India Profile Updated in ClinRegs
April 1, 2020
The India profile in ClinRegs has been reviewed and updated to reflect current regulatory requirements. Key updates include:
- Additional checklists and FAQs issued by the Central Drugs Standard Control Organization (CDSCO) to facilitate the clinical trial application submission process (See the Regulatory Authority, Clinical Trial Lifecycle, Sponsorship, and Investigational Products topics)
- Information on the Ministry of Health and Family Welfare (MOHFW)’s requirement for institutions to designate ethics committees to review and oversee all biomedical and health research studies, and detailed registration requirements for these committees (See the Ethics Committee topic)
- Information on CDSCO’s new comprehensive global database of clinical trial sites and investigators (See the Site/Investigator Selection section)
- Expanded information on investigational product manufacturing and import requirements and clarification of process validation reporting requirements to conduct clinical trials (See the Manufacturing & Import and IMP/IND Quality Requirements sections)