Accepting 80 clinical trial deaths in the past seven years, the Centre on Friday admitted before the Supreme Court that the data relating to deaths and injuries to people during these trials were procured from pharmaceutical companies and that there was no independent government agency to collect such records.

Appearing for the health ministry, Additional Solicitor General Sidharth Luthra conceded that the data had been collected from the companies and that it was a shortcoming in the present regulatory system not to have an independent agency to gather such information. In an affidavit submitted to the court as per its directive, the ministry has said there were 2,644 “serious adverse events” of deaths during clinical trials during 2005-2012. Of these, 80 have been attributed to clinical trials, while the other deaths could be due to terminal illnesses or other life-threatening diseases. Compensation was paid to families of 44 victims till 2011. It added there were around 12,000 incidents of “other adverse effects” in this period, of which 506 directly pertained to clinical trials.

Perusing the affidavit, a Bench of Justices R M Lodha and Madan B Lokur expressed displeasure at the existing manner of collecting vital information relating to clinical trials and asked the ASG if he agreed that the existing regime was not good enough to ensure all norms were strictly adhered to during the trials.

Luthra accepted the shortcomings in the existing system but emphasised that there was a complete overhaul in the system after January 3, since when several corrective steps, including those relating to testing of new chemical entities, had been taken. He also referred to various cabinet-approved amendments in the Drugs and Cosmetics Act and Rules to ensure no illegal trial takes place and said the government was likely to place the new bill for approval in the upcoming monsoon session of Parliament.

“Certain standards and protocol should be followed while conducting clinical trials. We are concerned about human life. How do you monitor that clinical trial does not result in death and there are no side-effects. There should also be proper compensation but preventive steps must take the lead,” said the Bench, while expressing hope that the new legislation, like in the case of acid attack, should be sufficient to curb the menace. The court also favoured a role of state governments in the new regulatory regime so that local authorities could also have a say in the matter.

The Bench then asked the Union health secretary to convene a meeting with chief secretaries or health secretaries of all the states within four weeks to decide on the new legal framework. The court will now hear the matter on September 24.

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