Central Drugs Standard Control Organisation

New Drugs and Clinical Trials Rules, 2019 – A Regulatory Overview India 

Issues around payment of compensation in cases of clinical trial related injury, disability and death have long remained open. Despite a directive from the Hon’ble Apex Court, much was left open to question. On March 19 of this year, the Ministry of Health and Family Welfare (MoHFW) eventually took steps in this regard and notified the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules) under the aegis of the Drugs and Cosmetics Act, 1940 (D&C Act), thus bringing an end to a long-drawn-out process to codify the rules applicable to clinical trials.
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