India’s regulatory reforms on compensation for clinical trial injuries and deaths: urgent need for revisiting

Jerome Amir Singh | Indian Journal of Medical Research | Vol 10 No 3 | 2013

Financial compensation to participants in clinical trials for the immediate and long-term medical treatment of injuries sustained while participating in the trials, and payment to their next of kin when such injuries result in death, is a relatively neglected subject, particularly in developing countries. Some countries do not require investigators and/or sponsors to indemnify research participants against trial-related injury or death through insurance cover, while others do. In the case of the latter, the indemnity limit and determination of the quantum of compensation is dependent on the terms outlined in the insurance contract, assuming one exists. Furthermore, any actual compensation is ultimately left to the discretion of the sponsor or clinical trial insurer. The recent promulgation of regulations on such compensation by India (1) is thus noteworthy. While the new regulations are a reaction to the Indian Supreme Court’s finding that India’s Central Drugs Standards Control Organisation (CDSCO) failed to protect the rights of participants in trials (2) and are intended to enhance the rights of the participants, the regulations are deficient in several respects and may have unforeseen consequences for India’s wider population.

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