SC allows Centre time on clinical trial safety regimes

The Supreme Court on Monday allowed a plea by the Centre for time to apprise it about the safety mechanisms put in place before starting clinical trials approved on new chemical entities.

A two-judge bench, presided over by Justice R M Lodha, gave two weeks to the Ministry of Health and Family Welfare to tell about the safety regimes in place for commencement of clinical trials in 162 approvals received from the Drug Controller General of India (DCGI).

“We keep the matter for consideration to enable Additional Solicitor General Siddharth Luthra to give response in respect of the Prof Ranjit Roy Choudhury Committee report on clinical trials on new drugs and chemical entities, and also the existing regime which ensures safety of subjects of clinical trials and avoids any adverse impact,” said the court.

Earlier, the court had directed the Union health secretary to organise a meeting of chief secretaries from all states to discuss all facets and aspects concerning the legal framework for strengthening the regulation of clinical trials and other incidental matters. It had also asked the government to take into consideration the opinion of petitioner NGO Swasthya Adhikar Manch and the National Human Rights Commission.

In the additional affidavit filed by the health ministry, it was stated that out of 475 New Chemical Entities, only 17 were approved for marketing, which come to less than 4 per cent. But 2,644 people died in these clinical trials, out of which only 80 deaths were attributed to the trials. Similarly, out of 11,972 serious adverse events, 506 alone were attributed to the trials.

Senior advocate Sanjay Parikh, appearing for the NGO, pointed out that a total 259 applications regarding NCEs have been recommended for approval between July 3 and August 31, 2013. Out of them, 162 have been approved for clinical trials by the DCGI. He urged the court to ensure that clinical trials were not allowed on healthy individuals, which were resulting in death.

The bench was apparently not in favour of a complete ban on it. “It should not take place until complete protocols are put in place. NCEs are required even for our patients. We can’t stop it, but we have to have a complete safety mechanism. It is not a laboratory-confined process. It is a long-drawn process. You should not underestimate the value of clinical trials,” said the bench.

Meanwhile, the court gave 10 weeks' time to the Centre to come out with the actual implementation of the suggestions given by state governments, the NHRC and the petitioner to strengthen the regulatory framework of clinical trials in the country.
The court also issued notice to the Centre on a plea made by the Bhopal Gas Peedith Mahila Udyog Sangathan.