NEW DELHI: India’s drug regulator has given approval to three domestic biotech firms to start tests and analyses to develop a vaccine for swine flu,
or the H1N1 virus, which killed hundreds across the globe this year, subsequently classified by the World Health Organisation as a “pandemic”. Bharat Biotech, Panacea Biotech and Serum Institute will now be able to procure seed strains from labs in the US and UK, but will have to follow the strict bio-safety standards mandated by the Drugs Controller General of India (DGCI). Novartis AG had claimed last month that it has successfully produced the first batch of vaccines for the virus, but the global markets are yet to see a product. The WHO had recently said that a fully licensed swine flu vaccine might not be available until the end of the year. In India, however, producing the vaccines may take more time. “We have given approvals to three Indian companies to get seed strains from the US-based Center for Disease Control and the UK-based National Institute for Biological Standards and Control (NIBSC) to start preliminary research,” DCGI Dr Surinder Singh told ET. According to Dr Singh, the domestic companies are expected to take at least six months before they apply for an approval for the next stage of trials. Once the companies submit their preliminary test and analysis data, they will have to apply for potency test, pre-clinical trials and finally clinical trials before launching the medicine in the market. The WHO has said countries could use emergency provisions to get the vaccines out quicker if required. In India, the Drugs and Cosmetics Act (DCA) has a provision through which the government can allow relaxations in launching of a drug or a vaccine in the country if there is an emergency. However, such provisions are used only after weighing the risk and benefit ratio. At present, the government has no plans to evoke any such provision as there is no community-wide spreading of the virus reported in India, Dr Singh said. He added that by September, global companies might be able to roll out a vaccine in the country.