On March 19, 2019, the Ministry of Health & Family Welfare (‘MoHFW’), pursuant to Sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (‘DCA’) notified the New Drugs and Clinical Trials Rules, 2019 (‘NDCTR’). Chapter IV of the NDCTR, which deals with regulations governing ‘biomedical and health research’ came into force only on September 16, 2019 i.e., 180 days after publication of notification in the Official Gazette.

Before the implementation of the NDCTR, the Central Drugs Standard Control Organization (‘CDSCO’) regulated the research and clinical trials relating to ‘new drugs’ and required such clinical trials to be monitored/reviewed by an independent Ethics Committee (‘EC’) registered with the CDSCO. However, there was no law in India regulating non-drug related research. Any non-drug research on human subjects was only required to be in compliance with The National Ethical Guidelines for Biomedical and Health Research (‘NEGBHR’).

The NDCTR now provides for establishment of a new EC, specifically for ‘biomedical and health related research’ which has to be constituted as per the NEGBHR. Rule 15 of the NDCTR also requires any institution or organizations which conducts ‘biomedical and health research’[1] to have an EC review and oversee the conduct of such research. Given the broad definition of the term ‘biomedical and health research’, all individuals, organizations, companies and institutions, conducting either academic or commercial research, provided such research falls within the scope of the definition, will likely be impacted and will have to get a duly registered EC to oversee conduct of such research and may have to submit research results to such an EC. The regulations in relation to ‘biomedical and health research’ have been promulgated by the MoHFW with to improve the quality of health related research in the country and safeguard rights of human participants in such research studies.

[1] Defined under Rule 2(1)(h) of the NDCTR as: “research including studies on basic, applied and operational research or clinical research, designed primarily to increase scientific knowledge about diseases and conditions (physical or socio-behavioral); their detection and cause; and evolving strategies for health promotion, prevention, or amelioration of disease and rehabilitation but does not include clinical trial as defined in clause (j)”.