SC:Clinical Trials on Humans require Mandatory Standards

Jul 27, 2013 11:40 IST

The Supreme Court of India on 27 July 2013 ruled that clinical trials of untested drugs on humans require certain mandatory standards to be followed. The directed the Union government to put in place a mechanism to monitor them.

The apex court directed the Government to convene a meeting of Chief Secretaries or Health Secretaries of all the states to frame a law for regulation of clinical trials of drugs by multinational pharma companies.

A division bench granted four weeks time to the Union government to convene the meeting and for framing rules. In an affidavit, the Union government had admitted that 2 thousand 6 hundred 44 people died during clinical trials of 475 new drugs between 2005 and 2012.

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