Tuesday, April 28, 2009

Thomson Reuters announces India Research Front Awards 2009

Mumbai-Thomson Reuters' Healthcare and Science business has announced the "Thomson Reuters Research Excellence - India Research Front Awards 2009." India's leading eight scientists were honoured for their research and influential contribution to global R&D on four research fronts. Eight awardees were presented with the accolade after their research was analysed using Thomson Reuters Research Front Methodology to assess their level of influence on specific scientific fields. Research Front Methodology looks at patterns of intense communication between scientists and is compiled, using citation analysis of a list of highly cited papers, defined as the top 1 per cent of papers in each of 22 disciplines. Discovering how these highly cited works are related and determining how often these papers have been jointly cited (frequency of co-citation of the two highly cited papers) is achieved by Essential Science Indicators (ESI) from Thomson Reuters, and is called research front analysis. This tool can assist in identifying areas where important work is being conducted and where the scientific community is focusing its attention. Based on the findings, the four research front areas where Indian scientists have had greatest emphasis and world-class influence are: Research Front #1751 - Professors Aniruddha B Pandit, Dr. Parag Ratnakar Gogate, Institute of Chemical Technology, University of Mumbai; for their contribution to research into advanced oxidation processes and techniques. Research Front #6810 - Dr. R Panneerselvam, Dr. Gopi Ragupathi, Dr. Abdul Jaleel Cheruth, Dept of Botany, Annamalai University, Tamil Nadu; for their contribution to research into antioxidant metabolism and defence system in higher plants.Research Front #7435 - Dr. GPS Raghava, Dr. Manoj Bhasin, Bioinformatics Centre, Institute of Microbial Technology, Chandigarh, for their contribution to research into MHC class I binding peptides, using SVMHC.Research Front #9007 - Dr. Ayyappan Pillai Ajayaghosh, National Institute for Interdisciplinary Science and Technology (NIIST), Triuvanathapuram, for his contribution to research into chirality-sensing supramolecular systems. The awards ceremony was held at Le Meridien New Delhi, is part of a series of Asia Pacific Research Days hosted by Thomson Reuters. These events recognise research excellence in countries and regions demonstrating they are leading the world through innovation in their respective fields. The guests-of-honour were Dr. Rajagopala Chidambaram, principal scientific adviser to the Govt of India and Prof. Deepak Pental, Vice-Chancellor, University of Delhi. Wong Woei Fuh, commercial director, Asia Pacific, Thomson Reuters, Said: "India has become an important contributor to the global research community - and the steadfast pursuit of scientific discovery by these eight award winners certainly bears testimony to this. At Thomson Reuters, we understand the importance of trusted information, be it scientific literature or citation indexing data, to help the research community accelerate research, discovery and innovation, and make better decisions faster. Our methodology has helped Indian researchers identify the fields where they are taking the global lead and making a significant contribution. We hope to continue working closely with India's institutions to help them identify research excellence."

Stride Arcolab net profit dips by 80% to Rs 10.5 cr in Q1

Bangalore-Stride Arcolab has generated lower consolidated net profit of Rs 10.50 crore during the first quarter ended March 2009 as against Rs 52.6 crore in the corresponding period of last year, a fall of over 80 per cent mainly due to devaluation of local currencies. Its consolidated net sales increased by 37.3 per cent to Rs 284.3 crore from Rs 207 crore. Stride has surpassed all targets and projections in respect of Indian operations. Arun Kumar, vice chairman & Group CEO, said, "I am extremely delighted that we have been consistently delivering improved performance quarter after quarter. We are able to repeat success owing o our continued focus on execution excellence while meeting challenges such as currency volatility to maintain profitability." Recently, Stride announced corporate reorganization to align global operations into three separate entities viz., specialty pharmaceutical, pharmaceuticals and R&D. The board approved for preferential allotment of upto 6.2 million warrants to promoters and the company convened EGM to be held on May 13, 2009.

India emerges as best option for contract manufacturing: Global Pharmatech chief

Bangalore-Contract manufacturing is one of the best options for the global pharma companies to look forward to in the wake of global recession. The attraction for the global companies to choose India as the ideal hub for contract manufacturing is the opportunity of submission of increasing number of drug master files which has grown to almost 46 per cent in 2007 from a mere 14 per cent in 2000. In contract manufacture, India is ahead of China because of the highest number of US FDA and EU regulatory compliant units. The country also recorded the largest number of Drug Master File submissions which has been 1155 filings between 2000 & 2007 as compared to China's 329 DMFs in the same period. This has given India a head start in the area of contract manufacture of formulations over China, Kaushik Desai, CEO & director, Global Pharmatech, told Pharmabiz. Globally, US$ 80 billion worth of drugs are expected to go off-patent by 2010.Innovators and generic companies are both increasingly facing pressure on their bottom line. Manufacturing, which represents about 30 percent of the annual cost base for a typical global pharmaceutical companies, now have an opportunity for significant cost savings by off loading contracts to India. A visible trend is that innovators like Pfizer, Merck and AstraZeneca have already expressed their intentions to contain production costs by increasing outsourcing of manufacturing activities to emerging economies and India stands to gain in this scenario, stated Desai. The cost of production in India is a fraction of the cost of manufacturing in the US and Europe. It also has one of the lowest manpower rates. To have a second and third shift of plant operation is difficult considering labour laws and hostile weather conditions in the US or Europe. Hence running a plant 24x7 basis is extremely difficult. This is where Indian pharma sector offers the biggest choice of labour and plant accessibility, he added.The outsourcing opportunities unfold in contract research & development, bulk drug & formulation manufacture, co-marketing & sales, clinical trials including technical services like data management, expertise in herbal and nutraceuticals, primary packaging materials, bioinformatics, biostatistics and software development. According to the Merrill Lynch report, global outsourcing market is valued at US$ 44 billion in 2007 and is expected to touch US$ 73 billion 2011. Globally, India is fourth largest pharmaceutical market in terms of volume and 13th in value terms. Indian contract manufacturing market is estimated US$ 1.0 billion in 2008 and is likely to grow at a CAGR of about 42 per cent to touch US$ 2.5 billion by 2010Companies outsource because of temporary lack of capacity and with the objective to encash on core competencies of low cost destinations like India. It is found that branded companies outsource around 40 per cent of their bulk needs and 30 per cent of their drug product needs. While generic companies report outsourcing 80 per cent of bulk and nearly half of their drug product needs, said Desai. Globally, contract manufacture market is segmented into injectables, solid & liquid dosage forms spanning across North America, Europe and Asia. Injectables are expected to show highest growth during next five years. Solid dosage form represents 47 per cent of the global market while Liquid dosage forms are projected to grow slowest in next five years. The demand for specialized technologies and services such as sterile products, biopharmaceuticals & lyophilization is likely to drive the contract manufacturing market to a significant extent, informed Desai. Among the notable contract manufacturers serving multinational companies in India include Piramal Healthcare, Cadila, Kemwell, Shasun, Dishman, Jubilant, Matrix, Divis, Strides, IPCA.

Gujarat Pharma Park for SSIs to be launched within five months

Mumbai- Gujarat Industry Development Corporation (GIDC) Pharma Park, a pharma cluster project initiated by the Gujarat State Board of Indian Drug Manufacturers Association (IDMA) is expected to be launched in next five months, it is learnt.The GIDC Pharma Park, promoted by IDMA state board to support the small scale pharmaceutical companies in the domestic market, will be coming up in an area of 1,600,00 square yard area at Changodar, Ahmedabad with a total of 35 plots, informed the association. The park will facilitate space for 33 pharma units apart from an administrative office and a common effluent treatment (CET) plant."We have initiated the works on preparing infrastructure and will start allotting plots to the companies within next two months. Our expectation is to inaugurate the park with a set of pharma units by the end of August," said R S Joshi, executive secretary, IDMA Gujarat State Board. GIDC Pharma Park will be the first of its kind pharma cluster programme set up in the country through an industry body, he added.The IDMA state board has signed a Memorandum of Understanding (MoU) with the state government in the much known investor summit, Vibrant Gujarat 2009, in January for setting up the park. The investment for building the primary infrastructure is estimated as Rs 4 crore, including the separation of plots, setting up of administrative office and CET plant, informed Joshi.The Pharma Park will have allocated space for packaging and logistics facilities along with accommodation for formulation and bulk drug manufacturers. The Pharma Park is expected to support the small scale industry to address the highly quality conscious export market with a standard manufacturing facility and will encourage them to grow in contract manufacturing business.The state is contributing almost 45 per cent of the total national pharmaceutical production. With the support of the government and the regulatory bodies, the pharma industry in the state can increase its contribution to more than 50 per cent, comments Joshi. The cluster project will support the small scale industry to catch up the overall growth of the state pharma industry.

Govt gives diplomatic push to pharma exports to Africa

NEW DELHI: India has started a diplomatic exercise to counter a ‘propaganda’ by multinational pharmaceutical companies against Indian generics or

off-patent drugs exported to Africa. In an effort to ensure that its genuine pharmaceutical exports to African countries do not get rejected as fakes, the government, on Friday, gave a presentation to ambassadors and high commissioners of African countries on the scientific way in which generic drugs are manufactured in the country. It also stressed on the need for African countries, which account for a substantial share of India’s pharma exports, to differentiate between spurious drugs and counterfeits while framing laws to check fakes. The move follows an anti-counterfeit legislation passed by Kenyan Parliament which could hamper exports from India if not implemented in the right spirit, the official said. India also wants to send the right message across to the African countries before the meeting of African Union health ministers next month where countries exchange notes on best practices in the area of health implemented by them. African countries including Kenya, Nigeria and Uganda account for about 15% of India’s $1 billion pharmaceutical exports. “Certain multinational pharma companies have started a false propaganda against Indian generics claiming that they are fake. A number of African countries, therefore, now have apprehensions about the quality of medicines that we export. We have thus started an exercise to educate them about our generic drugs industry, which is totally in alignment with Trips regulations,” the official said. The Friday meeting, convened by the commerce department, was attended by several representatives of the industry and the drugs controller general of India (DCGI). Kenya’s anti-counterfeit legislation passed last month lays down that generics having patent protection anywhere in the world can be considered counterfeit in case of an intellectual property dispute with the patent holder. This means that in case a drug company, which does not hold a patent for a medicine in India but holds a US patent, challenges the generic version sold by an Indian company in Kenya, it will be classified as a counterfeit. “Such regulations may result in denying access to quality medicines at affordable prices. It would also kill the nascent generic industry in African countries, where small units have just started emerging in countries such as Kenya and Uganda,” said Indian Pharmaceutical Alliance president D G Shah.

Cipla net up by 9.5 per cent to Rs 768 crore during FY'09

Mumbai-Cipla, the third largest pharmaceutical company in India, has achieved satisfactory performance during the year ended March 2009 despite slow down in world economy and significant jump in interest cost. The company's net profit increased by 9.5 per cent to Rs 767.83 crore from Rs 701.43 crore in the previous year. Its net sales moved up strongly by 24.4 per cent to Rs 4972.69 crore from Rs 3997.90 crore. The company's total exports has taken quantum jump and increased by 31.1 per cent to Rs 2754.41 crore from Rs 2101.74 crore in the 2007-08. Exports contribute 54.7 per cent to its sales as against 51.4 per cent in the previous year. Its exports of formulations increased by 39.8 per cent to Rs 2172.48 crore from Rs 1553.68 crore and that of APIs and others increased by 6.2 per cent to Rs 581.93 crore from Rs 548.06 crore. Its domestic sales increased by 14.7 per cent to Rs 2279 crore from Rs 1987 crore. The operating profit went up by 49.1 per cent to Rs 1284 crore from Rs 861 crore with a operating profit margins of 24.1 per cent as compared to 20 per cent in the last year. The foreign exchange loss amounted to Rs 10 crore as against a gain of Rs 25 crore in the previous year.

Piramal Healthcare consolidated net falls by 5.3% in 2008-09, dividend at 210%

Mumbai-Piramal Healthcare (formerly known as Nicholas Piramal Ltd), has posted lower consolidated net profit of Rs 316.25 crore during the year ended March 2009 as against Rs 333.78 crore in the previous year mainly due to slowdown in the world economy. The company's consolidated net sales increased by 14.4 per cent to Rs 3281 crore from Rs 2867 crore. With fall in profits its earning per share worked out to Rs 15.1 as compared to Rs 15.9 in last year. The board of directors has recommended equity dividend of 210 per cent (Rs 4.20 per share of face value of Rs 2 each.) for the year 2008-09.Ajay Piramal, chairman, said, "Despite challenging economic conditions, uncertainties, unfavorable foreign exchange rates and significant rise in raw material cost in the first half of 2008-09, the company managed to achieve strong growth in top line. We are now expanding our foreign facilities and we are integrating recently acquired facility in US. Due to economic slowdown our revenues from custom manufacturing declined. Domestic markets and global critical operations will be key growth drivers in the current year."Piramal Healthcare has incurred a forex loss of Rs 82.11 crore during 2008-09 as against a gain of Rs 5.36 crore in the previous year. "There will be no foreign exchange losses in the future as the company has taken proper measures." Ajay Piramal added. Operating profit grew by 7.5 per cent to Rs 590 crore and operating profit margin for the year was lower at 17.7 per cent as compared to 18.9 per cent in the previous year.The company's Healthcare Solutions (Domestic Formulations) division reported growth of 24.3 per cent with sales of Rs 1600 crore. "The company now ranked first in the consulting physician and second with the dentists. We launched 42 new products during the year. Our market share has gone up to 4 per cent from 3.6 per cent in the last year Diagnostic business increased by 42 per cent to Rs 170 crore from Rs 120 crore," Pirmal added.Its Pharma solutions (custom manufacturing) division's sales increased by 5.2 per cent to Rs 1060 crore and the same from Indian facilities went up by 73.8 per cent to Rs 390 crore as compared to Rs 220 crore in the previous year. The company has commissioned a new facility at Ahmedabad dedicated exclusively to formulations development. It implemented expansion program at its Ennore facility and added a new business line of clinical packaging at Morpeth in UK. Its Global critical Care business moved up by 33.7 per cent to Rs 130 crore, with the acquisition of RxElite Inc. in December 2008, from Rs 98.45 crore in last year.Pirmal Healthcare's standalone net sales increased by 21 per cent to Rs 2333 crore during the year ended March 2009 from Rs 1928 crore in the previous year. However, its standalone net profit declined by 8.7 per cent to Rs 275 crore from RS 301 crore. The company performed well across all therapies and witnessed significant growth particularly in anti-biotic, dermatology, respiratory and cardiovascular therapy segments.

Sandoz gets Canadian nod to market Omnitrope

Sandoz Canada has received market authorization for Omnitrope in Canada. Omnitrope is the first version of a previously approved recombinant biotechnology drug to be approved by Health Canada under the regulatory term Subsequent Entry Biologic (SEB).Omnitrope, a somatropin (rDNA origin) for injection, is approved for the long-term treatment of children with growth failure due to an inadequate secretion of endogenous growth hormone, and long-term replacement therapy in adults with growth hormone deficiency due to an underlying hypothalamic or pituitary disease or who were growth deficient during childhood.The Omnitrope Pen 5 and 10, with liquid cartridges, have been approved by the Biologics and Genetic Therapies Directorate of Health Canada in 5 mg/1.5 mL and 10 mg/1.5 mL strengths. This new delivery system is more convenient for patients because the liquid is already dissolved in a ready-to-use cartridge and can be loaded into the pen for injection."Subsequent Entry Biologics, known as biosimilars in Europe and follow-on proteins in the US, are a key part of the Sandoz strategy to focus on difficult-to-make products that provide added patient benefits," said Pierre Fréchette, president and CEO of Sandoz Canada. "Due to the rising cost of health care and the growing need for more complex treatments, they will play an increasingly important role in ensuring access to medicines."Sandoz is the pioneer in this new field, with three biosimilar medicines already approved and marketed in Europe: Omnitrope (somatropin), Binocrit / Epoetin alfa Hexal (erythropoetin) and Filgrastim Hexal (GCSF) - also approved as Zarzio. Omnitrope was the first ever medicine to be approved under the regulatory term 'biosimilar' in Europe and is also approved and marketed as a 'follow on protein' in the US. Sandoz continues to develop a comprehensive biopharmaceuticals pipeline, with numerous projects at various stages of development.This pioneer position is based on decades of experience in biotechnology manufacturing for both internal and external customers as well as significant cross-divisional synergies within the Novartis Group including a joint global Technical Development and production network. Sandoz strongly supports a balanced position on SEBs, which advocates that the same standards of high quality and science consistently be applied to all medicines, and recognizes the role that generic drugs and Subsequent Entry Biologics can play in the healthcare system.With more than 209 molecules, Sandoz offers one of the broadest portfolios of products in Canada. Sandoz continues to showcase its leadership by adding to its portfolio each year through product development and innovation in oral, injectable and difficult-to-make products, such as modified release and Subsequent Entry Biologics. Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products.

Indian cos eye Japan as next generic export market as margins decline in US, EU

Bangalore-Increased price erosion and market saturation in US, EU and Asia-Pacific countries have forced Indian pharma majors to look at Japan, which is the world's second largest market for generics after US. Companies plan to cash in on the lucrative generics space as a logical progression in their international forays.The top 25 Indian companies in the country are looking at a strategic entry into Japan through acquisition, collaboration or entry through distributors. These companies including Micro Labs, Bal Pharma and Biocon from Karnataka are keen to leverage the advantage of an early entry into Japan.Rising healthcare costs, ageing population and high cost of drug development in Japan will offer Indian generic majors an opportunity, stated TS Sampath Kumar, Senior Advisor, Japan External Trade Organization (JETRO). Among the companies which have entered Japan are Lupin and Zydus via acquisition in 2007. Lupin has a majority stake in Kyowa Pharmaceutical Industry Co Ltd (Kyowa), a leading Japanese generics company ranked amongst the top 10 generic companies. It has also received approvals from the Ministry of Health & Labour Welfare, Japan (MHLW) for 10 products. Zydus obtained a 100 per cent stake Nippon Universal Pharmaceutical Ltd. Dr Reddy's and Aurobindo export active pharmaceutical ingredients (APIs). If Indian companies enter Japan through the acquisition route, it would help bridge competencies and flatten the learning curve faster. Japan, which is known for innovation, expects its customers to constantly offer valued added options in the development and supply agreements. Therefore it may not be easy for Indian pharma companies to trade in the region, stated RS Iyer, pharma consultant. It is a complicated market with challenges including long gestation period, reluctance in the supply chain management to shift from existing practices and language. Therefore, perseverance is needed to build up a strong business relationship with constant two-way communication, stated Archana Dubey Mitra, associate vice president, API & Exports, Bal Pharma Limited.The price offering is the main attraction and this ensures market sustainability which is key for exports to thrive. Karnataka companies are looking at the value-added generic formulation space. Approvals are being sought and plans being worked out to open up an office to tackle the supply chain strategies and practices in Japan, stated sources, who did not want to be named. Of the 50 generic players in Japan, there are only three foreign companies, Mylan, Hospira and Sandoz. The top five companies are Japanese majors. Between 5 and 20 ranked companies are in the large and medium sized generic producers. Companies ranked from 21 to 50 slot are the small units finding it difficult to survive. This is where Indian companies looking at Japan can tap a possible acquisition route, stated sources.In spite of a strong generic production base in Japan, global recession has resulted in huge infrastructure cost. A recent legislation encourages prescription of generics over patent drugs. 'Yakka Kijun' or National Health Insurance (NHI), which sets the drug price standard, has allocated 9 per cent of Goss National Income (GNI) valued at Yen 36,129 billion for healthcare expenses a 6 per cent increase over last year.In 2008, Japanese generics market was valued at Yen 440 billion. A growing ageing population has created a demand for CAD, CNS, diabetes and osteoporosis generics. If Indian companies qualify on quality and time line deliveries, they can make it big in Japan, added sources.

Elder Health Care eyeing brand acquisitions

KOLKATA: Elder Health Care, the FMCG arm of the Rs 560-crore pharma major Elder Group, is evaluating two Indian brands for acquisition. The two

potential targets are in the areas of oral care and body care and will help Elder consolidate its presence in the personal care segment. Elder expects to close each of the deals at a valuation of Rs 5-10 crore. The company wants to complete the acquisitions soon since it wants to capitalise on the present moment when valuations are low. "We are looking at acquisitions to consolidate our presence in the personal care segment. We soon plan to appoint a merchant banker for reviewing the deals," Elder Health Care Ltd managing director Anuj Saxena told ET. Incidentally, Elder already has an oral care brand AMPM Mouthwash. Other popular brands include Fairone (fairness cream), Tiger Balm (pain relief) and the recently launched deodorant body spray ‘Fuel for Men’ in partnership with VLCC. Elder, on Friday, announced its plan to enter the Indian colour cosmetics market. Elder has entered into an exclusive marketing agreement with Germany’s Innovative Cosmetic Brands GmbH to roll out their mid-to-premium segment brand ‘BeYu’ in India. The range will comprise mineral make up, lipstick, foundation, eye shadow, mascara, eye liner and nail enamel. The brand will target urban women in the 25-40 years of age. "Innovative Cosmetic has another premium brand ‘Artdeco’ which we might bring into India. We plan to bring another 2-3 foreign brands in this segment to grow the colour cosmetic segment," said Mr Saxena. The Indian make-up market is estimated at Rs 1,000 crore and growing annually at 30%. Of this, the premium segment is worth around Rs 350-400 crore. Elder also plans to expand its men grooming portfolio by extending the ‘Fuel for Men’ brand into hair gel and after-shave products. "We might foray into the male cologne segment. The idea is to consolidate our presence in the personal care segment with launch of several SKUs," said Mr Saxena.

Ranbaxy sees $150 mn loss in 2009

NEW DELHI: Ranbaxy Laboratories Ltd said on Friday that it anticipates a loss of $150 million on sales of $1.4 billion in the year ending December

2009. Ranbaxy, in which Japan's Daiichi Sankyo owns about 64 percent, had posted a net loss of $187 million in 2008.

Elder Health Care eyeing brand acquisitions

KOLKATA: Elder Health Care, the FMCG arm of the Rs 560-crore pharma major Elder Group, is evaluating two Indian brands for acquisition. The two

potential targets are in the areas of oral care and body care and will help Elder consolidate its presence in the personal care segment. Elder expects to close each of the deals at a valuation of Rs 5-10 crore. The company wants to complete the acquisitions soon since it wants to capitalise on the present moment when valuations are low. "We are looking at acquisitions to consolidate our presence in the personal care segment. We soon plan to appoint a merchant banker for reviewing the deals," Elder Health Care Ltd managing director Anuj Saxena told ET. Incidentally, Elder already has an oral care brand AMPM Mouthwash. Other popular brands include Fairone (fairness cream), Tiger Balm (pain relief) and the recently launched deodorant body spray ‘Fuel for Men’ in partnership with VLCC. Elder, on Friday, announced its plan to enter the Indian colour cosmetics market. Elder has entered into an exclusive marketing agreement with Germany’s Innovative Cosmetic Brands GmbH to roll out their mid-to-premium segment brand ‘BeYu’ in India. The range will comprise mineral make up, lipstick, foundation, eye shadow, mascara, eye liner and nail enamel. The brand will target urban women in the 25-40 years of age. "Innovative Cosmetic has another premium brand ‘Artdeco’ which we might bring into India. We plan to bring another 2-3 foreign brands in this segment to grow the colour cosmetic segment," said Mr Saxena. The Indian make-up market is estimated at Rs 1,000 crore and growing annually at 30%. Of this, the premium segment is worth around Rs 350-400 crore. Elder also plans to expand its men grooming portfolio by extending the ‘Fuel for Men’ brand into hair gel and after-shave products. "We might foray into the male cologne segment. The idea is to consolidate our presence in the personal care segment with launch of several SKUs," said Mr Saxena.

Monday, April 27, 2009

Glenmark seeks action against govt hospital for falsifying data

NEW DELHI: Mumbai-based MNC drug manufacturer Glenmark Pharmaceuticals has complained to the drug regulator that the government-funded research

centre, Guru Govind Singh Hospital in Jamnagar (Gujarat), is indulging in unfair practices while conducting human trials. The company discontinued the clinical trial for its lead asthma drug Oglemilast undertaken by the research centre in March this year after it found that the hospital was manipulating data, a government official, who didn't wish to be named, said. The US-based Omnicare Clinical Research chose Guru Govind Singh Hospital as one of the sites to conduct clinical study of Oglemilast on behalf of its client Glenmark. The company has sought an immediate audit of the site by the Drug Controller General of India (DCGI), the official said. It also expressed suspicion about improper screening of the volunteers before enrolling them for the trial. "Immediately upon suspecting fraudulent activity, Glenmark and Omnicare carried out appropriate for-cause audit and confirmed the fraud. This was immediately brought to the attention of the chairman of the ethics committee, who is also the hospital superintendent," a company spokesman said. While clinical trials at the Jamnagar site is stopped, it is being conducted at 27 other sites across the country. Experts in pharmaceutical industry say that majority of trust hospitals and government hospitals in Gujarat are indulging in unethical trials. "For enrolling a poor patient , doctors are being paid commissions up to Rs 120,000," Rajkot Cancer Society trustee Kishore P Ghiya said. A health ministry official confirmed the development and said that the DCGI will soon initiate an audit of the hospital. Oglemilast is a potential molecule of Glenmark Pharmaceutical. Glenmark through its wholly-owned swiss subsidiary Glenmark Pharmaceuticals SA has a collaborative agreement with Forest Labs for Oglemilast. As per the agreement, Forest Labs would develop register and commercialise the drug in the North American market, while Glenmark will retain commercialisation rights for the rest of the world

Delhi High Court dismisses Roche plea on patent


NEW DELHI: The Delhi High Court on Friday allowed Indian pharmaceutical company Cipla to manufacture and sell the generic version of patented lung

cancer drug 'Erlotinid' of Swiss pharma firm Hoffman La Roche Ltd. A bench headed by Chief Justice A P Shah vacated its interim order by which Cipla was restrained from exporting the drug to other countries in which La Roche has patent rights. The Court dismissed the plea of the Swiss company saying that the Indian company should be restrained from manufacturing and selling the generic drug till the issue of patent rights was decided through litigation. The Swiss company had approached the Division Bench of the High Court after a single Bench had dismissed its plea to restrain Cipla. The Court also imposed a cost of Rs five lakh on the Swiss company.

Teva, Glenmark call an end to patent dispute

MUMBAI: Israeli generic major Teva and Mumbai-based Glenmark Pharmaceuticals have settled a patent dispute over various generic versions of Coreg —

a drug used for treating congestive heart failure — out of court. Teva had filed a case against Glenmark Generics (Glenmark Pharma’s US subsidiary) over the latter’s process patent for preparing Carvedilol, the main pharmaceutical compound used in the generic version of Coreg. Glenmark had, in turn, filed a lawsuit challenging two of Teva’s patents related to the drug. When contacted about the out-of-court settlement, Vijay Soni, executive VP, Glenmark Generics, told ET: “We confirm the withdrawal of the lawsuit.” A stipulation of dismissal signed by Judge Garrett E. Brown Jr. of the US District Court of New Jersey has brought an end to the litigation. The settlement will in no way impact Glenmark’s product, Carvedilol, which is being currently sold in the US market, and is likely to be mutually beneficial to both parties, industry sources said. Carvedilol is a pharmaceutical compound, referred to in industry jargon as the active pharmaceutical ingredient (API), used in the product sold by GlaxoSmithKline (GSK) under the trade name Coreg. In 2006, just before it went off patent, Coreg had a turnover of 195 million pounds. It was GSK’s fifth best-selling drug in the second-quarter of 2007. Teva currently controls a majority share in this market, going neck-and-neck with GSK. Other manufacturers have a comparatively smaller share of the pie. According to IMS Health data, annual US sales of drugs using Carvedilol as API were about $1.7 billion for the 12 months ending June 2007, making this a significant market for either company. Teva, which filed its case in August 2008, claimed that Glenmark was not using a novel method to make the drug, and had instead infringed on a process which the Israeli firm had patented. Glenmark contended that it had an innovative process for manufacturing the drug. In December 2008, the Indian company filed a set of counter-claims calling Teva’s patents invalid and unenforceable due to misrepresentation to the US Patent and Trademark Office. It also accused Teva of engaging in “sham” litigation and violating federal antitrust laws. Glenmark is not the only company that Teva had filed a lawsuit regarding this product. The Israeli firm had filed lawsuits against seven Indian companies related to Carvedilol. Ranbaxy and Dr Reddy’s had already settled out of court with Teva. In 2007, the USFDA approved 14 generic versions of Coreg (Carvedilol), dealing a blow to GSK and its partner, the French firm, Flamel Technologies. Some of the other Indian firms, who received USFDA approval to market this drug, were Aurobindo Pharma, Caraco Pharma (the US subsidiary of Sun Pharma), Dr. Reddy’s Laboratories, Lupin, Ranbaxy and Zydus.

Trivitron, BioSystems, Spain to set up facility in Chennai

CHENNAI: Medical technology company Trivitron has forged an alliance with BioSystems of Spain to manufacture IVD Reagents. Through this tie-up,

BioSystems will manufacture IVD reagents for diagnostic lab use by setting up its manufacturing facility at Trivitron's Medical Technology Park (MTP) in Chennai. An investment of Rs 40 to Rs 50 crore is envisaged in the first phase at the facility. "This facility will cater to both domestic and foreign market. Products are expected to be rolled out by mid-2010. The MTP is coming up on a 23-acre land at Sriperumbudur, near Chennai, on which Trivitron has already invested Rs 170 crore," Trivitron MD G S K Velu said. The plant will be set up with the help of a specialist technical expert from Spain and will operate according to the good manufacturing practices (GMP), the ISO 9001, the ISO 13485 and the European Union laws on ‘In Vitro’ diagnostics products. BioSystems MD Antonio Elduque said it decided to expand its operations by setting up a facility in India through a JV as it has considered India an emerging preferred healthcare destination having infrastructure and technology matching that of the UK, Europe and USA. "We have identified Trivitron for the tie up as it is creating the first-of-its-kind, world class medical technology park ( MTP) in Chennai. This will be the first facility outside Spain, for the manufacture of clinical chemistry products. Production is expected to commence during 2010," he said in a release here on Wednesday. BioSystems is among the largest manufacturers of clinical chemistry reagents and instruments in Europe and the alliance will benefit from its three decades of research, advancements and expertise in clinical chemistry

Glaxo, Pfizer’s patent claims turned down

NEW DELHI: Indian authorities have rejected the patent applications of GlaxoSmithkline’s anti-diabetic drug Avandia and Pfizer’s cholesterol

lowering drug Caduet, allowing other companies to sell generic versions of these drugs. The applications were rejected as they did not measure up to the criteria of being new as well as being more useful than existing compounds. The application for Avandia (rosiglitazone) was refused because it failed to show any “enhanced efficacy over the existing compound”, while that for Caduet was rejected as the patent office did not find any “inventive step”. A patent grant would have ensured that no other company could make them without the consent of the patent-holder for the next two decades. The Delhi Patent Office accepted the objections raised by Ahmedabad-based Torrent Pharmaceuticals while rejecting a patent for Caduet, a combination of Pfizer’s two existing drugs Norvasc (amlodipine besylate) and Lipitor (atorvastatin calcium). The law allows interested parties to raise objections on patent applications. In the case of rosiglitazone, which is marketed as Avandia by GSK, the Patent Office said the company could not establish that the compound is “better in terms of efficacy with respect to its parent compound”. Several domestic companies, such as Dr Reddy’s Laboratories, Torrent Pharma and Sun Pharma, manufacture generic versions of rosiglitazone in India. Both the applications were turned down under a crucial section in the patent law, which says that mere modifications of existing substances cannot be granted patent, unless they establish significantly enhanced efficacy. “Both the applications lacked merit to overcome Section 3(d) of the Indian patent law, and hence, rejected. Combination (Caduet) application is unlikely to be granted patent in India, unless it shows unexpected results or synergy,” said Mumbai-based patent lawyer Varun Chhonkar. According to some estimates, global market for Caduet is around $589 million, of wkhich $120 million is from markets outside the US.

Piramal plans to buy 2-3 firms in US, Europe

NEW DELHI: Piramal Healthcare Ltd is eyeing acquisitions in the US and Europe, and expects growth in business during the current fiscal year to

remain same as that in FY09, a senior official said on Wednesday. "We expect to buy 2-3 companies in advanced markets like the US and Europe," Swati Piramal, director, Piramal Healthcare told reporters. "The company expects the same level of growth as witnessed in the last fiscal," she said, adding the firm plans to add 300-400 professionals in the super-speciality marketing division. She ruled out any proposal to sell stake in Piramal Healthcare or Piramal Life Sciences Ltd.

Cipla's SA deal rejection may scupper local takeover

JOHANNESBURG: A threat by Cipla India to end a 20-year supply deal with Cipla Medpro South Africa (CMSA) may scupper a takeover bid by Adcock

Ingram, analysts said. This comes in the wake of a statement by Cipla India joint managing director Amar Lulla that it would end its long-term drug supply agreement with CMSA if Adcock was successful in its takeover bid, as it saw the latter as a competitor. Cipla India, which does not have any stake in CMSA, is estimated to earn about 15 per cent of its export revenues from the deal with Cipla Medpro from the 35 per cent of its products, especially anti-retrovirals, which it exports to the African continent. Although Lulla said Cipla India would not oppose the attempt by Adcock to buy a majority stake in CMSA, analysts here said the deal was in jeopardy because the long-term supply agreement with the Indian pharmaceutical giant was a key component of its bid to take over CMSA. "If Adcock can't continue on similar terms and conditions that CMSA has with Cipla India, the condition precedent (set by Adcock to retain the supply agreement) won't be met and the deal will be unlikely to happen," equity analyst Jonathan Larcombe of Old Mutual Investment Group told the daily Business Report here. "But it will depend on just how Adcock intends addressing the issue with Cipla India." Nazeem Hendricks, a portfolio manager at Argon Asset Management, told Business Report that it would not make sense for Adcock to proceed with the offer if it could not have access to the Cipla India pipeline. "To me that would have been the justification for making this offer," Hendricks said. Earlier, Adcock chief executive Jonathan Louw had said that both companies could benefit from the merger, which is now turning out to be a hostile takeover bid after CMSA chief executive Jerome Smith and about 20 per cent of shareholders in CMSA turned down the offer. Adcock has said that it would be happy with 51 per cent of CMSA, where the board has decided to consider the bid.

UPDATE 1-IMS lowers global phamaceutical forecast for 2009

NEW YORK -
* IMS now sees global growth of 2.5-3.5 pct
* Sees $750 bln 2009 sales, down from prior $820 bln view
* US market to decline by 1-2 percent
* China set to become 3rd largest market in 2011

The worldwide economic crisis is taking a tougher-than-expected toll on the pharmaceutical market, according to the leading tracker of prescription drug data.
IMS Health Inc (RX.N) now expects the global pharmaceutical market to grow by an anemic 2.5 percent to 3.5 percent in 2009, down 2 percentage points from the forecast it issued six months earlier, and the lowest growth rate in at least 25 years.
"We see the worldwide financial crisis contributing to record-low sales growth this year," Murray Aitken, senior vice president for Healthcare Insight at IMS, said in a statement.
Traditionally considered more impervious to economic downturns than other sectors, the pharmaceutical industry is feeling the pinch this time. Sales in the world's largest market, the United States, are seen declining by 1 percent to 2 percent in 2009 -- the first decline since IMS started tracking U.S. sales data in 1957.
With the first quarter of the year in the books, IMS now foresees global pharmaceutical sales of $750 billion, down from the $820 billion it forecast for 2009 last October.
"To the now familiar factors impeding market growth, such as patent expirations, a slowdown in innovative product launches, and hurdles imposed by payers on market access, we can now overlay the economic downturn," Aitken said.
A Thomson Reuters health care survey released this week found that one in five U.S. households postponed or canceled medical care over the past year. IMS said it has seen a reduction in patients beginning chronic therapy regimens in areas such as diabetes, hypertension, insomnia and depression.
Patent expirations of a number of billion-dollar drugs in 2011 will impact U.S. growth to the end of the forecast period in 2013, according to IMS.
Many of the world's top selling medicines will face competition from cheaper generic versions over the next few years, including Pfizer Inc's (PFE.N) more than $12 billion a year cholesterol fighter Lipitor in 2011. Sales of branded drugs quickly evaporate when faced with generic versions.
Volatility in currency markets caused by the reeling global economy also impacted the projected global growth rate once local currencies were converted into U.S. dollars, IMS said.
The emerging pharmaceutical markets of China, Brazil, India, Korea, Mexico, Turkey and Russia are expected to see sales grow by 13 percent to 16 percent through 2013, IMS said.
The forecast sees China becoming the third-largest market by 2011, up from its current sixth place ranking.
By contrast, IMS sees a compound annual growth rate of just 1-4 percent through 2013 from the mature markets of Japan, France, Germany, Italy, Britain, Spain and Canada.
Overall, IMS projects global sales to rise by 3-6 percent a year on average through 2013.
Some two thirds of the 50 to 60 new medicines expected to be launched over the next two years will be specialist-driven drugs aimed at narrow patient populations, IMS predicted.
It sees six to 10 drugs with billion-dollar a year potential among the expected 2009 and 2010 launches. The likely winners cited by IMS include Eli Lilly and Co's (LLY.N) blood clot preventer prasugrel, Amgen Inc's (AMGN.O) osteoporosis treatment denosumab, Novo Nordisk's (NOVOb.CO) diabetes medicine liraglutide, and the Johnson & Johnson (JNJ.N) psoriasis treatment ustekinumab.
But predicting blockbusters can be a tricky proposition. There have been some high profile busts among drugs once listed as future 'can't miss' blockbusters, including the Sanofi-Aventis(SASY.PA) weight loss pill Acomplia, that proved to be a major disappointment, and a Pfizer cholesterol drug, torcetrapib, that never reached the market.

Monday, April 20, 2009

Drug MNCs tightening grip over domestic market by hiking stakes in Indian subsidiaries

Mumbai- The multinational drug companies seem to be all set to recapture the Indian pharmaceutical market they lost to the domestic pharma companies in the eighties. One after another the MNCs are tightening their grip over the Indian market by grabbing every opportunity by either hiking the stake in their Indian arms or acquiring large Indian companies.Crash in the stock market over the last one year has helped the MNCs to realize this dream as the share prices are at a relatively low level. While increasing stake, these companies are also considering factors like the huge Indian market size, cost effective outsourcing, better infrastructure and strong R&D base. The higher stake will also help to cope up with rising cost in highly regulated markets. During last couple of months there were increasing number of public offers by the MNCs like Abbott India, Novartis India and now Pfizer Ltd to raise equity stakes. The trend is likely to gain momentum in the near future with stock prices of pharma companies show no significant upward movement.Pfizer Inc, a US$ 48 billion pharma giant, has decided to raise its equity stake in its Indian arms from present 41.23 per cent to 75 per cent through an open offer from public shareholders at a price of Rs 675 per share. This worked out to investment of Rs 680 crore for Pfizer. The Indian sales of Pfizer touched to Rs 682 crore during the year ended December 2008, but its net profit declined sharply to Rs 300 crore from Rs 340 crore in the previous year. The analysts said that the higher stake will help Pfizer to take decisions about market expansion in the domestic market. Novartis AG is planning to acquire an additional stake of upto 39 per cent in its majority owned Indian subsidiary, Novartis India Ltd., from public shareholders at a price of Rs 351 per share. At present Novartis AG has a controlling stake of 50.9 per cent in its Indian arm. The offer is likely to open in May 2009. This will increase the stake to over 90 per cent with investment of Rs 440 crore. During September 2008, Abbott India has completed its buy-back offer of 7,97,500 fully paid-up equity shares of the face value of Rs 10 each from the existing owners of shares through a tender offer at a price of Rs 630 per share with aggregate amount of Rs 50.24 crore. With this offer, the promoters have increased their stake from 65.14 per cent to 68.94 per cent. There is good scope for promoters of other MNCs to increase their stakes. Currently, the parent holdings in GlaxoSmithKline stood at only 50 67 per cent, Aventis Pharm at 60.39 per cent, Merck Ltd at 51 per cent, Wyeth Ltd at 57.15 per cent, Solvay at 68.85 per cent and Fulford India at 53.93 per cent. The parent companies of these MNCs have every right reason to hike their states in near future considering their low share prices on Indian stock exchanges. The current share price of Pfizer is moving around Rs 690 on BSE and the parent company is planning to purchase shares at Rs 675 each under its tender offer. Considering the current higher price, the promoters' may increase the purchase price to complete its tender offer. Similarly, Novartis will also have to increase their tender offer price of Rs 351 as its current price is around Rs 370. The public shareholder will get better returns if the promoters stepped up their offer price. The analysts are of the view that there will be more and more such cases likely to happen in India as the world's leading pharma corporations are facing a serious crisis. The low returns from R&D activities and tremendous pressure on margins on account of generic competition will make situation worse for them. Unless there is huge sales volume, the margins will be under pressure and likely to slowdown further. In this situation, Indian market looks very promising one with huge untapped rural market. MNCs are likely to focus on this with their Indian arms. It is easy to tap ready market and strengthen R&D capabilities with very little cost for cash reached MNCs. The analysts from foreign broking firm expressed the view that it is high time for Indian government to enforce all provisions of the new Patent law in the country. Though the cost of product will play a key role in Indian market, MNCs will manage the same by introducing cost effective products made in India. Regarding Pfizer acquisition of additional stake, the analyst said that it is a part of its worldwide consolidation of its activities. The acquisition of Wyeth and raising its stake in India are just signals of this strategy. At present there are 13 pharma MNCs operating in India and listed on the Indian stock exchanges, which includes Ranbaxy Laboratories, a subsidiary of Daiichi Sankyo of Japan with effect from November 2008, Matrix Laboratories, a subsidiary of Mylan Inc. from January 2007 and Fresenius Kabi Oncology, which acquired major stake during August 2008 of Dabur Pharma. Daiichi is holding over 65 per cent in Ranbaxy, Mylan is holding 71.16 per cent in Matrix and Fresenius over 91 per cent in Fresenius Kabi Oncology Ltd. After acquisition of statutory stake, it is easy to delist the company from stock exchanges. Matrix management is now considering the delisting of shares from BSE and NSE and the trend is likely to continue.

Patent application for Tamiflu rejected on pre grant opposition from Cipla



Mumbai- The Delhi Patent Office has rejected the patent application of the California-based Gilead Science Inc for its anti-influenza drug, Tamiflu (oseltamivir phosphate), in favour of a pre-grant opposition filed by the Mumbai-based Cipla Ltd. The refusal of patent gives a green signal for Cipla to go ahead with their marketing operations of oseltamivir phosphate, it is learnt.The deputy controller of patents and designs, Delhi Patent Office, refused the application stating that the Gilead failed to furnish any supportive evidence for its claims on lengthy biological half lives, elevated potency, substantial oral bioavailability (more than 15 per cent) and clinically acceptable or absent toxicity compared to known compounds, by means of comparative data. The patent office opined that the description of the innovation provided by the company is ambiguous amounting to insufficiency and alleged that invention falls under section 3 (d) of the Patent Act 1970. The decision comes as a breather to the Indian companies including Cipla and Ranbaxy. The refusal of patent for Tamiflu even at the preliminary stage of filing clearly shows that the Indian generic companies can go ahead and market their oseltamivir phosphate product, said Varun Chhonkar, CEO with the Mumbai-based intellectual property consultancy firm, IP Feathers. Currently, oseltamivir phosphate is the only known drug that combats a bird flu infection in humans."There is few option for Gilead or Roche to go for an appeal on the rejection, as the decision has gone against the patent right at the initial stage of filing. The decision denies novelty to the particular basic drug compound and any Indian generic company can manufacture oseltamivir phosphate based on this," he averred.Roche Holding AG, which holds the manufacturing and marketing rights of Tamiflu worldwide, has sublicensed the Hyderabad-based Hetero Drugs to produce the drug thereby reducing the generic threat from the latter. The generic version developed by Hetero in 2003 was expected to be 30 to 35 per cent cheaper than Tamiflu, according to a claim made by the company in 2005. At present the country has stocked around nine lakh doses of Tamiflu, as per reports."After having considered all the circumstance of this case, representation for opposition, reply of the applicants, expert evidence in support of the applicants, written submissions and arguments in the hearing made by both parties and also my discussion and findings as mentioned above, I am of the opinion that the alleged invention as clamed is not only obvious to person skilled in the art and lacking in inventive step but also insufficient and ambiguous as described in the specification," states the official. Gilead has filed their patent application No 396/Del/1996 on 26th February 1996 as WTO application under section 5(2) of the Patents Act 1970 for the grant of product patent for their invention entitled carbocyclic compounds claiming the priorities of three US applications No 08/395,245, 08/476,946 and 08/580,567 filed on February 27, 1995, June 6, 1995 and December 29, 1995 respectively. However, the request for examination was filed with the Indian Patent Office on June 17, 2005, after the Patents Act 1970 was amended. Tamiflu is marketed by Roche in India right from 2005.

Pharma cos upset over delay in issuing minutes of DTAB meeting to SLAs

Mumbai- The drug manufacturers across the country are upset over the delay on the part of DCGI in issuing the minutes of the Drugs Technical Advisory Board (DTAB) meeting held early this year in which it has approved 44 out of the 294 controversial fixed dose combination (FDC) drugs. But even after months of the meeting, the DCGI is yet to issue the minutes of the meeting to the state licensing authorities (SLAs). The manufacturers are upset over the fact that inordinate delay in issuing a new directive to the SLAs are adversely affecting the industry, as they are not getting their licenses renewed by the SLAs in the absence of written communication from the DCGI office. In the absence of a formal letter, the SLAs are still following former DCGI Dr M Venkateswarlu's directive in October, 2007 in which the former DCGI had asked the SLAs to cancel the licenses of 294 contentious FDC drugs.It may be noted that the FDC issue is almost two years old and the drug manufacturers are annoyed over the SLAs continued refusal to renew licenses for their products in spite of the Madras High Court stay on the issue. In view of the court stay, the SLAs are not cancelling the already issued licenses and not withdrawing the products from the market, but their application for license renewal is returned asking the manufacturers to approach DCGI office in Delhi for new licenses which is very expensive. Part of the blame goes to the extremely slow pace at which the FDC issue is being handled by the new DCGI. There is apprehension among the manufacturers that if the present snail's pace continues, the FDC issue cannot be settled in the near future. Though the new DCGI, Dr Surinder Singh, after the initial dilly-dallying, has taken the initiative to resolve the vexed issue by calling a DCGI-industry meeting on July 14 last year, the delay in taking the follow-up action is irking the industry. Even though there was consensus on 138 of the total 294 contentious combination drugs way back in July last year, the DCGI did not issue any directive to the SLAs for allowing renewal of license of these combination drugs. The second DCGI-industry meeting held on October 1, 2008 decided to constitute an expert panel to screen the remaining 156 drugs. It was also decided in the meeting that the panel, headed by DCGI Dr Surinder Singh, will take up the FDCs in batches and finally report to the DTAB for final clearance. The first expert panel meeting was held on January 23 and 24. The panel, which examined 48 of the remaining 156 combination drugs, found most of them rational and referred to DTAB for final recommendations. The DTAB, which met on February 23, also found 44 drugs rational. Even though almost two months have passed, the DCGI is yet to issue any communications to the SLAs in this regard.

Common ethical code for sales promotion planned to check inducements to docs

New Delhi-A common ethical code of conduct for all pharmaceutical companies, instead of separate guidelines by different organisations for their members, is likely to be framed to check the increasing unethical trade practices in the name of sales promotions.

However, it may take final shape and can be implemented only after the ongoing elections. The Department of Pharmaceuticals has formed a panel, comprising representatives of different organisations, to work out the common code of conduct which will be binding on all companies, it is learnt.

A meeting convened recently by the Department Secretary, Ashok Kumar and attended by different pharma organisations and CEOs of member companies have decided to entrust the OPPI to take the lead in framing the common ethical code for marketing. A brainstorming session, involving experts and representatives of the industry, will be held by the end of May in Mumbai in the run-up to framing the code and the OPPI will compile the common code by obtaining guidelines from other associations.

The meeting is learnt to have discussed the different codes of conduct submitted by various associations as was desired in the first meeting in January. Pharma bodies like IDMA, IPA, OPPI and SPIC submitted their own set of codes for their respective members. However, the department was said to be keen on having a common code of conduct for all pharma companies in the country and strict adherence of it by all. The department also expressed keen desire for a suitable mechanism in this regard and hold quarterly review and deal with instances of misuse of promotional expenses.

The department took the initiative of holding the meetings on the subject of sales promotions after a series of newspaper reports exposed unethical trade practices by some pharma companies to induce doctors and the matter drew increasing concern from different quarters. The department wanted a mechanism for strict enforcement and wanted the associations to inform the public as to what steps were taken to remove the prevailing negative perception. It wanted all associations to adopt good standard operational procedures (SOP) by sharing the SOP prepared by the OPPI.

Pharma secretary Ashok Kumar, in the first meeting, wanted the companies to restrict their lavish spending as the extra promotional expenditure would have direct implications on the pricing of drugs and their affordability. Noting that it was creating an impression among on the minds of the public that such activities were carried out at their cost, he had warned that government would step in to check it and 'the industry will not find the measures to their satisfaction', if the associations did not set code for members. He also pointed out that the companies showed same promotional expenses in the case of both old and new products.

Scientists identify new genetic variants associated with increased risk of stroke

Maryland- Scientists have identified a previously unknown connection between two genetic variants and an increased risk of stroke, providing strong evidence for the existence of specific genes that help explain the genetic component of stroke. The research was funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health and by several other NIH institutes and centres.

The analysis of over 19,000 participants is published online on April 15, 2009, by the New England Journal of Medicine and will appear in print on April 23, 2009.

The genetic variants were discovered by analyzing the genomes of individuals from the CHARGE (Cohorts for Heart and Aging Research in Genomic Epidemiology) consortium. This extensive resource includes participants from the Framingham Heart Study, Atherosclerosis Risk in Communities study, Cardiovascular Health Study and Rotterdam Study.

"This study, which integrates longstanding observational trials such as Framingham with cutting edge genomic technologies, moves us closer to the era of personalized medicine," said NHLBI Director Elizabeth G. Nabel, M.D. "As we learn more about the role that an individual's unique genetic makeup plays in their overall health, we will ultimately be able to tailor care to better diagnose, prevent, and treat conditions such as stroke."

Stroke is the third leading cause of death in the United States and causes serious long-term disabilities for many Americans.

The research team included Sudha Seshadri, M.D., associate professor of neurology, and Philip A. Wolf, M.D., principal investigator of the Framingham Heart Study and professor of neurology, Boston University School of Medicine, and involved investigators from numerous universities. Supported by a grant from the National Institute of Neurological Disorders and Stroke (NINDS), Dr. Wolf has studied the risk factors for stroke in the Framingham Heart Study over the past three decades.

The researchers discovered that two previously unsuspected common genetic variants or single-nucleotide polymorphisms (SNPs, pronounced 'snips') were consistently associated with total stroke (all types) and ischemic stroke in white persons. The SNPs were located on chromosome 12p13 near the gene NINJ2, which encodes ninjurin2, a member of the ninjurin nerve-injury-induced protein family.

"Consistent with the discoveries from genome-wide association studies in many other common disorders, the risk of stroke associated with these SNPs is not sufficiently high to make an individual change their stroke prevention plan. However, the results will lead scientists to direct their attention to new, important biologic mechanisms and hopefully new treatments to prevent stroke," noted Walter Koroshetz, M.D., deputy director of NINDS.

The association of one of the genetic variants was replicated in two independent samples: North American black persons and Dutch white persons. The association held when the analyses were adjusted for systolic blood pressure, hypertension, diabetes, atrial fibrillation, and current smoking.

"This impressive report shows how the power of genome-wide association studies can be enhanced by pooling data from large, population-based studies that follow participants over long periods of time. It also underscores the value of replicating initial results in populations with different demographics," said National Human Genome Research Institute Acting Director Alan E. Guttmacher, M.D.

Genome-wide association studies (GWAS) are a relatively new tool that allow researchers to rapidly scan the complete set of DNA (a genome) of many individuals in order to find genetic variations, or misspellings, associated with a particular disease or condition. This technique has revealed numerous relationships between genetic variations and conditions such as type 2 diabetes, obesity, and heart disorders. GWAS are possible due to the completion of the human genome in 2003 and the International HapMap Project in 2005, the advent of powerful information technology, and the participation of thousands of study volunteers whose confidentiality is safeguarded.

"Discovering genes for stroke has been a challenge in part because there are many different types of stroke. These results provide strong evidence for a previously unknown gene that may predispose to stroke and suggests that more genes will be discovered -- improving our chances of reducing the toll from this important public health problem," said Christopher O'Donnell, M.D., M.P.H., senior advisor to the NHLBI Director for genome research and associate director of the Framingham Heart Study.

There are two major types of stroke. The most common kind, ischemic stroke, is caused by a blood clot that blocks a blood vessel in the brain. The second type, hemorrhagic stroke, is caused by a blood vessel that breaks and bleeds into or around the brain. Stroke causes permanent brain injury. Stroke survivors suffer from disability that varies from mild to extremely severe.

The research was funded by NHLBI grants and contracts and was also supported by the National Human Genome Research Institute (NHGRI), National Center for Research Resources (NCRR), National Institute on Aging (NIA), National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK), National Institute of Neurological Disorders and Stroke (NINDS), and the NIH Roadmap.

GSK to acquire Stiefel Labs for $3.6 billion


United Kingdom- GlaxoSmithKline plc (GSK) and Stiefel Laboratories Inc announced that they have signed an agreement to create a new world-leading specialist dermatology business.

Under the terms of the agreement GSK will acquire the total share capital of Stiefel for a cash consideration of $2.9 billion. GSK also expects to assume $0.4 billion of net debt upon closing. A potential further $0.3 billion cash payment is contingent on future performance. GSK's existing prescription dermatological products will be combined with Stiefel's and the new specialist global business will operate under the Stiefel identity within the GSK Group.

Andrew Witty, chief executive officer of GSK said, "As part of our strategy to grow and diversify GSK's business, we are continuing to make new investments through targeted acquisitions. This transaction will create a new world-leading, specialist dermatology business and re-energise our existing dermatology products. The addition of Stiefel's broad portfolio will provide immediate new revenue flows to GSK with significant opportunities to enhance growth through leveraging our existing global commercial infrastructure and manufacturing capability. We look forward to working with Stiefel to develop this exciting opportunity."

Charles W. Stiefel, chairman and chief executive officer of Stiefel, said, "The combination of Stiefel and GSK will create a leading company in global dermatology with a strong presence in the prescription, consumer and aesthetic skin health markets. Along with adding hundreds of marketed dermatology products, this deal will increase the value of Stiefel's unparalleled dermatology pipeline by expanding the customer base to which we will be able to offer these products. It also gives GSK access to one of Stiefel's greatest assets - its valued relationships and shared understanding with dermatologists around the world."

The new business will have a broad portfolio of dermatology products including Stiefel's leading brands: Duac, for acne, Olux E for dermatitis and Soriatane for the treatment of severe psoriasis. GSK's key dermatology brands include: Bactroban, Cutivate and recently launched Altabax.

Combined pro forma revenues for the calendar year ended 2008 were approximately $1.5 billion, representing an 8 per cent share of the global prescription dermatology market. Sales of Stiefel's products for the calendar year ended 2008 were approximately $900 million. Sales of GSK's prescription dermatology products were approximately $550 million.

The new business will have a robust development pipeline, with Stiefel currently having more than 15 projects in late-stage development across a wide variety of dermatological conditions, such as acne, dermatoses and fungal infection. The new business also has access to significant innovative and proprietary formulation technologies.

Charles Stiefel will continue in the role of CEO and chairman of the board of Stiefel until closure of the transaction and he will lead the new business thereafter.

The formation of the new business will provide significant opportunities for both sales and cost synergies. Stiefel's products will benefit from GSK's global distribution and commercial organisations, particularly in markets such as Brazil, Russia, India, China and Japan. GSK's products will benefit from Stiefel's specialty sales force, relationships and experienced management in dermatology.

Cost synergies for the new business are expected primarily from combining manufacturing and administrative functions. The companies expect to deliver annual pre-tax cost savings of up to $240 million by 2012 with integration costs of approximately $325 million over the next three years. These integration costs will be reported within the middle column of GSK's income statement together with other ongoing major restructuring costs. Excluding integration costs, the transaction is expected to result in minor earnings per share (EPS) dilution for GSK in 2009 (less than 1%) and to be 1-2 per cent accretive to EPS in 2010.

The transaction has been approved by the Stiefel stockholders. Closing of the transaction is conditional upon certain matters including receiving certain regulatory clearances and no material adverse change occurring in respect of Stiefel's business prior to closing. The transaction is expected to close in the third quarter of 2009.

Stiefel Labs is enthusiastically committed to advancing dermatology and skin science around the world. The company's deeply-rooted dedication and drive for innovation along with its sole focus on dermatology has led Stiefel to become the largest independent dermatology company in the world.

Centre to talk MNC pharma cos into keeping a check on prices

NEW DELHI: A government move to regulate prices of patented medicines imported and marketed in India by multinational drug-makers may come as a big

relief to those suffering from diabetes, arthritis, cancer and heart diseases.

The proposed mechanism, whereby prices will be regulated in consultation with the drug marketers, is currently being finalised, said a senior official who didn’t want to be named. “After negotiations with the government, companies will sell imported drugs at two different prices—one for bulk medicines sold to the government-run hospitals and the other for the retail market,” he said.

“Forced pricing may lead to shortage of imported drugs and free market would mean these drugs will not be affordable for the poor. Therefore, we decided to arrive at a price through negotiation,” he said.

An official in the department of pharmaceuticals confirmed the move saying the government has called for a meeting on Monday with all the stakeholders, including multinational drugmakers, consumer organisations and patient groups.

While the National Pharmaceutical Pricing Authority (NPPA) regulates prices of all notified drugs sold in the country, the government finds it difficult to keep a check on prices of imported medicines even if they are under price control. Imported brands often circumvent price control norms as the pricing authority has no means of verifying their production cost. To determine the cost, the NPPA relies on MNCs’ version of the production cost and sets profit margins as a percentage of their landed costs. As the margin is decided in percentage terms, raising the landed cost helps MNC drug companies get a higher margin.

The move is expected to benefit consumers as big pharmaceutical companies launch their patented medicines in the country at high prices and with a 20-year patent protection, resulting in monopoly pricing. The proposed pricing mechanism for patented drugs would ensure that essential medicines are affordable for the common man.

A panel chaired by Pronab Sen had first suggested price negotiation for monopoly drugs. The ministry of chemicals and fertilisers appointed a high-level government committee in February 2007 to look into high cost of new medicines in the country.

The committee, chaired by a deputy secretary in the department of pharmaceuticals, comprises representatives from the National Pharmaceutical Pricing Authority, department of industrial policy & promotion, National Institute of Pharmaceutical Education & Research and the Drug Controller General of India.

Indian vaccine cos want a slice of US pie

MUMBAI: Indian vaccine makers are setting their sights on tapping the growing US market after the Obama administration committed $300 million for

implementing immunisation programmes in the country. Companies like Bharat Biotech, Serum Institute and Biological E, regular suppliers to World Health Organisation’s (WHO) vaccines programmes, are now looking at entering the US market — it represents the largest market for human vaccines with sales of $6.9 billion for 2007.

All the vaccine makers in the country have been selling their vaccines the world over, but have left developed markets like the US and Europe untouched.

Adar Poonawalla, executive director (operations) at Serum Institute, told ET: “We don’t have a presence in the US, but we do intend to enter the market in the next 2-3 years. The US market is tricky and has spelt bad news for a lot of pharma companies because of the lawsuits and the high entry barriers. The barriers are less in the vaccine space.”

Hyderabad-based Bharat Biotech, whose rotavirus vaccine (116E) is entering phase 3 clinical trials, feels it would be a great opportunity for Indian vaccine makers to enter the US market. Sai Prasad, vice-president (business development) at Bharat Biotech said: “We also have plans to enter the US market in the next 2-3 years. The vaccine allocation by the government could be a good thing, but it would depend on the specific vaccines the US govt would be procuring, and if these vaccines manufactured by Indian vaccine makers are licensed for sale in the US.”

The Section 317 program, under which this falls, provides funding for immunisation operations and infrastructure necessary to implement a comprehensive immunisation program at the federal, state, and local levels. Some of the vaccines that are covered under the US government’s immunisation program include those to treat Hepatitis B (HepB), Rotavirus (Rota), Diphtheria and tetanus toxoids and acellular pertussis (DTaP), Haemophilus influenza type b conjugate (Hib), Pneumococcal, Influenza, Measles, Mumps, and Rubella (MMR), Varicella, Hepatitis A (HepA), Meningococcal, Inactivated polio virus (IPV) and Varicella.

After Ranbaxy, FDA finds gaps at Cipla


The US Food and Drug Administration (FDA) has found nine deviations in Indian drug maker Cipla’s manufacturing process during a recent

inspection of the company’s Bangalore plant. The Mumbai-based company, however, said the deviations are minor ones relating to manufacturing practices.

“The deviations are of a routine minor nature, suggesting need for improvements in good manufacturing practices
(FDA’s drug manufacturing quality standards). One of the nine deviations is related to incorrect data entry,” a Cipla spokesman said. He said the company has taken immediate steps to correct deficiencies, and will mail a formal response to FDA within the stipulated 30 days.

The US drugs regulator refused to comment on the issue. “FDA does not comment on ongoing investigations,” said FDA spokesman Christopher Kelly in an email response.

FDA periodically inspects plants approved by it, in the US and in other markets, to ensure that drugs made at these facilities are safe to be sold in the US. For Indian plants, the FDA usually makes a biannual inspection. Industry experts said the development is not a matter of immediate concern. “The FDA has merely pointed out deviations which happen even with the case of global pharma majors. But if Cipla fails to address the issues, it could invite a warning letter, followed by harsher action,” said a Mumbai-based analyst with an investment bank, who asked not to be named.

Harsher steps from FDA could even mean freezing of new approvals from the plant. But Cipla’s US sales are small, unlike the case of other large Indian drug makers that are dependent on the US market for bulk of their revenues.

In September last year, FDA had banned 30 Ranbaxy drugs, which are manufactured at two of its plants in India. A month later, the regulator issued a warning letter to Caraco Pharmaceutical, Sun Pharma’s American subsidiary, and has also halted approval of new drug applications from its Detroit facility. In November, the agency found 15 manufacturing deficiencies at Lupin’s plant in Madhya Pradesh.

The domestic industry is divided on FDA’s actions against Indian companies in recent times. “FDA is now tightening its scrutiny of all overseas plants, as imports of generics have significantly increased over the years. India being one of the largest exporters of low-cost drugs to the US, it’s natural to have more inspections of domestic companies,” an industry official said, requesting anonymity.

However, some say FDA’s action may have been influenced by global innovator companies. “The business of global innovator companies is clearly threatened by the increasing exports of low-cost quality drugs from India,” said an industry veteran, who asked not to be named.

Last year, while defending Ranbaxy, Indian health ministry officials had said American drug companies were behind FDA decision to ban the firm’s 30 drugs.

Indian pharma industry may gain $18.4 bn from global mkt



With the global pharmaceutical market likely to witness products worth 123 billion dollars loosing patents by 2012, the generics driven

Indian drugs industry could get benefit of around 18.4 billion dollars (about Rs 91,576 crore) from those products.

According to a report of an inter-ministerial task force headed by a Joint Secretary of the Commerce Ministry, at a conservative estimate of 15 per cent opportunity, India can garner 18.4 billion dollars of all the drugs that would go off patent in the next three years.

"Approximately $ 123 billion worth of products are at risk of loosing patents by 2012. Even at a conservative estimate of 15 per cent opportunity, this translates into 18.4 billion dollars opportunity for India," the report said.

To cash in on the opportunity, it said intense science, good understanding of patents and manufacturing to the stringent requirements of access regime are key requirements for future success.

Generic drugs are copies of branded products which have lost their patents and comes at much cheaper price.

According to Pharmaceuticals Exports Promotion Council, total exports in December surged by 46.3 per cent to 1.01 billion dollars from 609 million dollars in the same month of the previous fiscal.

The overseas sales in the first nine months of 2008-09 went up by 21 per cent to 8.44 billion dollars against 6.97 billion dollars in 2007-08.

India's main pharma export destinations are the US, Europe, South Africa, Brazil and Canada.

The report further said that India and China could potentially account for 35 per cent to 40 per cent of the outsourced market share for active pharmaceutical ingredients, finished dosage formulations and intermediates.

Adcock's plan to buy Medpro hits Cipla hurdle



NEW DELHI: South African company Adcock Ingram’s plans to buy Cipla Medpro, with whom Indian pharma major Cipla has a 20-year drug-supply agreement, has run into trouble with the Mumbai-based company opposing the $228-million takeover.

Cipla’s joint MD Amar Lulla told ET: “The drug-supply agreement allows us to terminate the supply programme if there is a change in the management. We oppose the takeover by Adcock. We will exercise all options, including legal process.” He added that Cipla can also change the registration of the drugs currently being supplied to Cipla Medpro and instead sell the same drugs independently.

When contacted, Adcock CEO Jonathan Louw said: “Adcock has not had any formal response from Cipla India since making its formal offer to Cipla Medpro. We remain convinced that the strategic rationale for the deal is compelling and is in the interest of all shareholders, Cipla Medpro, and Cipla India.

It is Adcock’s preference to have the support of Cipla India, particularly with respect to continuing supply of pharmaceutical product from Cipla India, and we will look forward to engaging the Cipla India board in this regard over the coming weeks.”

He added that while the transaction is currently conditional on Cipla India confirming the continuation of the supply agreement, as it has been disclosed to the public, this condition may be waived off by Adcock. Mr Louw said that Adcock has received support from almost 35% of Cipla Medpro’s shareholders, namely Stanlib, Allan Gray, Sanlam Investment Management, Visio Capital and RMB.

Mr Louw said the company has not done due diligence of Cipla Medpro, and therefore, cannot comment on the financial impact if Cipla chooses to terminate the supply agreement.

Last week, South Africa’s second-largest drugmaker Adcock Ingram announced that it plans to buy Cipla Medpro at 4.75 rand per share, a 36% premium over the previous day’s closing price. Cipla has no equity in Cipla Medpro, which is one of South Africa’s top 10 pharma firms and has a $100-million turnover, but has a 20-year agreement to supply key mainly HIV drugs which expires in 2025.

The acquisition would have allowed Johannesburg-based Adcock to control a quarter of the South African market. Adcock Ingram has a partnership with Bangalore-based Medreich for the past seven years. It formed a manufacturing JV in Bangalore 18 months ago, to manufacture OTC products for the South African and African region.

Acetic anhydride seized from AI plane


NEW DELHI: In what could be a major embarrassment for the government here, Afghanistan has seized 210 litres of acetic anhydride, used for processing heroin, from an Air India flight that took off from New Delhi.
The quantum of the seized chemical is enough to produce more than 200 kg of heroin. Acetic anhydride is used to refine opium into high-grade heroin, which is pushed into international market and the proceeds used for funding Al Qaida and Taliban.
The seizure from India's official carrier, which was made on March 22, led the Hamid Karzai government to lodge a strong protest with India, sources said. For the contraband to reach Kabul on board India's official carrier is puzzling because the narco smugglers behind the operation managed to get past surveillance agencies, which had been alerted against the strong possibility of such an operation taking place.
Afghanistan had, just a month ago, alerted New Delhi to take preventive steps to ban export of the chemical as there was no legitimate use of the chemical in the war-ravaged nation.
Based on Kabul's request and an advisory from the UN's International Narcotics Control Bureau, the government had issued an alert on March 6 to all its intelligence and anti-narcotics agencies to check any diversion of the chemical to Afghanistan.
The seizure has also raised questions about the security apparatus as a whole, with authorities grappling with the fear of collaboration of government functionaries.
A high-level investigation has since been initiated here involving ministries of external affairs, home and finance. The role of Customs personnel, besides those belonging to RAW and IB — tasked with keeping a watch on narco smugglers operating from India —are under the scanner.
For India, which is involved in an extensive rebuilding effort in Afghanistan, the seizure comes as a major setback considering that a large part of Afghanistan under Taliban control has been under opium cultivation and part of the proceeds goes into funding of Al Qaida and Taliban.
Opium cultivation in Afghanistan this year has been to the tune of 7,700 tonnes of which nearly 725 tonnes of heroin, worth more than Rs 7 lakh crore in European market, is estimated to have been manufactured, largely in areas under Taliban control.
In fact, one of the reasons of US's unhappiness with the Karzai government is its inability to crack down on narco trafficking amid rising suspicions that the kin of the Afghan president, particularly his brother, was involved in the drugs trade.
Sources said initial investigation had revealed that the consignment, masquerading as pharmaceutical goods, had been booked from Mumbai. Reports coming in suggest no official export of the chemical had been allowed to Afghanistan this year.
The role of Narcotics Control Bureau (NCB), the nodal agency under the home ministry monitoring production, distribution and consumption of precursor chemicals, has also come in for scrutiny as in the last one year alone, at least 2,000 litres of acetic anhydride had been seized by different agencies across India.
The leakages hinted at alleged involvement of manufacturers as the individual annual requirement of a majority of pharmaceutical companies within India is much below the quantity seized by agencies.
The UN Office on Drugs and Crime is currently running Operation Tarcet to target smuggling of precursor chemicals into Afghanistan which supplies more than 90% of the world's heroin and is considered as a source of funding for terrorists.

Thursday, April 16, 2009

Ranbaxy may take Rs 2,500-cr m-t-m hit on forex contracts

Ranbaxy Laboratories, India’s largest drugmaker by sales, may be sitting on mark-to-market (MTM) losses of over Rs 2,500 crore on foreign currency

derivatives transactions entered into with various banks, according to estimates by one of its lenders in February this year.

With this lender alone, the company is running an MTM loss of Rs 600 crore on the derivatives contracts it had signed in April-May 2008. A Ranbaxy spokesperson declined comment when contacted by ET.

However, Ranbaxy is not the only company that has been hit by forex derivatives losses. The losses have cut across sectors. According to rating agency Fitch, India Inc’s estimated MTM losses on forex derivatives transactions are in the range of $4-5 billion.

Within the pharma sector, other companies such as Wockhardt, Orchid Chemicals, Cipla, Biocon and Jubilant Organosys have suffered extraordinary losses either in the form of translation losses on their foreign borrowings, hedging losses or MTM losses on foreign currency convertible bond (FCCB) issuances.

In case of Ranbaxy, sources close to the development have told ET that the drugmaker entered signed “forex options strips” contracts with the foreign bank for hedging its dollar receivables from exports for a period of eight years. A strip is like a series of options maturing on certain dates over a period of time, usually with a specified frequency. These contracts have to be settled on a monthly basis and monthly settlements with the bank started in June 2008.

When these deals were struck, the dollar/rupee exchange rate was at Rs 39.90. Ranbaxy’s forex dealers took a view that the rupee would appreciate further against the dollar and hedged its dollar receivables at an exchange rate of Rs 43.50 to the dollar at a leverage of 1:2.5. The contract stipulates that Ranbaxy delivers $1 million (out of its exports) at Rs 43.50 if the exchange rate is below Rs 43.50. Therefore, even if the dollar is trading at Rs 39, the drugmaker would collect Rs 43.50 for every dollar.

But the flip side is that if the dollar exceeds Rs 43.50, Ranbaxy delivers $2.5 million every month for a period of eight years at Rs 43.50. With the dollar quoting at Rs 50 currently, the leverage clause has been triggered, resulting in a huge MTM loss for the company.

It is not unusual for exporters to enter into options contracts to manage exchange rate risk. In a simple options contract, an exporter who expects the dollar to fall against the rupee buys an option from a bank by paying a small premium. The option allows the exporter to sell its dollar receivables at a pre-determined rupee price.

In case the dollar rises, all that the exporter loses is the premium paid for buying the option, which is set off by the gain that the exporter will make due to the dollar’s rise against the rupee, because the exporter can earn more rupees for every dollar it sells in the market.

Complications on these deals arise, when exporters start selling options to banks. In this case, Ranbaxy bought “put options”, the right to “sell” dollars to the bank at a pre-determined exchange rate, and sold “call options” to the bank, giving the bank a right to “buy” dollars from Ranbaxy at a pre-determined exchange rate.

Since the dollar has risen, contrary to what Ranbaxy expected, the bank is now exercising the “call options” at Ranbaxy’s peril, resulting in losses. Ranbaxy declared a loss on fair valuation of derivatives of Rs 784 crore in its results for the September-December quarter of 2008.

Pharma cos have it tough this quarter

The pharma sector is expected to be an underperformer during the fourth quarter of FY09. The growth in revenues and earnings is likely to be lower

than that observed in the previous three quarters of the fiscal.

High base-year effect for some companies, delay in US FDA approvals, lower demand in the exports market, increase in the receivable days and high interest cost for companies in debt are likely to adversely affect companies’ profits. Some respite is likely to come from the rupee depreciation of around 5% and easing off of raw material costs. With AS11 no longer mandatory, drug makers are not expected to report MTM loss on their foreign exchange borrowings.

Average estimates of leading seven pharma companies by ETIG and five brokerages indicate 43% drop in net profits during the quarter ended March 2009, against the corresponding quarter in the previous year. Revenues are expected to increase by a modest 6% y-o-y. The net profit margin is estimated to drop by 957 bps to 11.4% for the quarter ended March 2009.

While Ranbaxy is estimated to report a loss due to its ongoing issues with US FDA, companies like Sun Pharma, Piramal Healthcare and Dr Reddy’s are likely to report a significant drop in their profits. In absence of exclusivities that were enjoyed during the fourth quarter last year, Sun Pharma is likely to report a drop in revenues and earnings. DRL’s profits are likely to be dented on account of writeoffs by its German subsidiary. Piramal Healthcare is expected to report a drop in profit due to one-time writeback of NCE research expenses in Q4 FY08.

While the pricing pressures in overseas markets of Europe and North America continued, the quarter also witnessed increase in US FDA’s scrutiny of the regulatory compliance practices followed by domestic pharma companies. Many Indian companies are now facing increased inspection and enquiries by the US healthcare agency.

The quarter ended March is the fourth quarter for most pharma companies. Hence, the companies would try to put their best figures forward. While the demand at the retail level is under pressure, it may not be immediately reflected.

This is because companies have pushed up their primary sales at the stockist level. The current quarter ended June may show a better picture of the demand strength in the domestic and export market. Nevertheless, Sun Pharma, Cipla, Cadila Healthcare, Piramal Healthcare and Lupin are companies to look out for.


According to critics like All India People’s Science Network secretary Amit Sengupta, the government move is too little too late.

The government relaxed earlier laws to allow clinical trials of drugs developed in foreign countries and now Indians are treated as guinea pigs to promote clinical research organisations who are sub-contractors of foreign multinationals, he said. “In this background, if the government wants to safeguard public interest, this is bolting the door after the horse has run away,” Mr Sengupta said.

Experts also say very few pathology laboratories in India follow good laboratory practices and the data they generate are often fake. There is also a lack of adequate infrastructure and expertise for conducting clinical trial

Unethical clinical trials may invite painful penalty

NEW DELHI: The government plans to amend the Drugs & Cosmetics Act to slap up to 10 years’ imprisonment and cancellation of licence for

violating norms for testing drugs on humans in India, a government official said.

“The new set of guidelines would ensure that those who do not follow the norms approved by the Drug Controller General of India (DCGI) for conducting clinical trials on humans are brought to book and punished,” Dr Vishwa Mohan Katoch, secretary in the department of health research and director general of the Indian Council of Medical Research (ICMR), told ET.

The move comes in the wake of the drug regulator’s failure to take action against several companies even after finding gaps in their clinical trials during audits, due to the absence of legal provisions.

The proposed guidelines for conducting clinical trials of experimental drugs in India, framed by ICMR, have been approved by the ministries of law and health. The move is intended to improve the country’s image in this area, which has been sullied by some cases of alleged unethical and sub-standard practices.

India has become a hub for clinical trials of drugs with a clinical research market estimated at $389 million, which is forecast to touch $1 billion by 2010.

Having a tough, credible regulatory set-up is crucial to enable the growth of this industry while protecting the rights of Indians who volunteer to become test subjects.

India does not allow Phase 1 trials, or initial experimentation on human subjects after a drug is found effective on laboratory animals, for molecules developed abroad. This prevents Indians from being the initial guinea pigs for foreign drug companies.

Recently, DCGI conducted the first audit of a clinical trial for Wyeth’s advanced pneumonia vaccine after an infant’s death was reported during the trial last October. It turned out that the child had been administered not the experimental vaccine but an already licensed, widely distributed vaccine in the double-blind study.

But the child should not have been enrolled in the study at all on account of a cardiac condition it suffered from, the drug regulator’s audit had found.

However, in the absence of legal provisions, the regulator is still weighing future action in this case.
In another incident last year, 49 children died during clinical trials at the country’s premier medical institution All India Institute of Medical Sciences. Later, a high-level committee found that none of the drugs had been tested on healthy children and rather they were suffering from high-risk illnesses and were also in a serious condition.

“Even as the DCGI prescribes certain protocols while allowing any company to conduct clinical trial, it does not have statutory powers to punish companies that do not follow these guidelines or violate any norms,” said a health ministry official who asked not to be named.

The most important part of these guidelines is that the person undergoing the experiment is informed about the risks involved while giving consent. The norms also specify the eligibility of a human subject to participate in the experiment.

The health ministry now plans to bring in a separate provision in the Drugs and Cosmetics Act to deal with offenders to check unethical human experiments in India.

So far, India has established only voluntary guidelines for testing experimental drugs on humans. Drugmakers as well as companies which do such experiments for a fee may choose to register themselves with the ICMR or with the World Health Organisation (WHO). But this is not yet mandatory.