Questions over clinical trials in India

Western pharmaceutical companies have pinpointed India as a prime candidate for outsourcing clinical trials, due to its population and lax regulations, which help slash research costs. Many restrictions on drug trials were lifted in 2005, and 150,000 Indians are involved in at least 1,600 clinical trials for companies like Pfizer, AstraZeneca and Merck.

Estimates suggest the Indian clinical trials industry may be as large as US$265 million. Dr Chandra Gulhati, a retired doctor who edits the Indian Monthly List of Medical Specialties, has collected information about trials going back more than a decade. He claims that official figures suggest that at least 1,730 people died in India during trials or after participating in them between 2007 and 2010. Many of them may have been so ill that they would have died anyway but it is difficult to know. He said there was a lack of clarity because it was left primarily to the doctors supervising the trial, the ethics committee and the drug companies to determine whether the deaths were linked to the trials.

India’s Health Minister, Ghulam Nabi Azad, told parliament that 10 foreign companies had made payments to relatives of 22 people who had died during or after trials in 2010. The payments totalled an average of 238,000 rupees, or US$4,500, for each individual. “Indians are being used by companies to make money selling expensive medicines in the West,” Dr Gulhati claimed. “[They are] using illiterate and poor Indians who will never be able to afford these kinds of medicines.” ~ The Independent, Nov 14

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