Clinical trials: Supreme Court wants safety net for new drugs in India

Centre sought time to apprise Supreme Court on the clinical trials safety mechanism…

The Centre on Monday sought two weeks to apprise the Supreme Court on the safety mechanism put in place before commencement of the clinical trials with regard to new drugs/chemical entities.

Besides, the apex court also asked the ministry of health and family welfare to place before it the existing regime that ensures safety to subjects on whom trials are conducted and ?avoidance of serious or adverse events?.

A bench headed by Justice R M Lodha gave two-weeks time to the ministry to tell about the safety regimes for commencement of clinical trials in 162 cases for which approvals have been received from the Drug Controller General of India (DCGI).

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Just short of passing a formal order to ban clinical trials in the country till proper mechanism is in place to avoid any serious and adverse impact, the court on assurance by additional Solicitor General Siddharth Luthra kept the issue for consideration after two weeks.

Luthra told the court that no clinical trial will take place for 162 drugs permitted by it earlier unless he apprised the bench about the existing safety regime to protect the lives of people.

However, Justice Lodha observed that 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.

?We keep the matter for consideration to enable additional Solicitor General Siddharth Luthra to give response in respect of Prof Ranjit Roy Choudhury committee report on clinical trials on new drugs and chemical entity.?

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First published on: 30-09-2013 at 20:54 IST