press trust of india
New Delhi, 26 July:
Clinical trials of untested drugs on humans require certain mandatory standards to be followed, the Supreme Court said today 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 24 September 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 2009.