India Profile Updated
The India profile in ClinRegs has been reviewed and updated with the following information:
- New amendment to the New Drugs and Clinical Trials Rules which provides the timelines for when ethics committee registration, clinical trials, investigational product manufacturing, and active pharmaceutical ingredient manufacturing may proceed if no response has been provided by the Central Licensing Authority (See Scope of Assessment, Oversight of Ethics Committees, Timeline of Review, and Initiation, Agreements & Registration)
- New webpage on the Indian Council of Medical Research (ICMR)’s Health Ministry Screening Committee (HMSC) (See Specimen Import & Export)
- Additional resource and clarification related to the Certificate of Pharmaceutical Product validation (See Quality Requirements)
Sources Added During this Update:
(Regulation) New Drugs and Clinical Trials (Third Amendment) Rules, 2022 (2022-CTRules-3rdAmdt - Hindi and English) (Effective October 14, 2022)
Ministry of Health and Family Welfare
(Document) Office Memorandum: Certificate of Pharmaceutical Product Issued Under WHO Pharmaceutical Inspection Scheme (IND-75) (May 8, 2018)
Central Drugs Standard Control Organization
(Webpage) Health Ministry Screening Committee (HMSC) (IND-74) (Last Updated January 31, 2023)
Indian Council of Medical Research
Sources Revised During this Update:
(Webpage) National Ethics Committee Registry for Biomedical and Health Research (NECRBHR) (IND-51) (Last Updated April 1, 2022)
Department of Health Research, Ministry of Health and Family Welfare