New Delhi|HL
Indian Council of Medical Research’s (ICMR) National Ethical Guidelines for Biomedical
Research has become mandatory and needs to be adhered to for all biomedical research in the
country as per the New Drugs and Clinical Trials Rules 2019 released recently by Ministry of
Health and Family Welfare, Government of India.
It is for or the first time all biomedical and health research is going to be regulated through the ethics
The move will be effective after 180 days from thedate of publication of Gazette. These details are included under clauses 15, 16, 17, 18 under
Chapter IV of the New Drugs & Clinical Trial Rules.
This is for the first time that biomedical and health research is going to be regulated through the
ethics committees and the system is being set up by Ministry of Health and Family Welfare
which has designated Department of Health Research, as the authority for registration of ethics
committee that review such research and thereby help in safeguarding the safety, rights, welfare
of research participants. The salient requirements are:
1. Any institution or organization which intends to conduct biomedical and health research shall
be required to have an Ethics Committee (EC) which has been constituted, functions and
maintains records in accordance to ICMR National Ethical Guidelines for Biomedical and
Health Research Involving Human Participants, 2017. ECs shall review the research before
initiation and oversee throughout the duration of the research.
2. The EC shall be required to register with the Authority and the registration would remain
valid for a period of five years from the date of its issue, unless suspended or cancelled by
the authority. The ICMR National Ethical Guidelines will guide the ethical requirements for all
institution that are engaged in such research whether it is medical colleges, research
institutions, universities, public or private funded institutions, non-governmental organisation
or others.
Dr. Balram Bhargava, Secretary, Department of Health Research and Director General,
ICMR, stated “The inclusions of clauses to govern biomedical and health research in the New
Drugs & Clinical trials Rules, 2019 will bring about the much needed transparency and
accountability in the regulation of biomedical and health research in India. This would help to
improve the quality of research outcomes while ensuring protection of research participants and
responsiveness to the health needs of our people.”
View the guidelines here:
https://www.icmr.nic.in/sites/default/files/guidelines/ICMR_Ethical_Guidelines_2017.pdf
