Foreign drug firms to conduct H1N1 vaccine trials in India

Dec 8, 2009, 11:24 GMT

New Delhi - Multinational pharmaceutical firms GlaxoSmithKline and Baxter have received approval to carry out human trials in India for their H1N1 swine-flu vaccine, news reports said Tuesday.

Since India reported its first swine flu case in May, more than 20,000 people have been affected by the virus and 627 deaths have been reported so far.

'GlaxoSmithKline (GSK) and Baxter have received approval from the drug controller of India to carry out human trials in India,' federal Health Ministry official VM Katoch was quoted as saying by IANS news agency.

Katoch, who heads the department of health research, said a bridge study with volunteers would be conducted to determine whether the medicines of the two companies were safe for Indians.

India has already placed orders for more than 1 million doses of swine flu vaccines from GSK and Novartis, but the government wants to ensure that the vaccines are absolutely safe before they are administered.

'We are trying to ascertain the safety factor. Whether they are toxic, paralysing or have any other side effect,' Katoch said. He added the human trials would be conducted by the pharmaceutical firms on volunteers at their own research centres.

Indian pharma firms are also in the process of developing indigenous swine-flu vaccines which are expected to be much cheaper than the international drugs. Katoch said these were expected to be ready by April 2010.