Thousands die in clinical trials in India, but compensation is rarely paidBMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h6149 (Published 13 November 2015) Cite this as: BMJ 2015;351:h6149
Around 2209 people have died in clinical trials in India since 2011, figures released by the office of the Drug Controller General of India have shown.
The figures, which go up to 20 October 2015, included 1335 deaths since January 2013. They were released as a right to information response on 17 September.
Death during clinical trials in India is a longstanding problem that shows no sign of improvement. Previous figures released by India’s ministry of health, in response to a public interest litigation case filed by Swasthya Adhikar Manch, showed 2868 deaths between 2005 and 2012.
Swasthya Adhikar Manch, an Indore and Pune based non-government organisation working against unethical clinical trials in India, said that bereaved families rarely received any compensation, with only 12 of 443 deaths in 2014, and none of 302 deaths in 2015, having been compensated.
Swapan Jana, secretary of Kolkata based Society for Social Pharmacology, told The BMJ that the high number of deaths during clinical trials indicated that companies and authorities were just “ignoring” safety concerns related to trials of new and experimental drugs. “The government should take steps to change the situation; we can’t play with the lives of poor people,” he said.
However, Samiran Nundy, dean of the New Delhi based Ganga Ram Institute for Postgraduate Medical Education and Research, told The BMJ, “It’s very difficult to attribute the deaths to the fact that the patients were in the clinical trials. Some of them may have been due to the disease being studied and others to ‘natural’ causes.”
He added that, as a member of a research ethics committee, he “noticed that most study protocols did not include compensation to ‘volunteers’ for untoward effects, that most doctor participants in international trials had not read or understood the protocols, and that many were being compensated for each patient added to the trial.”
Cite this as: BMJ 2015;351:h6149