On March 19, 2019, the Ministry of Health and Family Welfare of India released the “New Drugs and Clinical Trials Rules, 2019.”[1] 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.
[1]New Drugs and Clinical Trials Rules, 2019, Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019)
