The Supreme Court has asked the Centre to create a fool-proof mechanism to save the lives of the people while allowing the clinical trials and stayed the approvals granted to 162 applications for trials.
The Apex court gave 10 weeks time to come out with a proper plan for implementing the suggestions by the States and stakeholders to create the mechanism, based on the meetings with them.
The order was passed on Monday by a bench headed by Justice R M Lodha on a petition filed by health activist group Swasthya Adhikar Manch which alleged large number irregularities.
Between July and August this year, the Drug Controller General of India (DCGI) had received 1,122 applications for clinical trials, of which the New Drug Committee approved 285 and the regulator cleared 162.
Earlier, the 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.