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Contents

E|X|P|R|E|S|S

Pharma VOL 7. NO. 18 JULY 16-31, 2012 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Photo Editor Sandeep Patil BUREAUS Mumbai

market In India, the need of the hour is for continuing research in integrative medicine, so that the benefits of traditional healing substances and methods can be subject to scientific scrutiny, and newer applications for traditional healing can be explored

Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap MARKETING

Dr Gunvant Oswal Founder Centre for Life Sciences Health and Medicines (CLSHM) Page 16

Deputy General Manager Harit Mohanty

interviews

Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Production Manager Bhadresh Valia Asst. Manager - Scheduling & Coordination Arvind Mane Asst. Art Director Surajit Patro Chief Designer Pravin Temble

‘We intend to build the HiOwna brand into a ` 100-crore business’ Recently, the Himalaya Drug Company launched 'HiOwna-Jr' flagging its entry into the nutraceutical and dietary supplement market. The prescription-based nutritional supplement promotes physical and mental growth and enhances immunity in children from two years of age right up to their pre-teens. Philipe Haydon, Chief Executive Officer—Pharmaceutical Division, The Himalaya Drug Company, talks about HiOwna-Jr and shares the company’s plans for the new segment with M Neelam Kachhap

SC hearing of Novartis patent case re-scheduled for August 22 The final arguments in the Indian Supreme Court case of Novartis vs. Government of India Section 3(d) patent case, due to start on July 10 , has been re-scheduled for August 22 Page 18

products

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Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma C I R C U L AT I O N Circulation Team Mohan Varadkar

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Reg. No.MH/MR/SOUTH-77/2010-12 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 & Administra-tive Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021)

*Responsible for selection of news under the PRB Act.

Appointment Pfizer appoints Aijaz Tobaccowalla as Managing Director, India Previously from Wyeth, Tobaccowalla now leads Business Technology for all Pfizer’s biopharma business units

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Editor’s Note

New guidelines for biosimilars in India he release of guidelines for biosimilar drugs in India reportedly created a buzz at last month’s BIO meet at Boston. The 52-page document, titled, ‘Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India’ covers both biosimilars developed in India as well as those imported into the country. There has been a fair amount of interest in these guidelines, both from Indian biopharma companies as well as global players. In fact, an industry observer at the BIO meet tweeted that officials associated with DBT projected these guidelines “as the start of a major regulatory reform process in 2012.” When it comes to regulating biosimilars, the European Medical Agency (EMA) has been the clear leader, releasing guidelines for the licensing of biosimilars way back in 2005. Other regulators, including countries in Asia such as South Korea, Malaysia, Taiwan, and Sri Lanka have since referenced these guidelines while preparing their own, with the first three countries choosing to tweak them to meet their local scenarios, without, of course, compromising patient safety or product quality. In the interests of harmonising biosimilar regulations across the world, the WHO also released biosimilar guidelines in 2009 that could be adopted by national regulatory agencies worldwide as a base to formulating their own guidelines. The US released its Biologics Price Competition and Innovation Act of 2009 in 2010 as well. The Indian biosimilar guidelines follow what is now more or less the accepted practice of requiring a biosimilar to prove similarity to an approved reference biotherapeutic product. Again following the EMA’s experience, Indian regulatory authorities held many consultations with industry representatives during the draft stages. Thus while it is early days as yet, one expects that the guidelines will be generally well accepted by Indian biopharma companies, who have long felt that having such rules in place would benefit not just the patient but also ultimately lead to a better image of Indian biosimilars in the global market. Global players will have the usual concerns. For instance, in February this year, a letter from BIO hoped that the guidelines would preserve the “incentives to research, develop and manufacture new and innovative therapies and cures, as well as new indications.” It had also advised that non-patent data exclusivity needs to be awarded to the original innovator so that biosimilar companies cannot rely on any health authority’s prior approval of the innovator’s reference biologic product. What is a fair period of data exclusivity? How well has India’s biosimilar guidelines addressed these issues? Is there a balance between the interests of the various stakeholders involved? Do write in with your comments on India’s biosimilar guidelines and we’ll be sure to feature it along with a detailed analysis from industry experts.

Viveka Roychowdhury viveka.r@expressindia.com

8 EXPRESS PHARMA

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July 16-31, 2012

Market

THE BUSINESS OF PHARMACEUTICALS

UPFRONT Serum Institute of India buys Bilthoven Biologicals

MSCDA calls off strike

erum Institute of India, the flagship company of Poonawalla Group and India’s largest vaccine company, has acquired Bilthoven Biologicals of Netherlands. Through the acquisition, Serum Institute will get access to technology and expertise for making the Injectable Polio Vaccine (Salk). This first overseas acquisition by the Poonawalla Group will also provide the Group and Serum Institute, an important manufacturing base in Europe, with access to the important European and the US markets. Dr Cyrus Poonawalla, Chairman, Poonawalla Group and Serum Institute said, “The Poonawalla Group has constantly striven hard to provide the highest quality vaccines at affordable prices to the world. This acquisition will significantly strengthen our position in the global vaccines market, while giving us access to the technology and production facility of Injectable Polio Vaccine (Salk), which is the only logical solution available to the world for the eradication of polio. This will also significantly enhance our earlier offerings in the pediatric vaccines segment including DPT, Measles and MMR vaccines where we are the global leaders today.” Adar Poonawalla, Executive Director, Poonawalla Group and Serum Institute said, “The Poonawalla Group is committed to investing over euros 70 - 80 million over the next three years to augment the infrastructure and enhance the manufacturing capacity of the Bilthoven’s facilities. Serum Institute has one of the world’s largest vaccine manufacturing facilities in Pune and with this second manufacturing facility based in Europe, the company aims to access the developed markets of Europe and US for its existing and future products in the pipeline.”

MSCDA to meet authorities after July 25 for further discussions

Page 18

EP News Bureau— Mumbai

July 16-31, 2012

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M|A|R|K|E|T AJIT MAHADEVAN

DR MANU CHAUDHARY

DR RB SMARTA

Partner, Ernst and Young

Joint Managing Director and Director- Research, Venus Remedies

Managing Director, Interlink Marketing Consultancy

Traditional sector being practiced over ages in India and country also have strong manufacturing base. Burgeoning global demands bound to propel the growth of integrated medicine market

Use of integrative medicine appears to be increasing, especially among persons with chronic illnesses. Little data is available on Indian market size but US had a market size of $ 45 billion in 2009 and is estimated to grow at 20 per cent per annum

Education and awareness, consistent health consciousness, fear of falling sick, increasing purchasing power would decide the growth of integrated medicine market in India

ntegrated medicine brings together the traditional and modern medicines. India-born ayurveda is one of the oldest forms of medicine in the world. In many European countries, ayurveda has made its presence felt in some form or other. Surprisingly, though India holds the privilege of being home to ayurveda, the market for integrated medicines in India is very negligible. Ajit Mahadevan, Partner, Ernst and Young, says, “When we say alternative medicines it may be any of the following line of treatments emanating from ayurveda, homoeopathy, unani, siddha, naturopathy and yoga. If we look at the evolution of this system, till 1950s it was spearheaded by vaidyas, the second stage was phased by the government bodies in India, and lately, the third phase is being led by biotech pharmaceutical companies in the global healthcare industry. Historical evidences point to the fact that during the cholera epidemic of early 20th century, ayurveda had successfully treated patients in different regions without

forced mass quarantine.” He adds, “It's believed to be practiced since ages and people perceive it with a positive notion for alternative treatment therapy rather than solely believing on allopathy.” However, he also points out that while modern therapies often are not affordable for people who fall below the average income levels in India, ayurveda poses a challenge due to inaccessibility and availability of certain herbs. AYUSH, a key organisation developed by government, supports the framework of integrated medicine in India, comprising a total number of c9,228 companies (mostly micro and small, 2010 data), with a turnover of Rs 88 billion (2010 data) and total export of Rs 10 billion (2010 data). The ayurvedic drug market size is c$65billion globally, with neutraceuticals amounting to c$100 billion, where the Indian share is c$1billion.” According to Dr Manu Chaudhary, Joint Managing Director and DirectorResearch, Venus Remedies, use of integrative medicine appears to be increasing, especially among persons with

chronic illnesses. Little data is available on the Indian market size but US had a market size of $ 45 billion in 2009 and is estimated to grow at 20 per cent per annum.

Lack of awareness could well be the basic reason behind lesser penetration of integrated medicines in the Indian market. People in India have been using ayurveda for ages and yet the market for integrated medicine in India is struggling to make its point. Industry experts believe that if more serious research is done in this segment then it will only add to its acceptability among masses

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Awareness is an issue? Lack of awareness could well be the basic reason behind lesser penetration of integrated medicines in the Indian market. People in India have been using ayurveda for ages and yet the market for integrated medicine in India is struggling to make its point. Industry experts believe that if more serious research is done in this segment then it will only add to its acceptability among masses. Although modern medicine has made a huge contribution in bringing high quality healthcare to millions worldwide, there are still areas such as neurological conditions, where it does not have many answers. Pune-based Centre for Life Sciences, Health and Medicines (CLSHM), is one of the largest integrated medicine centres which work on neurological disorders. Dr Gunvant Oswal, Founder, CLSHM, says, “We have come out with a drug, Neuro G (previously known as G Therapy), which is an excellent example of integrated medicine to better the life of patients suffering from neurological conditions. Integrative medicine, which combines modern medicine with alternative approaches such as ayurveda and homeopathy hold a lot of promise. Today, integrative medicine is increasingly becoming popular. The world is accepting this form of medicine.” He adds, “We know that countries in the West, in their medical schools have research in ayurveda, Chinese medicine, etc. I feel the awareness has increased many folds. In India, the need of the hour is to July 16-31, 2012

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continue research in integrative medicine, so that the benefits of traditional healing substances and methods can be subject to scientific scrutiny, and newer applications for traditional healing can be explored. We are approaching pharma companies who could come ahead to do clinical trials for Neuro G, a drug which has till date treated more than 20,000 patients worldwide.”

Market drivers According to Mahadevan, the traditional forms of medicine have been in practice over ages in India and the country also has a strong manufacturing base. Burgeoning global demands are bound to propel the growth of integrated medicine market. They also have good export potential. Medical tourism in India would further drive the growth of integrated medicine market in India. Moreover, strong thrust on promotion of this sector by Government of India would ensure that this medicine system consolidates its place in the Indian market. No single system of medicine provides a holistic approach to the wellness of human beings. Modern systems of medicine have their own limitations in causing side effects. Need for safer, efficient medicine system would drive the growth of integrated medicine market in India, feels, Dr Manu. Dr R B Smarta, Managing Director, Interlink Marketing Consultancy,

July 16-31, 2012

In the global arena, alternative medicines have increased their presence in a consistent manner. World market for alternative medicine is experiencing a robust growth triggered by growing demand for nature-based products and a belief that herbal products cause minimal side effects when compared to modern medicines points out that, education and awareness, consistent health consciousness, fear of falling sick and incurring more cost of sickness, as well as increasing purchasing power would decide the growth of integrated medicine market in India. Dr Manu informs, “At present there is no separate governing body for integrated medicine in India, as different systems of medicine have their own governing council/body. There are few educational institutions and organisations such as IIM Jammu, which are imparting training and awareness programmes for integrated medicine. There is a need to explore this field and take more initiatives to establish this medicine system.”

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The global scenario In the global arena, alternative medicines have increased their presence in a consistent manner. World market for alternative medicine is experiencing a robust growth triggered by growing demand for nature-based products and a belief that herbal products cause minimal side effects when compared to modern medicines. “Global traditional medicine market to reach $114 billion by 2015, according to a new report published by Global Industry Analysts,” informs Mahadevan. He adds, “Complementary and alternative medicine currently provide healthcare to about 75 per cent of the population in developing nations and over 50 per cent of the population

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in the developed world for lifestylerelated diseases such as diabetes and hypertension. In 2011, the market for alternative medicines in the UK was estimated at nearly $340 million, with one in five adults thought to be consumers and some treatments such as homeopathy available from National Health Service (Source: The Economist). In the UAE, demand for alternative medicine is bound to increase due to the affluent market structure, say local experts.” According to Mahadevan, from May 1, 2012; sales of ayurvedic drugs and other herbal medicines have been banned across European Union (EU), owing to a growing concern over adverse effects of such medicines. Ayurvedic products marketed before the legislation came into force in 2004 were allowed to to market their product until April 30, 2011, under the transitional measures. After this time limit, all herbal medicinal products must have prior authorisation before they can be marketed in the EU. Despite these measures, the use of alternate medicines are on the rise. Dr Manu agrees with the fact that world over the penetration of integrated medicine is increasing at a fast pace. She asserts, “The metaphor of pharmaceuticalisation of herbal medicine system in the recent decades, by standardising herbal diagnostic and treatment protocols by in situ studies, documenting clinical practices and using modern techniques, is faster than ever.” One wing of Venus Medicine Research Centre (VMRC) is involved in the research on integrated medicine. Company is working on wound management and skin care segment and stress relieving, detoxifying products wherein they have developed a novel formulation of herbs using modern techniques and have generated enough scientific knowledge at par with international requirements. While countries like India and China have long age-old traditions of alternative medicine systems, in recent years the West is also growing up to the benefits of integrative medicine. Oswal informs, “In the US, 38 per cent of adults and 12 per cent of children use alternative medicine according to the National Institutes of Health estimates. 40 per cent of French have been treated with homeopathy according to another estimate.” According to Dr N P Dubey, President, World Association of Integrated Medicines, the Traditional Chinese Medicine (TCM) is the most popular system in the name of integrated medicine. Most of the developed countries like US

DR NP DUBEY

DR GUNVANT OSWAL

President, World Association of Integrated Medicines

Founder, Centre for Life Sciences, Health and Medicines (CLSHM)

The Traditional Chinese Medicine (TCM) is the most popular system in the name of Integrated Medicine. Most of the developed countries like US and Australia where the modern medicine is the official system, they have also used integrated medicine to certain extent

In India, the need of the hour is for continuing research in integrative medicine, so that the benefits of traditional healing substances and methods can be subject to scientific scrutiny, and newer applications for traditional healing can be explored

and Australia, where the modern medicine is the official system, they have also used integrated medicine to certain extent. In most of the developed countries it is known as complementary medicine while developing countries address it as alternative medicine.

sometimes lead to serious sequels, sometimes death. In contrast, there is a growing evidence which shows that ingredients of medicinal plants act synergistically and that suitable combinations neutralise side effects. There is a need for mass awareness campaigns to educate society that herbs can also be developed as per latest standards of medicines and hence integrated medicines can be the drug of choice for masses,” opines Dr Manu. She adds, “The integrative medicine approach recently re-emerged with the hope of providing an affordable practical resolution to the global healthcare crisis. Many countries like Norway (Tromsø), Sweden (Karolinska), Australia, China and also countries in the Asian, African, European and Latin American regions have integrated medicines initiatives. Generally, it involves the interplay between various systems of medicine and therapies including allopathy and complimentary and alternate medicines (CAM). With shift of developed countries to integrated medicine system, the future prospects are bright.” According to Mahadevan, many successful pharma drugs were originally made from plants and herbal medicines are regulated by FDA, but in the US herbs and extracts are sold as supplements (neutraceuticals) irrespective of lesser toxicity levels and side effects compared to synthesised chemical molecules used for conventional therapies. He signs off, “More often, herbal extracts or alternative medications are used for cosmetic purposes rather than for curative purposes. Though there is already a market for alternative therapies in the West, the regulatory challenges and weaker support from government to promote them as a second line therapy will remain key hurdles for the medium in the long term.”

Future dilemma With the growing number of diseases, new medicines have also been getting introduced in the domestic and the global market. However, allopathy remains the first line of treatment in majority of the cases globally. Unfortunately, modern medicines couldn't ever do away with their 'side effect' tag. This tendency of modern medicines has propelled the use of traditional medicines to a great extent. Yet, the market penetration of integrated medicines still remains less in India and in the overseas market. However, it is an undeniable fact that a combination of traditional and modern medicine can do wonders. “It is true that doctors are beginning to recommend alternative (herbal) remedies to their patients when modern drugs do not work or because herbal medicines have fewer side effects, are less toxic and habit forming, in contrast to allopathic medicine, where toxic side effects may

With the growing number of diseases, new medicines have also been getting introduced in the domestic and the global market. However, allopathy remains the first line of treatment in majority of the cases globally. Unfortunately, modern medicines couldn't ever do away with their 'side effect' tag

sachin.jagdale@expressindia.com

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July 16-31, 2012

M|A|R|K|E|T INTERVIEW

HiOwna Jr is fortified with 13 essential vitamins and nine minerals. It also has Ragi (finger millet) that improves

nutritive status, Maricha (black pepper), a bio-availability enhancer, Mandukaparni (centella), a

cerebral activator, also known as ‘brain food’ in Ayurveda and Amalaki (Indian Gooseberry), an immunity

An Investment in Drug Protection Tell us about the size of nutraceutical market in India. According to a recent report by Frost and Sullivan, the nutraceuticals market in India is pegged at $1480 million in 2011, growing at CAGR of 13 per cent. It is expected to reach $2731 million by 2016. Of this, the nutritional and health supplements are the largest sub-category accounting for 64 per cent of the market. What is the current market scenario and market trends in this segment? Despite being a relatively ‘new’ product category, nutraceuticals have been growing at an exceptional pace. While majority of the growth is fuelled by dietary and weight loss supplements, pediatric health drinks are also gaining momentum. Presently, pharmaceutical companies have a significant presence in the micronutrient, vitamins and minerals segment of the nutraceutical business. Especially in the pediatric segment, most of the products are cross-overs from pharmaceuticals, initially being promoted through doctors before going direct to consumers. Why did you choose to focus on the nutraceutical market? Ayurveda is about ‘wellness’ or staying healthy and nutraceuticals in effect focus on maintaining a state of good health. Hence, from our point it is quite a logical extension of the expertise that we currently possess. We felt that we could apply our knowledge of Ayurveda to develop something truly unique. For example, during the development process of HiOwna-Jr, we July 16-31, 2012

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enhancer and the richest source of Vitamin C in nature. HiOwna-Jr also has the distinct advantage of being the only health supplement in India to contain pea-protein, a natural, vegetable, easy to digest protein, that has an essential amino acid profile very close to the ideal protein required for human nutrition, as recommended by the WHO and FAO. It also contains colostrum or ‘first milk’, which fortifies the immune system. Why did you choose to launch this segment with HiOwna-Jr? HiOwna-Jr is first in the series of prescription nutri-health products that we are planning to launch. HiOwna-Jr is the first that has been developed and hence, it is the first one that we have introduced in the market. (The company has a number of products in the pipeline which will be launched in the next two to three years. Main among them are products on pregnancy-lactation, weight management, meal replacement, diabetes, and women’s health. By the year end, it would introduce HiOwna-Sr) Since this is a prescription product

what would be your marketing strategy? Like all pharmaceutical products by Himalaya, HiOwna-Jr will also be marketed solely through prescriptions. The marketing strategy involves training our medical representatives about the benefits of HiOwna-Jr. and through them, reaching out to a large number of pediatricians. Himalaya already has a considerable equity with doctors and we enjoy their confidence of being a R&D driven company. While we do not have a fixed budget earmarked for this activity, around 650 medical representatives will be marketing the product to approximately 175,000 doctors across India. That’s around one fourth of our entire field staff. What will be this new segment's role in strengthening Himalaya’s pharmaceutical division? HiOwna-Jr is our foray into the prescription nutri-health segment, which in itself has a lot of potential. We intend to launch a whole range of nutri-health products, which will further strengthen our pharma portfolio. Over the next two to three years, we intend to build the

HiOwna brand into a Rs` 100-crore business. Eventually, we will have a separate business vertical exclusively focused on nutritional and health products for children and people of different age groups addressing different conditions. What will be your focus area in the nutraceutical segment? Our focus will be on developing nutri-health products that offer clear therapeutic benefits. A health supplement for general health, convalescence, another for diabetes management and a fourth variant for pregnant/lactating women will be launched shortly. What are the challenges faced by nutraceutical segment in India? How do you plan to work around it? There is a fair amount of challenge in trying to convey the benefits of nutrihealth products to patients. Therefore, it is vital that patients are prescribed these supplements by their doctors, who know their medical history and who are the key influencers. HiOwna-Jr and other products launched under the HiOwna banner will be routed only through doctors. mneelam.kachhap@expressindia.com

MSCDA calls off strike MSCDA to meet authorities after July 25 for further discussions Sachin Jagdale he Maharashtra State Chemists and Druggists Association's (MSCDA) much publicised statewide strike has been called off. In a meeting with ministers from the Maharashtra Government including Satej Patil, FDA State Minister, and Manohar Naik, FDA Minister, along with Mahesh Zagade, FDA commissioner, Maharashtra, MSCDA representatives tabled their grievances. The State Government has assured the MSCDA that all the issues raised by them will be sorted out in the best possible way. Of late, the MSCDA has taken a very aggressive stand to address the concerns of its members. During the proposed strike, as per the 'work to rule' strategy, chemists were directed to keep their premises open from 10am- 6pm from

July 11-17. Moreover, if the Government would not have intervened, then complete shut down of the medicine shops was also planned from July 18-20. In this process no prescription of allopathic medication given by homeopathic, ayurvedic, unani or electropathic practitioners would have been honoured to avoid violation of the Drugs and Cosmetic Act (the Act). Moreover, MSCDA members had even decided not to dispense schedule drug across the counter to any patient without a valid prescription. Sale of medicine falls under profession bound by and Rules there under 1945. The Maharashtra FDA commissioner had decreed that as per the Act, doctors with degrees like BHMS, DHMS, LCEH are not allowed to prescribe allopathic medicines. According to MSCDA, such restrictions would affect the availability

of medicines to patients as there are insufficient doctors to cater to the needs of India's patients, with the situation worse in rural areas. In this scenario, MSCDA reasoned that it was not practical to follow these provisions of the Act and be expected to take care of patients by providing them required medicines in an emergency. Meanwhile, a committee has already been set up by Patil to look into the problems faced by MSCDA members. However, as per sources, some of the issues raised by MSCDA fall under Central Government and a separate proposal needs to be sent to the Central Government for this purpose. Government authorities and MSCDA representatives are scheduled to meet again post the monsoon session on July 25 for further discussions. sachin.jagdale@expressindia.com

SC hearing of Novartis patent case re-scheduled for August 22 Postponement due to a request from lawyers representing Novartis he final arguments in the Indian Supreme Court case of Novartis vs. Government of India Section 3(d) patent case, due to start on July 10 , has been re-scheduled for August 22. The request for postponement was from the legal counsel of the pharma major due to the unavailability of their main counsel. In January 2006, the Patent Controller of India gave a decision against Novartis stating that its application for a patent on the beta-crystalline form of 'imatinib mesylate', Glivec,

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lacked novelty and was not patentable under section 3(d). Novartis then challenged the validity of Section 3(d) of the Indian patent law. Though it lost this case in 2007, the pharma major approached the Supreme Court directly in 2009 by filing a special leave petition challenging the IPAB’s interpretation and application of section 3(d) to its patent application. A press release from Médecins Sans Frontières (MSF) points out that the Novartis case is now scheduled just a day after the hearing of another crucial

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intellectual property issue impacting the pharma industry: the legal appeal against the grant of a compulsory license on Bayer anti-cancer drug Nexavar before the Intellectual Property Appellate Board in Chennai. Bayer is challenging the first-ever compulsory license issued by the Patent Controller on March 9 this year which authorised generic major Natco Pharma to market a more affordable version of Bayer's patented cancer medication Nexavar in India. EP News Bureau – Mumbai July 16-31, 2012

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AIOCD to support market-based pricing formula based on all-brands Likely to address patient needs and balance industry growth he All India Organisation of Chemists and Druggists (AIOCD) has welcomed the government’s draft proposal to move away from costbased pricing to market-based drug pricing policy saying that it will best address patient needs and balance industry growth. It, however, said the proposal can be further strengthened if the weighted average of the prices (WAP) of all brands formula is taken rather than taking WAP of top three selling brands as mentioned in the proposal. JS Shinde, President, AIOCD said, “At a time when the Indian pharmaceutical industry is facing challenges on multiple fronts, the WAP of all brands formula will result in greater impact on the industry in comparison to the WAP of top three brands formula proposed in the draft NPPP 2011 to best meet access, affordability, innovation and quality needs of patients.” It may be noted that the Department of Pharmaceuticals has made a strong effort to address the severe drawbacks of cost-based pricing by introducing a market-based pricing mechanism in the National Pharma Pricing Policy 2011. Overall the industry also felt that the market-based formula is the simplest,

July 16-31, 2012

most transparent and balanced formula. Shinde said, “WAP of all brands formula takes in to account almost 90 per cent of the cumulative market share under price control (formulations as listed in the NLEM) by value in comparison to around 60 per cent taken in to account by WAP of top three brands.

Facilitate an environment that would attract more players to the market, further intensify competition and provide more options to patients WAP of all brands formula will result in more patient savings on NLEM formulations than the WAP of top three brands formula.” Over the last two decades, patients in India have suffered on account of the non-transparent and complicated cost-

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based pricing regime (DPCO, 1995), which has hampered patient access to essential medicines. The association is of the opinion that market-based pricing would balance patient as well as industry interests, and prevent formulations going off the market on account of an unviable manufacturing environment as happened during cost-based pricing regime. It would also facilitate an environment that would attract more players to the market, further intensify competition and provide more options to patients. According to Shinde, “Many therapeutically efficacious and cost-effective medicines such as Methyldopa and Doxycycline used in the treatment of hypertension and urinary tract/ other infections respectively have become unavailable due to cost-based price control.” The association also suggested that non- essential strengths, dosages and combinations not specifically listed in the NLEM 2011 be not included in the scope of the policy as such a move would burden the industry and stifle growth and adversely impact availability of essential medicines. EP News Bureau - Mumbai

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M|A|R|K|E|T

Astrazeneca and Cellworks collaborate to find new treatment for tuberculosis It will pave the way for the creation of platforms and approaches to handle Multi Drug Resistant Tuberculosis straZeneca and Cellworks have announced a collaboration supported by the Wellcome Trust to speed the design of novel combination therapies for the treatment of drug-sensitive and resistant tuberculosis. This collaboration will also pave the way for the creation of platforms and approaches to handle Multi Drug Resistant Tuberculosis (MDR-TB), a condition that is reaching epidemic proportions in many developing parts of the world. Current therapies for tuberculosis (TB) are based on creating combinations of three to four drugs and cycling through ad-hoc regimens, which are largely ineffective against MDR-TB. Together, Cellworks and AstraZeneca will pull from a pool of existing antiinfective drugs and attempt to find an effective combination with better efficacy and lower toxicity than the treatment

regimens provided today. Under this collaboration, Cellworks will use its proprietary predictive platform, which it pioneered in oncology and autoimmune disorders, to model drug MDR-TB and rationally identify ‘synergistic combinations’ that might have the highest efficacy and lowest possible toxic burden compared to all currently available combinations. AstraZeneca will then validate the top 10 most effective combinations identified by Cellworks in-vitro in its laboratories, followed by validation using in-vivo models. Dr Anand Anandkumar, Managing Director, Cellworks Group India said, “Cellworks is honoured to take the lead on this unique drug development project which has the potential to save thousands of lives globally. Its results may also have positive implications in other infectious disease areas where drug

resistance is prevalent.” Dr Manos Perros, Head of the AstraZeneca Infection Innovative Medicines Unit, said, “Our continued investment in infectious disease research has positioned us to collaborate with organisations like Cellworks who share our passion for medical innovation. AstraZeneca would like to acknowledge and thank the Wellcome Trust for funding this important work.” Dr Richard Seabrook, Head of Business Development at the Wellcome Trust, said, “MDR-TB is both a major global healthcare threat and a scientific challenge. Tackling it requires new approaches to drug discovery and we are delighted to be supporting this collaboration which has a strong mix of both innovation and drug development expertise.” EP News Bureau – Mumbai

Mylan confirms first-to-file patent challenge relating to Pristique tablets Pfizer, Wyeth, Wyeth Pharmaceuticals, and PF Prism CV sues Mylan ylan has been sued by Pfizer, Wyeth, Wyeth Pharmaceuticals, and PF Prism CV in connection with the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Desvenlafaxine Succinate Extended-release tablets, 50 mg and 100 mg. This product is the generic version of Pfizer's Pristiq tablets, which are indicated for the treatment of major depressive disorder (MDD) in adults.

Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a paragraph IV certification for both strengths and expects to share 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the lawsuit in the US District Court for District of Delaware. Accordingto IMS Health for 12 month ending March 31, 2012, Pristique tablets registered a total sales of approximately

$559.4 million. Currently, Mylan has 169 ANDAs pending FDA approval representing $83.9 billion in annual sales, according to IMS Health. 37 of these pending ANDAs are potential first-to-file opportunities, representing $25.6 billion in annual brand sales, for the 12 months ending December 31, 2011, according to IMS Health. EP News Bureau – Mumbai

Natco Pharma and Mylan to appeal against US court ruling on Teva's Copaxone The decision by the US court covers several patents for the chemical composition of Copaxone ndia-based Natco Pharma and USbased Mylan plans to appeal against the judgement by a district court in New York that dealt the two companies a severe blow denying them permission to make a version of generic giant Teva Pharmaceutical's Copaxone. The decision by the US court covers several patents for the chemical composition of Copaxone, methods of using the product and processes for manufacturing the product. The last of the patents expires in September 2015. Both Natco and Mylan are looking at alternative options of dealing with this directive. The district court judge is

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expected to deliver the entire order in detail with the reasons for striking down permission to make drugs in two

Both Natco and Mylan are looking at alternative options of dealing with this directive

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weeks’ time. Heather Bresch, Chief Executive Officer, Mylan commented: “Although Mylan is disappointed with the court's decision, and while we have not yet had the opportunity to review the court's opinion, we fully intend to evaluate our options for an appeal once the court's full opinion becomes available. Importantly and as previously stated, Mylan’s earnings guidance for 2012 and earnings targets for 2013 are not reliant on the launch of a generic Copaxone, and therefore our expectations for these periods are unchanged.”. EP News Bureau – Mumbai July 16-31, 2012

M|A|R|K|E|T

Provepharm signs three new distribution agreements in Europe Agreement will cover eight additional European countries rovepharm, a company specialised in the development of pharmaceutical applications, has extended its international distribution network by signing new agreements covering eight additional European countries. Provepharm has recently concluded one licensing and distribution agreement with NordMedica for the distribution of its product in the five Scandinavian countries – Norway, Sweden, Finland, Denmark and Iceland - and has also signed agreements with A VIPharma in Greece and Cyprus, and with Fresenius Kabi Portugal for the Portuguese market. As the product is already commercialised in France, the UK and Ireland, these new agreements mean that it will now be available to one-third of Europeans (more than 175 million people). Following the centralised European regulatory marketing approval granted for its drug, these agreements represent another important milestone in the development of Provepharm’s distribution network in Europe. “The expansion of the Provepharm distribution network throughout Europe is an important step to enable Provepharm to respond to a medical need that is currently unmet or poorly met at a world level, by commercialising a drug that complies with the most recent quality and regulatory requirements,” said Christian Neuman, Director of Business, Development and Licensing, Provepharm. Michel Feraud, President, Provepharm said, “The European expansion is part of a wider international strategy for our distribution network. This began with a major partnership concluded with the

It has recently

Japanese company Daiichi Sankyo in 2011. Having recently created our American subsidiary, Provepharm, in New York state, the next part of our strategy is to develop our distribution network throughout North America.”

In order to anticipate the rolling-out of this strategy to other regions of the world and its extension to new therapeutic applications, Provepharm has also strengthened its management in France by hiring five new executives. Three

have been recruited by the R&D department as project managers in the areas of regulatory affairs, chemistry and galenical formulation, while another has joined the marketing department as project manager. A new director of

supply chain post has also been created to ensure full control over the procurement of active substances and finished products supplied by CMOs. EP News Bureau – Mumbai

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July 16-31, 2012

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M|A|R|K|E|T DEAL TRACKER

Pharma M&A activity witnesses significant decline in volume Asia Pacific sees highest fall in M&A activity in volume terms in June 2012, according to the Datamonitor-MedTRACK database with the Indian pharma sector witnessing only one deal, against the average of 2.1 deals over the previous six months M&A (including private equity) trend analysis

Mergers & acquisitions &A activity in the pharmaceutical segment recorded a downturn in volume terms across the globe. AsiaPacific witnessed the highest fall in volume terms, recording three transactions in June 2012, a significant decrease of 76 per cent over the previous six month’s average of 12.5 transactions. In one of the key deals announced during the month of June 2012, Bristol-Myers Squibb agreed to acquire Amylin Pharmaceuticals, a US-based biopharmaceutical company, for approximately $7 billion. With this acquisition, BristolMyers Squibb will gain access to Amylin’s approved and marketed products indicated for diabetes. Products gained by Bristol-Myers Squibb include BYETTA and BYDUREON, both type II diabetes therapeutics which are approved in the US and Europe; Metreleptin, a diabetes drug in patients with rare forms of inherited or acquired lipodystrophy, which is under review with the US FDA; and SYMLIN, a treatment for type I & II diabetes in patients with inadequate glycemic control on meal-time insulin which has been approved by the FDA. The transaction also complements current portfolio of Bristol-Myers Squibb by creating a more comprehensive disease management platform with the addition of GLP-1 agonist franchise. The M&A activity in the pharma sector decreased in both volume and value terms, when compared to the average of the previous six months (Dec 2011 – May 2012). According to Datamonitor's MedTRACK database, the pharma sector recorded 24 M&A transactions in June 2012 against the previous six months’ average of 55 transactions. In value terms, the sector recorded deals worth $8.2 billion against the previous six months’ average of $9.5 billion. The Indian pharma sector witnessed only one deal during June 2012, against the average of 2.1 deals over the previous six months in which Bliss GVS Pharma acquired 70 per cent stake in Kremoint Pharma, a manufacturer and exporter of pharmaceutical products.

Source:

Top M&A deals (June 2012) Rank

Date

Target

Acquirer

Deal value ($m)

Jun 29, 2012 Amylin Pharmaceuticals, Inc. (US)

Bristol-Myers Squibb Company (US)

Jun 13, 2012 Proximagen Group plc (GB)

Upsher-Smith Laboratories (US)

553.68

Jun 15, 2012 OraPharma, Inc. (US)

Valeant Pharmaceuticals International, Inc. (CA)

426.00

Jun 4, 2012

The Cooper Companies, Inc. (US)

189.00

Jun 21, 2012 Xanodyne Pharmaceuticals, Inc. –Zipsor (US)

Depomed, Inc. (US)

25.90

Jun 13, 2012 NeuroNova AB (SE)

Newron Pharmaceuticals S.p.A. (IT)

19.23

Jun 18, 2012 Suzhou Erye Pharmaceutical Co.,Ltd. (CN)

Undisclosed Acquirer ()

12.28

Jun 1, 2012

Southridge Partners II, LP (US)

10.00

Jun 25, 2012 Pivotal Therapeutics, Inc. (CA)

ORIGIO a/s (DK)

Entest BioMedical, Inc. (US)

Crossover Healthcare Fund LLC (US)

7,000.00

4.88

Source:

Venture financing trend analysis

Venture funding Companies in the pharma sector raised $153.1 million during June 2012, against the previous six months’ average of $258 million. In terms of volume, the sector recorded 18 venture funded deals, compared to the previous six months’ average of 26.1 transactions.

Notes and Definitions

Source:

Top venture financing deals (June 2012) Rank

Date

Target

Investors

Deal value ($m)

Jun 12, 2012

Igenica, Inc. (US)

Third Rock Ventures, LLC; The Column Group; OrbiMed Advisors, LLC; 5AM Ventures

33.00

Jun 13, 2012

Rhythm Pharmaceuticals (US)

MPM Capital; New Enterprise Associates, Inc.; Third Rock Ventures, LLC; Ipsen S.A.

25.00

Jun 5, 2012

PhaseBio Pharmaceuticals, Inc. (US)

New Enterprise Associates, Inc.; Astellas Venture Management LLC; Johnson & Johnson Development Corporation; Hatteras Venture Partners; Fletcher Spaght Ventures

23.10

MedTRACK is a comprehensive, fully integrated, global biomedical database providing information on companies, products, patents, deals, venture financing, and epidemiology. It is a live database, constantly updated with news, milestones, trial information, etc. MedTRACK’s unmatched coverage is supported by a user-friendly, highly dynamic set of decision support tools and analytics. Inhouse analysts and researchers add key insights and conclusions to provide you with the primary and secondary information you need. Key uses of the database include competitive intelligence, target identification, screen potential licensing and investment opportunities, patent assessments, product due diligence, royalty valuations, and developmental benchmarking. For more information, visit us at www.medtrack.com

Definitions

Jun 19, 2012

Nuevolution A/S (DK)

Industrifonden; Sunstone Capital A/S; SEB Venture Capital; SEB Utvecklingsstiftelse

13.70

Jun 21, 2012

EndoGastric Solutions, Inc. (US)

Advanced Technology Ventures; Canaan Partners; Chicago Growth Partners; De Novo Ventures; Foundation Medical Partners; Oakwood Medical Investors; Radius Ventures, LLC

13.00

1.Deal value trend is based on transactions where associate values have been disclosed. 2.Trend analysis excludes rumored and terminated deals. 3.Value and volume analysis excludes private equity exits.

Source:

EXPRESS PHARMA

www.expresspharmaonline.com

July 16-31, 2012

M|A|R|K|E|T PRE EVENT_

DIA’s to host IT Life Sciences Summit Summit on September 6-7, 2012 in Mumbai to focus on technology-enabled pharmaceutical business transformation IA will host the first ‘IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation’ in Mumbai on September 6-7, 2012. Michael Davies, Vice President, Global Sales, Oracle Health Sciences will be the Guest of Honour at the summit. Anil Raghavan, Managing Director, Quintiles India and Sairamkumar J, Global Delivery Head, Life Sciences, Cognizant will be the keynote speakers at this conference. The two-day summit will see keynote speakers set the stage for technology, contract research, pharmaceutical, biotechnology and medical device organisations. The summit will provide an ideal platform for the life sciences industry, regulators, IT and IT-enabled services industry to converge and consider IT intervention for enhancing competiveness; reducing costs and bringing affordable medicines to market. Professions from clinical operations, regulatory affairs, data management, drug safety and pharmacovigilance, manufacturing, finance, sales and marketing, research and development life science companies, IT software, hardware and services organisations are expected to attend this summit. Participants will have an opportunity to gain knowledge about the latest developments, case studies and solutions from life science industry experts. Sessions will feature expert presentations on the latest trends and technology advances that are reshaping the life sciences industry. Sessions will be segmented into Pre Clinical and Discovery, Clinical Development, Manufacturing, Commercialization, Regulatory and Quality. There will be special sessions on Social Media in Life Sciences, Emerging Markets and Future Technologies. A panel discussion on thought provoking topics has been scheduled on both the days. Attendees will have the opportunity to meet with life sciences organisations and technology companies to build collaborative relationships with peers, thought leaders and current and future vendor and partners. Globally, pharmaceutical companies are faced with drugs coming off patent, declining R&D productivity, increased regulatory scrutiny and compliance requirements, pricing challenges, and recession threat. In this

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GUEST OF HONOUR

Michael Davies, PhD, Vice President, Global Sales Oracle Health Sciences

KEYNOTE SPEAKERS

Anil Raghavan Managing Director Quintiles India

PROGRAMME ADVISOR

Sairamkumar J Global Delivery Head, Life Sciences Cognizant

Kamal Biswas Global Management Consulting Practice Leader Life Sciences Infosys Limited backdrop, India has attracted attention in the past decade and especially in the past five years, both as a producer and consumer of pharmaceutical products and

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services. Global companies are actively looking at India to increase efficiencies across the value chain from increasing market share, clinical development, manufacturing and IT outsourcing. Indigenous local pharma industry too has made its mark as one of the leading generics manufacturers of world. The Indian market in itself is turning out to be an attractive market for the pharma companies with its growing and affluent domestic population. Indian Pharma market is estimated to reach USD 74 billion sales by 2020, according to a July 16-31, 2012

M|A|R|K|E|T

PROGRAMME CO-CHAIRS

Santhosh Francis Director, Sales Oracle Health Sciences Global Business Unit Oracle India

Giridhar RK Vice President, Business Process Outsourcing Accenture

PricewaterhouseCoopers (PwC) report. Local pharma companies require open, industry-specific and standards-based information technology (IT) solutions to

address unique opportunities and challenges to retain global competitive advantage. The impact of IT across the Pharmaceutical Value Chain will

play an important role in helping to shape the competitiveness and future of Life Sciences industry. EP News Bureau—Mumbai

Seminar on EU-GMP Regulations

Georgia India Life Sciences Opportunities Summit” in Mumbai, India. The summit will feature a one-day “how-to-with India life sciences” series of speakers, a Business to Business matching (B2B) focus tailored for Atlanta companies in the biopharma, vaccines, healthcare IT, medical devices , and Clinical Research Organization (CRO) or Contract Manufacturing Association (CMO) areas. This will coincide with Metro Atlanta’s India trade delegation visit in August 2012 to India. FDASmart will mobilise its daylong conference / B2B networking forum in Mumbai, India to jumpstart Atlanta-based business development initiatives in the Indian markets. It will feature an online company profile matching service called SmartBiz that includes a company to company “meet & greet” to assist the launch of new business opportunities, relationships, etc. The goals of FDASmart's collaboration with the Metro Atlanta Chamber to jointly present the US Georgia- India Life Sciences Opportunities Summit are to promote and establish bilateral economic trade with SME (small medium enterprises) life science companies in Georgia for new markets in emerging regions lead by India, generate exports of Georgia healthcare and medical devices products and services including healthcare IT systems and services and thirdly, foster

online and face to face networking relationships that lead to new business development for Georgia and India Contact details: USA Office: 7 Barlow Court, Amawalk, New York-10501 Cell USA : 1-516-515-9642 Cell India : +91 97149 84499 (Dharamvir Singh) +1 201-913-0558 Email:Rbalani@fdasmart.com Skype: 'rambalani' India Office 2/7, Tagore Park, Nehru Nagar Cross Road, Ambawadi, Ahmedabad – 380015 Gujarat, India. Cell: +91 97149 84499 Email: Dharamvir@fdasmart.com

Date: August 6 & 7, 2012 Venue: Hilton Hotel near Sahar Airport, Mumbai Summary: The seminar to be held for the first time in India, will be important for persons of Regulatory Dept./ QA/QC/Production of pharmaceutical companies. Senior Inspector Knud Ryhl of Danish Medicines Agency (a Danish Government Organisation) will give a presentation on EU-GMP regulations. Visitors will be able to gain first hand knowledge from a senior inspector of government agency who has done number of inspections worldwide including India. Discussions will be held on some of the most important aspects coming up in 2013 in EUGMP Regulations. Contact details: Bharati Phone: 25360198/9867026512 M/S Trends Exports

US Georgia- India Life Sciences Opportunities Summit Date: August 23, 2012 Venue: ITC Maratha, Mumbai Summary: FDASmart, a New York and India-based emerging regions life sciences services company in collaboration with Metro Atlanta Chamber of Commerce, will conduct a full-day “US July 16-31, 2012

Bala S Senior Vice President Re-engineering Genpact

IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation Date: September 6-7, 2012 Venue: The Lalit Mumbai, Sahar Airport Road Summary: The summit will provide a platform for the life sciences industry, regulators and information technology (IT) and IT enabled services industry to converge and consider IT intervention for enhancing competitiveness, reducing costs and bringing affordable medicines to market. Contact details:

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EXPRESS PHARMA

M|A|R|K|E|T

Confidence means using better science for more consistent compliance. Agilent’s Enterprise Edition uses a direct, automated approach to consistently perform qualification testing, validate calculations, and harmonize reports. Ensure your consistent, cost-efficient compliance and reduced regulatory risk with Agilent’s Enterprise Edition.

Manoj Trivedi Senior Manager Marketing & Program Development Drug Information Association A 303 Wellington Business Park I, Marol, Andheri - Kurla Road Andheri (East) Mumbai - 59 Tel: +91 22.2859476 Cell: +91 98.19777493| Fax: +91 28.594762 Email: Manoj.Trivedi@diaindia.org

Pharmac India 2012 Date: September 8-10, 2012 Venue: Gujarat University Exhibition Hall, Ahmedabad Summary: Pharmac India 2012 is the third international exhibition of India’s prominent pharma machinery, equipment and material industry. The exhibitions' aims to bring pharma manufacturers, pharma packaging material and machinery along with API’s ,bio pharma with largest suppliers, distributors under one roof. Contact details: Varsha Surve Project Coordinator Orbitz Exhibitions 402, Navyug Industrial Estate, T.J. Road, Sewri (W), Mumbai 400015 Tel: +91 22 2410 2801-03 Fax: +91 22 2410 2805 Cell: 09322037955 www.orbitzexhibitions.com www.pharmacindia.com

2nd International Symposium on Frontiers in Pharmaceutical Research and Nanotechnology (Nanopharma2012)

For more information visit: www.agilent.com/chem/comply

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Date: September 28-29, 2012 Venue: Mohamed Sathak AJ College of Pharmacy Sholinganallur, Chennai - 600119 Tamil Nadu, India Summary: Clinfocus Research Pvt Ltd, India in collaboration with Mohamed Sathak AJ College of Pharmacy, Chennai, Tamilnadu will host 2nd International Symposium on Frontiers in Pharmaceutical Research and Nanotechnology (Nanopharma2012). The focus of this symposium 'The future vision and challenges in Nanotechnology'. On this platform, experts from different fields from different geographical locations will come together to discuss, to explain and share their future ideas suitable for profitable research. Participants can expect expert advice in the special discussion forum which is the speciality in this symposium. Students can start their project based on the novel ideas dis-

cussed, teachers can update their knowledge and researchers can widen their knowledge by attending this symposium. Contact details: G Karthikeyan, M Pharm Convener-Nanopharma 2012 Tel: 91 9894286283

CPhl India 2012, P—MEC India 2012 Date: November 21-23, 2012 Venue: Bombay Exhibition Centre, Mumbai Summary: CPhI India into its sixth year, it is co-located events with more than 800 exhibitors is the largest and most comprehensive pharma industry event in South Asia. CPhI India is a great gateway to meet with key decision makers in pharma industry from around the world including India, China, Japan, the US, the UK, Germany, France, Italy, etc. P-MEC India is South Asia’s number one pharma machinery and technology exhibition and will give those involved in pharma manufacturing an unprecedented insight into the future of mechanical equipment and machinery. The exhibition will highlight the latest knowledge and the newest trends within the industry. Contact details: Milind Dixit Director - Exhibitions UBM India Tel: + 91 22 66122600 Fax: + 91 22 66122626 Email: milind.dixit@ubm.com

64th Indian Pharmaceutical Congress (IPC) Date: December 7-9, 2012 Venue: SRM Institutions Campus, Chennai. Summary: Association of Pharmaceutical Teachers of India will host the 64th Indian Pharmaceutical Congress, with the theme: 'Pharmacy Education: Innovation, Strategies and Globalization'. Contact details: Prof BG Shivananda Secretary-APTI HQ: Al-Ameen College of Pharmacy, Opp Lalbagh Main gate, Hosur Main Road, Bangalore – 560027 Email: aptienquiry@gmail.com

BioAsia 2013 Date: January 28-30, 2013 Venue: Hyderabad

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Summary: Biotechnology being an emerging industry, gamechanging strategies and relevant application of the knowledgeintelligence resource pool, drive the process of growth. BioAsia seeks to enhance, enrich and encourage newer innovations, path-breaking discoveries and effective solutions in the industry by offering a vibrant global platform for convergence of the key stakeholders - Biotech & Biopharma companies, research institutions, investors, service providers, policy makers, regulators and analysts. Contact details: BioAsia Secretariat 204, Imperial Apartments Greenlands Circle, Ameerpet Hyderabad 500016 Andhra Pradesh, India Tel: +91 40 6644 6477 +91 40 6644 6577 Web: info@bioasia.in

PHARMA Pro&Pack 2013 Date: April 24—26, 2013 Venue: Mumbai Exhibition Center, Goregaon (East), Mumbai Summary: Indian Pharma Machinery Manufacturers’ Association (IPMMA), will be organising PHARMA Pro&Pack Expo 2013 (PPPE 2013), an international exhibition to showcase the BRAND INDIA pharma machineries and allied products/services. The event is an initiative of IPMMA and is being jointly organised by the IPMMA and and GPE Expo. The event will offer a single platform for more than 200 exhibiting companies from India and across the world to showcase their products/ services to entire pharma fraternity of India and neighbouring countries. Exhibitors’ profile includes pharma processing and packaging machinery and materials, API, bulk actives and pharma chemicals, lab instruments and consumables, utilities, biotechnology, research, consultants, trade associations and publications and related services. Professionals and decision makers, regulatory officials, from India, SAARC region, Gulf region will attend. Contact details: Paresh Jhurmurwala GPE EXPO Global, Opp. Priyadarshini Tower, Near Judges’ Bungalows, Bodakdev, Ahmedabad 380 015, Tel: +91 792687 1390 / 4000 8253 / 4000 8233 Email: contact@pharmapropack.com July 16-31, 2012

Management

he European Union (EU) Parliament's July 4 vote against the ratification of the Anti-Counterfeiting Trade Agreement (ACTA) had organisations like Médecins Sans Frontières celebrating the ‘death of ACTA’. But any illusion that this experience will force the EU Parliament to give India and other countries some leeway in other similar discussions, like the free trade negotiations (FTAs) being pursued by the European Commissioner (EC), is just that ... an illusion. As DG Shah, Secretary General, Indian Pharmaceutical Association, cautions, "Many who voted against the ACTA also stressed the need to find alternative ways to protect intellectual property in the EU. I therefore do not think that it would lead to any softening of the EC's negotiating position in the EU-India FTA." Shah's Association represents many big Indian pharma companies, some of who have seen their consignments of generic medicines grounded at ports in the EU. These EU countries seized these generic medicines for 'trademark violations' of patented drugs even though these generics were recognised in the destination countries like Africa and Latin America. Dr P V Appaji, Director General, Pharmexcil comments that the EU Parliament's decision has come as a "great relief from the attempts of vested interests to show that legitimate generics are substandard quality." Tapan Ray, Director General, Organisation of Pharmaceutical Producers of India (OPPI), points out

July 16-31, 2012

that the agreement has not been formally approved by any of the signatory countries, as yet though it now appears that it will not be applicable to EU. The rejection in the EU is therefore not expected to reverse the other countries' support for ACTA. Proponents of ACTA warn that the EU's Parliament rejection of ACTA dilute IPR protection in the EU but IPR experts like Professor Prabuddha Ganguli, CEO, VISIONIPR, Mumbai and MHRD IPR Chair Professor, Tezpur University, Assam rubbish this claim. He feels that ACTA is "clearly superfluous and unnecessary as it attempts to creates a additional framework that brings no value to the system" and the rejection of ACTA in no way dilutes EU's strong intention to enforce IPR in its members. Ganguli opines that the TRIPS Agreement in Article 51 read with Footnote 14 adequately addresses issues related to measures against "anti-counterfeit" and further jurisdiction specific enforcement of patent rights, trademark rights and copyright are addressed within the framework of the IPR laws including civil and criminal procedures in each country.

More IP hurdles ahead There has been a long history of push back. For instance, one of the earliest well-organised attempts to discredit off-patent medicines was the launch of the International Medical Products AntiCounterfeiting Taskforce (IMPACT) by the WHO in 2006. WHO was forced to water down its role in

INSIGHT FOR MANAGING PHARMA

IMPACT after there were clashes between member countries at the both the 2008 and 2010 World Health Assemblies. WHO member countries from the developing world criticised WHO's role in IMPACT as well attempts use the word "counterfeit" as a public health term. The argument was that counterfeit matters should be handled by WTO and WIPO and not the WHO. A Third World Network report on the WHA 2010 proceedings featured a very telling reaction from WHO Director-General Dr Margaret Chan, who reacted to this tussle clarifying that WHO would focus on public health problems, and confirmed that the WHO had no role to play in IPR enforcement. She spoke of the need to take a multi-disciplinary and multi-faceted approach but only on the public health aspect and not on law enforcement or IP enforcement. Commenting on the perception that WHO was waging a war on generic medicines she said that if there is anything that WHO is doing to attack genuine, quality, generic medicines, "I will punish those staff". Added to this alphabet soup are the Patent Law Treaty (PLT) and Substantive Patent Law Treaty (SPLT) in the WIPO; and the Trans-

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Pacific Partnership (TPP) Agreement. The Patent Law Treaty (PLT) concluded on June 1, 2000 and Substantive Patent Law Treaty (SPLT) in the WIPO aims at going far beyond the formalities of the PLT to harmonise substantive requirements such as novelty, inventive step and non-obviousness, industrial applicability and utility, as well as sufficient disclosure, unity of invention, or claim drafting and interpretation.

The TPP threat Indeed, the next immediate threat on the horizon is thought to be the TPP, which "is more expansive than ACTA and potentially far more destructive," opines Swaraj Paul Barooah, IP Scholar at UC Berkeley's Law School in his blog post titled 'Exit ACTA, Enter TPP' on SpicyIP. As Barooah explains in this blog post, TPP is ostensibly a free trade agreement (FTA) that the US is negotiating with eight other nations (Australia, Peru, Malaysia, Vietnam, New Zealand, Chile, Singapore and Brunei); Mexico and Canada have also been invited to join in and Japan is expected to join in as well. He points out that the 'secretive' negotiations have been going on EXPRESS PHARMA

M|A|N|A|G|E|M|E|N|T DG SHAH Secretary General, IPA

“I do not think that it (rejection of ACTA by EU Parliament) would lead to any softening of the EC’s negotiating position in the EU-India FTA”

PROF PRABUDDHA GANGULI

SWARAJ PAUL BAROOAH

CEO, VISION-IPR, Mumbai and MHRD IPR Chair Professor, Tezpur University, Assam

IP Scholar, UC Berkeley's Law School

“ACTA is clearly superfluous and unnecessary as it attempts to create an additional framework that brings no value to the system”

“TPP is more expansive than ACTA and potentially far more destructive”

since 2009 and are expected to be complete by the end of 2012. Based on leaked drafts and documents, Barooah lists out five primary areas of concern in the TPP. While the lack of transparency is common to the early days of ACTA, TPP seems to propose extra-judicial enforcement, in that the dispute resolution process sets up an international tribunal which seems to circumvent domestic judicial systems. Barooah comments that it also seems to be very MNC friendly, granting them power to challenge countries' laws, regulations and court decisions in this international tribunal. Thirdly, Barooah opines that the TPP makes corporate responsibility "a joke" as it obliges member countries to provide a host of extreme new privileges (taking some of the worst aspects of NAFTA) while there are no general exceptions to safeguard environmental, health, labour or consumer protection policies. Specific to the pharma industry, the proposals on pharma pricing include introducing new administrative and judicial appeal systems to ensure that governments are 'properly valuing' drug patents when they buy them for their public health programmes. The attempt is to bring in provisions which allow pharma companies to sell en masse to governments while also raising the prices. And Barooah's fifth point is on the IP front, where he says that the TPP seems more restrictive than ACTA because all signatory countries will have to bring their domestic laws in line with the IP provisions laid out in TPP. Some of the problematic IP proposals are that temporary reproductions, which could include digital copies of nearly anything online, are included as copyright infringement. TPP also proposes to further extend the copyright period making the minimum duration for corporate owned works-for-hire as 95 years, +70 years for the standard copyright protection and 120 years for unpublished works. Regardless of copyright violation,

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DR PV APPAJI

TAPAN RAY

Director General, Pharmexcil

Director General, OPPI

“It's a great relief from the attempts of vested interests to show that legitimate generics are of substandard quality”

“The agreement has not been formally approved by any of the signatory countries, as yet though it now appears that it will not be will not be applicable to EU”

the TPP proposes anti-circumvention provisions so that even after an extended copyright protection period, one can continue to 'protect' work simply by attaching a technological protection measure (TPM). The TPP also provides for TRIPS plus damages for copyright infringement. Barooah hints that there are many more such proposals in TPP. While Ganguli is a "supporter of strong and enforceable IPR laws as they are essential for the socio-economic development of any country and also to build and support an innovation ecosystem", he believes that there is no need for more such jurisdictions like ACTA or for that matter TPP. Instead, he advocates strengthening and better implementation of the existing framework.

People power The July 4 vote of the EU Parliament is the latest manifestation of another trend when it comes to IP issues: the battle has long since gone from behindclosed-doors to street protests, sometimes coordinated across the globe in full media glare. These days, NGOs can match the ‘big industry’ backers of these IPR treaties, in terms of reach and mind space of the consumer, if not funding. In fact, Appaji of Pharmexcil opines that the ratification process of ACTA in the proposed form would not be possible due to the very active role played by international NGOs. Shah of IPA also points to other allies: the media which played an important role in creating awareness and educating people on what is just and equitable as also the convergence of various forces (like health activists, civil liberty movement and internet users) to a common position. EU citizens organised street demonstrations, e-mails to MEPs and calls to their offices. EU Parliament also received a petition, signed by 2.8 million citizens worldwide, urging it to reject the Agreement. These efforts managed to turn the tide, reversing the unanimous support ACTA receivedfrom the EU, with the heads of all 27 EU member countries

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signing it last December. By July some member states obviously had second thoughts and feared a backlash. A ratification needed the consent of all member states, and with only 22 states consenting, ratification was not possible. The overwhelming vote against the ratification - 39 in favour, 478 against, with 165 abstentions – is a testimony to the increased awareness levels on this issue. Of course, there is always the chance that ACTA could be resurrected in the EU. Shah points out that the EU Parliament has referred the ACTA to the European Court of Justice (ECJ) seeking opinion on its consistence with the EU Law. A favourable opinion could provide an avenue to modify the objectionable provisions and seek endorsement of the Parliament, he reasons. But this tactic might just back fire, as the Kenyan Government found out the hard way when it tried to push through an anti-counterfeit act. Appaji refers to the recent judgement of the Kenyan Supreme Court, directing the Government of Kenya to re-look the anti-counterfeit act, and he feels that "the attempt of vested interests in blocking the use of generics is losing ground." Coupled with the Indian Government's initiative of taking the 'Brand India Pharma' campaign global, Appaji feels that Indian pharma will strengthen its position in international markets. Pharmexcil is also organising the first ever India Show at this year's CPhI World Wide in Madrid. Projected as the first such show exclusively for the Indian pharma sector, this is another indication of the Government's determined effort to establish Indian pharma as a dependable source for quality generics at affordable prices. Signing off, Shah opines that this is an ongoing battle (i.e. protecting India's ability to manufacture and supply offpatent medicines at the affordable prices) and it would have moments of success as well as failures. One hopes that as IP law continues to evolve and mature, consumer/patient interest will reign supreme. viveka.r@expressindia.com July 16-31, 2012

M|A|N|A|G|E|M|E|N|T INSIGHT

FSSA and the emerging OTC landscape Anil Khanna, an independent strategic consultant and investment banker, talks about FSSA guidelines and its implications OTC drugs inally Food Safety & Standards Act (FSSA) guidelines were drafted and finalised in the third quarter of last year, after much delay. It would be instructive to mention here that the law was passed by the Indian Parliament way back in 2006. But this speed of forward movement seems to be at par for the course in Indian scenario. Despite the delay, we now have, at least, a clear definition and classification of nutritional food, novel food, health claim, nutritional claims etc. This is a much better situation, than having no definition of Over the Counter (OTC) medicines. Readers may be reminded that as per Indian Drug laws, there is no clear definition / categorisation of OTC medicines, even though the OTC segment is decent in size and growing as well. So what will be the impact of FSSA on the OTC landscape? The clue to the answer for this ques-

July 16-31, 2012

tion lies in a simple exercise. If we were to divide the Indian OTC landscape before 2000 and post 2000, and were to list the key OTC brands of both these periods, a clear and interesting trend emerges. It is quite clear that, the pre-2000 period was dominated by the therapeutic / curative segments like analgesic, cough / cold etc., while the post2000 period is dominated by supplements brands. It seems, what Thomas Edison said long back - â&#x20AC;&#x153;The doctor of the future will no longer treat the human frame with drugs, but rather will cure and prevent disease with nutrition.â&#x20AC;? is coming true with a little twist! Thus in this context, the final guidelines of FSSA, notified last year, have come at an appropriate time. The question is, will FSSA give further impetus to this trend and how? While the jury is out on the likely impact, the chances seem bright that more companies will want to capitalise

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on this growing opportunity and regulatory clarity.

Key highlights of FSSA Before analysing its impact, it would be prudent to briefly mention the key highlights of the Act. Key point is that this Act will impact the entire spectrum of the nutritional market, which is more than $ 1 billion plus, as mentioned below The Act defines health supplements as foods intended to supplement the normal diet of a person, and which are concentrated sources of one or more nutrients, like minerals, vitamins, proteins, metals or their compounds, amino acids or enzymes, other dietary substances, plants or botanicals , substances from animal origin or other similar substances with known and established nutritional or physiological effect, and which are presented as such, wherein the composition of these foodstuffs differ significantly from the composition of ordinary foods of comparable nature, and are offered alone or in combination, but are not drugs as per the Drugs and Cosmetics Act 1940 and Rules made there under. The Act also defines a novel food - as a food that does not have a history of

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human consumption in India or has any other ingredient used in it which or the source from which it is derived, does not have a history of human consumption as a food ingredient in India or foods and or has ingredients obtained by new technologies or processes. It includes foods and food ingredients which have been produced by a technology not currently in use or being used for the first time, where the process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect the nutritional value, metabolism or level of undesirable substances. Foods for specific nutritional or dietary purposes are defined as foods intended for particular nutritional uses, which owing to their special composition or process of manufacture, are clearly distinguishable from foods intended for normal consumption, and are sold in such a

way as to indicate its suitability for its claimed nutritional purposes.

Categories of the nutritional market

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Health claims being defined by the Act are as follows: ◆ Any claim that states, suggests or implies that a relationship exists between a food or a constituent of that food and health and include nutrition claims which describe the physiological role of the nutrient in growth, development and normal functions of the body ◆ Other functional claims concerning specific beneficial effect of the consumption of food or its constituents, in the context of the total diet, on normal functions or biological activities of the body and such claims relate to a positive contribution to health or to the improvement of function, or ◆ To modifying or preserving health, or disease-risk reduction claim relating to the consumption of a food or food constituents, in the context of the total diet, to the reduced risk of developing a disease or health related condition The Act also clearly defines the labelling guidelines which are quite stringent. For example, it states that the labels shall clearly mention the purpose, the target consumer group and the physiological or disease conditions which they address, apart from the specific labelling require-

Pre 2000 era

Post 2000 era

Crocin

Revital

Red-Bull, a very small category of less than ` 100 crore, which have high dose of Caffeine will also be covered under FSSA, as it has prescribed the cap for caffeine content in such drinks.

Gelusil

Supractiv

Marketing and distribution implications

Benadryl

Pediasure

Glycodin

Nutrigo

Moov

Olesan

D’Cold

Digene

Strepsils

I-Pill

Pricing of VMS, since they are categorised and marketed as drugs, is governed by Drug Price Control Order (DPCO), hence, in many cases is regulated. On the other hand, pricing of food supplements is out of DPCO purview, and hence is market driven. Similarly, while VMS products, marketed as a drug, can be only distributed at pharmacists, food supplements, can be distributed through normal stores. This would be a big advantage for food and FMCG companies. Hence, it is likely that FSSA will make more food companies entering into this space due to their distribution advantage.Thus FSSA will enable wider reach & coverage of OTC products.

Comparative drug prices

ments as mentioned against each type. Thus guidelines of the Act clearly enunciate the key associated issues entirely and give a whole lot of clarity. Similar guidelines already existed in the Western countries and, in fact, in China also.

Likely impact of new FSSA guidelines Most fundamental impact would be that it will throw open new opportunities for pharmaceutical, food companies, and FMCG companies on the common platform of ‘wellness’ So products which give some kind of instant gratification would be the best options to take the OTC route and largely be in the pharma company’s domain. So in a category like VMS, where ‘tiredness/energy/stamina’ and ‘immunity’ being the two main positioning platforms, many brands like Revital, Supractiv, A2Z or even Seacod, could be marketed as food supplements, if the respective marketers chose to do so. Some of them have already categorised themselves as ‘food supplement’ by even changing their formulation. For food companies, the area of interest would be ‘fortified food’ – normal food enhanced by the presence of vitamins, minerals or supplements. We already have examples like iron fortified cornflakes, probiotic curd, or biscuits. This segment will most likely grow rapidly and become pretty large in near future. Finally, in wellness space related to skin care (cosmeceuticals) FMCG companies will play a dominant role, like HUL, Dabur etc, with atleast two to three years horizon needed to build the equity.

Company will tweak their products To take the advantage of FSSA, companies, with the intent of getting their products classified as food supplements, instead of drugs, will either modify their formulation or offer sub-therapeutic dosage of the key ingredients. This will ensure that they are out of price control and can be freely marketed. Already many leading VMS brands (marketed both OTC and Rx way) have tweaked their formulation. Even Direct marketing companies like Amway, Daehsan Trading and Elken International, which are also planning to enter dietary supplements market, are reformulating their composition for the Indian market. Thus FSSA will not only modify the existing VMS products, but also tweak the composition at the drawing board stage itself. What’s more, with novel foods also being defined under FSSA, it will lead to many new products being importedto India Even energy-drinks products, like

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Advertising implications Since VMS drugs operate in ‘deficiency’ space and food supplements operate in ‘improvement’ space, it will impact the kind of claims they can make. So while a drug can make a claim like, “will make you recover from illness fast”, a food supplement can make a mild claim like, “will rejuvenate you, or enhance your energy level”. Thus while food supplement will enjoy distribution advantage, they will have to live with milder claims. While drug VMS brands can make any advertising claim which is substantiated, a food supplement has to strictly adhere to label claim due to stringent labeling norms. For example, last year, a leading children milk food drink brand faced the advertising self-regulatory body objection on both its advertising claim and label claim. It claimed four signs of brain development which was refutable and also claimed 28 ingredients, which wasn’t the case to be. Thus, FSSA will make OTC supplement brands to be very disciplined about their ingredients and their mention on the label. Slightest of deviation will make them liable for violation of norms

Emerging opportunity The United States Pharmacopoeia Convention (USP) has decided to join hands with Indian scientific community for developing safety standards for the entire range of dietary supplements and nutraceuticals. Central Food Technological Research Institute (CFTRI), Mysore will be the Indian side associate. This will not only help in growing the domestic nutritional supplements market, which is already more than $ 1 billion, with more companies planning to enter this space. Conversely, this initiative will help Indian companies to exploit the $ 75 billio US and European nutritional supplements market. Thus it seems that FSSA will probably take us closer to realisation of what Hippocrates said more than a century back that “Our food should be our medicine and our medicine should be our food”. That day doesn’t seem to be too far. The author can be contacted at anil.khanna@taipi.in July 16-31, 2012

M|A|N|A|G|E|M|E|N|T LEGAL EAGLE

Regulatory woes of pharma SMEs Jagmohan Rai Agarwal, after elucidating about the regulatory woes of the Indian pharmaceutical industry in the last issue, draws from his four decades’ experience in the SSI sector and dealing with the Indian drug regulatory authorities across the country, to elaborate on the legal procedure of handling of Not of Standard Quality (NSQ) drug producers and the role of the drug inspectors in doing so Action/Reaction of drugs inspector on receipt of NSQ report he drugs inspector (DI) relying on the bottom line of the test report, declaring the drug as Not of Standard Quality (NSQ), without examining the same, without studying relevant reference book(s), which are normally not available in his office, in majority of cases proceeds as below: 1. The action/reaction of DI varies from person to person and from state to state. 2. Sending of sample portion and original report to the manufacturer of alleged NSQ drug also depends on person to person and from state to state. 3. Copy of the report may also be forwarded to the Licensing Authority FDA of the manufacturing state. 4. Depending on his/her whims, DI after complying with provisions of the law may write to the manufacturer of disputed drug to forward copies of records of manufacturing, testing, sale, particulars of expert staff, constitution of the firm / company etc. 5. Again depending upon the level of EGO / DEAL, the DI may either drop further proceedings or refer the matter to the FDA of manufacturing state for

July 16-31, 2012

further needful action or may launch criminal prosecution for contravention of sec. 18(a)(i) r/w sec. 27(d) of the ‘Act’, mostly in the sampling state which may be at a long distance from the manufacturing place. It is to be remembered that administrative action u/r 85 of Rules only by the manufacturing state legally possible. It is matter of record that Drugs Consultative Committee (DCC) in its 26th meeting, held on September 1415, 1989, vide item no.22 had resolved as under: “The members agreed that guidelines approved in 22nd DCC (1993 guidelines) meeting should be adhered to as far as possible. However, it should be left at the discretion of the concerned drugs controller to file a prosecution in his state or to refer the case to the drugs controller of manufacturing state as circumstances warranted. That every drugs controller should invariably supply the information sought by other drugs controller in case a prosecution is to be launched irrespective whether the drugs controller of manufacturing state agrees to the decision of the drugs controller where the sample has been drawn to launch prosecution.”

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It is the above decision of DCC which resulted in launching of prosecutions in other than manufacturing states. In the name of investigation in majority cases copies of certain documents like manufacturing, testing, sale and constitution of firm/company etc are asked for. If this is being considered sufficient, investigation for fastening person(s) under criminal law for vicarious liability then there is no effective purpose of appointing qualified pharmacists in regulatory. The guidelines formulated by the Central Government after Drugs and Cosmetics (Amendment) Act 2008 and forwarded as Directions u/s 33P to all state governments, just to satisfy the agitating SMEs, is nothing but lollypop. Section 33P: The Central Government may give such directions to any state government as may appear to the Central Government to be necessary for carrying into execution in the state any of the provisions of this Act or any Rule or order made there under. A drug manufactured in Madhya Pradesh and its sample reported NSQ in Karnataka proposed ‘Screening Committee’ of which state shall examine the matter and report to drugs

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controller of which state? Important provisions inserted vide Amendment 2009: 1. Constitution of ‘Screening Committee’ of three senior officials not below the level of assistant drugs controller on whose written opinion the Controlling Authority shall decide course of criminal prosecution. 2. Criminal prosecution shall be launched by the DI after obtaining written permission of the Controlling Authority. Drugs Consultative Committee (DCC) 1. In the year 1993 guidelines in respect of NSQ drugs were circulated among all State drug controllers. 2. NSQ drugs were divided into ‘Major’ and ‘Minor’ defects and guidelines were issued for taking appropriate actions. 3. Investigation is the important part of those guidelines before proposing any action whether administrative or legal. 4. Prosecution was stated to be last resort where all other remedial measures had failed. Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the drugs and cosmetics (amendment) act, 2008 effective from 10.8.2009. Legal/administrative actions as required under the said Act and Rules for the violation of the provisions of the Act are taken by the State Licensing Authorities. The actions are normally initiated on the basis of test reports of government analysts declaring the drug samples as not of standard quality. The major categorisation of not of standard quality reports could be as under:-

Salient features Category A (Spurious and Adulterated Drugs Category B (Grossly sub-standard drugs) Category C (Minor defects) In the case of drugs manufactured by a licensed manufacturer under a valid manufacturing licence and has been found grossly sub-standard, the matter may be investigated at the manufacturer’s end, and where criminal intent or gross negligence has been established and if the merits of the case so demand, and where it is felt that administrative measures would not be sufficient to meet the ends of justice,

the re-course to prosecution should be resorted to. In the case of drugs manufactured by a licensed manufacturer under a valid manufacturing licence and found grossly sub-standard and where criminal intent or gross negligence is not established, weapon of prosecution should be used judiciously, where it is felt that administrative measures like suspension or cancellation of licenses or compounding of offences would not meet the ends of justice. In the case of not of standard quality reports because of minor defects arising out of variations from the prescribed standards or contraventions of other provisions of chapter IV of the Act, administrative measures including suspension/cancellation or compounding of offences may be resorted to. Prosecution may only be launched where it is justifiably felt that above measures would not meet the ends of justice. The State Drug Control Departments shall constitute screening committees consisting of at least three senior officers not below the level of assistant drugs controllers or equivalent to examine the investigation reports of the cases where prosecutions are proposed to be launched. The committee may submit written opinion on the investigation reports regarding their feasibility of taking legal action. The criminal intent or gross negligence should be taken into consideration while recommending actions like prosecution etc. Care should be taken that charges framed are not based on inappropriate provisions which may be difficult to prove in the court of law in the absence of proper justification or evidence. Cases of failing in assay, brand name disputes and non-renewal of manufacturing licence in time should be examined on their merits before recommending prosecution in such cases. Prosecutions by the inspectors shall be launched on the basis of written permissions of the controlling authority and this authority in turn shall consider the opinion of the screening committee while taking final decision in the matter. Prosecutions under section 18(a)(i) r/w sec. 27(d), in case drug is declared NSQ, barring some exceptions, are being launched against firms/companies, mostly SMEs’, across the country, no body in the profession is objecting and raising the voice, judiciary is also

The provisions of Drugs and Cosmetics Act 1940 and Rules 1945 made there under are well designed, except the latest amendment of 2009, but these are being misinterpreted, misguided, misused, wrongly targeted, abuse of powers vested in so-called experts in department of Drug Control, whether Central or State 32

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taking cognizance of alleged offence and criminal matters attracting vicarious liability are dragging in various courts not only for years but for decades causing undue hardship to so called accused persons in addition to mental agony, torture, humiliation and financial burden. If reporting of a drug as NSQ is the basis for launching the prosecution then nearly 10,000 samples reported to NSQ annually must result in prosecution in each and every case. But it does not happen so and the system of ‘pick and choose’ is being adopted depending on the ‘deal’, size and category of the company and its influence on the FDA, superior officials and political leadership. The author is of the firm view that simply if a drug is declared as Not of Standard Quality (NSQ) and even if the test report either in form 13 or in form 2 is accepted as it is, there is no contravention of sec. 18(a) (i) and nor legislator has prescribed any punishment u/s 27(d) under such circumstances UNLESS: It is established, on real investigation 1. That while the drug was manufactured and released for sale/distribution, it was not properly manufactured/tested for some or the other reason, either partially or wholly. OR 2. That the drug is NSQ and falls within the ambit of sec. 27(a) of the ‘Act’. OR 3. That the drug was being sold / distributed even after receipt of adverse test report. There is no provision in the ‘Act’ for punishment under sub-sections (a), (b), (c) and (d) of sec. 27 if the drug is allegedly declared as NSQ and if findings in the investigation, in above respect, is negative. Hon’ble Supreme Court while dealing with a case on limitation (State of Rajasthan Vs Sanjay Kumar and Others Drug Cases 1998, SC, 7), under Para 9 have observed as under: “On the date of collection of samples from respondent no. 16, on February 29, 1988, it could not have been said that any offence was committed as selling of drugs per se is no offence and the quality of drugs was not known to the Drugs Inspector, the complainant on that date. It is only, when the report of the Government Analyst was received, that it came to light that the provisions of the Act are violated and offence is committed.” Thus it is only on receipt of the adverse test report by the DI, subject to investigation and scrutiny thereof technically, it could be attributed that the offence, if any, is committed. The responsibility could be fastened on person(s) after detailed investigation. While disposing of bundle of criminal applications on the issue of tenability of Regular Criminal cases, Hon’ble Bombay High Court, Bench at Nagpur made the following observations: “Looking to the scenario discussed by me above, I conclude that the Food and Drugs Department and its officers from the cadre of Food Inspectors to Joint Commissioner do not have any July 16-31, 2012

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legal knowledge, legal skill and seriousness with which the provisions of these Acts concerning human health is required. They are casual, callous and hardly concerned. Relevant and concerned provisions/amended provisions of Code of Criminal Procedure are not even known to them to make use thereof. They are making cases only to show that cases are being prepared and instituted in courts and finally tell the people that courts have discharged or acquitted the accused persons and thus save their skin. In my opinion, the Government is simply wasting money on Food and Drugs Department and serious view for revamping this department will have to be taken by the Government with strict ‘accountability’ to be fixed for each and every officer”. (Bombay High Court, Nagpur Bench, Cr.Appl. Nos. 3439 of 2006 with Cr. Appl. Nos. 3440 of 2006, 3442 of 2006, 3444 of 2006, 3441 of 2006, 3445 of 2006, 1290 of 2008 and 3443 of 2006) In the same matter Hon’ble Court, was pleased to direct as below, under Para 23, to the Secretary, Food and Drug Department: “I have already pointed out in details in para 7, 8, 9, 19, 20 & 21 the acts of omissions and commissions on the part of the officers of the department and I clearly find that the officers of the Food and Drug Department in

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these cases who are public servants have disobeyed the law with intention to cause injury by their acts of omissions and commissions and thus they have committed offence punishable under section 166 of Indian Penal Code. Since the offence is noncognizable, this court directs the Secretary, Food and Drug Department, Government of Maharashtra, to identify the concerned officers responsible for the acts of omissions and commissions in all these cases and cause filing of private complaint for the offence punishable under section 166 of Indian Penal Code against them in the Court of law, and report compliance about filing thereof to this Court on or before 31.7.2010”. (www.indiankanoon.com) A Firm/Company whose drug is alleged to have violated prohibitory provisions under section 18 (a) (i) is invariably sought to be punished under section 27 (d) of the ‘Act’. Each and every licencee authorised to manufacture drugs for sale or distribution complies with mandatory provisions of Drugs and Cosmetics Rules 1945 (Rules) in as much as that every raw material is utilised in formulation only on its compliance with prescribed standards and the finished goods is released for sale /distribution only when the batch is reported as of standard quality conforming with pre-

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scribed standards. Every licencee maintains proper record of raw material and finished goods as prescribed under ‘Rules’. The testing of raw material and finished goods is conducted either in in-house laboratory of the licencee or in an institution duly approved by the SLAs under the provisions of the ‘Rules’. In-house testing unit of the licencee and the institution approved by SLAs are subjected to FDA inspections periodically for maintenance of qualified staff, equipment, instruments, and methods of analysis adopted, chemicals/reagents, floor area etc. Subsequently, on reporting of a drug/batch NSQ by the GA the process begins. The so called ‘Investigation’ carried out by Drugs Inspector (DI) concerned before launching of prosecution in the Court of Law, is nothing but collection of record related to manufacture, testing, sale, constitution of the firm, names and residential addresses of technical staff responsible for the manufacture and testing of disputed drug, licence copies with renewal, if any. For collection of these records, some State Authorities have adopted a practice to visit the licencee, may be located in other states, with or without the local FDA Authorities. In the meanwhile, the SLA in whose jurisdiction the licencee operates normally serves

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Show Cause Notice (SCN), to such licencee, under rule 85 of ‘Rules’. Thereafter depending of whims of concerned DI and his superior authorities, the private complaint (Prosecution) is launched in the Court of Law alleging contravention of sec. 18(a) (i) and seeking punishment u/s 27(d) of the ‘Act’. There is not a single known example in the country where the court did not take cognizance of the matter applying judicial mind as has been observed by high courts in number of judgments and dismissed the complaint ab-initio. It is reiterated that solely on the basis of author’s interpretation of secs. 18(a) (i) and 27(d) that if a drug/batch is reported as NSQ and even if the said report is accepted as it is, and if the relevant batch of the drug is not sold by the licencee thereafter, there is no contravention of sec. 18(a)(i) and sec. 27(d) does not prescribe any punishment in such circumstances. This legal thought is being narrated in sequence as under: a)The allegation that the accused have manufactured the drug/batch as NSQ and sold/distributed the same as such is unfounded, without any evidence to that effect. On the contrary the record related to manufacturing/testing may or may not be filed with the complaint goes to establish beyond any doubt that the drug/batch when was manufactured and released for sale/distribution, was of Standard Quality. There is practically no specific allegation that what material in those records would be treated as supportive to the allegation made in the complaint. b) It is the test report issued by the GA opining that the drug/batch is NSQ at a subsequent date is the basis of presumption that the drug/batch must have been NSQ when manufactured and sold/distributed. c) The Hon’ble Supreme Court of India in the matter between State of Rajasthan Vs Sanjay Kumar and Ors, (DC 1998, SC, 7) in Para 9 observed as “On the date of collection of samples from respondent no. 16, on Feb. 29, 1988, it could not have been said that any offence was committed as selling of drugs per se is no offence and the quality of drugs was not known to the DI, the complainant on that date. It is only when the report of the Government Analyst was received, it came to the light that the provisions of the Act are violated and offence is committed.” d) Allegation of contravention of s.18 (a) (i) seeking punishment u/s 27(d) of the ‘Act’ could be possible only if:i) There is documentary evidence that at the time of release of drug/batch for sale/distribution and based on manufacturing and testing record, the drug was in fact NSQ at that itself. There is not a single known example where allegation of violation of sec. 18(a) (i) is levied with aforesaid or any similar documentary evidence with the complaint or otherwise. The DI and all other superior officials in the Regulatory in the Centre

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and states, baring exceptions, are claiming to be qualified and experienced in the profession and therefore, in appropriate cases investigation on above technical aspect is definitely expected. Such officials are not supposed to act as Bada Babu and Babu. ii) The manufacturer-licencee continues sale/distribution of disputed drug even after receipt of adverse test report. Almost in each and every case no unsold stock of the disputed drug is available with the manufacturerlicencee, at the time when such adverse test report is received by it, therefore, question of sale/distribution of disputed drug after receipt of adverse test report does not arise and any allegation to that effect is unlawful and unfounded. On the contrary in 100 per cent cases, the manufacturer-licencee, on being directed, as provided u/r 74(j), 78(i) by the State Licensing Authority, initiates effective steps to recall stocks of disputed drug/batch, as for as prac-

tical, from the market/institutions to whom the said drug was sold. The manufacturer-licencee is also required to intimate SLA of the quantity, if any, received back from the market and ensure its due destruction in presence of FDA official. e) The object of sec. 18(a) (i) also aims at dealers/institutions etc. who if ignore the intimation about adverse test report received either from the DI or manufacturer-licencee and continue the sale/distribution etc. of the disputed drug/batch. In such circumstances and if due investigation is carried out only such dealers/institutions are liable to be prosecuted. f) There is no provision in sec. 27 to punish any body even if a drug/batch is found NSQ, except as described above, and except as provided u/s 27 (a), if attracted, the relevant portion is abstracted here below: “Solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be,” which means any drug if is likely to cause death or is likely to cause such harm on the body as would amount to grievous hurt within the meaning of sec. 320 of Indian Penal Code solely on account of such drug being not of standard quality, is punishable. Sub-sections (b) and (c) of sec. 27 are not relevant to this article. Sub-section (d) of sec. 27 being

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residual section is invariably applied seeking punishment for violation of sec. 18(a) (i) particularly for drug reported NSQ. This section provides punishment for any drug, other than a drug refered to clause (a) or clause (b) or clause (c) in contravention of any other provision of this chapter or any rule made there under. Now if we relook at sec. 18(a) (i) which is prohibitory provision and as demonstrated above, there is hardly any evidence in support of allegation that the drug/batch when manufactured and sold was NSQ at that stage only; seeking of punishment u/s 27(d) is absolutely irrelevant. In other words sec. 27(d) does not prescribe any punishment even if drug/batch is reported NSQ unless and until prohibitory provision of sec. 18(a) (i) is contravened. There is yet another landmark judgement reported in 2010(1) Drugs Cases 277, Allahabad, DB, (Brahmaji Vs State of U.P. & Ors). High Court issued the following directions: (i) that the Central Government and the State Government will both give a clear indication as to how they plan to take effective action for controlling menace of spurious drugs; (ii) the State Government to ensure within two months all the requisite manpower and required infrastructure, i.e. creating adequate number of laboratories etc; (iii) both the Central Government and State Government to inform this court as to what strategy they propose to adopt so that focused raids are conducted and samples taken so that effective measures can be made for identifying the manufacturers or dealers in spurious drugs; (iv) the State Government to inform the court about the time frame in which the computerisation system of which the plan has been submitted by the NIC will be operational. Note: Uttar Pradesh has 71 districts, 53 DI, 400 manufacturing units, 180 blood banks, 50,000 retail and 40,000 wholesale outlets. The provisions of Drugs and Cosmetics Act 1940 and Rules 1945 made there under are well designed, except the latest amendment of 2009, but these are being misinterpreted, misguided, misused, wrongly targeted, abuse of powers vested in so-called experts in department of Drug Control whether Central or State. It is very convenient to demonstrate with evidence that these officials are involved in activities against the provisions of the ‘Act’ and ‘Rules’. They are least interested to safe guard public health even on written complaints with evidence, they prefer to negotiate with the erring person(s) and keep shut. Such officials in majority cases are badly infected with CColi (Corrupto Coli) and could be for the time being be treated with veterinary dose of Mcillin Tabs. 10,000 mg S.S. Therefore it is rightly said ‘POWER CORRUPTS AND ABSOLUTE POWER CORRUPTS ABSOLUTELY. The author can be contacted at sharda_jollo@yahoo.co.in July 16-31, 2012

Research

EXPERTISE FOR DRUG DEVELOPMENT

Eight potential osteoarthritis susceptibility genes discovered It brings the total number of osteoarthritis susceptibility genes isolated in European populations to 11 he largest genome-wide association study (GWAS) of osteoarthritis to date, published Online First in The Lancet , has uncovered eight new genetic variants or loci that appear to increase susceptibility to the most common form of arthritis, which affects about 40 per cent of the world population older than 70 years. These findings bring the total number of osteoarthritis susceptibility genes isolated in European populations to 11. “The health economic burden of osteoarthritis is increasing commensurate with obesity prevalence and longevity. Our findings provide some insight into the genetics of arthritis and identify new pathways that might be amenable to future therapeutic intervention,” explains John Loughlin from Newcastle University in the UK, who led the research (funded by Arthritis Research UK). Inherited factors could account for as much as 60 per cent of the variation in risk for osteoarthritis.

July 16-31, 2012

But despite extensive efforts, it has proved difficult to identify the genes involved. The three variants discovered in GWAS to date (GDF5, chromosome 7q22, and MCF2L) account for only a small fraction of that risk, suggesting that the number of participants in previous studies might not have been large enough to identify genes with modest effect. Here, Loughlin and colleagues compared the genomes of more than 7,400 people with severe hip and knee osteoarthritis (80 per cent of whom had undergone total joint replacement) with over 11,000 unrelated controls from the UK. The most promising sites identified were then replicated in an independent group of almost 7,500 people with osteoarthritis and about 43,000 individuals without the condition from Iceland, Estonia, the Netherlands, and the UK. Results confirmed the three previously reported gene variants and found a further eight sites associated with osteoarthritis. Five of the new

loci were significantly associated with the disease and an additional three loci were approaching the threshold for genomewide significance. The strongest association was variant rs6976 on chromosome 3p21.1 in the region of the GNL3 gene whose encoded protein (nucleostemin) plays an important role in cell maintenance. The authors explain, “Nucleostemin protein levels were substantially increased in cultured chondrocytes (cells usually embedded in cartilage matrix) from patients with osteoarthritis compared with controls, raising the possibility that this gene might be functionally important in the pathogenesis of osteoarthritis.” Three other new loci (CHST11, PTHLH, and FTO) are located in regions of considerable biological interest that encode proteins involved in the modulation of cartilage proteoglycan (already targeted by anti-osteoarthritis drugs such as chondroitin sulphate), the

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regulation of endochondral (within cartilage) bone development, and body weight (a strong risk factor for osteoarthritis). Marc C Hochberg and colleagues from University of Maryland School of Medicine, Baltimore, US say, “The challenge will be to connect the biology of these genes to the development and progression of osteoarthritis and to investigate the therapeutic potential of these pathways for disease prevention and treatment.” The Lancet

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Insufficient doses of vaccines hinder elimination of polio in Pakistan and Afghanistan In 2011, polio cases in Pakistan reached a decade high oo few children have received sufficient doses of vaccine to wipe out polio in Pakistan and Afghanistan, two of only three countries in the world where endemic polio has yet to be eliminated, according to new research published Online First in The Lancet. The findings suggest that the newly introduced bivalent oral poliovirus vaccine (OPV) has the potential to eliminate polio in these countries if sufficient numbers of children could be reached by vaccination programmes. “In 2011, in the worst affected regions of Pakistan and southern Afghanistan, an estimated 40 per cent of children under age three were unprotected against type I, the predominant circulating wild poliovirus,” explains Kathleen O’Reilly from Imperial College London, UK, who led the research. “One of the reasons for the low vaccination coverage is access to all populations due to insecurity, in particular in some parts of Southern Region in Afghanistan, and Federally Administered Tribal Areas (FATA) in Pakistan. These regions are a potential reservoir for the virus into polio-free countries, jeopardising worldwide polio eradication.” Despite mass immunisation campaigns and the introduction of the more effective bivalent OPV in Pakistan and Afghanistan in 2009, incidence of virus type I has increased. In 2011, polio cases in Pakistan reached a decade high. Using vaccination history data from

almost 47,000 children with acute flaccid paralysis between January 2001 and December 31, 2011, O’Reilly and colleagues estimated vaccination coverage, the protection offered by OPVs, and examined their association with incidence of poliomyelitis over the study period in seven regions of Pakistan and Afghanistan. Their findings indicate that with each

Despite mass immunisation campaigns and the introduction of the more effective bivalent OPV, incidence of virus type I has increased dose of the bivalent OPV received, there was a greater than 23 per cent chance of being protected against type I poliomyelitis, compared with about a 35 per cent chance with the monovalent OPV, and around a 13 per cent chance with the trivalent OPV. But despite the bivalent and monovalent OPV proving very effective, limited access to children during recent vaccination campaigns has severely limited the

effect of these vaccines, they say, “Substantial drops in vaccination coverage during 2006–11 in FATA, Balochistan, and Khyber Pakhtunkhwa in Pakistan, and in southern Afghanistan, have resulted in lower vaccine-induced population immunity and resulted in an increase in the incidence of poliomyelitis during 2010–11.” In contrast, in regions outside of southern Afghanistan that are free from conflict, where both routine immunisation services and supplementary immunisation activities have been able to reach the majority of children, there has been a consistently high percentage of children receiving more than three doses of the OPV. These areas have experienced significant increases in population immunity during the study period. The researchers conclude, “If vaccination coverage during the two trivalent and four bivalent OPV campaigns planned in Afghanistan and Pakistan in 2012 could be increased to at least 80 per cent, and if persistently missed children could be reached by the programme, the proportion of unprotected children would decrease to less than 10 per cent and eradication would become feasible.” Philip Minor from the Health Protection Agency in the UK says, “These results provide an example of the need to tailor immunisation programmes to epidemiological circumstances, particularly where the goal is eradication.” The Lancet

Population Genetics, Cambridge University to study genetic causes of Asperger Syndrome Population Genetics to retain commercialisation rights to any biomarkers discovered; results of study expected during this year opulation Genetics Technologies and the University of Cambridge’s Autism Research Centre have begun a joint study to identify sequence variants in two genes, both of which have been previously associated with Asperger Syndrome. Under the agreement Population Genetics will undertake the genetic analysis and retain rights to commercialise any biomarkers discovered. Results of the study are expected during 2012. The study is based on 1000 samples, half of which are from people with high functioning autism or Asperger Syndrome, and half are from controls. In this study, Population Genetics will be applying its proprietary Reflex technology that allows variant discovery along a discrete contiguous target in large populations. The study uses buccal (mouth swab) samples, which are less invasive to collect than blood samples. Having a technology

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such as Reflex which can make use of buccal samples is important for the large population studies in which Population Genetics specialises. Professor Simon Baron-Cohen, Director of the Autism Research Centre (ARC) at Cambridge, said, “Most genetic studies have focused on classic autism but the genetics of high-functioning autism may yield valuable insights because these are individuals who do not have associated learning disability or language delays. Working with Population Genetics gives us an exciting way to test our previous findings that variations within these two genes are associated with high functioning autism or Asperger Syndrome.” Dr Bhismadev Chakrabarti, Director of Genetics at the ARC, said, “These genes are prime candidates for helping us understand abnormalities in sex-steroid hormones and neural

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connectivity respectively”. This study is one of a number being conducted by the ARC to examine if single nucleotide polymorphisms (SNPs) in these candidate genes differ in their frequency between cases and controls; or if these SNPs are associated with phenotypic measures that the ARC has developed, such as the Autism Spectrum Quotient. Another of the ARC’s goals is to test if the same or different associations are found in Asperger Syndrome and classic autism. Alan Schafer, CEO, Population Genetics, commented, “We are pleased to be working with Professor Baron-Cohen on a syndrome of such genetic and symptomatic complexity. Unravelling the underlying genetic contributions could provide a path towards a better understanding of causation and potentially to markers to guide further investigation.” EP News Bureau – Mumbai July 16-31, 2012

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Medicyte, Reinnervate to develop next generation predictive 3D cell toxicity assays Will work together to combine their upcyte and Alvetex Scaffold technologies

Medicyte’s upcyte hepatocytes combine the benefits of quantity (generation of up to 2000 vials per donor) with the quality of primary hepatocytes July 16-31, 2012

Przyborski, CSO, Reinnervate. “We are excited about working with Reinnervate to explore the growing area of

3D cell culture. The combination of both technologies will undoubtedly lead to a more predictive culture model without the limitation

wo market leading companies in the field of cellbased assays and predictive toxicology have announced a new product collaboration. Medicyte (inventors of the upcyte technology) and Reinnervate (market leaders in the growing field of 3D cell culture) said they will work together to combine their upcyte and Alvetex®Scaffold technologies to bring next generation cell bases assays to the biopharma and academic research markets. According to a press release, early data, already presented at academic meetings, indicates that Medicyte’s upcyte hepatocytes combine the benefits of quantity (generation of up to 2000 vials per donor) with the quality of primary hepatocytes. Furthermore, upcyte hepatocytes, grown with a more native 3D morphology in Reinnervate’s alvetex scaffold, seem to outperform their 2D counterparts. “We are delighted that Medicyte have chosen to put Alvetex Scaffold at the heart of their new product development plans. The ability of 3D cells to better predict in vivo responses to therapeutic and environmental challenges makes alvetex scaffold technology an important new tool for scientists,” commented Prof Stefan

of cell supply,” commented Dr Joris Braspenning, Managing Director, Medicyte. The two companies

did not disclose financial terms relating to the collaboration. EP News Bureau – Mumbai

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Microbiota and the gut brain axis: When microbiology meets neurosciences Chantilly, France cientists from around the world invited by Lallemand to its Second Scientific Exchange on the Gut-Brain Axis shared their latest findings about the implications of the gut and the microbiota in response to stress and anxiety. This topic was a rare occasion to gather in the same room neurobiologists, behavioural experts, microbiologists gastroenterologists, but also animal nutritionists. The communication between the brain and the gut, which is sometimes called 'the second brain', is a bidirectional dialogue that co-ordinates brain and gut functions. However, if the relationship between the brain and the gut, which harbours 70 per cent of our nervous cells (the enteric

nervous system), has been known for a long time, Dr Theodorou from INRA in Toulouse, who chaired the symposium, explained in her introduction that new players have emerged along the way: the immune system (also largely represented in the digestive tract since 60-70 per cent of our immune cells are associated with our gut), and, more recently, the microbiota, which has certainly been overlooked until now. Our guts harbour around 10 times more bacteria than the number of cells in our body, and 100 times more genes than our own genome. If several animal studies and hypothesis around digestive pathologies prove the implication of the microbiota in the gut-brain cross-talk, or Gut-Brain Axis, Dr Theodorou admitted that the exact mechanisms involved are still a 'black box' needing further investigations. Exciting data were presented about the great potential of probiotics to modulate the gut-brain axis and, for example, to impact our response to stress and anxiety.

The chicken and egg dilemma Some scientists have recently noticed that, in certain behavioural conditions such as autism, anxiety or depression, the microbiota is altered, and they are trying to link the condition to a particular microbiota profile. But is it the microbiota

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which determines the behaviour or the other way round? Prof. Collins, from Mc Master University, in Canada, gave another approach to this chicken and egg dilemma by showing that stress, by altering the gut environment, can alter the microbiota. In an animal model for anxiety and depression, his team showed how behavioral changes or stress alters the gut microbiota and that a particular neurotransmitter involved in the stressresponse (the corticotrophin releasing hormone - CRH), could play a role by altering the gut physiology and hence the habitat of the microbiota. Several studies presented during the meeting showed that an alteration of the microbiota can affect the behaviour of

animals or modify the stress response and visceral sensitivity. In particular, Prof C Collins presented some microbiota transfer experiments in mice which lead to a 'behavioral transfer'. The gut-brain axis is essential for maintaining intestinal homeostasis and wellness, and we now know that the disruptions of this axis could be implicated in certain pathologies in human, ranging from functional and inflammatory intestinal illnesses to behavioral disturbances, particularly those recently associated with intestinal dysbiosis. One of the questions raised from the tri-party cross-talk is whether we can act on the gut-brain axis by rebalancing the gut microbiotia with probiotics? Prof John Cryan, from Cork University, in Ireland, brought the neurobiologist point of view. He recognised that it is not until very recently that neurobiologists have started to consider the role of the microbiota and he presented several animal studies that could be considered as real proof of concept of the role of the microbiota on the stress response. What he wanted to know was whether probiotic could affect the stress response in adults, and also affect the cognitive behaviour. He presented some recent works showing the positive effect on stress and anxiety behaviour in rodents of a strain of L rhamnosus, effect which was accompanied by improved

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cognitive performance. Knowing that irritable bowel syndrome has a slight effect on learning memory, it could be interesting to see if the modulation of the gut microflora could also enhance cognitive performance in addition to stress response in human. Professor Didier Desor, an expert in cognitive science from Nancy University, in France showed that a particular probiotic formula (L. helveticus R052 and B. longum R175 â&#x20AC;&#x201C; Probioâ&#x20AC;&#x2122;Stick) displays anxiolytic-like activity in rats. In humans, two previously published studies have shown that this probiotic was able to reduce physiological symptoms associated with chronic stress, in particular abdominal pain and nausea, reduce signs of anxiety and depression, using different psychological tests and a biomarker for stress (cortisol). In Montreal, Professor Guy Rousseau, tested the same formulation on a rat model of post-myocardia infarction depression, a condition associated with 20 per cent mortality in human not only could he show a preventive effect against depressive behaviour, but he also observed an effect of the probiotic at brain-level in areas of the brain associated with mood and behaviour (lymbic and hippocampic areas), the tendency of brain cells to enter into apoptosis (also named programmed cell death, a form of cellular suicide) was decreased thanks to the probiotics. Looking into the 'black box' Dr AitBelgnaoui, presented a new study conducted at INRA in Toulouse, which aimed at further investigating the 'black box' by looking at the effect the probiotic could have on brain cells. Using a mouse model of chronic psychological stress, she showed that the stress-targeting probiotic formula had the ability to decrease the neuroendocrine response to stress, and prevented the stress-induced activation of certain neurons in some areas of the brain which are involved in stress response. In another region of the brain, the probiotic normalised neuronal activity which is normally depressed by chronic stress. It thus appeared that the probiotic was able to restore the negative response associated with chronic stress at brain level. In the recent study presented by Prof Cryan with L rhamnosus in mouse, the researchers also demonstrated that the probiotic had an effect on the expression of GABA receptors (GABA is the main inhibitory neurotransmitter) at brain level, and that the probiotic effect was mediated via the vagal nerve. If all these recent works clearly illustrate the fact that the probiotic effect on the digestive microbiota is reflected at brain level, most of the black box still remains a mystery. However, these novel findings are very exciting and open a wealth of opportunities in the management of pathologies linked to a dysfunctionning gut-brain axis, such as IBS. EP News Bureauâ&#x20AC;&#x201D;Mumbai July 16-31, 2012

Packaging S P E C I A L ith a steady growth in the pharmaceutical industry, the pharma packaging industry will continue to fare well. Packaging of any product obviously plays a vital role in the perception of any product, particularly in the case of medicines, and the industry will need to continue ideation on the best packaging solution for consumers. Consumers demand quality, genuine medicine and the industry will need to assure that this is delivered through quality, consumer centric packaging. Counterfeit medicine is a significant problem, in India as well as globally. While the scope and definition of the problem differ, there is no debate over the pressing need to take preventive actions for combating counterfeit medicines and protecting the lives of millions of consumers. According to a FICCI committee report, counterfeit drugs make up to 15-20 per cent of the market. Didier Lacroix, Global Senior Vice President - Sales and Marketing), Cognex states, “It is difficult to estimate the seriousness of the problem of drug counterfeits in India. There is a possibility that more than 25 per cent of the medicines consumed in the poor or developing countries could be counterfeit. The extent of counterfeit medicines is difficult to obtain as there are no global specific studies on them as of now. The various numbers can only be known from organisations like WHO and drug regulatory authorities implementing various policies to counter drug counterfeiting.” The Indian Government estimated that about 0.4 per cent of the country’s drugs are counterfeit and that substandard drugs account for about eight per cent. But independent estimates range from 12 to 25 per cent with poor traceability of medicinal packages playing a key role in the growth of fake drugs across the country. Hence, tracking and tracing of individual pharma packages as well as an entire export pallet using a high-end bar coding mechanism is an important tool in fighting drug counterfeiting in India.

Notification in place The Indian government is taking effective measures to counter proliferation of spurious drugs within India and is also working towards curbing the exports of counterfeit drugs. Recently, the task force for the Union Ministry of Health recommended SMS authentication as the ideal solution to protect medicines meant for sales within the country. On the export side, the Directorate General of Foreign Trade (DGFT) July 16-31, 2012

COUNTERACTING counterfeiting with packaging With the threat of counterfeiting looming over the Indian pharma industry, it is unable to achieve its full potential. Usha Sharma examines how packaging can be of utmost importance in annihilating this threat and accelerating Indian pharma’s growth trajectory

notification of October 2011 (see article ‘Decoding the barcode’, Express Pharma, October 16-31, 2011) has been an important step in taking preventive measures to protect drugs. Additionally, packaging machines currently available also cater to other, non-pharma industries. Packaging technology should evolve to create smaller, more cost-effective machines that can cater specifically to pharma companies’ needs. Such machines should consider both the budget of large pharma companies as well as small and medium enterprises, whose products make up a large portion of ‘Brand India pharma’.

FAKE DRUGS HAVE TWO TYPES OF EFFECTS ◗ Direct effects: harm to human

health, including death, and unnecessary expenditure which could lead to a notable financial burden ◗ Indirect effect: increase in the

resistance to genuine drugs which could limit the treatment options for millions of people

IATA PCR from July 1 Another interesting change in healthcare packaging is the mandated www.expresspharmaonline.com

requirement for the transportation of time and temperature sensitive health cargo shipments. The air cargo industry is using IATA Perishable Cargo Regulations (PCR) as an essential reference guide for all those stakeholders involved in the packaging and handling of perishables for air transport. Based on the recommendation of the Time and Temperature Task force and working group members and endorsed by the IATA Live Animals and Perishables Board, the IATA Time and Temperature Sensitive labels became mandatory for the transportation of the health cargo shipments from July 1 this year Ashifi Gogo, Chief Executive Officer, Sproxil says, “Government could encourage adoption of such machines from statutory taxes for the EXPRESS PHARMA

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ASHIFI GOGO

KISHORE KAR

DIDIER LACROIX

Chief Executive Officer, Sproxil

Vice President-Sales and Marketing PharmaSecure

Global Senior Vice President - Sales and Marketing), Cognex

The changes needed to implement the mandated barcode solution at the secondary and primary levels can have high cost implications depending on the way the solution is implemented

The DGFT notification is a welcomed move by the industry as it is an attempt to standardise security mechanisms across the industry

Not more that 10 per cent of companies have implemented this system in their organisation. Government needs to take major action and implement a hard and fast rule to install this system within the mentioned deadline

initial few months and incentivise pharma companies to comply with the mandate as per the deadline.”

system in their organisation. Government needs to take a major action and implement a hard and fast rule to install this system within the mentioned deadline. Only few top companies have implemented this system in their organisation. “ Kishore Kar, Vice President-Sales and Marketing, PharmaSecure highlights,“The DGFT notification is a welcome move by the industry as it is an attempt to standardise security mechanisms across the industry. Many of our customers have already complied with these standards, taking the necessary moves to implement the system.” No doubt the system change presents challenges. As Kar reveals, “Implementation of any new notification takes time at the operational level. The manufacturers have to make the necessary hardware arrangements to comply with the change.” Lacroix says, “The recent recommendations of the task force on track and trace is a great step to detect counterfeit drugs before they go for sale. Cognex’s InSight Track & Trace works with networked in-sight vision systems to create a complete identification and data verification solution for labels on pharma packaging.” Kar explains,“The implementation of primary packaging is on target. Primary level packaging is more challenging and takes more time for the industry to fully implement than tertiary and secondary. We started primary level coding with SMS authentication in 2010 and are continually seeing the market expand. Reaction from all stakeholders across the industry has been very positive to our solutions for the simple reason that our mobile authentication system is backed by a very strong and secure back-end. Its simplicity, scalability and smooth integration with a variety of manufacturing systems make the association with our clients highly valuable.” Describing the salient features of

PharmaSecure’s solutions from a patient/consumer point of view, Kar says, that as a SMS authentication solution it is a consumer-centric solution that empowers consumers to authenticate their products. “Ease of mobile usage, and quick response time guarantees convenience and limited time consumption thereby making the solution extremely user friendly,” sums up Kar.

Types of track and trace systems SMS authentication service is one of the best ways for a consumer to know if the product purchased is genuine or fake. Sproxil offers this SMS authentication service for both pharma and non-pharma products. By using technology already highly prevalent in developing markets, Sproxil’s mobile product authentication (MPA) solution empowers consumers to actively avoid counterfeits and only purchase genuine products through their mobile phone. Track and trace technology has helped various companies protect their product and assured consumers that the medicines they are consuming are reliable and safe. It is the need of hour that technologies like this should be made mandatory for pharma companies so that it can assist them in tracking fake medicines within the country and ensure patients that they are safe from illegal drugs existing in the market. The proposed track and trace technology is capable of tracking the drugs right from the manufacturers to the retailers to check the threat of counterfeiting of drugs in the country. The rules are in place but industry uptake of these solutions has been poor. Lacroix informs, “Not more than 10 per cent of companies have implemented this

Track and trace technology has helped various companies protect their product and assured consumers that the medicines they are consuming are reliable and safe

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Lack of clarity adds to challenges The DGFT’s intent to help protect Brand India from the impact of the counterfeiters, led it to implement new barcoding measures after a thorough review of the measures suggested by the different stakeholders of the pharma business. However, without clear direction on the use of these barcodes (like for consumers to validate products or to prevent reimbursement fraud), there is a lot of apprehension surrounding the use of barcodes on product packaging. Further, many critics of the mandate are of the opinion that barcodes alone will not be able to hinder the increase of spurious drugs in the market. The lack of barcode readers, computers and point of sale (PoS) systems at all points of the supply chain significantly cripple the commercial overall value derived from implementing the DGFT barcode mandate. The barcodes are meant to create a more robust track and trace system, but if there are not enough scanners to document information on products moving down the supply chain, the system remains flawed. Finally, unreliable infrastructure characteristics of developing countries such as irregular internet connectivity and unreliable power (if available at all) poses another major challenge to the barcode solution. According to Gogo, the changes needed to implement the mandated barcode solution at the secondary and priJuly 16-31, 2012

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mary levels can have high cost implications depending on the way the solution is implemented. For complicated or sub-optimal manufacturing plants, implementation is currently not easy for the SME’s given their oft-limited budgets for technology adoption. He further highlights that the government’s role should be to facilitate and encourage adoption of a consumer-level SMS authentication service. It should set standards for the service providers to sell their solutions to the industry and facilitate healthy competition for private players already established in this field. In return, service providers can provide valuable market information collected from their databases and report to the authorities immediately of any anomalies or suspicious activity. Many of India’s small and medium scale pharma enterprises are challenged to keep up with the technological complexities and the implementation costs. Some of the large Indian pharma organisations are also apprehensive about the impact that the barcode implementation will have on their high-speed manufacturing lines. New affordable printing technologies have to be developed to keep up with the pace of barcoding innovation. So far, implementing DGFT norms of compliance at the tertiary packaging (shipper) level has not been much of a problem, mainly because of the much slower packaging speeds and fewer units to be labelled at this level. However, with so many issues still unresolved some stakeholders are now adopting a ‘wait and see’ approach especially since the entire barcoding exercise was halted by the Chennai High Court in December 2011. As the July 1 deadline came and went, the decision is still pending, and industry continues to be in limbo. On one hand, the Chennai Court’s stay has brought relief to industry players, especially SME players, but for how long?

while being cost effective at the same time. Kar says, “The government initiative is strategic in two ways: first, the ‘Made in India’ brand is protected from counterfeiters; and second, globally the industry is moving in the direction of serialisation and track and trace systems. Serialisation is a widely prevalent authentication measure being used across the globe and this notification will help Indian

manufacturers comply with global standards.” He makes the point that enhanced security mechanisms strengthen the confidence levels of foreign players sourcing from India. India is known as a major global player in drug manufacturing. In 2010, India’s pharma industry was worth $10 billion and ranked 15th globally, according to IMS Health. Inbuilt counterfeit control mechanisms such as coding

of primary, secondary and tertiary drug packaging ensures a high level of security and global compliance for domestic Indian manufacturers, emphasises Kar. Gogo too alludes to the benefits of investing in such technologies, advising, “To compete with the international brands, the Indian packaging industry must utilise unique collaborations or in-house development of technologies such as UIDs

with mobile phone based consumer verification technology to curtail counterfeits.” The future clearly lies in a unified system that allows both track and trace as well as consumer authentication. Thus it is high time that industry players accept the fact that some form of authentication will need to be deployed and plan their budgets accordingly. u.sharma@expressindia.com

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Ecobliss India bags three awards for packaging It has bagged awards for new packaging products like LED lamps, agriculture seeds and innovative lighting cobliss India’s all three entries has won WorldStars at the International Packaging Excellence Awards competition, at a function held in Croatia. Ecobliss won the awards for new packaging products like LED lamps, agriculture seeds and innovative lighting products. The WorldStars winners were selected by a jury in the UK consisting of 23 country representatives and a representative from the International Packaging Press Organisation. The pre-eminent international award in packaging, WorldStar illustrates the continual advancement of packaging in India. WorldStars are presented only to those packages which, having already won recognition in a national competition, are compared by an expert panel of judges to similar packages from around the world. Awards are based on the judges' consensus that a package is superior in its own right and better in its class in execution or innovation by comparison. AVPS Chakravarthi, Managing Director, Ecobliss India said, “Seeing is believing. You will only buy what you see. And this is exactly why packaging is essential in capturing that first moment of truth. It only takes seconds for a consumer to notice a product on the store shelf. That moment presents

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an incredible marketing and selling opportunity. Nearly 70 per cent of all purchase decisions are made at the shelf or point of purchase. Nearly half of all packaged goods are sold without any additional marketing support.” Ecobliss offers various user-friendly, innovative packaging solutions including cold seal blister packs, heat seal blister packs, pharma wallets, fold over trap blister cards, clam shell blisters, transparent boxes and range of Ecobliss cold and heat sealing machines. It also offers contract packaging for customised jobs. EP News Bureau—Mumbai

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July 16-31, 2012

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‘The Pune base will reinforce Coesia’s ability to work directly with clients’ Vinayak Savadi, Managing Director, Coesia India, speaks with Usha Sharma about the company’s presence in the Indian market, the role of the Pune office in the Group’s global operations and future growth prospects Give us an overview about the Coesia Group. Headquartered in Bologna, Italy, Coesia is a group of innovation-based industrial solutions companies operating globally. Coesia’s customers are leading players in health and beauty, consumer goods, tobacco, aerospace, racing and automotive industries. The group consists of 12 companies: ACMA VOLPAK, ADMV, CIMA, CITUS KALIX, FLEXLINK, G.D, GDM, HAPA, LAETUS, NORDEN, SACMO and SASIB. The group has 60 operating units (48 of which are production facilities) spread across 27 countries. Of these companies, the ones relevant to the lifesciences and healthcare industry are FLEXLINK, HAPA, LAETUS, NORDEN and SACMO. FLEXLINK is the leading provider of production logistics solutions to manufacturing industries, within the automotive, electronics, healthcare and fast moving consumer goods segments. HAPA manufactures ‘on demand’ printing systems for the pharmaceutical and cosmetic packaging industries. LAETUS produces on line packaging security and vision inspection systems for the pharma industry to verify presence, completeness and correctness of packaging materials and drugs. NORDEN designs, builds and supplies fully automated tube filling systems covering all speeds and applications within various segments: pharma, cosmetics, toothpaste, food and industrial. SACMO designs complete packaging machinery lines and supplies refurbishments of existing machines, maintenance on customer’s site, retrofit of machines in production, second-hand machines, customer training, manufacturing of machine parts, emergency service for part manufacturing and assembly of complete lines. Tell us about your India operations. Coesia had set up its base in Pune in January 2011, with the aim of supporting other Coesia Group companies operating in the strategically crucial Indian market, including G.D, ACMA VOLPAK, NORDEN, HAPA, LAETUS and GDM. This region is one of the first to be created specifically to fulfil one of Coesia’s primary objectives: to better exploit the opportunities offered by potential synergies between its component companies, in order to be able to meet the requirements of diversified clients in a better way. This will be one of the key aspects of Coesia’s strategy to consolidate its global technological leadership through its presence in the most important local markets. The opening of the Pune base also aims to reinforce one of the group’s hallmarks, namely its ability to work directly with its client companies, to listen to their requirements and to develop July 16-31, 2012

new solutions to meet their specific needs. What are the advantages of operating from India? The presence of Indian technicians will mean quicker and better understanding of the specific requirements of our customers. In recent years, VOLPAK has notably reinforced its presence in the Indian market, installing lines for a range of functions and sectors - from machinery for packaging sauces and drinks for the food industry to packaging machinery for the cosmetics, chemical and pharma industries. Now, thanks to the opening of the new Coesia Region in Pune, VOLPAK can offer sales, technical and maintenance services to its clients. After an active plan identifying the supplier chain, train-

In the last few years the R&D has been committed to finding new solutions mainly in areas such as increasing production speed using new packaging materials, creating new packaging forms, developing new technical solutions for the production and packaging processes ing the technicians for machine assembly and set up, Volpak has started its commercial production of HFFS and VFFS machines in India. For NORDEN, the COESIA company that specialises in the tube filling for FMCG and the pharma sector, the new centre in Pune will be able to supply solutions both on a technical level and in terms of customer service. Present in India for the last two decades, HAPA and LAETUS will consolidate with the Group synergies and will offer effective sales, technical services, spares and consumables to customers through Coesia India’s regional branch offices in Mumbai and Delhi. What is the focus of Coesia’s R&D activities? The Coesia companies have always

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been technological leaders in their fields. The technological breakthroughs they created have changed the way machines are built, products are packaged and quality control is carried out. Today, the Coesia Group can count on 840 highly specialised designers and technicians working in its Research & Development departments worldwide, on an intellectual property based on over 2,400 registered patents and on over 30 scientific cooperations with leading universities, research centres and institutions worldwide. In addition, the Coesia Engineering Centre was created with the aim of both developing completely new process technologies and seizing opportunities originating from the cross-fertilization and technology transfer among Coesia companies. This allows our customers to benefit from a huge pool of innovative solutions at their disposal. In the last few years our R&D has been committed to finding new solutions mainly in areas such as increasing production speed using new packaging materials, creating new packaging forms, developing new technical solutions for the production and packaging processes, applying new technologies for quality control and printing systems, increasing flexibility in format and brand changeover, reducing energy consumption in the production process. In terms of sustainable innovation, we are committed to a responsible development of our business by using energy and resources in the most efficient way and minimising the environmental impact of our operations. To embed sustainability in every stage of the life-cycle of our products, our R&D is working to introduce new design techniques in the fields of fluid dynamics, thermal properties and electrical systems, in order to reduce electrical consumption (for electric motors, power supply in feed, cooling systems and vacuum generation for compressed air) and energy consumption in terms of tons of CO2e produced by our machine lines running at customer plants. A practical example is ACMA’s ‘Green Machine’. ACMA’s new SP2-NG horizontal flow pack machine can reduce energy consumption by up to 30 per cent compared to traditional machines. Based on the concept that resources can be managed only if their use is measured and assuming that only what can be controlled can be optimised, the ACMA SP2-NG machine allows the operator to actually see during the operation how much energy the machine is using, both in general terms as well as for each product packaged. To achieve this goal, ACMA worked with Schneider Electric in a very fruitful collaboration. u.sharma@expressindia.com EXPRESS PHARMA

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Selecting the right packaging solution One-go solution for the pharmaceutical product developers is to select an optimum packaging solution with maximum saving of time, no extra costs, no trials and errors. Chhanda Das, Head-Research Services, Bilcare India, gives an outlay about pharma packaging lister packaging is a versatile option and has the capacity to provide optimum protection with availability of wide range packaging components comprising different barrier properties. However, for the same reason, identifying the most suitable blister packaging material is complex. There are various issues involved in selecting the right material as well optimising the machine parameters. It needs a very good understanding of the film properties vis-à-vis application/machine parameters for getting an optimal packaging performance. Each drug is made up of molecules of different structures and nature. Even the same drug is formulated with various kinds of excipients. Hence, it is quite natural that each formulation behaves differently on environmental changes and hence packaging needs of each formulation are different from others. It is a normal practice to imitate the packaging of innovative products and also of other established brands, but never succeeds in getting the suitable packaging as the packaging requirements are different with different formulation even if the active ingredients are same. This could lead to failure in the stability study and also can cause recalls due to the failure in the market. Therefore it is of prime importance to understand each formulation for its environmental sensitiveness and design the packaging according to its needs. This is the prime draw back of conventional packaging development method, which is based on a trial and error method. Even the size and shape of the dosage form are trivial factors in deciding the film complex

Chhanda Das Head-Research Services Bilcare India

used for blister packaging. Any packaging selection done without understanding these factors is prone to failure. ICH stability study is often the method employed to decide on the packaging of pharmaceutical products. Formulators usually follow the innovators for presumed surety of passing the stability tests which is not scientific enough to yield ideal packing and leads in most cases to over protection or under protection not fully realising a product’s true barrier requirement. Also, as ICH stability does not cover product marketed under wider climatic conditions (tropical conditions), it may cause loss of markets, delay in product launch, higher developmental and packaging costs. An optimal packaging with respect to all techno-commercial aspects provides clear, quantifiable benefits to the product. Often these benefits are not been quantified and documented correctly. Hence, its importance is not understood properly. For new products it is presumed to be safe practice pack in highest barrier package to ensure that there is no failure in the stability study in order to avoid any delay in the launch of the product. However, in many cases this could be counterproductive. As an example, products with a tendency to release gas need a breathable film and it could be disastrous if one selects a high barrier packaging. Same with oxygen sensitive products, an expensive popular choice for highest moisture barrier film has lower oxygen barrier property and is surely not an option for product sensitive to oxygen also. If the initial moisture content is the triggering factor for auto-degradation, then even a

100 per cent barrier film cannot ensure stability. Study of absorption isotherm studies shows that products absorb higher moisture under low-temperature and high humidity conditions that prevail in the field than the high-temperature and high humidity conditions used in accelerated stability studies. Hence, a higher rate of degradation may be observed in moisturesensitive products under the actual conditions rather than those observed under accelerated conditions. BilcareOptima offers the pharma industry a reliable tool for scientific identification of the most optimum packaging that decrease the time to market and packaging cost without any fear of stability failure at the first attempt, in a span of 40 days only. It covers physical and chemical forced degradation tests of complete formulation, a software simulation of the blister geometry using finite element analysis and all about the available/innovative barrier packaging materials. It has been proven on various studies involving few major brands in pharma industry that cost reductions of about 30 per cent have been achieved not considering the internal savings on trials/first to file/launch of the product and finally advantage of selection of right materials. So with BilcareOptima, Bilcare Research bridges the gap between the pharma and the packaging industry, by providing the testing facilities and the required knowledge about the packaging process and the materials. (The author can be contacted at chhanda.das@bilcare.com)

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July 16-31, 2012

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Connecting for good health Kishore Kar, Vice President, Sales and Marketing, PharmaSecure shares details about the company’s newly launched mobile health platform, psConnect which offers medicine authentication with a suite of user-friendly health services oor medication adherence costs the pharmaceutical industry hundreds of thousands of crore in lost sales per annum. Findings from a number of medical studies show patient adherence ranges from 50-80 per cent. Non-adherence can lead to poor health outcomes, drug resistance, prolonged illness, mortality and increased medical costs. Across the globe, mobile health (mhealth) technology is improving healthcare delivery. In Sub-Saharan Africa, short-messaging service (SMS)

Authentication and psConnect messages reminders have been used to increase medication adherence and improve short-term health behaviours. In India, telemedicine has taken off, allowing patients to speak to a health advisor over the phone, and speciality hospitals are offering free refill reminders to their patients. Based on experience in mobile authentication and the huge potential of mobile health care to transform healthcare delivery, PharmaSecure is launching psConnect - a mobile health (mhealth) platform that enables a variety of providers to offer mhealth services. Now consumers can opt-in to health services when they authenticate a PharmaSecure coded medicine package. Initially, three services will be provided: free health tips, free refill reminders and talk to a health advisor. PharmaSecure entered the India market in 2009 to provide pharma companies with anti-counterfeiting solutions through mobile authentication. Globally and in India, counterfeit medicines are a huge problem costing the lives of hundreds of thousands of people per year. Counterfeit medicines can result in patients experiencing prolonged illness, ineffective treatment and drug resistance. According to a FICCI committee report, counterfeit medicines make up to 15-20 per cent of the Indian pharma market. Mobile authentication empowers July 16-31, 2012

the end consumer to check and authenticate his own medicine by sending a simple verification SMS. A random and unique alphanumeric code is printed at the manufacturing line on each medicine package (strip or blister pack) along with a mobile number where this code can be sent by an SMS. When a consumer sends this message, an immediate reply is received that verifies the medicine is a genuine product of the manufacturer. Now with the psConnect a patient can authenticate a hypertension medicine, opt-in for refill reminders, receive customised health tips about his condition and talk to a health advisor when he has a question. In addition to the primary benefit of empowering consumers to check that they are buying an authentic drug, this solution has the added benefit of establishing a twoway channel of communication between the manufacturer and the consumer. This can be used to disseminate important drug safety information, educate consumers about their particular ailments and inform patients about key public health initiatives. The platform providers manufacturers numerous possibilities to increase their market advantage, distinguish their brand and create loyal consumers. To enhance the interactivity of this mobile solution, PharmaSecure has introduced a value-added service called psConnect. The psConnect mhealth platform currently provides free reminders to refill medicines, health tips and quick connections to a health advisor.

How it works After a consumer authenticates her medicine by SMS she receives a sequence of two messages. The first message verifies the authenticity of the product. The second SMS presents her with a menu of service options from which she can select.

Application 1: Refill reminders Poor medicine compliance contributes to sub-optimal outcomes to treatment. SMS reminders are a simple but powerful tool to keep patients on track. Through the psConnect platform, patients can opt-in for refill reminders for every seven, 10 or 15 days.

Application 2: Health tips We all want to make informed decisions about our health. By signing-up for health tips, now patients can have the information they need to lead healthier lives and enjoy the maximum benefits of the medicines they take.

Application 3: Speak with a health advisor Poor health literacy leads to improper medicine use and poor compliance. In many cases, physicians and chemists cannot spend sufficient time talking to patients about their condi-

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tion or how to take their medicine properly. Now patients can be linked to medically qualified advisors over the phone who can provide: ● Medicine information ● Stress management ● Nutrition advice ● Disease information ● Treatment recommendations ● Nearby hospitals, clinics, doctors and more! Over the past decade, the telecom industry has boomed with now over 900 million wireless subscribers in India alone. This makes the mobile phone by far, the best medium for communicating with and reaching the masses, especial-

Elements that make mobile authentication solution feasible

Security It should not be easy for a counterfeiter to guess or replicate. This is achieved through randomly generated, alphanumeric codes.

Usability Consumers should be able to easily type in and SMS the code for verification. This means especially long codes may have the drawback of increasing error rates and hence defeat the purpose.

Scalability Since every single unit in a batch gets its on code, there must be enough codes available to cover all production for a reasonable amount of time. PharmaSecure proprietary algorithm is capable of generating trillions of unique codes. ly people located in physically remote areas of the country. Mobile phones are now being used to disseminate information about government services (e.g. passport application status), provide financial inclusion (e.g. opening of bank accounts in villages) and create access to health services. Counterfeit drugs are a global menace, and it is time to take aggressive measures to prevent the proliferation of this menace in India. The rapid growth in mobile phone usage provides the opportunity to do so in a lowcost, effective, scalable manner. Uniquely coding drugs and enabling them to be authenticated via a simple SMS may be just the solution to do the trick. It is important for both manufacturers and the government to seriously evaluate the potential and take the right steps to put this power in the hands of the Indian consumer. (The author can be contacted at kkar@pharmasecure.com) EXPRESS PHARMA

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Migration in drug packaging – a challenge for Indian pharma industry Ashish Moghe, Market Manager - Pharmaceuticals, Label and Packaging Materials, Avery Dennison (India) points out the challenge that arises due to migration in drug packaging and recommends ways to overcome it effectively oday, India is considered as the “pharmacy of the world” since it now supplies one third of all the pharmaceutical products sold worldwide. Indian drug manufacturers attribute this success to continuous R&D on products and standardised process infrastructure. India has the largest number of FDA-approved manufacturing plants outside the US. Low costs of production, innovative scientific manpower and increased outsourcing of manufacturing processes to India combined, makes Indian pharma a powerful industry group. The sector is currently experiencing an annual growth rate of around 16 per cent. This phase of rapid expansion is due to the anticipated loss of patent protection on major blockbuster drugs worth $120 billion, over the next few years, with Indian generic drug manufacturers planning to capture more of this market. There are approximately 250 large units and about 8,000 small-scale units that form the core of the pharma industry in India. This includes five central public sector units. It is now the third largest in the world in terms of volume and stands 14th in terms of value. According to data published by the Indian Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, total industry turnover between September 2008 and September 2009 was $21.04 billion, of which the export market was worth $8.25 billion. The Indian pharma market has the potential to reach up to $70 billion by 2020. For the first time in many years, the international pharma industry is finding great opportunities in India. It was once an extremely fragmented market with severe price competition and government price control. Now, the process of consolidation, which has become a generalised phenomenon in the world pharma industry, has started taking place in India.

Risks and issues Over the past decade, pharma companies have entered a difficult period where shareholders, the market and

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regulators have created significant pressures for change within the industry. The Indian pharma industry has had to contend with several challenges including the effects of new product patents, drug price control, infrastructure development, regulatory reforms, quality management and conformance to global standards. The pharma business is a global one and, if manufacturers’ markets include the US and Europe, they must abide by the regulatory requirements set by the US FDA, and the European Medicines Agency (EMEA), as well as national boards such as the Drug Controller General of India (DCGI). In particular, compliance with the regulations dealing with the migration of contaminants from packaging to contents should be a major focus for India.

The migration process Where glass containers were impervious to chemicals leaching through, the same does not apply to the new generation of drug containers and delivery systems that are made of plastics such as LDPE, HDPE and PP. Plastic containers are very convenient, especially for small units and where squeezing is required. They also offer increased efficiency, reduced breakages and costs. But, it is possible that components from label inks, lacquers, top coats, adhesives, paper or film face stocks, or even the container itself, will leach through and contaminate or react with the medicine inside. The highest potential for migration has been observed with solvent-based inks, UV inks, top coats and lacquers.

Threat to India’s sales The purpose of packaging is to keep medicines and personal care items fresh, and to protect them from direct contamination. It is important, therefore, for pharma manufacturers in India to be aware of the potential risks in changing from glass to plastic containers. Companies need to consider the threat to consumer safety represented by chemicals migrating from the packaging of all pharma products. Drugs might no longer have the

that can in any way alter or affect the safety or efficacy of the drug.

EMEA guidelines for drug packaging

Ashish Moghe, Market Manager Pharmaceuticals, Label and Packaging Materials, Avery Dennison (India) expected effect, or there could be health-related reactions to the presence of unwanted chemicals. Such problems could cause loss of consumer confidence in the particular brand, resulting in reduced market share. By ensuring that all pharma packaging meets industry regulations, manufacturers can be confident in the safety of their products. Although many Indian pharma companies are not aware of the stringent regulations and requirements regarding the migration of chemicals from packaging, others are realising the importance of this issue and are meeting the challenge. Enhanced consumer protection is the main aim of these guidelines, so those who are leading the change will be in a strong position to benefit.

FDA guidelines for drug packaging The American FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)]. Any product that is defined by the FDA as “a drug” must conform to Regulation 21 CFR 211.94 - Drug product containers and closures, which states that: (a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements. (b) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product. (c) Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilised and processed to remove pyrogenic properties to assure that they are suitable for their intended use.(d) Standards or specifications, methods of testing, and, where indicated, methods of cleaning, sterilising, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures. This can be interpreted as that the package must not have anything migrate out of it into the product

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The EMEA, through the Committee for Medicinal Products for Human Use (CHMP) and the Committee For Medicinal Products For Veterinary Use (CVMP), published guidelines in 2005 on plastic packaging intended to be in contact with medicinal products. They indicate the requirement for extraction and interaction studies, as well as the availability of toxicological data for any extractables and leachables detected. Also, the products of the interaction between packaging migrants and the pharma ingredients must be taken into account. These regulations apply to all packaging components: containers, closers, stoppers, over-seals, container inner seals, administration accessories and container labels.

Testing for migration The purpose of interaction and E&L studies (testing for extractables and leachables) is to demonstrate whether the packaging of a pharma product is safe under normal storage conditions and/or whether the drug contained within is being contaminated by migrating chemicals. Extractables: When testing for extractables, the pack is subjected to solvents of varying polarity and at high temperatures, without destroying it. The solvent used for extraction should have the same propensity to extract substances as the active substance/dosage form as appropriate. In the case of medicinal products, the preferred solvent would be the medicinal product or placebo vehicle. The obtained extracts are analysed extensively to gain as complete a picture as possible of all the compounds that might contaminate the drug. Interaction studies: Interaction studies can include migration studies to monitor the leaching of substances from the plastic material into the formulation/active substance and/or sorption studies to evaluate a possible loss of drug quality due to adsorption or absorption effects. They detect any reactions between the plastic packaging components and product that lead to unacceptable changes in the quality of the product under normal usage conditions. Migration studies: If the plastic material is composed of layers of different plastic materials, the possibility of migration of components of the external layers into the medicinal product should be evaluated, depending on the nature of the roduct and its intended use. Furthermore, it should be demonstrated that no components of ink or adhesives applied to the outer surface of the container/closure system will migrate into the medicinal product. Migration studies during development are necessary when extraction studies have resulted in one July 16-31, 2012

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or several extractables. In these situations, it should be demonstrated that in conditions representative of the intended use, substances will not migrate in such quantities as to alter the efficacy and stability of the active substance/medicinal product or to present a toxicological risk. Tests should be performed on at least one batch of the active substance/medicinal product. A leachables study follows a toxicological evaluation. Substances classified as critical are analysed within the pharma product itself, under conditions that reproduce those of the intended use. Sorption studies: Developmental studies may be necessary to investigate interactions between the packaging material and the formulation due to sorption of the active substance or an excipient to the packaging material, leading to changes in product quality. Sorption studies have to be performed when changes in the stability of the medicinal product are observed, during stability studies, which may be affected by adsorption or absorption of formulation components to the plastic packaging. Migration tests and E&L studies are, to some extent, based on official standard methods and regulations, with numerous techniques needed to get a complete picture. Once all this information is correlated, it can be used to optimise any packaging system with regard to migration properties. Good packaging design provides stability and shelf life to the drug and the delivery systems, and becomes fundamental to the safety convenience and compliance of drugs.

Avery Dennison has the right solutions Faced with the potential loss of lucrative local and export pharma markets, it is vital that packaging designers and manufacturers in India ensure that any new pharma packaging they develop complies with the relevant standards and regulations. It is just as important to choose a label manufacturer that has the experience and expertise to provide compliant labels. Avery Dennison has dedicated R&D facilities in the US, Europe and Asia, where experienced scientists and technicians work together with customers to develop sophisticated, cutting-edge labelling solutions. As a result, Avery Dennison is able to offer a guaranteed product portfolio of dedicated pharma label materials and adhesives that meet the regulatory and compliance requirements of the highest industry standards.

A sophisticated range They produce a sophisticated range of lightweight variable information products, as well as removable adhesives and flexible face stocks that are suitable for thermal transfers, direct thermal and laser printing. The portfolio features both film and paper face stocks, which deliver excellent print quality. Understanding the demands of pharma packaging, these products deliver consistent low migration properties and excellent mandrel performance, even with small, thin-walled LDPE containers. Extraction studies, comparing a range of adhesives available on the market, have shown that Avery Dennison S692NP, a clear permanent adhesive, has the lowest risk of migration. One international pharma company tested it during qualification for use on containers of animal eye-drops. The extraction test delivered such excellent results that they decided not to continue testing other adhesives.

Additional support and consultancy services Avery Dennison offers additional support to customers, providing a consultancy service and helping to produce any documentation that is needed to meet regulations. They have developed their own reliable testing methods and have data sheets and migration analyses available for standard products. The technical representatives at Avery Dennison are also able to work with customers to develop customised solutions for particular applications, such as syringes, saline bags and blood bags that have critical packaging requirements. Apart from low migration characteristics, customers can also choose track and traceability features, plus anti-counterfeiting and anti-tampering devices.With an eye on the future, the change management policy at Avery Dennison requires that any necessary updates in packaging are planned at least an year in advance. This gives packaging manufacturers and brand owners ample lead time to maintain operational stability.

Opportunities for packaging manufacturers The burgeoning pharma market presents packaging manufacturers in India with huge opportunities for business growth, provided that they meet the stringent regulatory requirements of world markets. With its global experience and expertise, Avery Dennison can be trusted to help manufacturers develop innovative pharma packaging solutions and to obtain regulatory conformance and quality compliance certification for their products. (The author can be contacted at ashish.moghe@ap.averydennison.com) July 16-31, 2012

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Pharma Ally Thermo Fisher Scientific launches free-standing microbiological incubators Thermo Fisher Scientific has introduced new large-capacity Thermo Scientific Heratherm microbiological incubators in Europe, the Asia-Pacific region, Latin-America and Africa. The new products complete the range of Heratherm microbiological incubators, adding two more sizes for high sample volume or larger samples: 400- and 750-litre capacity

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‘Using Desktop Virtualisation, pharma companies can cut down costs’ Vishal Khare, Director Sales - Corporate Accounts, India Subcontinent, Citrix Systems, answers key queries put across by Sachin Jagdale on how implementation of desktop virtualisation (DV) would increase operational efficiency in the pharma industry Tell us about the concept of DV. Traditionally, individual desktops have been a hard-coded combination of operating system, applications, and user settings, and managed one-by-one on an ongoing basis. Many IT organisations we speak to are looking at Desktop Virtualisation (DV) to upgrade their entire approach to desktop management. In this context, DV is a natural technology evolution to deliver high value, high performance enduser computing that is simple to consume and optimised for operational efficiency. To simplify the concept, the applications, desktop operating system and user data is hosted in the data centre and decoupled from the endpoint (any device such as smart phone, tablet, PC etc) rendering it as a mere access point for users. So the user gets the same experience as his original PC terminal, but the data is secure in the data centre with no transactions happening at the endpoint devices and no data being stored there. In India, we have seen a change in mindset of IT organisations. Most of them are looking for virtualisation and cloud like models of delivering IT, which means services are on an ‘on-demand’ format. In what way pharma companies would benefit in getting FDA approval if they implement DV solutions? Do you have any case study to prove this? The process of drug discovery is extremely lengthy and very tedious. To market a product after the process of drug discovery takes about 12-20 years and it costs about $one billion to the pharma company. Also, only 0.01 per cent of the drugs that are discovered receive the FDA approval. There is also a lot of due diligence that is required. Some of the steps which are very

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INTERVIEW

important during the period of 1020 years are drug discovery and development, clinical trials, FDA review and finally the approval. Today, IT is increasingly becoming a very relevant component of the pharma industry. With declining R&D productivity, change in drug discovery technologies, it is very clear that the pharma industry is in the phase of transition. The future of pharma sector will ultimately see pharma manufacturers, regulators, prescribers and patients taking advantage of the technology. Across the industry, value chain research and time-span for business process determine who read the profit from years of intensive research and development. Pharma companies will actually need to go beyond the traditional R&D for their globalisation strategy to achieve success. For a pharma company, it is very important that they look at the holistic picture, where they can reach out to with their new drug and how they can market it to a larger audience within the country and beyond. In the overall scenario, technol-

ogy becomes very relevant to the pharma industry. There are many companies who are investing in various kinds of networks, sales force automation technologies, ERP for their organisation. How DV fits into the entire process of FDA approvals or other important steps that a pharma company requires to take, is that it can play a role in securing access to information: in FDA approval process, drug discovery and development process, reclinical trial or clinical trial. This is because there is lot of data exchange and information sharing required between different groups of people in a pharma organisation. There are pharma companies that are operating at a global level, where the teams are based in multiple locations and they need to collaborate and have a secure and flexible access of information flowing between them. Inter-branch collaboration is another area where DV plays a significant role. Leading pharma companies are using Citrix technologies internally that has helped them to maintain security of the information and also helped in other internal processes. Efficient and productive field force is a necessity for any pharma company. DV would add to the productivity of this field force. However, will it add to the cost as well? In a pharma company, the field force is an integral part of the organisation. The employees have to make face to face visits to physicians or purchasing managers in the hospitals and try influencing the prescribing habit for their drug within the medical fraternity. They look at various ways or methods to ensure increase in current prescriptions, build relations with doctors and deliver samples of their drugs to them.

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DV adds value to most of these activities. In case of all these activities, information is very critical. Companies need to have a repository of the information which has to be available with the employee at all times to be able to complete these kind of activities. When the employee talks about various drugs, he has to ensure effectiveness of communication while convincing the doctor about the value addition of the drug, share data on how the drug is helping the patients, etc. In case of DV, all the data is moved into a central location and Citrix delivers everything that is required from the central location. It becomes very easy for the employees to be able to access the information in a handy format. Another advantage is that they can carry any device, as it is not necessary for them to carry a laptop or any other heavy or costly device. They can even access the required information from cyber café etc. The deliverables of the sales person can be very easily achieved by DV in a much more effective and optimised format, since the information is relayed in a secure format and it is always available. Cost can be managed by using various innovative methods such as adopting to work-shifting policy, or encouraging employees to bring their own devices etc. The field force does not require a special training as the technology is very simple. There is a common utility called the Citrix Receiver across all devices. The user needs to click on the icon and the user name and password window opens. The look and feel is very similar to what the employees have been using. The employees can continue to use all documents, files and folders as they have been doing in the past. Initially, a bit of hand holding July 16-31, 2012

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may be required to showcase the new way to use the solution. However, the biggest advantage of Citrix’s DV solution is the rich-user experience which makes the user feel like nothing has changed as part of his desktop experience.

with application, data base, servers, etc and a PC, which is at the front end. They communicate with each other and there is a network where data flow takes place. In a traditional set-up, there are multiple points where the data can be compromised.

Pharma industry deals with a very confidential data. What are the chances of this information getting leaked/ hacked during the process of its transmission from the server to the field force? Pharma companies are very heavy on R&D and information regarding new drug developments, new deliverables to existing drugs, etc is really critical. When a company continues to work in the traditional desktop environment, an employee can store data on his local desktop, which could lead to the event of his data being compromised or stolen. DV helps you to centralise everything including the OS files and folders, which means that everything is moved to a central repository, thus the IT and the pharma sector are at an advantage. Firstly, it is very easy to manage as the data is centralised. Secondly, since all the data is within your access, it is easy to control it. Thirdly, you can check or monitor the users. DV technology also has a feature that allows you to record everything the user does during his/ her work hours. Thus, DV makes it very simple and secure for companies to manage and monitor. Also, the solution is secure by design. It means that, conceptually there is nothing moving out of the data centre which can be compromised. The only thing moving out of the data centre is the virtual image or the interface of the desktop, applications and data, so no one can hack or take information out of it. The entire communication is also encrypted. Whereas, in a traditional computing format, there is a backend data centre

Who are your clients from the pharma industry and how DV is helpful to them? In India, we have over 3,000 customers and in 2011, we have implemented over one lakh virtual desktops. For desktop/application virtualisation, we work with pharma companies such as Anthem Biosciences and Ind-Swift Laboratories. DV is used by the pharma sector mainly for the following reasons:

Information Security In traditional environments, employees typically save data on their individual PCs. A full back up is not always possible, thus the companies are concerned about the security. Virtual desktop is a great way to manage and control where critical data flows in the organisation. Here, your data is secure in the data centre with no transactions happening at the end point devices and no data being stored there. All the user sees and accesses is the image of the application on his device.

Field force mobility DV helps the executives who are travelling to various locations and they want ready access to information. Since all the data is moved to a centralised location, it can be delivered to any device at any time.

Bring Your Own Device (BYOD) Using DV, pharma companies can cut down costs. Instead of supplying devices to the workers, companies can tell the employees to use their own devices, thereby saving costs on either procuring those devices or management of devices over a period of time.

Application and Desktop Centralisation In case of one of the organisations that we worked with, their challenge was that they were unable to manage a very large infrastructure with multiple locations, multiple users and hundreds of applications involved. It was a very complex setup. But, by using DV, they were able to get everything in a central location and then relay it back to the user. It became very easy for them to manage and run it.

Workshifting Many organisations are using DV for workshifting by allowing employees to work from home or other locations, instead of them operating out of the same location. There are many support functions that can be moved out of the organisation which will cut down on a lot of costs. Besides field force who are the other members of an organisation that can use DV? DV can be used by everyone in an organisation. The senior management can use DV as they can have access to all information from any of their mobile devices and anytime. The top management of companies usually require maximum flexibility, and thus, DV is a good tool to meet their demands. In a scenario, where the company wants to setup a large head office or a new branch and they want to replace traditional desktops with Virtual Desktops, a lot of users can make use of DV. Also, if a company has third party employees such as distributors, etc who need access to the system, all applications and data can be delivered inside or outside the office without compromising on security. Departments such as R&D Treasury, deal with very sensitive information which can be protected with DV. sachin.jagdale@expressindia.com

VENDOR NEWS

Rockwell Automation’s dual-port EtherNet/IP I/O adapters to benefit machine and equipment manufacturers Allen-Bradley FLEX I/O Dual-port EtherNet/IP communication adapters simplify network design and increase network resiliency ockwell Automation has AllenBradley FLEX I/O dual-port EtherNet/IP adapters. It will help machine and equipment manufacturers, system integrators and end users with demanding applications to simplify network design while maintaining resiliency. It will also aid OEMs connect machines to their end customers’ IT infrastructures using a single network. With the dual ports, users can also leverage the adapter to display diagnostics via a simple Web browser, helping reduce troubleshooting and downtime. The new EtherNet/IP adapters support a device-level ring (DLR) topology,

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which provides robust network infrastructure and extremely fast recovery time, while keeping implementation cost down. DLR infrastructures are connected at the end device versus the switch. With no need for unnecessary switches and cabling, users can reduce design time and simplify implementation. The ring also adds a measure of redundancy that is very effective when a connection fails – as a single network failure, such as a cable break, will not lead to the failure of the other devices in the ring. A DLR network can recover in less than three milliseconds for a 50node system. During this time, the con-

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nection between the programmable automation controller and the I/O device is not interrupted. The adapters also support the daisy-chain topology for applications that involve devices located long distances from CPU subsystems. The adapters (1794-AENTR and 1794-AENTRXT for extreme environments) are compatible with these Rockwell Software products: RSLogix 5000 programming software version 16 and higher and RSLinx version 2.58 and higher. The adapters also can connect up to eight FLEX I/O modules. EP News Bureau—Mumbai EXPRESS PHARMA

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Waters India completes 25 years of service To house 16,000 sq feet India Technology Centre in Bangalore aters India recently completed 25 years of service in India. The company has been investing in the country towards creating world class infrastructure and manpower to address industry requirements. In 2011, 17 per cent of Waters’ revenue was from academic and government institutions. Pharmaceutical organisations, including biotech companies, contributed 59 per cent while industrial, food and environmental organisations comprised 24 per cent of Waters' revenue. In order to meet the ever increasing requirement of the local market, waters India is coming up with an additional office space of more than 16,000 square feet in Bangalore, which will house its India technology centre. The centre will have all modern equipment to train and educate the customers and assist in their research activities. Waters has also built a support and application development infrastructure in Singapore. Arthur ‘Art’ Caputo, President, Waters Corporation said, “The Singapore market has been designed to service the entire market in South East Asia. We do see South East Asia as a potential growth area and will continue to invest as the markets there develop.” Over the past several years, Waters has expanded the Centers of Innovation (COI) Programme around the globe and across industries. This unique programme recognises and supports analytical scientists who facilitate breakthroughs in health and life science

Art Caputo President Waters Corporation

research, food safety, environmental protection, and sports medicine, amongst others. Scientists from the near by 20 COIs, in partnership with Waters, are using liquid chromatography and mass spectrometry to unlock the mysteries of science and take research down new and exciting paths. Caputo revealed that the company would soon be announcing the establishment of their first Indian COI, which is in the final stages of discussion, marking the participation by Indian scientists in the COI programme. Talking about the impact of the global economic downturn on the lab analytical business, Caputo made a strong case for the sector's resilience, saying, “In a year that saw the world’s population top seven billion people, societies across the world are ever more dependent upon laboratory science to improve our health, our food, and our environment. This is not to suggest that challenging economic conditions do not affect our business, because they do. However, laboratory science is more important and more dependent upon than any time in human history.” Elaborating on the challenges of sustaining growth in such depressed conditions, Caputo said, “Innovation is key to our customers’ success. Innovation spans a wide definition from the novel new category of separation science of ACQUITY UPC2, to improved workflow management found in Waters NuGenesis 8, to technology that can be used by a broader range of

scientists from Waters’ Engineered Simplicity designed into our mass spectrometers. Even during periods of economic uncertainty, our customers are dependent upon their laboratories. Waters innovations allow those laboratories to improve their productivity, which is much more crucial during challenging economic times.” Caputo while speaking about the company's position in 2015 said, “Our vision is that Waters, through the ‘Science of What’s Possible’, will continue to bring purposeful innovation to laboratory-dependent organisations, delivering meaningful impact in terms of better healthcare, safer food and a cleaner environment. Through this, we hope to maintain our clear marketleadership position in our industry through 2015 and beyond.” According to Caputo the company has very respectable competitors, but none share the focus and commitment to innovation. Caputo reasons that no other competitor has – or could have – delivered breakthrough innovations in chromatography and mass spectrometry, such as Waters' ACQUITY UPLC, which changed the landscape of the separations science; Empower, the de facto standard chromatography data software; and ion mobility for mass spectrometry, for studying individual molecules in three-dimensions because “they don't have our technology focus, our closeness to the customer, nor do they have the technological legacy we've built up.” EP News Bureau—Mumbai

Lonza launches next generation GS Gene Expression System Will be available for use globally in all major pharmaceutical and biotechnology markets, including Asia onza, a leader in gene expression and biopharmaceutical development of protein therapeutics, has launched GS Xceed Gene Expression System. This is the latest generation of Lonza’s world renowned GS System, which has already been used to create over 100 high producing cell lines and 13 therapeutic drugs currently on the market. The GS Xceed System has been shown to reduce cell line development timelines by up to six weeks over the existing CHOK1SV-based system and has achieved titers of up to 6 g/L. Both emerging and established companies with protein therapeutics in their pipeline can access this new system by either a Research Evaluation Agreement or a Commercial License. The new system is also available worldwide, allowing multinational

EXPRESS PHARMA

companies global access to the system in all pharmaceutical and biotechnology markets. “We are pleased to offer our global customers a robust, easy to use, next generation expression system, based on the proven GS technology that has become the industry standard. Our new GS Xceed Gene Expression System allows our customers to significantly reduce their timelines for the generation of clinical supply material while continuing to achieve titers well above industry standards,” said Janet White, Head, Lonza Development Services. The key element of the new system is the CHOK1SV GS Knock-out host cell line, which is a derivative of Lonza’s suspension adapted CHOK1SV host cell line in which both alleles of the endogenous glutamine synthetase

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gene have been “knocked out”. Cell lines are selected in Lonza’s Version 8 (v8) Commercial Platform Process which allows for faster future scale-up into a GMP manufacturing system. Successful cell line construction, selection and development are on the critical path to achieving first in human studies. By shortening the development timeline by up to six weeks, customers gain a significant advantage in their product development lifecycle. The complete GS Xceed System includes, cGMP banked CHOK1SV GSKO host cells, GS expression vectors, full protocols, access to Lonza’s latest Commercial Platform Production Process (chemically defined, animal component-free media and feeds system) and access to Lonza’s GS technical team. EP News Bureau—Mumbai July 16-31, 2012

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Rockwell Automation launches Rockwell Software PharmaSuite, version 4.0 Brings new performance and improved timetoresults to the life sciences industry ockwell Automation has launched Rockwell Software PharmaSuite, version 4.0, the next generation of manufacturing execution system software specifically targeting regulated industries. Leveraging more than 20 years of experience in pharmaceutical manufacturing, Rockwell SoftwarePharmaSuite enhancements set a new standard for lower risk, lower cost and time to results while meeting the regulatory requirements found in the life sciences industry. John Genovesi, Vice President, Information Software and Process Business, Rockwell Automation said, “The enhancements to Rockwell Software PharmaSuite reinforce our commitment to the life sciences industry. The new version offers significant performance, usability and deployment advantages enabling our customers to reduce cost of compliance and improve their manufacturing capabilities.” Rockwell Software PharmaSuite contains a comprehensive set of functions that address the most common applica-

tions, like dispensing, quality and electronic batch recording. The software suite allows regulated manufacturers to meet their operational goals and productivity requirements in a consistent and predictable way. The software tracks material, equipment and personnel involved in the manufacturing process and maintains a complete electronic batch record. Rockwell Software PharmaSuite is based on S88 and S95 standards which allows for better integration with other enterprise systems involved in manufacturing operations. The software suite is built on the FactoryTalk ProductionCentre platform, proven in multiple installations across different industries and scales of deployments. It leverages a service-oriented architecture for cost-effective, flexible deployment and integration with business and automation systems. Its object-oriented design makes it simple and quick to build and modify applications, and systematically deploy them across multiple sites.

Janice Abel, Principal Consultant, ARC Advisory Group said, “Rockwell Software PharmaSuite offers a comprehensive solution for the supply chain and manufacturing that can be used for collaboration and integration to enforce quality and compliance, reduce costs and increase efficiencies in the life sciences industries.” “From the very beginning of PharmaSuite development we embarked on a path of relentless innovation in pursuit of time to results for every user. With every new release we broke limitations in performance, usability and deployment time previously known in life science manufacturing execution systems. Release 4.0 takes this tradition even further with introduction of Intelligent Migration and Modeling Support in recipe authoring, and extensive enhancements in performance and content extension capabilities,” said Vladimir Preysman, Chief Software Strategist, Rockwell Automation. EP News Bureau—Mumbai

Dürr and Caloric sign environmental systems agreement Will collaborate in the field of incinerators for disposal of saline exhaust gases and residual liquids ystem manufacturers, Dürr and Caloric, will collaborate in the field of incinerators for disposal of saline exhaust gases and residual liquids. The two companies confirmed this partnership in a collaboration agreement. The collaboration is initially agreed for a period of five years. Caloric brings many years of experience with this technology, while Dürr will contribute immense market penetration and a strong presence in such target locations as Europe, Gulf Cooperation Council countries ( GCC), China, and India. Dürr has been active in India for nearly 50 years, with a local presence for over 20 years. Dürr wide array of activities in India include industrial cleaning and

automation solutions and consulting. Dürr has made India an important hub for their worldwide engineering activities offering its customers international knowhow and local experience. Werner Zondler, Vice President in charge of Environmental Systems Sales at Dürr Systems, and Dr-Ing. Peter Neumann, Head of Sales at Caloric Anlagenbau said, “These synergies will allow us to offer our customers superior technology and support for the complicated, highly demanding disposal of saline exhaust gases and liquids.” These particular types of exhaust gases and residual liquids with high or low calorific values are generally produced in the pharmaceutical, chemical

and petrochemical industries. A special case is the incineration of saline exhaust gases or residual liquids, for which Dürr and Caloric now offer joint solutions. Here, salt slag is formed in the combustion chamber of an air pollution control system and must be removed. This removal is generally achieved by means of a vertical arrangement of the combustion chamber with subsequent quench. The salts are dissolved in water, and insoluble constituents are collected and removed by a suitable system. Special attention must be paid to the design of the lining in case of alkaline salts because these salts attack the lining and destroy it over time. EP News Bureau—Mumbai

Cole-Parmer presents fluid handling and lab equipment at ACHEMA 2012 A full range of Masterflex pump systems and related accessories were displayed ole-Parmer, having its experience in fluid handling, life science, general laboratory products, instrumentation, and equipment, presented a wide range of fluid handling and lab equipment at Achema 2012, which was recently held in Frankfurt. Attendees of ACHEMA had the opportunity to see a variety of Masterflex pump systems. This selection of high-performance peristaltic pumps serves the biotechnology, chemical, industrial, research and development, manufacturing, and pharmaceutical industries, among others. In

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addition to the Masterflex C/L (Compact/Low Flow), L/S (Laboratory/Standard), and I/P (Industrial/Process) pumps, various tubing styles and pump heads were operated to demonstrate applicationbased pumping systems. Lab equipment featured included the Cole-Parmer Rotational Viscometer, which offers greater chemical resistance and the ability to withstand chemically corrosive materials. The StableTemp Modular Block Heaters provide the flexibility to heat different sizes of microtubes, centrifuge tubes, vials,

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microplates, and PCR strips or tubes. Each digital or analog heater accepts more than 40 interchangeable heating blocks which accommodate sample enclosures. The Stir-Pak High-Speed, Low-Torque Overhead Stirrer System is a heavy-duty modular system that allows users to customise components to suit their mixing application. Several high-quality Oakton thermometers were also available, including the Oakton TempTestr Infrared Thermometer with laser vision to pinpoint the centre of the measurement area. EP News Bureau—Mumbai EXPRESS PHARMA

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Benefits of VEEGUM magnesium aluminum silicate products Products comply with the European Pharmacopoeia (EP) monograph s-based Vanderbilt manufactures VEEGUM R, VEEGUM F, VEEGUM HV and VEEGUM K in compliance with the (USP)/National Formulary (NF) monograph for magnesium aluminum silicate. In addition, Vanderbilt also produces similar grades which comply with the European Pharmacopoeia (EP) monograph for aluminum magnesium silicate. VEEGUM magnesium aluminum silicate products are naturally occurring water-washed smectite clays used worldwide to stabilise emulsions and suspensions and to thicken a wide range of products. Smectite clay (also known as bentonite) is valued for its ability to swell in water and to impart useful rheological properties to aqueous compositions. VEEGUM and VAN GEL clays have consistently been the preferred choice among formulator's in India and across the world to stabilise suspensions, perfect emulsions and optimise flow properties . VEEGUM products are used extensively in India primarily for pharma and personal care applications, although they are widely used in other industrial and household care areas as well. Pharma and cosmetic grades of VEEGUM clay are also controlled for arsenic, lead and bacteria content. Formulators find that the value of VEEGUM and VAN GEL clays as stabilising and rheological agents is due to their colloidal structure in water. When clay and water are mixed, water penetrates between the platelets, forcing them further apart. For most VEEGUM and VAN GEL grades, the speed with which platelet separation occurs is directly related to the amount of energy introduced during hydration. Once the clay is hydrated (i.e., the platelets are separated) a three dimensional colloidal structure commonly called the "house of cards"is formed . This colloidal structure accounts for the characteristic rheology imparted by these clays. Dispersions of VEEGUM and VAN GEL clays are thixotropic and pseudoplastic, in addition to contributing useful yield value. Formulators highly value this colloidal structure for its ability to trap and segregate solids in suspensions, oils in emulsions, and gases in foams or mousses. Once the clay is hydrated, the colloidal structure builds rapidly at first, providing a quick increase in viscosity. As time passes, the remaining free platelets take a longer time to find an available site in the structure, so viscosity increases at a progressively slower rate. Formulators find that Smectite dispersions are also pseudoplastic as an increase in the rate of shear results in decreasing viscosities. The colloidal structure also provides the smectite's most useful property - yield value. This is a measure of the resistance of the structure to breakdown. From the point of view of formulators, a unique and valuable feature of VEEGUM and VAN GEL clays is their ability to impart yield value at low viscosity.With VEEGUM and VAN GEL, stabilisation of the dispersed phase is possible even in thin, fluid systems where flowability is important.

EXPRESS PHARMA

Formulators are impressed with the behavior of VEEGUM and VAN GEL clays in the presence of other ingredients, not just in water alone. Most water-soluble components will modify the rheological properties of smectite clay, usually beneficially. Salts, surfactants and water-miscible solvents will increase the smectite's viscosity and yield value contribution and decrease thixotropy, but still provide a shear-thinning composition. From the formulators point of view , one of the most useful features of VEEGUM and VAN GEL clays is their ability to stabilise oil-in-water (O/W) emulsions at low concentrations. VEEGUM and VAN GEL clays reduce the tendency of emulsions to thin out and break at elevated temperatures. Small amounts (typically 1-2 per cent) will stabilise emulsions containing anionic or nonionic surfactants that include a wide variety of oils, fats, and waxes. In case of water-in-oil (W/O) emulsions , most formulators have found VEEGUM clay to be an effective W/O emulsion stabiliser, increasing internal phase viscosity to inhibit coalescence in their formulations. Besides , formulators also use VEEGUM clay in the production of fluid W/O emulsions that are otherwise difficult to stabilise. Apart from its emulsion stabilising property, the colloidal structure of VEEGUM and VAN GEL clays provides excellent suspension of fine particles in aqueous systems. Its high yield value enables the successful suspension of even high density particulates which is a huge advantage to formulators looking for long-term stability of their emulsions. From the formulators point of view , VEEGUM and VAN GEL products have many advantages as suspending agents. They prevent hard packing of the suspended material; control bleeding, suspensions that tend to settle are easily redispersed; ensure products of uniform dosage in pharmaceutical suspensions and pesticide concentrates; achieve maximum suspension without losing pourability; do not form gelatinous, irreversible gels, as is the case with many organic gums and offer better suspension efficiency than organic gums; especially at low viscosities. In the personal care and cosmetics segment, formulators have found that VEEGUM clay contributes spreadability and cosmetic elegance to topical products. Owing to the insoluble, platy nature of its aqueous dispersions, formulators used it to produce tackfree topical products. It is also used to reduce or eliminate the tacky, gummy or stringy nature of organic gums and polymers. In addition to their tactile and organoleptic benefits, formulators often use VEEGUM and VAN GEL clays with organic thickeners to enhance the best characteristics of each. The smectites contribute to synergistic viscosity and yield value, while the gums' and polymers' protective colloidal action improves the clay's stability in the presence of electrolytes, surfactants, and other water solubles.

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Formulators in the cosmetics and home care segment routinely use VEEGUM and VAN GEL clays in products spanning the pH 2 to pH 13 range. These include AHA emulsions, anti-perspirant, internal analgesic suspensions, chlorine bleach scrubs and caustic oven cleaners. Being anionic , VEEGUM and VAN GEL clays are compatible with most anionics and non-ionic; they are incompatible with most cationics. Their dispersions can be combined with water-miscible solvents: up to 20 per cent alcohol, 50 per cent glycerin and 30 per cent propylene glycol and polyethylene glycols. A unique benefit to cosmetic, industrial and home care formulators stems from the fact that by virtue of being minerals, VEEGUM and VAN GEL clays are not decomposed by bacteria, heat or excess mechanical shear. They are insoluble in solvents and water, and can be used at pH values encompassing nearly all household and industrial cleaners. This feature is very convenient in addressing the shelf life issues around finished formulations using VEEGUM and VAN GEL. Formulators use VEEGUM and VAN GEL clays as non-migratory binders in tablets, sticks, and pressed cakes. They do not migrate to the product surface during drying, thereby ensuring uniformity and the desired level of hardness, rub-off, and colour value. They also function as lowbulk disintegrants in pharma and industrial tablets. Formulators in the industrial and household care segments report that industrial grades of VEEGUM and VAN GEL products offer clay purity and uniformity equal to that of the cosmetic and pharma grade VEEGUM products. For this reason, they use them in household and industrial cleaners, agricultural pesticide concentrates, abrasive suspensions, ceramic glazes and bodies, coatings, polishes, and industrial specialties. The industrial grades are used to provide suspension, emulsion stabilization, and tailored rheology even at extreme pH ranges. VEEGUM and VAN GEL products are often used synergistically with organic thickeners. The viscosity or stability of formulations containing these mixtures will be greater than that of the same formulation made with either component. These combinations allow the formulator to fine-tune viscosity, yield value, and flow properties beyond what is possible with either the clay or organic thickener alone. In the agrochemical segment in India, VAN GEL B clay and xanthan gum combinations are widely used by formulators to stabilise flowable, concentrated (up to 70 per cent solids) agricultural pesticide suspensions. On the personal care front , formulators often use VEEGUM clay with nonionic cellulosic thickeners to improve suspension stability and flow properties in anti-dandruff shampoos. VEEGUM and VAN GEL have found wide acceptance in India and are a preferred choice for most formulators in the personal care, pharma, household care segments and are here to stay. July 16-31, 2012

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QA Tech by GMP Technical Solution offers validation, qualification and calibration services

n the past decade, many far-reaching changes have taken place in the application of cGMP regulations relating to the pharmaceutical industry. Continuous quality improvement thus is ingrained in the cGMP concept. The design, construction, commissioning, and validation of pharma facilities play a very important role in the risk mitigation of product quality and safety. Keeping its motto as achieving continually better levels of customer satisfaction in providing validation, qualification and calibration services,

Validations at QATech

we at QA Tech (A division of GMP Technical Solutions) maintain professional approach in working and comply with applicable national / international codes and standards. Above all, QA Tech upgrades the knowledge and skills of its personnel through training to ensure continuous human resources development. QA Tech (A division of GMP Technical Solutions), an ISO 9001:2008 Certified company is known for prompt, economical and reliable calibration, validation, mensuration services since 2003 mainly to pharma segments. In India Cipla group of companies, Sandoz, Pfizer, Lupin Pharma, Emcure Pharma, Sanofi-Aventis are some of the major pharma companies which are getting services from QA Tech.

integrity, air flow shooting, recovery study, temperature RH mapping etc. As there's increased emphasis by regulators on compliance with GMP requirements for controlled temperature storage requirements. QATech has the equipment and experienced professionals to help you to achieve compliance in this area. Temperature mapping experience includes autoclaves, Lyophilizes, Stability Chambers, Incubators, Ovens, Dry Heat Ovens, etc.

QATech provides and extensive range of services pertaining to clean room validations, qualifications, by our panel of expert professionals. QA Tech performs the HVAC validations as per ISO 14644, EU cGMP, US Federal Standard 209E, USFDA, Schedule M (National Regulatory Body), WHO Geneva, TGA (Australia), European (EMEA), MHRA (European Countries) guidelines for all room classifications. Some of the tests carried out are air velocity particle counting, filter

Calibration and mensuration at QATech QATech also undertakes onsite calibration jobs for a wide range of electrical and mechanical measuring devices like, pressure and temperature instruments. QATech has, high precision, high

accurate master instruments to calibrate wide industrial instrument range including Building Management System Instruments. Some of parameters we calibrate are pressure, temperature, RH, Current & Voltage, Flow etc… QA Tech has been providing Stage Mensuration services for Cascade Impactors since 2005 in India .The Quick Vision Measuring instrument is highly accurate and capable of Mensurating many stages automatically. The methods for Mensuration have been developed by

a group of experienced people from pharma industry. QA Tech continuously updates its methods for Mensuration as per the requirements of pharma industry and hence has become a unique service provider for mensuration in india. Contact details: Head Office 3rd Floor, 309/316, Swastik Disa Business Park Near Wadhani Ind. Estate LBS Marg, Ghatkopar (West) Mumbai-400086 Tel- +91 22 6116 4808, 6116 4809, 6116 4812 Fax: +91 22 6116 4865Email enquiry@qatech.co.in, admin@qatech.co.in Web: www.qatech.co.in

New printer series by Zebra Technologies

ATI of USA launches aerosol photometer

ebra Technologies Corporation launched ZT200 printer series, a new line of printers intended for light industrial and commercial applications. It offers advanced printer integration capabilities and complete device management. The printers allow organisations to improve efficiency in a variety of verticals. These include: Manufacturing – light work-inprocess tracking, inventory management; Transportation and logistics – order picking and packing, shipping and receiving, and compliance labelling; Retail – warehouse logistics and back-of-store applications; Healthcare – specimen labelling and pharmacy labelling. The new line of printers is durable and able to withstand harsh environments. Also, the ZT200 series helps limit ownership costs and maximises printer uptime because it is easy to connect to the network and maintain without the use of tools while the intuitive user interface simplifies the user’s learning curve for the product. The printers address a number of customer needs with its design, which is a smaller size to fit into crowded workspaces and which features a bi-fold door, making it easier to change the media.

Contact details: Zebra Technologies India Boomerang, A-202,Main Chandivali Farm Road, Near Chandivali Studio, Andheri (East) Mumbai - 400072 Tel: 022 67275555

Contact details: Jyoti Gangwani MeasureTest Corporation 94 Atlanta, Nariman Point, Mumbai- 400 021 Tel: 022-22027982, sheesh@mtnl.net.in www.measuretest.com

July 16-31, 2012

TI of USA has launched aerosol photometer for leak testing of HEPA filters. Known as Model 2i, this latest version has several unmatched features not found in any other photometer in the world.

The salient features are: The upstream aerosol mass concentrations are displayed in actual mass concentration values of micrograms per litre (µg/l). User settable Aerosol Noise Suppression (ANS) allows for more stable aerosol measurements when poor mixing is present There are three unique data report functions – continuous, monitoring and summary modes. The thermal printer option meets documentation requirements. It has USB output Reagent settings- PAO, DOP, Ondina, corn oil, paraffin etc Large 4.3 " LCD display Flow rates displayed on screen

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Thermo Fisher Scientific launches microbiological incubators

hermo Fisher Scientific has introduced new large-capacity Thermo Scientific Heratherm

microbiological incubators in Europe, the AsiaPacific region, Latin-America and Africa. The new products complete the range of Heratherm microbiological incubators, adding two more sizes for high sample volume or larger samples: 400- and 750-litre capacity. Designed with sample safety in mind, the units have excellent temperature performance for reproducible results. The General Protocol incubators are designed for routine applications in pharmaceutical, medical, food and research laboratories. Gravity con-

Thermo Fisher Scientific introduces free-standing heating and drying ovens hermo Fisher Scientific has launched its new large-capacity Thermo Scientific Heratherm heating and drying ovens in Europe, the AsiaPacific region, Latin-America and Africa. The new products complete the range of Heratherm ovens by adding two more sizes for high-sample volume or larger samples: 400- and 750-litre capacity.

Designed with efficiency in mind, the units use significantly less energy to operate (up to 23 per cent less) than previous models. For convenience, all models connect to a standard 230V circuit – no need for special outlets or wiring. The Heratherm General Protocol ovens are designed for day-to-day drying and heating applications. Gravity convection technology ensures gentle airflow. The flexible shelving system provides optimal use of the internal chamber space. A timer function offers additional energy savings potential. Set up on lockable casters, the units can easily be installed and moved as needed. The Heratherm Advanced Protocol ovens feature mechanical convection technology for fast drying and optimal temperature distribution. The programmable control enables pre-defined temperature ramps, including changes of damper position and fan speed. A sophisticated timer extends the automation options even further. An optional stainless-steel exterior meets demanding needs in pharmaceutical and clinical laboratories. For high-temperature applications, up to 300°C, and fastest heat-up or recovery times, the 750-litre models will be available in 400V with a three-phase connection. Contact details: Meenal Shinde Sr Executive - MarCom Laboratory Products - India Thermo Fisher Scientific India Pvt. Ltd. 403-404, B-Wing, Delphi, Hiranandani Business Park, Powai. Mumbai - 400 076 Tel: +91 22 6716 2200 Direct No : +91 22 6716 2259 Fax: +91 22 6716 2244 Toll Free No : 1800 22 8374 www.thermofisher.com or www.thermo.com

SHARP launches Plasmacluster Ion air purifiers

Tecan updates Gas Control Module

harp has launched Plasmacluster Ion Technology for indoor air treatment. Plasmacluster Technology creates forestfresh environment indoors by generating negative and positive ions which are created in natural environments like a forest. These ions kill all harmful substances like pollen dust, allergens, virus, mould, gases and foul smell not just from the air but also from the surface of things kept indoors and thus creating a neutral and fresh environment to breathe easy and safe air. The effectiveness of Sharp’s Plasmacluster Ion air purifiers have been verified by renowned academic and research institutes around the world. It has been certified by the Asthma Society of India and British Allergy Foundation to be most effective in removal of triggers that cause Morning Allergy and Asthma. The Plasmacluster Ion air purifiers can be used wherever the threat of air and surface contamination remains high like doctors chamber, homes, toilets, wardrobe, in car, public spaces like hotel lobbies and rooms, theatre and banquet halls, office, changing rooms, pharmaceutical and food storage to name a few.

ecan has updated the patent pending Gas Control Module (GCM) for the Infinite 200 PRO multimode reader to offer simultaneous control of O2 and CO2 concentrations, providing rigorous environmental control for an even wider range of cell biology applications. The original GCM, which was a breakthrough for cell-based experiments, has now been further enhanced to provide increased measurement accuracy and minimise cross-interference for oxygen measurements. Combined with re-designed, independent gas inlets, this offers precise, independent control of both O2 and CO2 levels within the reader, with automatic compensation for variations in the atmospheric partial pressure of CO2 via a unique altitude correction function. The new and improved features ensure greater biological relevance for a wide range of studies, extending the experimental window for microplate-based investigations of anaerobic or facultative anaerobic bacteria, and allowing close replication of hypoxic or physiological conditions for eukaryotic cells. Together with the Infinite 200 PRO’s cell biology oriented functions – including Optimal Cell Reading (OR), linear and orbital shaking, advanced temperature control and automated Z-focusing – this comprehensive solution sets new standards for cell-based assays.

Contact details: Shuvendu Mazumdar National Manager - Plasmacluster Business Tel: 011-46665555 Email: smazumdar@sharp-oa.com

vection provides gentle airflow and minimal drying out for samples. Safety features include two measuring sensors and an automatic over-temperature alarm for peace of mind. The intuitive user interface and large vacuum fluorescent display are designed for ease of use. The advanced protocol security incubators come with mechanical convection technology for excellent temperature performance – keeping sample environment stable, even according to highest requirements. The unique 140°C decontamination cycle is comparable to sterilization, supporting the scientist in avoiding sample contamination. A sophisticated timer function, under-temperature and door alarms are additional features that make work easier and safer. An optional stainlesssteel exterior meets demanding needs in pharma and clinical laboratories.

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Contact details: Tecan Trading AG Cornelia Kegele / Antonietta Allocca Seestrasse 103, CH-8708 Männedorf Tel: +41 (0)44 922 81 11 Fax: +41 (0)44 922 81 12 email: info@tecan.com, Web: www.tecan.com

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Pharma Refrigerator Incubator Oven Stability Chamber Walk-in Stability Chamber

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OSWORLD QUIZ

Q1) Which of the following routes of administration is considered a parenteral route? Subcutaneous Injection Feeding Tube Oral Ingestion

None of the above

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Intravenous

Q3) What is the most prominent side-effect of anti-histamines? Restlessness Drowsiness Rebound Congestion Puritus Q4) A continued desire for an analgesic for reasons other than pain relief would best be described as: Dependence Addiction Threshold Tolerance Q5) Diphenydramine is found in all the following products except: Antihistamines Cough Suppresants Decongestants Sleep Aids For more details about Osworld and our products: Osworld Scientific Equipments Pvt. Ltd., B-44, New Empire Industrial Premises, Kondivita, J.B. Nagar, Andheri(E), Mumbai - 400 059 Tel.: +91-22-28320880/ 28390487, E-mail: info@osworldindia.com Send your answers to info@osworldindia.com . All correct answers win you a surprise gift! Disclaimer: Quiz reproduced by Osworld from various sources. Any errors regretted. Advertisement inserted to enthuse readers.

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Processing technology expertise from granulation to tableting

 Fluid bed systems for drying,

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units through to large-scale production

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melt granulation and coating)

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process technology manufacturers

hensive consulting, system engineering,

Hüttlin and Manesty (now Bosch

development, installation and after-

Packaging Technology Ltd.) last year,

market services.

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granulation through to tableting.

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Bosch Limited

Personalized medicine

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APPOINTMENTS

Pfizer appoints Aijaz Tobaccowalla as Managing Director, India Previously from Wyeth, Tobaccowalla now leads Business Technology for all Pfizer's biopharma business units fizer has appointed Aijaz ‘Jazz’ Tobaccowalla as Managing Director, India. He will succeed Kewal Handa, who had announced his intention to retire in August 2012, earlier this year. “With more than 20 years of experience in the pharmaceutical industry, Jazz is a seasoned leader who will continue to lead Pfizer India through this exciting period. His leadership experience, demonstrated versatility, and successful management in a constantly changing business environment, make him the ideal leader for Pfizer India,” said Ahmet Goksun, Regional President, Emerging Markets Europe, Russia, India and Turkey (EURIT), a part of the Emerging Markets Business Unit. Jazz joined Wyeth in 1991 and

He joined Wyeth in 1991 and has held a number of positions in Business Technology as a member of the leadership teams of Pfizer WBB, R&D, and PCBU

since then has held a number of positions in Business Technology as a member of the leadership teams of Pfizer WBB, R&D, and PCBU. In 2009 he was appointed to his most recent role, leading Business Technology for all biopharma business units. He has a Masters in Business Administration from Stern School of Business, New York University and an undergraduate degree in computer science and mathematics. “We thank Handa for his many contributions at Pfizer. Under his leadership, Pfizer India became the first multi-national pharma company to enter the branded generics market, and became a leader in exploring unique partnerships with the government to increase market access,” Goksun added. EP News Bureau – Mumbai

Frank Pieters joins Cipla He has been appointed as Head of European Region and Global Respiratory Business ipla has appointed Frank Pieters as the Head of European Region and the Global Respiratory Business, effective July 3, 2012. Prior joining Cipla, Pieters served as Senior Vice President Southern Europe Region in TEVA Pharmaceuticals. He comes on board with over 30 years of experience in the pharma industry in different senior management positions, with the unique background in respiratory medicine. Announcing the appointment of Pieters, Dr Yusuf K Hamied, Chairman and Managing Director, Cipla said, “Pieters brings a wealth of expertise in the respiratory domain. With him at the helm, Cipla would like to capture the huge commercial upside of 30 years experience in Cipla’s respiratory medicine; both in emerging and regulated markets. This appointment signals Cipla’s strengthening of senior

July 16-31, 2012

management positions and also illustrates Cipla’s desire for senior onground talent in overseas markets to build its product portfolio and brand. Apart from global respiratory business, Pieters will also spearhead the generics and value-added product portfolio across the European region through strategic alliances.” Pieters said, “After spending very

Pieters will also spearhead the generics and value-added product portfolio across the European region www.expresspharmaonline.com

interesting years both at GSK and TEVA, I am thrilled to join the Cipla Team, helping to expand both the respiratory business worldwide and the European Business. Building further on the outstanding capabilities and business network will definitely bring exciting times for the company in these domains.” Pieters played a significant role in accelerating the growth of TEVA’s Respiratory business globally. He has served as Senior VP Global Biogenerics and Global Respiratory Commercial business for TEVA Pharmaceutical Industries since 2009. He was also a member of the TEVALonza Joint Steering Committee. From 1989 to 2004, Pieters spearheaded several senior positions at GlaxoSmithKline, last of which was as VP and General Manager. EP News Bureau – Mumbai EXPRESS PHARMA

P|H|A|R|M|A| L|I|F|E JOB TREND

Hiring activity in pharma sector picks up in June 2012 Records 19 per cent higher growth than the same time a year ago harma sectorsâ&#x20AC;&#x2122; hiring activity in June 2012 has been 19 per cent better than what it was a year ago and three per cent higher than in teh previous month. Thus as compared to all sectors where hiring has been in doldrums, this sector has been consistently showing good hiring activity over the last few months. Jobseekers in this sector can look forward for good opportunity in the year ahead. This was also witnessed in the Naukri Hiring Outlook Survey where almost 67 per cent recruiters from the sector had said that new jobs will be created in 2012. Methodology: The Naukri Job Speak index is on the basis of job listings added to the site every month. To calculate the index, job listings added to the site in July 2008 have been taken as 1000. The subsequent months have been indexed with data of July 2008. The monthly report shows hiring trends across industry sectors, geography and functional areas. There might be high volatility for certain fringe cases like smaller cities, niche industries etc. owing to a small base, but more than 42,000 clients using Naukri.com leads to high reliability of the data.

Pharma sector

The Naukri job speak index for the pharma sector is a monthly report that indicates hiring trends across industry sectors, geographies and functional areas

Jobs from Naukri.com Clinical Research Associate Company: Profile: Exp: Location: Email:

Chartered Accountant

Indus Biotech Must be PG Diploma in Clinical Research with work experience as CRA or CRC in clinical research, regulatory affairs or other relevant position. 1-5 Pune vacancy@indusbiotech.com

Company: Profile: Exp: Location: Email:

Parenteral Drugs (India) Candidate should have worked Independently in manufacturing unit and must have working knowledge of SAP/ERP & MIS. 3-4 Baddi gautamt@pdindia.com

Asst Manager-Finance & Accounts Manager Training Company: Profile: Exp: Location: Email:

Troikaa Pharmaceuticals The candidate should be a B Sc, B Pharm / M Sc with minimum 3/5 yearsâ&#x20AC;&#x2122; experience in Training & Development function. 3-5 Ahmedabad career@troikaapharma.com

Executive-Clinical Nutrition Company: Profile: Exp: Location: Email:

Exp: Location: Email:

ENovate Biolife Must have knowledge of Physiology, Pathology, Biochemistry, Nutrition and pathophysiology of diseases related to nutritional deficiencies. 1-4 Mumbai hrd@enovatebiolife.com

Exp: Location: Email:

Icon Clinical Research India Ideal candidate must have experience in clinical data management testing experience with 1-5 years of experience in relevant field. 1-5 Chennai Nilamadhab.Mahapatra@iconplc.com

Head -HR Plant Company: Profile:

Scientific Research Instruments Company Must have the complete knowledge of the product and its applications. 3-5 Bengaluru/Bangalore info@srico-labworld.com

Surya Pharmaceutical Limited Candidates should be CA with minimum 4-9 years of experience. 4-9 Chandigarh mamta@suryapharma.com

Clinical System Tester Company: Profile:

Product Executive Company: Profile:

Company: Profile:

Exp: Location: Email:

Cadila Pharmaceuticals Candidate should be MBA in HR from good university and must have an experience of 22 to 25 years in Pharmaceutical Plant. 22-25 Ahmedabad naitik.dave@cadilapharma.co.in

Manager - Marketing Company: Profile: Exp: Location: Email:

G.C.Chemie Pharmie Responsible for marketing plans & execution to meet monthly and annual targets. 5-10 Mumbai hr@gccpl.com

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July 16-31, 2012

P|H|A|R|M|A| L|I|F|E CAMPUS BEAT

Manipal College of Pharmaceutical Sciences conducts XI Summer Training Programme More than 50 post-graduate students take part in the programme anipal College of Pharmaceutical Sciences (MCOPS) recently played host to a summer training programme in biopharmaceuticals for post-graduate students. There were fifty participants, most of them postgrad-

uate (M Pharm) students of MCOPS. This was the 11th summer training programme in all and the fifth to be conducted at MCOPS. Dr PD Gupta, an adjunct professor of MCOPS from Jaipur was the co-ordinator of the programme along with Dr N Udupa, Principal, MCOPS. Dr HS Ballal (Pro Chancellor,

Manipal University) inaugurated the programme in the presence of Prof P Gundu Rao and Prof N Krishnamurthy (a former principal and vice-principal, respectively), Dr N Udupa and Dr PD Gupta. After the lecture, the trainees dispersed and worked either in the library for reference search or in the laboratory carrying out the assigned project works. Every trainee was assigned one minor project capable of being completed within the stipulated period of one month. To round up a day’s work, Dr Gupta engaged the candidates for a discussion. Among the resource persons were three top officers of Manipal University, Pro-Chancellor, Pro-vice Chancellor and Registrar, viz., Dr HS Ballal, Dr H Vinod Bhat and Dr GK Prabhu, respectively. Dr Prabhu spoke of the '6Is'- idea, inspiration, innovation, influence, invention and incubation for success in professional life. Dr Vinod Bhat gave a talk on the relevance of publishing and printing. Dr Ballal discussed the role of drugs and radiology in his talk titled, 'Pharmacoradiology modality based uses of pharmacological agents.' Besides lectures from Dr Gupta, other eminent persons too delivered

effective presentations. These include Dr PM Gopinath, Dr KG Rajendran, Dr MD Burande, Dr Suman Kapur and Dr RN Saha (both from BITs, PIlani), Dr Akbar Shah, Dr S Badami (Tumkur), Dr Bharti Chogtu (KMC Manipal), Dr Shreemathi Mayya (Manipal University) and Vasudeva Shenoy (Ecron Acunova). A number of faculty members gave lectures. They are: Dr J Venkata Rao, Dr MK Unnikrishnan, Dr Rekha Arun, Dr D Sreedhar, Dr Yogendra Nayak and Anoop Kishore. The participants were expected to work on a small research project and submit a written report in the end. Each one was also required to make a presentation of their project. These were evaluated and the prizes were given for best project, best participation and best presentation. Winners declared for this year were Sanam V Pavan Kumar (Best Project); Jessy John (Best Participation) and M Naga Laxmi Prasanna (Best Presentation). Certificates were issued at the valedictory function. Dr N Udupa and Dr PD Gupta summed up the gains of the XI Summer Training Programme. EP News Bureau—Mumbai

SVKM’s Narsee Monjee Institute of Management Studies hosts Convocation 2012 338 students graduated from the institute VKM’s Narsee Monjee Institute of Management Studies, a deemed-tobe university, hosted its Convocation 2012 for Pharmacy & Technology Management at Bhaidas Hall, in

(From L-R)- BP Sheth, Dr Sourav Pal, Dr Rajan Saxena, Sunandan Divatia and Varsha Parab

July 16-31, 2012

Mumbai. Dr Sourav Pal, Director, National Chemical Laboratories (NCL), Pune was the chief guest who delivered the convocation address. The ceremony began with the academic procession led by the registrar of the university Varsha Parab followed by declaration of “Convocation 2012 Open” by Balwantrai Sheth, Vice President-SVKM. Successful students, faculty and staff members were pre-

sented with awards. Pal congratulated 338 students for graduating from the institution and extended his wishes for them. He also released the convocation brochure and roster during the ceremony. He continued by appreciating the progress made by Pharmacy & Technology Management schools and the way in which their school is excelling in delivering education in the country since last seven years. He also elaborated the contribution of NCL to the society. He urged the outgoing graduates that they should use their knowledge to encourage and help others with less privilege and set goals to have a balanced, successful life. Dr Rajan Saxena, Vice Chancellor, NMIMS University, in his welcome address, said, “Schools of Pharmacy and Technology Management of NMIMS completed another year of accomplishment and, has set new benchmark in pharmacy education in India. He congratulated the dean, faculty, staff and students of pharmacy and technology management. Talking about the activities and achievements of Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management (SPPSPTM),

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Dr RS Gaud, Dean stated that the School of Pharmacy & Technology Management of NMIMS has been rated fourth in the country by pharma recruiters which has now emerged as a final destination for youth aspiring to become techno managers. He gave an in-depth review about the progress of the college, outstanding achievements during the academic year and presented the achievement and progress of the schools and pointed out that faculty have contributed more than 67 research paper, 87 presentation at national and international level, seven books and six patents. Mentioning the placements of pharma graduates, he informed that the average compensation for the Batch of 2012 stood at ` 5.6 lakh per annum, while the highest CTC offered on campus raised to ` 12.65 lakh per annum. Leading companies like Ranbaxy, Ernst & Young, GlaxoSmithKline, Biocon, Mylan, Abbott Health Care, Shreya Life Sciences, Strides Arco Labs etc. have offered jobs to our students. The evening concluded with a vote of thanks presented by Dr Bala Prabhakar, Associate Dean, SPP SPTM, NMIMS thanking all the dignitaries. EP News Bureau—Mumbai EXPRESS PHARMA

P|H|A|R|M|A| L|I|F|E

Book Shelf Nanotechnology Intellectual Property Rights: Research, Design, and Commercialization Authors: Prabuddha Ganguli; Siddharth Jabade his book titled Nanotechnology and Intellectual Property Rights….Research, Design and Commercialization has been designed to comprehensively address the interrelated issues in an integrated and comprehensive manner. The book employs illustrations and lucid explanations to examine the integration and exploitation of intellectual property rights (IPR) as a tool in research and development, technology transfer, and safe commercialisation. Requiring no prior legal experience of readers, it illuminates the nuances and integral role of IPR in technology development, from product inception through commercialisation. This indispensible book destroys illusions in the minds of stakeholders and builds confidence to establish a framework for an agile, working product development model. The first three chapters illustrate the evolving patent landscape in nanotechnology, patenting procedures as applied in diverse jurisdictions, searching for nanotechnology prior art including the creation of search strategies and the international patent classification system. The fourth chapter on patent led nanotechnology businesses provides a spectrum of perspective learnings using a plethora of case studies involving building of valuable patent portfolios, growth of start-ups, consolidation of IP led nanobusinesses through mergers, acquisitions, joint ventures, strategic investments, etc. The fifth chapter dealing with patent litigations in nanotechnologies exemplifies

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the significance of strategic crafting of agreements related to IP transactions, compliance of contractual obligations, importance of well drafted patent specifications, sensitivities in conducting technolegal due diligence prior to the development and marketing of products, vulnerabilities in challenging / defending validity of patents and negotiating settlements. Chapter six gazes into the future of IP landscaping in nanotechnology especially in terms of the grey areas on patentability, public

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perceptions of risks to health and ecosystem, institutionalised management of Intellectual Property Rights and the steps that will be necessary to meet such challenges. Capacity building in IP will continue to be a key factor that will determine success of businesses and model IPRinternalise has been described for institutional adoption to continually build human and infrastructural resources to meet the emerging and unforeseen challenges of “the day after”. The book also illustrates content supported by lucid explanations, making information accessible to those who are not lawyers. It demonstrates the nuances of IPR and how to lay a solid foundation for design and implementation of research programmes in technology-intensive areas, such as nanotechnology besides familiarising the reader with the power of patent information. It also offers future perspectives and case studies and includes an appendix with data tables and links.

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July 16-31, 2012

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