Post-Submission Update:The Evolving Regulatory Landscape for Clinical Trials in India

Mark Barnes, Jamie Flaherty, Minal Caron, Alishan Naqvee, Barbara Bierer

Updated July 2019.  View the original here


Following submission of this article to the Food and Drug Law Journal, there have been further developments related to India’s 2018 draft clinical trials rules (“2018 Draft Rules”). In the Fall of 2018, the Supreme Court of India issued an order reopening the period for comment to the 2018 Draft Rules, and the Central Drugs Standard Control Organization (“CDSCO”) then re-opened the comment period. Following these procedural developments, and specifically referencing the Supreme Court’s desire that “new clinical trial rules [ ] be finalized urgently,” India’s Ministry of Health and Family Welfare (“MoHFW”) released, via notification dated March 19, 2019, final new clinical trials rules, entitled the “New Drugs and Clinical Trials Rules, 2019” (“2019 Rules”). As with the 2018 Draft Rules, these finalized rules consolidate and clarify the myriad notices, orders, and other regulatory notifications issued by the CDSCO over the past few years and reflect ongoing efforts to improving India’s clinical trials regulatory framework.