12 April 2019 | News
For the first time all biomedical and health research is going to be regulated through the ethics committees
image credit- bostonmagazine.com
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.
This will be effective after 180 days from the date 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:
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.”