New rules in India will force pharmaceutical companies to pay higher compensation if patients in clinical trials die or are injured.

New rules in India will force pharmaceutical companies to pay higher compensation if patients in clinical trials die or are injured. According to the health minister, Ghulam Nabi Azad, at least 211 people died between January and June this year from “serious adverse events” (SAE) during clinical trials, although most of these deaths were probably not due to the drugs themselves. In 2011, there were 438 SAE, 16 due to the trials, and in 2011, there were 668, 22 due to the trials.

At the moment, the rate of compensation depends on generosity of the drug companies. In US dollars, the amounts appear very meagre. According to the Times of India, the families of the 22 people who died in 2010 were paid, in total, about US$90,000.  The companies involved in the trials included major firms like Wyeth, Lilly, Amgen, Bayer, Bristol Mayer, Sanofi, and Pfizer. Most of the families received between US$2,700 and US$4,500. The newspaper claims that the companies “initially refused to pay compensation for majority of the deaths”.

Under the new arrangements, compensation will be calculated “on the basis of age of the deceased, income, seriousness and severity of the disease the subject was suffering at the time of his/her participation in the trial and percentage of permanent disability.” ~ Times of India, Aug 18

Michael Cook
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