Indian government may loosen clinical trial rules

The government of India may do an about-face on clinical trial rules put into place in 2013 and loosen restrictions for drugmakers.

Soumya Swaminathan, secretary of the Department of Health Research and director-general of the Indian Council of Medical Research, said drug testing in the country had suffered since the tighter rules were put into place and, as a result, fewer tests were taking place and no new drugs had been registered, according to a report by the New Indian Express.

She said under the planned rule change, new trials will be cleared by "local ethics committees" and would not need to be overseen by the Drug Controller General of India.

The stricter rules put into place in 2013 came about because of an HPV trial funded by the Bill & Melinda Gates Foundation in 2009 in which 7 participants died. The deaths and appeals from 68 human rights and women's groups calling the test "unethical" caused the country's Supreme Court to halt all drug trials and impose a three-tiered screening process for all future trials. Many multinational companies moved their tests out of the country as a result, according to the report.

The report said that applications for clinical trials in India fell to 207 in 2013 from 480 in 2012 and that since the court's decision, 162 trials that had been approved were put on hold.

- here's the report from the New Indian Express

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