Apr 22, 2019
New Rules Released in India
On March 19, 2019, the Ministry of Health and Family Welfare of India released the “New Drugs and Clinical Trials Rules, 2019.” These rules included significant definitions, clarifications, opportunities, and expectations that, together, improved the clinical trial regulatory environment in India.
Several provisions are particularly notable: compensation provisions for death, permanent disability, and injury related to participation in a clinical trial; the DCGI through expert committee review, retaining the responsibility for determination of the quantum of compensation if any; publication by schedule for the amount of compensation; clarification of requirements for medical management of trial-related injury; procedure for post-trial access to investigational products determined to be beneficial to the participant; clarification of the requirement for audio- versus audiovisual recording of the informed consent process; definitions of academic trials and of vulnerable populations; certain provisions for research ethics committees; expedited review of the application for new clinical trials, including a 30 day review for any new drug that was discovered in India or will be manufactured and marketed in India; definition of special situations wherein the regulations for a new drug can be relaxed, abbreviated, or modified; introduction of pre- and post- submission meetings; penalties for non-compliance and the right of the aggrieved party to appeal; among other provisions.
Taken together, the rules constitute a significant advance for the country and encompass welcome clarifications for sponsors and investigators seeking to site clinical trials in India.
New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019)
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