370 die in clinical trials, just 21 compensations in 2 years, shows government data

A total of 370 persons have reportedly died during clinical trials in India since February 2013, but compensation have been paid in only 21 cases, according to government data.

According to a senior official from the Union Health Ministry, these 370 deaths were examined by a regulatory panel on clinical trials out of which only 21 death cases were found eligible for compensation. The amount of compensation paid by pharmaceutical companies ranged between Rs 4 lakh to Rs 40 lakh.

The official said that such incidents area dealt by an independent regulatory panel established as a part of a patient safety cell at Drug Controller General of India's (DCGI's) office comprising of clinicians and pharmacologists.

However, according to experts, there is lack of clarity on the regulations on which eligibility for compensation is decided even as companies argue they follow the global standards. "It is only on basis of the details provided by the investigators involved in the trial that it is decided whether compensation should be given in a specific case. So credibility is also a matter of question," said the official.

From 2005 to 2012, pharma firms on average paid compensation of Rs 1.5-4 lakh for clinical trial-related deaths, according to health ministry data.