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clinical trial deaths in 7 yrs: Centre to SC

Clinical Trial deaths in 7 yrs: Centre to SC

Even as the Drugs and Cosmetics Act awaits penal provisions, the Centre has informed the Supreme Court that at least 80 people have died due to illegal clinical trials in the last seven years.

In an affidavit submitted to the court as per its directive, the health 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.

According to the ministry, there were around 12,000 incidents of "other adverse effects" in this period, of which 506 directly pertained to clinical trials.

The existing Act does not have a single penal provision prescribing a jail term for illegal clinical trials. The Centre has said it is trying to correct the "deficiency" by replacing the old law with a 2013 amendment Bill.

The health ministry has said the Bill seeks to expand the responsibility of the sponsor (firm which conducts the trials), investigator and ethics committee.

The Bill also mandates complete adherence to the protocols and good clinical practice guidelines for conducting trials. In case of non-compliance, it seeks to authorise the Drugs Controller General of India (DCGI) to recommend rejection of the study as well as suspension and debarment of the sponsor.