Less than two weeks after the country’s drug regulator, the Drugs Controller General of India (DGCI), asked pharmaceutical majors to compensate the deaths of volunteers during clinical trials conducted by them last year, 16 of the 25 deaths have been compensated.
While global contract research organisation PPD paid Rs 1 million as compensation to a clinical trial victim, French multinational Sanofi has provided Rs 500,0000 as treatment expense to compensate an adverse effect linked to the clinical trials, according to health ministry officials. Of the nine companies involved in the trials that resulted in deaths, the response has been near complete, they added. Bristol Myers Squib, Bayer, Pfizer, Quintiles, Eli Lilly, Amgen and Wyeth had been summoned by the DCGI on June 6. In most cases, the compensation offered was in the range of Rs 1.5 lakh to Rs 2.5 lakh.
Company representatives, speaking on the condition of anonymity, said compensation was never an issue, since all clinical trials conducted by global pharmaceutical companies are mandatorily insured. “The compensation was not given because there were no claimants. The ethics committees that oversee such clinical trials should have taken care of this”, a company official said.
The DCGI action followed an inquiry carried out after a parliamentary panel — the Committee on Government Assurances, headed by BJP member of Parliament Maneka Gandhi, issued a directive. The panel said companies had not provided compensations in the majority of cases in which the trials led to deaths or serious injuries to volunteers.
The 671 deaths, which involved 44 global pharmaceutical firms, were reported in 2010. The ministry had traced 25 deaths to causes related to clinical trials. In all other cases, deaths were the results of natural progression of the critical illness of the volunteers. Almost 88 per cent of the clinical trial deaths were linked to diseases such as cancer, cardiovascular and cerebrovascular disorders.