No clinical trial of untested drugs in absence of mechanism: Supreme Court

No clinical trials should be allowed for new drugs till a mechanism is put in place to monitor them and to protect the lives of people on which drugs are tested, the Supreme Court on Monday said.

A bench headed by Justice RM Lodha said that a system must be put in place to protect the lives of people and asked the Centre not to allow clinical trials for untested medicines.

The Centre also assured the apex court that it will not allow clinical trials for 162 drugs permitted by it earlier. The bench also asked the Centre to consider suggestions of various stakeholders in putting in place the mechanism to avoid any serious and adverse impact.

The court had earlier said that clinical trials of untested drugs on humans require certain mandatory standards to be followed and had also directed the government to put in place a mechanism to monitor them.

It had 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 multi- national pharma companies.

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 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 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.