Thousands of Indians Dying in Unethical Clinical Trials

Sep 20, 2018 | India, Patient Clinical Trials, Patient Safety, Site Challenges, Site Watch, Unethical Trials

Samanth Subramanian reports from the National World that thousands of Indians have died in unethical clinical trials over the past decade, even as a lawsuit to improve regulation of these trials has dragged unresolved through the Supreme Court for six years.

Between January 2005 and November 2017, 4,967 people died during the course of drug trials and research, according to government data obtained by a non-profit called Swasthya Adhikar Manch (SAM). Another 20,000-odd people have suffered adverse reactions in such trials.

Pharmaceutical companies have offered compensation to the families of the deceased only in 187 of these cases, said Amulya Nidhi, who founded SAM. At least 475 drugs have been tested in trials during this time, according to Sanjay Parikh, the lawyer representing SAM in the lawsuit it filed against the government in 2012.

The trials take advantage of loopholes in rules, loose oversight, and India’s large population of poor people who are often unaware of their rights as trial subjects, Mr Nidhi said. “We need a strong regulatory system, and we need action on violators.”

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