lack of updated information on the frequent amendments to policies and provisions governing trade.

Divergent opinions between the industry, traders and policymakers also lead to delayed and ineffective implementation of these policies. These are some of the challenges which need to be immediately addressed.

What measures would you

Exchange of information proves to be an important factor influencing pharma manufacturing, trade and market success suggest to protect Indian pharma trade from market volatility?

Pharma industry is characterised by innovation.

Developments in the regulatory environment over past years provide an opportunity to analyse the correlation between the three main driving

forces behind demand supply dynamics of the pharma industry namely product innovation, trade facilitation and the corresponding market response. In the wake of these dynamics, exchange of information proves to be the most important factor influencing pharma manufacturing, trade and market success. Thus, integrating robust systems to organise and efficiently process public information such as patent application, publication, trade policies and pricing competitiveness with market strategy and stock market returns would have widespread influence in guarding against potential supply chain disruptions and losses due to market volatility.

leading industry experts, ONESOURCE Global Trade simplifies the entire global trade management process by automating routine tasks and opening up the opportunity for professionals to focus on valueadded activities. The solution comprises various modules viz. imports, exports, special programmes, restricted party screening and Free Trade Agreements encompassing all the aspects of global trade including transaction management, screening and compliance, document management, visibility and exception control, license management, reporting and analytics to help organisations achieve their objectives of operational efficiency and cost control.

How does Thomson Reuters help global corporations in the pharma industry to manage their international trade?

Thomson Reuters ONESOURCE Global Trade Solution helps global corporations in the pharma industry overcome all the various challenges related to international trade by providing access to content related to product classification, licenses and changes in foreign trade policy as well as process automation and document management.

ONESOURCE Global Trade Solution is a cloud-based enterprise software solution for management of information, content, processes and documentation related to global trade. Built with worldclass technology and backed by

If GST gets a green signal, how would it impact your business and what changes it would bring to the solutions you offer to your pharma clients?

Goods and Services Tax (GST) primarily applies to domestic taxation and its impact to business would largely be relevant for landed cost and warehousing model. Thomson Reuters ONESOURCE Global Trade Solution already has flexible features for adding or modifying any tax or duty charges consequent to changes in the tariff schedule, of which GST reform is just another example, albeit, a major one.

Just as for clients in any other sector, even the pharma clients would benefit from the solution. raelene.kambli@expressindia.com

POST EVENTS

Healthcare Sabha paves way for public health revolution in India Policy makers and stakeholders of public healthcare in India came together to deliberate and discuss on the way forward to revolutionise healthcare delivery in India at the first edition of Healthcare Sabha, held in Hyderabad THE FIRST edition of Healthcare Sabha — The National Thought Leadership Forum on Public Healthcare was held in Hyderabad on March 4-5, 2016.

The event, organised by The Indian Express Group and Express Healthcare, and supported by the The National Health Mission (NHM), Ministry of Health and Family Welfare, Government of India, brought an interdisciplinary group of professionals working in public healthcare on the same platform to deliberate on cohesive, unified and innovative ways to achieve the

(L-R) Viveka Roychowdhury, Editor, Express Healthcare, Dr Srinath Reddy, President, Public Health Foundation of India, Dr Henk Bekedam, WHO Representative to India, Dr Kenneth Thorpe, Chairman, Partnership to Fight Chronic Diseases and Navin Mittal, Secretary Finance & Commissioner & Ex-Officio Secretary, Information & Public Relations Dept, Govt of Telangana

NHM of providing ‘Universal Access to Equitable, Affordable and Quality Healthcare Services.’

The event began on an auspicious note with a lamp light ceremony by the Chief Guest, Navin Mittal, Secretary Finance & Commissioner & Ex-Officio Secretary, Information & Public Relations Dept, Govt of Telangana, and the Guests of Honour, Dr Henk Bekedam, WHO Representative to India, Dr Srinath Reddy, President, Public Health Foundation of India, Dr Kenneth Thorpe, Chairman, Partnership

to Fight Chronic Diseases and Viveka Roychowdhury, Editor, Express Healthcare.

Mittal, in his address, said that the government of Telangana was working towards quality healthcare for all. Bekedam gave the key note address titled ‘Investing in health is investing in India’s growth.’ He said that the life expectancy of a country is directly proportional to its growth in GDP and if the life expectancy of a country goes up by one per cent then its GDP grows by four per cent. He also said that the spend has to

The Standard of Comparison

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

www.SheffieldBioScience.com

• The original patent for Anhydrous Direct Tabletting (DT) Lactose • Batch to Batch Consistency • Global technical service, regulatory and application expertise to ensure regional and global market compliance

Registered Office Address: 17th Floor, Nirmal Building, Nariman Point, Mumbai - 400021 Corporate Identification Number: U15400MH2010PTC202946 Tel.: +91 22 27815003, Fax Number ; (022- 27815989) Email: Kerry-India.Info@kerry.com

MARKET be increased by the government to increase the life expectancy in the country from the present level of 66 years. “Invest in health and protect your people.

You don’t need to be a rich country to start universal health coverage. You just need to start,” he advised.

The evening also saw a slew of dignitaries enriching the audience with their presentations.

Among them were Chhitz Kumar, CEO Philips Capital & Head- Govt Affairs, PPP, Philips India who spoke about ‘Models of financing public healthcare to aid the masses.’ Girish Mehta, CEO, MedGenome India spoke about ‘Genomics in precision medicine’ and Dr BK Murthy, Executive Director, C-DAC spoke on the subject of ‘Improvising healthcare by implementation of health informatics solutions.’

One of the highlights of the evening was a thought provoking speech by Dr Soumya Swaminathan, Director General, Indian Council of Medical Research, who highlighted the ‘Importance of evidence-backed public health strategies.’ An equally compelling presentation was made by Dr Damodar Bachani, Deputy Commissioner (NCD), Ministry of Health & Family Welfare. He shared some interesting observations on the ‘Emerging threat of lifestyle diseases and their risk factors – Where are we today and the way forward to deal with NCDs as a public health priority.’

The first day also comprised two interesting panel discussions. The first discussion, moderated by Dr Reddy, was on ‘Implementation of Universal Health Coverage/ Assurance: 4point road map.’ The panelists, Bekedam, Dr PV Ramesh IAS, Principal Secretary to Government (R&E) Andhra Pradesh, Finance; Dr Gullapalli N Rao, Chairman, LV Prasad Eye Institute, Hyderabad and Merai Chatterjee, Director, Social Security at Self-Employed Women’s Association (SEWA) discussed and raised several pertinent points that need to be addressed on priority to achieve UHC. The second panel discussion was moderated by Dr Suresh Saravdekar, Ex Assistant Director, & Consultant, Procurement,

14

EXPRESS PHARMA

March 16-31, 2016

(L-R) AG Prasad, Vice President- Sales and Marketing, Glenmark Pharmaceuticals; Dr Leila Varkey, Senior Advisor – RMNCH, Centre for Catalyzing Change; Col Kanwar Badam, VSM Head – Piramal Swasthya, Piramal Swasthya Management & Research Institute; G Chandra Sekhar, Vice Chair, LV Prasad Eye Institute; Dr Jayaprakash Narayan, Ex IAS, and presently Lok Satta party MLA from Telengana; T Rajasekar, Vice President Marketing, HLL Lifecare; Dr Srinath Reddy, President, Public Health Foundation of India; Dr Prof AK Gupta, Medical Superintendent, PGIMER Chandigarh, Anurag Khera, Senior Vice President Corporate Affairs, Glenmark Pharmaceuticals; Rahima Khatun, Secretary, Nari-O-Sishu Kalyan Kendra; Dr DK Sharma, Medical Supreintendent, AIIMS Delhi

Ministry of Medical Education and Health, Maharashtra. He first presented a talk on ‘Medicine procurement: Assumption versus Assurance of quality’ and followed it with a stimulating discussion with Dr Avinash Supe, Director, Medical Education & Dean, KEM Hospital, Mumbai and Prof AK Gupta, Medical Superintendent PGIMER Chandigarh.

The second day of Healthcare Sabha saw the same enthusiasm and opened to a full house. Experts and policy makers of healthcare in India congregated to continue their discussions on their vision and strategies to reform public healthcare in India.

It started off with a keynote address by Thorpe speaking on the topic, Sankalp – Disha Swasth Bharat Ki – Implementing a blueprint for NCDS. He highlighted that NCDs have emerged as one of the major health concerns in India and there is an urgent need to implement strategies which would help tackle these challenges effectively.

The next session was on the role of mobile and cloud-based solutions for comprehensive

primary healthcare. Sunita Nadhamuni, Head, Healthcare Solutions, EMC Software and Services presented on how various technologies can be utilised to good effect to better healthcare delivery and improve health indices in the country.

Her session was followed by one on the power of open source software within the public healthcare space. Dr Vivek Singh, Technical Architect at ThoughtWorks, elaborated on how open source software can be deployed to make healthcare delivery simpler, efficient and effective.

Continuing the focus on technology and its potential to revolutionise healthcare delivery, the next speaker, Dr Deepak Agrawal, Head IT, AIIMS gave a user perspective of implementing technology in hospitals with examples of IT initiatives which have been put into place at AIIMS under his aegis.

The next speaker, Dr Prof AK Gupta, Medical Superintendent, PGIMER Chandigarh addressed a crucial topic, challenges and innovations in hospital administration. He gave examples of measures implemented by him at his institution

and their impact.

Sabu Jose, General Manager - Government Accounts, Carestream Health India speaks on the potential of digital medical imaging to change the way healthcare is delivered and ensure better outcomes. He shared examples of utilising digital DR to provide better services in a hospital.

This was followed by a panel discussion on ‘Models of financing public healthcare.’

Moderated by Dr Prateek Rathi, Special Executive Officer-ESI Scheme, Department of Public Health, Maharashtra, it saw a lively debate between eminent panelists – Kavita Singh, Director (Finance), NHM, MoH&FW, K Srivatsava, VP-Marketing, Natco Pharma, Chhitz Kumar, CEO Philips Capital & Head-Govt. Affairs, PPP, Philips India and Dr Ananth Phadke, Senior Advisor, Sathi CEHAT. The panel, however, was unanimous in their opinion that public healthcare spending in India has to be increased.

After the panel discussion, Gyanesh Pandey, CMD, HSCC gave his insights on furthering frugal innovations in medical

technology, while PR Sodani, Dean (Training), The IIHMR University elaborated on the need for skill enhancement programmes to bridge the workforce deficit in healthcare.

K Srivatsava, VP-Marketing, who took the stage next, spoke on the models of financing oncology medicines, in particular and highlighted EMIs as an option to finance cancer drugs.

The next panel discussion for the day was on ‘PPPs on Public Healthcare: The expanding role of NGOs, Foundations and Corporate Hospitals’ Outreach Programmes in TB control.’ The moderator of the session, Dr Atul Kharate, State TB Officer/Joint Director Health Services, Government of Madhya Pradesh and the panelists, Dr Sreenivas A Nair, National Professional Officer – Tuberculosis, WHO, Country Office for India and Dr Aravind Swaminathan, Paediatrician, MSF, gave valuable insights on various ways in which the private and public sector can collaborate to control the rising menace of TB. The last panel discussion for the day was on ‘The role of frugal innovations in medical technology.’ Dr Jitendar Sharma, Director, WHO Collaborating Centre for Priority Services and Head, Division of Healthcare Technology, NHSRC was the moderator for this session. Innovators, Dr Pankaj Parashar, Director/ General Manager, MP Health Services Corporation; Mihir Shah, Founder and CEO, UE Lifesciences and Dr Yogesh Patil, COO, Biosense were the panelists.

The sessions were followed

by Express Public Health Awards which sought to laud the great work being done in the public health sphere by state governments, NGOs and the private sector. Glenmark was the Presenting Partner and PHFI was the Knowledge Partner for the awards.

The evening ended on a high note with a gala dinner and live orchestra. Thus, the first edition of Healthcare Sabha was a resounding success.

(With inputs from M Neelam Kacchap, Raelene Kambli, Lakshmi priya Nair, Sachin Jagdale and Usha Sharma)

MARKET

Powerpacked discussions on drug procurement process at Healthcare Sabha 2016 Discussions served as a platform for healthy brainstorming HEALTHCARE SABHA 2016 also saw two power discussions presented by Glenmark Pharmaceuticals that brought to the table insightful food for thought. The first power discussion kicked off with AG Prasad, Vice President- Sales and Marketing, Glenmark Pharmaceuticals welcoming nearly 15 dignitaries from Mumbai. The topic before the house was 'Partnering in Quality Procurement.'

The discussion began with Dr Suresh Saravdekar, Ex-Assistant Director and Consultant (hospital supplies procurement), Ministry of Medical Education & Health, State of Maharashtra pointing out the need for quality medicine procurement processes within public hospitals. He went on to say, “Equity in quality of medicine is of utmost importance. We as key stakeholders working in the public health domain need to come up with solutions that can harmonise the standards for medical procurement. Today, we have gathered here to come up with those solutions that can make a difference.” This comment got the ball rolling for the rest of the interaction.

Tarun Goel, Assistant Manager, KPMG, Advisor to Maharashtra government said, “To ensure quality drug procurement, it is necessary to revisit the tenders that come in. Apart from this, quality checks is a must without which medicine procurement process is incomplete.”

Dr KBK Dora, Additional Chief Medical Director, Central Railways immediately responded to this suggestions and said, “We need to have a filtration process in place for (purchases of) all kinds of medicine and surgical equipment. This will ensure quality procurement.” Dr Nirmala Barse, Deputy Dean, LTMG Sion, also agreed to this and said, “This needs a change in mindset.”

Dr Prateek Rathi, Special Executive Officer and Surgeon,

EXPRESS PHARMA

15

March 16-31, 2016

Employees State Insurance Scheme, Public Health Department, Government of Maha-

rashtra then emphasised that the medical procurement process must be kept transpar-

ent. “Transparency can be maintained by bringing in a third party to check for quality

and then uploading the results on the net for everyone to see.”

Sanjay Deshmukh,

MARKET Additional Municipal Commissioner W S, Mumbai Municipal Corporation agreed with Rathi.

He also endorsed the idea of using e-commerce to maintain transparency. Ram Bhau Dhas, Dy Municipal Commissioner (Z-III), Mumbai Municipal Corporation, replied saying, “We have to find all the loopholes in the current procurement mechanism and fix them so that we can improve the quality of drugs and equipment supplied to public healthcare institutes.”

Further, Dr Avinash Supe, Dean, KEM Hospital, Mumbai recommended that a random inspection system be introduced by the government to ensure quality procurement processes. He also suggested that the price control mechanism should be reviewed once again.

This suggestion by Supe was applauded by all. However, Dr Alaka Despande, Former HODDept of Med & Director, Center of Excellence,HIV/AIDS management, JJ Hospital, said, “Quality is maintained within public hospitals as qualified doctors and healthcare staff conduct the procurement of medicines and surgical equipment.” Nevertheless, she pointed out that there is an urgent need to have a cap mechanism to ensure highest standards.

Along the same lines, Dr Yogesh Patil, Co-Founder & Director, Biosense Technologies, criticised the raised turnover criteria in the medicine procurement process. He was of the opinion that there is a need to find a new mechanism (other than turnover) to identify innovation based companies to provide high quality products at affordable rates.

To add more insight to the discussion and to inform the dignitaries about the developments at the state government level, Dr Pravin Shingare, Directorate of Medical Education & Research, Government of Maharashtra, said, “Decentralisation of medical procurement should be stopped. There should be one agency who will look after the standardisation of the procurement process. Also, post procurement scrutiny is also required to ensure quality maintenance. Currently there is

16

EXPRESS PHARMA

March 16-31, 2016

no control on the aging of drugs.” He also pointed out that pharmacovigilance is crucial to provide good quality drugs to the people.

On this, Goel chipped in,“Maharashtra will soon come up with its HMIS model to maintain transparency. The government is also adopting 5S and Kaizen for process improvement.”

This news was appreciated by all at the discussion.

The next suggestions came from Ganesh Kanate, General Manager- Corporate Affairs, Glenmark. He urged the need for a dedicated PRO for each public health facility/hospital as negative news about public hospitals is most often highlighted, while positive news seldom got covered in the media. He therefore felt that if an agency is hired or committee formed, this could help disseminate the right information on the state of affairs within the public healthcare sector.

Prasad then concluded the

discussion by thanking all the dignitaries for sharing their view on this extremely sensitive subject and coming up with ideas that can give rise to apt solutions.

The success of the first power discussion set the tone for the second panel discussion which attracted state government officials from various states. The conversation was once again led by Saravdekar, who asked the other dignitaries to talk about the drug procurement process in their own states. Dr Manjunath B, Medical Superintendent, KC General Hospital, Malleshwaram, Bengaluru under Govt of Karnataka, spoke about the drugs procurement mechanism maintained within his state. He then highlighted the problems which his organisation is currently facing and requested for a solution to overcome it. “Money is allocated for increasing access to medicine; however, we are not able to utilise it properly,” he added.

Prasad agreed that underutilisation of funds by state health departments is a real concern. He then touched upon the budget allocation for the healthcare industry in the Union Budget 2016-17 and made a point that in India we whine about scarcity of funds but it is equally important to know whether these funds are efficiently utilised. “Most of the funds allotted to either state or national programmes do not even get utilised. So to avoid such situations, both government as well as private players should identify how to utilise it,” he replied.

Moving on, Dr Pradeep Naik, Dean, Goa Medical College explained the procurement mechanism being followed by his hospital. He informed that in 2014, the Goa government formed a common drug purchase committee to ensure quality drug procurement process and maintain high standards. “The core responsibility of the committee was to follow

the National List of Essential Medicines (NLEM) list and procure medicines. However, the committee has also prepared non-NLEM drugs list and shared this with all public hospitals located in Maharashtra”.

Adding in, Dr Shankar L Vig, Deputy Medical Commissioner, ESIC, briefed about the criteria adopted and followed by the ESIC for 'Not of Standard Quality' drugs and non supply of drugs. “We have a centralised committee that looks after this process. We follow a two step standardisation process for quality checks,” he informed.

During the discussion panelists also discussed how pharma manufacturers are not willing to manufacture certain drugs under price control which leads to scarcity of medicines in the market. For instance, Dr Atul Kharate, State TB Officer & Joint Director Health Sservices, Government of Madhya Pradesh raised concerns on the drug procurement process for TB treatment. He revealed that some TB drugs are not available in Madhya Pradesh and hence even the RNTCP is facing many problems when arranging for certain drugs for TB. Dr PK Devadass, Dean and Director, Bangalore Medical College and Research Institute echoed Kharate's point that he and his institution finds it difficult to procure drugs.

At the end of discussion, the participants were unanimous in their conclusion that functional integration is key to quality drug procurement in India. Dr Prathajyoti Gogoi, Director, Regional Drug Testing Laboratory, CDSCO, DGHS, Ministry of Health & Family Welfare, Government of India summing up the discussion saying, “Healthcare Sabha has highlighted several problems being faced by stakeholders working in the public health domain. I assure you that I will discuss these issues at the ministerial level and present some solutions that have surfaced during our discussion.”

(With inputs from Raelene Kambli and Usha Sharma)

EVENT BRIEF APRIL 2016 13

Optel Vision’s CMO seminar

OPTELVISION’S CMO SEMINAR Date: April 13, 2016 Venue: Goa Summary: Optel Vision, in collaboration with Conval Group and TraceLink is organising a common platform for the Indian pharma industry to understand various strategies that can be implemented for global T&T deployment. The event will see more than 100 national and international speakers and delegates.

Supported by industry bigwigs Apotex, Fresenius Kabi, Par Pharmaceutical and Domino amongst other renowned pharmaceutical brands, the event will see attendance of top executives from the pharmaceutical industry. A platform for exchange of knowledge, the congress will have delegates from engineering, project management, IT, QA and supply chain functions across the industry. The one-day event will feature presentation, case studies, strategic roundtable discussion and cover various issues related to serialisation global compliance plus various approaches for facing them.

Contact details http://www.serialisationcmo.in/

PHARMA PRO&PACK EXPO 2016 Date: April 27-29, 2016 Venue: Mumbai Exhibition Centre, Mumbai Summary: IPMMA and GPE Expo will organise PHARMA Pro&Pack Expo 2016. The exhibitors profile include: machineries and equipment: Pharma processing M/c (tablet, capsule, injectables, ointments, dry syrup powder) packaging machineries lab and biotech instruments, glassware, packaging materials, lab-wares and consumable, clean room and environment control products and services, utilities equipment and services, project consultants and turn key

EXPRESS PHARMA

17

March 16-31, 2016

contractors.

Contact details PHARMA Pro&Pack

27

PHARMA Pro&Pack Expo 2016

Expo 2016 / Mumbai GPE Expo Global, 402-403, Abhijyot Square

B/h Divya Bhaskar, SG Highway Ahmedabad 380 051

T: +91-79-40008233 / 40008253 E:mail@PharmaProPack.com W: www.PharmaProPack.com

cover )

18

EXPRESS PHARMA

March 16-31, 2016

(

To subscribe: bpd.subscription@expressindia.com

THE MAIN FOCUS

EXPRESS PHARMA

19

March 16-31, 2016

cover ) THIS YEAR’S UNION BUDGET HAS SOME MEASURES FOR PHARMA SECTOR

T

he budget presented is a well-balanced one given the way the global economy has been over the last one year. The good part is that the finance minister has chosen to maintain the fiscal deficit at 3.5 per cent and has to be one of the most inclusive budgets in recent time given the government’s tilt towards stepping up on developing rural infrastructure and providing impetus to India’s rural economy.

There are some prudent steps taken, from an employment generation standpoint which is the need of the hour.

The allocation of Rs 1804 crore for skill development will provide the right fillip for the manufacturing sector by providing access to skilled manpower, in turn creating employment. This year’s Union Budget also has some measures for the pharma sector such as encouraging innovation in the industry with a 10 per cent rate of tax on income from worldwide exploitation of patents developed and registered in India by a resident. In addition, service tax on services provided by Biotechnology Industry Research Assistance Council (BIRAC) approved biotechnology

RAMESH SWAMINATHAN Chief Financial Officer, Lupin

incubators to incubates being exempted will provide an impetus to start-up biotech enterprises and new units, as this exemption could have a direct impact of 14 per cent on the bottom-line of such enterprises.

Having said that, the deduction for expenditures on scientific research (R&D) being cut from 200 per cent to 150 per cent beginning in April '17 and eventually phasing out from 2020 will have a negative impact on the Indian pharma industry. The duty drawback schemes have also been widened and deepened to include more products and countries which would be a

positive for export-oriented pharma companies.

The devil is of course in the details, for example key impact areas across sectors from an indirect tax perspective could be as follows: ◗ A new Krishi Kalyan Cess is being imposed @ 0.5 per cent on all taxable services w.e.f. June 1, 2016. This would have a negative impact on cash flows, even though it would be creditable. ◗ Service tax credit can now be distributed to outsourced manufacturers, i.e., to LLM and P2P manufacturers. This would result in lesser burn-out of service tax at the time of distribution,

going forward. ◗ Interest rates have been standardised at 15 per cent p.a., w.e.f.

April 1, 2016, a move away from the variable rates presently applicable (between 18 per cent and 30 per cent). This would provide relief to assessees as a potential tax liability on an interpretation matter could actually result in a huge interest burden. ◗ A clause has been inserted (w.e.f. March 1, 2016) restricting the quantum of rebate to the value of such goods sold in India.

Due to this change, the Central Excise rebate which is presently being claimed on export of goods may get restricted on high margin export consignments. ◗The normal limitation period for issuance of a show cause notice by the Department has been raised from one to two years in case of Excise and Customs matters; 30 months in case of service tax matters. Thus, any tax/ duty related risk would extend for a longer period, even in cases where there is no malafide intent.

Even though, the budget has increased healthcare spends with announcements such as the health protection scheme which will provide health cover

up to Rs 1 lakh per family and ensuring quality health services to a larger populace which may entail increased demand for pharma products and ancillary medical equipment. The proposed ‘National Dialysis Services Programme’ is a good initiative which would decrease the financial impact of prolonged and expensive treatment for dialysis patients. In addition to that, the proposal to open 3,000 stores for generic drugs is a step in the right direction for creating accessibility to affordable medicines, however, demand for branded products could be impacted due to this. Having said that, the budget, as has been the case in the past five years, needs to do more when it comes to making healthcare and medicines accessible. The budget must focus on incentivising the creation of requisite healthcare and medical infrastructure; it must incentivise research and development, encourage pharma manufacturing and exports from the sector. Also, last but not the least the implementation of the GST bill will give a big push to increasing ease of business across sectors.

I HAVEN’T SEEN A BOLD APPROACH TO INCREASE FINANCIAL OUTLAY FOR HEALTHCARE SECTOR

W

e welcome the fact that the finance minister has named healthcare as one of the nine pillars of the Union Budget 2016.

Our country’s demographic dividend can accrue only if we give priority to healthcare sector. I haven’t seen a bold approach to increase financial outlay for healthcare sector, in view of the stated objective of increasing healthcare spends from current 1.2 per cent of

20 EXPRESS PHARMA March 16-31, 2016

GDP to 2.5 per cent of the GDP. There are relatively few salutary provisions for this sector.

Insurance cover, benefits for the elderly and more government drug stores are welcome steps, as are the proposed national dialysis centres, where the equipment will also have concessional duties. From pharmaceutical sector perspective the expectations were higher, but I haven’t come across any specific provision that merits

DR SHAILESH AYYANGAR

President – OPPI and Managing Director – India and Vice President –South Asia, Sanofi

attention. The only relevant provision is the taxation of royalty income at 10 per cent in respect of innovations discovered and registered in India. We had hoped that concessions on R&D for the life sciences sector would continue at 200 per cent, but these are to be phased out to become aligned with other industries. There was also no mention of incentives for pharma clusters, especially for API manufacturing.

(

THE MAIN FOCUS

'IT IS AVERY WELCOME AND INNOVATIVE MOVE BY THE GOVERNMENT'

T

he announcement to make available quality medicines at affordable prices by reinvigorating the supply of generic drugs, through opening of 3,000 stores in 2016-17, under Prime

PRADEEP DADHA Founder & CEO, Netmeds.com

Minister's Jan Aushadhi Yojana, is a very welcome and innovative move by the government.

Online pharmacies in India like Netmeds.com, which have started up in India in the last one year or so will also contribute to the government's intent by providing affordable generic drugs across the country by supplying to remote location through online connectivity. The 100 per cent tax exemption for three of the first five years announced in the budget to start-ups will also help online pharmacies and aggregators of prescription and generic drugs to cater to the vision of providing affordable generic drugs in a more longterm and sustainable way.

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

21

March 16-31, 2016

cover ) BUDGET IS POSITIVE ON INTENT, EXECUTION IS KEY

T

he finance minister has presented a growth-oriented budget amid concerns over stagnating growth and global economic crisis. He needs to be applauded for his long-term focus and commitment for achieving inclusive growth. Infrastructure and agriculture has undoubtedly been given special thrust, which will help in employment generation and boost the economy in the long run. In addition, the finance minister has provided strong impetus to inclusive growth by significantly investing in the longterm drivers of the economy such as education, skill development and growth of the rural economy. He has indeed done a good balancing act in meeting the aspirations of the weaker

sections of the society and building a strong infrastructure platform to catapult the economy on a sustainable high growth path in the next couple of years.

Some of the other positives in the budget presented were — no increase in the services tax, which was speculated to rise by two per cent, and no change in capital gains tax. The ‘Make in India’ movement has also been given a fillip through incentives for new manufacturing companies and relatively small enterprise companies.

A move that has come as a slight disappointment for research-driven companies like ours is the reduction of benefit of deduction for research to 150 per cent from April 2017 and 100 per cent from April 2020.

GLENN SALDANHA

Chairman and MD– Glenmark Pharmaceuticals This reduction has come without the corresponding tax rate being reduced. The government’s support for innovation R&D is required in the form of

BUDGET 2016 HAS BEEN A MIXED BAG OVERALL

SATISH REDDY

Chairman, Dr Reddy’s Laboratories

B

udget 2016 has been a mixed bag overall. The focus on infrastructure, rural development and social sector spending are important catalysts for boosting the economy’s growth rate.

On the healthcare front, the budgetary emphasis on the sector was fairly muted. While cer-

22 EXPRESS PHARMA March 16-31, 2016

tain initiatives such as the new health insurance scheme or the National Dialysis Services programme are good, perhaps a more holistic, well rounded thrust would have served the sector better in delivering good health to those in need of it.

The initial outlay of Rs 1,000 crores to fund higher education is simply not enough, given the

huge gap and growing need for students to have access to high quality education. One hopes that the government will build upon this and expand access to higher education to a much larger section of society.

The plan to set up the National Board of Skill Development in partnership with industry and academia is definitely a step in the right direction. This move will foster an environment of understanding and collaboration that will ensure skill development is mapped to industry needs, thereby creating more job opportunities in the long run.

The finance minister began his speech by articulating the nine pillars on which his budget proposals were built, that would have a transformative impact on the economy and people. The social sector, including healthcare was in the top five. We now look forward to a positive impact on this important aspect of India’s growth story.

tax incentives, regulations and grants for various research projects in sectors like pharmaceuticals. On the other hand; the ‘Special Patent Regime’ proposed to power innovation and research has come as a welcome announcement; but one has to go through the fine print for a complete clarity on this.

Like in the preceding years, the budget did not announce anything specific for the pharma sector; although there were a couple of positives for the healthcare sector. Measures like providing of health insurance of up to Rs 1 lakh per family and the opening of 35,000 medical stores under Pradhan Mantri Jan AushadhiYojana are welcome moves for making medical treatment accessible and affordable for

the poorer sections of the society. The budget proposal has also mentioned a national dialysis service programme along with excise duty waiver for dialysis equipment. But the healthcare sector was hoping for schemes like increased national spend for overall healthcare, larger insurance coverage, infrastructure related to healthcare development and increased access to primary and secondary healthcare; which were missing in the budget provisions.

In conclusion it may be said, the finance minister deserves full marks for presenting a wellbalanced, growth-oriented budget. So, we can conclude that the budget is definitely positive on intent but now execution is key.

THE BUDGETWILL BOOST GROWTH SENTIMENTS AND REVIVE THE DOMESTIC ECONOMY

O

verall the budget is very balanced. It will give boost to growth sentiments and revive the domestic economy. The Finance Minister has kept the fiscal discipline by keeping the budget deficit to 3.5 per cent in 201617. This will give greater confidence to investors, both in India and overseas.

The Finance Minister has taken the reform process forward with emphasis on nine pillars. Jubilant Life Sciences particularly welcomes the focus on agriculture, rural economy, social and infrastructure sectors. The focus on rural economy will generate demand, increase consumption and create opportunities for the corporate sector.

HARI S BHARTIA Co-Chairman and Managing Director, Jubilant Life Sciences

The minister has addressed both short and long-term issues facing the economy.

(

THE MAIN FOCUS

‘I FEEL ITWILL TAKE OUR COUNTRYTO A MUCH NEW REQUIRED GROWTH TRAJECTORY’

T

his budget will help us as a nation achieve our objectives of economic growth keeping in mind the equitable distribution of various benefits and re-

SATISH VARMA Managing Director, Fermenta Biotech

sources at a much more faster pace.

The fact that the increase in allocation to the tune of Rs 151,581 crores for social sectors including education and health which translates to an eight per cent growth from the last year’s allocation is a welcome change.

The proposed health insurance scheme which intends to protect one-third of India’s population against hospitalisation expenditure is indeed worth mentioning. An additional 3,000 generic medical stores which will be opened under the Pradhan Mantri Jan Aushadhi Yojana will definitely give a positive boost to healthcare access.

Holistically looking at the budget, I do feel it will take our country to a much new required growth trajectory.

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

23

March 16-31, 2016

MANAGEMENT INSIGHT

Getting bigger & better Sreedevi Yallamrazu, Business Manager, CubeX, elaborates on the success strategies of leading consumer healthcare companies in india

SREEDEVI YALLAMRAZU, Business Manager, CubeX

IN THE recent past, healthcare has become a buzzword among many players across industries from FMCG to durables, resulting in healthier and fresh food, water purified with the latest technology and even purified air to enhance the quality of life. Have pharmaceutical companies – who are key custodians of healthcare – got lost in this maze? Not anymore.

The Indian OTC industry is witnessing new players entering the domain, strategically launching promotional switches, banking on the rich heritage and popularity of Rx brands. Cipla has re-entered with Nicotex and Glenmark too is now active with VWash and Candid – a long overdue entry. While this can be attributed partly to regulatory crimps and the spree of global consolidations with India implications, the fact that consumers are taking their health more seriously can’t be undermined as it is a long-term growth opportunity.

In this evolving scenario, leading players too are consolidating their position, revamping brands and enhancing their presence to reach consumers where they are.

CubeX has delved deep to understand the growth drivers of top 10 dynamic consumer healthcare companies in its recent 2016 report, Getting Bigger & Better: Success Strategies of Leading Consumer Healthcare Companies

EXPRESS PHARMA

25

March 16-31, 2016

MANAGEMENT MNC FMCG companies with OTC Brands

in India, benchmarking them across five key functions viz. portfolio, marketing, sales infrastructure, supply chain and innovation. The business models followed by these trend setters have been elaborated in this article, which can be adopted by marketers seeking to enter the Indian OTC market or to accelerate the next wave of growth.

Indian FMCG companies with OTC brands In case of FMCG companies such as Dabur and Emami, the portfolio is well-spread across key OTC categories.

Dabur optimises its resources by marketing healthcare products alongside the wide range of FMCG products to gain synergies across functions. However, the healthcare portfolio is distinctly identified as OTC and ethical ayurvedic products. In case of Emami, most of the acquired brands from Zandu are marketed under a separate Zandu Healthcare division.

FMCG companies stand out in terms of their marketing and distribution reach.

The marketing strategies are highly consumer-focused (plugging the insights into the R&D teams as well), making up for lack of professional advocacy for the brands. However, it is noteworthy that now most of them have developed platforms for interaction with healthcare professionals (HCPs), while continuing to spend 15-20 per cent of sales on advertising and promotion. Emami ropes in celebrities for its brands (over 60 of them been involved since 1970) as it believes their popularity can help in building consumer connect since most of them are in niche categories. The company has gained immense returns through the endorsements. However, for brands like Zandu Pancharishta, the Medifacts platform is used to educate consumers on the brand’s multiple gastro-related benefits.

Another growth driver for FMCG companies is the sales infrastructure comprising relatively larger teams (2000 or more representatives) to max-

26 EXPRESS PHARMA March 16-31, 2016

imise feet on the ground to reach out to approximately five million pharmacy and non-pharmacy outlets (directly as well as indirectly).

Moreover, the sales team is structured for channel management, with emphasis on visibility in modern trade, which is a significant growth contributor. FMCG companies are also setting new benchmarks in terms of distribution strength. While online pharmacies take time to set

base, these growth-oriented companies are already utilising the digital medium to provide shopping convenience to consumers. Dabur’s e-commerce strategy has been made robust with four portals, tying up with major e-tailers like Snapdeal. It has even set up dedicated distributors to cater to online demand. Piramal tied up with Snapdeal to exclusively sell one of its new launches, Untox and has also set up an e-com-

merce division. (Let’s minimise the individual company details) The presence of ayurvedic products which escape price and distribution curbs, complemented by the robust sales infrastructure which reaches across urban as well as rural areas through dedicated initiatives (such as Dabur’s Project Double and Project CORE and Emami’s Project Swadesh), give these companies an edge over competitors.

MNCs such as GlaxoSmithKline Consumer Healthcare (GSKCH), Johnson & Johnson (J&J) and Reckitt Benckiser (RB) tend to leverage the global legacy of their successful brands, although they are opening up to products outside the core portfolio through M&As – which is expanding their otherwise limited portfolio. RB has created three distinct categories of health, hygiene and home, with increasing thrust on healthcare.

The acquisition of Paras Pharma has given it the much-coveted traction it seeks in the Indian OTC market and GSKCH is further consolidating its position post JV with Novartis’ consumer healthcare business.

The marketing campaigns of MNC FMCG companies are comparable to the scale of their Indian counterparts with presence in digital media as well as ATL and BTL promotions. J&J launched a singing competition on radio, Benadryl BIG Golden Voice, which ran its third season last year. Winners got a chance to collaborate with Shankar Mahadevan.

Acquiring brands with prescription strength like J&J’s ORSL can be an asset, as establishing HCP presence through franchise field force (typically the norm) can be an arduous task. GSKCH is one of the exceptions having successfully built expert marketing teams. In terms of supply chain, contrastingly, penetration into rural areas is not as strong as Indian FMCG companies and thus the reach is limited to one to two million outlets. Nonetheless, RB has an exclusive 'Dettol Shop' on Amazon where Dettol products are sold and Moov too finds a place there. High focus on niche categories, innovation and claims backed by consumer insights and clinical research drive the growth of these companies, augmented by inorganic strategies.

Indian pharma companies with OTC Brands Indian pharma companies like

MANAGEMENT FMCG companies stand out in terms of their marketing and distribution reach.

The marketing strategies are highly consumer-focused (plugging the insights into the R&D teams as well), making up for lack of professional advocacy for the brands Sun Pharma-Ranbaxy usually have a wide product basket spread across categories but with skewed focus.

Mankind’s consumer healthcare portfolio largely comprises products for sexual health while Piramal’s OTC division veers towards women’s intimate health (expanded i-pill into an i-range).(we may want to mention Piramal separately as it is not a pharma company.) Brands like Revital and Volini have epitomised the concept of 'Rainbow Marketing' which involves reaching out to all stakeholders – doctors, consumers and pharmacists by leveraging the prescription legacy while expanding the consumer base. This, in fact, has prompted FMCG companies to create brand advocacy programmes through experts to add to their aggressive advertising and promotional strategies.

The strength of the field force in OTC divisions in pharma companies is comparatively lesser as compared to FMCG companies. Mankind Pharma, well-known for its aggressive sales strategy, has a sales force of 900 in its Special Mankind Division, which exclusively markets consumer products through almost two million outlets. Besides, its geographical presence spanning urban as well as rural areas, warrants such a strategy. OTC divisions in most pharma companies are predisposed to share resources with prescription brands, which can pose constraints due to competition with other prescription brands and limited trade presence.

MNC pharma companies with OTC Brands MNCs pharma companies such as Abbott India and Pfizer offer only one to two OTC brands, which are promoted along with a larger number of deemed OTC and OTx brands.

These brands are promotional OTC switches which have high loyalty among doctors especially, apart

from consumers and retailers. The brand sales are being catapulted through unique campaigns with high consumer involvement such as the Harvard-famous Mumbai’s Dabbawalla service was utilised to promote Digene.

Abbott Healthcare has expanded Digene’s presence with its latest offering Digene Fizz which is available in grocery stores as seen with competitor brands like Eno and Pudin Hara. It reiterates the wide distribution reach ayurvedic products enjoy, as distribution reach is far lesser (0.4-0.5 million) for brands available purely through chemists.

Outlook for marketers Considering the fact that the target audience for consumer healthcare differs from pharma business, the business model too would have to carved accordingly. Companies like erstwhile Ranbaxy spun off the consumer healthcare division into a subsidiary. This business model seems to have worked wonders as it roped in marketing talent from the FMCG industry and deployed the necessary resources to further build on the prescription legacy of Revital and Volini, gained through the years in pharma business. Similar seems to be the case with GSKCH, another high growth company, which is in a formidable position after the tie-up with Novartis Consumer Healthcare.

While companies may get caught in evaluating the incremental sales through consumer marketing, it is necessary to evaluate the brand connect with the consumer and to find opportunities to leverage its potential. Innovation will have to assume high importance, not just in terms of offerings but also in terms of business strategies.

Taking a cue from Marshall Goldsmith’s best seller, it may be appropriate to say, ‘What got you here, won’t get you there’.

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

27

March 16-31, 2016

MANAGEMENT

NCDs on a rise,India needs a paradigm shift in allocation of funds to health

DR KENNETH E THORPE, Chairman, Partnership to Fight Chronic Disease

Dr Kenneth E Thorpe, Chairman, Partnership to Fight Chronic Disease, explains that the government hasn’t focused on NCDs which account for 53 per cent of disease burden in India

UNDER THE Union Budget 2016-17, the Finance Minister (FM), Arun Jaitley has increased the health budget by 22 per cent, to `39, 533 crores.

The figure includes 20,037 crores for National Health Mission (NHM) and `1500 crores for Rashtriya Swastha Bima Yojna (RSBY). The other positive measures highlighted by the FM include the launch the new National Health Protection scheme which will provide health cover up to `1 lakh per family with an additional top-up package of up to `30,000 for senior citizens. One-third of India’s population is estimated to get protection against hospitalisation expenditure.

The government will start the National Dialysis Services

Programme which will be funded through PPP mode under the National Health Mission. Under the scheme, the dialysis services will be provided in all district hospitals. In addition, the government has proposed to exempt certain parts of dialysis equipment from basic customs excise and special additional duty. The government has also proposed to set up 3,000 Jan Aushadhi stores which will aim to provide quality and affordable medicines to the rural population.

While these measures are headed in a positive direction, what the government has not focused on is the burden of non-communicable diseases (NCDs), which account for 53 per cent of disease burden in

The NCD epidemic in India has not been given its due attention in terms of the increased allocation the country. It was estimated by the World Economic Forum that India stands to lose $4.8 trillion due to NCDs in the period between 2012 and 2030. 60 per cent of all deaths in India are caused by the four

leading NCDs - cardiovascular diseases, cancer, chronic respiratory diseases and diabetes. The probability of death during the most productive years (ages 30-70) from one of the four main NCDs is a staggering 26 per cent, which weighs down health, social and economic output as well as productivity.

It is no surprise then, that NCDs are the leading cause of mortality in India.

The healthcare sector has an extreme demand-supply gap but the government has not addressed the issue with the same level of severity. There has been no fundamental in bringing about change to increase public healthcare spending and give it the necessary boost towards two per cent of the GDP. India

spends a cumulative 4.2 per cent of its GDP on healthcare, out of which the public sector contributes only 1.2 per cent, which is among the lowest in the world.

Global evidence on health spending shows that unless a country spends at least five to six per cent of its GDP on health and the major part of it is from government expenditure, basic healthcare needs are seldom met. The NCD epidemic in India has not been given its due attention in terms of the increased allocation.

Prioritising preventive and curative care at the primary level and a healthy workforce are the prerequisites to achieve the ambitious goals set by the government to transform the nation.

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.

28 EXPRESS PHARMA March 16-31, 2016

Email your contribution to: The Editor, Express Pharma, Business Publications Division,

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 editorial.ep@expressindia.com

RESEARCH RESEARCH UPDATES

Celldex discontinues late-stage study of brain cancer vaccine An independent interim analysis suggested the therapy might not show a statistically significant benefit in patient survival compared with standard chemotherapy

CELLDEX THERAPEUTICS will discontinue a late-stage study of its brain cancer vaccine after an independent interim analysis suggested the therapy might not show a statistically significant benefit in patient survival compared with standard chemotherapy.

The vaccine, Rintega, belongs to an emerging class of drugs that spur the immune system to recognise and attack cancer. It targets tumours with a genetic mutation found in about a third of all glioblastoma multiforme (GBM) cases. This amounts to roughly 4,000 patients in the US. There is no cure for GBM, the most common and deadliest form of brain cancer. GBM tumours tend to become resistant to initial treatment relatively quickly. According to experts, the median survival rate for newly-diagnosed patients is about 14-15 months if they are given standard chemotherapy, such as Merck & Co’s Temodar. After a preplanned interim analysis, an independent data safety and monitoring board estimated that the overall survival in patients with newly-diagnosed GBM who

were given Rintega was at a par with those in the control group.

In the study, the overall survival of patients on Rintega was consistent with that seen in mid-stage studies.

However, the survival of patients on standard chemotherapy was significantly higher than expected. Celldex said it was abandoning the study on the board's recommendation and it did not expect to incur substantial additional costs.

Data from a mid-stage trial of 73 patients had shown last year that adding the vaccine to standard therapy helped patients with a recurrent form of GBM live longer. At the time, Celldex had sought to use the data to get accelerated approval for the vaccine, but the US Food and Drug Administration had advised the company to wait for late-stage study data before filing a marketing application.

Celldex, which is also testing other compounds for different kinds of cancer, is still reviewing the interim analysis, company executives said on a conference call.

Reuters

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

29

March 16-31, 2016

RESEARCH

Novartis’Cosentyx superior to Stelara for psoriasis patients Cosentyx granted first-line systemic indication for psoriasis in Europe and recently approved in psoriatic arthritis and ankylosing spondylitis in the US and Europe NOVARTIS ANNOUNCED new late-breaking data from the head-to-head CLEAR study, demonstrating that Cosentyx (secukinumab) remains superior to Stelara (ustekinumab) in achieving sustained skin clearance (PASI 90 response) at 52 weeks for adults living with moderate-to-severe psoriasis.

These findings were presented for the first time at the American Academy of Dermatology (AAD) Annual Meeting in Washington, DC[1].

Cosentyx is the first fully human interleukin-17A inhibitor approved for adults to treat moderate-to-severe plaque psoriasis, and was recently approved for the treatment of psoriatic arthritis and ankylosing spondylitis in the EU and US. “Cosentyx continues to demonstrate superior and sustainable efficacy against currently available biologics and is a proven first-line treatment option for adult patients with moderate-to-severe psoriasis,” said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. “Cosentyx has the potential to give more people with psoriasis than ever before the benefit of long-lasting skin clearance.”

The ultimate aim of psoriasis treatment is clear skin, and the Psoriasis Area Severity Index (PASI) 90 response is considered an important measure of treatment success[2],[3]. Meeting all primary and secondary endpoints at Weeks Four, 16 and 52, Cosentyx demonstrated it remains consistently superior to Stelara in achieving and sustaining PASI 90 response (76.2 per cent vs. 60.6 per cent; P<0.0001), and sig-

30 EXPRESS PHARMA March 16-31, 2016

Cosentyx is the first fully human interleukin-17A inhibitor approved for adults to treat moderate-to-severe plaque psoriasis, and was recently approved for the treatment of psoriatic arthritis and ankylosing spondylitis in the EU and US nificantly better in achieving PASI 100 (clear skin) response (45.9 per cent vs. 35.8 per cent; P=0.0103) at 52 weeks. Cosentyx also showed significantly greater and sustained Dermatology Life Quality Index (DLQI) 0/1 responses versus Stelara (71.6 per cent vs. 59.2 per cent; P=0.0008)[1].

The study also demonstrated Cosentyx had a superior rapid onset of action compared to Stelara, with half of Cosentyx patients achieving PASI 75 as early as Week Four (50.0 per cent vs. 20.6 per cent, P<0.0001)[4]. Cosentyx had a similar safety profileto that of Stelara in the study,

which was consistent with that reported in the pivotal Cosentyx Phase III studies[1].

Affecting around 125 million people globally, psoriasis is a chronic skin condition that causes itching, scaling and pain, and can have a significant impact on physical and psychological wellbeing[5],[6].

Despite this, up to half of the patients receive no treatment, and of those who do, many (52 per cent) remain dissatisfied with their disease management[7].

References [1] Blauvelt A et al. Secukinumab demonstrates superior

sustained efficacy vs. ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: 52-week results from the CLEAR study. Abstract presented at the 74th Annual Meeting of the American Academy of Dermatology. 2016 March 4-8; Washington DC. [2] Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. European Medicines Agency website. Available at:http:// www.ema.europa.eu/docs/en_GB /document_library/Scientific_gui deline/2009/09/WC500003329. pdf Accessed September 2015.

Accessed February 2016.

[3] Ryan C et al. Research gaps in psoriasis: opportunities for future studies. J Am Acad Dermatol. 2014; 70:146-167.

[4] Thaçi D, Blauvelt A, Reich K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol. June 17, 2015 [E-pub ahead of print].

[5] International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website.

"About Psoriasis." Available at: http://www.worldpsoriasisday.c om/web/page.aspx?refid=114. Accessed February 2016.

[6] Langley RG et al. Secukinumab in plaque psoriasis - results of two phase three trials. N Engl J Med. 2014; 371(4):326338.

[7] Armstrong AW et al. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013; 149(10):1180-1185.

EP News Bureau-Mumbai

BioCryst’s Zika drug shows promise in mice BIOCRYST Pharmaceuticals said a dose of its experimental antiviral drug improved survival rates in mice infected with the Zika virus in a preclinical study. Two doses of the drug, BCX443, were tested against a placebo and an oral antiviral called ribavarin for their effect on survival of immune-deficient mice infected with Zika.

Seven out of eight mice that received the ‘standard’ dose survived but none of the other mice that received either a low dose, the placebo or ribavirin were alive after 28 days.

The study was conducted at Utah State University under an ongoing program run by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health. The mosquito-borne Zika virus has been linked to brain damage in thousands of babies in Brazil.

There is no proven vaccine or treatment for the virus.

Reuters

RESEARCH

Genital talc boosts ovarian cancer risk in study Routine application talc to crotches, sanitary napkins, tampons and underwear had a 33 per cent higher risk of ovarian cancer THE RISK of ovarian cancer was onethird higher among women who regularly powdered their genitals with talc, a recent study found. Researchers asked 2,041 women with ovarian cancer and 2,100 similar women without ovarian cancer about their talcum powder use.

Those who said they routinely applied talc to their crotches, sanitary napkins, tampons and underwear had a 33 per cent higher risk of ovarian cancer, according to a report in Epidemiology.

Lead author Dr Daniel W Cramer, who heads the Obstetrics and Gynecology

Talc is a moistureabsorbing mineral made of magnesium, silicon and oxygen Epidemiology Center at Brigham and Women’s Hospital in Boston, has unsuccessfully called for warning labels on talcum powder. “This is an easily modified risk factor,” he said. “Talc is a good drying agent, but women should know that if it’s used repeatedly, it can get into the vagina and into their upper genital tract. And I think if they knew that, they wouldn’t use it.”

Cramer first reported a link between genital talc and ovarian cancer in 1982. But the current study is the first to confine the association to premenopausal women and to postmenopausal women who used hormone therapy – which might help explain earlier contradictory results on the link between talc and ovarian cancer, Cramer and his team write.

Cramer has testified as a paid expert in lawsuits against talcum powder makers. A St Louis jury last week ordered Johnson and Johnson to pay $72 million in damages to the family of Jacqueline Fox. After using the company’s Baby Powder and Shower to Shower for more than 35 years, Fox died from ovarian cancer last year at age 62.

Johnson and Johnson maintains that scientific evidence shows that talc – long marketed for babies’ bottoms – is safe. “With over 100 years of use, few ingredients have the same demonstrated performance, mildness and safety profile as cosmetic talc,” a company statement says.

Talc is a moisture-absorbing mineral made of magnesium, silicon and oxygen. In its natural form, it may contain asbestos, a known carcinogen. But all commercial products sold in the US have been asbestos-free since the 1970s. About 20,000 American women are diagnosed with ovarian cancer and about 14,500 die from it annually, according to the Centers for Disease Control and Prevention (CDC).

In 2006, the World Health Organization’s International Agency for Research on Cancer classified genital talc as possibly carcinogenic. Nonetheless, the CDC does not list talc as a risk factor for ovarian cancer. Dr Nicolas Wentzensen, head of the clinical epidemiology unit for the National Cancer Institute, said that the new study strengthens the evidence linking genital talc to the deadly reproductive cancer. He was not involved with the current study.

“The recent paper in Epidemiology has provided additional support for an association between talc use and ovarian cancer from a case-control study,” he said. Still, Wentzensen isn’t fully convinced of the link because even this new study was not of the most rigorous possible design. So-called prospective cohort studies would be particularly strong, he noted, because they would assess exposure at the start of an investigation and follow participants over time to see if they develop the disease.

“Scientific consensus emerges over time, especially in cases like this, where the results have been somewhat inconsistent,” he said. “While this recent analysis provides additional evidence supporting an association of talc and ovarian cancer, it will be important to test the methods used in this analysis in other data to see if the findings are confirmed.”

Reuters

EXPRESS PHARMA

31

March 16-31, 2016

RESEARCH

Research indicates another common mosquito may be able to carryZika Scientists in Brazil announced that they were able to infect another species, Culex quinquefasciatus, with the virus in a laboratory, raising concerns that Zika could be carried by a species more prevalent than Aedes aegypti RESEARCH BY scientists in Brazil indicates that a mosquito more common than the one primarily known to transmit Zika infections may possibly be able to carry the virus, a development that could further complicate efforts to limit its spread.

The mosquito species Aedes aegypti has been identified as the main transmitter of Zika infections, which have been linked to thousands of birth defects as the virus spreads rapidly in Brazil and other countries in Latin America and the Caribbean. But the scientists in Brazil announced that they were able to infect another species, Culex quinquefasciatus, with the virus in a laboratory, raising concerns that Zika could be carried by a species more prevalent than Aedes aegypti. They said much more research is needed to learn whether the Culex mosquitoes can transmit Zika infections. In Brazil, Culex quinquefasciatus is 20 times more common than Aedes aegypti, the researchers said.

The research, conducted by scientists at the governmentfunded Oswaldo Cruz Foundation in the northeastern city of Recife, is part of an ongoing trial in which researchers injected 200 of the Culex quinquefasciatus mosquitoes with rabbit blood infected by Zika. The virus, they said, circulated through the mosquitoes' bodies and into their salivary glands, meaning they might be able to transmit a Zika infection by biting a person. "We saw an ease of infection and an ease of dissemination of the virus to the salivary glands," Constancia Ayres, the lead scientist in the study, told Globo, Brazil's leading television network.

Public health authorities have cited Aedes aegypti as the mosquito overwhelming responsible for spreading Zika, with an-

32 EXPRESS PHARMA March 16-31, 2016

other species of the same genus, Aedes albopictus, also transmitting the virus in smaller numbers. There has been evidence about other mosquitoes linked to Zika. For example, researchers have found more than 20 mosquito species carrying the virus in Africa, although it was unclear whether they all transmit the disease effectively to humans.

The Brazilian research has yet to be published in a scientific journal or reviewed by scientific peers elsewhere. The foundation said more work was needed to determine whether Culex mosquitoes in the wild already are carrying the virus as well as whether they can transmit Zika infections. Foundation spokeswoman Fabiola Tavares said the researchers, who will begin capturing Culex mosquitoes in areas near Recife where the virus is known to be circulating, will now proceed toward answering those questions. The additional research could take up to eight months, Tavares added.

If a mosquito besides Aedes aegypti were found to transmit Zika infections in large numbers, it could make it more difficult to contain the current Zika outbreak that the World Health Organization last month declared a global public health emergency.

Much remains unknown about Zika, including whether the virus actually causes microcephaly in babies, a condition defined by unusually small heads

that can result in developmental problems.

Brazil said it has confirmed more than 640 cases of microcephaly, and considers most of them to be related to Zika infections in the mothers. Brazil is investigating more than 4,200 additional suspected cases of microcephaly. Traces of Zika virus have been found in the bodily fluids and tissue of mothers and babies affected by microcephaly. Culex quinquefasciatus also exists in more temperate climes, such as the southern United States, where it is known to carry the West Nile virus, and can survive winters. Unlike Aedes aegypti, Culex quinquefasciatus could keep a virus in circulation during cold months.

Though the Culex mosquitoes prefer to feed on the blood of birds, they also commonly bite humans, especially in rural areas. That means that targeted pesticide use and other mosquito control efforts for that species, which rests in trees and other high areas, would need to be different from those for Aedes aegypti, which rests in low spots, often indoors. "You can't spray up high the way you can around buildings," said Grayson Brown, director of the University of Kentucky's public health entomology laboratory who was not involved in the Oswaldo Cruz Foundation research.

Reuters

Prolonged aspirin use tied to reduced colon cancer risk Aspirin use was not tied to a decreased risk of breast, advanced prostate or lung cancers PEOPLE WHO regularly take aspirin over several years may be less likely to develop colon cancer, researchers say. They found that regular aspirin use for several years was tied to a lower risk of cancer in general, but that was mainly due to a reduced risk of colon cancer.

"We did find that aspirin reduced someone's risk of developing cancer overall," said senior author Dr Andrew Chan, of Massachusetts General Hospital. "Much of that reduced risk is of cancers of the gastric system." Aspirin reduces inflammation throughout the body, which may influence cancer risk.

Additionally, Chan said, aspirin may affect prostaglandins, natural compounds with a role in the development of colon cancer.

In 2015, the governmentbacked US Preventive Services Task Force said people taking aspirin for at least 10 years to prevent cardiovascular disease may also have a reduced risk of colon cancer.

Previous research also suggested that routine aspirin use is linked to a reduced risk of overall cancer, Chan and his colleagues write in JAMA Oncology. For their new work, the researchers used data on 88,084 women and 47,881 men participating in two large studies.

Women were between ages 30 and 55 when they enrolled in 1976, and men were between ages 40 and 75 when they enrolled in 1986. During about 32 years of follow up, there were 20,414 cancers among women and 7,571 among men. Overall, people who took aspirin regularly

were about three percent less likely to develop cancer than those who didn't regularly take aspirin. Aspirin use was not tied to a decreased risk of breast, advanced prostate or lung cancers.

Instead, the lower risk was mostly due to a 15 per cent reduced risk of gastrointestinal tract cancers, which was itself mostly due to a 19 per cent reduced risk of colon cancers.

The new study suggests aspirin use may compliment colon cancer screening and lead to benefits among people who don't follow recommendations to get screened, write Karen Colbert Maresso and colleagues of the University of Texas MD Anderson Cancer Center in Houston, in an editorial.

They write that about 17 per cent of colon cancers could be prevented with regular aspirin use among people who don't get colonoscopies.

About 9 per cent of colon cancers could be prevented with regular aspirin use among people who do get screened.

In the study, the reduced risk of gastrointestinal cancers was tied to taking 0.5 to 1.5 aspirin tablets per week for at least six years. "What it looks like is even reasonably low doses like a baby aspirin a day has some benefit," Chan said.

"What's unclear is if higher doses have more of an effect.

I think that question is still open."

The researchers warn that more information is needed on the cost-effectiveness of using aspirin for prevention and the possibility of side effects, including an increased risk of gastric bleeding.

Reuters

CLEANROOM SPECIAL

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

33

March 16-31, 2016

CLEANROOM SPECIAL INSIGHT

Innovations in cleanrooms and environmental monitoring Dr Tim Sandle, Head, Microbiology at Bio Products Laboratory and visiting tutor at the Department of Microbiology, University of Manchester, UK discusses some innovations relating to cleanroom and clean device operations, together with personnel control and environmental monitoring. The article emphasises the importance of ensuing that good cleanroom design factors necessary for ensuring contamination control are met

P

harmaceutical manufacturers of both sterile and non-sterile products, and medical devices, are required to demonstrate that manufacturing processes and procedures minimise any potential contamination to the product from the manufacturing environment. Contamination can arise from a number of sources: water, air, surfaces and personnel, each of which poses a potential risk to product.

These risks of contamination are avoided by putting environmental controls in place (through correct grade of air-supply, satisfactory cleaning and disinfection practices and so on). Where controls cannot off-set every contamination risk, and also as a means to demonstrate the level of control, environmental monitoring programmes are devised and put into action(1).

The primary protection from contamination is through well-constructed and maintained cleanrooms. This is supported by trained personnel, following strict gowning protocols, and cleaning and disinfection(2). Once environmental control has been accomplished, verification is undertaken through environmental monitoring (for both particulates and viable microorganisms).

34 EXPRESS PHARMA March 16-31, 2016

■

■

■

Cleanrooms Cleanrooms and clean air devices are typically classified according to their use (the main activity within each room or zone) and confirmed by the cleanliness of the air by the measurement of particles.

The primary objective of cleanrooms in pharma processing is to minimise and control microbial and particulate contamination. There

are many sources of contamination.

There are four principles applying to control of airborne microorganisms in cleanrooms. These are(3): ■ Filtration (through the use of HEPA filters). The air entering a cleanroom from outside is filtered to exclude dust, and the air inside is constantly recirculated through HEPA

(High Efficiency Particulate Air) filters (alternative filter are ultra-low penetration air (ULPA) filters). This is controlled through a HVAC (Heating, Ventilation and Air Conditioning) system.

Dilution (to ensure that particles generated in cleanrooms, in addition to those which pass the filters, are carried away by diluting the area with new ‘clean’ air).

Directional Air Flow (to ensure that air blows away from critical zones, as particles and microorganisms cannot ‘swim upstream’ against a directional air flow). This is achieved through pressure differentials.

Air Movement (rapid air movement is important for as long as particles and microorganisms stay suspended in the air they are not really a problem, for it is only when they settle out that they become an actual cause of contamination).

Innovations with cleanrooms There have been several advancements or changes in approach relating to cleanrooms. These include the use of modular cleanrooms and studies in energy efficiency, designed to make cleanrooms

cost effective whilst still maintaining contamination control principles.

Cleanroom design Modern approaches to cleanroom design is aimed at ensuring that the cleanroom is designed at optimising contamination control. It is important to dedicate time in designing cleanrooms and the equipment located in cleanrooms for, if there is a design fault in one part, this will affect the items of equipment and if there is a fault in conception stage this will be expensive and time consuming to rectify.

For cleanroom design, modern approaches utilise Computer Aided Engineering software for the design process, such as Building Information Modelling (BIM) software. Such software covers geometry, spatial relationships, light analysis, geographic information, quantities and properties of building components (for example manufacturers’ details) (4). Systems, assemblies and sequences can be shown in a relative scale with the entire facility or group of facilities. When designing modern cleanrooms, the following approach should be adopted: ■ The type and function of the cleanroom should be established. This should include the required

CLEANROOM SPECIAL

■

■

■

■

■

cleanroom grades or classes and how cleanrooms of different grades will interact (including requirements for air-locks and pressure cascades).

The most important aspect is drawing up the process flow.

Here the cleanroom management, together with engineers and quality assurance personnel, should map the path that equipment, product and operators will take in the cleanroom.

Established quality risk management tools like HACCP (hazard analysis and critical control points) or FMEA (failure modes and effects analysis) can be used for this purpose.

Areas which pose a contamination control risk should be noted and attempts should be made to design these risk areas out (the principles of quality by design). Other considerations can also be included at this stage, including whether there is adequate clearance under door frames for equipment to pass through.

In the design, there should be sufficient space for equipment and connections.

The cleanroom should be constructed from a material which is compatible with different cleaning and disinfection solutions.

Ideally, a mock-up of the cleanroom should be constructed.

This is particularly important for testing the process, product and personnel workflow. In terms of understanding contamination control it is essential to understand what objects are passed from one class of cleanroom to another.

Modular cleanrooms and bespoke design Modular cleanroom are cleanrooms that are assembled from prefabricated modules. This process of cleanroom construction differs from standard (or ‘common’) cleanrooms in that: ■ Common cleanrooms are assembled at the construction site from many elements ■ For modular cleanrooms a significant part of assembling works is done at the factory that produces modules. Only assembling of complete modules remains for the customer’s site.

Common cleanrooms are tailor made cleanrooms. Their design follows specific layouts that are drawn

by the technologist from understanding specific processes. Whereas modular cleanrooms are often designed to fit into existing spaces.

With modular cleanrooms other restrictions can appear. This is because the cleanroom construction process is separated into two parts, which are executed in two different places: the modules manufacturer and the customer’s site. This can present certain difficulties in terms of transport and later assembly (5).

Minimise Handling.

Minimise Damage.

Antimicrobial coatings Some types of equipment and surfaces can be manufactured with antimicrobial coatings. One example is the incorporation of silver or copper which are effective against a range of micro-organisms. An advantage of silver ions, for example, is that although they have antimicrobial properties, silver is rarely toxic against human cells. Examples of the application of silver include implements like forceps. Also, in relation to surfaces, the incorporation of wipeable surfaces onto equipment allows for the easier cleaning and disinfection. Some of these innovations include polythene covered computer keyboards.

Energy efficiency Cleanroom technologies are not only directed towards contamination control. The energy efficiency of cleanrooms is currently of great importance for companies who wish to save costs and to reduce the amount of carbon generated. To address this International Standard ISO 14001, which describes environmental management and practices and EN 16001, a European energy standard, are becoming increasingly used (both standards are likely to be amalgamated into international energy standard ISO 5001). Despite the appeal of controlling energy consumption, care must be taken when adopting such standards in relation to contamination control for actions to alter the operation of HVAC (heating ventilation and air conditioning) parameters can have an impact upon the level of non-viable particles and viable counts. Therefore microbiologists should always be involved in any energy saving projects.

Barrier technology

Key Advantages ! Made of polypropylene to prevent accidental tip damage.

No metal to metal contact. ! Serial number on each pocket for easy identification ! Special head support for easy punch removal ! Minimum handling as the tray along with tooling can be

The use of barrier technology protects critical cleanroom operations.

Within many cleanrooms unidirectional airflow (UDAF) units are found. A UDAF is classified as a

EXPRESS PHARMA

At Concept, in addition to manufacturing precision tooling, we also offer products that help maximise tool life. The tool storage box provides a safe storing system for Punches & Dies while minimising tool handling.

used for transportation and ultrasonic cleaning ! Inbuilt recessed handles for easy lifting

35

March 16-31, 2016

Mfg. Tablet Tooling since 1968

55 Unique Indl. Est., Dr. R. P. Road, Mulund (W), Mumbai - 400080, India.

T: +91(22) 26858479 F: 26855108 E: info@adeptexport.com W: www.adeptexport.com

CLEANROOM SPECIAL minienvironment; an alternative term is ‘separative devices’ (separative devices range from open to closed systems and include isolators and Rapid Access Barrier Systems (RABS)). These are localised environments created by an enclosure to isolate a product or process from the surrounding environment.

The advantages in using a minienvironment include the following: ■ Minienvironments may create better contamination control and process integration.

■ Minienvironments may maintain better contamination control by better control of pressure difference or through the use of unidirectional airflows.

■ Minienvironments may potentially reduce energy costs.

Of these types of micro-environments, the most widely used for contamination control in relation to aseptically filled products are isolators.

Isolators intended for aseptic processing are required to be operated under positive pressure and are subjected to decontamination process before start of the batch processing. Modern isolators more often use vapourised hydrogen peroxide, although alternatives are available including peracetic acid or chlorine dioxide(6).

These methods can also be deployed for the decontamination of cleanrooms.

The key principles for isolator use are (7): ❏ The air exchange between the isolator and with the surrounding environment must occur only through a microbial retentive filter such as HEPA or /Ultra Low Penetration Air (ULPA). ❏ The positive pressure aseptic processing isolator must be decontaminated in a reproducible and quantifiable manner to ensure the sterility assurance level of 10-6.

This is assessed through the use of biological indicators of a suitable popu-

36 EXPRESS PHARMA March 16-31, 2016

contamination into the area via footwear or through equipment transfer (such as trolley wheels). One way to minimise contamination is to use special mats which are designed to remove dirt, particles and micro-organisms. Where such mats are used they have traditionally been sticky-mats. Although these are fairly effective, more efficient contamination control can be achieved from polymeric flooring.

Polymeric flooring is an especially designed ‘plastic’ which works through electromagnetic forces causing particles to be attracted from surfaces like footwear, and retained on the surface of the mat. This mechanism ensures that any contamination residing on the mat is not passed back onto the personnel who walk across it.

❏

❏

lation, species and resistance. For vapour phase hydrogen peroxide systems, geobacillus stearothermophilus is normally used.

Entire activity / handling of materials inside an isolator shall be achieved remotely; any part of human body cannot enter the isolator.

Asepsis shall be maintained for each unit operation and for material transfers. Any material entering the isolator must either be decontaminated inside the isolator or shall be sterilised and taken inside via a rapid transfer port.

Disposable sterile plastic technology A major advance with cleanroom technology is with single-use sterile disposable technologies. Such technologies have reduced risks by allowing organisations to move away from equipment which needs to be sterilised (such as stainless steel vessels). It also negates the need to use consumables that are recycled or which present a risk with their transfer into cleanrooms, to disposable and single-use sterile items. The advantages of this technology is

that it eliminates the need for cleaning, eliminates the need for the pharma company to perform in-house sterilisation, reduces the use of chemicals, reduces storage requirements, reduces process downtime and increases process flexibility, and avoids cross contamination. Single-use items are typically sterilised using gamma rays (electromagnetic irradiation), which kill microorganisms by destroying cellular nucleic acid(8).

Aseptic connectors A variant on single use technology is the aseptic connector. Innovations in aseptic connection technology have led to the development of single use connector systems.

These are based on the sotermed alpha-beta principle which allows the connection to be performed in an environment this does not require unidirectional airflow or other capital equipment to maintain sterility.

Disposable holding devices Plastic technology has also led to an array of sterile plastic holding devices. An example is with disposable mixing systems. These can be connected to capsule membrane filters

and a hold bag. These interconnected disposable systems have a considerable advantage in that they are gamma sterilised and ready to use.

Garments Given that people are one of the primary sources of microbial contamination in cleanrooms (through shedding of skin flakes, many of which contain microorganisms), attention has been paid to gowning. While behaviours and techniques for gowning can be addressed through training and procedures, aspects of the gown design require attention.

Manufacturing gowns using continuous strong fibres of pure high-density materials, like polyethylene, fabrics can be constructed that are low linting and free of inherent contaminants that could represent a risk in critical environments. Cleanroom managers are more often requesting certification for gowns to show that they are low in particulates. For gowns that are re-laundered, stipulating the maximum number of times that a gown can be washed and irradiated is important.

Polymeric flooring A risk to cleanrooms arises from personnel transferring

Monitoring technologies The most significant advancement with microbiological monitoring methods has been the advent of Real Time Laser-Induced Fluorescence Systems. These instruments continuously monitor both inert particulates and viable microorganisms in real time.

They are very sensitive, where the limit of detection can be down to 1 microbial cell. It provides both total particulate and viable counts.

The instruments are based on optical spectroscopy. This is an analytical tool that measures the interactions between light and the material being studied. These instruments work by elastic light scattering.

This measures two things (9): Particle counts: where the size of a scattering particle, as it passes through a light beam, is comparable to a certain wavelength of light. The intensity of the scattering is dependent upon the size of the particle. Such systems will detect and quantify particles within a 0.5 to 20 um range.

Microbial counts: a 405 nm laser that intersects the particle beam, so that as a particle passes through the inelastic scattering measures the intrinsic fluorescence of the particle, from the metabolites (such as NADH and ri-

CLEANROOM SPECIAL boflavin) inside microorganisms.

There is a growing trend within the pharma industry towards the use of Process Analytical Technology (PAT).

The goal of process analytical technologies (PAT) are to improve consistency of product quality, provide "right first time" manufacturing (to reduce costs and reduce cycle time), reduce the regulatory delays associated with changes in manufacturing, and improve the safety of chemical processes. PAT could also be used to reduce the end-of-line laboratory testing. The ‘real time’ counters fit well with this paradigm.

With more classical environmental monitoring methods (the use of agar plates), it is now commonplace to be able to track the use of the media through barcoding.

Scanning bar codes allows the

information about the plate, such as the media batch number and expiry time, to be transferred to a Laboratory Information Management System (LIMS). To ensure that the sample is not at risk to adventitious contamination, several types of Petri dishes now come equipped with lockable lids.

Environmental control Arguably the most important aspect of environmental control in a cleanroom is the control of airborne particulates as this is a direct indicator of cleanroom contamination.

Particles in the air are measured through particle counters. The most efficient means of monitoring particles is by linking particle counters to a facility monitoring system (FMS). It is consist of discrete particle counters, each with individual pumps, and the data is sent using wireless

ethernet to a central data capture system. Modern particle counters have the advantage that they meet the more rigorous demands of the new international standard for particle counter calibration (ISO 21501). In the event of a counter breakdown a spare counter can quickly replace the malfunctioning counter due to ‘plug-and-play’ features and the particle counting software will record the serial number for audit purposes.

This feature is important for aseptic filling where continuous particle counting is a GMP requirement.

References 1. Sandle, T. and Saghee, M.R. (2013). ‘Cleanroom certification and ongoing compliance’.

In: Sandle, T. and Saghee, M.R. Cleanroom Management in Pharmaceuticals and Healthcare, Euromed Communications: Passfield, UK, pp169-184

2. Sandle, T. (2012a). ‘Application of Disinfectants and Detergents in the Pharmaceutical Sector’. In Sandle, T. (2012).

The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey, UK, pp168-197 3. Halls, N. (2004): ‘Effects and causes of contamination in sterile manufacturing’ in Halls, N. (ed.): Microbiological Contamination Control in Pharmaceutical Cleanrooms, CRC Press, Boca Raton, pp1-22 4. Sandle, T. (2013). Application of Quality Risk Management to cleanroom design, Clean Air and Containment Review, 13, pp24-25 5. Sandle, T. (2014) Modern Approaches to Pharma Cleanroom Design, Controlled Environments, 17 (1): 8-10 6. Mau, T., Hartmann, V., Burmeister, J., Langguth, P. and Häusler, H. (2004) Development of a sterilizing in-place applica-

tion for a production machine using Vaporized Hydrogen Peroxide, PDA J Pharm Sci Technol. 58(3):130-46 7. Midcalf, B, Neiger, J. and Sandle, T. (2013). ‘Fundamentals of pharmaceutical isolators’. In: Sandle, T. and Saghee, M.R. (Eds.) Cleanroom Management in Pharmaceuticals and Healthcare, Euromed Communications: Passfield, UK, pp185226 8. Sandle, T. and Saghee, M.R. (2012). “Application of Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the Biopharmaceutical Sector”, Pharmaceutical Technology, Supplement: Bioprocessing and Pharmaceutical Manufacturing, May 2012, S20-S27 9. Sandle, T. (2012b). Realtime counting of airborne particles and microorganisms: a new technological wave?, Clean Air and Containment Review, Issue 9, pp4-6.

Surging demand for cleanroom technology Ravi Thakur, Director, Pharmintech Turnkey Solutions, elaborates on the immense growth potential for cleanroom technology THE CLEANROOM technology is witnessing continuous growth across the world.

There are countless factors which are responsible for the growth of pharma products and cleanroom technology such as stricter healthcare regulations, rigid standards, demand for good and quality products, growing frequency and awareness of contagious and infectious diseases, need for medicines and vaccines, growing facilities in the healthcare sector etc.

As per the current statistics and reports, the Asia market is witnessing a positive growth due to an increase in demand for medicines, cleanroom built products, semiconductors and micro biotechnology industry, increasing government initiatives for health, renewed focus on safety and efficiency of

products and increase in demand for quality products. A

majority of the growth in this region is due to growth and

development of the healthcare industry in India.

Nowadays, the Indian cleanroom technology market is highly industrialised but unfortunately uneven and fragmented. New companies are looking forward to invest in cleanroom technology owing to its high demand in the Indian market and the numbers in the times to come will go beyond the predicted figures.

Development in cleanroom technology is also an important factor for the growth of manufacturers and turnkey contractors like us.

Pharmintech has been able to keep up its pace with the latest trends and has developed skill sets to provide the best quality products and services instantaneously so that there are no gaps between the growing trends and

technology.

The clean-room technology market is expected to gain huge benefits in India. It is expected to be in the list of the top growing countries in the clean room market.

Quality, technology and needs are driving the industry at a very high speed. Cleanroom turnkey projects executors and contractors should take the opportunity to provide the best technology and quality to clients.

Pharmintech uses the best team of designers, engineers, officials to ensure that everything is done systematically and efficiently. This generates trust among the clients and makes the company a leader in the industry. Therefore, we have become one of the preferred choices of our customers in a short period of time.

EXPRESS PHARMA

37

March 16-31, 2016

CLEANROOM SPECIAL PRODUCTS

Fabtech launches three new products FABTECH HAS launched three new products.

Dedsting tunnel Dedusting Tunnel is designed to reduce initial non-viable particles from the raw materials received in drums, cartons, bags etc before they are transferred to ware house or while transferring from warehouse to the workshop, protecting personnel and environment.

Available options ● Integration with on line weight check ● Integration with on line sampling and dispensing ● Adjustable brushing system to maximise removal of non viable particle. ● Customised design to suit specific requirement like motorised sliding shutter, anti static PVC strips etc. ● Sequentially controlled PLC operation and process specific

38 EXPRESS PHARMA March 16-31, 2016

instrumentation. ● Modular reconstruction for retrofitting to other system.

MIST SHOWER Mist Shower is used to reduce the possible re-suspension of the particulate in the

operator breathing zone. Mist booth works by gently wetting the surface of an operators protective gown with a fine water mist, causing the powder to stick to the surface instead of becoming airborne.

Effectiveness of the misting booth at wetting particulate is dependent upon misting cycle duration time, the physical and chemical properties of the particulates , operator technique while misting and one the material and design on the protective garments.

Position of mist shower is generally at exit of potent or highly potent facility between processing and de-gown area.

Available options ● Dedicated skid mounted

water system as per specific requirement like water heating arrangement etc. ● Combo system (Air shower cum mist shower)

● Customised arrangement

for disposal of PPE. ● Custom built to suit any lay-

out. ● Sequentially controlled PLC

operation and process specific instrumentation. ● Modular construction for retrofitting to other system.

Online sampling Sampling Booth is designed to provide Class 100 working environment rest with built in scavenging system to ensure product operator as well as surrounding environment protection.

Contact details Fabtech Technologies International 615, Janki Centre, Off Veera Desai Road, Andheri (W), Mumbai 400053 Tel: 022 6159 2900 Mobile: +917718872725

CLEANROOM SPECIAL

IKAlaunches TUBE MILL and TUBE MILL 100 control THE TUBE MILL control and the TUBE MILL 100 control represents a unique product innovation – the world’s first batch mill with single-use milling vessels. For the first time, this unit will enable serial testing to be carried out under reproucible, contaminationfree conditions.

The single-use milling vessels reduce the cleaning, time and energy that is devoted to the application process. These vessels also prevent crosscontamination of the sample material – a major advantage for quality assurance.

The 40 ml and 100 ml capacity milling vessels and hood are made from transparent material, allowing sample milling to be observed during

the process itself. With the Tube Mill 100 control larger grinding chambers with a maximum volume of 100 ml

(MT 100) can now be used.

For sterile applications you can use the sterile disposable grinding chamber MT 40-10

sterile with a stainless steel beater. It reduces soft, medium, hard and brittle materials with a Mohs hardness of up to 5 (manganese or apatite: 5 Mohs).

The unit is easy to operate thanks to the user-friendly, multilingual OLED display and timer function. The Tube Mill’s versatility is particularly noteworthy. The IKA Tube Mill control can be used to process hard and soft, brittle and dry material. In combination with dry ice, it also allows damp, fatty, elastic and fibrous materials to be milled thoroughly.

The wide speed range of this unit equates to processing times that are less than one minute for most samples.

Particular attention was paid

to safety in the development of this mill, which only operates if the hood is closed and the milling vessel is connected to the motor and properly secured. If any of these safety features are omitted, an error message is displayed. The milling vessel cannot be opened during the milling process.

Contact details Sonja Steiert Project Manager – Sales & Marketing IKA India 814/475, Survey No.129/1 Mysore Road Kengeri | 560060 Bangalore | Karnataka Phone: +91 (080) 26253 960 Fax: +91 (080) 26253 901 E-mail: sonja.steiert@ika.in

Autofill Engineering introduces powder filling machine THE WEIGH filler has been specially developed to fill free and non free flowing powder in the range of 500.00 to 5000.00 grams. The performance of this machine is remarkable very good while filling high density powders such as veterinary powders. This machine can be used to fill powders in solid containers and also in premade plastic bags. Auto tare system takes care of variation in container weight.

The controlled suction unit

extracts the dust during filling keeps the filling chamber dust free. While using this machine to fill free flowing powders, the hopper stirrer can be switched off to reduce electrical consumption.

flowing powders, Granules, Veterinary Powders etc. ● Range: 500.00 to 5000.00 grams ● Output: 10 – 15 fills per minute. ● Accuracy: ± 1 per cent

Specification

Contact details Autofill Engineering, 218, Ramgopal Industrial Estate, Dr RP Road, Mulund west, Mumbai – 400 080.

Email: kannan_autofil@yahoo.com

● Machine: Weigh Filler – GMP

design ● Model: SASF-5K-LC ● Input: 230 Volts AC 50 C/S ● Power: 0.75 H.P + 80 watts ● Product: Free & Non free

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

39

March 16-31, 2016

CLEANROOM SPECIAL

Gandhi Automations offers clean room high speed doors A CLEAN room is an environment typically used in manufacturing and scientific research with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapours. A clean room has a less or no level of contamination.

vide environmental control and savings on energy costs ● Concept of low air permeability in pressurised rooms with positive and negative air pressure ● High door efficiency and low permeability values ● EN 12426 EN 12427 : < 12m3 / m2h ? 50 PA ● High leak tightness is due to curtain being tightly integrated in special SS 316 matt finish side guides ● Bottom safety edges and photocells combine to ensure operator safety at all times ● Heavy duty motor: 400V three phase, opening speed upto 1.5 m / s with inverter system ● Size upto: 4000 mm (W) X 4000 mm (H)

Usage and benefits of clean room doors In the pharmaceutical industry, clean room doors play a crucial role in the manufacturing of pharma products which require the environment to be free from microbial and particulate contamination and protected from moisture – controlled environment.

Clean room high speed doors have been designed and manufactured by Gandhi Automations. They are high in demand in industries such as pharma and chemical, which require quick open and close applications at the entry and exit points as controlled environment needs to be maintained.

These industries make

40 EXPRESS PHARMA March 16-31, 2016

high demands with respect to hygiene, sealing, operating reliability, fitting and a trouble free after-sales service. The Clean Room High Speed Doors satisfy all these requirements and work in strictly regulated operating conditions.

Gandhi Automations of-

fers custom-made solutions for these sectors, while investing a lot of time and money in courses and training for the company’s own production staff and technicians.

The key features of Clean Room High Speed Doors offered by Gandhi Automations are men-

tioned below: ● Clean Room High Speed

Doors are designed for inside applications and protects the environment against draughts, humidity, dust and dirt ● Operating speed and superior sealing properties improve traffic flows and pro-

Contact details Gandhi Automations Chawda Commercial Centre, Link Road, Malad (West) Mumbai – 400064 Off: +91 22 66720200 / 66720300 (200 lines) Fax: +91 22 66720201 Email: sales@geapl.co.in Website: www.geapl.co.in

CLEANROOM SPECIAL NEWS

Cleanroom consumables to witness highest growth by 2020 globally Various factors such as increasing demand for better quality products and safety of the working personnel are driving the global cleanroom technology market ACCORDING TO a market report published by Persistence Market Research, titled â&#x20AC;&#x2DC;Global Market Study on Cleanroom Technology: Consumables to Witness Highest Growth by 2020,â&#x20AC;&#x2122; the global cleanroom technology market was valued at $3,156.0 million in 2014 and is expected to grow at a CAGR of 5.2 per cent from 2014 to 2020 to reach an estimated value of $ 4,290.1 million by 2020.

Globally, the cleanroom technology market is witnessing significant

Asia is expected to experience a high growth rate in the global cleanroom technology market in the future growth due to growing regulatory concerns regarding the packaging, manufacturing, and processing of better quality products, and safety of the working personnel. Additionally, increasing demand for sterilised pharmaceutical formulations, and development of new biologics and its wide applications in the medical devices industry is driving the growth of the cleanroom technology market.

However, factors such as lack of skilled professionals and high cost associated with the setting up and maintenance of cleanrooms are restraining the growth of the global market for cleanroom technology.

North America is the largest segment in the global cleanroom technology market. This is due to technological advancements and growing

applications of cleanroom technology in the region. The North American market for cleanroom technology was valued at $ 1,209.3 million in 2014 and is expected to reach $ 1,580.8 million by 2020, growing at a CAGR of 4.6 per cent. In terms of type, cleanroom consumables are the fastest-growing segment. In terms of construction, standard/drywall cleanroom is the largest segment in the global cleanroom technology market.

Kimberly-Clark Corporation, Illinois Tool Works, and E.l. Du Pont De Nemours And Company are some of the leading players in the global cleanroom technology market. Some of the other major players in the cleanroom technology market are Azbil Corporation, Taikisha, Royal Imtech, Ardmac, M+W Group, Clean Air Products and Alpiq Group.

Asia is expected to experience a high growth rate in the global cleanroom technology market in the future.

This is due to improving healthcare infrastructure, rising popularity of certified products, and increasing adoption of cleanroom technology by the healthcare industry in Asian countries.

Various factors such as increasing demand for better quality products and safety of the working personnel are driving the global cleanroom technology market.

Additionally, increasing demand for sterilised pharmaceutical formulations, and development of new biologics and its wide applications in the medical devices industry are propelling the growth of the cleanroom technology market.

However, lack of skilled professionals and high cost associated with the set-up and maintenance of cleanrooms are restraining the growth of the global cleanroom technology market.

EP News Bureau-Mumbai

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

41

March 16-31, 2016

HALL NO.5 BOOTH NO. A-7 Mumbai Exhibition Center, Mumbai INDIA 27-29 April 2016

CLEANROOM SPECIAL

Global cleanroom disposable gloves market is expected to reach $1.4 bn by 2020 China, India, Vietnam and Philippines set for double digit growth rate from 2014-2020 ACCORDING TO a recent report by Allied Market Research entitled, "Global Cleanroom Disposable Gloves Market (Product Types and Geography) - Size, Share Trends, Regional Trends, Segmentation and Forecast, 2013-2020", the global cleanroom disposable gloves market is expected to reach $1.4 billion by 2020, registering a CAGR of eight per cent during 2014-2020. Neoprene disposable gloves would emerge as the fastest growing segment, at a CAGR of 17.5 per cent during the forecast period.

In order to maintain aseptic and contaminant-free environment during production, controlled environmental conditions are the prerequisites

for pharmaceutical, semiconductor and electronics manufacturing companies. The prerequisites can be achieved by setting up distinct and separate cleanrooms, which necessitates the need for clean room disposable gloves in the production environment. Factors such as a large base of consumers, stringent regulatory requirements and the popularity of 'cleanroom-customised' gloves are driving the growth of the market. Following the positive strides in the adoption of the clean room disposable gloves, the market is expected to reach 35.6 billion pairs by 2020. Natural rubber/latex disposable gloves, despite its conventional nature, continues to

Countries such as China, India, Vietnam, and Philippines exhibit a double digit growth rate during the analysis period dominate the market. It held about 2/5th of the market share in 2013 making it the leading market segment, and

shall continue to lead the market during forecast period.

Unchallenged physical attributes such as comfort and dexterity supplement the growth of natural rubber/latex gloves.

The study finds that nitrile gloves hold second highest CAGR i.e., 9.2 per cent during 2014-2020 while natural rubber/latex gloves would account for the largest market share, both in terms of volume as well as value through 2020, followed by vinyl gloves. Asia Pacific accounted for the 48 per cent of the global market in 2013, followed by North America, at 28 per cent of the global market share. China emerges as one of the most lucrative markets during 2014-2020.

Geographically, the market

share of developed countries in the global cleanroom disposable gloves market is expected to decline due to the use of industrials robots; whereas, the developing nations would witness a steady rise in their market share due to surplus work force and outsourced pharma manufacturing operations. Thus, countries such as China, India, Vietnam, and Philippines exhibit a double digit growth rate during the analysis period. Presently, US is leading the market in terms of volume and value; however, China would surpass US in the coming years and would subsequently emerge as a market leader.

EP News Bureau-Mumbai

Contamination Control Society of India – Voice of cleanroom industry CCSI faculty has over 150 years of combined experience in the field CONTAMINATION Control Society of India (CCSI) has recently organised several activities and many more have been planned for the current year.

CCSI brings together on a single platform, manufacturers and users of cleanroom equipment, instrumentation, consumables, furniture, panels, floorings, HEPA filters and validation contractors. It is an independent not-forprofit body, catering to the pharma and biotech industries, food processing, atomic energy, electronics, defence, education and research, consultants etc.

42 EXPRESS PHARMA March 16-31, 2016

CCSI brings together on a single platform, manufacturers and users of cleanroom equipment, instrumentation, consumables, furniture, panels, floorings, HEPA filters and validation contractors CCSI faculty has over 150 years of combined experience in this field and have conducted various such workshops /seminars / courses in India and abroad. CCSI is now

a member of the International Confederation of Contamination Control Societies, thus benefitting from international expertise. CCSI has also announced special in-house

training programmes for the cleanroom production/supervision staff of large pharmaceutical and biotech companies at their premises.

Some of the subjects that are covered in such in-house training courses are: ● Airborne particle counting theory and practice ● Airflow measurement, airflow pattern studies ● Certification and monitoring of cleanrooms ● Cleanroom protocol, gowning and housekeeping ● Complying with International Cleanroom Standards and GMPs ● Continuous particle moni-

toring systems HEPA filter testing and standards ● Microbial air monitoring ● Understanding the new revised ISO 14644-1&2 cleanroom standards A recently held training workshop in Mumbai was attended by over 100 participants. CCSI hopes to shortly get accreditation of their Associate Level certification course from the International Confederation of Contamination Control Societies. CCSI also circulates a newsletter with useful technical information on cleanrooms.

EP News Bureau-Mumbai ●

PHARMA ALLY I N T E R V I E W

â&#x20AC;&#x2DC;Not enough attention has been paid to quality by the Indian regulatory systemâ&#x20AC;&#x2122; GV (REX) Reklaitis, Professor of Industrial and Physical Pharmacy, Purdue University, sheds light on global trends in pharma manufacturing in a discussion with Sachin Jagdale What are India-specific growth drivers for the pharma industry?

India has a big presence in supplying generic active pharmaceutical ingredients (APIs) and drug products, both to internal markets as well as to developed countries. As shown by IMS Health, the largest growth around the world has been in generic medicines where currently 92 per cent of prescription volume is filled with generic drugs.

Indian companies have a significant opportunity to grow with this sector, providing that attention is paid to meet quality requirements and to minimise high visibility recalls and warning letters from regulatory agencies.

On the global front, what are the new developments that have taken place in pharma manufacturing technology? How is the Indian pharma industry responding to these changes?

One of the important developments that is receiving much attention in the US and Europe is the conversion from batch to continuous manufacturing. This spans both small molecule drug substance manufacture as well as solid oral drug product manufacture. Major reductions in capital and operating cost as well as improvements in quality are being reported. Industry meetings such as the FDA-AICHE Workshop on Adopting Continuous

Manufacturing (Feb 29-March 2) in which company experiences are being shared are attracting large attendance, indicative of the interest. The Indian industry has not yet pursued these developments.

India is a cost-sensitive market.

Are cost concerns restricting big pharma brands from entering this market?

Yes, cost is restricting entry into the Indian market, especially with the speciality drugs, a rapidly growing sector for innovator companies in

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

43

March 16-31, 2016

PHARMA ALLY the US. However, brand-name generics are certainly an opportunity for Big Pharma.

Besides lack of funding, what is hampering the growth of R&D in the Indian pharma industry? What are your suggestions to overcome these problems?

The leading members of the Indian pharma industry have demonstrated the capability to develop generic equivalents of sophisticated drug products, including biosimilars. This requires highly skilled scientific manpower and laboratory infrastructure. Thus, it is proof that the R&D capabilities do exist in the industry. Although the capabilities to develop

innovations also exist, this domain is very high risk and managing such R&D portfolios requires taking a long-term view which is challenging for all but the larger companies. For Indian companies to participate in this domain, it would seem prudent in the medium term to seek partnerships with innovator companies abroad for offering development and manufacturing capabilities in which Indian companies would have significant cost advantages. A successful track record in such partnerships would improve the odds of success with in-house innovative products.

In recent times, many big Indian pharma companies

received flak from overseas regulatory authorities over quality-related issues. What is the role of the Indian regulatory system in this scenario? Have they done enough till now to address this issue?

The frequency of these quality related events do suggest that not enough attention has been paid to quality by the Indian regulatory system. Of course, there seems to be a growing recognition that more should and can be done to address this issue. In fact, there should be a strong national incentive for doing more since the recurrence of these events does incline risk-averse external entities to seek other suppliers and partners, thus,

impeding growth of the Indian sector. A key step would be to have a regulatory framework that does not differentiate between products for internal and external markets. However, development of a culture of quality across the Indian industry will take time given the very large number of companies of various sizes in this sector.

According to you, what are challenges for the Indian and the global pharma industry?

Given the enormous pressures to control the rise in healthcare costs in all countries in the world, the key challenges for the pharma industry in India and the

world are in providing drug products of reliable quality at a reasonably low cost.

Manufacturing advances such as continuous manufacturing are part of the solution. But, cost control must not only encompass development and manufacturing costs but also the R&D costs associated with the discovery of innovative drugs. Strong industry-universitygovernment partnerships are being viewed as one avenue to make progress in all these areas. This mechanism might be worth developing in India, drawing on the enormous expat talent pool that India has across the global pharma industry. sachin.jagdale@expressindia.com

'We compete against world class producers from the US and Japan' Neelikon has emerged as a prime manufacturer of high quality colourants for food colour, pharmaceutical colours, cosmetic colours, personal care colours and ink industries. The company management talks about its three decades long successful journey, in a candid interaction with Sachin Jagdale How has food, drug and cosmetic colour industry in India evolved? What is your contribution in the same?

Colour is one of the most important qualities of food, it makes the food appealing and affects every moment of our lives. There have been colours used in foods for centuries to increase consumer acceptability. Centuries before, human race was using natural food colour to improve visual appeal. Some of these natural colours were turmeric, saffron and burnt sugar. These colours were obtained from plant, animal and mineral sources.

Unfortunately, natural resources are not available in uniform colours. There is quality and colour variation

44 EXPRESS PHARMA March 16-31, 2016

because of seasonal changes.

They are unable to sustain high cooking temperature.

They are also unstable in sunlight. They are not available in various shades in water-soluble form. Thus, natural colours had their own drawbacks like heat, pH and light instability, as well as poor stability against oxidising agents in food, which made synthetic colours gain popularity in the food industry.

Chemically synthesised colours were easier to produce, less expensive and superior in colouring properties. They blended easily without imparting flavours of their own to foods.

In the beginning of the 19th century, the bulk of synthetic

colours were derived from the petroleum product aniline, therefore they were called â&#x20AC;&#x2DC;coal-tarâ&#x20AC;&#x2122; colours because the starting materials were obtained from coal. As the use of synthetic colours in food increased, it raised safety concerns which led to numerous regulations throughout the world and in the US. After detailed study, 16 out of 700 colours tested were found suitable and safe for human consumption.

The Prevention of Food Adulteration Act of India permits the use of eight synthetic colours in specified food commodities.

In the last two decades, the food market has changed rapidly with a larger proportion of processed foods

and instant foods. To make processed foods appealing and to attract the consumer, application of an appropriate food colour is necessary and selection of food colour is a great challenge in terms of cost, stability and feasibility of the colour.

To meet the demand of food colours for application to a wide variety of foods including beverages and confectionery, eight synthetic colours, three for red shade (Carmoisine, Ponceau 4R, Erythrosine), two for yellow shade (Tartrazine and Sunset Yellow), one for green (Fast green FCF) and two for blue shade (Brilliant blue FCF and Indigo Carmine) and eleven natural colours are available under the current legislation

in India. Developments in the technology of food colour preparation, improvement in the stability of colours and preparation of colour formulations including the search for new colourants are important aspects of study in the area of colours.

For more than 30 years, Neelikon has been a prime manufacturer of high quality colours, dyes, cosmetic pigments and lakes for food, pharma products, cosmetic, personal care, homecare, stationary and inkjet ink industries. In our journey since inception, we have indigenously developed technologies for manufacturing food colours, drug and cosmetic colours, external D&C Colours. Today,

PHARMA ALLY Neelikon is recognised as a global supplier of colours for food, drug and cosmetic applications. Neelikon offers the following to the industry: ◗ US FDA certified FD&C colours, D&C Colours and Lakes ◗ Food colours, pharma colours and cosmetic colours meeting US-FDA, European and Japanese legislation ◗ Food colours meeting specifications recommended by Joint FAO/WHO Expert Committee on Food Additives (JECFA), and ◗ Speciality fluorescent colours used in production of daylight fluorescent pigments, textile dyeing, nondestructive testing (NDT), plastic colouration etc ◗ Neelikon colours are sold in more than 100 countries ◗ Neelikon is an ISO 9001 : 2008, FSSC 22000 (ISO 22000 + PAS220) & GMP Certified Company ◗ Neelikon colours are: Halal, Kosher, ISI & Non-GMO certified ◗ Neelikon is REACH compliant ◗ Neelikon is committed to supply best quality colours, meeting legislative and statutory requirements by adapting good manufacturing practices consistently What were the challenges in the initial days of the business? How did you overcome them?

Initially, after our promoter/MD Mukund Turakhia’s graduation from UDCT (Now BUDCT at Matunga, Mumbai) as a chemical engineer, we started the production of food colour Sunset Yellow with indigenous technology contribution from our in-house technical team. Today, apart from purity of the food colour, we look for other parameters like level of subsidiary dyes, metallic content, dyes intermediates etc. At that time there was no concept of purity of raw materials. After entering in this business, our challenge was to cater to the Indian market as well as to manufacture quality product complying with international norms like the US FDA. For the same, we worked hard to develop our indigenous technologies to manufacture colours complying with US FDA Norms.

When we started manufacturing, there was no awareness in the Indian market about quality with respect to purity. There were many challenges, being an Indian manufacturer in the global market, we have to depend on other countries for feedstock. In those days, it was challenging to get the raw material [irrespective of quality]. After receiving the raw

materials, the second task was to manufacture the product from available raw materials and there was no choice for selection of raw material supplier. Initially, we had to face many problems due to lack of awareness about the quality of raw materials. We were not aware about the right quality of raw materials.

After gaining experience, we started our in-house facility to process raw materials procured from the market to get the right quality as per our expectations. The next challenge was to market the finished product.

The physical appearance was a major parameter to confirm that we have manufactured the product. In order to cater to the local Indian market, the product needs to qualify as per BIS standards and for the same, we have developed our inhouse analysis facility. To comply with the specifications by global bodies like the US FDA, JECFA and Japanese FDA, we have to manufacture the product and test it before they are dispatched. A majority of the FDA testing was done by sophisticated analytical instruments. To get command over analysis, we trained our manpower, procured instruments and developed our sophisticated instrumental analysis facility. One of our strong point is from day one i.e. since the inception of Neelikon, we treat our customer feedback/complaints as suggestions for progress. Every customer’s complaints/suggestions are evaluated properly at our organisation irrespective of our business [whether for 1 kg order/ 1000 kg order]. Quality improvement based on the feedback from any customer is not only maintained for a particular customer but passed on to all of them.

Water soluble dyes were originally produced as fine powders.

The customers complained about the these colour powders due to the problem of dusting. We overcame the problem by offering some of our products in granule form.

So, if we look back on our business before 1990, there were only chemical test methods for evaluation of food colours. Today, Neelikon analytical laboratory is well equipped with sophisticated instruments like: ◗ Inductively Coupled Plasma [ICP] ◗ HPLC chromatographic Systems ◗ Spectrophotometer ◗ Color matching spectrophotometer

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

45

March 16-31, 2016

PHARMA ALLY ◗ Particle size analyzer Which industry is more challenging as far as manufacturing colours are concerned? Why? All are the same. Since the end use of the colour is for human consumption, it is our duty to make them aware about correct selection and application of colour with respect to quality.

Colourants are mainly used to impart a distinctive appearance to pharma dosage forms. There are many types of pharma formulations which need to be coloured such as tablets, tablet coatings, capsules (hard gelatin, soft gelatin), liquid orals, tooth pastes, ointments etc. The purpose of colouring varies with different formulations.

Colouring may be required to increase the aesthetic appearance, prolong the stability, produce standard reparations or for identification of a particular formulation. Colour psychology says that the colour of the product may also influence the efficacy of the therapy.

Colours are important in many pharma applications.

Pharmacists consider colour and shape as the most important attributes for

20 per cent.

LIST OF AWARDS RECEIVED Sr.no.

Year

Award Name

1

2002

Achieving good performance for most people is a journey not a destination. Invited for a lecture on scope of colours in food in India at the office inauguration of “The Society of Dyers and Colorists UK, Mumbai Region & Department of Dyestuffs Division UICT”In Mumbai

2

2003-2004

Udyog ratna puraskar in Konkan region of Raigad district

3

2004 -2005

Lalit Doshi Memorial Award.Awarded by Lalit Doshi Memorial Foundation & SICOM in recognition of outstanding performance in Maharashtra

4

2012

ECGC - D&B indian exporters' excellence awards 2012 for best manufacturerexporter (Small).

LIST OF CERTIFICATIONS RECEIVED Sr.no.

Year

Certification Name

1

2012

ISO 9001:2008

2

2012

GMP

3

2013

FSSC 22000

4

2013

HALAL

5

2014

STAR-K KOSHER

patients to identify medications. Coloured tablets significantly reduce medication errors.

Thus, the prime priority of colourants is to increase the aesthetic appearance of the product, so we can say that the colourants are the cosmetics for pharma

formulations.

Give details of your manufacturing plants (capacity, products, markets etc).

We have two manufacturing units situated at Dhatav which is 130 km away from Mumbai.

We have a total of 13 plants

and produce more than 70 products.

What percentage of your revenue comes from pharma business? What is your global share as far as pharma grade colours are concerned?

Our present revenue in India from pharma is approximately

How will you differentiate Neelikon from its competitors?

In line with our Prime Minister’s goal of 'Make in India', we are a proud Indian manufacturer competing with the best in the world. We compete against world class producers from the US and Japan. We consider our competitors as our strength.

Healthy competition is always good for all in the industry and of course, for our customers who will get a world class product and service.

What are your expansion plans? Do have any pharma industry-specific expansion plans?

Expansion is a continuous activity at Neelikon. We have plans to further expand in 2016-17 with new manufacturing plants for some of our fluorescent dyes and cosmetic dyes as also increasing the capacity of ETP, warehouses and sales offices. In the market there is an increasing awareness to use quality food colours and customers have started enquiring about the impurities present and its effects on human beings, especially children. sachin.jagdale@expressindia.com

POST EVENT

HEL group,UK with Skytech Systems India organise conference and workshop The conference was attended by 50 participants HEL GROUP, UK, in association with Skytech Systems India, recently organised a Process Development Conference and Workshop in Goa. The conference was attended by 50 participants where research ideas were shared with the audience. Presentations were held on the role of simulations tools and vent sizing for

46 EXPRESS PHARMA March 16-31, 2016

process optimisation and safety. The objective was to discuss applications and share experiences from a wide range of industries.

Topics on parallel process development solutions, high pressure catalytic/hydrogenation tools, calorimetry and process hazard assessment, automated bench and pilot

scale reactors, bioreactors, focusing particularly on R&D requirements were discussed.

Dr Neha Hebalkar, Scientist, ARCI presented her unique work on special solzee for thermal insulator. The process safety and scale up operation insight was explained by Dr Deepak Jain, Team leader and Head, Zoetis

and Vijay Chandratre, Vice President, AARTI. Also present were Amin Ismaili, Techincal head – Alembic, Dr Madhavan Buddha, Scientific Manager-Biocon and Dr Kirubagaran, Group head – marine biology, NIOT and Shravan Chandrashekar, Manager, DRL. EP News Bureau-Mumbai

PHARMA ALLY VENDOR NEWS

TAKE Solutions opens first pharmacovigilance peer network with PVIndia PVIndia is a membership-based network of emerging global pharma companies from India to meet and discuss some of the industry’s common challenges in pharmacovigilance TAKE SOLUTIONS announced the first meet of PVIndia, a unique pharmacovigilance peer network, organised and managed by one of TAKE’s Life Sciences division, Navitas.

PVIndia is a membership-based network of emerging global pharmaceutical companies from India to meet

The inaugural meeting was attended by 25 drug safety professionals representing 14 Indian pharma and global pharma companies

and discuss some of the industry’s common challenges in pharmacovigilance (drug safety). PVNet is a neutral platform for heads of drug safety from India to meet where insights can be exchanged and strategies can be developed and shared.

The inaugural meeting was attended by 25 drug safety professionals representing 14 Indian pharma and global pharma companies. The

key discussion topics at the event were, global harmonisation of regulations, how companies adapt to a variety of international regulations and inspection readiness. Navitas plans to organise the second edition of PVIndia in October.

Ram Yeleswarapu, President and CEO, TAKE Solutions said, “We are pleased to announce the introduction of our networks to India. The scale and convenience of collaboration facilitated by the network meets will explore and help generate new solutions to the challenges faced by players in the Indian pharma landscape.” He added, “The ambition for PVIndia is to become an active think tank to improve safety practices across India, in order to ensure the ongoing protection of public health and increase awareness of the importance of drug safety amongst healthcare professionals and patients.’’

“I am glad to be a part of the inaugural meet of PVIndia. At times when Indian companies like their colleagues in the US and EU are frequented by inspectors of internal health authorities, there exists significant strain on any organisation.

Being prepared for any inspection is a priority for the Indian pharma industry in such scenarios,’’ said Dr K Bangarurajan, Deputy Drugs Controller of CDSCO West. He further added, “PVIndia will help companies to prepare for inspections triggered by these regulations.’’

To subscribe: bpd.subscription@expressindia.com

EP News Bureau-Mumbai

EXPRESS PHARMA

47

March 16-31, 2016

PHARMA ALLY

Waters unveils new line of calorimeters, new solid-core column chemistries Glycan Analysis Kit has saved biopharmaceutical industry nearly four years of lab work WATERS CORPORATION unveiled its new line of differential scanning calorimeters reaffirming TA Instruments' position as the technology and global leader in thermal analysis at the 2016 Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy.

Additionally, the company highlighted new CORTECS column chemistries and reported that its GlycoWorks RapiFluor-MS N-Glycan Kit has already saved biopharmaceutical laboratories industry-wide approximately four years of work based on sales in just its first year of availability.

The new line of Differential Scanning Calorimeters, the Discovery DSC 2500, DSC 250, and DSC 25 feature enhanced sensing technologies resulting in unprecedented performance in baseline flatness, sensitivity, resolution, and reproducibility.

At the core of every new Discovery DSC is the exclusive TA Fusion Cell, which incorporates design concepts that 'fuse' together features of the Q-Series and first generation Discovery DSC, patented Tzero technology, and new proprietary manufacturing processes. Addition-

ally, an app-style user interface is standard with each new model and combined with powerful new TRIOS software, automated calibration and verification routines work seamlessly to dramatically improve laboratory work-flows and productivity.

The Discovery DSC measures the change in energy in a sample as the temperature is raised or lowered. It is used for a wide range of applications, including material science, pharmaceuticals, chemistry and studies of biomaterials. It excels in both research environments and production control processes.

The DSC 2500 comes standard with all options, which includes the all-new linear autosampler that allows for enhanced flexibility in assigning sample and reference pans to any combination of the available 54 positions. We believe that it is the only DSC on the market capable of making and storing heat capacity measurements in a single run.

The DSC 250 is a flexible and configurable researchgrade DSC that includes Tzero technology, and is well-

equipped to satisfy the most demanding researcher. The DSC 25 is a cost-effective, easy to use, general purpose DSC with performance superior to competitive research grade systems. It is ideal for research, teaching, and quality control laboratories that require a rugged, reliable, basic DSC. Emphasising the impact of its innovations, Waters revealed that its GlycoWorks RapiFluorMS N-Glycan Kit has already saved biopharma laboratories industry wide approximately four years of work in just its first year of availability. These calculations are based on purchases by all 15 top revenue generating pharma companies and 90 per cent of the top biopharma companies with glycoproteins in their pipeline.

Most biotherapeutic proteins available in the market today are glycoproteins. The heterogeneous glycan populations on these proteins are critical quality attributes that affect potency, stability, and therapeutic safety profiles. As a result, biopharma companies must provide detailed structural information pertaining to the glycans attached to their bio-

therapeutics when submitting new applications to regulatory authorities and on an ongoing basis throughout the manufacturing process. Waters estimates about 4.4 million released glycan analyses are performed per year, and that number is growing at double digit rates.

A ground-breaking technology for characterising glycoproteins, the GlycoWorks RapiFluor-MS N-Glycan Kit combined with Waters' ACQUITY UPLC System, the ACQUITY UPLC FLR Detector and the ACQUITY QDa Detector, and enables scientists to analyse released N-glycans and achieve new levels of speed, sensitivity, simplicity while obtaining previously unattainable structural information.

Waters also added to its CORTECS Columns product family with the introduction of two new LC column chemistries. Built on Waters proven solid-core particle technology, the Waters CORTECS C8 and CORTECS Phenyl analytical columns are designed for scientists who need to expand their chromatographic separation space while maximising the

speed, resolution and sensitivity of their small molecule HPLC, UHPLC or UPLC separations. Capable of operating at very high column efficiencies and low back pressures, the new columns give scientists additional selectivity choices and allow them to develop methods quickly, and generate more information with every analytical run. The CORTECS C8 and CORTECS Phenyl chemistries are available in two particle sizes, 1.6 and 2.7 micron, and are offered in a total of 50 unique column configurations.

CORTECS C8 Columns exhibit a lower hydrophobicity when compared to typical bonded C18 phases and are useful for separating strongly hydrophobic compounds. They are also ideal for chemists looking to transfer or scale compendial C8 HPLC methods to a more robust column technology.

CORTECS Phenyl Columns are an excellent alternative to typically bonded C18 phases, particularly for aromatic compounds, based on the unique selectivity provided by the phenyl bonded phase.

EP News Bureau-Mumbai

SCHOTT India conducts its FIOLAX Scholarship Program Awards nine scholarships to meritorious students pursuing Bachelors (B Pharmacy) and Masters (M Pharmacy) degrees in pharmacy in Mumbai and Gujarat IN THE second year of SCHOTT FIOLAX Scholarship Program, SCHOTT awarded nine scholarships to meritorious students pursuing Bachelors (B Pharmacy) and Masters (M Pharmacy) degrees in pharmacy in Mumbai and Gujarat.

Seven B Pharmacy stu-

48 EXPRESS PHARMA March 16-31, 2016

dents, Rachana Subhash Kelkar, Deepika Ratanlal Patel, Rehman Irfan Jirait, Rupali N Madapura, Vrishali Salian, Malvika Rangu Chandnani and Deep Raithatha, and two M Pharmacy students, Shachi Vipulkumar Bheda and Khushboo Patel were awarded gift cheques of

` 25000 each by Sundeep Prabhu, Vice President Sales and Marketing, SCHOTT Glass India, during a special award ceremony.

The winners have also been offered an exclusive tour of SCHOTT Glass Indiaâ&#x20AC;&#x2122;s pharmaceutical tubing plant in Jambusar district,

Gujarat.

The process of selecting candidates for the SCHOTT FIOLAX Scholarship Program 2016 was completed in December 2015, in which nine meritorious students were shortlisted from various colleges in Mumbai and Gujarat.

More than 100 applicants

were able to clear the eligibility criteria that demanded more than 70 per cent in Second Year for B Pharmacy and M Pharmacy students. It took more than six months to complete the screening process.

EP News Bureau-Mumbai

PHARMA ALLY PRODUCT

BOGE sets new standards in the 11 kW performance class THE NEW oil-injection cooled screw compressor C 16 F(D) from BOGE sets new standards in the 11 kW performance class. Its excellent specific characteristics predestine the new BOGE C 16 F(D) compressors for achieving high energy savings. With its broad control range, it caters for widely fluctuating compressed air demand. A silenced intake filter and sturdy grey cast iron housing afford extremely quiet operation even when working at full capacity – enabling it to operate right at the workstation. The optionally available focus control 2.0 intelligent

compressor control can be used with up to four compressors and lends itself to Industry 4.0 applications.

BOGE C 16 F(D) provides the highest free air delivery in the 11 kW compressor segment – despite its extremely low speed level. This is the result of using the BOGE compact compressor air-end from the effilence family which trumps with outstand-

ingly low specific power consumption due to its high-efficiency IE3 motor.

With this minimal power consumption rating and the extremely low flow losses, these belt-driven BOGE C 16 F(D) compressors achieve record energy efficiency. Their sound pressure levels also get top ratings – the C 16 F(D) is one of the quietest compressors in its class.

The advantages of integrated frequency control are particularly apparent when compressed air demand fluctuates: The frequency converter provides continuous free air delivery in the roughly 25 – 100 per cent control range. The free air delivery is constantly matched to the operating conditions. If the demand for compressed air drops off, compressor energy use also falls. Idling times are virtually eliminated in this way. Customers who use BOGE C 16 F(D) screw compressors achieve energy savings of up to 30 per cent as a result.

The design of BOGE’s C series is both intelligent and simple. All maintenance-relevant parts are arranged for easy reach to minimise waiting times.

Equipping these compressors with additional options such as a refrigerant dryer or the focus control 2.0 intelligent compressor control makes them into flexible all-rounders. It is not without reason that customers can choose between different versions: The models in the C 16 F(D) series are available with a maximum pressure of 8, 10 and 13 bar and free air delivery from 0.46 to a maximum of 1.99 m3 per minute.

Contact details BOGE India #216, Third Link Street Nehru Nagar Industrial Area, Kottivakkam, Chennai - 600041 Franklin Comforter Jayakaran, Country Manager, BOGE India Tel: +91 44 4359 3454 Fax: +91 44 4359 3452 E-mail: fc.jayakaran@boge.com www.boge.in

To subscribe: bpd.subscription@expressindia.com

EXPRESS PHARMA

49

March 16-31, 2016

BUSINESS AVENUES

EXPRESS PHARMA

2

Designers, Engineers & Manufacturers of Machinery & Filteration Equipments for:

es Decad ies. ustr Over d In to ice of serv ing Stronger Grow t & Integrity us with Tr

Pharmaceuticals, Packaging, Chemicals, Food, Beverages, Distilleries, Breweries, Paints, Food, Oils & Consumers

MAJOR PRODUCTS MANUFACTURED AT UNIPACK Linear Vial/Bottle Washing Machines Sizes: vials 2ml to 100 ml & Bottles 15 ml to 500 ml Scramblers/Unscramblers Sizes:24” dia, 36” dia. 48” dia 60” dia Hydraulic Loading Platforms Inspection Tables Loading and unloading Conveyors Liquid Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials Powder Filling, Rubber Stoppering & aluminium Cap sealing Machines for Vials

Sterlity Testing Units in S.S. Sizes: Single Place, Three Place & Six Place Plate and Frame Type Filter press in SS Size: 20 cm X 20 cm, 40 cm X 40 cm, 60 cm X 60 cm, 100 cm X 100 cm Zero hold up/Sparkler Filter press Size : 600 LPH to 15500 LPH Sterile Pressure and Storage Vessels Size : 10 ltrs to 500 ltrs Membrabe Filter Holders (Size: 293 mm, 142mm, 90mm) Inline Filter Holders (Size:47mm, 25mm, 13mm) Basket/Bag/Catridges Filters

We Supply different sizes of Filter Sheets and Filter Modules of Major International Brands

Our Achievements: Over 2500 installations of our major products manufactured in-house are supplied to all Leading Companies in India & Multinationals abroad

EXPRESS PHARMA

March 16-31, 2016

51

BUSINESS AVENUES

52

March 16-31, 2016

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

March 16-31, 2016

53

BUSINESS AVENUES

54 March 16-31, 2016

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

March 16-31, 2016

55

BUSINESS AVENUES

56 March 16-31, 2016

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

March 16-31, 2016

57

BUSINESS AVENUES

58 March 16-31, 2016

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

March 16-31, 2016

59

BUSINESS AVENUES

60 March 16-31, 2016

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

March 16-31, 2016

61

BUSINESS AVENUES

62 March 16-31, 2016

EXPRESS PHARMA

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

PAMS HVAC CONTROLS

C L E A N R O O M H VA C S O L U T I O N

PAMS HVAC executing turnkey HVAC & Clean room project. Comprising Design, Supply, Installation, Commissioning & Validation Certificate of DQ, IQ, OQ &PQ of HVAC & Clean room system rating from class 100 to class 100000 with control Pressure, Temprature, Relative humidity & Filteration suitable for clean room system.

Product Range

Double Skin AHU with DX / Chilled Water Coil.

HEPA, Microvee & Prefilters.

Pass Box, Air curtain, Dispensing / Sampling booth in SS / CRCA Mumbai : 2/4, BMC Tenament Bldg., G.D. Ambekar Marg, Dadar (E), Mumbai -400 014 Goa : 581/2, Tuem, Pernem, Goa - 403 512 Tel.: +91-22-24124257 • Mob.: 09322298502 • Email : pamshvac@gmail.com

EXPRESS PHARMA

March 16-31, 2016

63

BUSINESS AVENUES

EXPRESS PHARMA

To Advertise in

Business Avenues Please Contact: ■

Mumbai, Ahmedabad: Rajesh Bhatkal 09821313017 ■

Delhi: Ambuj Kumar 09999070900 ■

Chennai: Arun J

91-9940058412 ■

Bangalore: Amit Tiwari 8095502597 ■

Hyderabad: Mujahid 09849039936 ■

Kolkata: Ajanta 09831182580

64 March 16-31, 2016

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

March 16-31, 2016

65

BUSINESS AVENUES

EXPRESS PHARMA

SILICONE TRANSPARENT TUBING DMF No.

Certified Cleanroom

Braided

Peroxide Cured

With End Fitting

Platinum Cured US FDA regulations CFR 177.2600 for contact with food USP class VI requirements European Pharmacopoeia 3.1.9 Animal derivative free

INDIA

QM 002

205 & 206 Hill View Industrial Premises, Amrut Nagar, Ghatkopar (W), Mumbai - 400 086, India.

Tel.#:022-2500 4576 E-mail :sales@mksilicone.com

66 March 16-31, 2016

Blue Heaven

M. K. Silicone Products Pvt. Ltd.

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

March 16-31, 2016

67

BUSINESS AVENUES

EXPRESS PHARMA

Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

www.criverindia.com

OSMOMETER 3250

Milk Cryoscopes Available

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

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in 68 March 16-31, 2016

EXPRESS PHARMA

BUSINESS AVENUES

EXPRESS PHARMA

Turnkey Solutions Pvt. Ltd.

CLEAN ROOM TURNKEY SOLUTIONS

CLEAN ROOM PARTITIONS & DOORS

PPGI / PCGI Modular Panels

Walk able / Non- Walk able False Ceiling

Flush Metal Doors

Various Insulations like Rockwool / PUF / PIR

HVAC SERVICES

Air Handling Units

Pre Fabricated Ducts

Air Distribution Products

Validation

CLEAN ROOM EQUIPMENT

Static Pass Box

Mobile LAF

Dynamic Pass Box

Bio Safety Cabinets

Laminar Air Flow Units

Air Showers

Sampling/Dispensing Booth

Garment Storage Cabinet

108, Swastik Regalia, Off Ghodbunder Road, Waghbil, Thane West-400615

@

sales@pharmintech.net

EXPRESS PHARMA

www.pharmintech.net

022-2597 1641 / 42

+91 - 992 032 4980 / + 91 - 809 777 9747

March 16-31, 2016

69

BUSINESS AVENUES

EXPRESS PHARMA

WANTED ASOUTH INDIAN PHARMACEUTICAL COMPANYhaving Marketing Network in South India,Maharashtraand parts of North India worth Rs 15 Crore is looking to sell its Registered and Non Registered Marketing BrandsApprox 100 Products.

Interested parties readyto invest more than 20 Crores Maysend their details to Email: medicalhub2016@gmail.com 70 March 16-31, 2016

EXPRESS PHARMA

PHARMA LIFE INSIGHT

Hiring right: Pivotal to progress Amogh Deshmukh, Member, Key Leadership Team, DDI India, speaks on the role of HR leaders in ensuring that the right person is hired for the right role in pharma organisations

AMOGH DESHMUKH, Member, Key Leadership Team, DDI India

I

asked at an interview. Like I said earlier, a smart candidate can lead you to ask questions he/she wants. Another fact is that all these questions are heavily tilted towards knowledge and knowledge alone. Hence, if a candidate has prepped an evening before it becomes relatively easy to give the ‘right answers’.

n the last two articles we saw how rapid growth in the pharma sector can lead to challenges in succession planning and leadership development. But I want to remind all that a good leadership development programme cannot substitute a poor selection process.

Statistics will show that middle and senior levels of most pharma organisations are stable and they don’t have attrition figures that would bother anyone, but that does not take away the importance of hiring the right fit for your organisation.

Over the years I realised that there are two types of HR leaders when it comes to hiring; and the other type of leaders who with time and experience learn to spot the right person for a job.

Many of us might believe that we can tell who is the right person for a job. Well, in a few cases you might be right, but not always.

Most of us have a huge blind spot and rather find it difficult to accept that we need to develop this skill.

Retrospect on the few of the recent interviews you have conducted and think of the type of questions you asked the interviewer.

The first question and a favourite at almost all interviews is, ‘Tell me something about yourself?” Most of us don’t ask this question because we really want to know about the candidate. It’s often because we have not found time to review the resume. I can see you are smiling. Well, research shows that reviewing a resume is one of the most important steps that the interviewer must complete before the start of an interview.

This step is to prepare the interviewer. On searching for questions like, ‘How to crack an inter-

Some important facts that every HR leader should know: 1. The top talent of your competition need not always be the top talent of your company 2. Top talent will not leave their organisation unless something has gone majorly wrong 3. The most average talent would like to portrait them as the top talent of competition If the above statements are true then how would you differentiate talent and hire the one you need. I would recommend three simple steps:

Define the target role well

view’, ‘How to prepare for an interview’ etc, you will find that there are many websites which inform the interviewee what to say and how to say it. Remember, that a smart interviewee knows how to lead the interviewer to a place where he/she wants.

Then comes, ‘Tell me how series’ of questions. Most interviewers go through a series of very fact-based or knowledgebased questions. For e.g., Tell me how the following is done; tell me how this works etc. These questions are very theoretical in

To subscribe: bpd.subscription@expressindia.com

nature. So, most good candidates would have refreshed themselves on these queries just an evening before the interview.

Next is the, ‘How would you series’. These are questions that do have lot of theory but I like to call them fantasy-based questions because the candidates may not have experienced such a situation but is allowed to answer how ideally he/she would have dealt with it, if it occurs. It’s the easiest ball to hit out of the park and the candidates are well prepped to give answers to questions that are based on

hypotheses. Most of the interviewees are well aware that even if they get selected they may never have to live through these situations in actuality.

Another commonly asked question is, ‘What do you know about this company and the job you applied for?’ Candidates know how to respond to this question as well as most of the information about the company and the job is provided on the company’s website.

Thus, it means that the candidates nowadays are well aware of the questions they might be

It all starts with the end goal in mind. Whatever the role, one needs to understand what it would take to be successful in this role. We call this a ‘Success Profile (Check figure A). It comprises knowledge, experience, competencies and personal attributes. As we start going higher up in the hierarchy, personal attributes become very significant. In fact they get so critical at the top that they can over shadow every other factor if not managed well. But for lower levels the other three aspects are more relevant and rather than interviewing for conceptual clarity one need to assess the applicants’ experience in the past job. By interviewing the leaders and employees of the target role one needs to build a

EXPRESS PHARMA

71

March 16-31, 2016

PHARMA LIFE clear picture of how the role plays out in the organisation. It would be difficult to compare and contrast with other competing organisations as the drivers of these elements are very different. They are impacted by the culture of the organisation, the stage of evolution that role or organisation might be in at this point, etc. The best solution is to define it as per your organisation’s needs. If you anticipate any changes in external factors (market, government policies, etc.) in future and require changes in the role then modify it accordingly. This will allow you to review what works for your organisation.

2) Interview the applicant to understand his/her knowledge and competencies in the past job A simple rule of the thumb that works is, ‘Past behaviour predict future behaviour’. Hence, the questions need to be targeted to-

wards the recent past jobs of the applicant and how he/she applied his/her learnings into it.

This provides the interviewer with the right information as it highlights whether the candidate is really experienced and how he/she would respond to a similar problem, if it occurs. A few might argue that it doesn’t take much to fake the same, but a trained interviewer can pick up clues and judge whether the candidate is being truthful or not.

This approach calls for a big mindset change from the traditional approach, as it interprets an interview as a data gathering exercise and not a judgement call. Hence, this is a radical shift from what we are trained for.

When you suspend the judgement, you get less impressed by the responses and your focus is on data collection. Post the interview, the interviewer gets enough time to review the data and score/decide on the next steps. This prevents biases from

A study should be conducted to understand what your organisation and your job has to offer the prospective candidate creeping into the interviewing process.

Now the interviewer is working towards a plan, he has set questions to get responses, and can score/compare them between the candidates reviewed. This allows reducing the Type A/Type B errors during interviewing.

3) Define and hire the

right person towards the target role We link this towards the retention likelihood of the probable candidate in the job at your organisation. A very simple study needs to be undertaken to understand culturally what your organisation and your job has to offer the prospective candidate and whether he/she enjoys the same. For instance, if the job has lot of quick decisions to be made on operational tasks and the candidate doesn’t enjoy the same, you know the person will feel very frustrated in this job as he/she will be confronted with decisions too often. On the flip side, if the job has too many processes and procedures to be followed and the candidate loves to follow processes you have your guy. He will enjoy a job where there is less ambiguity and more well documented processes to follow. Similarly, there are many elements that the organisation, its culture,

and the job has to offer which to a person working day in and day out will not notice or feel is important. But, this can be a big enough trigger for someone to stay in the job or leave immediately. Interviewing for these along side other things is highly recommended so you are not up for unpleasant surprises.

In conclusion, the war for talent is only going to get fierce in the pharma sector and leaders need to be equipped to hire, develop or grow talent within the organisation. For long we have looked at hired and developed employees for the technical side. Make in India could be a distant dream if the softer elements of talent and leadership management are ignored.

With capital one can buy equipment, but it is people who are needed to run them. If we don’t start investing in them right now we might be ignoring the most important element – ‘the human capital’.

S N A PS H OT

Cadila Pharmaceuticals recently organised a women’s cricket match on the occasion of International Women’s Day at Dholka and Bhat Corporate Campus. The match started with a cake cutting ceremony to celebrate birthday of February born pharma Cadilians.

72

EXPRESS PHARMA

March 16-31, 2016

conferenceseries.com Unique destination for Conferences

Publishing

Global Networking

Research

Exhibitions

Business

Collaborations

International Memberships

Careers

Advertisements & Promotions

Are you thinking about working in the pharmaceutical industry? Do you know where to start and do you have the skill sets to enter the sector?

Want to showcase your industry/organization with decision makers in pharma from Asia, Europe, USA, Middle East and other continents across the Globe? Meet the best and largest Assembly of Pharmaceutical competitive Intelligence executives in the World!

Pharmaceutical Conferences & Expos 8th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems March 07-09, 2016 Madrid, Spain

5th Global Pharmacists Annual Meeting July 14-16, 2016 Brisbane, Australia

5th International Summit on GMP, GCP & Quality Control Aug 15-16, 2016 Toronto, Canada

Asia-Pacific Drug Formulation & Bioavailability Congress Sep 05-07, 2016 Beijing, China

6th International Conference and Exhibition on Biologics and Biosimilars Oct 19-21, 2016 Houston, USA

International Conference on Advances in HPLC and Chromatographic Techniques March 14-15, 2016 London, UK

International Pharmacy Conference July 14-15, 2016 Philadelphia, USA

6th Pharmacovigilanace Congress Aug 15-17, 2016 Toronto, Canada

2nd International Conference and Expo on Biopharmaceutics Sep 14-16, 2016 San Antonio, USA

International Pharmaceutical Method Development and Validation Conference Oct 20-22, 2016 Dubai, UAE

International Conference and Expo on Industrial Pharmacy April 28-29, 2016 Dubai, UAE

4th European Pharma Congress July 18-20, 2016 Berlin, Germany

Pharma Expo Aug 22-24, 2016 New Orleans, USA

4th Global Experts Meeting on Neuropharmacology Sep 14-16, 2016 San Antonio, USA

International Conference and Expo on Generic Drug Market and Contract Manufacturing Oct 31-Nov 02, 2016 Barcelona, Spain

5th Global Pharmacovigilance Summit April 28-29, 2016 Dubai, UAE

Euro Pharma Expo July 18-20, 2016 Berlin, Germany

2nd International Conferences on Clinical Trails Aug 22-24, 2016 Philadelphia, USA

7th International Conference and Exhibition on Pharmacovigilance Sep 19-21, 2016 Vienna, Austria

2nd International Conference and Expo on Seperation Techniques Oct 31-Nov 02, 2016 Barcelona, Spain

7th Global Pharma Summit Aug 22-24, 2016 New Orleans, USA

Global Pharmaceutical Industry Summit Sep 19-21, 2016 Vienna, Austria

2nd International Conference and Expo on Parenterals & Injectables Nov 07-09, 2016 Istanbul, Turkey

2nd International Conference and Exhibition on Europe Surgical and Medical Devices Expo Pharmacology and Ethnopharmcology July 18-20, 2016 Berlin, Germany May 02-04, 2016 Chicago, USA 5th European Biosimilars Congress June 27-29, 2016 Valencia, Spain

2nd International Conference on Current Trends in Mass Spectrometry July 20-22, 2016 Chicago, USA

Medical Devices Expo Aug 24-25, 2016 New Orleans, USA

6th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR Sep 29-Oct 01, 2016 Miami, USA

World Pharma Congress Nov 07-09, 2016 Las Vegas, USA

9th World Drug Delivery Summit June 30-July 02, 2016 New Orleans, USA

International Conference on Marine Drugs & Natural Products July 25-27, 2016 Melbourne, Australia

7th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit Aug 29-31, 2016 Atlanta, USA

Asia Pacific Mass Spectrometry Congress Oct 10-12, 2016 Kuala Lumpur, Malaysia

2nd International Conference and Expo on Drug Discovery & Designing Nov 07-09, 2016 Istanbul, Turkey

6th Asia-Pacific Pharma Congress July 11-13, 2016 Kuala Lumpur, Malaysia

3rd World Congress on Pharmacology Aug 8-10, 2016 Birmingham, UK

4th International Conference and Exhibition on Pharmacognosy, Phytochemistry & Natural Products Aug 29-31, 2016 Sao Paulo, Brazil

2nd World Congress and Exhibition on Antibiotics Oct 13-15, 2016 Manchester, UK

International Pharma Marketing Nov 10-12, 2016 Alicante, Spain

pharmaceuticalconferences.com Our Global Supporters Virology-2014

Nanotek-2014

Harald zur Hausen Prince Mahidol Award (2005) Nobel Prize-Physiology/Medicine (2008)

Food Processing & Technology-2015

Vaccines Asia Pacific-2016

Physics-2016

Harold Walter Kroto M. S. Swaminathan Peter Doherty Nobel Prize-Chemistry (1996) Padma Shri (1967); Padma Bhushan (1972) Nobel Prize Michael Faraday Prize (2001) World Food Prize (1987), Padma Vibhushan (1989) Physiology/Medicine (1996)

Shuji Nakamura Nobel Prize-Physics (2014) National Inventors Hall of Fame (2015)

Meet Inspiring Speakers and Experts at our 3000+ Global Events with 600+ Conferences 1200+ Symposiums and 1200+ Workshops on Pharma, Medical, Engineering, Science, Technology, Business 700+ Open Access Journals OMICS International Conference Highlights • Global networking opportunities • B2B meetings & World class exhibitions • Live broadcasting of conferences across the globe • Panel discussions and interactive sessions • Young Scientists, Careers, Best Posters & Travel-Awards • Distinguished lectures & Prescheduled meetings

Our Imprints

OMICS International Journal Highlights • 700+ Open Access Journals • 21 Day rapid review process • 50000 Editorial team • 25 Million readers • Publication immediately after acceptance • Quality editorial and review processing

Conferences By Continent USA & Americas USA

Brazil

Canada

Asia-Pacific Australia

Mexico

China

India

Japan

Malaysia

New Zealand

Philippines

South Korea

Singapore

Europe & Middle East Austria

Denmark

Finland

France

Germany

Italy

Netherlands

Norway

Poland

South Africa

Spain

Switzerland

Turkey

UAE

UK

Ukraine

REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2016 – 18,PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001