DCGI Has Started Online Ethics Committee Registration

Mumbai, 3 Oct 2019:

The Drugs Controller General of India (DCGI) has started online Ethics Committee (EC) registration for Biomedical Health and Research (other than clinical trials) for its effective regulation.

This will facilitate ECs reviewing biomedical and health research in India to register with the Ethics Committee Registration authority under the Department of Health Research (DHR) functioning under the Union health ministry.

“An office for EC Registration is set up under DHR for coordinating and monitoring EC registrations and related activities that can bring about the much needed transparency, accountability and structure to regulate and monitor biomedical and health research in India,” according to DCGI DR V G Somani.

This office will receive applications for registration of EC, review and make decisions on the EC registrations or re-registrations. This office will also closely work with DHR and Indian Council of Medical Research (ICMR).

All ECs conducting biomedical and health research shall make an application with the office along with necessary documents as specified in New Drugs and Clinical Trials and Rules for registration and renewal of registration. The provisional registration will remain valid for two years and the final registration granted by DHR shall remain valid for a period of five years from the date of its issue, unless suspended or canceled by the designated authority at DHR.

The Union health ministry had notified the New Drugs and Clinical Trials Rules -2019, that became effective from March 19, 2019.

Under the Rules, Chapter IV entitled “Ethics Committee for biomedical and health research” states that ECs reviewing biomedical and health research should register with the authority designated by the Union health ministry under DHR.

A large number of biomedical and health research studies are being conducted across the country at various research centres, medical institutions, universities etc.

ECs are entrusted with the responsibility to undertake the ethical review of research proposals prior to initiation. they also have a continuing responsibility to regularly monitor the approved research to ensure ethical compliance during the conduct of research and to ensure that the rights, safety and well-being of research participants is protected.

These ECs reviewing biomedical and health research shall be constituted and are required to function in accordance with the ICMR National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2017.

These guidelines are applicable to all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data.

The research should be conducted under conditions such that no person or persons become mere means for the betterment of others and that human beings who are participating in any biomedical and/or health research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency.

The socio-cultural ethos in India and its varying standards of healthcare pose unique challenges to the application of universal ethical principles to biomedical and health research.

The last decade has seen emerging ethical issues necessitating further revision of the earlier guidelines and preparation of the current National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.

These guidelines have covered some newer areas like public health research, social and behavioural sciences research for health and responsible conduct of research, and research during humanitarian emergencies and disasters while a few other specialized areas like informed consent process, biological materials, biobanking and datasets and vulnerability have been expanded into separate sections. Pharmabiz