SC blocks 157 clinical trials, says must follow new regime

The fate of 157 government-approved global clinical trials seemed uncertain on Monday as the Supreme Court ordered the Centre to wait for its nod while the authorities re-examined the cases under the new regulatory regime.

Making it clear that clinical trials being conducted in India must be done for the benefit of the people here, a bench of Justices R M Lodha and S K Singh directed the government to put the trials through the new stringent three-tier test.

The Indian Express had reported that of the 162 approvals granted by the Drug Controller General of India until August 31 this year, 157 trials were cleared in 2012, after a nod from just the New Drug Advisory Committees (NDACs). They escaped the new regulatory regime — a three-tier test involving the NDACs, technical committee and apex committee — which was put in place following the SC’s order in January.

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