All the three Indian biotech players ? Serum Institute of India Ltd, Bharat Biotech and Panacea Biotec Ltd ? are now set to start human clinical trials after two of them received the Drug Controller General of India?s (DCGI) go ahead. The third one was scheduled to get the nod on Thursday. The three companies have got the initial seed virus from the World Health Organisation (WHO) for developing H1N1 vaccine.

While the DCGI?s office has already granted approval to Bharat Biotech and Serum Institute, Panacea?s application would in all likelihood have got approved by the drug regulator on Thursday. If the schedule of the companies remain undisturbed, they should be able to launch the vaccine by the end of March or latest by early April, according to confirmation that FE got from two out of the three players. ?If we get the DCGI approval now, we should be able to launch the vaccine by the end of March or start of April, provided all goes well,? Rajesh Jain, joint managing director, Panacea Biotec told FE.

The Pune-based Serum Institute, which is commencing phase-I clinical trial this week in Ahmedabad with a subject strength of 50, is also targeting first week of April for the launch of the vaccine. ?With the presumption that everything else falls into place we should be ready to launch the vaccine in early April,? said Rajeev Dhere, senior director, Serum Institute. He added in the interim period the company would be in regular touch with drug regulator?s office to fulfill all clinical trial related obligations. The WHO had shortlisted these three companies from India and supplied them the sample strain of H1N1 virus around July-August last year so that they could develop the small quantities of the H1N1 flu vaccine needed for animal trials.

However, the Ahmedabad-based Zydus Cadila became the first Indian company to get a clearance from DCGI office in December for conducting human clinical trial for the H1N1 vaccine. Subsequently, the company has begun the process of testing its vaccine on human beings and reportedly plans to do so in four locations across the country.

The DCGI?s office has also given approval to the French vaccine maker Sanofi Pasteur to conduct bridge study in the country to test the safety and efficacy of the vaccine on the Indian population. Similar permission has already been given to global players, UK-headquartered GlaxoSmithKline Plc (GSK) and US-based Baxter International Inc, which have already conducted their clinical trials in other countries and have since then rolled out their vaccines in other markets. Till Wednesday, the H1N1 virus had affected 27,985 people and claimed 1,098 lives in the country, according to the health ministry data. According to WHO?s latest weekly update posted on Friday, ?? worldwide more than 208 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 12,799 deaths.? It further alerts that the most active areas of pandemic influenza transmission currently are in parts of central, eastern and southeastern Europe, North Africa, and South Asia. ?In South Asia, pandemic influenza transmission remains geographically widespread and active across the subcontinent ? particularly in northern India, Nepal, and in Sri Lanka ? where an increasing trend in respiratory diseases activity was reported,? the WHO said.