GLAXOSMITHKLINE (GSK) GETS GOVERNMENT NOD FOR HUMAN TRIALS OF SWINE FLU VACCINE

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THE government has decided to let Anglo-American drugmaker GlaxoSmithKline (GSK) conduct human trials of its swine flu vaccine here to make it available for patients by the year-end, director-general health services (DGHS) Dr RK Srivastava said.

The vaccine is likely to be launched in India by December 2009 if the trials are positive. The health ministry is also planning to place an initial order of over 10 million doses of the vaccine with the company, provided the experiments are successful.

The government had to place the order to encourage the company to test its vaccine on Indians and make it available here. But it would do its own experiments on the vaccine simultaneously to be fully satisfied of the final product. The initial procurement will be for health workers and high-risk groups like pregnant women, Dr Srivastava said. The country has reported 101 deaths due to swine flu till now.

The move came after the health ministry wrote to four global pharmaceutical companies—GSK, Novartis, Baxter and Sanofi Aventis— to start testing the vaccine on Indians. “These companies are already testing the vaccine in other countries and we wrote to them to start testing on Indian population simultaneously,” Indian Council of Medical Research director-general and health ministry secretary Dr Vishwa Mohan Katoch said.

"GSK in its reply said the government will have to place a certain order for the vaccine with the company before it starts human trials in India,” Dr Srivastava said.

Replies from other companies are awaited, Mr Katoch added.

The government has also given approval to three domestic biotechnology companies— Serum Institute, Panacea Biotech and Bharat Biotech—to develop the vaccine in India. While Serum Institute has already entered the animal testing phase, the other two are also likely to start testing their vaccines on animals very soon. “Domestic companies are likely to come up with a vaccine by March,” Mr Srivastava said.

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