On 19th November 2019, the Indian Council of Medical Research (ICMR) released the National Guidelines for Gene Therapy Product Development and Clinical Trials. The aim of this document is to provide basic guidance for research involving human participants, including clinical trials, pertaining to the broad area of gene therapy covering all technologies and processes. Disease-specific guidelines will also be developed subsequently.
On 12th September 2019, the Department of Health Research, Ministry of Health and Family Welfare (MoHFW) released a circular mandating the registration of Ethics Committees for Biomedical and Health Research involving human participants. The registration can be done through the DHR website on the Naitik Portal.
On 19th March 2019, the Ministry of Health and Family Welfare (MoHFW) released the New Drugs and Clinical Trial Rules, 2019, which are effective from the date of publication (the only exception is Chapter IV – Ethics Committee for Biomedical and Health Research – this will come into force 180 after the publication date). The Clinical Trials Toolkit for India has been updated to reflect the New Drugs and Clinical Trial Rules, 2019.