Supreme Court directs government to set up mechanism to monitor clinical trial of untested drugs

The Supreme Court directed government to put in place a mechanism to monitor the clinical trials of untested drugs on humans.

The Centre has been directed by the court 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.

The apex court directive came during a hearing of a PIL filed by an NGO which alleged large-scale clinical drug trials across the country by various pharmaceutical firms using Indian citizens as guinea pigs in those tests. The NGO had alleged that the clinical trials by several pharmaceutical firms were conducted indiscriminately in various states.

Previously, the court had said that uncontrolled clinical trial of drugs by multinational companies was creating “havoc” and lambasted the Centre for failing to stop the “rackets” which caused deaths. It had earlier ordered that all drug trials will be done under the supervision of the Union Health Secretary. The Centre had admitted that 2,644 people died during clinical trials of 475 new drugs during the period of 2005 to 2012.

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