India’s health ministry has proposed a new rule that would require
drugmakers to compensate victims in cases where death or injury was
caused by a clinical trial. The proposal would also place the burden of
proving that a clinical trial did not cause death or injury on the
drugmaker. This comes in the wake of media reports of 671 deaths during
clinical trials in 2010. “Under the proposed rule, it would be the
responsibility of the trial sponsor on behalf of the pharma company to
prove before the ethics committee that the injury or death is not on
account of clinical trial within 30 days of receiving the report of the
injury or death from investigator, failing which the sponsor shall be
liable to pay the compensation within 60 days or as decided by the
ethics committee,” according to a health ministry official.
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