Express Pharma (Vol.10, No.8) February 16-28, 2015 by Indian Express

VOL. 10 NO. 8 PAGES 86

www.expresspharmaonline.com

Market Anti-fungal market: In High Gear Cover Story A Wait and Watch approach

16-28 FEBRUARY 2015,` 40

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CONTENTS

AWAITAND WATCH APPROACH

Vol.10 No.8 FEBRUARY 16-28, 2015 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury*

All sectors, including the pharmaceutical and supply chain industry, are eagerly waiting the implementation of the Goods and Services Tax (GST) bill in April 2015. Till then everyone is keeping a watchful eye on what happens next | P24

Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua

MARKET

'WE ARE ON TRACK TO SERVE 10,000 CUSTOMERS BY MID 2015'

'WE ARE ACTIVELY EXPLORING THE OPPORTUNITY TO ADDRESS THE INDIAN MARKET'

DOP DECLARES 2015 AS ‘YEAR OF ACTIVE PHARMACEUTICAL INGREDIENTS’

ADOPTING DIGITAL CULTURE IN PHARMA MARKETING

BIOASIA 2015 CONCLUDES SUCCESSFULLY

Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka

P28: INSIGHT GST and its impact on pharma

MANAGEMENT

Senior Artist Rakesh Sharma Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia

P44: VENDOR NEWS AIGMF reiterates stand on unhindered supply of glass bottles to pharma cos

P46: PRODUCT Yale – Maini 1.5 ton 3 wheel electric forklift truck: High on performance and ergonomics, with lowest TCO

P50: RESEARCH UPDATES

PHARMA TECHNOLOGY REVIEW

Roche study shows Gazyva offers strong benefits as lymphoma drug

Scheduling & Coordination Rohan Thakkar

P80: AWARD

CIRCULATION Circulation Team Mohan Varadkar

Fellowship of PIPA, UK awarded to Dr J Vijay Venkatraman

BUDGET 2015: AWAITING ACHHE DIN

‘INDIAN PHARMA MARKET WILL SPEARHEAD GROWTH IN THE COMING YEARS’

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited 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 @ 2011. The Indian Express 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

The politics of IPR policy

he draft National IPR policy, unveiled last December by the Department of Industrial Policy & Promotion (DIPP), has already garnered a fair bit of critical comment. Spicy IP has a blog post summarising comments submitted to the DIPP by Prof NS Gopalakrishnan and Dr TG Agitha, both from Cochin University of Science and Technology (CUSAT) who point out that it does not live up to its own introductory comments, which gave the impression that it was aiming for a balanced IPR policy. They caution that such a policy may only benefit 'the foreign denomination of IP holders in India, making economic benefits to themselves using the Indian economy as a market.' If the draft national IPR policy is any indication of Prime Minister Modi’s stance on IP, academics are worried that his government is getting set to undo decades of hard won victories. This opinion is echoed by Prof Brook K Baker, Professor of Law at the Northeastern University, US who is even blunter in an article exclusively written for Express Pharma. (Will a new US-led IP empire in India put access to medicines at risk? Pages 35-37.) Shattering the afterglow of the Obama-Modi bonhomie which was very much on view this Republic Day, Baker reads between the lines of the joint release and warns that the Modi government’s accelerating flirtation with the US and its investors is dangerous to hundreds of millions of people worldwide whose lives depend on Indian generics. For a government obsessed with global rankings, it must be particularly galling that India is at the second-last position of the global IP rankings recently released by the US Chamber of Commerce’s Global Intellectual Property Centre (GIPC). But many see this low ranking as a badge of honour. Commentators like Shamnad Basheer, founder of Spicy IP and a recent recipient of the Infosys Prize in Humanities for his contribution to Indian IP law, have rightly panned the practice of global IP rankings (see his Op-ed column,‘These rancid rankings’, in Indian Express http://indianexpress.com/article/opinion/columns/theserancid-rankings/99/)) as these rankings are based on flawed framework and irrelevant indices. Indeed, there will be no easing of the political pressure on this front. While closing the Out-ofCycle Review (OCR) of India’s IP protection measures last December, the Office of the US Trade Representative (US TR) had reminded us that the 2015 Special 301 Review process, generally released every April, was just a few months down the line. The US is not the only political heavyweight pushing for tighter IPRs. Reports have come in that Japan is taking on the US’ role at the ongoing

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February 16-28, 2015

Will a government so focused on India’s global image,be ready to risk political and economic isolation at both the global and regional levels?

negotiations on the Regional Comprehensive Economic Partnership (RCEP) between the 10 ASEAN nations and Australia, China, India, Japan, New Zealand and South Korea. Patient advocacy group Delhi Network of Positive People (DNP+) has raised concerns that the leaked text of a draft IP chapter tabled by Japan which will probably be discussed by the RCEP’s Working Group on Intellectual Property (WGIP), could restrict the ability of governments to take decisions in the interest of the public health and delay the vailability of low-cost generic versions of medicines. In the 36-page document, Japan proposes measures that include dilution of patentability criteria, strengthening data exclusivity, patent term extension and IP enforcement measures across borders which target legitimate generic medicines. If these provisions become part of the RCEP, then India would be forced to extend patent protection beyond its current IP policy. There are already rumours, based on the tone and tenor of the draft National IPR policy, that the Modi government is ready to change its position on patentability, data exclusivity and patentregistration linkage. Will a government so focused on India’s global image, be ready to risk political and economic isolation at both the global and regional level? Especially when the recent poor show in the Delhi state elections has the ruling party on the back foot. Will Finance Minister Arun Jaitley’s maiden full budget be populist rather than fiscally prudent, with an eye on several other state elections due in the near future? With the Modi government already pruning the health budget, the signs don’t appear to be too good for the pharma and healthcare sectors. But hope springs eternal. Do take a quick look at this year’s wish list from pharma honchos (Budget 2015: Awaiting Achhe Din, pages 30-34). The Goods and Services Tax (GST) regime is expected to be one of the most important policy implementations of this year. Our cover story in this issue, (GST: A wait and watch approach, pages 24-27) features perspectives from pharma manufacturers, as well as allied players who supply to them. We also have experts from two leading tax advisory firms provide a detailed analysis of the tax implications of GST; do catch these insights as well. (GST and its impact on pharma page 28 and GST: The road ahead page 29) Will industry continue to suffer the paralysing play of politics on policy? Or will the Modi government manage a balancing act? VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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IN HIGH GEAR ANTIFUNGAL MARKET:

With growing awareness and understanding of fungal infections, India's anti-fungal market is slated to grow phenomenally in the years to come BY SACHIN JAGDALE

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dvances in medical technologies have made detection of fungal infections easier than ever before. Pharma companies also complemented to this change by launching drugs to treat these infections. India's tropical environment is a breeding ground for varied types of fungi and hence provides a lot of opportunities to the pharma operators to keep the drug market flooded with various anti-fungal drugs. According to AIOCD Pharmasofttech AWACS data, total anti-fungal market across categories is pegged at ` 1069 crores, growing at 26.9 per cent and 16.6 per cent on units.(See table on pg no. 13)

Growth drivers Invasive procedures at hospitals also give rise to risk of fungal infections at an alarming rate. Therefore, the market for anti-fungal drugs have started considering these risk factors as well. “The anti-fungal drug market is driven by the improved understanding of the ICU patient’s risk factors to develop invasive fungal infections,” says Dr Somnath Datta, Business Unit Head Critical Care Sales and Marketing, Mylan Pharmaceuticals He adds, “For decades, doctors taking care of immunocompromised patients understood the scourge of fungal infection in their patients such as hemato-oncological malignancy, transplant etc. Now, they are cognizant of the same even in patients with risk factors such as diabetes, old age, total parenteral nutrition (TPN) which are latent immunocompromised states. The other growth driver is the awareness about the myriad fungal infections that can affect the Indian patients and that the empirical or prophylaxis therapy with the standard anti-fungal drug may not suffice. The newer anti-fungals (anidulafungin etc.) have seen a robust growth in the last three to four years, so has been the resurgence of reserve drugs such as amphotericin B which is now being used for these difficult-to-treat fungal infections.” Government’s role has also proved instrumental in driving anti-fungal drug market in India. Understanding the rising episodes of fungal infections in the country, the government employed various measures on its own including public private partnership (PPP). This development is largely responsible for propelling the market. While echoing Datta’s views, Sharad Dahatonde, General Manager-Biotechnology, Elder Pharmaceuticals, says that growing invasive techniques at the hospitals have indeed helped pharma operators from anti-fungal drug category grow. According to Dahatonde, conditions like AIDS compromise immunity of the patients and make them susceptible to fungal infections.

Dahatonde informs that Mycoses, which are fungal skin infections, are expected to provide a promising market for growth currently due to prevalence of numerous diabetes patients and, population’s changing lifestyle and environmental conditions. The dermatological antifungal market is ` 605 crores, whereas the anti-infectives fungal market is ` 378 crores. Glenmark is the leader at ` 183 crores followed by Macleods at ` 122 crores and Mankind at ` 83 crores. Panderm Plus is the biggest brand at ` 122 crores followed by Candid at ` 59 crores and Cancidas at ` 35 crores (Source: AIOCD Pharmasofttech AWACS data.)

ANTI-FUNGAL DRUG MARKET IN INDIA

COMPANY

MAT VAL IN CRS

MAT VAL GR

GLENMARK PHARMACEUTICALS LTD.

182.7

22.6

MACLEODS PHARMACEUTICALS PVT.LTD

122.5

79.1

MANKIND PHARMACEUTICALS LTD.

82.7

40.1

RANBAXY LABORATORIES LTD

67.6

43.2

MSD PHARMACEUTICALS PRIVATE LTD.

51.2

11.1

GLAXOSMITHKLINE PHARMACEUTICALS LTD.

49.9

22.5

CIPLA LTD.

48.9

34.5

HEGDE & HEGDE

38.0

15.8

EAST INDIA PHARMACEUTICAL WORKS

33.5

26.9

ZYDUS CADILA

33.3

6.8

MARKET

1069.3

26.9

Physicians’ influence Doctors and physicians also have an impact on the growth of the drug market. These physicians are spread across different categories. Datta informs, “Physicians across various specialties including critical care, microbiology, infectious disease etc. have helped raise awareness of fungal infection among the hospital patients. Numerous researchers including the HOD of PGIMER, Chandigarh, Dr Arunaloke Chakrabarti have collated and published India-specific data to help clinicians understand the prevalence of various fungal species that invade our ICUs. Plus, the MNC pharma companies have also helped to create awareness by numerous programmes involving case studies, inviting international speakers etc. This has helped in identification of species, better understanding of the resistance pattern and usage of right anti-fungals to manage the patient. Usage of Azoles, Echinocandins and Amphotericin B – all have increased henceforth improving the overall mortality and morbidity rates in such patients.” Physicians' prescriptions

Source: AIOCD Pharmasofttech AWACS data.

are among the biggest drivers of anti-fungal drug market. However, on the other hand, random administration of these medicines have given rise to drug-resistant varieties of fungi. This has again made pharma companies work on new drugs and launch them in the market. Dahatonde says, “Physicians leave major impact on the anti-fungal drug market in India. There is need to bridge the gap between policy makers and health-care service providers to help the ailing population.” AIOCD Pharmasofttech AWACS data suggests that

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Clotrimazole followed by a combination of Terbinafine, Clobetasol, Ofloxacin and Ornidazole are the biggest molecules in the market.

India-specific challenges Medical advances have brought in enormous understanding regarding fungal infections, however, these technologies may not have reached many hospitals across the country. Moreover, in a country with more than one billion people, it is a big challenge to recognise and reach the potential infection carrier. “The major challenge is

the lack of diagnostic facilities for fungal infections. Most private and government hospitals have inadequate lab facilities for speciation of the fungus and assessing the resistance pattern. This leads to lower diagnosis rates which leads to lower treatment rates and false sense of security among ICU physicians that fungal infections are rare in their centres,” says Datta. “The number of therapeutic options for the treatment of invasive fungal infections is quite limited in India as compared with those available to treat bacterial

Most private and government hospitals have inadequate lab facilities for speciation of the fungus and assessing the resistance pattern. Dr Somnath Datta, Business Unit Head - Critical Care Sales & Marketing, Mylan Pharmaceuticals

The development and approval of new products, additional indications and formulations, and increased Indian market penetration will be driving factors for the market over the next decade Sharad Dahatonde, General Manager, Biotechnology Elder Pharmaceuticals

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MARKET infections,” reveals Dahatonde. There is also a demandsupply gap. Still a considerable chunk of population is deprived of necessary anti-fungal treatment. Dahatonde explains the situation, “Anti-fungal drug development has not kept pace with the clinical needs in India so far and the rate of anti-fungal drug discovery is unlikely to be sufficient for future demands. The number of patients at risk for fungal infections is increasing as immunomodulatory therapies continue to expand and our ability to support highly immunocompromised patients improves. Consequently, we are faced with the challenge of an expanding set of at-risk patients, increasing the prevalence of difficult-to-treat organisms, and a slow pace of new drug development.” Deepali Chile, Chief Executive Officer, Brassica Pharma,

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also says that resistivity towards current anti-fungal drugs e.g acquired and intrinsic resistance in Aspergillus and Candida is currently a big challenge. Though pharma companies in India sell drugs really cheap in the world, cost is still an issue for most of the population and this is again a hindrance in treating fungal infections. It is very necessary to make advanced diagnostic options available at affordable rates in tier two and three hospitals as well.

Future market drivers India is the diabetic capital of the world. There are many other diseases like cancer, AIDS which are growing among the Indian population. Transplants and immunological complications are common with patients suffering from these diseases. This scenario

Echinocandin and pneumocandins are the new class of anti-fungal drugs which would serve as main targets of the future research Deepali Chile, Chief Executive Officer, Brassica Pharma

is going to drive anti-fungal drug market in future. Also, on the economic front, Indian population is doing good and most of the Indian population is in a position to spend money on drugs and advanced diagnostic methods. Datta says, “The major growth drivers are primarily macroeconomics and population dynamics. As more patients undergo transplant surgeries, the incidence of fungal sepsis will increase. Also, with higher age-wise longevity, more disposable income and better diagnostic facilities (also linked to macroeconomics), more patients will get diagnosed with fungal infection at the right time and would get treated in the right way to improve survivability. With large scale prevalence data specific for India coming up, doctors will be able to choose

the medicines better and that should lower the cost of therapy as well.” According to Chile, Echinocandin and pneumocandins are the new class of antifungal drugs which would serve as main targets of the future research. Dahatonde signs off saying, “A growing and ageing population, increasing incidence of fungal conditions, the development and approval of new products, additional indications and formulations, and increased Indian market penetration will be driving factors for the market over the next decade. The market can expect to see a continued demand for products; however, the low cost of generic products will generate added pressure for marketers of brand products. Generic competition will remain highly competitive.” sachin.jagdale@expressindia.com

MARKET I N T E R V I E W

'We are on track to serve 10,000 customers by mid 2015' Preventive healthcare might be the buzzword, but a company down South is working towards a paradigm shift in personalised medicine, the next frontier. Shalini Gupta finds out more in an interview with Saleem Mohammad and Abdur Rub from Xcode Life Sciences

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personalised nutrition and personalised medicine. Of course, we might very well be few years away before these concepts become popular, yet a laudable goal worth striving and sacrificing for. How far has Xcode come in the last few years? Abdur: The preventive health check up market and also the fitness and wellness market have evolved quite rapidly in the past few years. Xcode has seen a significant traction for its preventive health product, 100andLife. We started off as a single person company with an idea and now we are a company of more than 25 with four products in the Indian and internal markets and several more products and services in the pipeline. Preventive healthcare in India is currently associated with diagnostics, where do you think we stand there, especially given that the sector is very fragmented? Abdur: Yes, the dominant public understanding of preventive healthcare is that its a diagnostic test. Unfortunately, this is not completely accurate. Diagnostic tests only detect biomarkers that are present in blood at detectable levels, which means the disease process should have already started in the body, otherwise it would be undetectable. The only truly preventive tool which advises on the personal predisposition (likelihood) way before any symptoms show up in blood is the genetic assessment. And thats only part of the story. A major component of preventive health approach is how we can take charge of our health through nutrition, physical activity and a healthy lifestyle. Here too, genetics play a major role in how our body processes various foods and physical activity. In other words, the scientific developments in the field of human genetics have enabled for the first time in human

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history, a self-mediated, truly preventive health care regime. Xcode is at the forefront of this paradigm shift, helping individuals and families achieve truly preventive and personalised health, longevity and lifelong wellness. How has genomic sequencing and the thousand dollar genome inturn changed personalised medicine? Is India ready for it? Abdur: Yes absolutely, the drop in the cost of sequencing is what is driving the personalised medicine revolution today and this will only accelerate in the future as the prices come down further. We at Xcode believe that India is certainly ready for it. We find that the awareness levels of preventive health among our Indian customers are on par with what we find in our international customers. Even as sequencing has been generating lot of data, the interpretation is subject to scrutiny considering most of the genome has junk DNA, how do you respond to it? Abdur: With cost of sequencing coming down rapidly, enormous amounts of data is being generated which leads to a deeper analysis, interpretation and understanding of the genetic landscape. What is meant by 'junk' DNA is that currently there is lack of an understanding of the functionality of those sections of the DNA code, which does not imply no functionality. In Xcode's genetic assessment only those genetic markers are used which have demonstrated strong correlation with health and nutritional aspects using scientifically validated methods. We follow stringent criteria in formulating our test panels and recommendations, which are meticulously developed by our scientific team after extensive research and approved by our scientific board.

lifestyle and activities. However, the genetic assessment does not change and indicates how likely the individual is to develop the condition, long before the condition ever occurs. This enables the individual to lead a truly preventive lifestyle and avoid development of these conditions right from the beginning.

Here was an opportunity to become the largest repository of genetic and environmental information

We only focus on lifestyle conditions that can be prevented through lifestyle interventions

How do you use disease genomic and nutritional genomics to predict the onset of chronic diseases? Which diseases in particular can be predicted? Can the genetic predisposition to cancer also be predicted? Abdur: We only focus on lifestyle conditions that can be prevented through lifestyle interventions such as obesity, type II diabetes, cardiovascular conditions etc. Our product philosophy is one of preventive health, where we empower our customer with actionable recommendations which will inform and enable them to take actions that will lead to better health. Its important to distinguish between predisposition and predetermination. Its possible to assess predisposition to cancer through genetic testing. A famous recent example is Angelina Jolie who underwent a procedure to

prevent breast cancer based on a genetic test. How many patients have been so far enrolled for these tests? What is your target audience? why do they prefer such a test over a diagnostic test? Abdur: We have just begun our marketing efforts and we are already seeing numbers roll in. We are on track to serve 10,000 customers by mid 2015. Our target audience is wide and varied. We have products for toddlers all the way to geriatrics. Like we explained earlier, diagnostic tests only indicate what is present or not present in the blood. For example, when someone goes through a battery of heart tests, what they find out is whether they currently have a heart problem or not as indicated by higher cholesterol etc. But these numbers can change quickly depending upon the changes in the persons diet,

Personalised medicine is at the intersection of lifesciences and health, how do you look at it? Given that most of pharma companies(esp in India) are working in silos from healthcare institutions? Abdur: Though our business model is fairly independent as a direct to consumer company, we do seek out and form partnerships with strategic partners. We have both intellectual partnerships with institutions such as the prestigious CCAMP, Bangalore and commercial partnerships. Given that we have the lofty goal of changing the existing paradigm of hospital-mediated sickness care to self-mediated preventive health care, we look forward to be forefront of enabling synergistic partnerships among various entities that ultimately add significant value to consumer health How is the funding environment for biotech startups like? Is it conducive for start-ups such as yours? How does funding help? What do biotech start ups need to do in order to get funded? Abdur: The current funding environment is very good for startups with several national and international VCs stepping up to fund Indian startups. The angel scene is also quite vibrant. As long as the idea and execution plan are sound with a strong team we find that funding is not a bottleneck. shalini.g@expressindia.com

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'We are actively exploring the opportunity to address the Indian market' Gabriel Perera, Director, Product Development and Business Development – Asia, Blackmores, talks about tropical diseases in India and possibilities of sharing R&D expertise between Indian and Australian pharmaceutical companies, in discussion with Sachin Jagdale

What are your observations about treatments/medicines available in India for tropical diseases? Based upon my recent visit to several Indian pharma companies, it certainly appears that they are very focussed on developing quality products to address the burden of tropical diseases. Additionally, several of Australia’s leading universities based in our tropical far north are working on innovative natural and synthetic therapies that may be of benefit. It was also apparent that there are still several unmet medical needs in this area. What kind of association are you looking at with Indian pharma companies? This is still being determined – conversations we have had so far include possible marketing, sales and distribution collaborations in specific states or across India more broadly. Australia has very good R&D expertise and infrastructure. Will you be helping Indian counterparts build such

infrastructure in India as well? Yes, certainly where that is relevant. We are fortunate to have a long tradition of research in natural medicines in Australia that we hope may be of benefit to both the academic sector and to any potential commercial collaborators in India. Do you use Ayurvedic ingredients in your products? Please elaborate Blackmores produces products and formulations which are naturopathic, supported by evidence, both primary and secondary source. Often, we use ingredients from the Ayurvedic pharmacopoeia, drawing references from both traditional (e.g. Charaka Samhita) and contemporary scientific literature. For example; we use Ashwagandha (Withania somnifera) in a number of our formulations, alongside supporting vitamins, nutrients and herbs and we use Brahmi (Bacopa monnieri) in several more formulations. Most recently, we’ve launched a product for cognitive function, where the primary ingredient is a highly concentrated turmeric (Curcuma longa) extract,

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standardised to curcumin.

We are fortunate to have a long tradition of research in natural medicines in Australia

A huge section of Indian population is still not aware of complementary medicines or nutraceuticals. How are you going to handle this challenge? I would respectfully beg to differ. In my opinion, India has an incredible tradition of complementary medicines and therapies used in Ayurveda. What we have found in other countries who also share a rich local medical tradition is that their appreciation and understanding of self-care is very strong. In parallel, we are fortunate that our business Blackmores as well as the Australian vitamins and dietary supplements industry and manufacturing environment has a strong international reputation for quality and regulatory controls. Finally, our fundamental approach is one of education – educating health professionals, pharmacists and other allied health professionals about the evidence supporting a particular ingredient or product, while in parallel providing a very high level of education and information to health consumers to

support their health decision making. What is your take on Indian Government's approach towards handling tropical diseases? My takeaway from attending the Australia Business Week and learning directly from some of your leading public health experts and academics, through presentations and conversation, was a real sense of optimism in this regard – both with respect to the Indian Government’s commitment to addressing the burden of tropical diseases and in the level of innovation that was apparent in your medical schools and universities. I would hope this would positively impact the fight against tropical diseases. What are your future plans for the Indian markets? We are actively exploring the opportunity to address the Indian market and greatly appreciate the hospitality and conversations we have had with significant Indian industry players to date. sachin.jagdale@expressindia.com

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MARKET COMPANY WATCH

DoP declares 2015 as ‘Year of Active Pharmaceutical Ingredients’ BDMA in association with DoP will conduct following programmes. The '2015 The Year of Active Pharmaceutical DEPARTMENT OF Pharmaceuticals (DoP), Ministry of Chemicals and Fertilisers, Government of India under 'Make in India' programme has decided to declare the year 2015 as 'Year of Active Pharmaceutical Ingredients.' It has also been decided that Bulk Drug Manufacturers Association (India) (BDMA) will be the nodal agency to organise various activities through-

out the year under the banner to project India as a major API producer globally. BDMA in association with DoP will conduct following programmes. The '2015 - The Year of Active Pharmaceutical.’ The Minister of Chemicals and Fertilisers, Government of India will be the chief guest. The event will be addressed by presidents of BDMA, Indian

Drug Manufacturers' Association (IDMA), Indian Pharmaceutical Association (IPA) and Pharmaceuticals Export Promotion Council of India (Pharmexcil) followed by secretary, Dept of Pharma, secretary Ministry of Commerce and Drugs Controller General (India). The chief guest will address the delegates. Interactive sessions will be conducted with the minister and the

manufacturers of bulk drugs. Announcement of policy on bulk drugs are likely to be done in March 2015 by the Ministry of Chemicals and Fertilisers, Government of India. Meetings are fixed with the state health and industry ministers, senior government officials and stakeholders at Hyderabad in May/June 2015, Ahmedabad in July/ August 2015, Mumbai in September/October 2015 and

Gavi releases figures of children vaccinated in the last 15 years Half a billion children vaccinated: Gavi NEW FIGURES released by Gavi, the Vaccine Alliance show that half a billion children have been reached with lifesaving vaccines in the 15 years since the organisation was founded. The figures also reveal that the number of deaths averted through Gavi-supported immunisation programmes now tops seven million. Dr Seth Berkley, Chief Executive Officer, Gavi announced the figures during a press conference at the World Economic Forum in Davos. Berkley said, “We are

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The figures also reveal that the number of deaths averted through Gavisupported immunisation programmes now tops seven million proud of this milestone but we want to go further and immunise a further 300 million children against lifethreatening diseases between 2016 and 2020. We believe we can defeat vaccine-preventable illness, further preventing child death and helping communities lift themselves out of poverty.” Berkley was joined by

President Ibrahim Boubacar Keïta of Mali, Canada’s Minister for International Development and Minister for La Francophonie Christian Paradis, Special Advisor of the Secretary-General on Post2015 Development Planning Amina Mohammed, speaking on behalf of the UN Secretary-General Ban Kimoon, and German actress,

physician and ONE campaign ambassador Dr Maria Furtwängler, all of whom highlighted the importance of working together to reach children with vaccines. Under the patronage of German Federal Chancellor Dr Angela Merkel to secure the $ 7.5 billion required to fund vaccine programmes in the world’s poorest countries in the 2016 to 2020 period. Chancellor Merkel will be joined by world leaders, donors including Bill Gates, developing country representatives, civil society organisations and other experts for the Gavi Replenishment Conference. This is the first official event of Germany’s G7 presidency. EP News Bureau – Mumbai

Bangalore in November/December 2015. Under the 'Make in India' initiative, it is expected that the government will introduce many industry-friendly policies and incentives to give a major thrust to the growth of Indian bulk drug industry to make it a formidable force globally. EP News Bureau – Mumbai

US FDAbans imports from Ipca Labs plant in Madhya Pradesh THE US Food and Drug Administration (FDA) has banned imports from Indian generic drug maker Ipca Laboratories' plant at Ratlam in the central Madhya Pradesh state due to violations of standard production practices. According to a Reuters report, Ipca had voluntarily halted shipments to the US from the plant in July last year after the FDA outlined half a dozen violations including data integrity issues. The FDA announced the ban, called import alert, in a notice on its website. It did not elaborate. Over the past year, large Indian drugmakers such as Ranbaxy Laboratories and Wockhardt have been hit by a spate of regulatory sanctions due to concerns about production processes at their local plants. EP News Bureau – Mumbai

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HBL launches cost effective Pentavalent & Hepatitis B vaccines To roll vaccines for measles, BCG, rabies (Human), Japanese encephalitis and Hib for supplying to National Immunisation programme HLL BIOTECH LTD (HBL), a subsidiary of HLL Lifecare Ltd (HLL), a Government of India Enterprise under Ministry of Health and Family Welfare has notched up another major milestone by becoming the first public sector undertaking to launch cost-effective Pentavalent vaccine and Hepatitis B vaccine in the country. Lov Verma, Secretary, Ministry of Health and Family Welfare, Government Of India launched the new vaccines at his chamber. Dr M Ayyappan, Chairman, HBL was present during the occasion. Verma said that launch of

Pentavalent vaccine and Hepatitis B vaccine manufactured by HBL is a milestone of HBL’s vaccine project “Integrated Vaccines Complex” for making available cost effective vaccines. This will primarily strengthen the Immunisation programme of India”. A large number of babies born every year in India do not have access to newer vaccines like Pentavalent vaccine. The launch of PENTAHIL will make available cost effective Pentavalent vaccine, to protect them from five potentially deadly diseases by a single injection. By the launch of PENTAHIL and

HIVAC-B, HBL will fill the gap of availability for affordable vaccines in the country. In order to minimise the danger arising from the volatility of the global market, and thereby ensure long- term national health security; NHP-2002 (National Health Policy) envisages that not less than 50 per cent of the requirement of vaccines will be sourced from public sector institutions. The launch of PENTAHIL and HIVAC B by HBL will strengthen the health policy of the country by making available Pentavalent vaccine and Hepatitis B vaccine in public sector.

Dr M Ayyappan, Chairman, HBL said that “The launch of PENTAHIL and HIVAC –B vaccines is a remarkable achievement to HBL and this proves that public sector organisations can deliver effectively, if given the freedom to operate”. He also said that the construction of “Integrated Vaccines Complex” (IVC) is progressing as per schedule and once commissioned, HBL will roll out other vaccines like Measles, BCG, Rabies (Human), Japanese encephalitis and HIB vaccines for supplying to national immunisation programme. The IVC project was

approved by the Cabinet Committee on Economic Affairs (CCEA) in its meeting held on 26th April, 2012 and the IVC was declared as a "Project of National Importance". The PENTAHIL and HIVAC B will be made available initially in Indian private market, starting with Kerala and Tamil Nadu and followed by pan India marketing. Subsequently, HBL will start supply Pentavalent and Hepatitis B vaccines for GoI immunisation programme and will cater the requirement of other institutions as well. EP News Bureau – Mumbai

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Mylan to acquire Famy Care to create women’s healthcare franchise The transaction is expected to close in the second half of 2015, subject to regulatory approvals and certain closing conditions MYLAN INC’S Indian subsidiary Mylan Laboratories signed a definitive agreement to acquire certain female healthcare businesses from Famy Care, a speciality women’s healthcare company with global leadership in generic oral contraceptive products (OCPs) for $750 million in cash plus additional contingent payments of up to $50 million. The acquisition will build on Mylan’s existing partnerships with Famy Care in North America, Europe and Australia, and provide Mylan with an enhanced and now vertically integrated platform that will accelerate the company’s growth in the important global women’s healthcare space. This transaction especially complements Mylan’s pending acquisition of Abbott’s non-US developed markets speciality and branded generics business, which also in-

The acquisition will build on Mylan’s existing partnerships with Famy Care in North America, Europe and Australia cludes a women’s healthcare portfolio and sales and marketing capabilities. The transaction is expected to close in the second half of 2015, subject to regulatory approvals and certain closing conditions. Heather Bresch, Chief Executive Officer, Mylan commented, “In 2008, Mylan established a partnership with Famy Care, significantly enhancing its presence in the women’s healthcare segment in the US and other developed country markets. With today’s acquisition, we are build-

ing on this successful partnership and further accelerating our global growth in this important therapeutic area.” Rajiv Malik, President Mylan added, “By adding this vertically integrated business and globalising our women’s healthcare platform, we are creating the right foundation to become a leader in this growing, attractive sector. We see opportunities for generating more front-end sales, in addition to Famy Care’s successful partnering strategy, as a result of our exceptional global infrastructure.”

JP Taparia, Non-executive Chairman of Famy Care said, “We foresee significant opportunities in the women’s health care business across developed and emerging markets, and the proposed transaction provides an opportunity for our team to capture the opportunity in an even more effective manner. In 2010, we started the process of transitioning from a family-owned business into a meaningful institutional player in the global pharma industry by enlarging our shareholder base with the investment by pan-Asian private equity firm, AIF Capital. Their involvement and support for Famy Care have been very helpful in the company’s achievement of critical corporate milestones over the last four years. ”

patient safety.” Pant commented that he was very impressed and that the visit was quite enlightening and informative. He noted the commendable work being done at the facility in the field of standards, testing and research and the various collaborations in the interest of the Indian pharma industry. Pant hopes that other governments and private institutions will benefit from the presence of USP’s world class facility in Hyderabad.

PANACEA BIOTEC, among the largest producer of vaccines and a research based pharmaceutical and biotechnology company has been elected for supply of Pentavalent Vaccine DTP-HepB-Hib by Pan American Health Organization (PAHO). The company has been awarded for supply of 5.99 million doses of EasyfiveTT (DTPHepB-Hib) fully liquid pentavalent vaccine for calendar year 2015 and 2016 worth $13.49 million (equivalent to around Rs 83.52 crores) to meet the requirements of global immunisation programme. Commenting on the development Dr Rajesh Jain, Joint Managing Director, Panacea Biotec said, “We are pleased with this opportunity of supplying Easyfive-TT vaccines to meet the requirements of PAHO once again after a gap of three years. Panacea Biotec has been playing a leadership role in the vaccines R&D, manufacturing and supply to meet demands of national and international agencies of good quality affordable vaccines for the developing world.”

EP News Bureau – Mumbai

DoPvisits USP India facility in Hyderabad The visit aimed to understand the efforts USP is making in India to create standards for medicines, ensure full safety and quality of medicines and bring to India international standards in drug manufacture SUDHANSH PANT, Joint Secretary, Department of Pharmaceuticals (DoP), visited the US Pharmacopeia’s (USP) India facility in Hyderabad. He toured the facility and met with senior level scientists. Reportedly, the purpose of this visit was to better understand the efforts USP is making in India to create standards for medicines, ensure full safety and quality of medicines and bring to India international standards in drug manufacture. USP develops the reference standards to ensure the quality of Active Pharmaceutical Ingre-

20 EXPRESS PHARMA February 16-28, 2015

dients (APIs) and is supportive of government initiatives to strengthen and revive the domestic manufacturing of intermediaries and APIs. The Joint Secretary’s discussion with USP India touched upon various aspects of ensuring the quality of medicines in India and how USP standards could help Indian manufacturers to import their products both to the US and to other countries. Pant also enquired about the verification programme and process and showed interest in the education

and training programmes conducted by USP. Dr KV Surendranath, Senior Vice President- International Sites Operations said, “We welcome this opportunity to showcase our technical expertise to the Department of Pharmaceuticals. We see ourselves as partners in India’s efforts to produce safe and high quality medicines that meet all global standards. We hope to continue with future engagements with the DoP on various aspects related to quality of medicines and to address issues of critical importance to

Panacea Biotec gets PAHO order for supply of Easy Five-TT vaccines worth $13.49 mn

EVENT BRIEF FEBRUARY 2015 — MAY 2015 18

ASSOCHAM Pharma Summit

ASSOCHAM PHARMA SUMMIT Date:February 18, 2015 Venue: Hotel Le Meridien, New Delhi Summary: Associated Chambers of Commerce and Industry of India is organising the Pharma Summit with the theme ‘Changing Dynamics the Road Ahead,’ in association with Organization of Pharmaceutical Producers of India, Indian Drug Manufacturers’ Association and Confederation of Indian Pharmaceutical Industry and Indian Pharmaceutical Association. The objective of this summit is towards creating a platform for discussing the various issues to streamline the regulatory framework and imparting more practicability in the Government policies.

Contact details: Bharat Kumar Jaiswal Assistant Director, The Associate Chambers of Commerce and Industry of India 5, Sardar Patel Marg, Chanakyapuri New Delhi – 110021 Tel: 46550514 (D), 46550555 (Hunting line) Fax: 46550550 Mobile: 9971047550 Email: bharat.jaiswal@ assocham.com

INTERNATIONAL CONFERENCE ON REGULATORY IN EMERGING MARKETS. Date: 9-10th Apr 2015 Venue: - Hotel Westin, Mumbai Organiser: Alliance India Summary:Asia has a population of around 4.3

International conference on regulatory in emerging markets billion and is home to about 60 per cent of the world’s population. China alone has a population of approximately 1.3 billion, which is three- to fourfold bigger than Europe or the US. Adding in the other developing markets, such as those in Latin America, this makes for a huge potential market for the pharmaceutical industry, and one important not to miss. The growth markets popularly include Brazil, Russia, India, China – the BRICs however Mexico, South Korea, and Turkey are now added to BRICs to be known as the BRIC-MST countries. In terms of the submission format, countries are beginning to move closer to the international submission template (eCTD — electronic common technical document).

PHARMA Pro & Pack Expo 2015

Similarly, the trend is toward more harmonisation in legal frameworks among the countries. For example, China’s regulatory processes are evolving, creating a framework that is more closely aligned to the US and European legislation and in both South Korea and China, the regulatory agency has been raised to the ministry level. Contact details: Phone +91 9619633320 Email: admin@allianceindia.co.in

PHARMA PRO & PACK EXPO 2015 Date: May 13-15, 2015 Venue: Bombay Exhibition Centre, Mumbai Summary: PHARMA Pro & Pack Expo 2015 will be organised by IPMMA. 20,000

pharma trade professional/ decision makers and 250 industry majors will exhibit their technologies/ services. Visitors’ profile include biotechnology specialists, plant management, CEOs, engineers, technocrats and scientists, policy makers, diplomats and foreign commercial corp, compliance, process engineering, corporate management, procurement department, custom manufacturing/ marketing services and purchase officers. Contact details: Indian Pharma Machinery Manufacturers’ Association 52, 1st floor, Suyog Industrial Estate LBS Marg, Vikhroli (West) Mumbai – 400 083 Tel: +91 22 6561 9272/ 2578 6007/ 2685 5108

POST EVENTS

Adopting Digital Culture in Pharma Marketing The conference was organised for pharma marketing personnel with an aim to share the importance of ‘Why and How of Digital Marketing, especially in pharmaceutical domain’ MUMBAI, JAN 16, 2015: ‘DigiSights 2015’, Conference on Digital media for Pharmaceuticals and Healthcare Marketeers in India is hosted by MediaMedic Communications in association with Centre for Excellence in Healthcare, SIES College of Management Studies, Navi Mumbai. This is the second year of this coveted event. MediaMedic Communications, the India partners of Global Health PR Network brought together a diverse group of professionals for a whole day of lively intellectual exchange. Healthcare providers, IT innovators, health and pharma leadership,

and entrepreneurs gathered to hear insights, ideas, case studies and analysis from digital leaders from this sector. DigiSights 2016 witnessed speakers such as Sanjiv Navangul, Managing Director, Janssen India; Rahul Avasthy from Abbott; Rupali Digrajkar from Merck; Pooja Krishnani from MSD; Priti Mohile, Cofounder and MD, MediaMedic Communications; Dinesh Chindarkar, Co-founder of MediaMedic Communications; Ratan K K from GutsGo; Salil Kallianpur from GSK; Sunder Ramachandran from Pfizer; Sagar Pawar from PwC; Gurdeep Singh from Wockhardt; Prof. Suniel

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Deshpande, Chairperson of Centre for Excellence in Healthcare and many more Pharmaceutical experts. The conference was organised for pharma marketing personnel with an aim to share the importance of ‘Why and How of Digital Marketing, especially in pharmaceutical domain’. The eminent audience was engaged with thought-provoking sessions like ‘Adopting digital culture for pharma marketing’; ‘Achieving Patient centricity through Digital medium’; ‘Social Learning through Digital medium’; ‘Trends in Digital Marketing’; ‘Role of Digital PR in pharma marketing’ and

‘eMarketing Applications for Pharma marketeers’. Mohile shared her expertise on ‘Pharma marketing objectives that can be addressed by the Digital Medium’. She said, “Something fundamental has changed in the way doctors and consumers are participating in, and receiving communication. Specific targeting and CRM is now possible through this new medium. Through this conference, we hope to generate a dialogue within the marketing community to understand and use this opportunity to achieve their marketing objectives even within the regulatory framework of the industry”

An absorbing panel discussion was held on ‘The Why & How of Digital Marketing’. Global Digital Pharma Marketing cases were discussed through a video link by Global Health PR team from UK and US. This gave an international perspective and helped the audience understand the dynamics of digital marketing strategies in the healthcare world. The conference concluded with a roundtable discussion on ‘Adopting and adapting Digital media in Pharma marketing’ emphasizing on issues and solutions. EP News Bureau- Mumbai

EXPRESS PHARMA

February 16-28, 2015

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BioAsia 2015 concludes successfully About 1,350 registered delegates from biotech, healthcare, pharma and IT industries and regulatory bodies, from 50 countries participated THE THREE-DAY BioAsia 2015 concluded recently. Reportedly, many significant agreements and memorandum of understandings (MoU) were signed between the government and national as well as international organisations. Thought provoking discussions bringing together a large number of industry leaders and government officials (State/Centre and international), regulators and academic experts were part of the event. The last day of the event started with the inauguration of the healthcare conference by Pradeep Chandra, special chief secretary, Government of Telangana and the keynote address was given by Prof D Prabhakaran, Vice President, Public Health Foundation of India. The digital health and healthcare IT conference witnessed the participation of medical practitioners, IT experts and technologists. The topic under discussion was - Do you think India is ready for the rapid technological changes shaping healthcare globally? Eminent dignitaries who shared their insightful thoughts with the audience included Sangita Reddy, Joint MD, Apollo Hospitals, India, BVR Mohan Reddy, Founder and Executive Chairman, Cyient and Vice-Chairman of NASSCOM, India and TSY Aravindakshan, National Manager (Industry Solutions) – Health, Microsoft Corporation. Reddy said, “Healthcare is transformed by 3 Bs i.e. biology, bytes and bandwidth. Healthcare is also getting less invasive and more pervasive.” The speakers for the session on medical fraternity and usage of technology and analyticsdriven insight for improving healthcare effectiveness included Srinivas Prasad, Chief Executive Officer, Philips Innovation Campus, India, Dr Prem Kishore V, Global Head Healthcare and Medical Device Practice, Tech Mahindra, India,

22 EXPRESS PHARMA February 16-28, 2015

BVR Mohan Reddy, Founder and Executive Chairman, Cyient addressing the delegates during BioAsia 2015

Pradeep Chandra, Spl Chief Secretary, GoT inaugurating Healthcare Conferences at BioAsia 2015

Sangita Reddy, Joint MD, Apollo Hospitals addressing the delegates during BioAsia 2015

Ameera Shah, Managing Director Promoter and Chief Executive Officer, Metropolis Healthcare, India to name a few. Martin Kelly, Chief Executive Officer, HealthXL, Ireland also addressed the delegates. The sessions under Public Health and Access track covered important topics like the efforts to prevent and control NCDs from Government of In-

dia, preventing blindness due to diabetes and hypertension, role of corporate in management and prevention of NCDs, bringing clinical research into the next decade: innovations and global strategies, role of information technology to help clinicians and patients for better management of NCDs and DSS in the new healthcare landscape. Experts who shared their thoughts in-

cluded Prof D Prabhakaran, Vice President, PHFI, Dr Damodar Bachani, Deputy Commissioner (NCDs), Ministry of Health and Family Welfare, Government of India, Dr Nikhil Tandon, Professor and Head– Department of Endocrinology and metabolism, AIIMS, New Delhi. Shakthi Nagappan, Chief Executive Officer, BioAsia said, “This edition of BioAsia has been instrumental in bringing together the stakeholders of biotech, healthcare, pharma and IT industry. Partnerships like TSIIC and China Medical City and FABA and Thailand Centre of Excellanace for Life Sciences would help each of them resulting better medical facilities for people. Around 1,350 delegates registered at BioAsia 2015 during these three days representing 50 countries.” Under the clinical research track, a panel discussion was conducted on the Indian regulatory landscape. The discussed points included role of lower cost innovation from Asia/ India, industry’s expectations from the Indian regulatory, key developments in the Indian regulatory landscape in the last few months, simplifying clinical trial approval process at the centre and so on. The panelists included Solomon Yimam, Assistant country director, US FDA India Office, India, Maggie Massam, head of business development, Clinical Practices Resource Datalink (CPRD), UK MHRA, etc. The session on Indian biosimilar guidelines and the global alignment discussed about the need to have a view on the approach to biosimilars, comparison and contrast between Indian biosimilar guidelines and the global alignment. It also had a roundtable discussion on whether India can be considered as a preferred destination for conducting biosimilar clinical trials. The chairperson for the session was Dr Maurice R Cross, Group Medical Director,

Veeda Clinical Research and other speaker was Dr Anand Eswaraiah, Head Clinical Development and Regulatory Affairs, Clinigene International. The session on bioequivalence studies in India focussed on the challenges and solutions for BA-BE studies in India, volunteer safety and compensation, sharing of volunteer database between CROs and import and export of biological samples. The chairperson for the session was Apurva Shah, Founder and Group Managing Director, Veeda Clinical Research and other speakers were Dr Charu Gautam, Director, Global Clinical Operations, Cliantha Research and Dr Mukesh Agarwal, Vice President, Clinical Research Division, Vimta Labs. The last session on the challenges and solutions for conducting clinical trial in India deliberated on challenges and solutions for conducting clinical trials in India, restriction of three studies per investigator, certifications of investigators/institutions, video recording of the informed consent process, as well as protocol development and site management to comply with Indian regulators. The speakers included Dr Kiran Marthak, Director, Lambda Therapeutic Research, India, Dr Jeroze Dalal, General Manager, Clinical Operations, GlaxoSmithKline Pharmaceuticals, India and Dr Shariq Anwar, Head Operations, Max Neeman Medical International India. In the course of the day, the jury also selected the best solutions developed during the first BioAsia Devthon. Three teams were given grants totalling two lakh rupees for their solutions. Winner teams will be working with BioAsia and Technology Business Incubator (BITS Pilani Hyderabad) to develop their prototypes further. TBI will provide them free incubation services for six months and monitor progress. EP News Bureau-Mumbai

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Asia Pharma Expo completes 12 highly successful years as catalyst for the growth of the South Asian pharmaceutical industry 492 companies from 27 countries and 8354 were visitors participated during the show ASIA PHARMA Expo 2015 concluded at the Bangabandhu International Conference Centre in Dhaka, Bangladesh during 8 -10 January, 2015. As South Asia’s largest pharmaceutical manufacturing expo, the total number of visitors expanded notably compared to that of the previous year. Asia Pharma Expo 2015 had a grand beginning witnessed by top management persons of major pharma manufacturing companies of Bangladesh. The exhibition was inaugurated by Tofail Ahmed, MP, Minister of Commerce, Government of the Peoples’ Republic of Bangladesh. The minister appreciated the efforts of Bangaladesh Aushad Shilpa Samity and the joint organisers; GPE EXPO for their efforts towards the establishment of a pharma manufacturing hub in Bangaladesh capitalising on the vast stride made by Indian pharma industry in meeting the quality drug requirements worldwide at affordable prices. Asia Pharma Expo 2015, a vital business molecule has been contributing to the growth and innovation of the Asian pharma markets in general and Bangladesh pharma industry in specific for many years, generating new business opportunities for exhibitors and visitors. Bangladesh is one of the fastest growing economies of the world and pharma segment has always been top priority for the nation. There are more than 300 pharma national and multinational units operating in the country producing 97 per cent of the local demands for drugs. With an annual double digit growth rate, the pharma industry in Bangladesh is heading towards complete self sufficiency

in meeting local demand. There is a surety of steady growth in investments and sustained future development in the pharma industry in Bangladesh. In Bangladesh, the pharma sector is one of the fastest growing sectors. In 2008 the total size of the pharma market in Bangladesh was estimated to be $700 million and is growing at a steady rate. The pharma sector is the second highest contributor to the national exchequer and the largest white collar labour intensive employment sector of the country. There are 245 registered pharma manufacturing companies in Bangladesh. Today, the Bangladesh pharma industry successfully exports APIs and a wide range of products covering all major

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therapeutic classes and dosage forms to more 94 countries. Beside regular forms like tablets, capsules and syrups, Bangladesh is also exporting high-tech specialised products like HFA inhalers, CFC inhalers, suppositories, nasal sprays, injectables and IV infusions. These products have been well accepted by medical practitioners, chemists, patients and regulatory bodies of all importing nations. Also the packaging and the presentation of the products of Bangladesh are comparable to any international standards. The future of pharma exports from Bangladesh is bright. After the inclusion of the Doha declaration in WTO / TRIPS agreement, each and every country belonging to the

LDC category has the option not to opt for pharma product patent until 2016, which means they can now legally reverse engineer patented products and sell in their markets as well as can export to other LDCs. This creates a huge export opportunities for Bangladesh, because, among all the 50 LDCs, Bangladesh is the only country which has a strong base for pharma manufacturing. Besides direct export operations, there is also a huge opportunity for the Bangladeshi companies to go for contract manufacturing and compulsory licensing. Also the South Asia region offers several advantages. It is one of the fastest growing pharma economies of the world and also the rapid growth rate to meet the demand and supply

statistics of India, Bangladesh, Nepal, Pakistan, Bhutan, Myanmar, Thailand, and Indonesia has attracted the global attention. Over-all growth rate of the South Asian pharma industry is 14 per cent with more than 24,000 formulators. With the highest exports of formulation, Bangladesh offers all the advantages for its strategic location in the South Asian pharma region. Asia Pharma Expo 2015 was beneficial to all participants from local business associates to international machinery manufacturers and even API / bulk active manufacturers got benefits from participation in the exhibition. The confidence grows and reflects every year in the Asia Pharma Expo series. There were 492 exhibiting companies from 27 countries along with 8,700 sq. mt. of floor space and 8,354 trade professionals visited the show. Such active participation makes this exhibition a rewarding and result oriented experience. The exhibitor’s profile is also impressive and includes complete spectrum comprising pharma processing and packaging machinery and materials, API, bulk drugs, formulations, additives, intermediates, analytical and biotech lab instruments / glassware / lab. reagents – chemicals, lab-consumables, environment control equipment and services, utility products and services, plant maintenance engineering, R&D, biotechnology, CROs, healthcare and surgical products and consumables, contractors – turnkey, trade associations / trade publications, formulations and contract manufacturing. EP News Bureau-Mumbai

EXPRESS PHARMA

February 16-28, 2015

cover ) 'We expect the introduction of the long awaited GST, to be a reality, sooner rather than later and are confident that steps for its implementation will be undertaken speedily' SV Veerramani,

GST may not only change the tax system in many ways, but may change the way business is conducted Pratik Jain, Partner - Tax, KPMG in India

President, IDMA

A WAIT AND WATCH APPROACH

24 EXPRESS PHARMA February 16-28, 2015

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From a pharma industry perspective, the GST rate on formulations would be even more relevant than on Active Pharmaceutical Ingredients Ranjana Smetacek, Director General, OPPI

oods and Services Tax (GST), a much awaited uniform tax regime which was initially tabled in 2006-2007, is likely to be implemented almost a decade later from April 1, 2016,. The GST Constitutional Amendment Bill, which was introduced in the Lok Sabha in 2011, had lapsed and the NDA government thus needed to come up with a fresh bill. The

proposed bill will include indirect taxes like excise duty and service tax at the central level and VAT and local levies at the state level. However, industries seem optimistic after Prime Minister Narendra Modi's speech at the Vibrant Gujarat Investor Summit 2015 in Ahmedabad. Modi mentioned that the centre is ready with the long awaited GST bill and very soon it will be implemented across the nation which will help industries to grow at a much faster rate. GST will be a very important part of the roll out of the MP's ;Make in India' vision.

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Commenting on the proposed bill and its implementation, Suresh Pareek, Managing Director, Ideal Cures says, “I think the announcement of implementation of GST is true, however, its feasibility over given time frame looks a little difficult. With the appointment of Vice Chairman, Arvind Panagariya for Niti Ayog, who himself supports uniformity, the problem should find a solution.” Logistics play an important role in the supply chain and players seem happy with the announcement. Vikas Anand, Managing Director, DHL Supply Chain India responds saying,

“With the new government’s principal focus on development and economic growth, we expect the introduction of the long awaited GST, to be a reality, sooner rather than later and are confident that steps for its implementation will be undertaken speedily.” Anil Arora, Promoter – Director, MJ Logistic Services opines, “The current government seems to have the political will and the directional leadership to implement and execute this reform.”

Tax pattern Presently, the tax pattern differs from state to state and like other

industries, the pharma industry also needs to to follow.. SV Veerramani, President, IDMA feels that the announcement of GST implementation provided a sigh of relief to the industry and says, “With central GST expected to be a single rate for goods and services, going forward, the credit accumulation may not be an area of concern. We hope that the integration of tax on goods and services through GST would provide the additional benefit of providing credit for service tax paid by manufacturers. The multistage taxation along with the inability to take full benefit of the CENVAT

EXPRESS PHARMA

February 16-28, 2015

cover ) Under GST, inter-state sales transactions between two dealers would be cost equivalent and comparable with stock transfers/ branch transfers. Inter-state transactions would become tax neutral, making India one single common market no longer divided by state borders credit /refund has been an issue for the industry. Furthermore, if the legislation provides for carrying forward of the unutilised credit this would be an additional boost to the industry. The biggest advantage to the industry can be that of reduction in transaction cost, with an immediate impact coming from the discontinuance of Central Sales Tax (CST).” The pharma industry is heavily dependent on an effective supply chain. The industry needs to follow set guidelines and processes to avoid unwanted incidences. It helps companies in delivering safe drugs to needy patients at the right time. However, due to multi-level tax structure, which varies from state to state, logistic providers have faced several challenges. Anand says, “With supply chains maturing in India, the introduction of GST will lead to an enhancement and consolidation of infrastructure and transport partners. Hence, for the economy to move forward and show positive growth, robust supply chains are imperative and the introduction of GST is now only a matter of time.” Pareek showcases the key benefits to pharma manufacturers after GST implementation explaining, “GST will help in reducing time as different check posts at different state borders cause delay in the release of goods. Vehicles have to wait in long lines for a long time. A lot of paper work needs to be done. This problem will immediately be resolved. To a large extent, the corruption at the passing check points will be decreased.”

26 EXPRESS PHARMA February 16-28, 2015

It is also expected that implementation of GST will be a boon for perishable goods as well. As each check post takes around four to six hours for entry and exit of the state and considering the states travelled, it is likely that around 25 per cent of total transport time may be saved and this will be important for perishable goods. Also, traffic blockages at check points will be reduced drastically.

GST implementation There are various services including logistics involved in getting the input material to its final customers. With the implementation of GST, cost of any service, including logistics, may be considered as ‘value add’, and the manufacturer hopefully can get tax credit for the service tax paid. Under GST, inter-state sales transactions between two dealers would be cost equivalent and comparable with stock transfers/branch transfers. Inter-state transactions would become tax neutral, making India one single common market no longer divided by state borders. The pharma sector currently enjoys various location-based tax holidays on its manufacturing activities. Under the proposed structure of GST, such area-based exemption will be done away with. However, taking into account past precedents, suitable work around/refund process needs to be constituted to ensure that any ex-

The current government seems to have the political will and the directional leadership to implement and execute this reform Anil Arora, Promoter – Director, MJ Logistic Services

We expect the introduction of the long awaited GST, to be a reality, sooner rather than later and are confident that steps for its implementation will be undertaken speedily Vikas Anand, Managing Director, DHL Supply Chain India

isting hubs do not get impacted andcontinue to get the agreed benefits. Arora emphasises on the service tax which is paid on the cost of such services and explains, “The pharma industry has the highest volume to value ratio, i.e. for a given unit of volume, it has the highest value of invoice. Hence the highest tax, so it has to follow a model where it needs to have a warehouse even in the smallest of states to save tax. Imagine the efficiency, reduced stock holding cost, reduced shelf life issues if the industry could supply an entire region or the whole country from one location.” GST, by definition, is based upon the concept of minimal exemptions and concessions. Therefore, the current exemptions/concessions may not continue under GST. Further, the entire margin across the distribution chain would be subject to central GST, which is not plausible as central excise duty is currently not applicable beyond the manufacturing stage. This could, thereof, impact the pricing of these products, significantly. Pratik Jain, Partner Tax, KPMG indicates, “Since GST is expected to have a liberal credit regime, tax paid on most goods and services should not be a cost and could have a positive bottom line impact. However, overall cash flow requirements may change owing to the principles of minimal concessions and ex-

emptions, levy of GST on stock transfers, possible higher GST rate on imports, etc.” The Government of India has declared 2015 as 'Year of Active Pharmaceutical Ingredients' under the 'Make in India' initiative and its relevant to note that GST will have substantial impact on APIs. As Ranjana Smetacek, Director General, OPPI points out, “From a pharma industry perspective, the GST rate on formulations would be even more relevant for Active Pharmaceutical Ingredients. The issue of accumulation of GST credit will continue, unless specific provisions are made in the GST law to address this from the very beginning.” Implementation of GST will have a cascading impact down the line. “Simplifying the distribution network and merging smaller warehouses to regional centres will result in economies of scale being generated. Warehouse locations will no longer need to be fixed, depending upon CST constraints but will be based on demand and supply patterns, centre of gravity, longterm logistical and real estate considerations. Large shared distribution centers offer not only strategic, operational and financial benefits, but allow for better cost control, forecasting, inventory rationalisation and synergies for consolidation in transportation,” stresses Anand. Smetacek adds, “The draft amendment bill has kept the window open to decide on the existing benefits in tax beneficial zones. The industry will follow up

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for a favourable disposition in these zones as there are a high number of manufacturers who avail the benefits of exemption from excise duty payment and refund of excise duty paid in cash, subject to the value addition norms as per the applicable notification.”

Relief for the pharma sector? With the implementation of the GST, state barriers and tax efficiency planning will no longer be the key factors influencing the size and location of warehouses. The only considerations will be incoming draft of goods and the targeted coverage area of a distribution centre, and of course availability and quality of warehousing space. Anand feels that apart from the pharma industry, other industries will be benefited from the implementation of GST. With core investments expected to increase in cold chain logistics and a clear focus on GxP and quality, drug efficacy stands to increase with the ultimate beneficiary being the end consumers. Cascading effects on transportation will be that the state level transportation will have to transform into heightened intra-region delivery capability. Regional warehouses will primarily have large floor plates and efficiency driven, and transportation will need to be more organised, precise and time of delivery driven both these factors will bring in the required transformation of the business from fractional, unorganised vendors to organised vendors with capabilities in size and scale. All these developments and transformations will lead to smoother and more organised logistics, opines Arora.

Liability Currently, each state has its own tax regime but after the implementation of GST, the immediate question which arises is that which companies can optimise the benefit from this uniform tax regime and

how; and what are the requirements to avail of these benefits? The government has proposed that fixing the companies' annual turnover limit at ` 10 lakh may be a better idea. Pareek agrees, “It is totally justifiable as the company paying the tax will also avail the Modified Value Added Tax (MODVAT) of the GST they paid on the purchase. We are basically a B2B industry, so we will have a lot of relief like doing away with collection of CForms, submission and assessment which causes a lot of inconvenience, as they are not received on time, causing a lot of penalties in terms of money and resources. Also, different states have different forms that are to be submitted and all this can be avoided.” This indicates a positive side of the implementation, the application of a single tax rate across all goods and service can result in redistribution of taxes across all categories. Arora feels, “It is appropriate and fixing companies' annual turnover limit of ` 10 lakh is definitely justifiable. In order to prevent leakages in the tax net and bring a similar order to all trading activities, the GST net needs to be as wide as possible.”

..but will it meet deadline? There have been high hopes

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about the inception of the GST regime at regular intervals. GST implementation is absolutely necessary to tackle the problems faced by various industries and will play a role in curbing corruption. Arora while replying to a question on whether the government will take different routes if the situation doesn’t permit the rollout this time as well, says that the current government seems to have the political will and the directional leadership to implement and execute this reform. “Let there be no misnomer that the transition will be smooth but, if we cannot do it now, we will miss the bus to higher GDP growth,” he cautions. Dr Milind Antani, Legal and Tax Counseling Worldwide, Nishith Desai Associates feels, “With the current scheme of things, the discussions that are going on between the Finance Minister and the states it seems more likely than not that GST will become effective from the proposed dates.” However, Jain feels, “Given the fact that GST implementation (including rates, etc.) may still take some time, the question before the industry is how to prepare for the new regime. The action plan may need to include several important aspects such as, communica-

tion with vendors/customers, treatment of transition stock, pricing strategies, changes in systems and processes, and so on. GST may not only change the tax system in many ways, but may change the way business is conducted.” Pareek sums up, “I think it may involve different revenue sharing formula for different states such that the state should not lose the amount that it currently receives. By this I mean that the state economy should not be affected. This must be ensured otherwise it will be difficult to implement GST.” Given the magnitude of changes that need to be done, the preparation needs to start now. The first step towards the transition to a GST regime may be to assess the impact of GST (financial, supply chain, processes, etc.) on business. This could then help in preparing an action plan for the transition and identifying the points on which the industry needs to initiate advocacy efforts with the government. All verticals of the pharma industry are showing their eagerness in welcoming the implementation of the GST bill. Now it is time to watch whether the government gives a verdict in favour of the industry or simply disappoints … once again. u.sharma@expressindia.com

I think the announcement of implementation of GST is true however, its feasibility over given time frame looks a little difficult Suresh Pareek, Managing Director, Ideal Cures

With the current scheme of things, the discussions that are going on between the Finance Minister and the states it seems more likely than not that GST will become effective from the proposed dates Dr Milind Antani, Legal & Tax Counseling Worldwide, Nishith Desai Associates

EXPRESS PHARMA

February 16-28, 2015

cover ) INSIGHT

GSTand its impact on pharma

DR MILIND ANTANI Legal & Tax Counseling Worldwide, Nishith Desai Associates

Dr Milind Antani, Legal & Tax Counseling Worldwide, Nishith Desai Associates and Ashish Sodhani, Member, International Tax Practice elaborate on how GST implementation would impact the pharma industry ASHISH SODHANI Member, International Tax Practice

THE CURRENT indirect tax system in India is characterised by multi-stage taxation with levy of taxes not only at the central level but also at the state level. Customs duty is imposed on imports, central excise on manufacture, central sales tax (CST)/value-added tax (VAT) at the time of sale and service tax on provision of services. Other taxes such as octroi, entry tax and cess are also levied by municipal and local authorities. It is also not possible to get credit for taxes which could have been used to offset other indirect taxes that are payable by the taxpayer viz. CST is not creditable against VAT, service tax not creditable against CST/VAT, customs duty is not creditable at all.1 This results in cost of taxes increasing significantly and also increases compliance costs as the taxpayer has to file several returns every month with different authorities. With a view to simplify this tax regime, the legislature decided to bring about a comprehensive tax system which would reduce the burden on the taxpayer. The Goods and Services Tax (GST) is a single, broad-based comprehensive tax system which levies tax on manufacture, sale and consumption of goods and services at a national level. The tax has to be paid by the seller or provider of service with the right to claim input credit for the tax paid by him at the time of purchasing the goods or procuring the service. This removes credit anomalies which are present under the cur-

28 EXPRESS PHARMA February 16-28, 2015

GST is levied on manufacture, sale and consumption of goods and services at a national level. It’s paid by the seller or provider of service with the right to claim input credit for the tax paid by him at the time of purchasing the goods or procuring the service rent indirect tax law and in turn has a favourable impact on profits and pricing of goods and services. GST is not additional tax but will subsume excise duty, service tax, additional duties of customs and CST at the central level and value-added taxes, entertainment tax, luxury tax, octroi, lottery taxes, electricity duty, state surcharges related to supply of goods and services and purchase tax at the State level. GST system in India essentially envisages two taxes – State Level GST (SGST) and Central Level GST (CGST). Both the taxes will be levied on the taxable value of a transaction. The Government is expected to fix a combined GST which is expected to be at around 14-16 per cent. The the rates of CGST and SGST will then be fixed by the Centre and States. CGST and SGST combined together are referred to as IGST. If GST is implemented how it stands today, it could make various business decisions, ‘tax neutral’, thus, ensuring that

commercial efficiencies are not compromised on account of tax constraints. Some of the key aspects of business operations that would likely be impacted by GST are as follows: ◗ Change in tax rate for supplies as well as purchases; ◗ Transactions/supplies which are currently not taxable may become liable to GST, and vice-versa; ◗ Credit availability for input taxes; ◗ Amendment/withdrawal of tax schemes, valuation provisions.

Impact of GST on pharma industry The Indian pharma industry, estimated turnover at ` 450 billion, ranks fourth globally in terms of volume and is amongst the largest producer of pharma products in the world along with US, Japan, Europe and China.2 Similar to the manufacturing industry, the pharma industry also enjoys low cost of production due to economies of scale. But the

levy of multiple taxes, loss of credit of tax paid, compliance and litigation cost associated with the present tax set up tend to raise prices which eventually result in causing problems to the pharma industry. With the introduction of GST, the most visible impact appears to be the proposed discontinuance of CST. It is a cost to pharma manufacturers whenever they procure raw materials from outside their state and if sale is on interstate basis.3 This is because of the fact that CST paid in purchases cannot be set off against the VAT liability of manufacturer /dealer. Another impact would be a review of the present warehousing strategies followed by the pharma industry. The common practice of most pharma manufacturers is that they maintain warehouses in different states to evidence movement of goods from one warehouse to another so as to save on the CST.4 Some manufacturers also went to the extent of setting up warehouses at locations like Pondicherry or Daman as the CST rate at such locations were previously lower than the rate prevalent in other states.5 Therefore, with the implementation of GST, pharma manufacturers can set up warehouses for distribution at select strategic location without looking at the same tax planning options resulting in cost of operations. Currently, pharma goods attract excise duty at 4.12

per cent whereas the active pharmaceuticals ingredients (API), which are inputs for manufacture of pharma products, typically attract duty at 8.24 per cent. This result in accumulation of differential Cenvat Credit for the manufacturers not engaged in export of pharma goods due to the difference in duty rates of inputs vis-à-vis the finished goods. This becomes an issue because the Central Excise/ Cenvat Credit legislation does not provide any mechanism for refund of such accumulated credit. With the CGST presumed to have a single rate for both goods and services, going forward accumulation of credit may cease to be an issue for the industry. GST is proposed to be implemented from April 1, 2016. Essentially it is the States which need to accept GST for it to be implemented in the country. With the current scheme of things, the discussions that are going on between the Finance Minister and the States it seems more likely than not that GST will become effective from the proposed dates. Further, with the new government having majority in the Centre and also starting to have majority in the States, it will not be too difficult to implement GST. The continuous effort to have discussions with the representatives of the State governments to make GST consistent with what all the States wants will also be useful for implementing it on time.

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(

THE MAIN FOCUS

GST: The road ahead Pratik Jain, Partner â&#x20AC;&#x201D;- Tax, KPMG India shares insights on the way forward after GST implementation IN 2006, an announcement was made about the introduction of GST by 2010. Achieving one of the biggest indirect tax reforms of the century was not expected to be a cakewalk. Key areas of debate have been the fiscal autonomy of States, compensation mechanism for States in case of loss, ambit of GST, etc. After hectic parlays, including firm commitments towards compensation on potential revenue loss to states and acceding to their demand on levy of a non-creditable GST on inter-state transactions, the Union Finance Minister was able to reach a broad consensus which saw the Constitutional Amendment Bill (the Bill) being reintroduced in the Parliament in December 2014. Hopefully, the Bill will be passed in the budget session. This could further brighten the chances of GST getting implemented from April 1, 2016. GST may significantly impact the pharma sector in many areas. The first challenge could be to determine the rate of GST on pharma products, which generally attracts a concessional excise duty as well as a state VAT. Further, many life saving drugs are completely tax exempt. GST, by definition, is based upon the concept of minimal exemptions and concessions. Therefore, the current exemptions/concessions may not continue under GST. Further, the entire margin across the distribution chain would be subject to central GST, which is not plausible as central excise duty is currently not applicable beyond the manufacturing stage. This could, thereof, impact the pricing of these products, significantly. The quantum of benefits currently derived by the units operating from the excise free zones may undergo a change owing to conversion of current exemptions into a refund scheme. The mechanism for computation of GST refund needs to be worked out to protect existing benefits are under the new regime. There could be significant impact on the supply chain, both in terms of sourcing as well as distribution. Tolling and contract manufacturing arrangements may need to be reviewed in light of fundamental changes in law like; removal of central sales tax, GST on stock transfers

PRATIK JAIN Partner - Tax, KPMG in India

and liberal credit system. Similarly, the warehousing strategies may need to be reviewed, as in absence of CST multiple warehouses may be less attractive. However, the Bill provides for introduction of non-creditable, one per cent additional tax (in addition to GST) on inter-state supplies, which may continue to distort the otherwise efficient supply chain under the GST regime. As GST is expected to have a liberal credit regime, tax paid on most goods and services should not be a cost and could have a positive bottom line impact. However, overall cash flow requirements may change owing to the principles of minimal concessions and exemptions, levy of GST on stock transfers, possible higher GST rate on imports, etc. Further, the current IT, MIS systems and processes could require huge upgrades to meet the GST requirements. GST implementation may still take some time, but the question before the industry is how to prepare for the new regime. Clearly, given the magnitude of changes that need to be done, the preparation needs to start now. The first step towards transition may be to assess the impact of GST on business. This could then help in preparing an action plan for the transition and identifying the points on which the industry needs to initiate advocacy efforts with the government. The action plan may need to include several important aspects such as, communication with vendors/customers, treatment of transition stock, pricing strategies, changes in systems and processes, etc. GST may not only change the tax system in many ways, but may change the way business is conducted. (Disclaimer: The views and opinions expressed herein are those of the author and do not necessarily represent the views and opinions of KPMG in India)

EXPRESS PHARMA

February 16-28, 2015

MANAGEMENT

30 EXPRESS PHARMA February 16-28, 2015

‘We hope that the Government will act quickly on major healthcare reforms’

he Organisation of Pharmaceutical Producers of India (OPPI) has high expectations from the upcoming budget with respect to putting in place a robust framework that will help the pharma industry grow and contribute towards tackling India’s health challenges. We are encouraged by the positive statements made on the ambitious health insurance plans, support for research and innovation, consolidated procurement systems and on creating a conducive environment for doing business. We hope that the Government will act quickly on major healthcare reforms and announce more support for this sector in the new budget. In its pre-budget memorandum, OPPI has proposed budgetary measures and support in the following key areas: ◗ Direct taxes ◗ Indirect taxes ◗ Transfer pricing

Direct taxes 1. The Government should increase the percentage of weighted deduction to 200 per cent from the current 125 per cent for companies that are undertaking scientific research as allowed for the approved specified institutions. 2. In order to attract more investments in R&D activities, government should make provision for weighted deduction of 200 per cent for expenditure incurred outside the R&D units. Expenses on overseas trials, preparations of dossiers, consulting / legal fees for filings in US for new chemicals entities and ANDA (abbreviated new drug applications) should be considered for weighted deduction. 3. Provision should be made specifically for weighted deduction of R&D expenditure in case of companies incurring R&D expenses where a part/whole of manufacturing activity is outsourced. Hence, tax benefits should be provided for units engaged in the business of R&D and contract manufacturing by way of

RANJANA SMETACEK DIRECTOR GENERAL, OPPI

an express clarification should be made in simple and lucid language that the onus to prove avoidance of tax will be on the tax department.

Indirect taxes deduction from profits linked to investments. 4. Rural and semi urban areas in India do not have basic healthcare infrastructure. Strengthening infrastructure in such areas involves substantial investments and a long gestation period. A weighted deduction for expenditure incurred in the rural/ semi urban areas should be provided in order to promote investments in such areas. 5. If India has to emerge as a low cost healthcare medical destination, there is greater need to set-up state-of-the-art healthcare facilities in metros, tier I and tier II cities. For achieving this objective, appropriate tax benefits should be granted/extended. 6. There is a need to increase healthcare expenditure (revenue as well as capital) in India. This will happen only when there are investments from both public and private entities. In order to encourage more investments, weighted deduction should be allowed on expenditure incurred by the company. 7. The existing set of rules in GAAR need to be revisited before its implementation. While some of the recommendations of the Standing Committee of Finance for the Direct Taxes Code (‘SCF’) have been accepted, it is proposed that the other suggested recommendations should also be accepted. We recommend that

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1. The Finance Act, 2014 that proposes a mandatory pre-deposit of 7.5 per cent on first level of litigation and additional 10 per cent at second level on duty (if duty and penalty both in dispute) or on penalty (if penalty is in dispute) should be made optional and not mandatory. The assessee should have the option to decide on whether to follow the normal stay procedure or pay the pre-deposit amount upfront. The amount of predeposit at 7.5 per cent at the first level and additional deposit at 10 per cent should also be reduced as the amount blocked in the litigation process would be high. 2. The interest payable on delayed payment of service tax should remain 18 per cent, irrespective of the period of delay. The substantial increase in the rate of interest to 24 per cent and 30 per cent in case of default in service tax matters would negatively impact the industry and compel the assessee to pay service tax under protest to ring fence exposure to higher interest payouts. This would trigger blockage of working capital. 3. Service tax should not be levied on R&D /clinical trial services performed in India where the recipient of service is situated outside India. Withdrawal of the service tax exemption on clinical trials or technical testing of new drugs on humans could render the

said services costlier. India could lose its competitive edge in the clinical trials global market. Countries such as Malaysia, Bangladesh and Singapore are emerging as new hubs for conducting trials which could hurt the prospects of Indian CROs. Levy of service tax on said services would indirectly impact the cost of medicines also. 4. A large taxpayer unit (LTU) should be allowed to pass on the CENVAT credit to its other registered units.

Transfer pricing 1. The much awaited amendment in respect of roll back of advance pricing agreements (APA) should have detailed guidelines on the following: Applicability of roll back benefit (i.e. whether based on an APA application filed on or after 1 October 2014 or an APA which has been concluded on or after 1 October 2014) and option to extend the roll back option to APAs concluded prior to 1 October 2014 as well impact on the on-going assessment/ appellate proceedings of the taxpayer. Applicability of roll back provisions on bilateral APAs. Clarification that penalty should not be levied in case margins of international transaction negotiated under the APA is different/ higher vis-à-vis the price of the international transaction in the previous years as reflected in the transfer pricing documentation 2. The introduction of range concept for determination of the arm’s length price is expected to provide greater flexibility to the taxpayers in

respect of setting of transfer price and testing for arm’s length nature as compared to the existing ‘arithmetic mean’. While rules in respect of the same are awaited, detailed guidelines in respect of the scenarios under which the concept of ‘range’ and ‘arithmetic mean’ shall apply, should be prescribed. 3. By Finance Act 2012, the Government notified that the flexibility of the range as was provided in the second proviso to Section 92C(2) cannot exceed three per cent. Limiting the tolerance band to three per cent (one per cent for wholesalers) tends to be extremely restrictive, thereby requiring the taxpayers to be extremely rigid with their pricing which may not be commercially feasible. Thus, the tolerance band should be restored to the earlier limit of five per cent. 4. Local marketing expenditure on global brands should not be subject to transfer pricing audit as these payments are made to third parties for the purpose of sale of products of Indian subsidiary and no associated enterprise is involved in the transactions. Alternatively, it is recommended that a policy is framed to provide for benchmarking of marketing spend by companies for expenses which are routine in nature and for expenses which are of a niche/ non routine nature. 5. The ‘Specified Domestic Transaction’ amendment should be a situation wherein the exchequer does not incur any loss. Other than transactions between a profit making and loss making unit / company and transactions between taxpayers having different tax rates, a corresponding adjustment should be allowed in case of any transfer pricing adjustment in specified domestic transactions. 6. The penalty structure on transfer pricing adjustments requires to be toned down and should be levied only in exceptional cases. The penalty of two per cent is very high and is likely Continued on Page 34

EXPRESS PHARMA

February 16-28, 2015

MANAGEMENT

'We are hoping that this year government gives impetus to the burgeoning biotech industry'

e are hoping that this year government gives impetus to the burgeoning biotech industry. There is lack of funding support for biotech companies in India. Indian pharma companies and other corporates should be incentivised to invest their cash surplus in biotechnology research and commercialisation. Such investments by pharma companies and other Indian corporates and SEBI registered venture capital funds for biotechnology should be eligible for the weighted average deduction under section 35(2AB). Biotechnology Special Economic Zones (SEZs) enjoy 100 per cent tax free status, which should be increased from existing five years to 10 years because of inherent regulatory gestation in this sector. Innovation is the key to bringing effective treatment at an affordable cost to the market. Indian companies are already climbing the innovation curve for new drug discovery. Further to boost innovation in India, current tax incentives of 200 per cent weighted deduc-

SUJAY SHETTY INDIA PHARMA LIFE SCIENCES LEADER, PARTNER, PWC tion should be increased to 300 per cent with a validity of 10 years. This weighted tax deductions should be applicable to outsourced clinical trials and R&D and include: preparations of dossiers, foreign consulting/legal fees for NCE and ANDA filings with the US FDA and patent defending charges. When computing the MAT, weight deduction should

enus Remedies, research-based global pharmaceutical company, seeks incentives for R&Ddriven firms, safe harbour provision for generic exporters, reduction in excise duty on active pharmaceutical ingredients (APIs). We expect the government to boost the manufacturing sector and regulate it by making GMP compulsory. It should introduce some new policies to create a business environment to enable mid-cap Indian companies like Venus Remedies to match international standards and compete globally. The healthcare authorities should focus on promoting R&D in the pharma sector, particularly the in-house R&D undertaken by Indian companies. This will help India come up with lowcost innovative solutions in critical care segments like anti-microbial resistance and oncology. Since the pharma sector is

32 EXPRESS PHARMA February 16-28, 2015

be allowed under Sec-35 (2AB). as the current rate of MAT is very high (18 per cent, effectively 28.5 per cent including 7.5 per cent surcharge and three per cent cess). Service tax for the CRO industry is putting Indian companies at a significant disadvantage over some of our neighbours and competitors. Hence elimination or substantial reduction in the service tax, especially for overseas clients paying in foreign currency will benefit the industry at large.

Keeping in mind new government's make in India campaign, companies must be encouraged to start their manufacturing operations in India. However, the current duty and tax structure acts as a deterrent for local manufacturing as customs duty on complete system is lower than the components for manufacturing and in addition the buyers have to spend additional central excise duty and sales tax on locally manufactured goods making it prohibitively expensive compared to imports. Excise duty

â&#x20AC;&#x2DC;Give incentives to R&D-driven firms, slash excise duty on APIs by halfâ&#x20AC;&#x2122; PAWAN CHAUDHARY CHAIRMAN AND MANAGING DIRECTOR, VENUS REMEDIES

export-driven to a large extent, it is exposed to fluctuations in pricing. As of now, big pharma companies opting for contract research are getting benefited from the relaxed transaction

limit for availing the safe harbour rule facility. Since the safe harbour provision could prove to be a credible alternative for generic players with major exports to avoid transfer pricing disputes, the government should extend the safe harbour rules to them so as to reduce the cost of compliance and litigation. The central excise duty on active pharmaceutical ingredients (APIs) should be reduced from 12 per cent to six per cent, as in the case of certain formula-

tions. The higher rate of central excise duty on APIs as compared to the formulations has been resulting in accumulation of cenvat credit for manufacturers dealing only in domestic markets and those with minimal exports. Furthermore, as there is no provision for pharma manufacturers to get the accumulated cenvat credit refunded, it is eventually adding to their expenses. As clinical trials are a fundamental requirement before introducing any research

and service tax is payable at 12 per cent on input services, whereas the rate for output products is six per cent. Therefore, the inverted duty structure needs to be rectified with suitable amendments to the abatement available. Medical devices and formulations attract customs duty of 10 per cent. Duty on these products should be rationalised to five per cent. Customs duty on molecular diagnostic products should be exempted / nil rated to enable these tests to become more affordable. Duty exemption is currently available only to notified lifesaving drugs and devices, to be extended to all lifesaving drugs and devices for making the treatment affordable to masses as still in India insurance penetration is low and people have to pay out of their own pockets. Draft GST Bill should be released on passing of the constitutional amendment bill in Parliament, to enable industry transition to the GST regime. GST is expected to rationalise cost by bringing in supply chain efficiencies.

product in the market, all the costs incurred on these trials, whether in India or overseas, should be part of the R&D costs under Section 35(2)-AB of the Income Tax Act. The government should also devise a system to speed up the process of regulatory approvals for clinical trials and marketing. On the tax exemption front, MAT rate should be reduced and units in backward zones like Himachal Pradesh and Sikkim should be excluded from MAT. This will boost R&D in pharma companies as the reduction in MAT rate and exemption from MAT for units located in backward areas would help pharma companies generate healthy profits. Pharma is an export-oriented industry, and in the wake of global economic uncertainties, exports need some incentives. Export-based deductions, like under the erstwhile Section 80 HHC, should be reintroduced.

MANAGEMENT

'Government can do is to give a consistent and predictable policy environment'

he pharma industry in India has been on a roller coaster ride for the past few years with issues such as expanding span of price controls, weak enforcement of IPR and increasingly stringent yet ambiguous regulatory environment. While the Union budget has limitations in addressing some of these issues, the least Government can do is to give a consistent and predictable policy environment so as to plan the business for longer term rather than tinkering with taxes and duties every year and to offer few sops to balance the books. The first full budget of the BJP government is being eagerly awaited not only by the corporates but also by the Aam Aadmi for the Achhe Din to finally arrive. The first humble request to the Finance Minister is to shun verbosity and keep it short and simple. His first maiden budget with a record 253 paras and with a health break has broken all previous records of budget speeches. Hope this performance is not repeated. Now that Make in India has become the national anthem of the new government and the entire WEF town of Davos is plastered with Make in India billboards and Indian Adda is renamed Make in India lounge, the budget should give impetus to this initiative. To begin with, the corporate tax for domestic companies

DR AJIT DANGI PRESIDENT & CEO DANSSEN CONSULTING

should be reduced to 25 per cent from 30 per cent and MAT to a reasonable rate of 15 per cent from 18.5 per cent. We have seen what has happened to the SEZ concept which was touted as a game changer for manufacturing. Today, less than 48 per cent notified SEZs do any manufacturing activity and they have just become a tool for real estate players. Secondly, logistics plays a very important role in pharma distribution and supply chain which has always been a challenge due to poor infrastructure and multiplicity of state and central taxes, and their cascading effect. This is compounded by the fact the many medicines require cold chain storage and most of them

have limited shelf life. GST would have changed all this but it looks like we will have to wait till April 2016 till all states come on board. DTC is another area which needs urgent attention. CBDT has recently notified safe harbor rules for sectors like IT/ ITES, KPO, auto component manufacturing etc. Similar guidelines should be extended to pharma companies exporting and manufacturing products as contract manufacturer. The new companies Act now mandates that certain class of companies should spend two per cent of their average net profit on CSR. Since this activity is meant to benefit the society and not the company, it should be made tax deductible. Not long ago India was considered a destination of choice for conducting clinical trials on new drugs. Unfortunately this is no longer so.

Clinical research activity which is fundamental to drug discovery is down almost by half. While the budget has limitations in correcting this situation, the least government can do is scrap the service tax on CROs which was a major setback for them to remain competitive. Pharma industry is science based and innovation is at the core of its growth strategy. To encourage discovery research all expenditure on R&D whether carried out in house or outside, weighted deduction under u/s 35 (2AB) should be enhanced to 250 per cent from 200 per cent for a period of 10 years i.e.up to 31 st March 2024. All areas of discovery research such as clinical trials, patent filing, contract research, BA/BE studies etc. should be tax exempted to foster conducive environment for drug discovery research.

India’s bulk drug industry is on the verge of collapse. While we are proud of being called Pharmacy of the word, our growing dependence on Chinese imports for APIs is going to severely affect the industry in the long run and needs urgent intervention. Today out of 348 APIs of essential drugs only about 50 are manufactured in India. Pharma are integral part of healthcare value chain. The FM in his maiden budget announced creation of one AIMS type institute in every state. Time has now come to at least start laying foundation stones for this initiative. Our former 'Accidental Prime Minister promised to increase the Government’s healthcare spend to at least 2.5 per cent of GDP as against one per cent presently allocated. Instead, Nadda the new Health Minister recently announced a massive cut of ` 6000 crore in the healthcare budget citing non utilisation of allocated funds and simultaneously announcing that no flagship programme will get affected. Lastly, no more aggressive taxation and retro tax. We have now world class economists like Arvind Subramaniam, Raghuram Rajan, Arvind Panagariya, Bibek Debroy advising the government. All the Government has to do is listen to them with its ears and mind wide open.

Continued from Page 31

‘We hope that the Government will act quickly on... to subject the taxpayers to onerous financial hardship. 7. OPPI proposes issuance of a formal guidance for application of the transfer pricing method whereby, the innovator should be differentiated and not compared with the generics, except where such a comparison is based on a scientifically proven

method/ guidelines. Even in such cases, cognizance should be given to the research and development spends by companies. 8. Tax authorities should take into consideration the losses incurred by companies in the start-up year of the company/ year of launch of a product/ mol-

ecule and specific guidelines be prescribed to account for the cyclical nature of expenditure. This shall be in accordance with international standards and OECD guidelines. 9. There is conflict between the requirements of Transfer Pricing and Drugs Prices Control Order (DPCO). Transfer

pricing regulations may require reducing transfer prices of drugs which would result in reducing end selling prices due to the DPCO rules. Such reduction in prices would ultimately reduce the local margins, thereby beating the very intent of the regulations to optimise local margins. Also, in cases of ‘life

saving’ products, the assessee could be compelled to withdraw the products from the market due to poor local margins. Transfer Pricing Regulations should provide for harmonisation with conflicting regulations, in such cases. Alternatively, clarificatory guidelines to the same should be provided. u.sharma@expressindia.com

34 EXPRESS PHARMA February 16-28, 2015

MANAGEMENT OPINION

Will a new US-led IP empire in India put access to medicines at risk? Prof Brook K Baker, Professor of Law and Northeastern University, cautions that the Modi government’s accelerating flirtation with the US and its investors is dangerous to hundreds of millions of people worldwide whose lives depend on Indian generics

JANUARY 26 was a bad day for people around the world who rely on Indian generic companies for access to affordable medicines of assured quality. In the 19th century, the British Empire imposed a patent regime on India designed to guarantee monopoly access to its inventors and industries. In the 21st century, the US Empire is attempting the same, and there are troubling signs that the new government, led by Prime Minister Modi, might fail to resist the IP takeover. As widely reported in the news, President Obama recently completed a threeday visit to India. Although the photo highlights are about leaderships hugs, strolls through palatial government facilities, and Obama chewing gum at the Republic Day Parade, the real world background has been unrelenting US pressure against the Indian patent regime in the form of priority IP watch list status in successive Special 301 Watch Lists, a USTR out-of-cycle review of India’s IP and enforcement policies, multiple US Congressional hearings, two investigations by the US International Trade Commission, and countless visits by US dignitaries acting as spokesmen for Big Pharma’s monopoly interests. During Obama's visit, PM Modi addressed multinational business moguls at the India-US CEO Forum and later at the US-India Business Summit where Obama was also present. During the CEO Forum, Modi reassured business billion-

aires, “You will find a climate that encourages investment and rewards enterprise; it will nurture innovation and protect your intellectual property.” At the Business Council, he said, "India is ready to accept suggestions made by a joint working group with the US on intellectual property rights." Commerce and Industry Minister Nirmala Sitharaman told the media after her meeting with the US Commerce Secretary, Penny Pritzker that, “We have invited the Americans to look at the draft policy (on IPR) and give their inputs. We will then see what we can do with it.” Given these direct avenues to reforming India’s IP regime, President Obama clarified the US’s intentions: "We need to incentivise trade rather than stifle. We need to be transparent, consistent and protective of

EXPRESS PHARMA

February 16-28, 2015

MANAGEMENT intellectual property rights." The joint working group on IP that PM Modi referred to was established last year at the conclusion of Modi’s state visit to the US as part of the India-United States Trade Policy Forum. At that time, USTR Michael Forman said that it is “in India’s interest to have and enforce a world-class intellectual property rights regime.” He then listed patents, trade secrets, and compulsory licensing as being challenging issues from the US’s perspective, arguing that India must deal with them directly if it is to play a leadership role in the knowledge economy. Ominously the Joint Statement issued by President Obama and PM Modi during Obama January visit stated: “16. Recognising the progress made in constructive engagement on Intellectual Property under the last round of the IndiaUS Trade Policy Forum held in November, 2014, the Leaders also looked forward to enhanc-

ing engagement on Intellectual Property Rights (IPR) in 2015 under the High Level Working Group on Intellectual Property, to the mutual benefit of both the countries. 25. The Leaders reaffirmed the importance of providing transparent and predictable policy environments for fostering innovation. Both countries reiterated their interest in sharing information and best practices on IPR issues, and reaffirmed their commitment to stakeholders’ consultations on policy matters concerning intellectual property protection.” It is no secret that Big Pharma and the Obama administration want India to dismantle section 3(d) of the India Patents Act, which prohibits patenting on new uses of medicines and new forms, formulations, and dosages unless they shows significant enhancements of therapeutic efficacy. This provision famously led to the denial of a patent on Novartis’s cancer

The US also wants India to abandon all usage of compulsory licenses except in emergency circumstances in the wake of India having issued a single compulsory license ever on Bayer’s super-expensive cancer medicine, Nexavar

medicine, Glivec, leading to a seven-year court battle culminating in the Indian Supreme Court’s reaffirmation of section 3(d). Just two weeks ago, this same anti-evergreening provision was used to deny a patent on Gilead’s blockbuster hepatitis C medicines, Solvadi, potentially saving India hundreds of millions of dollars in treatment costs. The US also wants India to abandon all usage of compulsory licenses except in emergency circumstances in the wake of India having issued a single compulsory license ever on Bayer’s super-expensive cancer medicine, Nexavar. Even though the US routinely issues government use licenses on military and other technologies, it also regularly threatens other countries that adopt or issue compulsory licenses that are completely legal under national and international law. Unfortunately, there are signs that India has already acceded to this demand by

mothballing plans to issue additional compulsory licenses on other overpriced cancer medicines. A most troubling rumour is that the Modi government is beginning to weaken in its opposition to US-style data exclusivity and patent-registration linkage. Data exclusivity creates monopoly protection for regulatory data submitted to drug regulatory authorities making it virtually impossible for generic medicines to gain marketing approval for their therapeutically equivalent and much cheaper medicines. Likewise, linkage prevents a drug regulatory authority from granting marketing approval for a generic equivalent whenever the innovator company asserts that it has a patent that might be infringed by the generic product. In the US, data exclusivity on small-molecule medicines lasts five years and can be evergreened with additional threeyear extensions. Biologic medicines, on the other hand,

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MANAGEMENT What is meant by a transparent and predictable policy environment is one that is open to industry lobbying and one that only gets better and better from an investor’s standpoint – in other words, one that does not not frustrate investor’s expectations of profits based on 'secondary' concerns like public health, environmental and job safety, and the interest of indigenous enterprise currently have 12 years of data and marketing exclusivity. The joint statement also offers dangerous prescriptions with respect to investment policy, 9. The President and the Prime Minister affirmed their shared commitment to facilitating increased bilateral investment flows and fostering an open and predictable climate for investment. To this end, the leaders instructed their officials to assess the prospects for moving forward with high-standard bilateral investment treaty discussions given their respective approaches. What is meant by a transparent and predictable policy environment is one that is open to industry lobbying and one that only gets better and better from an investor’s standpoint – in other words, one that does not not frustrate investor’s expectations of profits based on 'secondary' concerns like public health, environmental and job safety, and the interest of indigenous enterprise. The US and its business community always try to draw an express link between stronger IP and more investments. In fact, the available economic and policy literature on the impact of stronger and broader IP on development, foreign direct investment, technology transfer, and even innovation is highly contested, with the majority of the evidence indicating that IP’s benefits are grossly over-emphasised particularly with respect to low- and lower-middle income countries. Most economies that have surged in the past 50 years, including India, have not done so through the policy of stringent IPRs and IP enforcement, but rather through a policy of copying and adapting technologies to local needs and protecting key emerging economic sectors. This approach explains how the generic pharma industry in India has achieved its unprecedented growth and importance both domestically and globally. Not only is the focus on IP-related investment incentives misinformed, the Indian government stands a great deal to lose if a US-style bilateral investment agreement is concluded. In these agree-

ments, the US seeks investment protections for intellectual property rights and then seeks investor-state-dispute settlement that allows disgruntled investors to bypass local courts and take governments directly to private arbitrations whenever their expectations of profits are thwarted by policies and decisions undertaken by government. Using such a provision in NAFTA, Eli Lilly is currently suing the Government of Canada of $500 million because two of its patents were invalidated after appellate court review. There are concerns about excessive patent and data rights in the US even as it seeks to impose higher IPR and investment standards on India. In a series of opinions, the US Supreme Court has raised the bar on inventive step in the US and outlawed patents on genes and isolates of natural products. Budget proposals in the US have attempted to role back data exclusivity on biologics from 12 to seven years. Patent reformers are trying to stop patent trolls and government procurers and insurers are struggling to gain price concessions on medicines that can now cost over a $100,000 per patient. It’s unclear why India should drink the IPmaximalist coolaid when the US is starting to throw it up. Even in the US, and more so in the EU, there are concerns about excessive investor rights and nontransparent, unreviewable investor arbitration. The Modi government’s accelerating flirtation with the US and its investors is dangerous if it passes beyond the courtship phase, even more so if it comes at the expense of dismantling India’s pro-health intellectual property regime. India has let the US IP fox into its IP policy hen house and the slaughter may be underway. The victims, however, are not the Big Pharma puppets, but hundreds of millions of people worldwide whose lives depend on Indian generics. Will that industry now be squeezed by IP concessions that will delay generic competition, raise the costs of medicines, and enrich Big Pharma magnates instead? The Empire is knocking.

EXPRESS PHARMA

February 16-28, 2015

DOP/PAO Leak Testing Air Flow Pattern (Smoke)Test

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

‘Indian pharma market will spearhead growth in the coming years’ Christophe Boulanger, Managing Director, NNE Pharmaplan India,in an interview with Usha Sharma, speaks about the company's future plans for the Indian market

How long you have been associated with the Indian pharma market and what have been your learning experiences? NNE Pharmaplan is a business partner to the pharmaceutical and biotech industries and is one of the leading engineering and consulting companies within the field. NNE Pharmaplan started its operations in 1996 in India and has been providing engineering consulting services to the pharma and biotech sector over the past 18 years. Personally, I have been associated with the global pharma industry for more than 20 years now. During the past eight years, I have been involved in various global positions within NNE Pharmaplan which has given me insights into the Indian pharma industry. The Indian pharma market, along with the markets of China, Brazil and Russia, will spearhead growth in the pharma industry in the coming years. The Indian market has some unique characteristics: First, branded generics dominate, making up for 70 to 80 per cent of the retail market. Second, local players have enjoyed a dominant position driven by formulation development capabilities and early investments. Third, price levels are low, driven by intense competition. However, the industry will need to strengthen three sets of commercial capabilities:

38 EXPRESS PHARMA February 16-28, 2015

marketing excellence, sales force excellence and commercial operations. In addition, players will need to put in place two enablers: strengthen the organisation to be able to sustain performance and manage rising complexity; and collaborate with stakeholders within and outside the industry to drive access and shape the market. NNE Pharmaplan is aligning itself to cater to these requirements and help the industry players to strengthen their operations by providing first-class consulting services driven by technology leadership. Tell us about the company's ongoing activities and the major projects which it is working on? In India, we focus on vaccines, OSD and injectables as well as the latest trends and technologies such as singleuse systems. To support this, we have established a consulting department focused on high-level business support, which is headed by Aeby Thomas. Aeby comes with a rich global experience in production and consulting, and has been with NNE Pharmaplan for more than seven years. Supporting him, we have local experts in India. At the same time, we are also utilising our global consulting department to look into critical domains such as containment, oncology and continuous

Our focus has always been to create value for our customers across the world. We strive to deliver a similar experience for our customers, irrespective of where they choose to work with us

processing. Our focus has always been to create value for our customers across the world. We strive to deliver a similar experience for our customers irrespective of where they choose to work with us. Our goal is to increase the quality of our deliveries while focusing on our core of pharma and biotech customers. We are currently engaged in the following domains in India: ◗ Vaccines ◗ Biopharmaceuticals and mAbs ◗ Containment within API and OSD Unfortunately, I cannot share the precise customer and project details with you due to confidentiality agreements. There have been regulatory compliance issues with many Indian manufacturing facilities. How critical are these challenges? What steps do you follow to overcome these issues? It's important to note that many Indian companies understand and adhere to current good manufacturing practices (cGMPs). The problems encountered by FDA investigators in India are similar to those seen around the world in manufacturing. These include inadequate or poor quality systems implementation, data integrity issues, inadequate validation of various

processes used in manufacturing or testing and product adulteration or contamination. While some Indian companies operate state-of-the-art facilities and meet cGMPs, others do encounter problems and operational challenges. Not only is quality critical to public health, but also the basis of the public's confidence in pharma. Overcoming these issues requires a willingness to change and a pro-active approach to looking into other high technology industries, investigate their practices and adopt these selectively so as to achieve the goals of transparency, traceability and therefore quality. When designing facilities, we have our GMP experts review the layout of the facility. Our GMP experts are up-to-date with latest guidelines and regulations laid down by FDA which helps us to design facilities in accordance with current guidelines. NNE Pharmaplan has devised internal tools called ‘Our model and our Wiki’ which are global platforms for sharing knowledge about latest trends and technological solutions available across the globe and for sharing best practises within the organisation. If a customer wants to check whether their facility is in compliance with latest guidelines, NNE Pharmaplan can provide GMP review and assessment

studies and make a review report with recommendations of corrective actions. Why should multinational pharma companies invest in India? Particularly in the Asia-Pacific region, which market do you feel have a huge business potential and why? India is expected to rank amongst the top three pharma markets in terms of incremental growth by 2020. Within APAC, NNE Pharmaplan has offices in India, Malaysia and China and we have the required muscle to support even the biggest and most complex projects in this region. However, I still believe that India has an advantage in these markets, primarily due to the following reasons: Workforce: India possesses a skillful workforce with high managerial and technical competences. Cost-effective chemical synthesis: The track record for development, particularly in the area of improved cost-beneficial chemical synthesis for various drug molecules is excellent. Legal and financial

framework: India is a democratic country with a solid legal framework and strong financial markets. There is already an established international industry and business community. Globalisation: The country is committed to a free market economy and globalisation, which is constantly increasing. Approval time for new facilities has been drastically reduced. India’s cost of production is significantly lower than that of the US and almost half of that of Europe. What will the consultant keep in mind while setting up new units? NNE Pharmaplan keeps in mind the following things while designing for new facilities: ◗ The facility should be cGMP compliant and adhere to international regulatory guidelines relevant to the customer’s target market ◗ The CAPEX and OPEX should be stabilised, driven by our rich knowledge database and technology leaders ◗ Effective space

NNE Pharmaplan adopts a modular engineering approach which enables expansion of operations without disturbing existing production management and efficient utilisation of site dimensions are ensured through use of 3D Revit where it is possible to visualise the entire facility before it is built ◗ The facility set up should be designed to allow for future expansion. NNE Pharmaplan adopts a modular engineering approach which enables expansion of operations without disturbing existing production. This is secured

by having regular constructability reviews during the design stages of the facility. How many people are associated with the group and out of them how many are technical experts? NNE Pharmaplan has a resource pool of 2,000 resources at more than 25 locations around the world. The resources are divided into two categories: operational and nonoperational. The operational resources are the technical resources that are involved in designing and engineering consultancy for pharma and biotech domains. Around 80 per cent of our employees are billable/operational. They are supported by 20 per cent non-billable/non-operational employees involved in IT, HR, sales etc. NNE Pharmaplan also has a pool of senior technology partners (STP) who are high level technical specialists within their own respective fields. We currently have STPs within vaccines, sterile and aseptic fill and finish, regulatory compliance, OSD, biopharmaceuticals, medical

devices and drug delivery systems. Most of our STPs are technology leaders within their domains and work to provide innovative solutions to our customers globally. Tell us about the company’s future plans. NNE Pharmaplan has set out on a journey to build long-term relationships with strategic customers based on a role as trusted advisor. We believe that we can deliver the right solutions through deep insight and understanding of our customers’ challenges and opportunities. So to say, our New Year’s resolution is to be more focused on our key customers, understand their pains, deliver customised solutions, move towards focused pharma engineering, attract the right talent and distinguishing ourselves from other players on the market by providing high value for our customers. We are on the right path of sustainable growth and we are entering the new year with a good pipeline. u.sharma@expressindia.com

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EXPRESS PHARMA

February 16-28, 2015

PHARMA TECHNOLOGY REVIEW INSIGHT

Overview of powder flow properties Brookfield Engineering US in this article gives insights on the flow patterns and flow obstructions that can occur inside the storage vessels on a processing line A TYPICAL industrial powder processing line will include several storage vessels (e.g. bins, bunkers, silos, hoppers, intermediate bulk containers or IBCs, sacks etc), feeding or handling steps (e.g. belt conveyor, screw conveyor, pneumatic conveyor, gravity chutes etc) and processing steps (e.g. milling, mixing, drying, bagging etc). A major industrial problem is getting the powder to discharge reliably from storage into the next process step.

What are the powder flow patterns that can occur in a process storage vessel? Principally there are two different flow patterns that can occur: Core-flow: Core flow (shown in Fig 1a) can be considered the default flow pattern and is characterised by powder discharge through a preferential flow channel above the draw down point of the outlet. Powder is drawn into the flow channel from the top free surface of the inventory. This gives a first-in last-out discharge regime and, if operated on a continuous (rather than batch) mode, the powder around the walls in the lower section will remain static in the vessel until the time that it is drained down to empty. Mass-flow: Mass flow (shown in Fig 1b) is the desirable flow pattern for powders that are poor flowing or time sensitive, but must be specifically designed for. Here the entire contents of the vessel are 'live', giving a first-in first-out discharge regime. To achieve this, the hopper walls must be sufficiently steep and smooth. For a given wall material/converging angle, the powder wall friction must be below a critical value. Also, the prod-

40 EXPRESS PHARMA February 16-28, 2015

uct discharge must be controlled by a valve or feeder that allows powder to flow through the entire cross sectional area of the outlet. (It is this final point that prevents many vessels from operating in mass-flow.) A wall friction test will be able to give an approximate assessment of whether a given hopper geometry will support mass-flow (with the proviso that the outlet area is fully active). For an exact calculation of the maximum mass-flow hopper half angle, both wall friction and flow function tests must be undertaken. What are the powder obstructions that can occur to prevent flow? Principally there are two flow obstructions that can occur: 'Rat-holing' (shown in Fig 2a) is the principle flow obstruction in a core-flow vessel where the powder in the flowchannel above the outlet discharges and leaves a stable internal structure. Arching(shown in Fig 2b) is the flow obstruction in a mass-flow vessel, where a stable powder arch forms across the outlet or converging walls of the hopper, thereby preventing flow. For a given powder there is a critical outlet dimension that must be exceeded to ensure reliable discharge of a core-flow or mass-flow vessel. These are the critical rat-hole diameter Drh and the critical arching diameter Dc or Dp (depending on the hopper geometry – see Figure 3). The Brookfield Powder Flow Tester (PFT) can calculate these critical dimensions following a flow function measurement. An accurate dimension requires a wall friction test as well. Note that for a

the shear rate. In powders the effect of these factors is reversed so that shear stress of a powder is strongly dependent on the normal stress but independent of the shear rate. Hence when characterising powders, test are undertaken at a single speed but over a range of normal stresses. The other key difference is that powders are anisotropic so the stresses are not equal in all directions and are frictional so that they can generate shear stresses at wall boundaries (see wall friction section).

Flow function test

given powder the rat-hole diameter is significantly larger than the arching diameter.

Key differences between

powders and fluids For Newtonian fluids the resistance to shear (viscosity) is independent of the normal pressure but dependent on

The primary measure of powder flowability is the powder flow function - which gives a measure of the amount of strength the material retains at a stress free surface following consolidation to a given stress level. The simplest way of explaining the flow function is with the uniaxial unconfined failure test shown in Fig 4, which measures the strength of a free standing column of powder. This condition is analogous to the condition of the powder arch across a hopper outlet shown in Fig 2b. i) Consolidation of sample Powder is placed in a cylindrical cell and compacted under a known normal stress ï ³1. ii) Unconfined sample The mould is now carefully removed to reveal a compacted column of powder. iii) Unconfined failure of sample The normal stress acting on the column of powder is gradually increased until failure occurs, and the peak normal stress ï ³c is recorded. The uniaxial unconfined failure test is conducted over a range of consolidation

PHARMA TECHNOLOGY REVIEW O2

O2=0

iii

Fig 4: Uniaxial unconfined failur test

Anticipated uses of the Brookfield powder flow tester Bench marking — Measure flow properties on all raw powders and blends to determine if there are differences in their flowability and whether these correspond with plant experience. New materials — Test new ingredients/blends versus existing ingredients /blends to determine whether the alternative material is likely to be easier or more difficult to handle. This potential material handling cost can be factored into the purchasing decision. Reverse engineering — If you have plant experience with powders on a given process line, you can use the PFT to determine the flow properties of each powder and use this as a flowability reference for future batches. Design — Design the geometry (converging angle and outlet size) of new hoppers/silos for reliable flow.

Alternative methods of displaying the flow function test results To demonstrate powder flowability, the flow function can be presented graphically (as in Fig 5) to describe behaviour over the stress range of approximately 0.3kPa to 13kPa. This stress range is

representative of that experienced by the powder in small to intermediate sized silos. However, describing flowability with a function may complicate the analysis as it is sometimes found that the flow functions of two different materials cross over one another, so that their relative ranking changes with stress levels. Alternatively, flowability rankings for specific stress levels can be determined by calculating the following parameters: ◗ Estimated critical arching diameter [m]: The minimum silo outlet size for reliable gravity discharge in massflow, calculated using the arching equation in Fig 2b. The stress value is the intercept of the flow function with an ff =1.4 line. This is the default flow factor settings but can be adjusted by the user within a 1.0 to 1.8 range for silo design applications. ◗ Estimated Critical 'Rathole' diameter in [m]: The minimum outlet diameter to prevent the formation of a stable 'rat-hole' in a core-flow vessel. The outlet diameter is calculated using the rat-holing equation in Fig 2a. The stress value is the intercept of the flow function with an ff=2.5 line and can be user-set to any stress level. ◗ Flow index: The gradient of a line from the origin to the last point on the flow function, typically in the range of 0.1 to 1.0. This index will give a comparison of materials behaviour at intermediate compaction stresses greater than one meter depth of powder. ◗ Flow intercept: The inter-

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Fig 5: The Powder Flow Function

Table 1 Stand and classification of powder flowabilty Non flowing

ff<1

Very cohesive

1<ff<4

Cohesive

2<ff<4

Easy flowing

4<ff<10

Free Flowing

10<ff

0 — wall frication angle = 0 deg

DEPTH OF VESSEL IN DIAMETERS Z

stresses and the flow function is constructed by plotting the unconfined failure strength versus the consolidation stress as shown in Fig 5. The greater the flow factor (ff ) value, the more free-flowing the powder (Table 1).

— wall frication angle = 20deg

0.5

— wall frication angle = 40deg 1

1.5

Hydrostatic pressure increase (pgh)

2.5

3.5

4 Major principal consolidation Stress a, Fig 6: Stress distributions in vertical walled vessels

cept of the best fit linear failure function with the unconfined failure strength axis giving a number in kPa. This gives a number that reflects powder flowability at compaction stresses typically less than 0.15m depth of powder. Note that a time consoli-

dated flow function test allows the user to investigate whether the material gains strength during long-term storage.

Wall friction test The friction acting at the wall/powder interface has a

significant influence on the stress distribution within processing vessels, silos and hoppers. The higher the wall friction, the more the powder weight is transferred down through the silo/ vessel/ container walls, rather than com-

EXPRESS PHARMA

February 16-28, 2015

PHARMA TECHNOLOGY REVIEW

42 EXPRESS PHARMA February 16-28, 2015

compacted to high stress.

POWDER SLIP

Summary

Øw Fig 7: Wall friction

Shear Stress

Wall Friction Locus (WFL)

Ø C Normal Stress o2 Fig. 8a: Wall friction locus

Wall Friction Angle Ø

Maximum Wall Friction Angle

Normal Stress o2 Fig. 8b: Wall friction function

Incompressible material

Compressible material

Bulk density q

pacting the bulk solid below. The lower the friction, the more the powder self-weight is transmitted through the bulk solid. This 'Jassen effect' is illustrated in Fig 6, which demonstrates how the vertical pressures in the vertical section of a silo would vary if the wall friction were increased from zero to a large value of 400. The presence of the wall friction has a negative feedback effect on the pressure increase with depth, so generally the stresses approach constant values at a depth of approximately four vessel diameters. Software can be used to estimate pressures in a container based on measurements of the bulk density ρ, wall frictionφw, internal friction δj and container diameter D. The principal consolidation pressure σ1 at depth Z is given by the equation: The wall friction angle Øw represents the angle to which a wall surface must be inclined as shown in Fig 7 to cause powder to slip. The wall friction angle is typically in the range of 10 to 45 degrees. The wall friction angle is also called the chute angle. While the results of the wall friction test can be displayed graphically in the form of a wall failure locus as shown in Fig 8a (representing the limiting shear stress the powder can support at a wall), or the form of a wall friction angle function as shown in Fig 8b (representing how the wall friction angle changes with reducing stress), one of the following four flow indices derived from the maximum wall friction locus are usually adequate. These wall failure properties are: θcθp The maximum massflow hopper half angle (measured to the vertical) for conical or planar hoppers. φw The maximum wall friction angle to determine the minimum chute angle for gravity flow (see Fig 8b). Grad The maximum wall friction angle displayed as a coefficient. cw The wall cohesion shear stress in kPa that can be supported at the wall under zero normal stress (see

Major principal consolidation stress O2 Fig. 9: Bulk density curve

Fig 8a). This determines the 'stickiness', i.e. whether powder is likely to stick to the wall surface under close to zero stress. i.e. will powder build up on the walls of the chutes around discharge/transfer points. An extended wall friction test allows the wall sample to be subject to large shear displacements (on the order of

30 metres) to establish whether long term powder build up on the wall would be expected.

Bulk density test It is the self-weight of the powder, its bulk density, that controls the stresses acting on the powder when flowing or when static in processing lines/ silos etc. The bulk den-

sity is measured during the course of the flow function test (and is required to calculate the critical outlet dimensions) and the wall friction test, but it can also be measured in a separate single test for bulk density alone. The bulk density is commonly displayed as a bulk density curve (Fig 9). Generally a free flowing material will be incompressible- so will show only a small increase in density with stress. A very cohesive, poorly flowing bulk solid by comparison will show a large increase in bulk density with increasing stress. ρfill The fill bulk density to be expected when the powder is poured into a container ρcomp The compacted bulk density will give an indication of the bulk density to expect if the material is poured and

The Brookfield Powder Flow Tester offers four standard tests 1. Flow function test Measures internal strength, flow function, internal friction function and bulk density function- used for characterising the flow strength and arching/ rat-holing potential of powders. 2. Time consolidated flow function test - Same as above but following static storage for a user defined time period. 3. Wall friction test - Measures friction between the powder and a given wall surface and the bulk density function used for assessing mass-flow hopper half angles and gravity flow chute angles. 4. Bulk density test - Measures bulk density curve of the powder. Note that to undertake a full silo design requires the user to run and combine the results of tests 1, 2 and 3.

PHARMA ALLY INSIGHT

Embracing smart warehousing S A Mohan, Chief Executive Officer, Maini Materials Movement elaborates on the growing concept of smart warehousing in pharma industry INDIAN ECONOMY continues to grow multi-fold and so does the challenges that it beholds. As compared to the situation in the last decade, this industry has come a long way in improving the intralogistic practices and we witnessed the same in 2014. This reflects in the phenomena of embracing the concept of smart warehousing through implementation of automation, verticalisation and lean design supported by the MHE industry. The present market size of MHE industry in India is growing annually at 10 per cent. Of course some aspects will remain in the forthcoming years as they are today; volatility in supply and demand will continue to bring in the element of risk management, the urge to deliver â&#x20AC;&#x153;more with lessâ&#x20AC;? will continue to drive the focus of the players in the growing field of intralogistics, skill gaps and business pressure forcing adoption of methods to increase efficiency and balance customisation with consolidation. The question remains, are we prepared for the future?

Emerging trends The volatile market environment, the ever-stronger online market, the shift in markets towards Asia, and the growing demand for special transport services necessitate new strategies and considerable investments on the part of logistics providers. The Indian warehousing industry is set to grow at a CAGR of eight to ten per cent with the industrial/ retail warehousing accounting for 55 per cent of market share. More international logistics companies are taking over specialised service providers in individual markets to tap into these logistics niches. This

strategy will pay off when it comes to tapping new markets and logistics segments. Another trend shaping the logistics industry is the rapid growth of e-commerce. The increasing size of the e-commerce marketplace is leading to greater push towards real-time package tracking while the need to optimise operations indicate inclusion of technology for supply chain analytics. Some of the key end users like Amazon and Google publically claimed that the future need would be ways to make material handling more automated, whether that means robotic order-picking systems or high-speed, economical automation for loading and unloading trucks. The entry of international

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The Indian warehousing industry is set to grow at a CAGR of eight to ten per cent players into the Indian market has also widened the scope of warehousing and intralogistics. The anticipatory introduction of the Goods and Service Tax (GST) and abolition of all indirect taxes as a fiscal reform by the Indian government will

hopefully open channels for consolidation of small warehouses, thereby, revamping the national warehousing network. Also, the 3D printing technology will be a must-have for a smart warehouse while lowcost sensor devices will be indispensable. Adoption of Omni-channels, transforming smaller cities to mega demand centres and the need for late customisation will increase the strategic roles and responsibilities of warehousing and material handling solutions. In order to meet the expectations of the end users and create a value proposition, infusion of advanced technology is essential.

Solutions approach Aligning with the pace of the

S A MOHAN,, Chief Excutive Officer, Maini Materials Movement

industry, Maini has launched several new products this year, starting from eight tonne industrial tugger, Wheel chair buggy, Yale Maini Reach Truck and the recent launch of Yale Maini diesel forklift truck. Armes Maini, a leading brand in industrial storage systems, also forayed into offering the next level of automatic storage solutions with the launch of Vertimag and would be introducing futuristic warehousing solutions in form of Flexy â&#x20AC;&#x201C; satellite for storage, heavy duty mobile racking systems and more for the Indian market. We believe understanding what to expect in the industry and staying relevant will help us meet the challenging requirements of our clients and the industry at large.

EXPRESS PHARMA

February 16-28, 2015

PHARMA ALLY VENDOR NEWS

AIGMF reiterates stand on unhindered supply of glass bottles to pharma cos Approaches the Ministry of Health and Family Welfare about its capabilities and capacity to supply glass bottles to the pharmaceutical industry ALL INDIA Glass Manufacturers’ Federation (AIGMF) has reiterated its stand of the glass industry's capabilities and capacity for unhindered supplies of glass bottles to pharmaceutical companies. AIGMF has recently approached the Ministry of Health and Family Welfare about its capabilities and capacity to supply glass bottles to the pharma industry once the final notification of prohibition is issued. According to a AIGMF release, in the light of the proposed ban on use of PET (Polyethylene Terephthalate) for

AIGMF officials aver that the impact of cost of packaging on the MRP would not so significant that the switchover from PET to glass should be of any issue to any manufacturer packaging medicines, an ill-informed campaign was started on the characteristic of glass bottles and on its suitability for primary packaging of pharma products. AIGMF opines that the misconception created about price

increase of drugs due to prohibition of PET packaging shows total disregard for human health especially of women and children. The release notes that the pharma industry currently uses glass bottles to fill its 40-50 per cent requirement and the

conversion from glass to PET /plastic packaging started only eight to 10 years back for sake of convenience, purely commercial benefits and due to lack of awareness. AIGMF officials aver that the impact of cost of packaging

on the MRP would not so significant that the switchover from PET to glass should be of any issue to any manufacturer, especially considering the huge health advantage women and children would enjoy in the long run due to this switchover. The glass industry, which believes in the concept of 'Make in India' has invested more than ` 5000 crores in the last five years to create capacities. This will enable the glass industry to cater to the additional demand from the pharma industry. EP News Bureau-Mumbai

EKF Molecular Diagnostics collaborates with ANGLE Combined technologies may identify all mutations in gene sequences associated with clinical utility of targeted cancer therapies EKF MOLECULAR Diagnostics has agreed a collaboration with specialist medtech company ANGLE, to investigate the combination of ANGLE’s Parsortix circulating tumour cell (CTC) harvesting platform with EKF Molecular’s PointMan DNA enrichment technology as a liquid biopsy. If successful, the resulting simple blood test could enable the investigation of unexpected ultra-low level mutations in a patient’s cancer for personalised cancer care. The collaboration will initially work on colorectal cancer and then expand to cover other cancer types. CTCs will be harvested from cancer patients’ blood using ANGLE’s Parsortix system and then analysed using PointMan DNA enrichment technology to identify genetic variation in the cancer.

44 EXPRESS PHARMA February 16-28, 2015

Both EKF Molecular Diagnostics and ANGLE believe that the combination of the Parsortix system with PointMan technology may be advantageous for two reasons. Firstly, the PointMan system preferentially amplifies variant sequences of interest whilst suppressing amplification of the wild type i.e. normal DNA. As a result, it has the potential to identify all mutations in gene sequences associated with clinical utility of targeted cancer therapies. In contrast, competing genetic analysis systems generally amplify only those areas which may be predicted to be mutant and therefore may miss unexpected mutations. Secondly, PointMan is highly sensitive with the ability to work with very low levels of target material, potentially as low

as one CTC. The high purity of the Parsortix harvest (low white blood cell contamination) and its epitope independence may enable the combined system to be widely deployed across different cancer types and stages of disease. Cancer patient blood samples will in the first instance be processed under ANGLE’s existing research collaboration with the University of Surrey and the Royal Surrey County Hospital (Guildford, UK). The University of Surrey Oncology Department has already processed 20 colorectal cancer patient samples with the Parsortix system and stored the harvested cells for analysis. This bank of samples is ready for analysis and should enable the collaboration to make rapid progress towards initial proof-

of-principle. If the collaboration is successful, EKF Molecular Diagnostics and ANGLE will explore ways to offer their respective systems as a combined solution addressing first the pharma drug trial and research use market and then, as patient data are developed, the clinical market. ANGLE’s patented Parsortix system can harvest rare CTCs in cancer patient blood – even when there is less than one CTC in one billion healthy cells. The resulting liquid biopsy (simple blood test), using technology such as PointMan, enables the investigation of mutations in the patient’s cancer for personalised cancer care. Andy Webb, Chief Executive Officer, EKF Molecular Diagnostics commented, “Our

PointMan DNA enrichment technology has demonstrable performance in the detection of ultra-low level mutations. The high purity of the CTCs harvested by ANGLE’s Parsortix system and the absence of immunomagnetic beads gives us confidence that it will be effective with the Parsortix harvested CTCs providing rapid molecular information to the oncologist.” ANGLE’s Founder and Chief Executive, Andrew Newland commented, “We are delighted to announce this collaboration with EKF. The combination of ANGLE’s Parsortix system with EKF’s PointMan system has the potential to provide a complete solution for the oncologist. We look forward to an early proof-of-principle.” EP News Bureau-Mumbai

PHARMA ALLY

Waters transforms Glycan analysis with New UPLC and UPLC-MS analytical workflows New RapiFluor-MS labelling reagent and sample preparation protocol greatly enhances speed, sensitivity, simplicity of released N-Glycan profiling and characterisation WATERS CORPORATION announced new technology for characterising glycoproteins. The technology introduction at WCBP 2015, includes the new GlycoWorks RapiFluor-MS NGlycan Kit, the Waters ACQUITY UPLC, the ACQUITY UPLC FLR Detector and the ACQUITY QDa detector, and enables scientists to analyse released N-glycans and achieve new levels of speed, sensitivity, simplicity while obtaining previously unattainable structural information. New RapiFluor-MS labelling reagent and sample preparation protocol greatly

This new set of technologies enables fast de-glycosylation and labelling, and a workflow that reduces sample preparation time from a day to less than one hour enhances speed, sensitivity, simplicity of released N-Glycan profiling and characterisation. This new set of technolo-

gies enables fast de-glycosylation and labelling, and a workflow that reduces sample preparation time from a day to less than one hour; allows

mass detection for characterization and development with sensitivity that is 100 to 1,000fold better than current approaches; and enables routine laboratory use supported by a simple robust protocol without involving MS experts. “Today’s introduction is a ground-breaking approach to glycan analyses. It means scientists can monitor and characterise released N-glycans like never before,” said Mike Yelle, Vice President, Consumable Business Unit, Waters Division. “The new workflows take what had been a specialised and complicated activ-

ity and transform it into one which scientists and laboratories can be successful with.” Most biotherapeutic proteins are glycoproteins and the heterogeneous glycan populations on these proteins are critical quality attributes that affect potency, stability, and therapeutic safety profiles. New drug submissions to regulatory agencies must contain detailed structural information pertaining to the attached glycans and proof the glycoprotein can be manufactured with a consistent glycan profile. EP News Bureau-Mumbai

TJU, Institute Pasteur, and Thermo Fisher Scientific establish training programme The programme is to prevent Ebola virus in Ivory Coast THOMAS JEFFERSON University (TJU), the Institute Pasteur, the Organisation of International Visitors of the US (OIV-US) and Thermo Fisher Scientific announced they have formed a collaborative training programme designed to preemptively combat the potential threat of an Ebola virus epidemic in Ivory coast. The partnership includes training of a visiting scientist who will learn to screen samples for the deadly pathogen using advanced qPCR instruments before returning to West Africa to train others in the field. The four-week training programme will take place in the lab of Matthias Schnell, PhD, professor, microbiology and immunology at TJU, whose research team is developing an Ebola virus vaccine that is ex-

pected to move into clinical trials in mid-2015. The collaboration also provides StepOnePlus Real-Time PCR (polymerase chain reaction) molecular screening instruments at TJU and in West Africa, where a training centre will be established in Abidjan, Ivory Coast. While initial training focuses on Ebola screening, there is potential to expand the programme to include other pathogens relevant to the region, including Malaria and Lassa and Dengue fever. “The Ebola outbreak and loss of life associated with it has affected many families, devastated the social structure and seriously compromised the regional economy and education system,” said Mohamed Cisse, President of OIV-US. “OIV-US is very proud to facilitate this proj-

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ect between Thomas Jefferson University and Thermo Fisher Scientific. The government of Cote d’Ivoire also welcomes this programme and is willing to lead its expansion to the neighbouring West African countries.” To date, the Ebola epidemic has led to more than 8,370 deaths across four West African countries since March 2014. Screening patient samples to identify, quarantine and treat those who test positive for the virus has been critical to slow its spread in Africa and elsewhere around the world. Fourteen cases have been identified outside of Western Africa as a result of these efforts. “My training has significant effect as it will improve our molecular testing quality and the implementation of new methods for surveillance and research,”

said Solange Ngazoa Kakou, Head of Molecular Biology Platform, Pasteur Institute in Abidjan. “The collaboration with TJU scientists will help our training of medical scientist in West Africa and efforts in haemorrhagic virus control." “It is important to provide the countries of West Africa with the proper resources and training to help them combat this outbreak,” said Schnell. “With the generous support of R&D leaders Junko Stevens, and Jonathan Wang, from Thermo Fisher, we have been able to move quickly to get the appropriate state-of-the-art equipment for the training centre.” It’s applied Biosystems qPCR instruments are widely used in public health laboratories around the world for clinical

research applications. Most recently, they have been used in labs to screen for the Ebola virus worldwide. They also proved critical to help identify the pathogens and screen samples during the H1N1 and MERS outbreaks in 2009 and 2012, respectively. “Preventative steps like those being taken through this collaborative training programme are critical to eventually put an end to this epidemic,” said Dan Didier, Head of Public Health, Thermo Fisher Scientific. “As we’ve seen with past outbreaks, this flexible molecular technology can play a key role in identifying and screening samples for many other pathogens affecting human health in the West African region.” EP News Bureau-Mumbai

EXPRESS PHARMA

February 16-28, 2015

PHARMA ALLY PRODUCT

Yale – Maini 1.5 ton 3 wheel electric forklift truck: High on performance and ergonomics,with lowest TCO ◗ Transistor control for precise load positioning ◗ Foot Directional Control (FDC) as an optional feature

RCF – the 3 wheel electric forklift truck from Yale-Maini scores high on operator comfort on account of its virtually effortless operations. This truck is designed for better operator comfort with the premise that a comfortable operator is a productive operator. This 3-wheel, rear wheel drive, electric forklift truck offers a cost-effective solution for medium duty application requirements. A compact and highly manoeuvrable truck, RCF is ideal for use in confined areas, indoor and outdoor applications and container stuffing applications. The RCF delivers high performance and productivity at low operating costs.

Lowest total cost of ownership Yale-Maini RCF is designed to cost you less, today and tomorrow. The RCFseries doesn’t just cost less to purchase, it costs less to run too. Every model of Yale-Maini RCF truck boasts energy-saving rear wheel drive while many new features have been added to maximise uptime and increase operating life.

Each RCF forklift truck from Yale-Maini boasts of: ◗ Energy efficient SEM motors and controller ◗ Transistor controlled hydraulics that contribute to increased battery life and help reduce component wear ◗ Auto regenerative braking, that increases battery, brake and brush life

Key features ◗ 24 volt system, super cushion tyres ◗ Energy efficient SEM traction motors and MOSFET controller ◗ Auto regenerative braking increases battery, brake and brush life ◗ Transistor hydraulics increase battery life and reduce component wear ◗ Service accessibility and diagnostic fault code facility reduce downtime ◗ Variable wheelbase increases longitudinal stability and reduces stacking aisle dimensions

Ergonomic excellence

46 EXPRESS PHARMA February 16-28, 2015

Yale – Maini RCF truck is designed with the premise of creating better operating experi-

ence. The truck boasts of: ◗ Exceptionally low noise level ◗ Spacious and comfortable op-

erator compartment ◗ "Light" steering, that reduces operator fatigue

◗ Service accessibility and diagnostic fault code facility, that reduce downtime

PHARMA ALLY

Compact Cooling Centrifuges by REMI REMI IS the industry leader in manufacturing laboratory/ magnetic stirrers and centrifuges, and blood bank refrigerators / freezers catering to over 50 per cent of the total Indian demand. Over the period the company has grown multifold having 16 company-owned sales and services offices all across the country, with a view to offer best in class products and services Driven by a strong motivation to excel, REMI meets stringent quality requirements, which help us, reduce risk and enhance competitive advantage, thus helping our customers march on the path to progress and us to global recognition REMI Compact Cooling Centrifuge or compact bench top Cooling Centrifuge (CM – 8 Plus) is silent while in operation with a very small footprint. The Centrifuge model CM-8 plus is suitable for

◗ Routine sample analysis in Medical ◗ Hospital ◗ Pathology ◗ Institutional laboratories REMI Centrifuge CM – 8 Plus (Compact Cooling Centrifuge) features ◗ Stable speed output: 6000 RPM ◗ High capacity: 4 X 100 ml ◗ Wide variety of rotors and reduction adaptors: Angled and Swing head ◗ Precise temperature control up to: - 8°C ◗ Pre-cooling and fast spin ◗ Calibration window on lid for speed (rpm) ◗ Brushless induction motor with variable frequency drive ensures gentle start ◗ Microprocessor based unit with alpha numeric LCD display, feather touch keys and 24 program memory ◗ Parameters setting through easy to use bi-directional encoder

99 minutes and continuous run Last set parameters recall (Useful for repetitive analysis) Automatic door opening due to gas hinge also prevents falling of door and safety lid interlock to prevent lid opening during centrifugation. Emergency lid lock release to open the lid during shut down of centrifuge Log of cumulative centrifuge run time Automatic rotor identification, imbalance detection and centrifugation stops with display of error. Also motor overload protection

◗ Self-diagnosis of errors like inverter fault detection with auto shutdown ◗ CFC free refrigeration system

3 accelerations, 4 deceleration profiles Choice of RPM / RCF setting and display Digital countdown timer 0-

Contact: Remi Elektrotechnik, Remi House, 11, Cama Industrial Estate, Walbhat Road, Goregaon (East). Mumbai 400063 Tel: 022-40589887 Email: mktg@remilabworld.com Website: www.remilabworld.com facebook.com/remilabs @remilabworld

Remi to introduce new range of products LAUNCH OF CO2 Incubator, Dry Bath, Visi Coolers, Ice Flaker, Micro Centrifuges and host of next generation products for laboratory, research and pharmaceutical industry. REMI has launched new range of products and instruments. The new range of products includes CO2 Incubator, Ice Flaker, Dry Bath, Laboratory Refrigerators, Deep Freezers, Magnetic Stirrers (motorless), Micro and Mini Centrifuges.

Below is a small brief about the new products: CO2 Incubator – Ideal instrument for immunology, genetics and bio-engineering. It is widely applicable for research and production of micro-organisms, agricultural science

and pharmacology. REMI CO2 Incubators will be available in three models having difference in volume and power consumption. Ice Flaker – REMI Ice Flaker comes with high quality, energy efficient, durable, reliable performance suitable for controlling of pharma and chemical processes, also can be used for laboratory applications. These machines will be available in two models 40KG/24Hrs and 80KG/24Hrs. Dry Bath – REMI Dry Bath widely used for preservation and reaction of the samples, amplification of DNA, pre – denaturation of electrophoresis and blood serum coagulation. These Dry Baths have LED display with replaceable metal blocks for replacement and

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cleaning. Deep Freezer – Deep freezers are designed for quick freezing and storing of blood components, serum, vaccines, biological and medical specimens, clinical samples, etc at low temperatures. REMI series of Chest Freezers and Upright Freezers are available in five models, gives temperature range of - 25°C instead of conventional - 20°C. Laboratory Refrigerators – The new range of laboratory refrigerators from REMI are designed for storage applications in pharma, microbiology, biotechnology, chemical, clinical diagnostic, hospitals and research institutions. The unit is supplied with glass door for convenient sample viewing. Forced air circulation system

ensures uniform temperature throughout the chambers. REMI series of laboratory refrigerators are available in five models based on capacity from 200 ltr to 1100 ltr. Micro Centrifuges – These powerful and easy – to – use REMI Micro Centrifuges are small enough so that each workstation can be equipped with personal centrifuge. These centrifuges have digital display with brushless motor. These units are supplied with PCR and micro tube rotors. Magnetic Stirrer – This ultra – flat compact magnetic stirrerwith capacity to stir 800 ml at maximumspeed of 1500 RPM, comes with modern magnetic coil technology. The stirrer is wear – free with no moving parts, to ensure better

mixing and maintenance free. The lab disc can forward – reversein direction of rotation automatically every 30 seconds. Speaking on the occasion, Sunil Saraf, “We launch products and add features to existing products based on customer feedback. With this launch, REMI plans to leverage its presence in existing customer base by offering these new products that will also enhance REMI’s product portfolio.” Contact: Moses Gomes, Manager – Digital Marketing, RemiElektrotechnik Ltd Mobile - +91 9833961636 Email: mktg@remilabworld.com

EXPRESS PHARMA

February 16-28, 2015

PHARMA ALLY PRODUCT INSIGHT

TOC Analysis Basic & UVPersulfate / NDIR Methodology ANALYSIS OF TOC are basically work with two steps i.e oxidation of organic to form CO2 and detection-to measure the CO2, All laboratory TOC analysers offered today use either the HTC method or heated/UV per sulfate oxidation. Both techniques either remove or measure the inorganic carbon (IC), defined asdissolved carbon dioxide, carbonate, and bicarbonate. One common technique measures non-purgeable organic carbon (NPOC), by introducing the sample and a small amount of inorganic acid to an inorganic carbon removal chamber. Through the acidification of the sample, the IC is converted to carbonic acid (H2CO3), also known as dissolved carbon dioxide (CO2). The sample is usually sparged (gas-stripped) with carrier gas to drive off any converted dissolved CO2. Loss of purgeable organic carbon (POC), in the form of volatile organic substances, can also occur during the sparging of the sample. Typically for many surface/drinking waters, the amount of POC is negligible and can be discounted. Thus in these cases, NPOC is the equivalent of TOC. Measurement of POC: The volatile organic molecules must be separated from the IC by passing the sample through a Scrubber (typically contain Soda lime) after the sample is acidified and the IC converted to CO2, the CO2 is absorbed by the scrubber. Subsequently, the POC continues to carry through the scrubber to an oxidation chamber. The POC is then oxidised to carbon dioxide and quantitated. For NPOC analysis, an oxidation step, following the removal of

48 EXPRESS PHARMA February 16-28, 2015

The NDIR will detect all CO2 passing through itâ&#x20AC;&#x201D; some of this CO2 may have originated from background carbon in the reagent. The QbD1200 will automatically recommend that the user take a background measurement at the beginning of a run if there has not been a background measurement taken recently IC, converts the remaining non-volatile organic carbon in the solution to carbon dioxide.

A detector measures the amount of carbon dioxide and applies that result to a calibra-

tion curve to attain the TOC value. The biggest challenge of

any offline TOC analyser is the interference it could be by any means 1.Sampling error 2.Sample retention error 3.Background error By adopting a good Sampling method will eleminate the error from sampling and also with adequate sampling rate will solve adress the sample retention erroe. Now left out error is back ground. Bag ground means any acessories/consumables that we use in the analysis will reflect in back ground error. The sources can be 1.Catalyst (poisoned) 2.Gas 3.Reagent (Acid and oxidisers) The contamination from the gas if it is being used for both oxidation and carrier will contribute more errors then the gas used only for the carrier but these errors can nullified by taking precausion of leaks, a background tests. Reagents used for the oxidation which get mix with the sample water also have the major impact. To eleminate you can use a prepared reagent (have very less self life) which make your running cost very high as these reagents are expensive and have small self life. The second option is to prepare the reagents in house and run a back ground test to estimate the TCO content of the solution. QbD1200 from Anatel Hach implemented the option of checking back ground and taring it so that the running cost of a LAB TOC analyser come down drastically. When measuring a water sample to quantify TOC, most TOC Analyzers add some

PHARMA ALLY combination of reagents and dilution water to the initial sample in order to complete the measurement. These added reagents and dilution water are a potential source of TOC that need to be accounted for (subtracted) from the final measurement result to obtain an accurate TOC value for the sample. The QbD1200 combines acid, oxidiser, and dilution water into a single reagent which makes this blank or background TOC subtraction simple and ensures a good TOC measurement of the sample. The QbD1200 automatically performs these calculations. The measurement strategy must account for TOC from two sources: 1. The sample: contains an unknown concentration of TOC 2. The reagent: contains a small amount of background TOC that is known after a background measurement is taken. The NDIR will detect all CO2 passing through it—some of this CO2 may have originated from background carbon in the reagent. The QbD1200 will automatically recommend that the user take a background measurement at the beginning of a run if there has not been a background measurement taken recently.

of unknown samples.

Overall measurement technique of TOC in QbD1200. : A water sample initially contains two types of carbon: ◗ Total Inorganic Carbon (TIC) (from CO2 gas dissolved in H2O and dissolved carbonates in the water) ◗ Total Organic Carbon (TOC) (from organic species) To measure TOC, first remove TIC. Then convert organic species into CO2 gas, measure the gas on detector, and convert the result into a TOC value.

The measurement strategy:

To understand this concept better, consider a measuring a sample which has 100ppb TOC: ◗ The first step the QbD1200 will perform is an autorange measurement which determines the ratio of sample to reagent that should be used during measurement. ◗ For a 100 ppb sample, this would result in combining 8 mL of sample with 2 mL of reagent. ◗ The NDIR detector will count all CO2 passing through it. This total count contains Carbon that originated from both the sample and the reagent. The small concentration of carbon present in the 2 mL of reagent is subtracted and called “background”. ◗ When the background is known, the calculations can

easily adjust based on how many mL of reagent are mixed with the sample.

Background TOC notes: ◗ QbD1200 automatically prompts user to initiate background measurement at the beginning of a run if there has not been a recent background measurement taken. ◗ All calculations are automatic and handled by the QbD1200.

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◗ One reagent is prepared by mixing one part stock solution with 100 parts pure water. The background measurement is taken on this reagent mixture. ◗ USP <643> specifies that all reagent water should be < 100ppb TOC. The QbD1200 background measurement automatically checks this. ◗ Careful consideration of background TOC ensures an accurate TOC measurement

Steps: ◗ Remove TIC. In presence of acid H3PO4, all dissolved carbonates are converted into CO2 gas. Blow carrier gas through reaction chamber to remove all CO2 gas derived from inorganic carbon. ◗ Convert TOC into CO2 gas. In presence of UV light and powerful oxidiser (NH4) 2S2O8, organic carbon species are converted into CO2 gas by oxidation. Blow carrier gas through reaction chamber to push all CO2 gas through NDIR detector (step 3). Detect CO2 gas as it goes through NDIR detector. TOC is quantified by integrating the area under the curve. ◗ Based on instrument calibration, convert CO2 gas signal (area under the curve) into TOC. Note that the area under the curve for TOC can also be referred to as ‘NPOC’ (NonPurge able Organic Carbon).

If the initial water sample contained a volatile organic, the volatile organic would likely be purged during the step to remove TIC. Thus, what remains after TIC removal is non-purge able organic carbon. Because the QbD1200 is designed for clean water applications where high concentrations of volatiles are not present, this should not be a concern.

UV / persulfate / NDIR method The general TOC analysis method described here has been widely used for many years in a variety of applications and conforms with numerous regulatory guidelines such as USP, EP, JP, and is also an approved method (5310c) under the US EPA guidelines. The QbD1200 is unique in that it combines all required reagents (acid, oxidizer, and dilution water) into a single reagent instead of requiring multiple reagents. Pharmacopeia requirement for a TOC analyser is simple, it has to pass the System suitability Test (SST) which has been mentioned in USP CHAPTER <643>. RE should be between 85-115 per cent. It is the user who should see the feasibility of owning the system with a perfect combination of oxidation and detection principle. For any clarifications please feel free to contact Ramesh Sahu, Product Manager rsahu@skytechindia.com

EXPRESS PHARMA

February 16-28, 2015

RESEARCH RESEARCH UPDATES

Roche study shows Gazyva offers strong benefits as lymphoma drug Roche is hoping to switch as many patients as possible to the newer product SWISS DRUGMAKER Roche said a late-stage study involving non-Hodgkin's lymphoma patients showed they lived longer without the disease worsening when treated with its Gazyva drug, giving a boost to its lineup of cancer treatments. Gazyva - marketed as Gazyvaro in the European Union and Switzerland is being positioned as an alternative follow-on medicine to Roche's Rituxan, or MabThera, which generated 6.9 billion Swiss francs ($7.46 billion) in sales last year. Roche is hoping to switch as many patients as possible to the newer product before Rituxan faces competition from cheaper copies when its patent protection expires. The study showed

that patients with relapsed slow-growing, or indolent nonHodgkin's lymphoma lived significantly longer without their disease worsening when

treated with Gazyva and bendamustine followed by Gazyva alone, the company said in a statement. "It suggests Gazyva works in

a Rituxan refractory (relapsed) population that offers sales potential in the $500 million to $1 billion range," analysts at Deutsche Bank, which has a "buy" rating on the stock, wrote in a note. Data from the study will be submitted to the US Food and Drug Administration, European Medicines Agency and other health authorities for consideration for approval, the company said. The performance of Gazyva against Rituxan in two ongoing head-to-head late-stage trials will be another important indicator, analysts said. The trials involve patients with large Bcell lymphoma and indolent non-Hodgkin's lymphoma. Reuters

US FDA approves Pfizer's high profile breast cancer drug Wall Street has considered the drug to be one of the most promising medicines in Pfizer's development pipeline THE US Food and Drug Administration approved Pfizer's Ibrance, a potential new standard of care for advanced breast cancer, in a regulatory decision that came more than two months earlier than expected. Wall Street has considered the drug, whose chemical name is palbociclib, to be one of the most promising medicines in Pfizer's development pipeline. It was approved for previously untreated postmenopausal women whose cancer cells have receptors to the female hormone estrogen and who do not have mu-

50 EXPRESS PHARMA February 16-28, 2015

tations in the HER2 gene that can contribute to uncontrolled growth of breast cells. Such patients represent the largest proportion of breast cancer cases and are typically treated with the chemotherapy tamoxifen or letrozole, a drug used to prevent production of estrogen. Cowen and Co analyst Steve Scala has estimated Ibrance could generate annual sales of $3 billion by 2020. It works through a new mechanism of action, by blocking two enzymes involved in cell division, CDK4 and CDK6. In

one clinical trial, the average patient taking Ibrance in combination with the standard treatment letrozole went 20.2 months without a worsening of symptoms - twice the length of time of those taking letrozole alone. "This approval represents the first treatment advance for this group of women in more than 10 years," said Mace Rothenberg, the head of oncology for Pfizer. UCLA which helped test the drug for Pfizer, in a statement, said Ibrance produced "groundbreaking results" in studies conducted at the university and has

potential to become a mainstay treatment. Ibrance will give a big boost to Pfizer as it attempts to bolster its medicine cabinet with new cancer drugs, including ones that work by harnessing the immune system to recognize and kill tumor cells. The largest US drugmaker badly needs big-selling new drugs to boost its earnings, following patent expirations on many of its biggest brands and a relatively thin supply of promising drugs in late-stage trials. Reuters

BlueBird's rare blood disorder drug gets breakthrough therapy status BlueBird's drug, LentiGlobin, aims to treat betathalassemia THE US Food and Drug Administration has designated BlueBird Bio's blood disorder drug a breakthrough therapy, speeding up the treatment's development process. The company's shares rose nearly 7 per cent in premarket trading. Breakthrough therapy designation is based on initial trial data and granted to drugs with the potential to treat serious diseases better than existing therapies. BlueBird's drug, LentiGlobin, aims to treat betathalassemia â&#x20AC;&#x201D; a disease that results in lower levels of hemoglobin in the blood. The disease is caused by mutations in the human beta-globin gene. Low levels of hemoglobin cause thalassemia patients to suffer from weakness, fatigue and other serious complications. The therapy involves the insertion of a functional human beta-globin gene into the patient's stem cells, which are then retransplanted into the patient. The treatment is currently in early-stage trials. Reuters

Isis Pharma's diabetes drug takes longer than expected to work The treatment is aimed at allowing patients to effectively use insulin ISIS PHARMACEUTICALS' experimental diabetes drug took a longer-than-expected 36 weeks to show a statistically significant reduction in blood sugar levels in patients with type 2 diabetes. The mid-stage study had aimed to prove that a 200 mg dose of the drug taken over 26 weeks would work better than a placebo on 92 patients suffering from uncontrolled blood sugar, despite treatment. Deutsche Bank's Alethia Young said the data looked less robust than some commonly prescribed treatments and Isis's own experimental glucagon receptor, ISIS-GCGR. Isis noticed

that blood sugar levels kept falling even after dosing was stopped after 26 weeks, and expects the drug to lower sugar

levels further over a longer duration, analysts said. The trial's other main goal assesses the "incidence, sever-

ity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety" at the end of 38 weeks. Type 2 diabetes is a chronic condition which occurs when the body does not use insulin properly. It afflicts up to 95 per cent of the roughly 29 million diabetics in the US. Isis's drug inhibits the protein tyrosine phosphatase-1B, or PTP-1B, which acts as a negative regulator of insulin. The treatment is aimed at allowing patients to effectively use insulin and treating those beginning to fail oral therapies, extending the time they have before becoming reliant on insulin.

Sanofi launches inhaled insulin for diabetics Inhalation promises to be faster acting and much more convenient than SANOFI LAUNCHED an inhalable insulin in the US in a potential boost for its flagging diabetes drug sales and for patient quality of life. Developed by Mannkind Corp, Afrezza will be the only inhalable insulin on the US market, where Sanofi competes with Eli Lilly and Novo Nordisk for sales of traditional injectable insulin. Inhalation promises to be faster acting and much more convenient than injections, but an inhaled product has failed in the past and there are concerns about the potential risks associated with breathing powdered insulin. Afrezza, which uses a whistle-sized inhaler and works to control blood-sugar levels in both type 1 and type 2 diabetes, was developed in the shadow of Pfizer's rival Exubera and approved by the US Food & Drug Administration in June. Exubera was ap-

Afrezza, which uses a whistlesized inhaler and works to control blood-sugar levels in both type 1 and type 2 diabetes, was developed in the shadow of Pfizer's rival Exubera proved in 2006 with expectations of $2 billion a year in sales but the inhaler was bulky, and patients were put off by the need for periodic lung function tests. Eventually it was withdrawn. In the Afrezza marketing deal struck last year, Mannkind won an upfront payment of $150 million, potential further milestone payments of up to $775 million and 35 per cent of future profits. Priced at $7.54 for a daily dose of 12

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units, Afrezza will be pricier than $3.14 Apidra, which is the injectable equivalent in Sanofi's drugs stable. Afrezza should not be used in patients with asthma, or those suffering from certain complications, however. It is also not recommended for smokers or recent exsmokers. Industry analysts have said they expect Afrezza to generate modest sales of about $182 million a year by 2019 according to Thomson

Reuters Cortellis, given Exubera's problems and the restrictions on use. Sanofi's diabetes division generates about $7 billion of sales annually and around 30 per cent of group profits, but the patent on its Lantus insulin, the world's most prescribed, expires this year, and it expects little or no sales growth through 2018. A poor diabetes performance in 2014 was one of the reasons Sanofi sacked chief executive Chris Viehbacher in October. The company is now betting on products like Afrezza and an improved version of Lantus called Toujeo. Orally delivered insulin is difficult to develop because the protein gets broken down in the stomach, but last year Danish group Novo Nordisk completed a phase I trial of an oral version. Reuters

Patients treated with ISISPTP1B had a 0.7 percentage points mean reduction in glycated hemoglobin, compared with a average fall of 0.2 percentage points in placebotreated patients, Isis said. Glycated hemoglobin, also known as HbA1c, is used to measure how well diabetes is being controlled. The company expects ISISPTP1B will be used in conjunction with most other commonly used diabetes drugs, including insulin, GLP-1 agonists and more traditional medicines such as metformin. Reuters

Lupin receives FDAnod for generic vancocin capsules Vancocin capsules had annual US sales of $ 164.2 million LUPIN HAS received final approval for its vancomycin hydrochloride capsules, 125 mg and 250 mg from the US Food and Drugs Administration (FDA) to market a generic version of ANI Pharmaceuticals, Inc’s Vancocin capsules, 125 mg and 250 mg strengths. Lupin Pharmaceuticals Inc. (LPI), the company’s US subsidiary would commence marketing the product shortly. Lupin’s Vancomycin capsules 125 mg and 250 mg are the AB rated generic equivalent of ANI Pharmaceuticals Inc’s Vancocin capsules and are indicated for the treatment of C.difficile-associated diarrhoea and also for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains). EP News Bureau

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February 16-28, 2015

RESEARCH

US FDAexpands uses of Vyvanse to treat binge-eating disorder The drug is the first FDA-approved medication to treat this condition THE US Food and Drug Administration has expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition. “Binge eating can cause serious health problems and difficulties with work, home, and social life,” said Mitchell Mathis, Director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “The approval of Vyvanse provides physicians and patients with an effective option to help curb episodes of binge eating.” Vyvanse was reviewed under the FDA’s priority review programme, which provides for an expedited review of drugs

that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy. The efficacy of Vyvanse in treating binge-eating disorder was shown in two clinical studies that included 724 adults with moderate-to-severe bingeeating disorder. In the studies, participants taking Vyvanse experienced a decrease in the number of binge eating days per week and had fewer obsessive-compulsive binge eating behaviors compared to those on the inactive pill (placebo). Vyvanse is dispensed with a medication guide for patients, which provides important information about the medication’s use and risks. The most serious risks include psychiatric prob-

lems and heart complications, including sudden death in people who have heart problems or heart defects, and stroke and heart attack in adults. Central nervous system stimulants, like Vyvanse, may cause psychotic

or manic symptoms, such as hallucinations, delusional thinking, or mania, even in individuals without a prior history of psychotic illness. The most common side effects reported by people taking

Vyvanse in the clinical trials included dry mouth, sleeplessness (insomnia), increased heart rate, jittery feelings, constipation, and anxiety. Vyvanse is not approved for, or recommended for, weight loss. Its efficacy for weight loss has not been studied. Vyvanse was approved in 2007 as a once-daily medication to treat attention deficit hyperactivity disorder in patients ages six and older. Vyvanse is a Schedule II controlled substance because it has high potential for abuse, with use potentially leading to dependence. Vyvanse is marketed by Shire US based in Wayne, Pennsylvania. EP News Bureau

FDA approves first tissue adhesive for internal use The FDA’s review of TissuGlu included data from a clinical study of 130 participants undergoing elective abdominoplasty THE US Food and Drug Administration (FDA) approved TissuGlu, the first tissue adhesive approved for internal use. TissuGlu is a urethane-based adhesive that a surgeon can use to connect tissue flaps made during surgery to remove excess fat and skin or to restore weakened or separated abdominal muscles (abdominoplasty surgery). Connecting the tissue flaps with an internal adhesive may reduce or eliminate the need for postoperative surgical draining of fluid between the abdominoplasty tissue flaps. Drops of liquid TissuGlu are applied by a surgeon using a hand-held applicator. After applying the drops, the surgeon positions the abdominoplasty flap

52 EXPRESS PHARMA February 16-28, 2015

TissuGlu is a urethane-based adhesive that a surgeon can use to connect tissue flaps made during surgery to remove excess fat and skin in place. Water in the patient’s tissue starts a chemical reaction that bonds the flaps together. The surgeon then proceeds with standard closure of the skin using sutures. “The FDA’s approval of the first synthetic adhesive for internal use will help some abdominoplasty patients get back to their daily routine after surgery more quickly than if surgical drains

had been inserted,” said William Maisel, M.D., M.P.H., deputy director for science at FDA’s Center for Devices and Radiological Health. The FDA’s review of TissuGlu included data from a clinical study of 130 participants undergoing elective abdominoplasty. Half of the participants received surgical drains while the other half received TissuGlu and no

drains. The study results showed that 73 per cent of participants who received TissuGlu required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps. In the 27 per cent of patients who did require invasive treatments, 21% received needle aspirations alone. Six percent of the TissuGlu group received both needle aspirations and drains for persistent seroma formation. Participants who received TissuGlu without surgical drains were generally able to return to most daily activities such as showering, climbing stairs, and resuming their usual routines sooner than those who had surgical drains. There was no differ-

ence between the two groups in reported levels of pain or discomfort due to the surgery. TissuGlu is manufactured by Cohera Medical, Inc., located in Pittsburgh, Pennsylvania. The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. EP News Bureau

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PHARMA LIFE AWARD

Fellowship of PIPA,UK awarded to Dr J VijayVenkatraman Dr Venkatraman is the first person hailing from India to be awarded this fellowship DR J VIJAY Venkatraman, Managing Director and Chief Executive Officer, Oviya MedSafe have been awarded the Fellowship of the Pharmaceutical Information and Pharmacovigilance Association, UK (FPIPA) recently. It is in line with the eligibility criteria set by PIPA as a professional accreditation association. Re-

portedly, Dr Venkatraman is the first person hailing from India to be awarded this fellowship. PIPA is the professional organisation for individuals who are involved in the provision and management of information and those involved in the fulfillment of regulatory requirements relating to drug

safety. The association was formed in 1974 and now represents over 800 members who work in a variety of pharma information management roles, such as medical information, pharmacovigilance, scientific research information and business information. PIPA, an international society, is headquartered at Hasle-

mere in Surrey, UK and has members from many countries. On receiving this fellowship, Dr Venkatraman said, “I would like to thank all my colleagues in the industry for their constant encouragement and strong support rendered to my various activities pertaining to pharmacovigilance,

IIHMR Bangalore signs MoU with Netherland’s Maastricht University The two institutes will seek opportunities to cooperate in research and will seek to facilitate student programmes

80 EXPRESS PHARMA February 16-28, 2015

EP News Bureau - Mumbai

APPOINTMENT

CAMPUS

IIHMR BANGALORE signed a Memorandum of Understanding (MoU) with the Netherlands’ Maastricht University’s Faculty of Health, Medicine and Life Sciences (FHML). Reportedly, the scope of activities between the two will focus on innovative student-centred and outcome-based learning methodologies, research as well as exchange of faculty and students. To provide higher education of the highest quality the two partners will apply innovative student-centred and outcome-based learning methodologies. Both parties will share knowledge, experiences and educational research results and to support each other in further educa-

over the past decade, without which this milestone could not have been achieved. I firmly believe that this recognition comes with an implicit responsibility and I take this opportunity to reinstate my commitment to the advancement of pharmacovigilance.”

Both parties will share knowledge, experiences and educational research results tional development. Among other things, this mutual support will include curriculum development, the development and application of innovative methodological approaches such as problem-based learning, student assessment, educational quality assurance, programme content develop-

ment, internationalisation of the curriculum, student support service, and management of education. Visits by academic staff members will be encouraged for the mutual benefit of both partners. Suitable arrangements will be made for the exchange of visiting scholars for collaboration in teaching and in research. The two institutes will seek opportunities to cooperate in research and will seek to facilitate student programmes. Elaborating on this tie up, Dr Biranchi N Jena, Director of IIHMR Bangalore said, “IIHMR is an institution dedicated to the improvement in standards of health through better management of health care and related pro-

grammes. It seeks to accomplish this through management research, training, consultation and institutional networking with a national and global perspective. Our tie up with Maastricht University’s FHML will further add to our global outreach and provide world-class facilities to our students.” Dr A Scherpbier, Dean of FHML, Maastricht University said, “With almost 16,000 students and 4,000 staff, we offer a wide choice of academic programmes, all of which are designed to bring out the best in our students. Our new partnership with IIHMR Bangalore will further enhance our globalisation efforts.” EP News Bureau - Mumbai

Biocon appoints Siddharth Mittal as CFO He has more than 15 years of global and diversified experience SIDDHARTH MITTAL, President – Finance has been appointed as Chief Financial Officer, Biocon effective August 1, 2014. He joined Biocon in May 2013 and takes over from Murali Krishnan, who retires after more than 30 years of distinguished service with the organisation. Mittal is a Chartered Accountant (India) and a CPA (US) and has more than 15 years of global and diversified experience. Prior to joining Biocon, he was Vice President-Finance and Corporate Controller with a leading US-based multinational information technology company based in Bangalore. EP News Bureau - Mumbai

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