Drugs

  • In The Pink Of Health

    R&D is a fast evolving segment of Indian pharmaceutical industry. Innovation, international partnerships, collaborations, inflow of funds, clinical trials partnerships and co-development deals are changing the landscape of R&D. However, the potential is far greater and to aid the harnessing of this potential, the Times Group organised the ET Bio-Pharma Development Summit in Mumbai. Dr Swati Piramal, director, Nicholas Piramal, was the chairperson of the forum, with the keynote speaker being Dr Ted Bianco, director, Wellcome Trust. The highlight of the event was the special address delivered by Kapil Sibal, union minister for science and technology and earth sciences. Dr Piramal delivered the opening address to a house full of delegates. She highlighted the need of innovation in R&D and how India can excel in the same. Her address was followed by an interesting speech made by Dr Ted Bianco, director, Wellcome Trust, UK. He provided an insight into early stage R&D through translational research funding and management of intellectual property arising thereafter. Then, it was time for Mr Sibal's speech. He termed the new disease pathogens the terrorists of the 21st century and said there was an urgent need to safeguard public health. He also made a strong case for growth of R&D in case of Indian pharmaceutical industry and how it could be harnessed in India to provide affordable cure. The minister stressed on the need for a forward-looking drug policy and government subsidies to boost innovation in the country. Malvinder Singh, MD and CEO, Ranbaxy Laboratories, the speaker for the second session, gave a address on the future of generics. He informed that the global bio-generic industry was worth $60 billion today. Indian pharma industry can capitalize on this opportunity and grow to become $100 billion industry in the coming years. He pointed out that having 50 NCEs being produced by 15-20 companies is not economically sustainable. Industry needn't duplicate infrastructure as it would be feasible to unite through partnerships and collaborations, he said. He also stressed upon the need for an enabling regulatory framework, which moves away from the price control regime. He pointed out that at present, R&D done internally by the companies alone qualified for weighted deduction under section 35(2AB) of Income tax act. He urged that the government to facilitate innovation by extending this benefit to outsourced R&D as well. The third session was a panel discussion providing an HR perspective on strategies for human resource management. Dr Ganesh Shermon, partner & country head, human capital advisory services, KPMG India, Rajorshi Ganguli, director, HR, Dr Reddy's Laboratories, Sanjay Muthal, president, HR, Nicholas Piramal and Shiv Raman Dugal, chairman, Instiute of Clinical Research of India, were the distinguished speakers forming the panel. Various strategies needed to drive excellence in research and cross-functional areas were discussed. The next session emphasising on what's next in Indian bio-pharmaceuticals was moderated by Utkarsh Palnitkar, national head of health and science industry, Ernst & Young, India. One of the speakers - Dr Ramani Aiyer, chief scientific officer, Actis Biologics - highlighted the new trends in bio pharma. He also delved into the concepts of angiogenesis, gene therapy, recombinant proteins and follow-on biologics. Kavita Khanna, president, Bharat serums & Vaccines, was the next speaker in the session and gave her views on the way forward in publicprivate partnerships. She presented a case study on 'Kala Azaar' (Leishmaniasis), to explain how public private partnership was being proposed to eradicate the disease by 2010. Adnan Naseemullah, a student of university of California, Berkeley, was one of the invitees to the session. He spoke about the growth and development of the Indian pharmaceutical industry and highlighted the variations in research strategies followed by the industry. The post lunch session was a two-speaker special session held by Dr S K Gupta, dean and director, Institute of Clinical Research of India (ICRI) and Dr Anand Bidarkar, VP, Siro Clinpharm India. They delved into the various clinical research strategies to maange research and development in India. Dr Gupta provided the statistical data on the infrastructure which is available for clinical research in India and how can India emerge as a world-class destination for conducting quality clinical research. Dr Bidarkar explained how MNCs were taking advantage of Indian clinical R&D to shorten their drug development timelines. He also highlighted how Indian companies could look at outsourcing to overcome their competitive disadvantages. The concluding session of the day was the CEO round table. Presided by Dr Piramal, with Pratibha Pilgaonkar, CEO, Rubicon Research, Dr Naveen Rao, MD, Merck India and Dr Ajit Dangi, president and CEO, Danssen Consulting, being the other participants in the discussion. Dr Piramal posed various questions to the panel relating to scope of R&D in India, possibility of doing a Nano in pharma and cost of innovation. Dr Naveen Rao, MD, Merck India, expressed the need for big pharma companies to look at India and its cost-effective resources. He also stated that partnerships offered an attractive method of risk and reward sharing. Ms Pilgaonkar pointed out that SMEs in Indian pharma industry at an early stage need the support and funding from big players in the industry to become agents of research and innovation. Dr Dangi stressed on the need for world class intellectual property (IPR) regime, lowering of transaction costs and a liberal price policy in the country. Strengthening of the infrastructure of Drug Controller General of India, approval of various protocols for clinical trials, framing of laws on cloning and neutraceuticals were other issues discussed by the panel discussion. Dr Piramal projected that by 2010, India would have discovered at least five new drugs . Her personal bet on the cost of innovation of a new drug in India stood at less than $50 million. The session concluded after a question and answer session where the audience put forth their questions to the panelists.

  • MNCs' diabetes drug patents worry experts

    Even as India is fast turning into the diabetes capital of the world, multinational drug companies are busy patenting new-generation diabetes medicines for exclusive marketing rights in the country. The Indian Patent Office has already awarded patents to at least three such products, say patent experts. Though the immediate impact of the patent protection to such drugs is not known, experts say prices of diabetes medicine has a long-term economic significance due to the fast-growing diabetic population of the country. Official estimates predict the number of diabetics in India to be 3.77 crore by 2010 and 4.58 crore by 2015. "Considering the World Health Organisation (WHO) estimates for Indian diabetic population, patenting of these drugs are sure to have significant impact on the diabetic population,' Varun Chhonkar, a Mumbai-based intellectual property consultant said. In February, a patent was granted (the most recent grant of such patent) to Swiss drug major Novartis for Vildagliptin, an anti-diabetic compound. Vildagliptin is the second drug in the class of dipeptidyl peptidase IV (DPP IV) inhibitors to reach the market. The first one was Merck's Sitagliptin which also received an Indian patent in December. Globally marketed as Januvia, Merck's Sitagliptin recorded $668 million in worldwide sales in 2007 and is projected to reach $2 billion by 2011. In June, Bristol-Myer had received an Indian patent for its Saxagliptin, a likely global blockbuster diabetes drug. "The drug companies will have to make medicines affordable to Indian patients. I have suggested Merck to have an India specific pricing for Januvia as the prices they charge in the US, $5 for a pill, may not be affordable for majority of our patients. Diabetic patients often have multiple medical complications and will have to take other medicines also, thereby making treatment very costly,' A K Jhingan, chairman, Delhi Diabetes Research Centre, said. According to World Health Organisation estimates, the projected number of diabetic patients in the next decade globally will exceed 20 crore. India had 3.2 crore diabetics in 2000 and might touch 8 crore by 2030, it has pointed out. The International Diabetes Federation (IDF) has also reported that the total number of diabetic subjects in India was 4.1 crore in 2006 and would rise to 7 crore by 2025. It should be noted that the chemicals ministry, the administrative ministry for the pharma sector, has constituted a committee to recommend a scheme for price negotiation of patented medicines to make such new generation drugs cheaper in the country.

  • Sun Pharma challenges J&J's drug patent

    Mumbai-based Sun Pharmaceuticals has filed a post-grant opposition with the Mumbai patent office against a product patent granted to the extended release version of Johnson and Johnson's (J&J) blockbuster drug Risperdal, used in the treatment of psychological disorders and schizophrenia. Risperdal, with the molecular name risperidone, is the second-largest selling drug of Johnson and Johnson with over $4.5 billion worldwide sales in tablet, injection, syrup and orally dispensable forms. It is also one among the largest selling psychiatric drugs, according to sources. Sun Pharma has been marketing a generic version of this drug for the last few years in India under the brand name Sizodone, according to company sources. The patent on Risperdal, granted in February 1986, will expire in the US on June 29, 2008. The Indian patent was for an extended release version and this had not been patented in the US, said patent experts having knowledge of the development. Patent wars Swiss drug maker Roche's anti-cancer drug, Pegasys, was given a patent in India in 2006 and this was challenged by Wockhardt and a Mumbai-based non-governmental organisation, Sankalp. Generic drugmaker Cipla is battling in the Supreme Court to revoke a patent granted in February 2007 to Roche's cancer drug Tarceva. Another patent granted to Roche's anti-HIV drug, Valganciclovir, is also being challenged in the court by Lawyers Collective, a Mumbai-based NGO, and Cipla. According to the Indian Patent Act, which was amended in 2005, a product patent that bars other companies from copying the drug for generics, can be challenged within one year. The Mumbai patent office granted a patent to Janssen Pharmaceutica, a group company of Johnson and Johnson, on July 20, 2007, with patent number 208191, against its mail box application number 188AL/1995. The patent related to sustained-release particles of risperidone, said sources. Company sources declined to reveal the sales figures for the drug in India. "We don't comment on litigations and patent-related issues as a matter of policy,' said a Sun Pharma spokesperson. Interestingly, Dr Reddy's Laboratories and US-based Mylan Laboratories were among the first to challenge the patent on Risperdal in the US, where the drug has sales of over $2 billion, said sources. "Since the product patent regime was introduced in India in 2005, we estimate that more than 150 product patents have been granted and over 90 per cent of this is for multinational pharmaceutical companies. So far, very few products have been opposed by Indian companies, according to our knowledge,' said Varun Chonkar, a patent expert. He said the Indian patent office was yet to officially announce data on the number of patents granted and challenged in India.

  • Risks of Anemia Drugs for Patients With Cancer to Get More Scrutiny

    With federal drug regulators planning another meeting on Thursday to weigh the safety of widely used anemia drugs, Dr. Athanasius Anagnostou resists any urge to say "I told you so.'

  • Panel Seeks New Limits on Anemia Drugs

    AnemiaA federal advisory panel, in response to mounting safety concerns, called on Thursday for additional restrictions on the use of anemia drugs by cancer patients.

  • Food Drug & Toxicology Research Centre

    The food safety, GM foods and pre-clinical toxicity testing of drugs are the important activities of FDTRC. The Centre also investigates the food borne disease outbreaks and identifies the causative factors.

  • Drugs and Cosmetics Act, 1940

    An Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics. This Act may be called the Drugs and Cosmetics Act, 1940.

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