Indian doctors and scientists have dismissed fears by foreign observers that their country is being turned into a nation of guinea pigs for drug companies. A widely circulated article in Wired by Jennifer Kahn recently asserted that the worst offenders were, to her surprise, Indian drug companies. “The accountability is very well laid on paper,” says Dr B.K. Rao, of Sir Ganga Ram Hospital in New Delhi. “Besides the ethics committees of hospitals which monitor the trials, there are international agencies like the FDA which have to finally approve the drug… The controls are so strict that if anything wrong is found happening, the drug is immediately rejected.”
Dr Umakanta Sahoo, of Chiltern International, a clinical research group, says that Indian regulations ban foreign companies from conducting phase I trials. Volunteers benefit from Phase II, III and IV trials because they receive improved care and free drugs during the trial, he says.
The market for clinical trials in India is booming. One study estimates that it will rise from US$200 million next year to between $500 million and $1 billion in 2010. As a result there is a shortage of qualified research staff. Running clinical trials “is emerging as a very lucrative career option for bioscience, medical and pharma graduates,” says Rajiv Verma, of the Institute of Clinical Research in New Delhi.
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