New Delhi: 7th July 2013
Criticised for drafting what the industry thought were untenable norms for clinical trials, India’s health ministry has amended guidelines for compensation of participants in trials that go wrong. In their earlier version, the norms under the Drugs and Cosmetics Act made it mandatory for companies to compensate trial subjects who suffered injury or death even if these had not been caused by the drugs being tested. The new norms specify that the compensation need be given only if there’s proof that the death or injury was caused by the trial.
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Criticised for drafting what the industry thought were untenable norms for clinical trials, India’s health ministry has amended guidelines for compensation of participants in trials that go wrong. In their earlier version, the norms under the Drugs and Cosmetics Act made it mandatory for companies to compensate trial subjects who suffered injury or death even if these had not been caused by the drugs being tested. The new norms specify that the compensation need be given only if there’s proof that the death or injury was caused by the trial.
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