SC seeks Centre's stand on relief for clinical trial victims

Govt says it will reply within eight weeks

The Supreme Court on Monday asked the Centre why those who suffered injuries during clinical trial of new chemical entities were not being compensated.

A bench of justices R M Lodha and Kurian Joseph asked Additional Solicitor General Sidharth Luthra to follow the legal regime which mandated payment of compensation to those who received serious adverse effects during the trial of new medicines.

“Why don’t you ask sponsors (of new chemical entities) to pay compensation to the case in which there were serious adverse effects because those must have suffered greater pains than even deaths,” the bench said.

The court made the observation after senior advocates Sanjay Parikh and Colin Gonsalves, appearing for NGO Swasthya Adhikar Manch and others, pointed out that there were 506 cases of serious adverse effects during the clinical trials between 2005 and 2012 but there was no record of any compensation having been paid in any case.

“This is an admitted position that the compensation would be paid.

Then make payment and recover from the sponsors. Why don’t you make inquiries and clear this position. Those who suffered must get compensation,” the bench said.
The counsel, however, sought a week’s time for clarifying the factual situation.

Meanwhile, the bench asked the government law officer to furnish details within eight weeks if the approvals were granted by the technical committee and the apex committee only after adhering to the three parameters of safety and efficacy, particularly in terms of risk and benefit to patient; innovation vis-à-vis existent therapeutic option; and unmet need in the country.