Clinical trial of untested drugs must be regulated: SC

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supremeNew Delhi, July 26;Clinical trials of untested drugs on humans require certain mandatory standards to be followed, the Supreme Court said on Friday while directing the government to put in place a mechanism to monitor them.

The apex court directed the Centre 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 bench of justices R.M. Lodha and Madan B. Lokur granted four weeks time to the Centre to convene the meeting and for framing rules.

“Certain standards and protocol should be followed while conducting clinical trials of drugs on humans. We are concerned about human life,” the bench said, asking the Centre to consider suggestions of the National Human Rights Commission on the issue.

“How do you monitor that clinical trial does not result in death and there are no side effects. There should also be proper compensation,” it said.

It said that there should be an oversight committee to monitor such trials and directed the Centre to file an affidavit by September 24 after consulting state governments.

Additional Solicitor General Siddharth Luthra submitted that the Centre is considering making amendments in the Drugs and Cosmetics Act by introducing penal provision for any violation.

Earlier, the apex court had said that uncontrolled clinical trial of drugs by multinational companies was creating “havoc” and slammed the Centre for failing to stop the “rackets” which caused deaths.

Observing that the Government has slipped into “deep slumber” in addressing this “menace”, the court had earlier ordered that all drug trials will be done under the supervision of the Union Health Secretary.

In an affidavit, the Centre had admitted that 2,644 people died during clinical trials of 475 new drugs between 2005 to 2012.

“Serious adverse events of deaths during the clinical trials during the said period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials,” the affidavit had said.

“Around 11,972 serious adverse events (excluding death) were reported during the period from January 1, 2005 to June 30, 2012, out of which 506 events were found to be related to clinical trials,” the Centre had said.

The court was hearing a public interest litigation (PIL), filed by NGO Swasthya Adhikar Manch, alleging 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 companies were going on indiscriminately in various states.

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