Formulate Rules to Regulate Clinical Drug Trials on Humans: Supreme Court

The Supreme Court Wednesday asked the Centre to formulate with rules to regulate clinical drug trials on humans by pharmaceutical firms.
A bench of Justices MB Lokur and Deepak Gupta said unregulated clinical trials have a “serious impact” on people’s health. The court made the remark after it was informed about the Centre’s draft rules, framed in February this year. The government counsel said the draft provides for compensation ranging from Rs 5 lakh to Rs 75 lakh to the people who undergo such trials, and that suggestions and objections to the rules have been invited.
Advocate Sanjay Parikh, representing one of the petitioners, said the rules have to be framed to regulate the trials as people were being treated as “subjects” during the process. “Nobody looks into the serious question of deaths because of these trials,” he said, adding that earlier clinical trials were conducted on people without them being informed.



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