Source - ET Bureau

India may soon get its own vaccine for swine flu, or the H1N1 virus, that has killed hundreds across the globe this year. Three domestic  biotech firms — Serum Institute, Bharat Biotech and Panacea Biotech — have submitted their plans to launch the vaccine by March 2010, an official in the health ministry said. The companies have already started the preliminary research and they have submitted a detailed timeline for developing the vaccine to the drug regulator, he said, requesting anonymity.

The country’s top drug regulator Drug Controller General of India (DCGI) had allowed the three biotechnology companies to procure seed strains from labs in the US and the UK in July 2009. “One of these companies has made real progress and we believe by the end of this year, we will have something in hand,” Indian Council of Medical Research (ICMR) director general VM Katoch said.

According to Mr Katoch, Serum institute is planning to start immunogenicity tests on the vaccine in August itself and the animal toxicity tests will commence from November 2009. Panacea Biotech and Bharat Biotech have also submitted their plans to the ministry. ET first reported that drug regulator has given approval to three domestic biotech firms to start tests and analyses to develop a vaccine for swine flu.

Meanwhile, the government is also planning to fast-track the trials of the vaccine. “The phase I, which generally takes at least one month, may be completed in 14 days and we are planning to club phases II and III so that the vaccine can be launched at the earliest,” a ministry official close to the development said.

While the Serum Institute is developing an “egg-based” vaccine, the other two are developing “cell line vaccines”, Mr Katoch said. However, the companies refused to comment on the present status of the research of the vaccine. A company official from Panacea Biotech said that the discussions with the drug regulator are going on and the company will soon “make a presentation to the drug regulator to update on the development of the vaccine”.

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 companies have been asked to regularly brief the drug regulator and the government on the status of the research of the vaccine,” the ministry official said. The government is also considering to involve ICMR to conduct human trials of the vaccine to have more candidates to test the vaccine. “We do not want to compromise on the quality of the vaccine. ICMR’s participation will ensure that safety measures are taken care off,” the ministry official said.