India New Drugs and Clinical Trials Rules 2019
India's 2019 rules for approving new drugs and running trials set deadlines for the regulator, fixed compensation for trial injuries, and allowed waivers of local trials for drugs already approved abroad, a waiver widened in 2024 for cancer and orphan drugs.
Overview
India, statutory rules under the Drugs and Cosmetics Act 1940. The New Drugs and Clinical Trials Rules, 2019 were notified by the Ministry of Health and Family Welfare on 19 March 2019 (G.S.R. 227(E)), replacing Schedule Y and the fragmented rules on trials, and are administered by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs Controller General of India. Primary text: the CDSCO website publishes the rules and amendments.
What they changed: fixed timelines of 30 working days for approving trials of drugs developed in India and 90 days for others, with deemed approval in some cases; registration of ethics committees and a formula for compensation for trial-related injury or death, following the 2013 Supreme Court intervention that had frozen trials over unethical practices; a definition of 'new drug' and of orphan drugs (prevalence under 500,000 in India) with fee waivers; and a provision (Rule 101) allowing the requirement for a local clinical trial to be waived for drugs approved in specified countries. In August 2024 the government listed the United States, United Kingdom, Japan, Australia, Canada and the European Union and waived local trials for categories including orphan drugs, cancer drugs and drugs for conditions with no therapy, subject to post-marketing studies.
Why it matters for oncology and the arguments: Indian patients had waited years for cancer drugs approved elsewhere while companies ran or avoided local bridging trials; the 2024 waiver is intended to close the gap, while Indian clinical researchers worry about losing trials and about dosing data in Indian populations. India's separate patent law, with its section 3(d) test and compulsory licensing, governs what those drugs cost once approved.
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