Express Pharma (Vol.11, No.13) May 1-15, 2016

VOL. 11 NO. 13 PAGES 58

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Market ‘India is the hub of our global delivery network of services’

1-15 MAY 2016,` 40

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CONTENTS MARKET Vol.11 No.13 MAY 1-15, 2016 Chairman of the Board Viveck Goenka

FDC ban: Haste makes waste?

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 Design Editor Bivash Barua Asst. Art Director Pravin Temble Senior Graphic Designer Rushikesh Konka

Reacting strongly against the ban on 344 FDC drugs, industry veterans call it a hasty decision and question the government's drug process which had earlier granted approvals to these drugs | P28

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‘INDIA IS THE HUB OF OUR GLOBAL DELIVERY NETWORK OF SERVICES’

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CII ORGANISES 13TH NATIONAL PHARMA CONCLAVE

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100+ PARTICIPANTS DISCUSS PRO-ACTIVE STRATEGIES FOR T&T DEPLOYMENT AT CMO SEMINAR

Senior Designer Rekha Bisht Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Ravindra Pawar - South 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

P25: INSIGHT Maharashtra, the pharma capital

RESEARCH

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THE IMPORTANCE OF SKILL FROM RESEARCH TO DELIVERY OF VACCINES

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COMMON MEDICINES TIED TO CHANGES IN THE BRAIN

P26: INSIGHT Pharma sector in Maharashtra till now and it will be…....

P34: INSIGHT Assessment of pharmacy registrations and renewals

P LIFE

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SCHOOL OF PHARMACY, LLOYD INSTITUTE OF MANAGEMENT & TECHNOLOGY ORGANISES MEGA PHARMA JOB FEST 2016

Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan

P52: APPOINTMENT

CIRCULATION Circulation Team Mohan Varadkar

MindCraft Software appoints Amol Bavdekar as CEO

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

To switch or not to switch ...

A

notice dated March 30 from the Drug Controller General (India) asking for ‘science-based suggestions/comments’ on the pros and cons of replacing animal-based gelatin capsules with cellulose-based capsules has pharma companies wary and capsule manufacturers in a panic.

The notice has asked for suggestions in six weeks, but there is no indication of the timeline post the mid-May deadline. However, given that the Bureau of Indian Standards (BIS) released guidelines for the production of cellulose-based capsule shells last year, some industry experts caution that the DCGI’s call for comments is the last stage in a consultative approach before a decision is taken.

India is not the only country to consider a ban on gelatin-based capsules. The BIS document released in January last year mentions that the cross linking of gelatin and drug incompatibilities as well as the strict regulations regarding the use of animal-derived gelatin requiring the absence of bovine spongiform encephalopathy (BSE), encouraged the search for gelatin replacements.

Such replacements have been in use for certain powdered herbs and dietary supplements, where, as pointed out by the BIS paper, a modified naturally occurring polymer cellulose considered safe for human consumption, hydroxypropyl methyl cellulose (HPMC) more commonly known as hypromellose, seems to have become the replacement of choice.

With a sizeable vegetarian population in the country, the move to switch from animal-based to vegetarian/cellulose-based capsule shells would obviously have many takers. But capsule manufacturers estimate that cellulose-based capsules might be more expensive than gelatinbased one, though this claim has not been backed by any numbers so far.

Also, the DCG(I)’s notice does not give any hints on to the scope of the switch (i.e. will all capsules have to be cellulose-based or will this be restricted to some medications?) Secondly, how much time will the industry be given to make this change? Lastly, will this change in the ingredients will need approval and if yes, does it have to be from the state and/or central agencies.

Seen in the light of recent orders, like the slashes in drug prices and the ban on 344 FDC medicines, this switch to cellulose-based capsules could be just a matter of time. As with the first two, the government will not back down once it has taken a decision unless industry can come up with ‘sciencebased suggestions/comments’ to either switch or not to switch.

10 EXPRESS PHARMA May 1-15, 2016

Seen in the light of recent orders,like the slashes in drug prices and the ban on 344 FDC medicines,the switch from gelatinto cellulose-based capsules could be just a matter of time

The May 1-15, 2016 issue presents a wide range of perspectives on the ban on FDCs. (See story: FDC ban: Haste Makes Waste?. Pages 28-33) While there is acknowledgment from most industry experts that many irrational FDCs needed to be weeded out, there is also a consensus that we must not regret the rationale of FDCs. What is needed is cool headed reasoning on all sides, much before each takes a stance which is difficult to reverse.

The regulator is willing to clarify and make some small concessions, whenever presented with sound logical arguments. For instance, DG Shah, Secretary General, Indian Pharmaceutical Alliance (IPA) gives one instance. After concerted efforts over nine months to do away with the retrospective pricing, the only tangible change conceded by the NPPA is to clarify in its office memo (OM) dated April 13, that ‘Recalling or re-labelling or restickering on the label of container or pack of released stocks in the market prior to date of notifications, is not mandatory, if manufacturers are submitting revised price list... and are able to ensure price compliance at the retailer level.’ (See story: http://bit.ly/1SGZFx6; Recalling stocks to relabel drugs with revised prices not mandatory: NPPA).

While this interpretation will address the practical problems faced by pharma manufacturers with regards to procuring stickers and handling the logistics of recalling and re-labelling batches, it is clear that the pricing authority is not letting the manufacturers completely off the hook.

To what extent are they expected to go to ‘ensure price compliance at the retailer level?’ Most companies, at least the larger ones, will not want to take chances and prefer to go the re-labelling/ re-stickering route. Retail associations have already informed the NPPA that this is the option they prefer.

The April 13 OM from the NPPA also cites the Supreme Court’s decision in the GlaxosmithKline Pharmaceuticals case, wherein the SC has held that ‘A consumer approaching a chemist/retailer can hardly be offered two prices for the very same product based only on the difference in batch numbers. Consumer must get the benefit of the notified price.’ In this game of passing the buck, the manufacturers stand to lose the most so they would prefer to play safe. A similar outcome could be in the offing on the gelatin versus cellulose-based capsule issue. In a toss up between health concerns regarding BSE and cost-competitiveness, which argument will prevail? Or is there a middle path?

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET I N T E R V I E W

‘India is the hub of our global delivery network of services’ Reportedly the world's largest CRO, 34-year-old Quintiles has been through many phases. As its founder Dennis Gillings, CBE makes his farewell rounds of the company's global locations, his successor Tom Pike, CEO, talks about India’s strategic fit in the company’s future blueprint as a healthcare services leader, with Viveka Roychowdhury What percentage of global revenues comes from India?

Where does India fit into the company’s plan as it evolves further away from a traditional CRO into a healthcare services leader?

We serve two segments of the market. One is the Phase I-IV clinical development services or product development services, where the market size is about a $100 billion.

Approximately 74 per cent of our revenues come from product development services.

The second revenue stream is integrated healthcare services, where the market size is around $101 billion. We expect our markets (product development and integrated healthcare services) to grow at six-eight per cent per year from 2015-2018. As a company, our aspiration is to grow faster than our markets.

Asia, and that includes India, has been our fastest growing geographic market.

We have been growing faster than the market growth, which has been significant, in the mid teens. Interestingly, here in India our growth is two fold. We do provide clinical development related services and laboratory services, but a lot of our growth in head count has actually been to be the service centre for the world in Quintiles. We have around 6400 people here in India and most of them help the global business processes to make

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sure that we are as efficient, as effective and as high quality as we can be. India is the hub of our global delivery network of services.

Where are the other hubs besides India?

Our general strategy is that while we are very global, we are also very local. The work that needs to be done locally with physician investigators will be done on the ground in those countries. But much of the other work can be done in more standardised processes in cost efficient locations. So, we’ve created a global delivery network that consists of Eastern Europe, South Africa, India, China. There are other locations that we are looking at bringing in. What we try to do is bring very consistent processes and technologies so that we can do the work where ever it makes the most sense.

We can shift work to different locations, for load balancing and generally do work more cost effectively for our customers.

About a decade back, India was pegged to be a major global clinical trial hub.

These expectations are now tempered by more stringent regulator oversight. Though there have been some signs of a more moderate and transparent approach of late, how do you see that evolving in India?

We are pleased with the progress under Prime Minister Modi. When we look at the last couple of years, we think there has been progress on the issues that slowed and in some cases even stopped clinical research in this country. We still believe that our industry can be very helpful for India. There continues be a great burden of disease and our industry can provide solutions to that burden of disease. We are hopeful that the practices and policies that this government is putting in place will help open up the clinical research environment again.

It’s not without some caution that I say that because I don't think that every element has been solved yet. There are certain issues around informed consent, around investigators making sure that inspections happen according to global quality standards; that we think probably need a little

more work. But that being said, we are pleased to see the progress. We are hopeful, that we will have a healthy industry again because of the opportunity for both MNCs as well as India.

The pendulum has swung a little bit and there are signs of positive movement. The issue now is to instil confidence in our customers and even internally. There was so much unknown about what was going on. Now it is a matter of education, talking to our customers, etc. And we're already seeing some of the positive movement come through. It will take a little bit of time for us to get that back in place. Provided the government consistently moves along that path it will be helpful to all of us.

It's been said that in India, you can do two trials for the cost of one. But cost cannot be a differentiator in the long term, because there will always be a destination where it can be done cheaper.

What do you think should be India's USP when it comes to regaining stature as a globally trusted clinical trial/research destination?

If as a global executive, I take a step back, I see some wonderful and unique things about this country. You have a relatively young country in terms of the workforce, a couple of hundred million highly educated

individuals. You have this mixture of socio-economic levels associated with the country that give both the opportunity to have people who have good means financially to be able to access the latest medicines and care. But at the same time, we have the real need to take care of the indigent population here.

I think that it is a unique opportunity for India to, over time, become one of the world's leading players in drug development and drug manufacturing and production.

If we think about helping this population with this burden of disease and really taking innovative medicines like immuno therapies, to those areas of the economy and socioeconomic levels where it make sense to do it, I think it is a great opportunity. And on the manufacturing side, you've got experienced manufacturers here who have the opportunity to get into innovative drug development and become global leaders.

I personally think that the sky is the limit for this country.

I've been visiting India for a long time. I helped develop Accenture's strategy around India and I think there is a tremendous potential for this country to be one of the world's leaders associated with drug development and manufacturing.

What is your impression of

the talent pool for CROs in India? There has been some talk that the pool is not deep enough or wide enough and certain roles need to be sourced from outside the country. And since Quintiles was one of the earliest in this field in India, it has been the poaching ground for competitors. Some of your top management recently left to turn entrepreneur, like Dr Ferzaan Engineer, who has now set up his own home health venture. How do you keep filling your pipeline of internal leaders as well as attract and retain talent?

That’s true. What we are trying to do is use the same techniques as other world class professional services firms. So at times we will introduce some expertise from outside of the company. For instance in areas like biostatistics. Obviously, there is a tremendous population of mathematicians in this country but biostatistics for our industry is somewhat nascent here. We’ll infuse biostatiscians from other parts

of the world.

We’re also working to bring in high quality talent and train them ourselves. As the market leader, we have an obligation to be a trainer of resources, and not just poach people from other companies. We’re doing this on a global basis, not just here in India. We feel we have to have high quality training programmes, career mapping and pathing, programmes that make managers better executives. We are trying to offer a complete career opportunity for our people from the campus all the way to executive management. As the leader, that’s the torch that we carry.

What will be Quintiles' next strategic milestone towards the vision of making 'a meaningful difference in health and patient outcomes'?

Our vision is to bring people and knowledge together for a healthier world. So, while we are clearly the leader in the CRO industry right now, I’d like

us to be viewed as a healthcare services leader on a global basis. A key part of that will be how we help the pharma industry bring medicines to patients but over time, I’d like us to be able to use our deep expertise to help population health and make sure that the right medicines get to the right patients at the right time. Many of our physicians have a deep interest in working on care pathways for healthcare provision. I’d love to see us in the long-term work all the way from the biopharma industry to the practice of medicine and really help patients.

Could you give us an example of what that would mean?

A little known fact about Quintiles is that we are already working with hospitals to examine the care pathways they use to figure out which ones the most effective. This ranges from evaluating physician effectiveness, to care pathway effectiveness, meaningful use guidelines. The lion’s share of our business

today lies in making sure that our medicines are safe and that they work. We are trying to bring that knowledge all the way out to market access and helping providers be more effective.

This April, you complete four years in Quintiles, in April 2012. Did it help that you were considered an 'outsider' with no experience of working with pharma or CRO industry?

I have actually consulted with the pharma industry since 1994 when I headed the healthcare practice at Accenture. We looked at the sector as an intersection between the pharma industry, the payer and the provider. This gave us a very rounded view of how all these revolve around the patient and the electronic healthcare record. We believed that the information that drives the industry is consistent between all of those players.

And one of the things that is happening right now is that is very much becoming true. The

information about where patients are, things like registries, are becoming a centrepiece of both clinical development all the way to population health. I think that background positioned me well for where we are taking Quintiles.Quintiles has been fascinating. It’s got 36000 people around the world. We've actually grown since I've joined by 8000 people. The story of Quintiles, which completes 34 years this year, is that we’ve been a pioneer of the clinical development industry since our founding.

This parallels what we've done here in India. When we set up base in 1997, we were one of the pioneers in clinical research here in India. What we are trying to do today, is see how clinical research and commercialisation is evolving.

We want to be the leaders as our industry continues to evolve.

You spent 22 years at Accenture and were on the leadership team that prepared

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EXPRESS PHARMA

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May 1-15, 2016

MARKET Accenture for its IPO. Quintiles too went through the same phases, of going public, then private and then you helped take it public again a year after you joined. What was your mandate when you took over Quintiles from the company's co-founder Dennis Gillings, CBE, four years ago?

Can you take us through the highlights of the re-structuring process?

Essentially, around 2003-2004, Quintiles went from a public company to a private company.

The company had done many acquisitions and during that period of time, the stock markets were swooning after the tech bubble. It was a great time for the founder to take the company private and he did it very successfully. I often like to say that our founder is very much like a Harvard Business Review case study in himself for the way he managed the company through this period.

During the time that we were private, there was a lot of restructuring done which involved changing the revenue

profile and the margin profile.

For instance, we got out of the pre-clinical business and focused on clinical. We got out of the investing business because as a public company, it’s difficult to be an investor and a services company simultaneously. We spun out the investing business and today it exists as a very successful independent entity called NovoQuest. We did some other restructuring and in 2013, we took the company public again. We’ve had a very successful run since then.

What are the top pain points for your client companies?

How has Quintiles positioned itself to address these pain points?

If you think about what we do, we help design trials very effectively. We have the deepest scientific therapeutic expertise in our industry: over 1100 doctors, (actually have over 250 are here in India), plus 800 biostatisticians. We have an exceptionally strong group of experts in the science of our

industry who help us design trials effectively.

We also have a global technology-enabled network, enabled by people, that lets us perform the trials really well.

For all those players in drug development and medical device development, the key is a well-designed trial (so you increase the probability of regulatory approval) and then also executing it as effectively and efficiently with as high quality as you can.

As you said, Quinitles has been a pioneer. It has also evolved from the time that Quintiles was founded in 1982 'to do statistical analysis work on a contract basis for pharmaceutical companies.'

How would you define a CRO and specifically Quintiles today? A consultancy? A financier? A commercialiser because Quintiles is also into marketing development of some of the molecules it takes through trials? Or is it all of the above?

I define ourselves as a

professional services firm. So if you go back to our early days, we were a consultancy. But then over the course of time, we got more into services and now we are the leader in our industry, a Fortune 500 company, one of America's most admired companies and we recently won an award as one of the Most Ethical Companies in the world. We've really become a Fortune 500 services company and our goal is to provide great services to our customers. In fact, our tagline is: Improving our customers’ probability of success. Because, we feel that in every service that we provide, if we are helping them be more successful, and improve their probability of success, then we'll be a winning company.

You mentioned that Quintiles recently won an award as one of the Most Ethical Companies in the world. So, how does Quintiles resolve potential areas of conflict of interest as it evolves further down the path of financing

drug development and then also playing a role in the marketing of these drugs alongside your pharma clients?

Right now, Quintiles does not invest in molecules. We are in the professional services business. Think of us as being from first-in-man (trials) all the way to the provision of healthcare. We help patients all along that continuum. We follow Good Clinical Practices (GCPs), ethical guidelines to make sure products are safe and that they work. Once they get approved, we help track the medicines through real world data, to check if they are as safe in the real world as they were in the trial. We do help the pharma firms think about how to get market access, how to commercialise the products.

We even have a smaller business that helps providers associated with electronic healthcare and population health. We bought a company called Encore which provides these services. viveka.r@expressindia.com

POST EVENT

CII organises 13th National Pharma Conclave The conclave with the theme ‘Make, Develop and Innovate’ addresses key issues of pharma sector CII’S 13TH National Pharmaceuticals Conclave was recently held in New Delhi. The theme of the conclave was ‘Make, Develop and Innovate’.

Present at the event was Hansraj Ahir, Minister of State for Chemicals and Fertilisers. Addressing the delegates at the event, he assured all support for the growth of the pharma and life sciences industry.

Ahir also said that the industry should come forward to address huge prospects and challenges ahead in segments like manufacture of bulk drugs, medical equipment and R&D. He said that the government will lend all its support in an endeavour to make India a quality and cost-effective pharma

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KG Ananthakrishnan, Co-Chairman, CII National Committee on Pharmaceuticals and MD, MSD Pharmaceuticals; Dr VK Subburaj, Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers; Hansraj Ahir, Minister of State, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers; Dr Rajiv I Modi, Chairman, CII National Committee on Pharmaceuticals and CMD, Cadila Pharmaceuticals; Dr Murtaza Khorakiwala, Co-Chairman, CII National Committee on Pharmaceuticals and MD, Wockhardt; Amita Sarkar, Deputy Director General, Confederation of Indian Industry

hub. He added that the programmes launched recently,

such as ‘Make in India’, ‘Skill India’, ‘Start up India’ etc. will

give a critical push to the entire chain of life sciences.

The minister observed that the pharma industry should make quality drugs at affordable prices to the common man. He mentioned the various initiatives taken by the present government to reduce the price of lifesaving drugs to make them affordable to the common man. He said, “Diseases like diabetes, cardiovascular problems etc. are afflicting a large number of people particularly from the poorer strata of the society. We have to find newer approaches for diagnosis and treatment of patients since such diseases go unnoticed, particularly among the poorer sections of the society.” While giving the keynote address, Dr VK Subburaj,

MARKET Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, said that the pharma sector in India will become a $300 billion industry by 2020. He said, “Achieving the target presents both prospects and challenges. On one side, the industry should proactively gear up to emerge as a quality drug producer of the world, and on the other, there is a need for forging greater synergies between the government, industry and other stakeholders.”

He also mentioned that it was important to have a positive approach towards conflict resolution among players since some of the simple issues are taking longer time for their resolution. “We have to develop a proactive approach to solve such issues based on the principle of give and take,” he pointed out.

Subburaj said that having consultations with the stakeholders, the government has finalised a uniform marketing code, which will be announced soon. He also said that an interministerial committee was recently formed where meetings were held to frame guidelines for environmental clearances needed for the manufacture of bulk drugs.

The notification of the guidelines will be issued any day from now, he disclosed.

Subburaj also referred to several initiatives taken by the state governments in setting up the bulk drugs parks, which are under various stages of planning and implementation. “Our exports are poised to increase in the coming years. We have achieved cost competitiveness and now we have to focus on quality to further enhance our global foothold,” he told the industry. He also explained the initiatives of the government in revamping the Drug Control Act and im0proving the regulatory mechanism.

Dr Rajiv Modi, Chairman, CII and CMD, Cadila Pharmaceuticals mentioned about the need for ensuring higher returns on capital invested in the pharma sector to motivate more domestic and international players to invest in the sector.

KG Ananthakrishan, Co Chairman, CII National Committee on Pharma and MD, MSD Pharmaceuticals, said that the pharma sector can play a pivotal role in achieving

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the vision of ‘Healthy India.’

The theme of the conclaveMake, Develop and Innovateencompassed the three critical components for the industry can grow and contribute

substantially to the national economy.

Murtaza Khorakkiwala, Co-Chairman, CII National Committee on Pharmaceuticals and MD, Wockhardt

recommended further incentivisation of R&D efforts and creating a strong patent regime.

EP News Bureau-Mumbai

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MARKET

100+ participants discuss pro-active strategies for T&Tdeployment at CMO seminar Organised by Optel Vision, Tracelink and Conval Group,the seminar highlighted that getting each stakeholder to understand the project and adherence to timelines is the foremost challenge in T&T projects PHARMACEUTICAL companies all over the world are facing challenges establishing and running cost effective serialisation/Track & Trace (T&T) programmes. With legislation already in effect in many countries, and other global deadlines quickly approaching, building an approach to select and implement the right solution can be a tall task.

Keeping this is mind, Optel Vision, Tracelink and Conval Group organised a common platform for the Indian pharma industry to understand various strategies that can be implemented for global T&T deployment. The CMO seminar held in Goa, saw a huge turnout of more than 100 national and international speakers & delegates. The seminar was supported by Abbott, Actavis, Apotex, Fresenius Kabi, Par Pharmaceutical, USV, Kemwell Biopharma, Domino and industry body Pharmexcil.

“Creating awareness in all stakeholders of the practical issues involved in implementation of Track & trace requirements is the need of the hour” stressed S M Mudda, former board member of Pharmexcil and Director Global Strategy (Technical), Micro Labs in his keynote speech.

Shaunak J Dave, Asian Market Director, Optel Vision succinctly stated that the rationale for this conference was ‘Care & Share’. Expanding on this, he said, “About 700,000 people die every year globally because of counterfeit medicines. This conference aimed to express our commitment to the society that we care. Industry,

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The major highlight of the seminar was the interactive round table discussions organised by Supply Chain Wizard that covered packaging line implementation challenges and solutions, CMO serialisation support strategy technology providers and government/ regulatory agencies across the globe must work together to share their knowledge, experience and key learnings towards common objective: Patient Safety.”

Daniel J Lentsch, Global Corporate Device Identification Programme Manager – Medical Device, Hospira, emphasised a pragmatic approach as he explained

the project execution challenges faced during T&T implementation.

Further echoing this perspective, Dr Vadlamudi Rao, President–Indian Pharmaceutical Association mentioned that “Ensuring a deep understanding on serialisation is critical in implementing a fool proof system.”

Clearly, the key take away from the sessions was that

getting each stakeholder to understand the project and adherence to timelines is the foremost challenge of implementing T&T projects in an organisation.

A platform for exchange of knowledge, the seminar saw attendance from engineering, project management, IT, QA and supply chain professionals from all over the industry.

The one-day event featured

presentation, case studies, strategic round table discussions and covered validation perspective on 21 CFR Part 11 compliance.

The major highlight of the seminar was the interactive round table discussions organised by Supply Chain Wizard that covered packaging line implementation challenges and solutions, CMO serialisation support strategy.

Ken Fallu, Marketing Director, Optel Vision concluded the day’s programme emphasising that Optel Vision is committed to organise such educational events with industrial collaboration primarily to facilitate the understanding of the challenges involved in T&T. EP News Bureau-Mumbai

MARKET GROWTH TRACKER

IPM registers ` 7917 crores in March 2016 South Rajasthan grew the highest followed by Chattisgarh and Haryana THE INDIAN Pharmaceutical Market (IPM) has clocked ` 7917 crores in March 2016, growing at 6.4 per cent. Amongst the top 10 corporates, Lupin grew by 20.6 per cent, Sun by 12.3 per cent and Mankind at 11.9 per cent. 23 corporates have crossed the growth of IPM amongst top 50.

Amongst the top 50 corporates, Janssen had the highest growth of 26 per cent followed by Bharat Serums at 25.8 per cent and Allergan at 25.4 per cent. 16 corporates have shown growths of more than 10 per cent amongst the top 50. Amongst the 11-20 ranked corporates, Intas had the highest growth of 16.2 per cent followed by Micro at 12 per cent and USV at 11.3 per cent.

Amongst the 21-30 ranked corporates, Novartis had the highest growth at 14.1 per cent followed by Cadila at 7.2 per cent and Eris at 5.5 per cent.

Amongst the 31-40 ranked dorporates, Bharat Serums grew at 25.8 per cent followed by Wallace at 16.4 per cent and JBCPL at 11.5 per cent. Amongst the 41-50 ranked corporates, Janssen had the highest growth at 26 per cent followed by Allergan at 25.4 per cent and Systopic at 18.8 per cent. Amongst the 51-60 ranked corporates, Boehringer grew at 43.3 per cent followed by Corona at 39.6 per cent and Fresenius Kabi at 37.2 per cent. Amongst the 61-70 ranked corporates, Shreya grew at 25.1 per cent followed by RPG at 15.1 per cent and Serdia at 5.3 per cent.

Amongst the 71-80 ranked corporates, Samarth grew at 29.1 per cent followed by Lincoln at 16.9 per cent and Danone at 13.9 per cent. Amongst the 81-90 ranked corporates, Dabur grew at 34.8 per cent followed by Veritaz at 27.7 per cent and Galpha at 27.1 per cent. Amongst the 91- 100 ranked corporates, Ind-Swift grew at 32.5 per cent followed by Curatio at 22.4 per cent and Serum Institute at 20.4 per cent.

The 100th biggest corporate is

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May 1-15, 2016

Curatio and 150th biggest corporate is UTH in the IPM. Wallace

as a corporate moved into top 40 as on MAT March 2016.

Indian companies have grown at 7.7 per cent versus two

per cent for MNCs in March 2016. Amongst the top 50 in

MARKET MNCs, Janssen grew at 26 per cent followed by Allergan at 25.4 per cent and Novartis at 14.1 per cent. Under the Non-NLEM category, Indian companies grew at 8.6 per cent whereas MNCs grew at 2.3 per cent.

The NLEM containing molecules market grew at -0.1 per cent whereas the non-DPCO market grew by 7.2 resulting in an overall growth of 6.4 per cent.

NLEM and Non-NLEM category showed unit growth of -2.4 per cent and -4.3 per cent respectively.

A total of 12 therapies have outgrown the IPM growth. The respiratory market grew at -4.6 per cent, gastrointestinal grew at 9.3 per cent, pain and analgesics at 4.8 per cent whereas anti-infectives grew at -1.8 per cent. The anti-diabetic market grew at 13.2 per cent and cardiac at 12.2 per cent in chronic business. The derma market grew by 13.3 per cent and urology market at 11 per cent and neuro/CNS at 13.8 per cent.

A total of 17 regions have outgrown the IPM growth. South Rajasthan market grew the highest at 13.2 per cent followed

by Chattisgarh at 12.9 per cent and Haryana at 11.8 per cent.

One region had negative growth in March 2016.

The Amoxycillin + Clavulanic acid market grew at -6.1 per cent and Glimepiride + Metformin market grew at 12.7 per cent.

The markets of paracetamol grew at 4.7 per cent, Atorvastatin 8.6 per cent, Probiotic Microbes at 29 per cent, Cefixime 10.5 per cent, Pantoprazole 15.1 per cent, Montelukast + Levocetrizine at 0.7 per cent, Glimepiride + Metformin + Pioglitazone at -3.6 per cent, Vitamin-D at 21.1 per cent, Hydroquinone + Mometasone + Tretinoin at -4.5 per cent, Voglibose + Metformin + Glimepiride at 36 per cent, Rosuvastatin at 18.6 per cent, protein supplements at 8.2 per cent, Azithromycin at -12.7 per cent, calcium carbonate + Vit D3 market at 0.4 per cent, Paracetamol + Phenylephrine + Chlorpheniramine at -9.7 per cent, Meropenem at 36 per cent, Montelukast + Fexofenadine at 14.2 per cent, Diclofenac at 18.4 per cent, Telmisartan at 25.5 per cent, Levetiracetam at 27.0 per cent. The 50th biggest market is

18

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May 1-15, 2016

Val in Crs CORPORATE IPM Sun+ Ranbaxy Abbott + Abbott HC + Novo Cipla Zydus + Biochem Mankind Lupin Alkem + Cachet + Indchemie Glaxo Pfizer Macleods Intas Emcure + Zuventus Aristo Dr. Reddys Glenmark Sanofi India Torrent USV

Cefoperazone + Sulbactam and 100th biggest market is Cefalexin.

Mixtard leads the pack with ` 33 crores followed by Glycomet GP at ` 28 crores, Lantus & Corex at ` 26 crores for March 2016.

Few brands who have gained ranks include Meronem (+47), Aciloc RD (+45), Rotarix, Unwanted Kit (+40), Betnovate N (+34), Ultracet (+30), Storvas, Rabipur (+29), Gluconorm-G (+27), Novomix (+23), Rosuvas (+21), Voveran (+20), Rantac (+19), Telma, Istamet, Pantop (+17), Vertin, Cardace (+16), Telma H, Galvus (+14), Synflorix, Electral Powder (+13), Dolonex, Omez, Duphalac (+12), Jalra M, Levipil (+11), Galvus Met, Susten (+10), Aztor, Zoryl M (+8), Lantus, Pan, Thyronorm, Atorva, Allegra (+7), Dolo, Mucaine (+5), amongst top 100 brands over March 2015 Revital H, Lonopin, Razo D, Mero, Metpure XL, Cilacar, Candid, Lobate GM, Orofer S, Enterogermina, Econorm, Pipzo are few brands which have gained ranks in 101-200 ranked brands. A few brands, which have moved up ranks fastest into Top 300 brands are Revital H, Hucog HP, Lonopin, Grafeel, Similac, Candiforce, Diapride M, Razo D. The 300th biggest brand is R-Cinex from Lupin.

A total of 200 brands and 379 SKUs were launched in March 2016. The top new brands were Gestarest, Ondero Met, Elmonea and Totaglipt M. One brand was launched in

Rank MAT

MTH

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

1 2 3 4 5 6 7 8 10 9 11 12 13 15 14 16 17 18

With Bonus Units at Full Value MAT Mar-16 Val (Cr) MS% 98414 100.00 8631 8.77 6040 6.14 4900 4.98 4183 4.25 3688 3.75 3442 3.50 3379 3.43 3182 3.23 2880 2.93 2844 2.89 2803 2.85 2575 2.62 2427 2.47 2376 2.41 2364 2.40 2356 2.39 2276 2.31 1968 2.00

Val in Crs Super Group IPM ANTI-INFECTIVES CARDIAC GASTRO INTESTINAL VITAMINS / MINERALS / NUTRIENTS ANTI DIABETIC RESPIRATORY PAIN / ANALGESICS NEURO / CNS DERMA GYNAECOLOGICAL HORMONES VACCINES ANTI-NEOPLASTICS OPHTHAL BLOOD RELATED UROLOGY OTHERS ANTI MALARIALS SEX STIMULANTS / REJUVENATORS STOMATOLOGICALS OPHTHAL / OTOLOGICALS

Teneligliptin category – Afoglip from Torrent. Within the VMS category, Dhup (Albert David), Bonmax D3 & Bestflow D (Zydus) were launched, within antidiabetic, Onderomet (Lupin), Afoglip (Torrent), Voglipack M ( Koye), within pain and analgesics category, Adfrar IB (Torrent), Afdiflam D (AFD) & Dolobest MR (TTK), within respiratory, 1 AL M (FDC), Kofcare AM (Unichem), within cardiac, Eritel CH Trio (Eris), Amlodac M (Zydus), Anoxilin (Lincoln) & Rosubest F (Cipla) and within gastro intestinal, Uricure

GR% 12.6 14.5 11.3 13.4 12.1 18.5 17.0 10.0 4.8 9.7 10.9 23.1 9.5 13.6 20.8 23.0 7.9 15.3 16.3

Val (Cr) 7917 718 495 391 342 301 272 252 239 230 236 229 210 194 185 186 183 177 162

MAT Mar 16 VAL IN CRS GR% 98414 12.6 14933 7.8 12276 14.1 11565 15.1 8643 9.6 8004 20.7 7687 10.8 6793 11.3 6110 15.7 6006 16.6 4928 10.9 1671 11.5 1652 10.6 1564 6.3 1436 12.3 1159 15.9 1074 15.9 1073 25.3 561 -2.1 546 12.5 402 7 215 -4.2

(Emcure), PPTroy D (Troikaa) & Iladac D SR (Zydus).

The biggest new launch by an MNC was Dalsiclear in March 2016.

Mar-16 MS% 100.00 9.06 6.26 4.93 4.32 3.80 3.44 3.19 3.02 2.90 2.98 2.89 2.66 2.46 2.34 2.35 2.31 2.23 2.04

GR% 6.4 12.3 3.8 3.5 5.9 11.9 20.6 -1.2 -6.1 3.5 7.0 16.2 9.3 5.9 7.0 10.4 -0.8 2.4 11.3

Month Mar-16 VAL IN CRS GR% 7917 6.4 1132 -1.8 1034 12.2 928 9.3 694 7.7 666 13.2 610 -4.6 526 4.8 511 13.8 483 13.3 408 7.2 135 6 127 -6.9 123 -7.9 128 12.9 91 7.5 89 11 98 31.6 30 -21.8 46 7.7 32 5.2 19 4.8

the underlying philosophy behind AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted

by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech.

AWACS (Advanced Working, Action & Correction System) reflects

Terminologies used MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage.

For more information, visit http://www.aiocdawacs.com

EVENT BRIEF AUGUST 2016 5

PharmaLytica 2016

PHARMALYTICA 2016 Date: August 5 and 6, 2016 Venue: HITEX Exhibition Centre, Hyderabad Summary: The third edition of PharmaLytica 2016, will see the pharmaceutical community pick up on the latest industry trends, innovations and do business with analytical, bio tech, lab, pharma machinery and outsourcing services.

PharmaLytica conference, collocated with the exhibition will bring an entire range of topics in analytical, outsourcing, laboratory, scientific and biotechnology sector.

The event is likely to witness 150+ leading local, regional, and international exhibitors, with 4500 expected visitors. It will be an industry focused conference with latest pharma market insights, in-depth case studies, and exceptional networking opportunities. Both the events are supported by Ministry of Science & Technology, Government of India Contact details: UBM India Times Square Unit No 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East) Mumbai - 400 059 Tel: +91 22 61727272 Fax +91 22 61727273

PHARMATECH EXPO 2016 Date: August 21-23, 2016 VENUE: Ahmedabad Summary: The 4th Edition of 'PharmaTech Expo 2016, a PharmaTechnology- Index.com venture will organise a pharma expo. The expo will be concurrently held with 'Pack & PrinTech Expo' and introduction of 'PIC India Expo.' It will focus on pharma ingredients and chemicals, giving a large scale exposure to pharma machinery, pharmaceutical ingredients and chemicals, packaging, printing, lab and analytical equipment etc. More than 150 exhibitors are likely to participate in the event.

A special pavilion has been

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May 1-15, 2016

created for 'Track & Trace and Vision Inspection Equipment' to focus on the superior technologies available in India and the major Industry Players

21

PharmaTech Expo 2016

involved.

Contact details Aarjav Shah PharmaTechnologyIndex.com (A Division of KNS Group)

Phone: +91 – 79 – 27540493 / +91 – 79 – 40306340, 9879616665 E-mail: expo@pharmatechnologyindex

.com / events@knsmedia.com Website: www.PharmaTechExpo.com / www.PackPrinTechExpo.com / www.SwarnimVision.com

cover )

STILLLEADING THE RACE? Maharashtra, a traditional hub of the Indian pharma industry, could face an uphill task to retain its decades-old dominance in this sector

BY SACHIN JAGDALE

20 EXPRESS PHARMA May 1-15, 2016

(

M

aharashtra has long been an Indian pharma hub.

However, benefits offered by other states such as tax holidays, low-cost land, cheap electricity etc. have managed to lure away many renowned pharma companies from Maharashtra. Though the state is still a leader, others like Gujarat, Goa, Himachal Pradesh, Andhra Pradesh, Sikkim, Karnataka etc are leaving no stone unturned to raise their credit amongst the pharma players. Hence, Maharashtra is likely to face a tough time ahead to ensure that it remains ahead of the race.

Steps to lead Pharma companies' exit from the state is perhaps more visi-

ble since it has long been a hub for the sector. The emergence of different tax havens in the country have caused pharma companies to look beyond Maharashtra and this has given rise to the question, “Wasn't the state proactive enough in addressing the needs of the pharma industry?” A detailed analysis reveals that while more could have been done, the state has introduced a few good measures for the pharma industry in the past few years.

Kapil Bhargava, Former Dy Drugs Controller (I) CDSCO and advisor to pharma companies in India, says, “I see the number of initiatives taken for e-governance replacing manual procedures. Licensing applications and grant, certificates application (e.g. Certificate of Pharmaceutical Product

Maharashtra FDA is well organised.

The new online FDA services for renewal of license, getting licenses for new products and new premises etc. are easy and fast in Maharashtra Sachin Purohit Managing Director, Genome Biotechnologies

THE MAIN FOCUS

(COPP), Free Sales Certificate (FSC) and others) and grant of certificates has eased the processes for applicants. Personnel from companies do not have to visit offices and wait for officers unnecessarily. The younger lot is much more electronic savvy and they too prefer this.” He finds this a significant step and lauds the government for it.

Sachin Purohit, Managing Director, Genome Biotechnologies, echoes Bhargava's words and points out, “Maharashtra FDA is well organised. The new online FDA services for renewal of license, getting licenses for new products and new premises etc. are easy and fast in Maharashtra.”

BG Barve, Joint Managing Director, Blue Cross Laboratories also feels that the state's

decades-old supremacy in the field of pharma is an outcome of Maharashtra's favourable policies. He explains, “Maharashtra is the only state where the work pertaining to manufacturing licenses under Drugs and Cosmetics Rules, 1945, is decentralised. From 1996, the FDA took up the task to computerise the entire system. The drug sample coding and analysis reporting has been computerised. To encourage new units, the Maharashtra government provides special incentives and exemptions such as waiving electricity duty for 15 years, exemptions in stamp duty, refund of octroi in certain categories, and Special Capital Incentives (SCI) to all SSI Units. The state continues to provide a conducive industrial and financial climate.”

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May 1-15, 2016

cover ) The companies which are becoming bigger and have their headquarters in Mumbai may re-start their more technical activities e.g. R&D centres, few of the companies may re-orient their business and move to contract research (in APIs, intermediates and also in formulations) and so on. They may not move back for their routine production operations

To encourage new units, the Maharashtra government provides special incentives and exemptions such as waiving electricity duty for 15 years, exemptions in stamp duty, refund of octroi in certain categories, and Special Capital Incentives (SCI) to all SSI Units.

The state continues to provide a conducive industrial and financial climate

Kapil Bhargava

BG Barve

Former Dy Drugs Controller (I) CDSCO and advisor to pharma companies

Joint Managing Director, Blue Cross Laboratories

What remains to be done...

With many new states joining the race, the time has come for Maharashtra to work on plugging the loopholes that's remained neglected for a long time. For e.g. There are many smaller pharma players operational in the state and their requirements are different than the bigger players and need enough attention from the state FDA. However, industry veterans like Subramanian Vaidya, Director – BlissGVS Pharma, Chairman – IDMA – (MSME – subcommittee), finds FDA a little careless in this regard.

Vaidya explains, “The government should encourage the FDA to give enough guidance to smaller manufacturers as the industry is a technology driven one. Moves of such nature would have made the smaller ones grow in size, which is perhaps not happening as it should have been. The FDA itself should convene a meeting with small and medium manufacturers and understand their problems. There are small associations in the districts, quite a few of them are in Mumbai itself. In the last two or three decades, one has not witnessed any meeting of all these bodies together to try and understand the problems of the industry. It might very well seem that the FDA is only interested in inspecting, regulating and

22

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seeking revenue for their department through different means.”

Giving a generalised perspective, Purohit points out that issues like octroi/LBT are still creating problems. Infrastructure and traffic problems are acute and progress is slow.

This is forcing people to think of other alternatives. He also highlights that the licenses for new justified formulations (necessary for growth) are difficult to get in Maharashtra.

While criticising the lack of common effluent plants, electricity supply issues and labour unions as few of the reasons for pharma companies looking at options other than Maharashtra, Barve asserts, “Maharashtra should be industry-friendly with supportive industrial norms for setting up pharma units.”

The pharma sector is a chemical-based industry and happens to be one of the leading polluting industries in the

world. So, it becomes the prerogative of the state to help the industry to become more environment compliant. However, according to Vishal Jajodia, Chairman, V-Group (Swati Spentose), this is perhaps not happening in Maharashtra. He says, “Gujarat has been ahead of Maharashtra by 10 years in environment compliance, which is not only a necessity but also an urgency given the serious environmental damage which industries cause and its

impact on common people's life.”

He adds that in Maharashtra, there is very limited environmental compliance among the pharma players. The Maharashtra government needs to learn from the Gujarat model.

If they can do this, the investment, progress and success of the pharma industry in the state will grow manifold. He says, “Increase in investment is not the definition of success.

Successful consistent profit

( making business is real success. The MNCs and large companies are ready to pay a price.

Market opportunity for profit is there, but the mind set needs to be aligned.”

continues to score in many other areas. For e.g., Maharashtra has well developed ports which make export easy. Though there

is a scope for improvement, infrastructure here is still much better than in the other states.

Besides international airports,

THE MAIN FOCUS

there are many small airports as well in Maharashtra. Above all, Maharashtra’s capital, Mumbai, is also the business capital of the

country. Having operations here does give pharma companies better access to the global world.

As Purohit informs,

Will Maharashtra retain its edge?

Though other states in the country are offering various benefits (mainly tax benefits) to pharma companies, the period of these sops was limited.

According to some experts, Maharashtra has always been a preferred choice for the pharma companies. Hence, they would return once the period for tax exemptions offered by other states get over. However, some others are of the opinion that since many pharma companies have already established their plants in other states and many of them have got global certificates, it will be difficult for them to relocate completely to Maharashtra.

Bhargava explains, “The companies have moved to other states mainly because of tax exemptions. During these years they have established their sites there. They are comparatively new (10 – 12 years old) and have procured approvals from regulatory bodies like Medicines and Healthcare Products Regulatory Agency (MHRA), US FDA, and WHO (PQ) in addition to The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PICS) countries and Rest of the World (ROW) markets. The companies which are becoming bigger and have their headquarters in Mumbai may restart their more technical activities e.g. R&D centres. A few of the companies may re-orient their business and move to contract research (in APIs, intermediates and also in formulations) and so on. They may not move back for their routine production operations. I do not know if some company has moved back to Maharashtra and recommenced its production activities.”

Tax benefits did offer a temporary advantage to other states but Maharashtra

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May 1-15, 2016

cover ) The government should encourage the FDA to give enough guidance to smaller manufacturers as industry is a technology driven one. Imminent moves of such nature would have made the smaller ones grow in size, which is perhaps not happening as it should have been

In Maharashtra, there is very limited environmental compliance among the pharma players. The Maharashtra government needs to learn from the Gujarat model. If they can do this, the investment, progress and success of the pharma industry in the state will grow manifold

Subramanian Vaidya

Vishal Jajodia

Director – BlissGVS Pharma, Chairman – IDMA – (MSME – subcommittee)

Chairman, V-Group (Swati Spentose)

“Despite the tax benefits given by other states, Maharashtra continues to host the largest number of pharma facilities.

Now, with the tax incentives given by other states coming to an end, many pharma companies are again tapping Maharashtra to set up their manufacturing bases. Mumbai is the major exporter of pharma drugs. The regulatory system in Maharashtra is one of the best in the world. It has the highest number of US FDA approved plants. Quality pharma production has always remained Maharashtra's feature.”

Barve reiterates Purohit's opinion and says, “Tax incentives offered by other states definitely convinced many pharma companies to move out of Maharashtra. But, it is a temporary phase. Now, as the tax incentives given by other states have been getting over, many pharma companies are again tapping Maharashtra to set up their manufacturing bases. He informs, “Many pharma companies are slowly relocating themselves in Maharashtra. In the years to come, the situation would improve further provided the Maharashtra government offer special benefits to the pharma industry.”

The global pharma community still looks at Maharashtra as a preferred location in India.

Almost every big pharma company has its corporate office in the state. It is true that Maha-

24

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May 1-15, 2016

rashtra has lost many pharma units to other states, but the mistakes can be rectified. Also, though many pharma companies have started their plants in other states, they have also continued with their operations in Maharashtra.

Barve says, “Maharashtra has always remained a hub of the Indian pharma industry with major centres in Mumbai, Thane, Tarapur, Nashik, Aurangabad and Pune. Maharashtra is also the first state to set up independent Intelligence Branch with separate police wing to assist investigation under Acts enforced by FDA.”

According to Purohit, the state government should be more proactive in terms of incentives and investment in talent creation and skill development. He suggests a few ‘must do’ things for the state government. He says, “The state should also encourage clusters and common facilities such as ETP and cluster-based projects. This will help in sharing the cost, enhancing quality and innovative capabilities. This will also help the state to consolidate its position as the most preferred destination for pharma companies.”

However, Vaidya wants the state to take immediate reme-

dial steps and convince pharma operators to open up new factories in the state for manufacturing both formulations and APIs. Describing how it could be done, he states, “The state has to seriously consider giving heavy concessions to the new venturing units in the state and provide relief at least in the initial first five years in terms of sales tax rebate, excise free zones, and cluster areas in the state. Common basic amenities in the clusters, including participative analytical centres and effluent treatment plants should be sponsored by the government.”

Going ahead Thus, it is clear that Maharashtra has suffered a setback where its image as a pharma hub is concerned, concerted and strategic efforts are needed from the government to implement proactive measures that can reverse the damage and bring back the pharma players back to the state. However, if the Maharashtra government addresses the changing demands of the industry then it will definitely continue its reign as the most preferred location for pharma players. sachin.jagdale@expressindia.com

(

THE MAIN FOCUS

INSIGHT

Maharashtra,the pharma capital Suresh G Kare, Chairman, Indoco Remedies, elaborates why Maharashtra has been a preferred destination for the pharma sector

T

he Indian Pharma market (IPM) today is almost ` 100,000 crores, and Maharashtra's contribution is about 11 per cent. While the IPM grows at twice the GDP, the growth in pharma sales in Maharashtra has been above the industry average.

This apart, a large chunk of pharma products are manufactured and exported from the state which has been instrumental in driving the growth of

pharma industry in India.

Hence, Maharashtra can be truly crowned as the capital of the pharma industry in India.

Over 3000 pharma units have been set up in Maharashtra with corporate offices in and around the state, like, Mumbai, Aurangabad, Pune, etc. The state is a leader in vaccine production and a number of Special Economic Zones (SEZs) have been notified within the state.

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On a broader scale too, Maharashtra has always remained the industrial and financial hub of India. Various industries started their operations in the state and grew substantially due to the conducive atmosphere for growth and favourable government policies. Among all the industries, the pharma industry has always been a key beneficiary from such policies. Today, almost all major pharma companies in India, including

Indoco, have their headquarters in Mumbai. Moreover, many pharma companies have chosen Maharashtra as a centre point due to its advantageous location for smooth distribution across various parts of the country.

As mentioned earlier, a large consignment of pharma products are exported from the ports in Maharashtra and the reasons are many. A number of shipping lines operate in the state, such as sea ports and in-

SURESH G KARE, Chairman, Indoco Remedies

land container depots (ICDs) located in various parts of the state. The port facilities are well equipped with latest technologies and state-of-the-art infrastructure. The custom clearance process is highly automised through Electronic Data Interface (EDI), which facilitates smooth clearance of import and export shipments.

Maharashtra ports have the advantage of docking high capacity vessels as compared to

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May 1-15, 2016

cover ) ports in other parts of India.

The Custom House Agents’ (CHA) services available in the state are the best and the CHAs are updated with the latest changes in rules and regulations.

However, it is true that other states provide tax benefits to the industry, and as a result, many companies have decided to set up shops outside Maharashtra to reap the benefits of excise and tax duties. This has resulted in Maharashtra losing tax revenues, employment and growth opportunities.

Indoco too has set up new manufacturing facilities at Baddi in Himachal Pradesh and Goa to grab the benefits offered by these states. Indoco has eight manufacturing facilities, of which four are located in Maharashtra and four in other states. In fact, Indoco com-

menced its manufacturing operations in Maharashtra with a small finished formulations facility in Thane, way back in 1960s, followed by a Andheri unit in 1974 and one in Aurangabad in 1990. The company also has three of its API manufacturing facilities based in Maharashtra. We are in the process of expanding our API manufacturing capacities and have already commenced construction of a greenfield API facility in the plot adjacent to our existing manufacturing facility in Patalganga with an investment of `100 crores, thereby making Maharashtra the API manufacturing hub for Indoco.

Most pharma companies, while establishing new facilities elsewhere, continued with the current manufacturing facilities in Maharashtra due to advantages like good infra-

structure, availability of skilled manpower and ease of doing business. The state also has the advantage of skilled manpower with so many pharma graduates passing out of the pharmacy colleges every year. This skilled manpower supply is essential to maintain the international standards of manufacturing due to the strict regulatory guidelines by the regulatory bodies of the world.

India has the highest number of US FDA approved plants outside the US and Maharashtra has the highest number of such plants in India.

The regulatory infrastructure in the state is of the highest order and the percentage of substandard drugs produced in Maharashtra is remote as compared to other states. Maharashtra is also the first state to set up an independent Intelligence Branch with a separate

wing to facilitate and speed up investigations under acts enforced by the FDA. Research and development (R&D) is the core of the pharma industry and the industry thrives only if substantial investments are made in developing new products for domestic as well as international markets. Indoco has never moved out of Maharashtra as far as its R&D efforts are concerned. We started our R&D centre in Andheri and then moved to Rabale in Navi Mumbai, where we have a world-class R&D centre, spreading over an area of 100,000 sq ft. The R&D centre has more than 300 scientists, developing new API manufacturing processes as well as finished products. The research activities in the pharma industry are now moving from development of generic prod-

ucts to super generics, value added generics and biosimilars.

Maharashtra has the ability to attract R&D investments in the new research areas and take appropriate steps to encash on this opportunity.

Now that the period of the tax incentives given by other states is almost over and after reaping the advantages of tax and excise incentives, many pharma companies are again looking at Maharashtra. The motivation to continue or expand the manufacturing infrastructure in those geographies is lost, as many of these states have poor infrastructure, including erratic power and water supply. Hence, Maharashtra can look forward to an increase in the number of pharma manufacturing facilities, provided appropriate incentives and assistance is offered.

Pharma sector in Maharashtra till now and it will be‌....

Shashank Sandu, Director, Sandu Pharmaceuticals, elaborates on how Maharashtra has become a favourite destination for pharma cos INDIA CURRENTLY represents just $6 billion of the $550 billion global pharma industry but its share is increasing at 10 per cent a year, compared to seven per cent annual growth for the world market overall. Also, while the Indian sector represents just eight per cent of the global industry total by volume, putting it in fourth place worldwide, it accounts for 13 per cent by value, and its drug exports have been growing at 30 per cent annually.

Pharma manufacturing units are largely concentrated in Maharashtra and Gujarat.

Both these states account for about 45 per cent of the total number of pharma manufacturing units in India.

Maharashtra has always remained the financial hub of India. Various pharma companies started their manufacturing plants in the state and

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grew substantially cashing in on the favourable industrial policies offered by the state government. However, among all the industries, the pharma industry might have been the biggest gainer of these policies. Today, almost all the major pharma companies have their headquarters in Mumbai. India has the highest number of US FDA approved plants outside the US, and Maharashtra has the highest number of these plants in India.

Maharashtra is home to around 3,139 pharma units and corporate offices, with major centres in Mumbai, Thane, Tarapur, Nashik, Aurangabad and Pune. The state also leads in vaccine production. Maharashtra contributed 20 per cent to India’s pharma output of $2.66 billion in FY13. The sector received a cumulative FDI inflow of $168

SHASHANK SANDU Director, Sandu Pharmaceuticals

million through 121 projects during August 1991 to March 2012. It has the highest number of pharma units and leading pharma companies Traditional medicine, including Ayurveda, contributes significantly to the health status of many communities, and is increasingly used within certain communities in developed countries. Traditional medicine has a long history of use in health maintenance and in disease prevention and treatment, particularly for chronic diseases. According to some sources, up to 80 per cent of people in India use

some form of traditional medicines, a category which includes Ayurveda.

Ayurvedic medicines are produced by several thousand companies in India, but most of them are quite small, including numerous neighbourhood pharmacies that compound ingredients to make their own remedies. It is estimated that the total value of products from the entire Ayurvedic production in India is around $1 billion. The industry has been dominated by less than a dozen major companies for decades, joined recently by a few others that have followed their lead.

Hence, today there are 30 companies earning a million dollars or more per year in business to meet the growing demand for Ayurvedic medicine.

Exports of Ayurvedic medicines have reached a value of

$100 million a year (about 10 per cent the value of the entire Ayurvedic industry in India). About 60 per cent of this is crude herbs (to be manufactured into products outside India), about 30 per cent is finished product shipped abroad for direct sales to consumers, and the remaining 10 per cent is partially prepared products to be finished in the foreign countries.

Ayurvedic manufacturing industry is different from the general pharma industry in terms of source of knowledge, nature and process of drug discovery, scientific applications, fragmentation of markets, consumer categories and pricing. It shares similarities with the pharma sector in case of product innovation, marketing strategies, institutional development and networking. Though the turnover from ayurvedic

( sector constitutes meagre in terms of actual, it also holds two per cent of the global herbal market.

Due to the recent new stringent regulations, the Ayurveda industry, which is still in its infancy, will be discouraged to grow. That is what has been happening since last the last two to three years.

Every month or two, there is a new regulation for this nascent industry. The Ayurveda industry is not against any regulations, but bringing in regulations one after the other in quick succession results in a very small window for the industry to operate, as well as upgrade to newer guidelines.

To add to this, rapid decline in the supply of medicinal plants, have caused a major concern to the large Ayurveda industries in the state. The

other cause of concern is quality deterioration of medicinal herbs. Procuring right quantity of medicinal plants at right time continues to be a challenge. Medium sized firms believe that the fall in supply of medicinal plants have led to a price rise. This has increased the cost of production, which has eventually led to price rise of drugs. The raw material cost constitutes to be around 40-45 per cent of total product cost. This price increase has to some extent affected the total sales of medium scale firms.

Large-scale transformation of land to non-agricultural activities have led to the fall in supply. Small firms are not able to buy all medicinal plants from the open market, which has has forced them to concentrate in the

production of a few most demanded medicines.

The resource depletion has affected all manufacturing units irrespective of the size, but differently. Large units are concerned about the quality of medicinal plants, mediumsized firms are apprehensive about the increased cost of production and finally the small and tiny firms about their survival. However, the government has taken no concrete steps to overcome this issue.

The approach of manufacturing units towards the consumers and attitude of the consumers towards Ayurveda have undergone a thorough transformation over the years.

Their acceptance for Ayurveda has grown by leaps and bounds. This has encouraged enthusiastic farmers and

THE MAIN FOCUS

agriculturalists to grow many medicinal plants. However, there are no proven agronomic models which can be implemented from lab scale to field scale and this results in large crop failures and distraught framers. The government must step in and create an farmer-friendly ecosystem, linking agricultural colleges, botany departments of science colleges etc, so a sustained supply of raw materials can be assured to the industry.

Modern-day lifestyle demands that Ayurvedic medicines are made available in a much user-friendly form, and this has called for largescale innovation in the Ayurvedic medicine manufacturing and packing.

Continuous supply of power is the backbone of any

industry and plays a vital role in fostering industrial activity.

Easy availability of power is one of the important factors for the development of any industry. Electricity is no longer an abundant factor and has turned out to be costly.

Shortage of power is regarded as a major problem by 70 per cent of the medium firms.

Irregular supply of power creates difficulties because the production process has to work continuously and any breakdown in between affects the entire production.

While there is tremendous scope and huge growth opportunities for Ayurevdic medicines, not only in India but world over, the Ayurvedic industry in Maharashtra requires government support and positive intervention to encash these opportunities.

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May 1-15, 2016

MANAGEMENT

28 EXPRESS PHARMA May 1-15, 2016

‘FDC ban will be bad for immediate financial health of any company’

T

here is substantial loss to companies as order prohibiting Fixed Dose Combination (FDC) was sudden. The industry has not been given any time and prohibition is with immediate effect. Companies have to stop production forthwith and it is expected that the packing material lying with them needs to be destroyed.

The raw materials may be used in other formulations, the packing materials cannot.

Government’s move in banning FDCs The issue to prohibit FDCs may be going on for the past 10 years.

The new drug department was occupied more for assessing ‘new chemical entities’ and probably did not have enough resources to see that all FDCs need a closer look from patient safety angle. Few of the state licensing authorities were referring cases to them for clearance.

It has appointed new drug approval committee (NDAC) and

later expert committee. It did not have the machinery to see that all FDCs are first approved by the DCG(I) and then granted permission to manufacture.

Secondly, the government did not have any power to exercise control over the state licensing authority.

thing that we are importing.

FDC ban will definitely be bad for immediate financial health of any company. It may withdraw the zeal of a company to contribute to PM’s ‘Make in India’ initiative.

Alternative to FDCs

Companies, having strong R&D base, may go for technology improvement and increase acceptance of their brand.

Simple products through nano-technology are appearing in the market now. I again emphasise different strategies for long-use and short-use products. Antibiotics are short-use products and I feel the FDCs may be marketed only when good synergistic action is demonstrated. Personally, I feel antibiotics need not be presented in FDCs except those where dose compliance has been demonstrated to be far superior to single antibiotics.

Physicians have to look for safer substitutes. Their source of information has to be very good. It may be easy in bigger cities, however, will be difficult in smaller cities and towns. A particular company’s price-tosales ratio (PSR) who was promoting his FDC may not be in a position to inform about the safer alternative. Therefore for sometime when the patients will shift from FDC to single drug, they may suffer. Physicians need to be constantly consulted even for long-use products e.g. such products where physician prescribes for six months or even more.

Alternative ways for growth

Kapil Bhargava, Former Dy Drugs Controller

Patients who visit nursing homes or hospitals may face more difficulties. This may be beneficial when FDCs with some synergistic effects will only be available and rest are weeded out.

Impact on ‘Make in India’ initiative The ‘Make in India’ initiative is to reduce dependency on any-

Road-map The discouragement of FDCs without scientific rationale is going to be there for some time with the Central Drugs Standard Control Organisation (CDSCO). Industry associations must emphasise to regulators that patient’s safety is equally their concern as well as that of regulatory bodies. Combination products need to be formulated with sound justification of each ingredient. Combinations are very useful for geriatric, illiterates and other patients for better medication compliance.

Industry must address this aspect and approach the regulatory bodies. I am sure regulators will understand this. Industry has to be there for fulfilling patient’s need and unwarranted curbs. Sudden notification gives the impression that genuine manufacturers have little concern for patient and are only profiteering.

‘The DCG(I) has no business to ban FDCs which are in the market for more than 30 years’

T

he recent ban on FDCs by the office of DCG(I) is a knee-jerk reaction to the recent observations by international agencies on the relatively poor regulatory standards of the CDSCO and DCG(I).

With the increasing global trends of TBT/NTB being built up and targeted towards India’s pharma exports, the Government of India (PMO, DIPP etc) has of late been pressuring the Ministry of Health and Family Welfare (MoHFW) and the CDSCO to join ICH and PICs at least as an observer. Fully realising the internal weaknesses of

Dr Gopakumar G Nair, Chief Executive Officer, Gopakumar Nair Associates

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the system and the CDSCO, the MoHFW and DCG(I) has apparently deflected the external pressures on to the pharma industry, through this ‘irrational blanket and abrupt ban.’

It is admitted that India is weak on pharmacovigilance.

Why so? Both IMA, DCG(I)-CDSCO, DoP and others are to blame. In the 70's, all formulations used to be packed into cartons with product inserts indicating mode of use, indications, contra indications, warnings etc.

With the increasing NGO influence, making ‘hue and cry’ about “Indian drug prices being

highest in the world”, the NPPA started cutting drug prices to below practical levels, forcing the industry to abandon all ‘frills’ in packaging thereby throwing to the wind, all product information through leaflets, which would have helped in pharmacovigilance.

Phenacetin, Analgin, Diiodohydroxyquin, Iodochlorohydroxyquin, Cox-inhibitors such as valdecoxib and Rofecoxib, Propoxyphene and Dextro propoxyphene, Methaquolone were all single ingredient drugs which were in market for three to four decades before getting

banned based on pharmacovigilance data i.e. evidence-based.

Some of the 344 drugs which are now banned unilaterally and abruptly are not only having no reports of side effects or adverse drug reactions, but also these very same combination drugs have become synonyms for lifesaving and well-being.

Patient misery I strongly feel that some of the drug combinations bed abruptly will hurt patients badly. I am surprised why the DCG(I) has not thought of this priority concern The sad part of the story is

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MANAGEMENT that the regulator has totally ignored the misery to the patient all of a sudden, denying access to a drug they were relying on for years.

The DCG(I) has no business or powers to ban FDCs which are in use in the market place for more than 30 years or thereabout. The ban is ultra vires, devoid of natural justice and merits to be struck down. While fully agreeing that there are true black sheeps and genuinely 'irrational' combinations, DCG(I) needs to ask each of the pharma companies who own and market the 344 banned drugs to explain why they should not be banned. Having killed the ‘clinical trial’ and pharma BA/BE study facilities, through poor and passive response to Supreme Court (under pressure from NGOs), DCG(I) cannot and should not ask each of these brand owners to conduct fresh clinical trials

and submit data for approval in new format. The historical data of use, benefit and lack of risk is good enough data to approve or formalise the approval.

If a high court judge in a patent injunction case, considers patient’s interest for access to treatment, the DCG(I), being custodian of patient health, on behalf of MoHFW, ought to have thought of the patients who were availing these combination drugs for years. If one looks at past history of ‘bans,’ they have all been through phasing out and not abrupt bans.

Actions against unapproved drugs It is unfair to say that there are “many unapproved drugs in the Indian market.” Being in the pharma industry for nearly 50 years, I can safely vouch that if there are any “unapproved drugs” in the Indian market, it has to be spurious or illegal. Any

person or company marketing or selling ‘unapproved’ drugs merit to be summarily put behind bars. All drugs legally sold in the Indian market are approved by one or other ‘licensing authority’. The dispute is due to the concurrent nature of Drugs & Cosmetics Act, which grants the power to approve both to the State FDAs as well as to Central CDSCO/DCG(I) in case (only) for ‘new drugs.’ ‘New drugs’ are defined in the Drugs Act, as those which are introduced for first time in Indian market. A ‘New Drugs’ ceases to be new drug after four years. If an ‘approved drug’ (whether by State FDA or CDSCO) is in the Indian market for more than four years (leave alone 40 years), it cannot be banned abruptly. The DCG(I) should give individual companies the opportunity to be heard, justify the combination, make changes if needed as per suggestion/ad-

vise of DCG(I)/State FDA and seek ‘minimum’ additional evidence, if required. The actual market place data is many times more valuable, reliable and evidence-based than any data generated through volunteers.

Need of intense focus The Indian pharma industry is being attacked on multiple fronts both openly as well as surreptitiously. Various treaties, agreements, non-tariff barriers, technical barriers etc. are being put up to stem the growth of Indian pharma. While the PMO, DIPP and Commerce Ministry is aware of this, the officers at the grass root level are becoming victims of NGOs and vested interests, both from within the country as well as overseas to dilute the gains made by Indian pharma industry post-1970 and mostly post-1995 (WTO-TRIPs).

The FDC ban will badly impact PM’s ‘Make in India’ initia-

tive. It will also malign Indian pharma’s name in the global markets. This will also stem the otherwise strong potential of Indian pharma to be world leader in combination drugs and therapies.

The roadmap from here onwards for the Indian pharma industry is to unite in national interests, insist for industry representation in all technical, legal and statutory committees.

Indian industry must take note (too late) of “JNU- Kanhaiya” type NGO activity, which is wellentrenched in the corridors of Delhi, the presence of which need to be alerted at the highest levels. These negative activities which are well planned to damage the fair name and contributions of Indian pharma industry, need to be countered unitedly by Indian pharma industry, at the same time identifying and weeding out the wrong doers within, if any.

‘FDC ban and the US FDA alerts are a wake up call for the industry’

T

he Indian pharma industry which has earned the distinction of being the ‘Pharmacy of the World’ is currently facing strong headwinds impacting its growth and profitability. Rigid price controls, weak IPR enforcement, US FDA alerts, intense competition from cheap API imports from China, reducing tax incentives for R&D etc. have taken its toll. As if this is not enough, CDSCO has now banned 344 FDCs with immediate effect many of which have been in the market for over two decades and some even approved by the DCG(I). Apparently some more are likely to be added to this ban, resulting in about ` 3500-crore loss in sales.

This is also likely to slow down M&A activity many companies were pursuing for inorganic growth. While the Delhi High Court has given an interim stay on the ban, resolving issues through litigation has always been painful and time consuming process. While financial loss

30 EXPRESS PHARMA May 1-15, 2016

‘Make in India’ will remain just a slogan if pharma industry does not focus on quality, efficacy and patient safety as a priority

Dr Ajit Dangi, President and Chief Executive Officer, Danssen Consulting

is only secondary to patient safety, in a science based industry like pharma, key decisions like this have to be taken based on scientific principles and laid down processes rather than knee jerk reaction as shown by the CDSCO. As regards the timing of the ban which came in to force one day prior to the PIL filed by the former Ranbaxy

whistle blower Dr Dinesh Thakur in the Supreme Court against DCG(I) for failing to ensure product safety, gives rise to speculation.

The root cause of this mess lies in having a dual regulatory control of state as well as centre.

To remedy this anomaly, the central government appointed a committee under the chairmanship of reputed scientist Dr RA Mashelkar way back in year 2007. The committee's recommendation of forming a Central Drug Authority (CDA) on the lines of US FDA was approved by the then Union Cabinet and the bill was introduced in the Rajya Sabha. Later, it was forwarded to the Parliamentary

Committee which is lying on back burner since then.

Formation of CDA is of utmost importance as in many small states FDA is virtually non existent. The irony is, product approvals given by such state FDAs are valid throughout the country. Also, appointing IAS and police officers as State FDA commissioners should be stopped as many a times they lack the necessary domain knowledge required to run the FDA effectively. Sometimes pharma companies launch FDCs to differentiate their product from over 70,000 branded generics which have cluttered the market. At times FDC strategy was also used to circumvent

DPCO, although this loop hole has now been closed.

While there are some FDCs which are irrational and unsafe, some are quite rational and offer the patient advantage of dosage convenience and reduced cost.

For instance the recent 14th WHO model list of essential medicines lists 312 essential medicines of which only 18 are approved as FDCs. Since pharmacovigilance system is quite weak in our country, an FDC is safe just because it is available in the market for decades is a weak argument.

Needless to mention the irrational FDCs should be weeded out in a phased manner based on the safety and efficacy data submitted by the manufacturer. The FDC ban and the US FDA alerts are a wake up call for the industry who should also introspect and take remedial action.

‘Make in India’ will remain just a slogan if pharma industry does not focus on quality, efficacy and patient safety as a priority.

MANAGEMENT

‘The government’s averment to ban FDC drugs has been undertaken due to issues concerning patient safety’

P

atient safety is of paramount importance and no matter how much is the economic loss, it cannot justify any sort of compromise with patient safety.

While the notifications banning the FDC drugs state that the banned FDCs are 'likely to involve risk in human beings whereas safer alternatives to the said drug are available', there is still uncertainty on whether that is actually the case or not.

The government in recent hearings has made averments that the move to ban FDC drugs has been undertaken in view of issues concerning patient safety. On the other hand,

Abhijeet Das, Senior Associate, Singhania and Partners

Most of the drugs banned in the notifications were already manufactured in India so if it is upheld by the court, the same would surely have an adverse impact on the manufacturing activities in India manufacture have stood by and asserted that these drugs are safe and beneficial for patients. The issue of economic loss has been taken into account by Delhi High Court while granting an interim stay against the applicability of notifications, however, such a stance would be irrelevant in case the government can establish that FDC drugs are unsafe.

Impact of ban Uncertainty as to whether these popular FDC drugs would continue to be in the market, would certainly pose some questions on the prospects of growing horizontally.

These FDCs in certain cases, represented more or less a fixed revenue stream for their respective manufacturers, which they cannot bank on, at least till the issue is resolved by Delhi High Court. While this might in some cases make the valuation attractive for merger and acquisition purposes, an uncertain legal/regulatory environment can never be conducive for business in general.

Most of the drugs banned in the notifications were already manufactured in India so if it is upheld by the court, the same would surely have an adverse impact on the manufacturing activities in India.

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MANAGEMENT

Already hit by global recession, FDC ban will further dampen the spirit of Indian pharma industry

B

oth, Indian regulators and Indian pharma industry have been globally applauded for their work.

But the scenario is very different at the national level. Far from the applause, the regulators and the industry have been questioned on various grounds, including high pricing, GMP implementation and now, very recently, on irrationality of combination drugs being sold.

The Central Government issued notification Nos 705(E) through 1048 (E) to ban the manufacture, sale and distribution of 344 FDCs. FDCs are combinations of two or more APIs, usually combined for a synergistic effect and patient compliance. The notifications banned 344 of such FDCs terming all of them as irrational combinations. It is noteworthy that the ban is not based on incidence of adverse effects observed on patients, but due to the rationality of the combining specific ingredi-

ents. Industry feels that generalisation of irrationality to all 344 combinations isn’t appropriate, and a second review, with all stakeholders on board, may be a good idea.

The domestic pharma industry is estimated to be over ` 98000 crores, of which the 344 FDCs constitute around ` 3800 crores. The sudden ban has come as a jolt to the trade and industry. It is estimated to have impacted around 17 per cent of the respiratory segment, around eight per cent of the diabetic segment and around four per cent of the anti-infective segment.

It is also estimated that a huge stock of these products will have to be recalled and destroyed. The distribution chain members — retailers, wholesalers and distributors will have a huge task in identifying, isolating and returning these products. The marketers and manufacturers have to undertake a herculean task in collecting these products and

Viranchi Shah, Vice ChairmanIndian Drugs Manufacturers Association, Gujarat State Board

destroying them. This calls for immense cost, time and efforts. Some feel that the government ought to have given a window for clearance of goods from the market, limiting financial losses to the trade and industry.

Over and above, the loss due to stock destruction, the money spent in developing and

marketing these brands will also go to drain. This is a big financial dent to the pharma trade and industry. This step has dampened the spirits of the pharma industry that is already facing the heat of global recession.

Few of the FDCs from this list have been prescribed widely by medical fraternity and used for over decades, without any serious adverse effects being reported. Industry people feel that many combinations could have been continued to be allowed considering their therapeutic value, leaving it at the discretion of the prescribers to weigh the pros and cons before prescribing them.

Some of these FDCs have been approved after studies or may have clinical evidences to back them. Some FDCs may have been approved even before FDCs came under the ambit of the New Drug definition. Affected industry players have such arguments for the debate.

Another argument that

runs in the industry circles is that none of these molecules are individually banned. It is just the combinations that are.

There is no mechanism to stop the co-prescription of these drugs by the prescribers. Assuming that it is irrational to combine these drugs, the real benefits to the patients cannot be achieved unless co-prescription is also banned.

The matters have already reached courts, and it is for the honourable courts to evaluate the legal aspects of the entire episode. However, on medical grounds, the industry and the government need to sit together to rethink what went wrong from each side, and ensure adequate corrective and preventive actions. The pharma industry and regulators in India have traditionally worked together constructively on several issues in the past, and one more time they need to hold hands and come out with a solution to this challenge.

‘Government failed to act with imagination, information, speed’

T

he authorities should have approached the subject in a time-bound manner rather than banning them overnight. They had the best opportunity and time to approach companies to self regulate in a given time frame keeping the safety aspect of FDCs for a patient. This should have been the prime factor for any FDC. It is unfortunate. The government could have educated our doctors too on this but the drug department and the government

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who control had a total disconnect with the medical profession on this subject.

The recipient doctor or doctors could have been sensitised too on this which would have automatically created a climate of safety for patients.

Indian Medical Association and other federating associations of different faculties in medicine could have played a major role in sensitisation of doctors. Even Pharmacy Council of India could have thrown

their weight around by educating manufacturing pharmacists.

Handling situation wisely Certain short duration timelines need to be set by the Drug Controller General (India) in doing this because from time to time the global regulatory authorities of different countries do spell and convey the unapproved drugs and their reasons in different forums.

The government has failed to act with imagination, informa-

tion and speed on this.

After all, this phenomenon was done for the patient’s safety globally. There is no segmentation in patients like an American or African or Indian. Patients are patients irrespective of their country. Doctors are capable of prescribing drugs and drug combinations individually and adopt a definite counselling session with the patient.

Will growth down?

Now pharma companies are

SR Vaidya, Director, Bliss GVS Pharma and Chairman, SME Committee, Indian Drug Manufacturers' Association

MANAGEMENT Indian Medical Association and other federating associations of different faculties in medicine could have played a major role in sensitisation of doctors temporarily in a fix but can recover through self regulation themselves.

Mergers can be delayed instead of distress mergers. All that they have to do is to modify the FDC in such a way that the FDC fits into the regulatory profile as well as of the safety profile of the patient. This is only a question of time.

The best attitude for the industry is to be proactive with the regulatory authorities of the country and thus create a climate of mutual trust and credibility in the industry.

Effect on ‘Make in India’ initiative One cannot think so because the healthcare industry is going to be a progressive process. The doctors will resort to change in their habits. The companies will sell alternative formulations.

In fact there will be an overall systematic change of perception in the manufacturing of both single ingredient products and FDCs henceforth.

A shock treatment of this nature was imminent and necessary and it will only promote a robust, accepted and trusted growth. Thus Make in India in no way will suffer but add more teeth to the manufacturing.

Road-map The road map for the pharma industry should be such that ◗ Their focus in the organisation should be with the scientific department more than marketing and sales ◗ There has to be a holistic approach while designing an FDC by putting a lot of clinical substantiation and promote the products in such a way that the doctor translates the information as credible rather than useful. ◗ The companies should promote the indications of the product surely but they also should convey the likely adverse reactions when used on a patient thus keeping the medical fraternity fully informed. ◗ In fact the doctors too should be encouraged to know the safety profiles of the products as many products are consumed for a long period due to the chronic nature of the disorders. ◗ A proactive attitude towards the regulatory authorities of the country and the state by establishing a full proof information system of manufacturing FDCs through reports.

FDCs ban is long overdue and must be lauded

M

oHFW's initiative to ban irrational Fixed Dose Combinations (FDCs), in the interest of patient safety, is long overdue and must be lauded. However, the overnight imposition of a blanket ban on 344 products remains a concern. Many of these FDCs have been previously approved by the Drugs Controller General India (DCG(I) as safe and efficacious. Some of these approved products currently have no alternatives; and banning them with immediate effect denies access for patients to medicines that are approved as safe and effective in India and abroad

Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India (OPPI)

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MANAGEMENT INSIGHT

Assessment of pharmacy registrations and renewals Mansi Shah, Clinical Pharmacist, elaborates on registration renewals of pharmacists and opines that they should be based on evaluating competence, skills and objective appraisals by continuous professional development appraisers of the regulatory authorities and not simply on employer opinions THE PROFESSION of pharmacy has clearly moved forward in the past five years.

This is obvious from a recent interview of Dr B Suresh, President, Pharmacy Council of India (PCI) (2015)1 and his earlier message of 20102 where he states the need for development in certain areas. The areas relate to Pharmacy Practice Regulations (2015)3, PharmD Regulations (2008)4.

It also comprises the introduction of a bridge course, presenting an opportunity for diploma pharmacists, to upgrade themselves and earn a degree. He also stresses on the need to provide professionally specialised clinical pharmacists in India as well as amendments to the Pharmacy Act 19485 and education requirement.

Every responsible pharmacist in India and especially, qualified competent clinical pharmacists with necessary skills and a drive to contribute to and improve the eventual stage of pharmaceutical care delivery, that every pharmacist ideally works towards, would salute to these developments.

We still have a long way to go. There is immense need for improvement, creating opportunity for practising pharmacists and continued development. Continuing education (CE) and continuous professional development (CPD) ought to be introduced in education and training years. Registration to practice should make this mandatory for every pharmacist in every sector with each of the degrees acceptable towards registration.

Education and training with CPD inculcated from the beginning would lead pharmacists in India to become responsible healthcare professionals. CPD standards and evaluation pro-

34 EXPRESS PHARMA May 1-15, 2016

cedures should be laid down by the regulator and CPD should be made mandatory. Assessments and appraisals of CPD should be conducted at regular intervals by the regulatory authorities directly. Registration renewals should be based on evaluating competence, skills and objective appraisals by CPD appraisers of the regulatory authorities and not simply employer opinions.

Pharmacy Practice Regulations 20153 states that for renewal of registration, pharmacist shall attend a minimum of two refresher courses in pharmacy, having a minimum of one day duration each within a span of five years, organised by PCI, state pharmacy councils, central government/state governments or a professional body recognised by the Council, and maintaining good pharmacy practice. The question remains on how state pharmacy councils will be reviewing attendance to these not just through certificates and learning. It is important that this additional learning, competence and skills gained are assessed appropriately. Procedures have to be standardised to evaluate objective and subjective learning skills, including critical appraisal skills for clinical evidence and competence.

Pharmacists should be professionally competent to interpret evidence and as relevant support prescribing and therapeutic management towards medicines optimisation and improved healthcare. Thus, it is important that pharmacists are assessed appropriately and registration to license is sound.

There are awareness of issues regarding registration and its misuse. Adding to this, lack of one specific countrywide regulated subjects’ specific and

MANSI SHAH, Clinical Pharmacist

pharmacy law (variability in case of state specific differences in pharmacy law) examination and pre-registration training towards pharmacist registration in our country.

A question thus arises about our assessment as competent health professionals to allow practice and registration rather than being told to surrender our registration when being registered elsewhere. A regular assessment or review of pharmacists’ practice and competence by regulatory bodies, at a set time of every specific few years, may be a better way for authorities to gauge competence, awareness of local regulations and legalities can ensure adequate practice for pharmacists within India and overseas.

Professional incompetence is said to be judged by peer group as per guidelines prescribed by the PCI. But, there is lack of practice or a clear process to evaluate experience or competence of a pharmacist requesting registration or renewal.

Introduction of internship with Pharm D4 is a major step and we hope every student who has the opportunity of this degree makes in to be a responsible pharmacist with hands on training. Significant initiatives have been taken by the PCI and state councils and academic pharmacy institutes to support bridging the gap between career and education, and refresher courses for pharma-

cists ‘in-service’. Examples include HK College of Pharmacy’s initiative ‘Involve to evolve’ to provide continuous practice-based guidance and support to students from such mentors, and Gujarat State Pharmacy Council sponsored refresher course organised by the SAL Institute of Pharmacy for ‘in-service’ pharmacists6.

Learning in India is based on current health needs, demands and scenario, and practice is foremost to our healthcare and professional development. Further to this, we need a standardised process of assessing currently registered and practicing pharmacists. This would lead currently registered pharmacists being appropriately assessed prior to registration renewal.

With reference to the first of these two articles about pharmacists’ registrations and renewals (See link: http://www.financialexpress.com/article/pharm a/management-pharma/pharmacists-registrations-and-renewals/231356/), permanent move of pharmacists to other countries will predominantly lead those individuals to not renew their registration. These moves mostly remain ‘only on paper’ and the ‘unwritten’ regulations, drive people away from our country and lead us, other health professionals and the public to not take the profession seriously. The same individuals when in a different country with strict regulations, reviews and recognition as professionals either completely abide by the profession to be responsible registered and practicing pharmacists or leave the profession out of choice.

It is unlikely that a pharmacist registered and working in a different country will attempt misuse of his pharmacist regis-

tration in India. This may only lead to him/her being stuck of his registrations elsewhere too.

It is essential that pharmacies in India are inspected appropriately, regularly and on ad hoc basis to gauge the presence of the said registered pharmacist.

This may lead to a better review of practising pharmacists in India and those working intermittently in different regions. As already mentioned in the first article on pharmacists’ registrations and renewals, pharmacists with registrations in more than one country may be better, may be more appropriately placed on a different register for such pharmacists and registration details in brief on their certificate rather than striking off practising pharmacists off the register in India.

One should be aware of the competence and skills of some pharmacists who may have maintained practising licenses in more than one country. In addition to self-appraisal, wider practice exposure and skill mix contribute to development in training and practice. CE and CPD requirements and strict assessments for registration and appraisals by licensing authorities every few years towards renewal demand and contribute to sound foundation and competence. In the current healthcare scenario and globalization in every aspect, why is a clinical pharmacist not allowed to work globally in different countries and develop skills to enhance development of better patient care worldwide?

As an example, the US has stringent requirements for professionals to undertake CE, continuing professional education (CPE) and continuing medical education (CME) with differences in requirements in

MANAGEMENT different states laid down and monitored by professional organisations and regulators7.

Like the PCI with state pharmacy councils, General Pharmaceutical Council (GPhC) in the UK, The PEBC in Canada and NABP in the US with boards of pharmacy in each state, are responsible for pharmacy registration/licensure to practice. The GPhC, the regulator for pharmacists in the UK, has a statutory duty to ensure that pharmacy professionals practice safely and effectively. For this, CPD standards, framework, rules have been laid to enable pharmacists to demonstrate skills and knowledge update and their competence towards continuously improving practice. To support this, GPhC has approved a format of recording CPD and make this possible through an online system or as hard copies. To complete this cycle and enable professionals restarting the process, pharmacists’ CPD records are reviewed at least once every five years8. CPD within Australia and New Zealand follows a model similar to the UK7.

National Pharmaceutical Association (NPA) in the UK supports CPD through a webbased learning service and provision of training courses9. The Centre for Pharmacy Postgraduate Education (CPPE) also supports pharmacists through professional development and CPD10. With PEBC as the regulator in Canada, CE in pharmacy is coordinated by the Canadian Council on Continuing Education in Pharmacy (CCCEP)11.

In the US, NABP supports pharmacists to ensure high standards of pharmacy practice and state pharmacy boards are responsible for licensure12.

The Accreditation Council for Pharmacy Education (ACPE) sets standards for the education of pharmacists to prepare them for the delivery of pharmacist-provided patient care.

According to a 2015 Survey of Pharmacy Law, 53 boards of pharmacy require pharmacists to participate in CPE activities as a prerequisite for license renewal. NABP, ACPE and ACPE providers have developed a CPE monitor (online system)

Individuals need to realise that pharmacy is a healthcare profession and ones responsibility in choosing and pursuing pharmacy. It is high time regulatory bodies start taking registration of pharmacists and premises more seriously as professionals and premises proving professional services, respectively as a format and mode for pharmacists to record and submit their CPE from accredited providers which can then be submitted when pharmacy boards request reports on licensees12, 13.

In India, PCI and a percentage of the pharmacy fraternity realise the need, implications and benefits of these requirements and may work slowly towards the same goal. But it takes each one of us to work towards this professionalism and our regulators to set professional and CPD standards, framework and rules and assess each of us pharmacists to become responsible and true professionals. Stringent assessments should be mandatory for pharmacy registrations and renewals.

Our President (2015)1 has highlighted that the council continues to put its efforts to address difficulties faced by pharmacists. Thus, with our professionalism in stride and responsibility to pharma care provision, I request our President to allow opportunities to our competent, skilled, ‘responsible’ practice pharmacists striving to make a difference clinically and develop professionally continuously.

In his message (2010)2 which is even today available as the President’s message on the PCI website, he mentions ‘updating knowledge bank of our pharmacists’ through refresher courses and material from Commonwealth Pharmaceutical Association, London, and talks about promoting continuing education and exchange programmes between countries. This clearly indicates that Council and office bearers are all aware of the need for our

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profession to learn from each other within the country and globally. Then why do we take a step back and not allow this.

Our own pharmacists from within the country and elsewhere could contribute significantly and that registration in more than one country leading to a wider range of professional experience would enhance our competence, skills and understanding of world health scenarios and present a better approach to healthcare management.

India is a vast country and reading this article may lead my peers, officials, regulators, council members, inspectors and other healthcare professionals, patients and the public to believe this to be one more write up with no action. But it takes each one of us to work towards achieving this goal.

Pharmacists are healthcare professionals and it is high time that they take this as a business start realising otherwise. It is for our council and regulatory bodies to enable this to happen with us being professional and responsible pharmacists. I contribute individually and create this awareness as an independent clinical pharmacist and work on a one-to one basis.

There is a need for all of us to act responsibly and our regulators to demand, review and assess competence, skills and knowledge base to be registered pharmacists (practicing register). Pharmacy premises should be permitted with registration only with specifics of the registered pharmacist present on site stated and requirement for the council to be informed with each change.

Individuals need to realise that pharmacy is a healthcare

profession and ones responsibility in choosing and pursuing pharmacy. It is high time regulatory bodies start taking registration of pharmacists and premises more seriously as professionals and premises proving professional services, respectively. Regulatory bodies also should look into the registrations because an application has the said ‘documents’ and pharmacists have ‘degrees’ and the required ‘said training thereafter ‘from the endless pharmacy colleges and courses that have sprouted in our country’.

References 1. Market. Interview: Dr B Suresh (Vice Chancellor, JSS University, Mysore and President, PCI) (2015) We expect as many as 8000 delegates to participate in the event’ Express Pharma (Usha Sharma), Nov 1630.

2. Pharmacy Council of India (2010) President’s message. Accessed via: http://www.pci.nic.in/PresidentsMessage.aspx (accessed 21.04.2015) 3. Pharmacy Practice Regulations (2015) http://www.pci.nic.in/Circulars/Pharmacy%20Practice%20Regulations.pdf (accessed 02.12.2015) 4. Pharm.D. Regulations 2008.

Published in The Gazette of India, No.19, PART III, SECTION 4] Ministry of Health and Family Welfare (Pharmacy Council of India) May 10, 2008. Accessed via: http://pci.nic.in/PDFFiles/PharmD-Revised-A.pdf (accessed 02.12.2015) Notification of Pharm D Regulations framed under section 10 of the Pharmacy Act, 1948. Ac-

cessed via: http://www.pci.nic.in/PDFFiles/14-126circular.pdf (accessed 02.12.2015) Guidelines for Pharm D Internship. Accessed via: http://www.pci.nic.in/PDF Files/Guideline%20for%20Phar m.D.PDF (accessed 02.12.2015) 5. The Pharmacy Act, 1948 (http://www.ipapharma.org/pdf /Pharmacy_act_1948.pdf) The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India. Accessed via: The Indian Pharmaceutical Association website under Regulations and Guidelines http://www.ipapharma.org/Regulations.aspx (accessed 02.12.2015) 6. Mukne A (2015) Campus News. Pharma Times 47(10), 34-5.

7. The CPD Standards Office (2016). CPD Accross the Globe.

Accessed via: https://www.cpdstandards.com/cpd-across-theglobe/ (accessed 01.01.2016) 8. General Pharmaceutical Council (GPhC) (2015) Continuing professional development.

Accessed via: https://www.pharmacyregulation.org/education/continuingprofessional-development (accessed 21.12.2015) 9. The CPD Standards Office (2016). CPD Sector Requirement. Accessed via: https://www.cpdstandards.com /sector-requirements/sector-requirement-search/?_sft_category=medical-healthcare; www.npa.co.uk (accessed 01.01.2016) 10. CPPE (2016) Crown Copyright. Accessed via: https://www.cppe.ac.uk/support/support (accessed 02.01.2016) 11. PEBC (2015) Accessed via: www.pebc.ca/index.php/ci_id/31 49/la_id/1.htm#Information about Continuing Education (CE) Learning: (accessed 30.12.15) 12. National Association of Boards of Pharmacy (NABP) (2016) Pharmacists. Accessed via: www.nabp.net/pharmacists (accessed 02.01.2016) 13. National Association of Boards of Pharmacy (NABP) (2016) Pharmacists: CPE and License Renewal. Accessed via: www.nabp.net/programs/cpemonitor/cpe-monitorservice/pharmacists (accessed on: 02.01.2016)

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May 1-15, 2016

RESEARCH INSIGHT

The importance of skill from research to delivery of vaccines

DR DAVINDER GILL, CEO, Hilleman Laboratories, New Delhi

Dr Davinder Gill, CEO, Hilleman Laboratories, roots for an educational programme for vaccinators to hone their skills and make them primary providers for vaccine education and administration THE INDIAN vaccine industry began as a network of stateowned manufacturers, supplying basic childhood vaccines to the national immunisation programme. In recent decades, the number of privately-owned firms has grown rapidly. Their success in bringing low cost solutions to public vaccine markets is an important driver behind the emergence of the sector in India. With increasing revenues and advancement in technology, the companies are increasingly shifting their focus on innovation.

The vaccine industry has also been supplying a large share of basic vaccines to a number of developing countries, and is now exporting more advanced vaccines as well. From a public health perspective, it is a significant contribution that our industry has made, by bringing down prices and keeping them low. Even though price will continue to play an important role, the industry is now in a translational phase, moving from a ‘pricedriven' to an ‘innovationdriven' model.

Currently, a dozen or so new vaccines are in clinical development in India. According to a 2013 report of the Netherlands Office of Science and Technology entitled ‘Vaccines Market in India’, the disease areas being worked on by vaccination experts are rotavirus, Japanese Encephalitis, typhoid fever, malaria, rabies, and influenza, amongst others. According to the report, many other projects were also in earlier stages of re-

36 EXPRESS PHARMA May 1-15, 2016

Even though price will continue to play an important role, the industry is now in a translational phase, moving from a ‘price- driven' to an ‘innovation-driven’ model search, including efforts on dengue, chikungunya and cholera. The Indian government supports such initiatives through growing investment in research and development (R&D). Relevant government funding agencies like the Department of Biotechnology, The Indian Council of Medical Research and Ministry of Health and Family Welfare have been scaling up their investments in R&D. The government is actively supporting the emergence of R&D in the private sector through joint investment in Public-Private Partnerships (PPPs). PPP’s are at the heart of many of the industries’ recent R&D successes which is why our government is now taking an active interest in vaccines and immunisation.

In terms of R&D, there have been particular focus areas for vaccines. Listed below are some that have been of primary concern to our organisation with its aim of creating safe, low-cost vaccines that are highly effective and can be easily incorporated into child immunisation programmes: ◗ Thermostability- The vaccine should be room temperature stable with a stability profile

that meets the needs of developing countries ◗ Ease-of-use- The vaccine should be easy to administer in field settings and limit biological waste ◗ Package size- The vaccine should be packaged in a manner that is easy to transport, store and administer ◗ Reduced cost of goods- The vaccine production cost by manufacturers should be affordable for use in developing countries These focus areas of R&D form effective strategies for protecting individuals from vaccine-preventable diseases.

It is important to account for all stages in a vaccination process so as to maintain the right level of skill from the beginning to the end, which is why the following strategies are also crucial: ◗ Develop new or improved vaccines and improve the use of vaccines ◗ Improve both the quality and quantity of the delivery of vaccination services ◗ Minimise financial burdens for needy persons ◗ Increase community awareness, participation, education, and partnership ◗ Improve disease monitoring

and vaccination coverage While there is plenty of skill and knowledge that can be found in India in the R&D stage of vaccines, the availability of skill decreases as one proceeds down the delivery chain. Skill plays an equally important role in the delivery and administration stage of a vaccination process, especially in remote and rural areas in developing nations. India’s health system is complex, and at its grassroots are people such as the Auxiliary Nurse Midwife (ANM), Accredited Social Health Activist (ASHA) and Anganwadi Workers (AWW) who serve at the frontiers between disease and health. Their role is critical for making immunisation programmes successful.

Vaccinators are therefore in a unique position to identify populations who form a target group for certain vaccinations.

They are one of the most accessible healthcare professionals as they are instrumental in providing patients with pertinent information to make informed choices when it comes to immunisations. They may also be able to ease the fears of many patients by providing them with the facts as well as the significant risks associ-

ated with not being vaccinated.

Since not all vaccines are administered in the same way, the level of expertise differs with programmes and diseases. Which is why, vaccinators should be adjudged to administer based on different criteria. The criteria can be anywhere from specific education to certification requirements before administering a vaccine.

India, however, is in need of an educational programme that teaches vaccinators the skills needed to become a primary provider for both vaccine education and administration.

The programme should be such that it teaches the basics of vaccines and focuses on both the practice implementation and societal/ethical issues with regard to vaccinations.

In rural areas health administrators who do not administer vaccines also have an important role in promoting the importance of immunisation which includes: ◗ history and screening of patients ◗ patient counselling ◗ documentation ◗ formulary management ◗ administrative measures ◗ public education and awareness Effectively all these measures serve one common purpose. It brings health to individuals who are at the danger of falling prey to deadly diseases and who can be important contributors to a nation which is still in its development stage.

RESEARCH UPDATES

Common medicines tied to changes in brain According to the researchers, people using these drugs score lower on tests of immediate memory recall and executive function compared to people who weren’t using these drugs COMMONLY USED drugs for problems like colds, allergies, depression, high blood pressure and heart disease have long been linked to cognitive impairment and dementia. Now researchers have some fresh evidence that may help explain the connection.

The drugs, known as anticholinergics, stop a chemical called acetylcholine from working properly in the nervous system.

By doing so, they can relieve unpleasant gastrointestinal, respiratory or urinary symptoms, for example.

The list of such drugs is long.

Among them, Benadryl for allergies, the antidepressant Paxil and the antipsychotic Zyprexa, Dimetapp for colds and the sleep aid Unisom. In the new analysis, researchers looked at brain scans and cognitive test results from 451 older adults – including 60 who had been taking anticholinergic drugs for at least a month. The study participants were about 73 years old on average.

None of them had been diagnosed with cognitive problems like Alzheimer’s disease or dementia.

But brain scans of people who used anticholinergic drugs showed lower levels of glucose processing in the brain – an indicator of brain activity – in a region of the brain associated with memory that’s also affected early in the course of Alzheimer’s disease. In addition, patients who used these medications had reduced brain volume and thickness in some regions linked to cognitive function, the researchers report in JAMA Neurology.

People who used these drugs also scored lower on tests of immediate memory recall and executive function compared to people who weren’t using these drugs, researchers found.

“There are definitely medical benefits to all of the anticholinergic medications we looked at, which could outweigh the cognitive risks,” said lead study au-

thor Shannon Risacher of the Indiana Alzheimer Disease Center at the Indiana University School of Medicine in Indianapolis.

“But if alternative therapies are available that provide effective treatment of these conditions, patients and doctors might want to consider avoiding anticholinergic medications,” Risacher added.

The study can't prove the an-

ticholinergics were the cause of participants' brain and memory differences.

The authors also acknowledge limitations of their study.

In addition to the small number of participants taking anticholinergic drugs, another problem is that the study relied on participants to accurately recall and report on drug use, which wasn’t verified by medical records or prescription data.

This study and others like it are limited as well by a lack of specifics about what dosage of anticholinergic drugs people took or how long they used the medications, noted Alain Koyama, an outcomes researcher at Health Advocate, a consultancy in Los Angeles.

“Therefore, it is yet unclear if lower doses or shorter durations of use can in fact mitigate risk of cognitive harm,” Koyama, who wasn’t involved in the study, said.

Still, the study adds to a growing body of evidence con-

necting anticholinergic medicines to cognitive problems later in life and offers new evidence to explain why this link exists, Koyama added. The findings should encourage doctors and patients to discuss the drugs, and to consider whether the potential risk of cognitive decline merits avoiding or limiting use of these medicines.

Not every patient will arrive at the same answer, however.

“Since the pathology underlying any effect of anticholinergic drugs on cognitive function likely takes years to manifest, if a patient is clearly benefiting from a drug in the short-term, but may not survive in the long term, any cognitive harm from the drug may be inconsequential,” Koyama said. “On the other hand, a healthier patient particularly concerned about future dementia risk, whether because of family history or other reason, may consider alternative treatments,” Koyama added.

Reuters

Bristol-Myers’Opdivo extends survival in head and neck cancer: Study Opdivo treatment led to a 30 per cent reduction in risk of death, with median overall survival of 7.5 months in the 361-patient trial BRISTOL-MYERS Squibb’s cancer immunotherapy drug, Opdivo, helped advanced head and neck cancer patients with a dismal prognosis live longer than other standard treatments, according to data from a late-stage study presented.

Opdivo treatment led to a 30 per cent reduction in risk of death, with median overall survival of 7.5 months in the 361-patient trial, compared with 5.1 months for those who received any of three commonly used treatments chosen by re-

searchers.

While a median survival difference of less than three months may not sound like much, some patients taking that type of immunotherapy experience far more durable responses. After one year, 36 per cent of Opdivo patients were still alive compared with 16.6 per cent of those who received either methotrexate, docetaxel or Eli Lilly’s Erbitux, researchers reported.The data likely paves the way for another approval for Opdivo, which is currently ap-

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proved to treat advanced melanoma, non-small cell lung cancer and kidney cancer.

“The most important thing is the difference in the proportion of patients who survived to a year,” Dr Maura Gillison, the study’s lead investigator who presented the data at the American Association of Cancer Research meeting in New Orleans, said in an interview.

Patients in the study had advanced cancer that had progressed within six months of receiving platinum-based

chemotherapy. "It’s a very devastating cancer when it recurs," said Gillison, noting an average survival of less than six months.

Earlier at the meeting, researchers presented data showing 34 per cent of patients who received Opdivo for advanced melanoma, the deadliest of skin cancers, were still alive after five years. Opdivo proved effective whether the head and neck cancer was positive or negative for human papillomavirus (HPV), researchers said. But the magnitude of benefit was

greater for HPV-positive patients, with median overall survival of 9.1 months versus 4.4 months for the standard treatments.

Merck & Co's rival drug, Keytruda, received a priority review for head and neck cancer from US regulators and could be approved for that use

by August. Both drugs belong to a class called PD-1 inhibitors that block a mechanism that tumours use to avoid detection from the immune system.

Reuters

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May 1-15, 2016

PHARMA ALLY VALUE ADD

Physical vs.Physiological energy value of food Dr Heinz-Dieter Isengard, Professor at the University of Hohenheim, Institute of Food Science and Biotechnology, Germany and Kai-Oliver Linde, Corporate Product Manager, IKA-Werke , Germany give a holistic view of ‘energy value’ of food

E

very food label contains the ingredients, the manufacturer's information and the expiration date along with information on the energy/caloric content. EU regulation no. 1169/2011 as well as the Food Information Regulation previously used the classic calorie unit (cal) and kilocalorie (kcal), but according to the current European regulation, the joule (J) and kilojoule (kJ) per unit of weight is now provided as well. But what exactly does this value tell us?

Where does the information come from and how is the caloric content precisely determined?

FIG 1

Calories and calorimeters The word ‘calorie’ is derived from the Latin word calor for ‘heat’. A calorie represents the amount of energy needed to heat 1 g of water by one degree Celsius. So-called combustion calorimeters (see Fig. 1) are used to measure the physical energy content in food.

A sample under pressurised oxygen is completely burnt here under controlled conditions. All components of the previously homogenised and prepared food are completely oxidised. The organic components are present after combustion in the form of CO2, water and acids in the combustion chamber of the calorimeter.

As shown in Fig. 1, the sample is burned in a combustion chamber (flame) and the released heat is transferred to the surrounding water. The water must be mixed sufficiently enough in order to ensure uniform heat

38 EXPRESS PHARMA May 1-15, 2016

TABLE 1: DETERMINED ENERGY VALUE IN COMPARISON TO THE LABELLED ENERGY VALUES Physiological energy value/J/g

Physical energy value/J/g

Label

Calorimeter

Noodles

15010

16238

-1228

Yellow gummi bears

14590

14173

417

Sugar

17000

16475

525

Zwieback toast

16930

18435

-1505

Sugar beet syrup

12670

12527

143

Almonds

24660

29134

-4474

distribution. Using a temperature sensor, the temperature can be determined to a precision level of one ten thousandth of a degree celsius prior to and after

the test.

The compact static jacket calorimeter from IKA shown here has an uncontrolled (static) jacket -- as the name

Differences / Label - calorimeter/ J/g

suggests -- that provides an insulating function. All of the work steps related to the calorimeter, such as water and oxygen handling, are

completed, entirely automatically, by the device. Since there is always a small flow of heat, this must be determined so that the temperature can

then be corrected. This is accomplished using one of the classic correction calculation methods in calorimeter standards for an isoperibolic calorimeter (Regnault-Pfaundler) (see Fig. 2).

FIG 2

FIG 3

Physical energy value The sample preparation is a decisive part in determining the energy value. Food should generally be placed in the calorimeter already freeze-dried and homogenised. The result is influenced mostly by the water content of the sample.

The calorimeter provides the so-called physical energy value.

This means that the sample was fully combusted. In our bodies, however, these processes do not work in the same way as in a combustion calorimeter, but are rather more staged in a great number of individual steps during which a comparably very small amount of energy is released. This energy is used for the synthesis of substances needed by the body and for maintaining the body temperature. Special energy-rich molecules are built up that can be used later and at other points for the biosynthesis of compounds. In other words, one does not need to constantly eat in order to have energy available and to build up materials. This means that the organism never fully breaks down the material it took in; it eliminates a part thereof, primarily a part that it cannot break down, but which can be physically burned.

The energy values measured in the calorimeter are thus generally higher than those listed on the food identification label, because these figures describe the value that is actually released from the organism--the so-called physiological energy value.

Physiological energy value So that a person can use food optimally, one prerequisite is first to crush it well, to chew it, to allow the saliva to act, then it can be better digested and the individual components optimally processed by the healthy body. Fats are in some cases

applied, such as in carrying out nutritional studies [1].

For food labelling, however, an average person is assumed, and this may also be defined differently depending on the country, which exhibits an assumed average metabolism for processing food. In humans, the process of food processing, energy use and usability is still affected by a variety of other factors. As a result, anyone who does not correspond to the average acts based on an incorrect energy value or caloric content.

Listing of caloric contents ENERGYVALUES Where do the energy values on food labels come from? In the beginning of the 20th century,Wilbur Olin Atwater determined the physical energy content of food using a bomb calorimeter.The main components were described according to the amounts of energy.The applicable physiological energy values were then determined. For proteins, this value was lower than the physical: 1 g protein

4 kcal

= 17 kJ (instead 5 kcal = 22 kJ)

1 g carbohydrate

4 kcal

= 17 kJ

1 g fat

9 kcal

= 39 kJ

1 g alcohol (ethanol)

7 kcal

= 29 kJ

stored or, to cover basic energy needs, are accessed directly and converted into energy.

However, the preparation of the food is important here. Some foods may be poorly digested in the raw state and poorly utilised by the body.

In order to know the optimal personal energy value for food, one would first have to determine one’s own basic energy expenditure. There are studies in which people were evaluated specifically in that regard. This includes, among other things,

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breathing, CO2 output ('combustion efficiency' of the body), at rest and while working.

As mentioned, the body does not always break down the substances absorbed with food with the same degree of completeness. This depends on the situation at the moment, but also, of course, on the particular individual. In addition, some physically oxidisable components such as dietary fibre are generally not broken down because humans lack the necessary enzymes. Thus, in order to

determine the physiological energy value, the energy content of the food must first be determined in a combustion calorimeter and then also the stool and urine examined. The energy in the food minus the energy in the faeces and urine is then the energy of the food actually released in the body of the person investigated.

Such studies are common practice, for example in the field of agriculture and animal feed research. Here the standard DIN EN ISO 9831 is frequently

Various foods were evaluated for their physical energy value.

The samples were ground to a fine powder, contaminationfree, in an IKA Tube Mill control (see Fig. 3). Table 1 shows the measured energy values compared to the specified energy value on the food label.

Since, however, as already mentioned above, food can be utilized very differently from person to person, and depending on how well cooked and chewed the food is, the physiological energy value is not equally applicable to all people.

The physical energy value allows for better comparability of the energy in different foods, as this can be determined directly and without detours and adjustments by simple combustion in the calorimeter under pressurised oxygen. Under this precondition, would a physical energy value not be better suited for a general comparison of the energy/caloric content of foods? Where applicable, the energy content of substances that are indigestible by humans could be subtracted from the total value.

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May 1-15, 2016

PHARMA ALLY PRODUCTS

Gandhi rolling shutters: Quality engineered GANDHI AUTOMATIONS, an entrance automation and loading bay equipment company, is the manufacturer of rolling shutters certified to ISO 9001 - 2008 quality management system. Over years of meticulously working on the design, fabrication and installation, Gandhi Automations has developed technical expertise in manufacturing various kinds of automated rolling shutters. The research and development team with its extensive know-how and experience are able to produce specific types of rolling shutters unique to certain sites and client requirements. A consistent quality product has thus become the hallmark of Gandhi Automations' manufacturing process right through installation to after sales service.

The rolling shutters are ideal for situations where side room is at a premium and security is required. It requires little head-

fabricated of interlocking galvanised insulated and non-insulated, stainless steel, patented aluminum or polycarbonate profiles and patented MS rolling grills.

The rolling shutters conform to IS 6248 and are solidly constructed to promote troublefree operation and long life. The shutters fit openings to a maximum width of 30,000 mm and height of 40,000 mm with an endless array of options to satisfy both aesthetic considerations as well as working requirement.

room above the structural opening.

The combined

strength with elegance along with durability are designed for

both external and internal applications. The rolling shutters are

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

36-38 rue de la Princesse, 78431 Louveciennes, France (phone) +33 1 39 17 20 41

(mobile) + 33 6 42 31 10 39 (VoIP) 63042041 elisa.eschylle@aptar.com

Aptar Pharma launches eDose Counter for metered dose inhalers APTAR PHARMA, a global solution provider of innovative and proven aerosol, injection and spray delivery systems for biotech, healthcare and pharma products, has recently unveiled eDose Counter for metered dose inhalers (MDIs), at the RDD scientific conference in Phoenix, Arizona.

MDIs are complex systems that integrate several components such as the metering valve, the canister and the actuator. These components must be carefully designed

40 EXPRESS PHARMA May 1-15, 2016

and manufactured to ensure they work together effectively.

This is particularly true for the valve and the dose counter.

Aptar Pharma’s expertise and experience enables a smooth integration of all MDI components, including the dose counter.

The patented eDose Counter for MDIs has been designed to be easy-to-use and reliable, and contributes to patient compliance. The unique sensing technology offers direct detection of the spray

which eliminates risks of miscounting. The sensing technology is versatile and compatible with any metering valve design. In addition, the eDose Counter for MDIs includes inhaler priming and medication reminders-to-use and end-ofproduct-life warnings (flashing digits) while remaining cost-effective.

Contact details Elisa Eschylle Events & Press relations Manager, Prescription Division

BUSINESS AVENUES

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BUSINESS AVENUES

EXPRESS PHARMA

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Salient Features :

Walk in Chamber Cooling Chamber

Most Preferred Chambers for USFDA & UK-MHRA etc. approvals Accurate Controls & Uniform Conditions.

Alternative PLC with touch screen display with Ethernet with automatic change over facility.

Computer Interface with 21 CFR Compliance software.

Complete validation package comprising DQ, IQ, OQ & PQ. 24 x 7 Online service support.

B-8, Karma Estate, Nr. Trikampura Patiya, Vatva, Ahmedabad - 382445 (Gujarat) INDIA. Tele : 079 - 25890727 Mobile : +91- 9427613646 Email : service@kesarcontrol.com Web : www.kesarcontrol.com

MFGRS. PHARMA AND LAB EQUIPMENTS 42 May 1-15, 2016

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Tel: (022) 6505 5819 EXPRESS PHARMA

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Fax: (022) 2613 4269

email: info@ptelectronics.in May 1-15, 2016 45

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SPECIALIZED IN PLATINUM CURED SILICONE TUBES,BRAIDED HOSES & INFLATABLE SEALS/GASKETS 1st Indian Silicone Rubber Product Mfg. Co. certified with Clean Room of Class 10000 For high purity & intricate application of Vaccines & Injectables, most of the Pharma companies are insisting only AMIs Silicone Tubing & Braided Hoses, accredited by US FDA DMF No. 26201 with Extractable & Leachable Studies.

GENERAL PRODUCT RANGE v v v v v v v v v v v v v v v v v v

Silicone Transparent Tubes (Peroxide & Platinum cured) Silicone Transparent Braided Hoses (Peroxide & Platinum cured) Silicone Autoclave Gaskets, Teflon Envelop Gaskets.

FBD Inflatable Gaskets for Fluid Bed Dryer Silicone Tri Clover Gaskets, Rotary Rack Oven Gaskets Butterfly Valve Gaskets, Isolator Gaskets O-rings (Silicone, Viton, EPDM, Nitrile & Neoprene Silicone Solid Cords ( Round & Square type) Silicone Sponge Cords & Gaskets Silicone Extruded Door Gaskets “ON PRODUCT Silicone Diaphragms, Silicone Bellows LOT TRACEABILITY Silicone & Viton Sheets THROUGH PERMANENT Lypholization Door Gaskets LASER MARKING Silicone Endless Gaskets IS AVAILABLE Viton Cords & Tubes ON REQUEST Rubber Bellows & Expansion Joint Silicone sleeve for Corona Treater application Validation gaskets & Sensor TC “SMART” Gaskets

We’re Exhibiting April 26 - 28, 2016 Javits Center I New York City

PLATINUM CURED SILICONE

SS BRAIDING

PTFE TUBE

SILICONE TRANSPARENT TUBE

SILICONE BI-COLOUR TUBE

PTFE SILICONE HOSE

SILICONE TRANSPARENT BRAIDED HOSES & TUBES

SILICONE EXTRUDED DOOR GASKETS

SILICONE FBD INFLATABLE GASKETS

SILICONE TC DIAPHRAGMS

SILICONE BELLOWS

SILICONE O-RING & FEP

Ami Polymer Pvt. Ltd. “Sealing Expert in Silicone”

An ISO 9001:2008/14001:2004/18001:2007 & Clean Room Certified Co. DMF No. 26201 accredited by USFDA

303 & 319, Mahesh Indl. Estate, Opp. Silver Park, Mira-Bhayander Rd., Mira Road (E), Thane - 401104. Maharashtra INDIA. Tel.: +91-22-28555 107/631/91. Fax : +91-22-28555 378. Cell : +91-9223290931 / 43.

Email : info@amipolymer.com website : www.amipolymer.com

BRANCHES : v Baddi(H.P.)- +91981659011 v Bangaluru- +9108123023922 v Goa- +919223290940 v Gujarat- +919223290936 v Hyderabad- +919246502942 v Indore- +917314092052 v Maharashtra- +919223290943 v Roorkee- +9109219691095 v Vizag - +917093319073

46 May 1-15, 2016

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OSMOMETER 3250 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

48 May 1-15, 2016

Milk Cryoscopes Available

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

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

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51

PHARMA LIFE APPOINTMENT

MindCraft Software appoints Amol Bavdekar as CEO Hemant Nerurkar will continues to be as the chairman

M

indCraft Software, a global software products, solutions and services organisation catering to the banking, financial services and pharmaceuticals industries has appointed Amol Bavdekar as Chief Executive Officer, effec-

tive this month. Bavdekar is the Founder-Member of MindCraft and has led the delivery, pre-sales and labs functions and managed fixed-price projects at different time periods. Hemant Nerurkar, Founder, and previously Managing Director, will continue

to be the Chairman of the company.

Nerurkar will focus on generating a larger customer base in the international market.

“I personally will focus on making our US and Singapore arms stronger. We have built

a huge capacity in India and we need to monetise this capacity in these markets,” said Nerurkar. “This will enable Bavdekar to focus on our existing clientele so we can deliver large projects for them.”

EP News Bureau-Mumbai

School of Pharmacy, Lloyd Institute of Management & Technology organises Mega Pharma Job Fest 2016 730 students from 106 different pharmacy institutions from all over the country registered for interviews SCHOOL OF Pharmacy, Lloyd Institute of Management & Technology, recently organised Mega Pharma Job Fest 2016 in association with Indian Pharmacy Graduates’ Association.

The event focused on career opportunities for B Pharm, M Pharm, Pharm D, Diploma In Pharmacy and PhD students from all over the country.

The chief guest of the event, Dr GN Singh was felicitated by the Manohar Thairani, President, Lloyd Group. Thairani gave the welcome speech. Other guests were Dr Ajay Sachan, Assistant Drugs Controller India, CDSCO, FDA, New Delhi, PP Sharma, Ex Vice President Pharmacy Council of India, Ex Dy Drugs Controller, Drugs Control Office, NCT Delhi, Pawan Kumar Jaggi, Chief Pharmacy Executive, Delhi State Cancer Society, Dr Arun Garg, Professor, Dept of Pharmacology, KR Manglam University,Gurgaon and K B Gupta, Community Pharmacist.

Singh emphasised on the quality education system with more of practical orientation and internships. He informed the audience about the various

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initiatives taken by CDSCO. Singh shared about the global presence of pharma industry in India and ample opportunities waiting for budding pharmacists. He also insisted on mutual

respect for each and everyone with honesty and commitment in all deliverables.

The main attraction of the event was distribution of participation certificates to 28 partici-

pating pharma industries. 730 students from 106 different pharmacy institutions from all over the country registered for interviews in different organisations as per their aspirations in key areas of pharmacy profession like production, QC & QA, research and development, DRA, clinical research, hospital pharmacist and sales and marketing.

Atul Nasa Licensing Authority, Drugs Control Office, NCT Delhi , President, IPGA, Vice President -AIDCOC, interacted with the students and informed about various career opportuni-

ties available in pharma regulatory affairs and also briefed them about the importance of joining professional associations.

SL Nasa, Registrar, Delhi State Pharmacy Council, President- IHPA, also congratulated the institute for maintaining such high standards of teaching in the Department of Pharmacy.

He told the audience about various initiatives that he, as the registrar of the Delhi Pharmacy Council had undertaken for the upliftment of the pharmacy profession.

EP News Bureau-Mumbai

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