The Pharmacy Council of India on 27th July 2022, has mandated all the ethic committees related to biomedical and health research involving human participants to register with the authority designated by the Central Government in the Ministry of Health and Family Welfare, Department of Health Research (DHR).
The New drugs and Clinical Trials Rules, 2019 makes it obligatory for all the entities/institutions/researchers whether in public or private, who are conducting or intending to conduct biomedical health research, involving human participants are required to get themselves registered with the designated authority in the department of health research in terms of provisions of chapter IV of the new drugs and clinical trials rules, 2019.
Therefore, the studies/research proposals involving human participants, their biological material and data that are not reviewed by ethics committees fulfilling the above requirements should not be considered or approved by any agencies for funding purposes.
