80 die during clinical trial in last 7 years: Ministry to SC

As the plans are afoot to bring an amendment bill to have penal provision for death during clinical trials, the Centre told the Supreme Court that at least 80 people lost their lives in the last seven years due to testing of new drugs on them.

The Union Health Ministry said Serious Adverse Events (SAEs) of deaths during the clinical trials between 2005 and 2012 have been 2,644, out of which 80 were attributable to clinical trials.

Other deaths could be due to terminal illness and other life-threatening diseases. There were around 12,000 incidents of other side-effects of trials and 506 of these were pertained to clinical trials directly. Compensations have been paid in 44 death cases, up to 2011, it said.

The information was revealed in an affidavit filed on the direction of the apex court.
It was said since the Drugs and Cosmetics Act does not have any specific provision for jail term over clinical trials conducted in violation of the norms, the Ministry would try to remove the deficiency by bringing an amendment.

The government intends to table the amendments during the ongoing Budget session.
According to the ministry, as per the amendments, investigators will inform the Drugs Controller General (DCG), ethics committee and the sponsor about all SAEs within 24 hours and an expert committee would be appointed by the DCG to look into the causes of deaths and ascertain the quantum of compensation to victims.