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The Indian government is increasing its surveillance of clinical trials, and has announced plans to set up a registry of trials and create legislation to enforce ethics guidelines.
The move comes in response to years of controversy over unregulated trials.
Clinical trials are highly profitable for India — in 2003, the country earned US$17 million in revenue from them. But, although international collaborators are keen to do more trials in India, delegates at a private conference on India’s capacity to conduct such trials last week said that the country is not ready for this expansion.
At the conference, the health ministry announced it had begun training inspectors to audit trials.
A survey by the Indian Council of Medical Research earlier this year showed that only 40 of 179 institutional ethics committees follow ethics guidelines. Although the rules were drafted more than five years ago, there is no legislation to enforce them.
India’s drug controller has said that strict regulation of clinical trials would not be easy because the country does not have ” a culture of policing doctors”.
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