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Contents

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

Pharma VOL 7. NO. 21 SEPTEMBER 1-15, 2012 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Photo Editor Sandeep Patil BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore

interviews ‘Pharmac will become the most popular show’ Within a short span of time Pharmac has emerged as a major event in the state of Gujarat and organisers are contemplating to make this a leading event in the industry. Kamlesh Patel, Chairman, IDMA-GSB reveals details about the preparations and plans with Usha Sharma

Neelam M Kachhap

Page 27

Delhi Shalini Gupta MARKETING Deputy General Manager Harit Mohanty Senior Manager Rajesh Bhatkal PRODUCTION General Manager B R Tipnis Production Manager

‘Increased drug inspectors will improve field operations... Gujarat FDCA has completely modernised its administrative set up both in terms of infrastructure and operating systems and it has recently recruited 65 new drug inspectors. Dr HG Koshia, Commissioner, Food & Drug Control Administration, shares details with Usha Sharma Page 28

Bhadresh Valia

Report on CDSCO functioning to be ready in three months Dr GN Singh, Drugs Controller General of India has indicated that the report on the CDSCO’s functioning could be ready within the next three months. The report is in response to the issues raised by the 59th Report of the Parliamentary Standing Committee on the functioning of the CDSCO

Asst. Manager - Scheduling & Coordination Arvind Mane Asst. Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Layout Rakesh Sharma

‘Nanotechnology brings new openings to stem cell R&D’ Polyclone Bioservices is working on application of nanotechnology in stem cell therapy. Naveen Kulkarni, CEO and Founder, Polyclone Bioservices, in discussion with Sachin Jagdale, reveals various scientific aspects of this research Page 44

C I R C U L AT I O N Circulation Team Mohan Varadkar Express Pharma

quote

Page 15

insight Tasting new trends in health supplements market CubeX’s comprehensive report titled ‘Tasting New Trends in the Indian Health Supplements Market’, gives a detailed understanding of the nutrition gaps that exist across regional food plates in India Page 39

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,

The empirical application of conventional vaccinology i.e. administering a ‘modified pathogen’ or antigen and hoping that immunity develops has not worked for HIV infection so far

Nariman Point, Mumbai - 400021)

Guido Silvestri Professor of Pathology and Laboratory Medicine Emory University School of Medicine

Page 43

or in part, without prior written permission is prohibited.

September 1-15, 2012

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Editor’s Note

Gleevec, Nexavar cases put India’s IP laws to test

he debate on patents vs patients remains on the boil, with the Bayer/Nexavar and Novartis/Gleevec cases keeping the issue live. While it has taken six years for the Novartis case to reach the final argument stage, the Bayer vs Natco Pharma case is just a few months old.

Both 'landmark judgements' which triggered these appeals have been hailed by global aid agencies like Médecins Sans Frontières (MSF). Commenting on Bayer's appeal, Michelle Childs, Director, Policy and Advocacy, MSF Access Campaign comments, “The patent controller has set an important precedent that can be applied to other drugs priced out of reach.” Patent holders too worry that these decisions will set a precedent. Thus the issue goes beyond Gleevec or Nexavar. As Professor Paul Herrling, Head of Corporate Research, Novartis explains to business blogsite Pharmalot, “What we really are interested in is a discussion or statement about the patent law in India. What kind of innovations can be protected and not be protected?” Other critics of these decisions, like Jay Taylor, Vice President – International, Pharmaceutical Research and Manufacturers of America (PhRMA) aver that “compulsory licensing will never cure the many issues facing healthcare around the world”, alluding to “the lack of core healthcare infrastructure and inadequate financing mechanisms” in India. He points out that even though less than one per cent of all medicines in India are patented and none of the medicines on India’s Essential Drug List are patented, the World Health Organization estimates that a mere 20 per cent of the country can afford those off-patent treatments. Indeed, both cases are indicative of how India's regulators feel that they need to use policy to address the country's healthcare burden. And India is not alone in this approach. A recent report from GlobalData, titled, 'Global Healthcare Policy Analysis 2012 – Regulatory, Pricing, and Reimbursement Assessment', examines how these two countries are crafting patent policies and drug pricing laws to meet these goals. The GlobalData report also examines how this stance of policy makers has forced industry to evolve a counter strategy. For instance, Roche has announced that it will introduce cheaper, differently branded versions of certain drugs in India to pre-empt the issuance of compulsory licenses. Many MNCs already have donation programmes. According to Herrling, 90 per cent of all patients in India requiring Gleevec get the medication free from the company's donation programme. Notwithstanding Novartis' and Bayer’s arguments, there is growing acknowledgement among MNC pharma that they have to change. “We must get the balance right,” said Andrew Witty, global

CEO,

GSK,

OPPI's

AGM

last

year.

(See

Express

Pharma

report:

http://www.expresspharmaonline.com/20111031/market18.shtml) While Witty made the point that there needs to be a level of certainty that success in drug discovery "will be rewarded reasonably", he stressed that this "does not equate with the right to charge a high price". Thus, the path chosen by India's policy makers seems to be the best choice, given the circumstances. Legal battles will take they own course, but if more companies evolve differential pricing options and expand patient access programmes; if only to thwart compulsory licenses and price cuts, patients will benefit. It seems to be a clear case of the means justifying the ends. Viveka Roychowdhury viveka.r@expressindia.com

10 EXPRESS PHARMA

www.expresspharmaonline.com

September 1-15, 2012

Market

THE BUSINESS OF PHARMACEUTICALS

UPFRONT ICDR rules in favour of Glenmark wins ruling to commercialise, distribute Crofelemer he International Centre for Dispute Resolution (ICDR) ruled in favour of Glenmark on the arbitration claim it filed on August 8, 2011 against Napo Pharmaceuticals seeking, among other things, a ruling that Glenmark's exclusive rights to develop, commercialise and distribute Crofelemer in 140 countries for treatment of diarrheal diseases. The claim also includes the exclusive rights to distribute though relief agencies in these countries and an injunction prohibiting Napo from sharing confidential information concerning the manufacture of Crofelemer. The ICDR ruled that Glenmark’s exclusive rights to commercialise and distribute Crofelemer include the exclusive right to distribute Crofelemer through relief agencies to 140 countries that comprise the Glenmark territory. The ICDR also ruled that Glenmark has two years from the time Crofelemer is approved in India (on an indication by indication basis) to file for regulatory approval in 140 countries in its territory. Finally, the ICDR found that Napo breached the collaboration agreement by disclosing confidential information concerning the manufacture of Crofelemer to Aptuit Laurus and enjoined Napo from disclosing such confidential information to third parties and from purchasing or obtaining Crofelemer from Aptuit. “We are delighted that the arbitrators have reaffirmed Glenmark’s rights to commercialise Crofelemer through relief agencies. This ruling will allow Glenmark to further its commitment to working with relief agencies to distribute Crofelemer to affected populations. We also are pleased that the arbitrators have prevented Napo from sharing confidential information concerning the manufacture of Crofelemer with our competitors and other third parties,” said Glenn Saldanha, Chairman and MD, Glenmark.

September 1-15, 2012

India, Sri Lanka to jointly fund pharma hub During his recent visit to Sri Lanka, Anand Sharma, Union Minister of Commerce and Industry , announced that the two countries will work together towards the establishment of a pharma manufacturing hub in Sri Lanka. This move will capitalise on the vast strides made by the Indian pharma industry towards meeting global quality standards at affordable prices. It is predicted that the hub will be ready in next two years

Page 14

‘Mylan can set a new standard in the treatment of HIV/AIDS in India’ Mylan recently started commercial operations in India with the launch of 18 ARVs, including heat stable, combination, and paediatric formulations, from its global ARV portfolio. In the next five years, the goal is to build Mylan’s brand equity in the country, says Rajiv Malik, President, Mylan Inc and gives more details to Viveka Roychowdhury on the company's strategy to be a top ten company in India What are the hallmarks of Mylan’s strategy for the India market? How would you differentiate Mylan's strategy from its global pharma peer group? In the next five years, our goal is to build Mylan’s brand equity in India and position ourselves as a high quality, innovative and cutting-edge pharmaceutical company with global standards. Long-term, we aim to be a top ten company in India. While we understand that we will be entering a highly competitive market, the key to differentiate ourselves from local players and other MNCs is by educating Indian physicians, pharmacists, customers and consumers about what the Mylan brand stands for unmatched supply reliability, outstanding customer service, operational integrity and high quality products. Our sales force will be another key differentiator. We have hired what we believe is the best talent and have provided them with world class training to empower them to be Mylan’s brand ambassadors in India. We will start in India with our high quality ARV portfolio and we believe that Mylan can set a new standard in the treatment of HIV/AIDS in India by providing healthcare providers and those living with the disease access to high quality, affordable medicines and by supporting physicians in their efforts to educate and treat their patients through our innovation, reliability and service excellence. Today, Mylan is widely respected for the quality, dependability and affordability of its ARV franchise, and the company’s ARV products are used by nearly onethird of all patients receiving treatment today for HIV/AIDS in developing countries. Mylan has also introduced a number of ARV innovations, for instance producing single blister 'combo' packs, which provide a reduced pill burden and once-a-day dosage. Mylan also developed three FDA/ WHO-approved

heat-stable ARV products, which can be distributed and used in countries where refrigeration infrastructure is not widely available. In addition, Mylan has been a global leader in producing ARV formulations for paediatric use. The Mylan portfolio will initially include a comprehensive range of 18 products, including heat stable, combination, and pediatric formulations. What are the other products in the pipeline, which were specifically developed for markets like India, which have warmer climates, as well as little or no access to proper storage conditions? Innovation is one of Mylan’s core values and we are constantly looking at ways to innovate across our product portfolio – as we have done with ARVs – and we will seek to bring to the Indian market additional innovative, market-appropriate products in other therapeutic categories over time. We cannot comment specifically on those products at this time. What is the projected timeline to launch other ARV products in India? We have launched a comprehensive portfolio of ARV products, composing 18 of the 43 products, which Mylan has in its global portfolio. We will launch additional ARV products depending on the market feedback and demand, as appropriate. In addition to providing a broad range of ARV products, Mylan has said that it will launch several initiatives aimed at educating and supporting medical professionals in their efforts to more effectively treat their patients and helping patients better manage their disease. Could you give more details of these educational efforts, in terms of timeline of launch, etc. Mylan will work closely with medical professionals to ensure that patients comply to the prescribed treatment by providing various tools and training.

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Which are the other therapeutic categories that the company is targeting for India and what is the timeline for these plans? Mylan expects to enhance its commercial portfolio in India by adding additional therapeutic categories. We intend to roll out these launches over time and will provide additional details on these areas in conjunction with launch. What is the projected sales force expansion for the next few years? We will continue to expand our sales force to meet market needs and to support our ongoing business expansion into additional therapeutic categories. At present, what is Mylan India's share of the global revenues? Given the growth potential in India, could you give some indication of what India's share could be in the next couple of years? We do not break out revenues at the country level. In 2011, third party net revenues for the Asia-Pacific EXPRESS PHARMA

M|A|R|K|E|T region, which includes India, were at $1.2 billion. We have indicated that our India commercial entry and our ARV business are both important strategic growth drivers for Mylan over the next several years. We anticipate ~13 per cent compound annual growth in revenues from 2011-2016 in our global ARV business, and we are targeting to become a top ten player in India. Which policy issues could become speed breakers to the growth potential of the India market? As with any market, health care policies, including pricing and reimbursement are keys in driving growth. Currently, discussions are taking place in India on increasing its expenditures on health, including providing universal health care, which depending on

the exact scope of the changes and implementation, could contribute to accelerated growth.

ness, inadequate infrastructure, restrictive laws, lack of appropriate treatment options, hurdles to testing, etc.

OPPI has stressed that India's weakness is lack of accessibility rather than affordability of healthcare services, including medicines. What are Mylan's efforts in the accessibility space and is this part of the strategy for India? Mylan’s mission is to provide the world’s seven billion people with access to high quality medicine. We strongly agree that cost is only one of the many barriers to access and we are working to do for access what we have already done for affordability in ARVs. In fact, we strive every day to break down barriers to access to medicine, in India and around the world. These barriers include lack of education/aware-

The US has its Obamacare/ Affordable Healthcare Act. Do you see chances of health becoming a political issue in India like in the US? Would this have a good or adverse impact on the pharma industry and healthcare as a whole? Currently, discussions are taking place in India to provide access to quality and affordable healthcare in the form of a universal healthcare plan. Both the central and state governments have a vital role in translating this goal into reality. The impact on the pharma and healthcare industry in India depends on the scope and implementation of the plan. viveka.r@expressindia.com

India, Sri Lanka to jointly fund pharma hub Sri Lankan pharma hub to be ready in the next two years, Pharmexcil to promote exports from India Usha Sharma Mumbai uring his recent visit to Sri Lanka, Anand Sharma, Union Minister of Commerce and Industry , announced that the two countries will work together towards the establishment of a pharma manufacturing hub in Sri Lanka. This move will capitalise on the vast strides made by the Indian pharma industry towards meeting global quality standards at affordable prices. It is predicted that the hub will be ready in next two years. The main objective of the weeklong visit was to increase bi-lateral relations between India and Sri Lanka. Sharma led a delegation comprising Pharmexcil as well as Indian pharmaceutical companies to the India Show. Pharmexcil is in the process of preparing a visit report of its meeting, which will be handed over to the Ministry of Commerce and Industry in the next three to four days. Dr PV Appaji, Director General, Pharmexcil said, “Our recent visit to Sri Lanka was a further step to promote exports from India to the Sri Lankan market besides creating a pharma hub in Sri Lanka and also to increase bilateral trad e. We discussed various topics about the pharma market in Sri Lanka with the Sri Lankan Ministry of Industry and Commerce

team led by Jayarathna Herath, Deputy Minister of Industry and Commerce of Sri Lanka, high ranking officials of the Ministry’s Department of Commerce and representatives from the top ten Sri Lankan pharma manufacturers.” Appaji pointed out, “Sri Lanka needs to source international investments in various ways. To make this appropriate, we will be strengthening our relationship through joint ventures, fresh investments, technology transfer etc.” Sri Lanka is an emerging pharma market and the market size is estimated to be around $400 million. Around 15-20 per cent of market demand is met internally while the rest comes from exports where India plays a major role. The top three drugs exported to Sri Lanka from India are amoxycilline (antibiotic), glucose liquid, and diloxanide furoate (for intestine/stomach issues). Appaji highlighted, “On a year-onyear basis, India’s pharma exports to Sri Lanka have increased by 15.95 per cent in 2011 to $126.9 million of which 93 per cent were formulations followed by bulk (seven per cent) and herbals (0.15 per cent).”

Sri Lanka is an emerging pharma market and the market size is estimated to be around $400 million. Around 15-20 per cent of market demand is met internally while the rest comes from exports where India plays a major role

“We will help Sri Lanka to create the pharma hub where Indian and overseas companies can establish their manufacturing sites. We have approached Indian infrastructure developers to provide services. During our visit, Ministry of Industry and Commerce, Sri Lanka, has shown some land for setting up the pharma hub. We are conducting the feasibility study of the land and it is expected that construction work will commence in next six months,” Appaji added. Appaji further said, “I am not saying that the local market in Sri Lanka is less important but to get Sri Lanka’s pharma hub moving, and to follow the India model, I stress that it is better to focus on export-oriented manufacturing aimed at the $956 billion global pharma market, which is growing five per cent annually and is expected to be $1200 billion by 2016. In fact, we are talking of a $1.1 trillion global generic drug opportunity here. Just like India, Sri Lanka can also capture this growth opportunity. Thereafter Sri Lanka needs to attract international investments such as JVs and then bring in the required critical technology for both bulk and formulation manufacturing.” As per a release from the Sri Lankan government, India has given a strong, structured recommendation on the way forward for Sri Lanka’s focus on the huge global market. Its first official discussions with Sri Lanka on the proposed pharmaceutical manufacturing hub has excited the Lankan private sector and concluded successfully. When asked about the funds for creating the pharma hub in Sri Lanka Appaji indicated that both countries will jointly fund the project. u.sharma@expressindia.com

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September 1-15, 2012

M|A|R|K|E|T

Report on CDSCO functioning to be ready in three months DCGI mulls rule to protect patients enrolled in clinical trials Usha Sharma Mumbai r GN Singh, Drugs Controller General of India has indicated that the report on the CDSCOâ&#x20AC;&#x2122;s functioning could be ready within the next three months. The report is in response to the issues raised by the 59th Report of the Parliamentary Standing Committee on the functioning of the CDSCO, which were presented to both houses of Parliament in May 8th this year. The issues pertained to the functioning of the organisation, including alleged approval of drugs without clinical trials. The CDSCO had constituted a three-member expert committee consisting of Dr VM Katoch, Secretary (Department of Health Research) and Director General, ICMR; Dr PN Tandon, President, National Brain Research Centre, Department of Biotechnology, Manesar and Dr SS Aggarwal, Former Director, Sanjay Gandhi Post-graduate Institute of

September 1-15, 2012

Medical Sciences, Lucknow to examine the validity of the scientific and statutory basis adopted by CDSCO for approval of new drugs. It has already been three months since the committee was formed and when pressed why the report will take a further three months Singh admitted that while the three-member expert committee may take some time to pres-

The committee is also examining the validity of the scientific and statutory basis adopted for approval of new drugs without phase-III clinical trials on the Indian population

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ent the data, the final report would be fairly comprehensive and in public interest. The committee is also examining the validity of the scientific and statutory basis adopted for approval of new drugs without phase-III clinical trials on the Indian population. The Government recently constituted committees of experts to give opinions/ recommendations to the CDSCO with respect to different categories of Investigational New Drugs/ New Drug proposals. Speaking exclusively with Express Pharma, Dr GN Singh, Drugs Controller General of India indicated that his office is also contemplating making a rule that no patients enrolled on clinical trials should suffer during trials. To further protect the safety of patients/volunteers participating in clinical trials, the DCGI recently released a notice giving a comprehensive check list of what details should be included in the informed consent form. u.sharma@expressindia.com

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M|A|R|K|E|T

Phase I trial of CSIR-IMTECH's clot buster to start by end October Ahmedabad’s Veeda CR to conduct the trial, CSIR aims to launch drug in India by 2014 Usha Sharma Mumbai he Institute of Microbial Technology (IMTECH), one of the national laboratories of the Council of Scientific & Industrial Research (CSIR) which recently received the Drugs Controller General of India (DCGI)’s nod for phase I trials for its clot buster drug is due to kick off the trial by end October at Veeda Clinical Research (Veeda CR), an Ahmedabadheadquartered CRO. The drug is likely to be launched in the Indian market by 2014. In an interaction with Express Pharma, Dr Girish Sahni, Director, CSIR-IMTECH, Chandigarh said, “It took almost six to eight months to get the final nod from DCGI for conducting human phase I clinical trials. We have generated the data as per the requirements by the DCGI's office and the entire process was fairly efficient.” The molecule to go to trial is a clotspecific streptokinase (CSSK), a pioneering biotherapeutic clot buster drug from CSIR-IMTECH which was earlier licensed to Nostrum Pharmaceuticals LLC, a New Brunswick, New Jerseybased firm. This drug has been successfully tested in animals including monkeys and the scale-up was achieved by a team led by Sahni. Sahni’s area of expertise is engineering of therapeutic proteins and the

mechanism of action of enzymes. Successful technologies developed by Sahni’s group at IMTECH include a complete high-efficiency process package for production of natural streptokinase for the first time in India, resuting in the launch of ‘STPase’ by Ahmedabad-based Cadila Pharma in 2002. The Chennai-based Shasun Drugs and Chemicals was the second beneficiary of the group’s expertise, when they successfully transferred the production process for recombinant (rDNA-based) streptokinase production. The product, Lupiflo, was launched in the Indian market in July 2009. On November 24, 2010, Nostrum Pharmaceuticals entered an in-licensing agreement with IMTECH for clinical development and worldwide commercialisation of next generation thrombolytics discovered at IMTECH. The protein-engineered, therapeutically improved "clot-specific" streptokinase that was licensed to Nostrum Pharma and Symmetrix Biotech, India is a modified molecule, which reduces the side effects associated with clot buster bleeding, reveals Sahni. The phase-I trial is likely to be conducted on 10-20 healthy human volunteers in order to check the efficacy of the molecule. Commenting on this achievement, Samir K Brahmachari, Director General, CSIR, said, “CSIR’s achievement in developing a series of clot buster drugs

is remarkable as it covers the whole ‘inventor/ innovation’ chain from economically robust process development to obtain affordable modern drugs to internationally competitive blockbusters. At the time, Dr Nirmal Mulye, President. Nostrum Pharmaceuticals, had said that this was an unprecedented example of a successful public-private partnership in India and thanked CSIR-IMTECH for being part of the project by providing the infrastructure for the biopharma manufacturing process development for CSSK. IMTECH’s CSSK candidate is being hailed as the first India-patented (nongeneric) biopharmaceutical (therapeutic protein). It is hoped that the trial molecule will not only help to save the lives of patients prone to heart attacks, but will also exhibit reduced sideeffects, such as internal bleeding often associated with the use of clot busters. The successful development of state-ofthe-art bio-therapeutic drugs such as CSSK marks a major milestone for the Indian biotech science community, which has already gained recognition for smart and economic processes for bio-similars, an area in which CSIRIMTECH has already contributed significantly by developing two clot busters (natural and recombinant streptokinase), which are already selling well in the market. u.sharma@expressindia.com

Merck acquires Biochrom The acquisition will strengthen Merck Millipore’s Process Solutions business unit erck has entered into definitive agreements to acquire Berlinbased Biochrom. The parties agreed not to disclose the purchase price. The acquisition is subject to customary closing conditions such as the approval of the respective antitrust authority. Closing of the transaction is expected in the fourth quarter of 2012. The acquisition will strengthen Merck Millipore’s Process Solutions business unit, which provides products, services and solutions that simplify production complexity for pharmaceutical and biopharmaceutical manu-

facturers. Biochrom’s cell-culture media products are highly complementary and innovative, adding liquid cellculture media and buffers including serum-free products and disposable packaging solutions to the existing portfolio. “With Biochrom we have a great opportunity to deliver an expanded portfolio of cell-culture media products to our global customers and address a growing demand for ready-to-use liquid solutions that drive safety and efficiency in the development and manufacture of clinical and commercial drug

materials,” said Robert Yates, Head, Merck Millipore division. Dr Bernd Frenzel, CEO, Biochrom said, “Merck Millipore is the ideal partner for Biochrom. With Merck Millipore we will be able to leverage their industry relationships and global footprint to reach more customers and offer a more comprehensive portfolio of media and buffers.” It is planned to maintain Biochrom’s operations in Berlin. Biochrom’s activities will be part of Merck Millipore’s Process Solutions business unit. EP News Bureau

Wockhardt gets US FDA approval for generic version of anti-hypertensive drug Plendil Will manufacture the felodipine API in its facility at Ankleshwar harmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing extended-release tablets containing 2.5 mg, 5 mg and 10 mg felodipine, which are used in treating hypertension. As per the company release, felodipine is the generic name for the brand Plendil, marketed in the US by Astra Zeneca. Wockhardt will soon launch the

EXPRESS PHARMA

product. According to IMS Health, the total market for this product in the US was over $66 million. Hypertension and related cardiac diseases remain a major health concern the world over. Dr Habil Khorakiwala, Founder Chairman and Group CEO, Wockhardt, “We have received four ANDA approvals in the last five days and two of these are extended release pharmaceutical formu-

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lations. This definitely is a reflection of Wockhardt’s R&D prowess in indigenously developing such products.” Wockhardt will manufacture the Felodipine API in its facility at Ankleshwar and the tablets of Felodipine ER at its facility in Aurangabad. The technology for the API and the extended-release tables were developed in-house. EP News Bureau September 1-15, 2012

M|A|R|K|E|T

Venus Remedies launches Trois for arthritic pain Trois is a patent protected topical nano emulsion with all natural ingredients and has no side effects enus Remedies for the first time has launched a research-based product, Trois, in the Indian market. This patent protected topical nanoemulsion has been developed by using the integrated natural medicine approach to relieve from all kind of arthritic pain. Talking about the product, Dr Manu Chaudhary, Joint Managing Director and Director-Research, Venus Remedies said, “The problem of arthritis is a constantly growing epidemic in India. As per the latest reports, almost 15 per cent of the Indian population is suffering with this crippling disease. We felt the pressing need to develop an alternative solution for rheumatic disorders and related infections, thus have come up for the first time with a topical nano emulsion

Trios to relieve the arthritic pain." According to the company release, prevalent treatment of rheumatoid diseases includes drugs such as nonsteroidal, anti-inflammatory drugs (NSAIDS), corticosteroids, slow acting anti-rheumatic drugs (SAARDS) or disease modifying (DM) drugs include penicillin amine like drugs such as cyclophosphamide, methotrexate, gold salts, azothioprine, levamisole and the like. All these drugs have severe side effects and most of them are cytotoxic. Dheeraj Aggarwal, CFO, Venus Remedies, “With the kind of response we are getting for this revolutionary nano-tech emulsion in pain management as topical pain killer in arthritis, we are hopeful of capturing a significant share of the rheumatoid arthritis drug

market in India, which is speculated to grow up to $672 million in 2013.” Trois has been awarded gold medal in 2011, under India Innovation Growth Programme, organised by FICCI, Lockheed Martin and IC2 Institute, Texas. He further added, “We have already filed patents for Trois in the major markets across the globe and based on the regulatory approvals, we are soon going to launch our products in the international markets as well.” Trois is indicated for the treatment of pain and inflammation as associated with osteoarthritis, rheumatoid arthritis, juvenile idiopathic arthritis, gouty arthritis, ankylosing spondylitis, psoriatic arthritis, backache, sprain and fibromyalgia. EP News Bureau

IPAB postpones hearing on Natco's CL for Bayer's Nexavar to Sept 3 Focus shifts to Novartis India's challenge to Section 3 (d), scheduled for tomorrow he Intellectual Property Appellate Board (IPAB) in Chennai has reportedly postponed hearing Bayer's appeal of the compulsory licence (CL) granted to Natco Pharma for Nexavar (sorafenib tosylate) until September 3. Hyderabad-based pharma company Natco Pharma was granted the country's first CL by the Indian Patent Office in March this year for its generic version of Bayer’s patented kidney and liver cancer drug but the MNC is appealing the CL and has asked for a

stay on the CL. It might see some action on another high profile legal battle: Novartis India's legal challenge to the country's patent law, more specifically, Section 3(d). The final arguments in this case, due to start on July 10, was re-scheduled for August 22. The case stems from Novartis India's attempt to obtain an Indian patent on Gleevec/ Glivec (imatinib mesylate), its drug for chronic myeloid leukaemia and other cancers, which was denied by India's

Patent Office in 2006. Both cases are landmark cases and are being closely observed by global experts as they could set the precedent for future cases. Legal experts indicated that given the impact of such cases, the IPAB would want more time to examine the legal merits of the case before hearing arguments and hence today's adjournment of the Bayer/ Natco matter should be seen in this light. EP News Bureau

US FDA clears Claris Lifesciences' facility after remedial action Approval allows Claris to re-enter US market laris Lifesciences has formally received a letter from The Food and Drug Administration of United States of America (US FDA), which states that the US FDA has completed its evaluation of the firm's corrective actions in response to their Warning Letter WL: 320-11-003, dated November 1, 2010. Based on their evaluation, the US FDA has; vide their letter dated August 14, 2012; confirmed that the violation(s) contained in the Warning Letter have been addressed. Claris had received seven ANDAs approvals across four products before the warning letter was issued. The company has filed for a total of 32 ANDAs across 21 products which includes niche products like propofol and iron sucrose. The estimated market size of all products in the US is approximately $1 billion. The company continues to develop

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additional generic injectable products for the regulated markets including the

This approval will allow the company to file more products in this lucrative market which is considered a key region for the future growth of the company

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US. This approval will allow the company to manufacture and sell its products into the US and also receive ANDA approvals. Protocol Link, a global project management firm providing compliance management, quality systems, regulatory affairs and validation services for FDA-regulated companies, assisted Claris in the process of remediation. The US is the largest market for generic injectables accounting for about 51 per cent of the global market. This approval will allow the company to file more products in this lucrative market which is considered a key region for the future growth of the company. “We are happy with this approval and we thank all stake holders for their support. We look forward to re-entering the US,” said Arjun Handa, MD and CEO, Claris Lifesciences. EP News Bureau September 1-15, 2012

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

‘It is a critical time to capitalise on the biotech opportunities available within India’ James C Greenwood, President and CEO, Biotechnology Industry Organisation (BIO) and a former Congressman from Pennsylvania, US believes that the biotechnology industry represents our best hope to cure disease. In an email interaction with Viveka Roychowdhury, he touches on policy issues like BIO's take on the twin concerns of accessibility and affordability and the need for a “positive policy and legal environment”. He believes that the upcoming third annual BIO India International Conference scheduled for September in Mumbai will build on the tremendous amount of existing activity led by Indian companies BIO’s stated mission is ‘to be the champion of biotechnology and the advocate for its member organisations—both large and small.’ What are the key advocacy issues impacting the sector and what have been BIO's initiatives on these fronts? BIO’s overall goals in India are to foster collaborations between the US and Indian industry in all areas relating to biotechnology. To help facilitate this collaboration BIO looks at a variety of factors including R&D potential, protections for biotechnology innovations and regulatory mechanisms. In terms of R&D potential, BIO along with the Association of Biotechnology Led Enterprises (ABLE), have co-hosted the BIO India International Partnering Conference. The Conference, which this

year will be held in Mumbai, brings together US and Indian business and thought leaders in the area of biotech for partnering. In addition, we have watched closely as India’s Department of Biotechnology in conjunction with the Drug Controller General of India (DCGI) has issued guidelines for the approval of similar biologics. Indeed, we worked with our Indian industry colleagues to provide comments. We believe the guidelines are a step in the right direction and we are continuing to work with our industry colleagues as these guidelines are implemented to provide additional input into the process. Our industry is eager to work with the Indian government and our Indian counterparts to help India achieve its public health goals. We

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believe we are quite well equipped in terms of technology, expertise and innovative capacity. We also watched with concern as the Indian Patent Office issued a compulsory license to Natco Pharma on a Bayer cancer drug recently. The majority of our members, those that we are hoping to bring with us to India for the BIO India Conference, are small and medium sized enterprises that have breakthrough technologies ripe for development. These companies truly rely on their patents to attract partners for the development of potential cures. The possibility that their patents may at some point down the road by compulsorily licensed, gives many of these companies pause. Currently, the decision is on appeal and we are watching to see its ultimate outcome. As President and CEO of BIO, how do you see BIO's engagement with biotech companies in emerging countries? BIO represents the entire biotech ecosystem and emerging markets can play an integral role in each phase of a biotech product’s development. For example, BIO’s companies are interested in collaborating with India’s scientists to push the boundaries of science and translate that science into new biotech products. BIO companies are also seeking partners to manufacture and distribute biotech products in markets like India and around the world. BIO’s role is to facilitate this broad engagement and ensure governments around the world create a positive policy and legal environment for biotech. As a former Congressman from Pennsylvania, you have played an role in shaping policy in the US in this sector. What are your views on the tug of war between originators/ innovators and governments who are under pressure to provide safe and effective treatments for patients? Our nation and our world face significant problems; and it is now more clear than ever that the biotech industry represents our best hope to cure disease, feed the hungry, discover newer and cleaner forms of energy, and provide protection from pandemic and bio-terror threats. Government policies and the economic environment should support and encourage innovation to ensure that patients receive safe and effective treatments. In the US, healthcare is a major political issue with ‘Obamacare’ becoming a rallying points for both Republicans as well as of course the Democrats. Do you think this extra attention benefits the healthcare sector? Or do you think it harms the sector because it forces politicians to take stances which may turn out to be unsustainable in the long run? In the US, a lot of attention is being devoted to healthcare right now as our industry strives to create a policy environment that supports and encourages innovation and, ultimately, enables the

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industry to deliver cures and treatments to patients. Similar to the US, India has a burgeoning biotech sector, and the Indian government has invested billions into biotech research. India’s biotech and pharma space is world class, and the number and type of collaborations between Indian and US or EU companies has grown rapidly in the past few years. During this period of tremendous growth in both the Indian economy and its healthcare sector, it is a critical time to capitalise on the biotech opportunities available within India. Launching the BIO India International Partnering Conference builds on a tremendous amount of existing activity led by Indian companies. In countries like India, accessibility is a twin concern with affordability. What is BIO's take on this issue? BIO’s Options for Increasing Access to Medicines in the Developing World (www.bio.org/advocacy/letters/optionsincreasing-access-medicines-developingworld) clearly outlines our position on this issue. In the letter it states, “BIO’s members believe that the goals of increasing access to medicines, respecting intellectual property rights, and maintaining commercial viability are not mutually exclusive.” BIO Ventures for Global Health (BVGH) and BIO recently collaborated on a new report on the biotech sector’s contributions to neglected disease product development across drugs, vaccines, and diagnostics. Biotechnology: Bringing Innovation to Neglected Disease R&D(www.bvgh.org/ Biopharmaceutical-Solutions/DataCenter/BVGH-Reports/2012-BiotechReport.aspx) describes the overall biotech business model and identifies some of the challenges facing biotech engagement in global health product development. Millions of lives could be saved through faster and more efficient R&D. It is critical to target our resources and R&D efforts to provide the greatest benefit to the world’s poor. The report found that biotech companies participating in neglected disease R&D represent engagement of less than five per cent of the total number of biotech companies focused on health research and development. Despite the large proportion of neglected disease pipeline products with biotech company participation, the 134 active companies identified represent a small proportion of the nearly 3,000 biotech companies worldwide. These data suggest biotech companies are an underutilised resource for neglected disease R&D. Furthermore, large pharma companies participating in neglected disease R&D represent engagement of approximately 65 per cent of the total number of large, innovator pharma companies. What are the special features/ new attractions at the third annual BIO India International Conference to be held September 12-13 at the Grand Hyatt in Mumbai, India? As the non-profit trade association

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that represents the biotech industry, BIO is pleased to bring the BIO India International Conference back to India in an effort to further create and drive business development and collaborations through investor and partnering conferences. BIO has partnered with the ABLE, as well as leading investment banks and venture capital firms. In addition to high-level keynote speakers and educational Indiafocused panels, the event offers networking opportunities, company presentations, and the BIO One-on-One Partnering system. Through this conference and ongoing advocacy efforts, BIO aims to help the industry flourish within India's borders and help patients and citizens benefit from the promise of biotech. Confirmed keynote speakers for BIO India include Sam Pitroda, Advisor to the Prime Minister of India on Public Information Infrastructure & Innovations and H Thomas Watkins, Former CEO, Human Genome Sciences, a GlaxoSmithKline Company. Dr Cyrus Poonawalla, Founder, Chairman, and Managing Director, Serum Institute of India will discuss Vaccine Development in India during a Fireside Chat on September 12. Other sessions at BIO India include a session on Commercialising Stem Cell Therapies and Regenerative Medicine, on the second day which will discuss India’s progress in stem cells and gene therapies, the increasing use of these technologies to treat a host of diseases and look at what types of collaborations and funding are fuelling the space in India. Companies at the forefront of the field will share their business strategies and discuss the commercial and regulatory issues involved with developing these specific treatments at the national and international level. Panelists include BN Manohar, CEO, Stempeutics Research and Dr Chandra Viswanathan, Head of Regenerative Medicine, Reliance Life Sciences The keynote and plenary luncheon session will be on Strategies for Success: India’s Global Role in Innovation, which will deliberate how while India’s healthcare market is vastly different from Western markets, the country is quickly establishing itself as a global leader in the life sciences. Moderated by Rashmi Barbhaiya, CEO and MD, Advinus Therapeutics and with panelists including Phil Kearney, Director, External Scientific Affairs, Worldwide Licensing, Merck the panel will feature a candid discussion of India’s global role in biotech innovation and the mechanisms engaged to ensure success. Some of the queries that will be addressed include strategies employed by multinational biopharma companies to bolster innovation in India, what kind of policies can help foster this continued innovation and how both Western and local companies can leverage these to ensure success. The panel will also look at what role public-private partnerships play in facilitating funding for innovation. viveka.r@expressindia.com September 1-15, 2012

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CPhI Worldwide 2012 to raise success story of Indian pharma industry Event to be held in Feria de Madrid, Spain from October 9 to 11, 2012 he CPhI Worldwide exhibition at Feria de Madrid, Spain, from October 9-11, 2012, will attract over 29,500 attendees from over 130 countries and 2,200 exhibitors. The conference aims to increase industry awareness through rigorous analysis of global and regional trends â&#x20AC;&#x201D; from sourcing APIs to advancing drug delivery. 2012 marks the 23rd edition of this industry leading event. From just 250 delegates at the inaugural convention, visitor numbers have subsequently grown more than one hundred fold to over 29,000 attendees from over 140 countries. The event now covers more than 60,000 square metres of exhibition space, hosting over 1,900 exhibitors and is the market leader for the global pharmaceutical ingredients industry. The key objectives of the event will be to improve the credibility of Indian pharma industry; to increase business on a sustainable basis and take it to the next orbit; to raise the awareness of Indian pharma success story; to create awareness that Indian generics are not counterfeits and they are bonafide medicines of standard quality; to protect it from dubious allegations by vested interests; to position India as global pharmacy of world and to highlight the growth drivers-government support and regulatory framework, cost efficiencies,

technical capabilities. Major activities have been planned for India Show at CPhI-Worldwide this year. Anand Sharma, Minister of Commerce and Industry, Government of India with other top government officials are expected to take part in the

event. Formal showcasing of Brand Pharma India logo, brand positioning statement, business kit, film release and website at various platforms and options are being considered during CPhI-Worldwide. Apart from this, press conferences and media interviews

highlighting India's pharma sector and its strength, showcasing of products from India by Council's members in India pavilion, global buyer seller meetings in India theme pavillion; business seminar including presentations by global/Indian pharma

CEO's on demand/supply positions, have been p l a n n e d . CPhI Worldwide is organised by UBM Live, a division of UBM Plc, a leading provider of business information services to many industries. EP News Bureau

The event now covers more than 60,000 square metres of exhibition space, hosting over 1,900 exhibitors. Visitor numbers have grown more to over 29,000 attendees from over 140 countries September 1-15, 2012

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IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation Date: September 6-7, 2012 Venue: ITC Maratha Sahar,Mumbai 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: 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 APIs, biopharma 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 400 015 Tel: +91 22 2410 2801-03 Fax: +91 22 2410 2805 Cell: 09322037955 www.orbitzexhibitions.com www.pharmacindia.com

IDMA-APA-PAC 2012 Date: September 21-22, 2012 Venue: Hotel Hyatt Regency, Mumbai Summary: Indian Drug Manufacturers’ Association

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(IDMA) and Association of Pharmaceutical Analysts (APA) will organise the 15th Pharmaceutical Analysts’ Convention (PAC) 2012. The main theme for this year's convention is 'Conformance to Emerging Global Quality Standards'. Eminent technical personnel from the Indian pharma industry, research and academia will converge and gettogether to interact on various recent developments. Dr Kamal Sharma, Managing Director, Lupin will be the Chief Guest and the keynote speaker. Dr Nitya Anand – Chairman, Ranbaxy Science Foundation will be felicitated with the Padmashree Award. Topics likely to be discussed at the convention are: Toxicology of Pharmacopoeial Impurities; New Developments in Chiral Chromatography; Quality Risk Management in Analytical Laboratory; Using QbD for Monitoring Product Quality; Pharmacoscintigraphy for Preclinical Evaluation of New Drugs and NDDS; Cultivating a GMP Culture; Disinfectant Qualification – Why and How; Microbial Films – A Growing Concern; Labelling Innovations and Solutions; Retrofitting of Labs in Green Way; Analytical Methods Update on Technology Transfer – SOP and Practice; Application of Separation Techniques in Pharma and Bio Pharma. Contact details: Prachi Rane, IDMA 102/B, A Wing, Poonam Chambers Worli, Mumbai-400018 Tel: +91 22-24974308 / 24944624; Fax: +91 22-24950723 Cell:+91 9867634383) Email: ppr@idmaindia.com

2nd International Symposium on Frontiers in Pharmaceutical Research and Nanotechnology (Nanopharma2012) 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, Tamil Nadu will host the 2nd International Symposium on Frontiers in Pharmaceutical Research and Nanotechnology (Nanopharma2012). The focus of this symposium is The future vision and challenges in Nanotechnology'. On this plat-

form, 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 projects based on the novel ideas discussed, teachers can update their knowledge and researchers can widen their knowledge by attending this symposium. Contact details: G Karthikeyan, M Pharm Convener-Nanopharma 2012 Cell: 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, with its 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. Contact details Prof BG Shivananda

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Secretary-APTI Association Of Pharmaceutical Teachers of India 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 Summary: Biotechnology being an emerging industry, game-changing strategies and relevant application of the knowledge-intelligence 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

Bangalore INDIA BIO 2013 Date: February 6-8, 2013 Venue: Bangalore, India Summary: Bangalore INDIA BIO is an annual event organised by Department of Science & Technology Government of Karnataka, under the guidance of Vision Group of Biotechnology. Since 2001, Bangalore INDIA BIO has been promoting the Indian biotech industry to the outside world and is one of the biggest event on life sciences. Bangalore INDIA BIO 2013 will be an opportunity to get insights about the latest trends and biotech business opportunities in India. It will also deliberate on issues related to the latest innovations in biotechnology and focus on business opportunities that exist for companies in biopharmaceuticals, bio-industrial, bio-services, bioinformatics and agri-biotechnology in the light of the emerging bio economy. September 1-15, 2012

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It will also discuss about collaborative and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a global bio-economy and will provide networking and knowledge sharing platform for business leaders, policy makers, research heads and academia. Event Highlights ● Multi-Track Conference ● International Trade Show ● BioPartnering India TM ● Vision Leadership Series ● CEO Conclave ● Poster Walkway of Discovery ● Bio Excellence Awards ● BioQuiz ● Workshops Contact details: MM Activ #9, UNI Building, 1st Floor, Thimmaiah Road, Millers Tank Bed, Vasanthnagar, Bangalore - 560 052 Tel: +91 80 4113 1912 / 13 Fax: +91 80 4113 1914 enquiry@bangaloreindiabio.in

bulk actives and pharma chemicals, lab instruments and consumables, utilities, biotechnology, research, consultants, trade associations and publications and related services.

Top-notch professionals and decision makers, regulatory officials, etc. from across India and SAARC region, as well as Gulf region, African nations are expected to attend the

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, September 1-15, 2012

Ahmedabad 380015, Gujarat Tel: +91 792687 1390 / 4000 8253 / 4000 8233 Email: contact@pharmapropack. com

32-year history of partnership with leading pharma companies

VALSARTAN GREEN Non-Infringing Process

active pharmaceutical ingredients & its intermediates* Commercial scale Antitubercular Pyrazinamide# * Isoniazid # *

Antimalarial PHARMA Pro&Pack 2013

event. Contact details: Paresh Jhurmurwala GPE EXPO Global, Opp. Priyadarshini Tower, Near Judges’ Bungalows, Bodakdev,

Artesunate Arteether Artemether# * Dihydroartemisinin Lumefantrine# * Piperaquine

Macrolides

Antihypertensive

Azithromycin Clarithromycin Erythromycin base # # Erythromycin estolate Erythromycin ethyl succinate+ Erythromycin oxime (intermediate) Erythromycin stearate #

Irbesartan # Losartan potassium Telmisartan Valsartan

Antihistaminic #

Sedative, Hypnotic Zopiclone

Antifungal Flucytosine

Cetirizine dihydrochloride # Hydroxyzine dihydrochloride

Under Development Antiretroviral

Antidiabetic

Hypnotic

Ganciclovir Valaciclovir Valganciclovir Maraviroc

Linagliptin Vildagliptin

Eszopiclone

* WHO APIMF

CEP / COS

*The Technical and Physical manufacturing capabilities exist with us for the above APIs and their intermediates. However these products will be offered only to the markets where any product or process patents are not infringing. During the validity of a patent the research quantities for developing products for regulatory submissions will only be offered to countries where such exemption exists (Hatch Waxman Act / Bolar exemption). While Calyx offers to work with the clients on Patent Status Verification, the final responsibility vests with the buyer. Recipients are requested to make their evaluation and determination as to the patent status prior to their use of the information or materials in their respective jurisdiction. Products under patent offered only for exempted research, clinical and development purposes. Only non-infringing products and processes are offered, subject to patent status verification by client.

Calyx Chemicals and Pharmaceuticals Limited Regd. Office: Unit No.2, Marwah's Complex, Marwah Estate, Saki Vihar Road, Andheri (E), Mumbai 400072, India. Corp. Office: Unit No.110, Marwah's Complex, Marwah Estate, Saki Vihar Road, Andheri (E), Mumbai 400072, India. Tel: +91-22-28571191, Fax: +91-22-66466416 Email: sales@calyxindia.com, crams@calyxindia.com, sales@calyxusa.com, crams@calyxusa.com Website : www.calyxindia.com Disclaimer : Calyx Chemicals and Pharmaceuticals Limited (the “Company”) has filed the Draft Red Herring Prospectus (the “DRHP”) with the Securities and Exchange Board of India (“SEBI”) for its plan to issue equity shares to the public by way of Initial Public Offering. (IPO). The DRHP is available on the website of SEBI at www.sebi.gov.in, the website of the BRLMs, i.e. PL Capital Markets Private Limited at www.plindia.com, YES Bank Limited at www.yesbank.in and Punjab National Bank at www.pnbindia.com as also the website of the Company at www.calyx-pharma.com.

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M|A|R|K|E|T POST EVENT

A clarion call to step up research for AIDS vaccine India renews its commitment towards collaborative HIV vaccine research: DBT and IAVI set up a new lab devoted to the same Shalini Gupta New Delhi esearch towards a preventive HIV vaccine seems to be heating up and scientific collaboration cutting across borders seems to be the mantra. The immediacy is much more given that India is the third largest country with an HIV infected population after South Africa and Nigeria. And so, soon after the 19th World AIDS Congress came to a close in Washington DC last month, a two-day international symposium, titled 'Accelerating India’s Response to Research for a Preventive HIV Vaccine', was recently held in Delhi at the New Delhi Municipal Council (NDMC) Convention Centre. Devoted exclusively to HIV vaccine design and development, the event was organised by the Department of Biotechnology (DBT), Ministry of Science and Technology (MoST), Government of India (GoI); in partnership with the Department of AIDS Control (DAC) and the Department of Health Research (DHR), Ministry of Health and Family Welfare (MoHFW), Government of India; the Forum of Parliamentarians on HIV/AIDS (FPA); the Translational Health Science and Technology Institute (THSTI); the Regional Centre for Biotechnology (RCB) and the International AIDS Vaccine Initiative (IAVI). Inaugurating the event, former President of India, APJ Abdul Kalam emphasised the need to integrate all R&D activities on HIV research with a mandate to develop and commercialise an effective vaccine for HIV. Minister of Health and Family Welfare Ghulam Nabi Azad lauded the efforts of the National AIDS Control Programme,

Ghulam Nabi Azad, Union Minister of Health and Family Welfare currently in its fourth phase, that helped reduce the number of HIV infected cases, a whopping 56 per cent from 2.7 lakh in 2000 to 1.2.lakh in 2009. However, he stressed the need for a preventive vaccine. “Only a vaccine can have a high impact on public health which is further elucidated by the efficacy that vaccines for small pox and measles have shown in the past. India hasn't reported a single case of polio since 2011 and hence has been removed from the list of countries with endemic polio cases. We can only hope that a cure for HIV would help us achieve a similar status in the future,” he said. It is to be noted that various preventive methods have been used to

treat HIV patients such as microbicides, voluntary male circumcision, and anti-retroviral therapy (ART) even as newer ones are being worked out. These have helped control HIV infections from a range of 90 per cent to as high as 96 per cent. Still there are more than 2.5 million new infections reported every year. Apart from an august gathering of scientists, researchers, and academia, the event saw a host of parliamentarians supporting the cause. Vayalar Ravi, Minister for Overseas Indian Affairs, Science and Technology, Earth Sciences and Micro, Small and Medium Enterprises praised the efforts of the forum of parliamentarians under the leadership of Oscar Fernandes for pro-

Speakers during the inauguration of the event

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September 1-15, 2012

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viding impetus to scientific endeavour in the development of technology towards an efficient public health programme. India has conducted phase I trials of two HIV vaccines, but they had to be abandoned later. While one showed no appreciable immunogenicity, the other a combination vaccine in which DNAbased vaccine ADVAX was used as prime and Modified Vaccinia Ankara (MVA) as boost, had issues related to MVA stability, informed RS Paranjpe, Director, National Aids Research Institute (NARI) Pune. India, though has played a leadership role in providing close to 80 per

A vaccine that kills HIV like Ram killed Ravana

iven the tricky nature of the HIV virus, Kalam compared it to Ravana, a demon with 10 heads who comes up with another head as soon as one is mutilated and hence is indestructible. Just like when Ram targets Ravan's navel, he drops dead,a precise strategy needs to be applied to, when designing a vaccine for HIV, to nip it in the bud, he said.

cent of the ARV drugs used to treat HIV patients across the world. Giving a global perspective on HIV vaccine research, Margaret Mcglynn, International AIDS Vaccine Initiative (IAVI) President and CEO said, “RV 144, underwent phase II clinical trials in Thailand, but it’s efficacy was too modest to bring it to the market.

India has conducted phase I trials of two HIV vaccines, but they had to be abandoned later. While one showed no appreciable immunogenicity, the other a combination vaccine in which DNA-based vaccine ADVAX was used as prime and Modified Vaccinia Ankara (MVA) as boost, had issues related to MVA stability, informed RS Paranjpe, Director, National Aids Research Institute (NARI) Pune

Another candidate in phase I trials showed greater efficacy but did not show neutralising antibodies.” “Around 20 broadly neutralising antibodies have now been identified and understanding their structure will help scientists design immunogens which when injected into the body can produce the right antibodies,” she added. Collaboration is the way to go for 21st century science in the light of global health challenges the world faces today, said, Ashwani Kumar, Union Minister of State for Planning, Science & Technology and Earth Sciences. Taking a cue from the same, an HIV Vaccine Translational Research Laboratory is soon to come up in Delhi, a new research facility in India that aims to design vaccines that elicit an immune response capable of neutralising a broad spectrum of HIV variants. The laboratory is a joint venture of the Government of India’s THSTI, an autonomous institute of the Department of Biotechnology, and IAVI. shalini g@expressindia.com

September 1-15, 2012

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‘Pharmac will become a most popular show’ Within a short span of time Pharmac has emerged as a major event in the state of Gujarat and organisers are contemplating to make this as a leading event in the industry. Kamlesh Patel, Chairman, IDMA-GSB reveals details about the preparations and plans with Usha Sharma

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Tell us about the success story of Pharmac 2011 Pharmac—2011 was a success show and I give credit to the industry because it was organised by the industry itself. As we know the fact that Gujarat is a hub of pharmaceutical companies and Pharmac 2011 was the most economical show for all Micro, Small and Medium. Enterprises (MSME) and Small Scale Industries (SSI). Therefore, we have registered a great number of participants from all SSI and MSM Industry. Last year, there was a last minute venue change. Why was it changed and how did you manage to make the show successful? Last year there was a request from the Government of Gujarat and the venue had to be changed at the last moment. We were provided with a better venue from the government at Mahatma Mandir, Gandhinagar, which happens to be one of the best exhibition venues in the country. So, we didn't face any problems last year and the show was a success. In comparison to last years' event, what additional features have been added in this year's event? There is no change in this year's event compared to last year. Only, we have added more number of foreign visitors and exhibitors in our list. Continued on Pg 32 September 1-15, 2012

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‘Increased drug inspectors will improve field operations and monitor sale and distribution of pharma products’ Gujarat Food and Drug Control Administration (FDCA) has completely modernised its administrative set up both in terms of infrastructure and operating systems and it has recently recruited 65 new drug inspectors. Dr HG Koshia, Commissioner, Food & Drug Control Administration, shares details with Usha Sharma What is the current status of Gujaratbased pharma companies and what support will the government provide to them? Gujarat-based pharma companies are on the growth track. Technology upgradation and regulatory enhancements are the priority areas for both large scale and SME pharma sectors in Gujarat. Apart from the indigenous sector, MNC’s such as Teva and Abbott have lined up their investment plans in the state. Several firms from the US, which have been established by the NRI‘s from Gujarat have now become operational in API and formulations segment and many such investments are in the pipeline. The Government of Gujarat through the land and revenue offices and FDCA is facilitating their establishment. FDCA in particular, is providing them all the support for fast clearance. How technologically advanced is FDCA and how it is helping the pharma industry? FDCA Gujarat has completely modernised its administrative set up-both in terms of infrastructure and operating system. The e-governance initiative with the help of NIC and state government has developed XLN-Extended licensing and laboratory node. The software-based system has integrated all the functions of FDCA and has networked all the district offices, laboratories with headquarter. This has streamlined the activities of licensing and increased the speed of processing of applications very significantly. It also provides the transparent interface with the applicants irrespective of their physical location to monitor the status of their applications. I am sure this has been a great help to the pharma industry. How will Pharmac support Gujaratbased pharma company? Pharmac is a good platform for Gujarat-based pharma SMEs. Many prospective importers from developing countries have visited Pharmac. Pharma manufacturers from Gujarat, pharma machinery manufacturers and various pharma services providers, find this event as a suitable platform to showcase their products. How is the government involved in the Pharmac show?

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Government of Gujarat considers these type of events as the reinforcing step, which will take forward the development potential generated by Vibrant Gujarat events and thus provide the continuity to the process on an yearly basis. The Government provides all the assistance for timely and satisfactory execution of this event. Recently, you have appointed 65 new drug inspectors. How is it going to help the pharma industry? The new drug inspectors will assist the headquarters and district offices for monitoring the sales and distribution of pharma products across the state. Gujarat is known for its vigilance and control over the menace of the spurious and substandard drugs. The increased task force of drug inspectors, which will improve the field operations and monitoring of the sale and distribution of pharma products, will be a good support to control substandard and spurious drugs. The control over the spurious drugs will help genuine manufacturers in Gujarat to sustain their reputation of credible and dependable manufacturers of pharma products. The increased task force will also serve the pharma industry in Gujarat for expeditious clearance of their inspections, reporting and compliance . Tell us about the major pharma projects in the pipeline with the current status? Today, there are 57 major pharma projects in the pipeline and most of these projects are in the advanced stages of implementation. During Vibrant Gujarat 2011, 80 MoUs were signed worth of ` 9,658 crore. Out of these 80 MoUs, 21 projects have already been commissioned. What is the contribution of the pharma sector in Gujarat's overall economy? What is the growth pattern? Gujarat has been contributing at an average of 35-45 per cent of national pharma output since last three decades and has sustained its growth pattern. The composition of its contribution has progressively increased in terms of exports of formulations in comparison to API and that too its share of exports to the developed countries has increased significantly.

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Tell us about the key steps being planned to carry in FDCA for the betterment of Gujarat pharma industry? FDCA Gujarat has been and will be the catalyst for the growth of pharma industry of Gujarat. Since the days of BV Patel, FDCA has played a critical role in nurturing the pharma industry with firm but facilitating approach to compliance and control. The most important steps towards this direction in recent past are implementation of eGovernance, strengthening the infrastructure of testing laboratories in Gujarat and recruitment of adequate inspectorate staff. These initiatives will go a long way in consolidation of the administration and all the more makes it capable of coping up with the rapid growth of pharma sector in Gujarat. In a way FDCA is modernised to keep pace with the the impact of global regulatory strides. Which issues have you identified so far and what are your plans to resolve them? There are no issues but there are challenges. The life style changes of people have given rise to many new concepts of therapies and has also triggered newer devices which impact the human health. It will be a great challenge to identify which of these developments are required to be brought in the ambit of the FDCA governance and how to standardise the regulations. The pharmacovigilance –post marketing vigilance is another big challenge to ensure that NCE's and NDDS do not generate any long-term adverse impact or safety issues –either to human, animals or to the environment. Being a FDA commissioner, what message would you like to like to share with Gujarat-based pharma industry? I expect that the industry to be knowledge partner with the FDCA and sharing the knowledge is the key to the process of dealing with growth and control. The speed with which the pharma industry is growing and the rapid updates of modern technologies which are being captured by pharma industry interaction between the regulators and industry has to be transparent and should complement with each other. u.sharma@expressindia.com September 1-15, 2012

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‘Canadian companies are looking at the serious opportunities available in India’ The Canada-India Business Council (C-IBC) recently hosted the 2012 Vibrant Gujarat Delegation in Toronto, Canada. The events featured a roundtable with leading Canadian companies and the signing of a Memorandum of Understanding (MoU) between C-IBC and the Government of Gujarat. Rana Sarkar, President and CEO, C-IBC speaks with Viveka Roychowdhury about the implications of this agreement and its importance in highlighting Gujarat welcoming business and investment environment The Canada-India Business Council (CIBC) has just signed an (MoU) with the Government of Gujarat. What are the broad objectives of this MoU? The MoU between C-IBC and the Government of Gujarat marks the importance of increasing Canada’s engagement with India at the state level and focusing more on the economic opportunities of individual regions. The MoU promotes business, investments and exports, as well as seeks to deepen international commercial relations between Canada and Gujarat. What has been the experience of Canadian companies looking to tap the Indian market? With over 300 Canadian companies currently working in India, Canadian companies are increasingly looking to engage over the long term in the Indian market. Canadian Prime Minister, Steven Harper supports this focus and the federal government has set a trade target with India of $15 billion by 2015 and $20 billion by 2020. Currently, the two governments are engaged in the free trade discussions (the Comprehensive Economic Partnership Agreement or CEPA) which will provide the legal and regulatory framework to make bi-lateral investment and business even easier. This is a significant change over the past decade, when India was far from front-of-mind for Canadian business leaders. However, even then there were trailblasers that recognised both the market potential and demographic dividend of India and the shifting global markets— Sun Life, Bombardier, Scotiabank and the EDC have been established in India for decades. Law firms like Bennett Jones, Torys and Heenan Blaikie have spent years building A-grade networks and are now key connectors. Today, they have been joined by other established Canadian players such as Cameco, AECL, RIM, Open Text, Brookfield, the Bank of Montreal, as well as the Canada Pension Plan (CPP) and the Caisse de dépôt et placement du Québec (CDP). Increasingly, we are seeing small to mid-size Canadian businesses and emerging entrepreneurs looking to establish Indian operations or market presence. Which sectors of the Indian market are

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attracting interest from Canadian companies? The main sectors attracting interest are: pharmaceuticals; agriculture and agri-food; education; power and renewable energies; transport and other infrastructure plus related consulting; environmental/cleantech industries; extractive industries; defence and security; information and communication technologies; life sciences; automotive and financial service Of India's 28 states, why did C-IBC choose Gujarat as the point of entry to the Indian market? Gujarat is the second most industrialised and third most urbanised state and for the past six years, it has witnessed an average growth rate of 10.28 per cent (one of the highest regional rates in India). On top of that, the economy continues to be strong despite global headwinds. It excels in many sectors like pharmaceuticals, renewal energy, port/infrastructure development, pharma/biotech, ICT and education — all which align well with our Canadian companies' capabilities. Gujarat is committed to creating an extremely welcoming business and investment environment which is exemplified by 'Vibrant Gujarat', the leading global event for international investors and companies interested in the region. Already, Gujarat has attracted major investments from Bombardier and McCain. More recently, a number of Canadian food processors and restaurant chains have announced their intention to use Gujarat to launch their entry into the larger Indian market. What are the specific areas in the Indian pharma industry which complement Canadian companies in the same space? Any successful tie ups, links, partnerships so far? India's pharma industry is the fourth largest in the world. India is also the world's largest supplier of generic medicine and Canada is one of many countries to take part in this investment. Recently, India’s drug patent laws have become more patient-friendly. This has allowed their generic medications to enter the Canadian market far sooner than other countries. Many of Canada’s brand-name drugs and most generics are

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manufactured with base ingredients supplied by India. Canada and India both continue to be part of international research consortia working on other anti-viral R&D. This cooperation relies heavily on Canadian and Indian universities and hospital/health groups for research, clinical trials, transfer of knowledge etc. Canada is also creating a Canada-India Research Centre of Excellence (CIRCE) set to be announced in the fall. Some examples of recent IndiaCanada partnerships in the pharmaceutical industry: Agila Specialties to launch injectable generic drugs in Canada. The Bangalore-based pharma company Strides Arcolab’s subsidiary, Agila Specialties, will launch a range of injectable generic drugs in Canada. This will be done through a joint venture with Canadian company Jamp Pharma. Agila will hold 70 per cent stake in the new company Agila-Jamp Canada Inc. Canada’s Apotex Inc now in Bangalore Apotex Inc, Canada's largest generic pharma manufacturing company, inaugurated its state-of-the-art large capacity formulation and manufacturing facility, with the capacity to manufacture one billion pills per year, at Bangalore on June 5. This investment of $100 million is the largest investment by Apotex outside of Canada. The R&D activities will initially focus on developing solid dose formulations, which will increase the company's capacity to deliver a greater number of new product submissions to their three key markets, Canada, the US and Europe. Source: Government of Canada Joint Canada-India R&D Support Programme Under the joint aegis of the International Science & Technology Partnerships Canada (ISTPCANADA) and the Department of Biotechnology (Government of India), a support programme has begun operating to help fund joint R&D projects in the spheres of pharma and biotechnology. The programme is for private Canadian and Indian companies working together. Proposals have already been submitted for review. Source: ISTP Canada September 1-15, 2012

Anti-Malaria Drug Research A novel Canada-India R&D consortium aims to identify, develop and test new drug ‘compounds’ (or ingredients) that improve the treatment and prevention of malaria. Building on promising research performed at the University of Toronto and University Health Network, the team will design new drugs. Leveraging more than $599,000 from ISTPCanada with additional funding from the Department of Biotechnology (India), this $1.9 million project brings together innovative companies such as Therapure Biopharma (Mississuaga, Ontario) and Lifecare Innovations (Haryana, India) with essential experience in drug development, delivery and licensing. Source: ISTP Canada Beyond the MoU, how will C-IBC help Indiabased pharma/biotech companies scout for opportunities to do business with Canada, in terms of exports or setting up R&D partnerships and the like? The C-IBC will continue to organise key CanadaIndia business events to facilitate the business-tobusiness interactions that push the export/import connections. Strong focus will be placed on supporting the development of R&D partnerships and jointventures, this being linked to the C-IBC's support partnerships between Canadian and India educational and research institutions. As C-IBC members, India-based pharma/biotech companies looking to be further engaged with Canada, receive consulting advice and access to Canada’s business community and public entities in order to activate links that cater to their specific needs.

Signing of the MoU between C-IBC and Government of Gujarat Can you give us more information on the annual Canada-India Business Forum scheduled for November this year? The Canada-India Business Council will host its second annual Canada-India Business Forum in New Delhi, India on November 5-6. Now in its second year, the Forum provides leaders from industry, government, academia and civil society with the opportunity to help shape the Canada-India agenda. Quickly becoming a focal point in the bilateral corridor, the Forum seeks to build relationships, deepen conversations and develop concrete, actionable recommendations to address pressing challenges in the evolving relationship. Visit the Canada-India Business Council website, www.canada-indiabusiness.ca for more information on the Forum. viveka.r@expressindia.com

‘Pharmac will become... Continued from Pg 27 On what scale do you compare Pharmac from other industry events? Pharmac is a comparatively big show than other industry events and it is more professional. How many exhibitors are going to participate in this year's event and out of them how many are from the international market? This year 115 exhibitors have registered and out of them around 15 exhibitors are from the global market. Being the Chairman of Pharmac event, what responsibilities do you have and how are you accomplishing it? Being the Chairman, I am responsible for the entire show and monitoring all the activities related to booking and marketing. At regular intervals I am coordinating with all the government departments and also doing follow-ups with them. In the early stage we conducted meeting once in a month and as event day is coming closer we take part in weekly meetings in order to ensure that everything is in place. We want to make the Pharmac event a successful event. This year Pharmac has received maximum number of participation from the SME/MSE sector. How will it leverage their existing business growth? I believe SSI and Micro, Small and Medium Industries will get better platform at Pharmac show where they will be able to display their products and make good branding about their

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company. Participants will be able to meet more than 10,000 visitors. Pharmac 2012 is being jointly organised by IDMA—GSB in association with Orbitz Exhibitors. Tell us about the role of each one of them IDMA-GSB is jointly promoting Pharmac show for the members of the pharma industry and has taken the support from organisations under the state government. IDMA-GSB is also organising seminar and conferences before and after the event. Orbitz is also our partner and they are also looking after financial, marketing and operational activities to make the show a success. Tell us more about the conference and why do you think participants would be eager to attend it? We are going to organise a two-day conference where we are expecting many industry leaders, speakers and pharmacy students. What message would you like to share with the industry leaders? I would like to inform the industry leaders that this is an industry event where all should participate as exhibitors or as a visitors and make it a successful one. Where do you see this event down the line in three years? Pharmac is becoming popular within the industry and I see that within a short span of time it will be the largest show for the pharma industry. u.sharma@expressindia.com September 1-15, 2012

National Pharma Machinery: End-to-end solution NPM achieves exponential growth in few years hmedabad-based National Pharma Machinery (NPM) provides end-to-end solutions for liquid processing and packaging. The company is catering an entire range of equipment. NPM has carved a niche in domestic and international market. It has four divisional manufacturing facilities spread across 23,000 square feet. Each facility is operating as an individual entity and contributing in the growth of NPM with separate development and manufacturing.

Services With its installed capacity NPM is capable to produce equipment for minimum 100 complete lines of liquid packaging starting from washing up to labelling and cartoning. NPM is determined to serve any latest need of the industry. Besides having major usage in the pharma industry, the entire range of equipment can cover several industries like food and beverages, cosmetics, distilleries, pesticides etc.

Quality Manpower A team of qualified and experienced engineers is always on company's toes to provide any technical services to the customers round the clock. A devotional team of over 150 employees is the core strength of the organisation. A tuned team of around 20 engineers in various departments of the company and an active group of around 15 marketing and customer support executives lead by five visionary top management people is the driving force of the company. With unmatched quality of products, committed delivery, alert services and customer-friendly attitude, NPM has achieved exponential growth in few years. The company is pursuing highest standards and passing through stringent stage-wise quality checks. To maintain the company's competitive position in national as well as the international market, stringent quality policy is maintained and implemented at all levels within the organisation. Inhouse R&D section, fabrication and machine shop using most modern machines and methods, QC department equipped with latest instruments, online assembly shop etc provides NPM an edge over its competitors.

The company aims to exceed the expectations of the customers in terms of quality and achieve the goal of being preferred supplier. The responsibility therefore rests within each department and ultimately with each individual employee. Its key product rotary bottle washing machine is compact and highly efficient machine with elegant look.

Operation The bottles are loaded on the subsequent indexing part of rotating platform and are cleaned in series of operations. Its specially designed bottle holders have been provided to hold bottles with neck diameter.

Exports So far the company has actively managed to supply its products to the US, Pakistan, Bangladesh, Iraq, Nepal, Ghana, Kenya, Nigeria, Tanzania, UAE, South Africa, Uganda, Romania, Israel, Zambia, Malawi, Jordan, Uzbekistan, Congo etc. and our targeting regions are South America, North America, the Middle East and North Africa, Eastern Europe and East Asia.

Karnavati Engineering: drives innovation The company has traced a glorious path filled with innovation to become a leader in its segment he Gujarat-based engineering arm of the Cadila group, Karnavati Engineering Ltd (KEL) began its operations in 1981, with a focus on transforming machines to pharmaceutical excellence. The company was mainly driven by a small initiative of its Chairman IA Modi, today the organisation has come of age and has been successful in carving out a tall name for itself in the market for its outstanding quality and customer service. It has obtained an ISO 9001:2008 certification with state-of-the-art infrastructure and manufacturing capabilities for pharma machineries, tooling, line and allied accessories that conform to the highest standards of quality and reliability. The company is accredited by Government of India as "Export House". It has invested a considerable part of its revenues into R&D and attributes all its success to the team work of their employees. A motivated work force and commitment from management has helped them maintain a steady pace at all times. KEL has a rich history of bringing many firsts into the market. The company was the first to introduce small batch of (R&D) tablet presses domestically. It led the industry for designing front controls for better ease of operation. The company also developed the table top fully automated capsule machine in the days when capsula-

September 1-15, 2012

tion was considered to be a bulky affair. It has a vast range of products for pharma machinery sector which make them an end-to-end solution providers. The company is present across the globe in tablet compression, tablet press accessories, capsule filling equipment, capsule filling equipment accessories, laboratory equipment and granulation equipment. Its executive committee, chaired by the chief executive, is responsible for establishing health, safety, social and environmental policies and standards for the group, and for ensuring their implementation by each of their business units. A group of people in health, safety and environment committee assists in the task of corporate governance, reviewing operational performance, anticipating potential future issues and advising on strategic options for improvements. Each of the company's business units is responsible for implementing KEL's health, safety, social and environmental policies and thereby implementing effective systems to identify, assess, monitor and control hazards and minimise risks. Its products have already achieved wide acceptance in domestic and international markets, and are exported to US, UK, CIS countries, Italy, Belgium, France, South Africa, Columbia, Indonesia, Malaysia, Syria etc. www.expresspharmaonline.com

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Five year away to celebrate Golden Jubilee: Cadmach Machinery Leading player in both domestic as well in the International markets ince its inception way back in 1967, Cadmach has a high reputation for continuous innovation, quality and high standards of performance. It has substantial market shares i.e. over 90 per cent in India and various pharmerging markets. Till now the company has successfully delivered over 10,000 machines and the Cadmach Tablet Press can be found in almost every country around the world. This has resulted in a very high level of application experience with the Cadmach team. It ensures quality in every aspect of business, including product, people or response to its customers. The company delivers products on time and continuously improves its business processes to meet the needs of its customers and work environment.

all, excellent after sales services and customer relationships, have helped the company emerge as a leading player not only in the domestic market, but also in over 54 countries with drug manufacturing activities. Cadmach has invested heavily to meet the demands, especially in high-tech CNC machines and other machines in the production lines.

Continuous improvement Apart from path breaking new models, Cadmach keeps improving its range of equipment with small and important modifications based on customer feedback and experience within the field with different applications. Cadmach installs hundreds of machines every year and a lot of experience is gained in the process, which results in product improvement.

Research and development The company, with its strength and profound experience of more than three decades, is ready to plunge into new avenues to cater the need of pharma industry. The company's key focus is on R&D to strengthen its existing product range, as well as launch new products and designs by keeping an eye on customers' requirements. Substantial investments in the field of cutting edge stateof-the-art technologies, constant research and development, and above

Tablet in tablet Cadmach has been at the forefront in introducing new concepts for formulation manufacturers, especially in the area of tablets. Tablet in tablet is a new concept, where a tablet is compressed with a core tablet in the centre.

Triple layer tablets The production of multilayer tablets requires precision equipment and experience in handling multiple granules and

powders. Cadmach has the right expertise alongwith high precision producing equipment to manufacture equipment that can produce multilayer tablets, up to three layers.

Innovation Innovations, quality and after sales technical services is a way of life at Cadmach. Cadmach has recently introduced the new Roll Compactor, KMRC120 for Lab and Pilot Scale. Cadmach has also introduced the new C 300 with an advanced control system. Also Cadmach's European sales office, obtained first orders after becoming operational.

Recognition Recently, CMC Machinery, a group company of Cadmach Machinery, a pioneer and leader in manufacturing and exporting of pharma machinery, has received an export excellence award from the Engineering Export Promotion Council (EEPC). At the recently held award ceremony in Mumbai, Dr Anup Pujari, Director General of Foreign Trade presented the award to Vinit Khambhatta, Executive Director, CMC Machinery. The company has bagged the award for the fourth time since the inception of these awards by EEPC.

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September 1-15, 2012

Management

INSIGHT FOR MANAGING PHARMA

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Krishna Prasad's decision to join the pharmaceutical business right out of college came as a surprise to many, especially given the fact that he had no background in pharma. However, he proved all the sceptics wrong when he traced a success story, initially with Triton Laboratories and after its amalgamation, with Granules India. Today, the MD of Granules India is a renowned name in India's pharma sector. The famous English author, HG Wells, had once said, “There is no upper limit to what individuals are capable of doing with their minds. There is no age limit that bars them from beginning. There is no obstacle that cannot be overcome if they persist and believe.” Prasad, perhaps is the genuine disciple of this philosophy.

Challenging the odds The company started its pharma activities as an Active Pharmaceutical Intermediate (API) manufacturer. Paracetamol was the first product of the company. However, Prasad wanted to do something different. He didn't want to get featured among the people from 'me too' league. Though devoid of any pharma experience, Prasad had a lot of logical thinking. There were initial failures too. “That was the period of intense hardships. It was a start up company. We needed to buy new equipment many times and re-do the plant. That was the struggle we somehow managed get through,” informs Prasad. He adds, “We didn't have a big facility or a big team.” Prasad learnt by the time-tested trial and error method and kept the product going .

Understanding the market Since its inception the company has always believed in negotiating paths that were never tried before. During the initial years, though small, the company never shied away from

C KRISHNA PRASAD MD, Granules India

DR BHASKAR KRISHNA ARUMUGAM CEO, Granules India

Customer may not always know what he wants but I would think about the things that would make customer's life comfortable

Given the nature of our products, marginal sustainable improvements can make the difference between leaders and laggards in our industry

revealing its global ambitions. “During the eighties, companies of our size would never think of exporting to markets like the US and Europe, however, we decided to try these markets. We made some contacts and travelled for marketing purposes. By 1987, we started dealing with the US market,” informs Prasad. The company's marketing approach was customer driven. Prasad was leading from the front in a campaign for company's products in the global market. He used to go to sale and look at the customer's need. “A customer may not always know what he wants but I would think about the things that would make his life comfortable,” says Prasad. Customer demands and requirements made Prasad expand the company’s product portfolio. Prasad is also credited for coining the term Pharmaceutical Formulation Intermediate (PFI).

Operational excellence (OE) OE is an innovative concept at Granules India to make maximum utilisation of available resources. There is a separate team to look after OE. This team looks at products and figures out how to efficiently manufacture it so that company can improve productivity and reduce waste. Prasad says, “This team is engrossed with how to save cents per kilo, which, given the volume of products, can make the difference between leaders and laggards.”

OE features Dr Bhaskar Krishna Arumugam, CEO, Granules India, says, “At Granules, we recognise that it is important to not only invest in cutting edge assets; it is important to unleash the full value of these assets to provide superior customer value. In view of this, Granules embarked on a OE

Gagillapur facility

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programme with a singular objective in 2008: to emerge as a preferred choice of customers through superior quality, service and cost.” Granules recognised that much of its OE objective would be achieved through a culture of shop-floor excellence. As a result, the company’s OE programmes focus on process improvements, raw material coefficients, chemistries and other areas that deliver sustainable wins. OE teams inspect each process step to determine how to increase yields throughput and achieve process standardisation while reducing wastage and enhancing quality. The OE culture enhanced operational capacity without a corresponding increase in capital expenditure which lets Granules offer more value to customers. Granules created Area Effectiveness Teams (AET), which were integrated with the operations team to disseminate knowledge through the following initiatives like, enrich the team with cross-functional competencies, discuss the performance parameters of the previous day, plan the day’s production schedule with achievement gap, use sophisticated tools including root cause analysis, arrange for one attendee to speak on a business topic for 15 minutes. The result is that at Granules there is a better understanding of sophisticated monitoring and analysis tools, as well as when, where and how they should be applied and the various parameters of plant and performance monitoring. The OE team comprises specialists in Six Sigma and engineers (chemical, mechanical and electrical) who work collectively to remove operational bottlenecks. There are 15 members in our OE team spread over our Indiabased facilities. “While Granules made notable strides with the OE programme, we believe there is still tremendous scope for improvement. Our OE culture has made our team more inquisitive; we constantly find ways to improve our systems and processes to remain as one of the most efficient pharma manufacturers. Given the nature of our products, marginal sustainable improvements can make the difference between leaders and laggards in our industry,”says Arumugam. September 1-15, 2012

R&D Granules has made hard work a norm and success a habit. Though termed as leader in the market for paracetamol, ibuprofen and metformin their quest for 'new' has only grown over the years. “We are investing in R&D to develop best process technologies that will give us global advantage,” informs, Arumugam. Traditionally R&D is not considered as a play ground

M OT I O N

for Indian pharma companies. Time, money and risk involved in the development of New Chemical Entities (NCE) have for a long duration kept pharma industry hostile towards this very important section of their own business. However, contrary to this trend Granules has shown an interest in R&D. Arumugam says, “Our investment in R&D is increasing steadily. Usually, considering the risk

V I S UA L I S AT I O N

“The reason why we could keep our cost low is because we are very focussed. We are not working on 100 products simultaneously. We will continue to increase our investment in R&D. We want to accelerate growth and for that we are adding on products,” assures Arumugam.

for the investor, mainly big pharma companies have occupied this space for a long time.” Granules also has global collaborations. “We are leveraging expertise that are available throughout the world. We are working with some of the top universities and talents across the globe,” states Arumugam. Granules provides not just affordable but also the best product to its customers.

CO N T R O L

SAFETY

Alliances Collaborations have remained a key feature of Granules' journey for so

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Growth trajectory ◆

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API units: Metformin nameplate capacity increased from 50 TPM to 150 TPM within three years and with negligible capital expenditure. We were able to successfully increase production from 100 TPM to 150 TPM within six months. The paracetamol facility, which was originally designed to produce 500 TPM, has been progressively debottlenecked to 1,000 TPM including going from 800 TPM to 1,000 TPM within six months. Guaifenesin capacity increased by over 50 per cent to 100 TPM. PFI units: The production of a particular paracetamol PFI increased from 6 tonnes perday to 11 tonnes through process improvements within 18 months. An ibuprofen PFI improved from six tonnes per days to ninetonnes with no capital expenditure. Finished dosage unit: Although the Finished Dosage facility is in the process of ramping up and has spare capacity, the OE team is focused on improving productivity. The team proactively analysed our machinery to increase throughput. The company’s OE programme is regularly cited by MNCs as a ‘best-in-class’ programme. This translated into a competitive advantage that lets Granules provide world-class quality products at a more cost effective price than competitors. The OE implementation earned Granules several recognitions including a Silver Certificate of Merit for the Gagillapur facility during the Manufacturing Excellence Awards 2011.

many years. The company has entered into marketing alliance for its Metformin Abbreviated New Drug Applications (ANDA) for US sales. To leverage its PFI and Finished Dosage (FD) capabilities JV was formed with a leading primary ibuprofen supplier, Hubei Biocause. Granules even entered into knowledge widening collaborations with IIT Chennai, NUS Singapore and a US laboratory to reinforce its goal of having applications that are the 'best to file' as opposed to 'first to file'. Moreover, one of the most interesting things that Granules has done is a Joint Venture (JV) with Ajinomoto

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Omnichem. Arumugam informs, “This JV has been set up in the Pharma City in Vishakhapatnam. Construction has already begun and the facility should be completed in about a year. This JV has brought us to CRAMS space, in a derisked fashion. It is difficult and time consuming to build the market and team on your own. This JV has helped us get instant market credibility. Ajinomoto Omnichem has a very good relationship with some of the big pharma companies. They have great technology. We are bringing in manufacturing and local expertise. This JV gives us an access to the molecules that

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could not have been easily available.” Granules took five years to grow from ` 256 crore to ` 654 crore. The company now expects to grow to over `1,000 crore within two years. In the future, Granules expects to reinforce its knowledge-led competitive advantage by manufacturing some of its critical raw materials, manufacture more high margin products and invest in green technologies. This will surely enable Granules to emerge as a stronger and more sustainable knowledge driven company over the foreseeable future. sachin.jagdale@expressindia.com

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September 1-15, 2012

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

Tasting new trends in health supplements market CubeX’s comprehensive report titled ‘Tasting New Trends in the Indian Health Supplements Market’, gives a detailed understanding of the nutrition gaps that exist across regional food plates in India. Sreedevi Yallamrazu, Sr Strategic Analyst, CubeX, Sorento Healthcare Communications, gives an insight about the nutritional concerns in India’s healthcare supplements market s the world turns into a global village, consumers are being exposed to various products across categories – from highend technology to products that are consumed on a daily basis. Global launches have broadened our horizons and 'modified our tastes'. There is a heightened demand for convenience products and in this scenario, food patterns have been one of the key areas that have witnessed this drastic shift. As the western world takes note of the ill-effects of high calorie foods and modifies its diet, we are once again developing 'new tastes'…healthier ones, this time. These new tastes are posing competition to traditional vitamin and mineral supplements. The health and wellness market is at an inflexion point where competition is being redefined. India has earned the reputation of being a nutritional paradox. A large section of the population is under nourished because they do not have the purchasing power and at the other end of the spectrum, is another section, equally large, if not more, which is over nourished with macro nutrients but deficient in specific micro nutrients. To put things in perspective, CubeX commissioned a study to understand the diverse food plates across the country. The nutritive content of food was analysed in relation to RDA of macro as well as micro nutrients. It was found that in most regional food diets, macro nutrients were in excess of RDA while vital micro nutrients fell short. Thus, there is a need for dietary supplements.

categories of iron supplements, multivitamins, chyawanprash, single vitamins and calcium contributed

over 90 per cent to the total market. However, multi-vitamins recorded low growth of 5 per cent (CAGR 7 per cent) as

most of the top brands (barring Revital) recorded single digit growth. The markets which have recorded higher

The need for innovation in OTC vitamins, minerals and supplements market Vitamins, Minerals and Supplements (VMS) market, the most attractive and highly cluttered category in the OTC market, was valued at $645 million in 2011, as per Nicholas Hall DB6 2012 database (CAGR as well as value growth in 2011 was 8.6 per cent - refer to chart 1). It contributed almost one-third to the total OTC market ($2 billion in 2011). The key subSeptember 1-15, 2012

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CAGR as compared to the overall OTC VMS market have been depicted in chart 2. Dietary supplements like chyawanprash and the more popular MFDs like Horlicks are positioned as energy and immunity boosters. On the other hand, traditional VMS like Becosules are generally perceived to be taken during convalescence. Revital changed the game with a shift in positioning from illness to wellness and educated consumers about “sustainable energy in today’s hectic times”. These brands have created a mirage of a lucrative market. In reality they are so well-entrenched that new brands without a differential positioning hardly have any scope to gain a sizeable share of the market. On the contrary, these new brands end up reinforcing the benefits of established brands, gaining little success themselves. Despite the heavy promotional activities, uptake of supplements among consumers was found to be low. The key reason being supplements are generally taken on doctor’s advice or for specific illness. Building awareness and creating brand credibility among a plethora of similar products is a huge task.

The rising popularity of functional foods Taking advantage of the fact that con-

sumers generally do not like taking tablets and capsules for maintaining good health but are keen to explore options for healthy living, are food and beverage companies. New concepts like 'better for you' variants with reduced unhealthy ingredients and 'fortified foods' incorporated with healthy ingredients (nutraceuticals) – mainly vitamins and minerals, probiotics, omega-3 fatty acids, fibre, antioxidants - have been introduced in the market. Media reports claim that func-

tional food products accounted for 60 per cent of the Indian nutraceutical market valued over $1,400 million in 2011. Major food companies have expanded into the health segment with products positioned for specific health benefits.

Britannia is creating a niche in the health and wellness food market by reaching out to diabetics with a tasty range of food products with its NutriChoice range and consumers’ testimony is proof of its success. Another case in point would be Yakult, the probiotic drink, which “created” the probiotics market in India, despite the availability of supplements, which could have easily taken a sizable share of the market by the time Yakult set foot in India. Probiotic curds soon followed but selling a product that is prepared everyday at home to Indian housewives is no mean task. Think of innovation and flavoured probiotic curds are storming the market with kids reaching out for it! Probiotics have moved on from being promoters of gut health to being recognised for their overall health benefits and thus, being classified as health supplements. These products have met with moderate success as consumers steadily warm up to these products. One of the major challenges faced by food companies is the taste of Indians for good food. Consumers are also unwilling to compromise on taste and hence products which offered health benefits at the expense of taste have not performed as well as expected. However, players are willing to bet on this market as it is yet in a nascent stage and needs to be built.

The future beckons for health supplements It is becoming imperative that healthcare companies will have to move into FMCG mode to understand consumers’ tastes and devise marketing strategies. Consumer focused FMCG companies will have to invest time and effort in understanding consumers’ perceptions of healthy living. Hence, it is important to view competition through a kaleidoscope to keep tab on the changing consumer pulse and to understand what constitutes competition from the consumers’ perspective. Healthcare companies need to take advantage of their deep understanding of health and ailments. Innovative products and convenient formats will see major advancements in near future. Products that aid in effectively preventing or delaying the onset of diseases like cancer, diabetes, arthritis and those targeted for specific segments i.e. women, kids would be much sought after (rather than typical energy boosters), as they are customised to cater to specific needs. The need of the hour for VMS supplements is a strong brand proposition to sustain consumers’ interest. CubeX’s latest report “Tasting New Trends in the Indian Health Supplements Market” covers many such interesting insights and encompasses the latest trends in the health supplements market. It also answers myriad questions that marketers would seek to enhance their presence in the booming health and wellness domain. (CubeX is the Strategic Consulting and Business Intelligence division of Sorento Healthcare Communications with expertise in the Consumer Healthcare and Wellness domain. To know more about reports from CubeX, you can write to reports@cubex.co.in.)

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September 1-15, 2012

M|A|N|A|G|E|M|E|N|T REPORT

Exim Bank releases study on Indian chemical industry Study titled ‘Indian Chemical Industry: Exploring Global Demand’, shows that Indian chemical industry has a lot of export potential Sachin Jagdale Mumbai s part of its endeavour to promote India’s international trade, ExportImport bank of India (Exim Bank) recently released a study titled ‘Indian Chemical Industry: Exploring Global Demand’ Exim Bank identifies sectors with potential for exports. Based on a detailed analysis of these sectors, specific studies are brought out, by way of publications. The bank had recently completed a study on the Indian chemical industry.

September 1-15, 2012

This report highlights the pattern of India’s international trade in chemicals with the primary objective of assessing the potential for exports of this sector by mapping it with the trends in international demand for chemical products. The scope of analysis has been confined to basic, specialty and agricultural chemicals. Thus the analysis in the study has included organic and inorganic chemicals, tanning, dye extracts and insecticides and pesticides. The Indian chemical industry is estimated to be the fifth largest in the world and second largest in Asia after China. The industry accounts for about 10 per cent of the output of the Indian manufacturing sector, 13 per cent of India’s total exports, and nine per cent of the country’s total imports. In terms of segmentation, basic chemicals is the largest sector with total revenues estimated at $43 billion, equivalent to about two-third of the industry’s overall value in 2010. Within this, the contribution of small and medium enterprises (SME) in terms of production of the chemical sector is estimated to be as high as 40 per cent, an indication of the significance of SMEs, and as a corollary, the importance of this sector in employment generation. As far as India is concerned while

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chemical export is growing, imports are growing even faster. Moreover, volumewise growth of Indian chemical industry is almost stagnant. India is exporting to almost similar markets that they used to export before. So, perhaps India could not identify and diversify its potential markets. Nadir Godrej, MD, Godrej Industries, said, “Different kinds of duties on raw materials is an issue for the chemical industry in India. Specialty chemical segment has an advantage as we have trained manpower. India has a lot of potential in chemical export. We should export to the countries where we haven't exported before.” Dr Arup Basu, President, Tata Chemicals, echoed Godrej’s views. He said, “Access to raw materials will always remain important. Specialty chemical business needs assured access of raw materials. Supply chain is a challenge for the chemical industry. There are hazardous chemicals where supply management is very important. All the MNCs are looking at Indian market but they are struggling as they are not getting fast approvals and this is the common complaint from all the MNCs. India has millions of consumers and that itself is a big attraction.” sachin.jagdale@expressindia.com

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Research

EXPERTISE FOR DRUG DEVELOPMENT

‘Nanotechnology brings new openings to stem cell R&D’ Polyclone Bioservices is working on application of nano-technology in stem cell therapy. Naveen Kulkarni, CEO and Founder, Polyclone Bioservices,in discussion with Sachin Jagdale, reveals various scientific aspects of this research

Page 44

Hunt for a

HIV

vaccine Scientists are devising new strategies for developing an AIDS vaccine capitalising on past lessons. Shalini Gupta reports

hen the first AIDS patient was reported in the 80s, it was believed that a vaccine to prevent HIV would take no longer than two years. However, the scientists underestimated the variability of the AIDS virus, which was unlike any other virus they had ever seen and has continued to befuddle them since the last 25 years. Having tried and tested several vaccine candi-

dates, they are beginning to gain a better understanding of their opponent.

Hits and misses so far Given the tricky nature of the HIV virus, several approaches have been tried to counteract infection. The first HIV vaccine to enter fullscale efficacy testing (phase III) was the AIDSVAX gp120-based vaccine,

VAX004 and VAX003 in 2003. A recombinant subunit protein vaccine(made of bigger pieces of proteins that are on the surface of the HIV virus) was designed to induce neutralising antibodies to inactivate the virus thus aborting infection. However, it produced little or no efficacy. The focus then shifted to T lymphocytes, the cell-mediated arm of the immune system in 2004 under

‘A confluence of scientific advances has spurred vaccine development’

Rick King Vice President Vaccine Design IAVI

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he regimen evaluated in the RV144 trial along with the globalisation of efforts to design and develop new vaccine candidates has proved vital to HIV vaccine development. HIV is a global problem, and any solution to the pandemic will have to involve researchers around the world working together to study the virus and its transmission, and to develop and combine new tools and strategies for HIV prevention. A confluence of scientific advances in a variety of fields, a more sophisticated understanding of HIV pathogenesis and the immune response to the virus has spurred the development of new vaccine concepts. Novel vectors and techniques for the study of mucosal immunology are contributing to the design of a new generation of candidates devised to induce immunity in the tissues where sexually transmitted HIV initiates infection. Similarly, the systematic assessment of antibody breadth and potency has helped streamline and speed up the identification of globally relevant broadly neutralising antibodies, and their isolation has been greatly aided by advances in biotechnology. Meanwhile, advances in computational biology and the rapid crystallization and structural analysis of complex protein molecules have dovetailed to boost the design of vaccine candidates that might elicit such antibodies.

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which V520, a modified Adenovirus was used to stimulate the body’s antibody response. Instead the Step trial that ended in 2007 reported an increased instance of infection in vaccinated individuals. Researchers then shifted to a combination of both these approaches to induce a stronger immune response. Called the prime boost approach, it uses a DNA or vector vaccine to elicit cytotoxic T cells that destroy infected cells followed by a subunit vaccine to induce neutralising antibodies(boost). The 2009 RV144 Thai vaccine trial (phase III) used a combination of two vaccines (Sanofi’s ALVACvCP1521 canarypox vector as the prime and AIDSVAX as the boost). It reduced the risk of infection by 31.2 per cent thus proving that a safe and effective vaccine can indeed be a reality. Researchers in India too have received better results with the prime boost approach using ADVAX, a DNA-based vaccine, as the prime and a vector, Modified Vaccinia Ankara (MVA) as the boost. The phase I trials conducted by the Tuberculosis Research Centre (TRC), September 1-15, 2012

R|E|S|E|A|R|C|H Chennai and the National AIDS Research Institute (NARI), Pune showed a modest immune response as compared to TBC-M4, a vector built from recombinant Modified Vaccinia Ankara (MVA) at TRC and found to be safe.

Newer approaches to vaccine design The success of the RV 144 trial has spurred a number of follow-up trials of vaccine candidates based on it, including the RV 152 study

the structure of the virus.” bNAbs target regions on the AIDS virus that remain the same, even as it mutates. These sites hold the key to virus replication and thus details on how bNAbs bind to them hold clues to effective vaccines in the future. Guido Silvestri, Professor of Pathology and Laboratory Medicine at the Emory University School of Medicine who was one of the key speakers at a recent conference organised by IAVI sums up the ideology behind current approaches. “The empirical application of conventional vaccinology i.e. administering a ‘modified pathogen’ or antigen and hoping that immunity develops has not worked for HIV infection so far. Rather a better understanding of the interaction between HIV and immunogens, process of virus transmission and disease progression including investigating the role of specific immune cell subsets along with structural and functional properties of immunogens designed to interact with these cell types, is the key to HIV immunology,” he said. Silvestri and his team are working upon T cell-based vaccines that will generate memory T cell responses against HIV.

Towards an efficacious vaccine The empirical application of conventional vaccinology i.e. administering a ‘modified pathogen’ or antigen and hoping that immunity develops has not worked for HIV infection so far Guido Silvestri Professor of Pathology and Laboratory Medicine Emory University School of Medicine and HVTN 505 trial, that will provide more immunological data for further research. “Experimental data so far suggests that a heterologous prime boost approach is good,” says Dr VD Ramanathan, Former Director, TRC. Prime boost strategy and the use of replicating vectors is a part of the cell-mediated immunity (CMI) strategy wherein infected cells are destroyed. Blocking HIV infection by engaging the body’s antibody response is another. However, novel approaches are being used today, including Broadly neutralising antibodies (bNAbs). Rick King, Vice President Vaccine Design, IAVI said, “bNAbs can neutralise a broad range of HIV strains with an efficacy as high as 90 per cent in laboratory assays. The NAC (Neutralising Antibody Consortium), with partners in nearly every continent has been successful in isolating many bNAbs. Ongoing studies including reverse engineering of the epitope, are likely to give us valuable insights into September 1-15, 2012

So, what exactly constitutes an effective vaccine, given that the earlier candidates have failed to do so? An effective AIDS vaccine will likely need to stimulate broad, potent, and durable neutralising antibodies and cell-mediated immunity responses, answers Ramanathan. We are looking at an efficacy of 6070 per cent, he adds. “About 30 candidates are currently in the pipeline globally. There are also several next-generation candidates testing a number of different vaccine concepts moving through the pipeline with most in the pre-clinical and a few in the phase I testing stage,” informs King. IAVI is working with its partners to evaluate in clinical trials four distinct vaccine candidates in various combinations and regimens. They include one protein candidate, one DNA vaccine candidate and two adenovirus vector candidates. India is also close on the heels of a HIV-1 DNA vaccine, being developed by a research team at the National HIV Reference Centre, AIIMS, New Delhi, the human trials of which is likely to start as early as 2013. “The current short-term priority is to build on RV-144 Trial and improve the efficacy seen in in the Thai trial, in the medium term have Heterologous Prime Boost candidates that shall address HIV variability and demonstrate a good efficacy and in the long term have next generation candidates aimed to elicit bNAbs that may be able to substantially bring down the infection,” concludes Dr Ramanathan. Shalini g@expressindia.com www.expresspharmaonline.com

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R|E|S|E|A|R|C|H INTERVIEW

â&#x20AC;&#x2DC;Nanotechnology brings new openings to stem cell R&Dâ&#x20AC;&#x2122; Polyclone Bioservices is working on application of nanotechnology in stem cell therapy. Naveen Kulkarni, CEO and Founder, Polyclone Bioservices, in discussion with Sachin Jagdale, reveals various scientific aspects of this research Even after many years of research, stem cell therapy has a very limited success in the treatment of various diseases. Will the use of nanotechnology make stem cell therapy more effective? Stem cells hold great potential for the treatment of several injuries and degenerative diseases. However, one of the big challenges of using stem cells as a therapy is coaxing them to grow into the specific type of tissue that is required. This happens in the body, thanks to precise chemical and physical signals, not all of which are yet understood or characterised. Using chemicals to direct the fate of stem cells has worked in laboratories, but the outcomes are not always safe or predictable. There are few other obstacles like development of advanced techniques to understand and control functions of micro environmental signals, novel methods to track and guide transplanted stem cells, long-term behaviour of transplanted stem cells in the target tissues, pluripotency/multipotency of stem cells to differentiate towards homogenous populations of specific cell types, control of transplanted stem cells to migrate to the correct micro environmental places, tracking of transplanted stem cells by labelling techniques and optimal time period for stem cell-replacement therapy for degenerative diseases are to be overcome to make stem cell therapy a successful therapeutic option. The application of nanotechnology would be able to address those challenges since it brings new opening to stem cells R&D. Nanotechnology is the term used to cover the design, construction, and utilisation of functional structures with atleast one characteristic dimension measured in nanometers. It is well-known that the nanomaterials own four basic unique effects such as small size effects, surface effects, quantum size effects, and tunnel effects, and ultimately these effects can lead to new technological opportunities as well as new challenges. In recent years, the application of nanotechnology in stem cell research and development has made great progress. For example, magnetic nanoparticles (MNPs) have been successfully used to

isolate and sort stem cells, quantum dots have been used for molecular imaging and tracing of stem cells, nanomaterials such as carbon nanotubes (CNTs), fluorescent CNTs, and fluorescent MNPs, etc. have been used to deliver gene or drugs into stem cells, unique nanostructures were designed for controllable regulation of proliferation and differentiation of stem cells, and all these progress speed up the development of stem cells toward the application in regenerative medicine. Has nanotechnology already been used in stem cell therapy? If yes, give more details? Nanotechnology in stem cell therapy is well proven at research level and it has been moved to clinical trials stage. This has not been used as a therapy yet. National Cheng Kung University (NCKU - Taiwan) research team has made a breakthrough in the regeneration of new blood vessels in cardiovascular therapy by using nanofibers and vascular endothelial growth factor (VEGF). The new technology helps endogenous stem cells achieve cardiac and vascular regeneration, and is seen as a promising cure for heart diseases. The study, led by Patrick C H Hsieh, associate professor and cardiac surgeon at NCKU, sheds light on cardiovascular therapy by providing a new strategy for cardiovascular repair. The study combines tissue engineering, nanotechnology and controlled protein delivery to induce endogenous stem cells to improve cardiac function. The experiments, done on rats and pigs, led to the growth of fresh blood vessels and improved heart function without harmful side effects. Polyclone Bio-services has signed an MoU with PSG Institute of Advanced Studies (PSGIAS) for application of nanotechnology in stem cell therapy. What will be the role of each partner in this collaboration? PSGIAS, having state-of-the-art nanotechnology facility and highly experienced researchers, will work in the areas

Being a technology-driven company, our hands are full at this point and we would like to have a focused approach towards our goal. Initial successes from these studies will lead us to understand and plan better for future

of biocompatible nanofiber matrix synthesis. Polyclone will be working in the areas of application of stem cells and ancillary processes like enrichment, expansion and differentiation of stem cells derived from various sources. The objective is to culture stem cells derived from various sources on the nanofiber matrix and to validate the effect of nanofiber matrix on the enhancement of adherence, proliferation and migration. What will be the focus of Polyclone and PSGIAS in the coming years? Our primary focus would be on collaborative R&D in application of nanobio-technology for stem cell delivery applications in established clinical practices like ophthalmology, which would also be extended to other disease profiles such as dermatology and oncology. Besides stem cell therapy, is Polyclone working on to introduce nanotechnology for other forms of treatments? Being a technology-driven company, our hands are full at this point and we would like to have a focused approach towards our goal. Initial successes from these studies will lead us to understand and plan better for future. Is Polyclone considering more such collaborations in future? Yes, academic bonding is part of the growth plan for Polyclone and there is much to be derived for better clinical outcomes from more partners. We have already partnered with SIT Tumkur for bioinformatics platform developments and also contributing towards studentsâ&#x20AC;&#x2122; engagement with the industry. We are currently in discussions with a reputed university with large hospital and stateof-the-art clinical facilities for collaborations to complete the circle. Sachin.jagdale@expressindia.com

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September 1-15, 2012

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NEJM publishes results of two phase III studies of ocriplasmin If approved, this could be the first pharmaceutical therapy to treat patients with vitreomacular adhesion ovartis announced that the New England Journal of Medicine (NEJM) published the results of two phase III studies of the investigational eye treatment ocriplasmin. The studies including 652 patients found that ocriplasmin, significantly resolved vitreomacular traction and closed macular holes compared to placebo in patients with vitreomacular adhesion (VMA). The results of these phase III trials, which both met their primary endpoints, demonstrate the efficacy of ocriplasmin which, if approved, could be the first pharmaceutical therapy to treat patients with vitreomacular adhesion. The ocriplasmin phase III programme was conducted by Alcon's partner ThromboGenics, NV. Vitreomacular adhesion, including vitreomacular traction (VMT) and macular holes, is an age-related progressive, debilitating eye disease that may lead to visual distortion, loss in visual acuity and central blindness. More than 300,000 patients suffer from this disease in Europe alone. “Results from the phase III programme with ocriplasmin are significant as they demonstrate the potential for using an enzymatic approach to

September 1-15, 2012

resolve vitreomacular adhesion. This represents a real advance for patients living with vitreomacular adhesion who currently only have the option of surgery at a later stage of the disease. The majority of patients who achieved resolution of their vitreomacular adhesion after a single intravitreal injection of ocriplasmin showed this positive outcome within the first seven days,” said Dr Peter Stalmans, Department of Ophthalmology, University Hospitals, Leuven, Belgium. In patients with VMA, the vitreous (jelly-like substance in the centre of the eye that is surrounded by a membrane) adheres in an abnormally strong way to the retina (light-sensitive

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layer of tissue at the back of the eye), which can lead to traction ('pulling') on the retina, causing symptoms including impaired vision. Further unresolved traction may lead to the development of macular holes and central blindness. The only treatment option for progressed VMT and macular holes is a surgical procedure called vitrectomy (removal of the vitreous from the eyeball). Ocriplasmin, a recombinant, truncated form of human protein (plasmin), works by dissolving the proteins that link the vitreous to the macula (centre of the retina), relieving the traction and resulting in posterior detachment of the vitreous from the retina. Alcon, a division of Novartis, acquired the commercialisation rights to ocriplasmin outside the US from the Belgian biopharmaceutical company ThromboGenics, who retains the rights to commercialise the drug in the US. As the global leader in eye care, Alcon is dedicated to bringing innovative eye treatments to patients with unmet medical needs. “The data from these studies provide a basis for worldwide regulatory filings,” said Kevin Buehler, Division Head, Alcon. EP News Bureau

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US FDA extends review for Pfizer's arthritis drug by three months Sets new deadline for reviewing the drug he US Food and Drug Administration (USFDA) extended by three months its review of Pfizer's experimental rheumatoid arthritis treatment tofacitinib, one of the most promising new drugs in the company's pipeline. In July, Pfizer disclosed that the FDA sought a 'routine' analysis of clinical trial data for the drug that could delay a decision by three months or more beyond the agency's August 21 deadline. If approved, the pill could offer a more convenient alternative to Abbott Laboratories' $8 billion-a-year injectable medication Humira.

The FDA now views the additional analysis as a major amendment to Pfizer's application for approval, and set a new November 21 deadline for reviewing the drug, the company said. It did not give more details of the data analysis it provided. Pfizer said it still believes trial results favour the drug's use, and is working with the FDA, as well as regulators in Europe, Japan and other countries, to bring it to market. Rheumatoid arthritis, a chronic inflammatory autoimmune disease, affects about 1.6 million Americans and 23.7 million people worldwide, the com-

pany said. Tofacitinib blocks signals that activate immune and inflammatory responses in the body, and is the first in a new class of drugs called Janus kinase (JAK) inhibitors. A panel of outside advisers to the FDA recommended the agency approve the drug during a May meeting, though many said it should be used only after patients had tried other treatments. Safety concerns included possible infections, such as pneumonia, or malignancies. Wall Street analysts estimate that tofacitinib could reap up to $3 billion in annual sales if approved. Reuters

Sanofi pulls leukaemia drug ahead of possible launch The withdrawal is already under way in some European countries and will be effective in the US Paris anofi's rare disease unit Genzyme is pulling leukaemia drug Campath to prepare for its launch under a different dosage and as a multiple sclerosis treatment that will be branded as Lemtrada. The withdrawal, meant to prevent the off-label use of Campath as a multiple sclerosis drug, is already under way in some European countries and will be effective in the US

on September 4, a Genzyme spokesman said. Lemtrada, which Sanofi submitted for approval with health regulators in Europe and the US in June, could be launched in 2013 if it wins approval. If approved, it will be given far less frequently and in lower doses than Campath, and is one of the new products the French drugmaker is betting on to restore growth after losing several aging blockbusters to generic rivals.

Lemtrada, which Sanofi submitted for approval with health regulators in Europe and the US in June, could be launched in 2013 if it wins approval. If approved, it will be given far less frequently and in lower doses than Campath

"We think that this stoppage shows Sanofi's confidence in the approval of Lemtrada in multiple sclerosis," said Bryan Garnier analyst Eric Le Berrigaud, who estimates the drug could generate sales of $400 million in 2018, if approved. The withdrawal will also enable Sanofi to adjust Lemtrada's price closer to that of rival multiple sclerosis drugs, Le Berrigaud said. Rivals include Tysabri, an injectable drug sold by Biogen Idec and Elan, while Novartis markets MS pill Gilenya. Campath, which last year had sales of $76 million, will continue to be available through patient access programs in the 50 countries where it has been available since its launch in 2001. "In most countries we will provide the drug for free, where this is permitted," the Genzyme spokesman said. The news was first reported by trade publication BioCentury. Reuters

Statins reduce pancreatitis risk, while fibrates may increase it: Study The study pooled data from all previously conducted large fibrate and statin trials esearchers have found that statins, drugs commonly used to lower cholesterol, reduce the risk of pancreatitis in people with raised blood fat levels. A team from the University of Glasgow also found that fibrates, drugs often given to patients with elevated blood fat levels – hypertriglyceridema – to reduce the risk of pancreatitis may actually make them more likely to develop the painful and potentially fatal condition. Scientists in the Institute for Cardiovascular and Medical Sciences carried out a meta-analysis of 28 clinical trials with 190,000 patients and found that statins, drugs taken by one in three adults over the age of 45 in the UK which were previously believed to be a risk factor for pancreatitis, are actually an effective means of reducing the likelihood of the condition developing. Conversely, the study found that

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fibrates, a different class of drugs often given to people with modestly raised levels of blood fat instead of statins, may actually increase the risk of developing pancreatitis possibly due to the raised risk of developing gallstones. The study pooled data from all previously conducted large fibrate trials and statin trials to examine whether these medications have any effect on risk of pancreatitis. Researchers concluded that statins could reduce the risk by 20 per cent while fibrates may actually increase the risk by up to 40 per cent. The results also suggest that current guidelines for primary use of fibrates in those with extreme triglyceride elevations are open

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to question. Dr David Preiss, senior clinical lecturer fellow, said, “Our research challenges the belief that fibrates are a good option for people with moderately raised blood fat levels. “Statins appear to be a better option, not only because they reduce the risk of heart attacks but also because they may reduce pancreatitis risk. These results are of great importance when you consider the number of people taking these medications.” The research, ‘Lipid-modifying therapies and risk of pancreatitis’ is published in The Journal of the American Medical Association. EP News Bureau September 1-15, 2012

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Poor evidence on WHO-backed hemorrhage drug: Study Urges WHO to urgently review its decision to put the drug on its essential medicines list London study published in Journal of the Royal Society of Medicine said that the World Health Organisation (WHO) should review its approval of a drug used to prevent life-threatening bleeding in women in childbirth because there is not enough evidence that it is effective. Research published mentioned that the evidence to support the use of misoprostol is 'at best inconclusive', yet it is increasingly used in poorer countries to prevent postpartum hemorrhage (PPH). "Developed countries would not dream of giving women misoprostol during labour on the basis of the current evidence, yet industry and health practitioners are pushing it hard in developing countries," said Allyson Pollock of Queen Mary University of London, who led the study. Although there is no proper evidence of benefit, the WHO and some countries have misoprostol on their Essential Medicines Lists, Pollock said, and countries such as Nepal, India and Uganda are promoting and using it. She called on the WHO

urgently to review its decision to put the drug on its essential medicines List - a list of drugs the UN health agency says are needed to 'satisfy the priority health care needs of the population.' Misoprostol, also sold under the brand name Cytotec by Pfizer, was originally developed to treat gastric ulcers but is increasingly used to prevent dangerous bleeding after childbirth. It is now manufactured and sold by various generic drugmakers round the world. Pollock and fellow researchers analysed 172 previous studies on the use of misoprostol during labour and found that only six had enough information to say whether or not the drug was effective in preventing PPH in rural and community settings in poor countries. These six studies did not provide enough evidence that the drug worked, the researchers found. According to the WHO's latest estimates, there were 342,900 deaths related to pregnancy and childbirth in 2008, most of them in developing countries. A quarter of these are thought to be linked to women haemorrhaging after giving birth. Experts say the main risk factor for post partum hemorrhage is anemia, which can be easily treated if it is diagnosed. But without antenatal screening for anemia it is impossible to find women who may have it and would be at increased risk of lifethreatening bleeding during labour. Pollock said one reason why misoprostol is popular in developing countries is that it is a fairly stable drug that comes in pill form and does not degrade if it is not kept in cold storage. Because the drug does not have to be given intravenously, it is more likely to be used outside hospitals in places like patient's homes and local clinics when women go into labour. Pollock said, however, that the drug was being misused. Pollock said, â&#x20AC;&#x153;Countries should be concentrating on improving their primary care facilities, rather than thinking there is a pill to prevent every ill. Misoprostol is being used inappropriately at present, and the money being spent on the drug would be better spent elsewhere, for instance in ensuring there are skilled attendants during delivery and adequate antenatal services that can detect and help to prevent complications.â&#x20AC;? Reuters September 1-15, 2012

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Pharma Ally VENDOR NEWS

West Pharmaceutical India Packaging breaks ground in Sri City To start construction of its new compression molding facility est Pharmaceutical India Packaging, an indirect subsidiary of US-based West Pharmaceutical Services hosted a ground breaking ceremony to mark the start of construction of its new compression molding facility located in Sri City, Andhra Pradesh. The plant will become part of West’s global supply chain for its world-class, standardsetting pharmaceutical packaging components. “We are experiencing a very exciting period of growth and business expansion in Asia and we are proud to begin construction of our first facility in India,” said Donald E Morel, Jr, Chairman and CEO, West. In June 2012, West signed a 99-

India and the wider Asia year lease on 72,800 square Pacific region. The built-up metres of land in the Sri City area of phase I will be 15,300 Special Economic Zone square metres, with commer(SEZ). Sri City offers all the cial production of metal comadvantages of an SEZ with a ponents expected to begin in metropolitan location and the first quarter of 2014. was selected primarily on Production of a range of suitability because of land, West’s high-quality standard availability of utilities, labour elastomeric components is suitability, logistics, quality of Warwick Bedwell expected to begin in the first life and SEZ special factors. Construction work of phase I has quarter of 2015. The capability to produce readybegun in August 2012 on a metal seal assembly and compression molding to-sterilise components will be availfacility that will produce metal and able by 2016. The built-up area for the elastomeric pharma components used plant and office will eventually reach in primary packaging of injectable 37,700 square metres at the complemedicines manufactured by West’s tion of phase III in 2023. Warwick Bedwell, President, pharma and biopharma customers in

Pharmaceutical Packaging Systems, Asia Pacific Region said, “This investment is important to our strategy of partnering with customers in India and the Asia Pacific region to help them provide medicines to patients more efficiently, reliably and safely. When the facility is completed, we anticipate a reduction in lead times for supply to our customers in India. By leveraging our global sourcing activities and process engineering expertise, we will be able to carefully manage the overall costs of production.” West plans to file Drug Master Files for the plant with the US FDA and Heath Canada’s Bureau of Pharmaceutical Sciences. EP News Bureau

Indegene introduces TrialPedia 2.0 with ‘Advantage Insights’ Clients can enhance the business value of clinical trial analytics with over 180,000+ trials across 200+ indications updated in real-time ndegene recently launched TrialPedia 2.0 with Advantage Insights. It is an enhanced clinical trial analysis and decision support platform that hosts a real-time repository of clinical trial information with advanced search, data mining, and specialised service bureau services including custom research, analytics and reporting. TrailPedia 2.0 will help clinical development and operations, R&D, Competitive Intelligence (CI), BD &

Licensing as well as strategic marketing professionals effectively analyse clinical literature and trial data seamlessly, and benchmark competitive Clinical Development Programmes (CDPs) across the industry. TrialPedia 2.0 has been designed to fulfill an unmet need in the industry to provide quick and comprehensive answers to strategic clinical development and marketing questions around market evolution, competitive label claims,

licensing options and future sales projections. TrialPedia is the product of over 300 man-years of effort in assimilating knowledge to build a comprehensive analysis and benchmarking solution. The value of clinical trial analytics within TrialPedia 2.0 can be significantly enhanced via Advantage Insights, for clients looking for a comprehensive clinical trial reporting, analytics and benchmarking service. Manish Gupta, CEO, Indegene

said, “With TrialPedia Advantage Insights, in addition to clients gaining access to this best-in-class platform, they can leverage our deep research and analytics expertise for all their reporting and analysis needs. We believe that the Advantage Insights service bureau will help clients realise the true value of clinical trial analytics and help them navigate the business environment more effectively.” EP News Bureau

Mastersizer 3000 breaks new ground in dry powder particle sizing Dry particle size measurement is efficient and useful for moisture sensitive materials ew experimental data published by Malvern Instruments illustrate the real-world capability and flexibility of the Mastersizer 3000 laser diffraction system for the particle size measurement of dry powders. Equipped with the unique Aero S dry dispersion unit, the Mastersizer 3000 breaks new ground in dry powder particle sizing and experimental results are described in ‘Extending the boundaries of laser diffraction measurements: Enhanced dry dispersion with the Aero S,’ a new publication on the Malvern website. Compared with other laser diffraction systems it significantly broadens the range of materials and applications to which this convenient measurement technique can be applied. Dry particle size measurement is efficient and useful for moisture sensitive materials, and since it requires no dispersants it is environmentally friendly. However, it relies on efficient

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dry dispersion of the sample, requiring sufficient dispersive energy to completely deagglomerate the sample but without inflicting particle damage. The standard venturi has no impaction surfaces and uses shear forces to disperse the sample, while

the high energy venturi uses impaction to achieve more aggressive dispersion. The data illustrate the suitability of different configurations of the Aero S for widely differing materials and shows how the flexibility of the system enables the user to develop a

robust method for each and every type of sample. All modular components are recognised by the system software so an optimised test set-up is readily locked into a standard operating procedure that automates all subsequent measurements. EP News Bureau

Leica Biosystems to acquire Aperio Both businesses will leverage each other’s strengths to expand digital pathology eica Biosystems announced that an affiliate has entered into a definitive agreement to acquire Aperio, a leading provider of ePathology solutions. Aperio will be integrated into Leica Biosystems, a leader in anatomical pathology solutions. Together, the two businesses will leverage each other’s strengths to grow and expand digital pathology into the global life science and healthcare markets. The integrated business will pro-

vide industry leading solutions in each step of the anatomical pathology workflow, from sample preparation and staining, to imaging and reporting. The company will continue to offer both the Aperio and the existing Leica portfolio of Digital Pathology solutions, so that customers will enjoy more freedom to choose a solution that meets their individual needs. “Together we offer the market an end-to-end solution from the time that

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the specimen is collected to the time that the results are delivered, to help our customers improve workflow efficiency and diagnostic confidence,” said Arnd Kaldowski, President, Leica Biosystems. David Schlotterbeck, CEO, Aperio, said, “The combined product offerings and improved reach into the diagnostic market will make our ePathology Solutions more widely available.” EP News Bureau September 1-15, 2012

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Real-time viable particle detection: Benefits and regulatory needs manufacturing environment; Instantaneous notification of microbial contamination events; enabling segregation of potentially exposed product; rapid initiation of root cause investigations, providing input to Process Analytical Technology (PAT)based process control measures; potential for real time product release. While real time viable particle counters offer significant potential benefits, they also present some new challenges to industry and regulators. GMP Technical Solutions The BioTrak Real-Time Viable Particle Counter from TSI provides a real-time solution that delivers with certainty the most discriminating data available. At its core is field-proven, patented Laser Induced Flourescence (LIF) technology that incorporates three-dimensional fluorescence optical spectroscopy

apid Microbiological Methods (RMM) have intrigued pharmaceutical manufacturers for several years. The benefits of RMM are well established as they enable better insight into the manufacturing process by providing microbial information much faster than the compendial methods that take multiple days to provide results. Most currently available RMM instruments are laboratory based and significantly reduce the time to obtain microbial results from a collected sample. Several manufacturers have recently introduced real time viable particle detectors similar to the BioTrak real time viable particle detector. Real time viable particle detectors use optical techniques to determine particle viability on a particle by particle basis. This capability provides for: trending of microbial content in the

Eppendorf launches tissue culture consumables ppendorf has expanded its Tissue Culture Consumables (TCC) product range with new Easypet 3, Cell counting plate and CellRepel TCC. In addition to tissue-culture (TC)-treated plates, dishes and flasks, Eppendorf has launched few more products to expand its range of tissue culture consumables. New Easypet 3 electronic pipetting aid gives greater accuracy by controlling the speed conveniently and intuitively with the use of the operating buttons. The new Easypet 3 boasts decreased battery charging time to three hours,

allowing for increased cordless operation time. Vibrant backlit LEDs highlight the battery status contributing to the user’s peace of mind. It is lightweight, well-balanced and extremely easy to use. Being cordless, it enables flexibility in the laboratory allowing the user to freely move around the workplace. Eppendorf Cell Counting Plate provides a convenient solution for cell counting. The pre-assembled single-use chambers save time and ensures cleanliness. Eppendorf CellRepel TCC with innovative hydrogel-based CellRepel surface have been designed to minimise cell and protein adherence. The CellRepel surface is available for a selection of tissue culture vessels (T-25 flask, 60 x 10mm dish, 6- and 96-well plate). Contact details: M Anthoni Jai Kumar Marketing Manager Eppendorf India Limited Doshi Towers, 4th Floor 156, Poonamallee High Road Kilpauk, Chennai – 10 Tel: 044-42111314/341 Fax: 044-42187405 Mob: 09380176423

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for unparalleled microbial detection. By utilising a high-flow rate, built in ISO 21501-4 compliant particle measurement, the BioTrak Particle Counter provides industry standard total particulate results. The integrated particle collection filter enables off-line analysis of the optically analysed particles. The end results are real-time microbial information, cost savings, and improved process control. Contact details: GMP Technical Solutions 309/316, Swastik Disha Business Park, Near Wadhani Industrial Estate, LBS Road, Ghatkopar(W), Mumbai-400086 Tel: 91-022-66083714/700 email: particlecounters@gmptech.net Web: www.gmpcleanrooms.com

Cognex introduces entry level vision system with autofocus and integrated lighting ognex Corporation has launched the In-Sight 7010, an entry level vision system developed specifically for inspection tasks where vision sensors are too limited and a standard vision system may not be cost effective. Every aspect of the In-Sight 7010 has been designed to make deploying a vision system easier than ever before. It is a completely self contained vision system that includes autofocus optics and integrated lighting in a compact IP67 rated industrial housing. Applications can be configured very quickly using the intuitive EasyBuilder user interface. The vision library on the In-Sight 7010 has been simplified to focus on the tools most frequently used in straightforward vision applications. Bhaskar Banerjee, Business Unit Manager, Vision Systems said, “We are excited about the In-Sight 7010. We believe it will open up a new range of applications where vision systems can be applied. The In-Sight 7010 can be taken right out of the box and put straight on the production line with minimum time, cost and effort.” The built-in autofocus capability of the In-Sight 7010 makes it ideal for production situations requiring regular part changes, or applications that require the vision system to be placed in hard-to-reach spaces where manual focus adjustment would be difficult. The In-Sight 7010 autofocus system is available with five different lens options to match the working distance and field of view requirements of each application. With autofocus, users can simply set and save the focus values associated with the inspection of each part. Users can also fine-tune focus levels manually with the interactive software. “All of this allows seamless part change over without any manual adjustment of the lens,” said Banerjee. The compact In-Sight 7010 features integrated white lighting that is suitable for most vision applications. If a specific colour light is required to highlight particular parts or features, four optional coloured lights are available. The autofocus optics and integrated lighting developed for the In-Sight 7010 are also being deployed as options across the full In-Sight 7000 product range. In-Sight 7010 features EasyBuilder and a selection of the key inspection, measurement, alignment and guidance vision tools found on other In-Sight vision systems. With the unique combination of hardware features and software tools, the In-Sight 7010 is the ideal out-of-the-box solution for many straightforward vision applications.

Contact details Sunil Vaggu Cognex Sensors India Email: vaggu.sunil@cognex.com Mob: 9881466003

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PGMIER organises Research Day Celebration in Chandigarh Panel of invited experts discuss issues related to biomedical research in the country

Page 84

AWARD

Novartis’ BioCamp concludes in Hyderabad Three students participate in the International Novartis Biotechnology Leadership Camp in Basle, Switzerland ovartis Biotechnology Leadership Camp (BioCamp), a seminar organised by Novartis for talented students from diverse faculties and different universities, recently concluded in Hyderabad. Esha Kakkar, an alumnus of the Indian Institute of Business, Hyderabad took top honours along with Dr Girish Naik of Christian Medical College, Vellore and Sagar Laygude of IIT - Chennai. Selected after an intense three-day programme, they represented India at the International BioCamp which took place at the Novartis Campus in Basle, Switzerland from August 26 - 29, 2012. The inaugural address of BioCamp India was delivered by Prof D Balasubramanian, LV Prasad Eye Institute who spoke on the pyramid model of eyecare delivery while the valedictory address was given by R Chandrasekaran, CEO, Cognizant India. Both speakers spoke of leveraging technology in science to

Winners after receiving the awards reach a larger section of society with better patient outcomes. Topics covered during the three-day programme

included clinical drug development, entrepreneurship, branding and commercialisation, the role of intellectual property rights, ethics and career opportunities in the pharmaceutical world. As part of the programme participants worked on a case study to address diabetes as a disease that impacts a large section of the Indian population. Speaking on the occasion, Ranjit Shahani, VC and MD, Novartis India said, “Novartis appreciates the opportunity to play a role in bringing top talent closer to the pharma industry and to partner with academia. BioCamp provides students on the threshold of their careers insights to the pharma and biotech industries. It offers bright minds a platform to interact with leaders in the field and network with students coming from different faculties across the country.” EP News Bureau

NEW COURSE

Harvard School of Public Health introduces online course on clinical research nder the recent collaboration between Harvard University and MIT called EdX, a new introductory course on clinical research has been introduced at the Harvard School of Public Health. The course is known as Quantitative Methods in Clinical and Public Health Research. Dr Swati Piramal, Vice Chairperson of Piramal Group, who was recently elected on the Harvard Board of Overseers was instrumental in bringing this course. The course will be offered online by Harvard School of Public Health to students in India and abroad from October 2012. The Quantitative Methods in Clinical and Public

Health Research course is an online adaptation of material from the Harvard School of Public Health's classes in epidemiology and biostatistics and will be taught by Harvard School of Public Health professors — Earl Francis Cook and Marcello Pagano. The course will be available to anyone in the world with an Internet connection, without any rigorous admissions process. The methodology plans to move beyond the standard model of online education that relies on watching video content and will offer an interactive experience for students. According to Piramal, an alumna of Harvard School of Public Health, a course like this is a great

opportunity for physicians in India. “One of the big shortages we have in Indian science is the lack of research curriculum in our medical training. India has over 900,000 doctors but few are trained to be physician scientists. This is a glaring gap in our country, she says. Providing medical doctors an introduction to the science of quantitative methods can be the first step toward interesting more of our physicians to become top professionals in clinical research and become investigators for clinical trials,” says Piramal. EP News Bureau

CERTIFICATION

Hikal receives Responsible Care certification Becomes first Indian life sciences custom manufacturing company to receive ICCA- governed certification ikal, a manufacturer of active ingredients, intermediates and regulatory starting materials successfully completed the Responsible Care audit at all its facilities. Hikal is the first Indian life sciences custom manufacturing company to receive the Responsible Care certification governed by the International Council of Chemical Associations (ICCA). “At Hikal, Responsible Care certification goes beyond our legal obliga-

September 1-15, 2012

tions and encompasses striving for excellence in safety, sustainability and environmental performance. We encourage our suppliers and contractors to strive for continuous improvement in safety and environmental standards. Compliance with all regulatory standards and guidelines is critical for Hikal, our customers and our suppliers. This certification is a true testimony to the

high standards of quality, regulatory compliance and operating standards at our company. Responsible Care and Sustainability is a commitment and responsibility of each and every employee and our goal is to be a positive contributor to the communities we operate in,” Jai Hiremath, Chairman and MD, Hikal said. According to the company release,

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Responsible Care is the worldwide commitment by the chemical industry to continuous improvement in health, safety and environmental performance, and open communication with all stakeholders. Responsible Care companies improve their performance by implementing world-class management practices; working with independent auditors; tracking performance through environmental, health, safety and security measures. EP News Bureau EXPRESS PHARMA

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

PGMIER organises Research Day Celebration in Chandigarh Panel of invited experts discuss issues related to biomedical research in the country ost Graduate Institute of Medical Education and Research (PGMIER), as part of its Golden Jubilee Celebrations, recently organised Research Day Celebration in Chandigarh. The event was inaugurated by Dr Ashwani Kumar, Union Minister of State for Planning, Science and Technology and Earth Sciences. The event provided a space for faculty and researchers of various departments to familiarise themselves with the work going on elsewhere within the institute. Researchers in the institute had the opportunity to present their work, besides showcasing the highquality research work being carried on in the institute. Delegates at the event Participants presented 200 research papers on posters, exhibited major infectious disease such as tuberculosis, malaria, HIV, respiratory infecin Zakir Hall. Eminent researchers present during tions, emerging viral infections, the occasion were Prof. SK Sarin, antimicrobial resistance, zoonosis and Director of the Institute of Liver and for chronic diseases, neurological, carliver, kidney and Biliary Science; Dr Rajiv Sarin, Director diac, diabetes, of the Advanced Center for Treatment, bone diseases. Kumar further said that global Research and Education in Cancer (a part of Tata Memorial Center), Mumbai innovation and technology alliances and Dr Girish Sahni, Director of the with strategic partners should form an Institute of Microbial integrated approach. For this, India needs new structures and mechanisms Technology, Chandigarh. The highlight of day was an ‘Open to create an innovation system which House’ in which the panel of invited enables indigenous methods for affordexperts along with the Director and able innovations and benchmarking of Dean of the PGIMER discussed issues global best practices for quality innoIn this direction the related to biomedical research in the vations. country, strategies to improve collabo- Department of Biotechnology (DBT) ration and quality of research and has entered into a partnership with advise today’s researchers on funding Stanford University (US) to create the Stanford-India Biodesign (SIB) opportunities for biomedical research. Addressing the gathering of emi- Programme which aims to groom the nent physicians, scientists and faculty future leaders of the Indian medical members on the need to strengthen the technology industry. Kumar added that innovation ecosystem in the country, India can become a global leader in the Kumar called for excellence in the futuristic areas of science, including translational research in order to bio-technology, regenerative medicine, ensure affordable health care to all. He neuro sciences and in translational outlined a series of steps including research among others. Considering development of post graduate integrat- India’s long heritage and knowledge, ed research programmes; Centres of he also emphasised the need to utilise Excellence linking key departments India's vast bio-resources for further within and across institutions for development of traditional system of

medicine and herbal drugs with the application of modern scientific tools. Prof Yogesh Chawla, Director, PGI introduced the chief guests and said, “The Research Day would give us an opportunity not only to have an insight on our research output, but also give a chance to develop collaborative researches with neighbouring sister scientific institutes. We also pledge on this day to work harder to take PGI to greater heights and continue to maintain the brand value of this institute.” Prof Amod Gupta, Dean, PGI while informing about the research activities in PGI said, “On an average faculty of PGI publishes nearly 550 research papers in various indexed journals and ever since its inception the Institute has published nearly 15,000 papers. There are a number of metrics to measure the quality of research, none perfect but it is very common to look at the number of citations. Our papers receive nearly 4,000 citations every year almost similar to the AIIMS. However, very discouragingly more than 90 per cent of the research that is published from leading medical institutes including PGI or AIIMS and even the IITs or the famed IISc get less than 25 citations.” EP News Bureau

ABLE conducts BEST workshop Workshop held in Bangalore was funded by Department of Biotechnology ssociation of Biotechnology Led Enterprises (ABLE) recently organised a four-day residential workshop Biotechnology Entrepreneurship Students Team (BEST) for science graduates to encourage entrepreneurship. The workshop held in Bangalore was funded by Department of Biotechnology (DBT). Around 160 business proposals were received in the areas of life sciences from renowned universities across India of which 20 proposals were shortlisted by a committee. Dr Shailendra Vyakarnam, Director, Centre for Entrepreneurial

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Learning, Judge Business School, University of Cambridge coordinated the workshop. CEOs of several biotech companies participated and advised the group led by Kiran Mazumdar Shaw, CMD, Biocon. On the final day, the teams presented their business proposals to a jury chaired by Dr Natesh, Advisor, DBT and CoChaired by Dr PM Murali, President, ABLE. Indian Veterinary Research Institute (Bangalore) finished first while the teams from University of Rajasthan and

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International Center for Genetic Engineering and Biotechnology (Delhi) were adjudged second and third respectively. The prize amount will be handed over to the teams during BIOINVEST — an ABLE flagship annual investor meet which will be held in December. The three winning teams will be provided an opportunity to present their business plans to explore funding opportunities. The first three winners were awarded ` 5 lakh, ` 3 lakh and ` 2 lakh respectively. EP News Bureau September 1-15, 2012

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