Update for all players interested in the medical, pharmaceutical and/or health-tech industry. The Ministry of Health and Family Welfare has notified the New Drugs and Clinical Trial Rules, 2019 (“New Rules”). Prior to this notification clinical trials in India were governed by a scattered set of rules and guidelines mainly found under the Drugs and Cosmetic Act, 1945 and the rules made thereunder and the Good Clinical Practices Guidelines issued by CDSCO(Central Drugs Standard Control Organization). It is surprising that there was no dedicated set of rules to guide researches in an area so critical to public welfare. The publication of the New Rules is bound to bring some clarity in an area where there should not have been any ambiguity to begin with.
