Drugs with composition change need fresh approval

NEW DELHI: Drugmakers changing the composition of existing formulations to escape price caps will now have to come to the Centre for fresh approvals. In a move aimed at keeping a check on companies, which replace price-controlled ingredients with ones outside price control, the Centre has directed state drug regulators not to allow them to sell such drugs with their old brand names.  Instead, such drugs will be treated as new ones and the companies will have to go through the Centre’s scrutiny before it gets a fresh approval, a government official said. The move is significant as companies are now likely to think twice before they make any change in the existing composition and approach the Centre for a fresh approval. This would also mean that companies will have to subscribe to a new brand name. The decision comes in the wake of the National Pharmaceutical Pricing Authority (NPPA) seeking action from the Drug Controller General of India (DCGI) against companies that dodge price control by tweaking ingredients of medicines and then misguide consumers by retaining the original brand name. “We have been receiving cases from NPPA for sometime now where companies have altered the composition and retained the brand names. This amounts to misleading consumers. We have, therefore, asked all state drug regulators to treat such drugs as new drugs and not give approvals to sell under the same brand name,” DCGI Dr Surinder Singh told ET. According to Dr Singh, even though NPPA referred such cases to DCGI, it could not do much till now as companies seek approvals or licences to sell from the state drug regulators. “Now, we have classified such cases as new drugs and hence the companies will have to come to the Centre to get an approval where we can evaluate the efficacy of the ingredients,” he said. While NPPA had come across such cases during its survey, it could not do much as the medicines no longer remain under the price control ambit of the government. It has been referring such cases to DCGI. It has also written to DCGI to take appropriate actions against such violations. “Our mandate does not include keeping a check on such violations. All we can do is to bring them to the notice of DCGI,” NPPA chairman Dr AK Banerjee said.

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.