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Health activists attack Indian compensation formula for deaths attributed to clinical trials

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f6295 (Published 17 October 2013) Cite this as: BMJ 2013;347:f6295
  1. Ganapati Mudur
  1. 1New Delhi

A formula proposed by the Indian government to calculate the amount of compensation that pharmaceutical companies would need to pay for deaths of subjects who volunteer for clinical trials has drawn criticism from health activists and industry analysts.

A committee of experts set up by the Central Drugs Standard Control Organisation, India’s drug regulatory agency, has proposed a formula that takes into account the age of subjects and a risk value linked to their health status to determine the amount of compensation payable when a death is attributed to a clinical trial.1 A healthy volunteer is assumed to be taking the highest risk and a terminally ill patient the least risk.

The formula leads to compensation amounts ranging from Rs 400 000 (£4064; €4783; $6509) for the death of a 65 year old terminally ill subject with expected survival …

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