Drugs

  • 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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