Over 24,000 clinical trial deaths in India in ten years

Pharmaceutical companies conducting clinical trials in India are increasingly taking advantage of the lacunae in the law and regulatory framework, which is resulting in a spurt in cases of “serious adverse events” (SAEs) and deaths of clinical subjects (participants on whom research/clinical trial is done). An RTI response received by NGO Swasthya Adhikar Manch, a copy of which is with The Sunday Guardian, reveals that a total of 24,117 cases of deaths and SAEs due to clinical trials occurred between January 2005 and September 2016. The RTI also revealed that out of the 4,534 deaths that have been reported, only 160 cases have received compensations from the pharmaceutical companies.

According to the RTI response, 341 cases of SAEs resulting in death were reported in 2015, out of which only four cases were compensated. In 2014 and 2013, respectively, 443 and 590 cases of SAEs resulting in death were reported, out of which 21 and 45 cases were compensated. In 2016, 252 cases of SAEs resulting in death were reported; the number of cases that has been compensated is still under examination. Other than the numbers, the Drugs Controller General of India (DCGI), in its RTI reply, has not provided any information on the compensations provided.

Researchers, lawyers and health activists that The Sunday Guardian spoke to, pointed to a lax clinical trial policy, irregularities in informed consent of the clinical subjects, and a nexus between pharmaceutical companies and doctors for financial