India Profile Updated
The India profile in ClinRegs has been reviewed and updated with the following information, which is current as of September 23, 2025:
- 2024 amendment to the New Drugs and Clinical Trials Rules establishing new clinical research organization (CRO) requirements (See Scope of Assessment, Regulatory Fees, and the Clinical Trial Lifecycle and Sponsorship topics)
- 2025 Central Drugs Standard Control Organization (CDSCO) notice and accompanying user manual on registering clinical research organizations via the SUGAM portal (See Regulatory Fees, Submission Process, and Definition of Sponsor)
- 2024 and 2025 CDSCO notices on submitting clinical trial applications to change a trial site and/or a principal investigator via the SUGAM portal for biological products (vaccine and rDNA); global and new drug clinical trials, subsequent new drugs, investigational new drugs, fixed dose combinations, bioavailability & bioequivalence studies; and for Phase I, II, and IIII cell and gene therapeutics products (See Submission Process, Timeline of Review, and Site/Investigator Selection)
- 2025 CDSCO guideline on Subject Expert Committee responsibilities (See Regulatory Authority, Scope of Assessment, and Timeline of Review)
- CDSCO ethics committee registration and inspection checklists (See Ethics Committee, Oversight of Ethics Committees, and Vulnerable Populations)
- Additional details on CDSCO responsibilities (See Regulatory Authority)
- Articles related to ethics review timeline, CRO requirements, and personal data protection in India (See Additional Resources)
Sources Added During this Update:
(Regulation) New Drugs and Clinical Trials (Amendment) Rules, 2024 (2024-CTRulesAmdt - Hindi and English) (Effective April 1, 2025)
Ministry of Health and Family Welfare
(Notice) Notice Regarding Clinical Trial Applications (Phase I, II, and IIII) for Cell and Gene Therapeutics Products through SUGAM Online Portal System (Notice9Jul25) (Effective July 10, 2025)
Central Drugs Standard Control Organization
(Notice) Notice Regarding Submission of Clinical Trial Site Addition and Change of Principal Investigator Applications for Clinical Trials of Biological Products (Vaccine and rDNA) (Notice24Feb25) (February 24, 2025)
Central Drugs Standard Control Organization
(Notice) Notice Regarding Submission of Clinical Trial Site Addition and Change of Principal Investigator Applications for Global Clinical Trials, New Drug Clinical Trials, Subsequent New Drugs, Investigational New Drugs, Fixed Dose Combinations, and Bioavailability & Bioequivalence Studies (Notice26Dec24) (December 26, 2024)
Central Drugs Standard Control Organization
(Notice) Notice Regarding the Launch of Clinical Research Organisation (CRO) Registration Applications through SUGAM Portal (Notice4Mar25) (March 4, 2025)
Central Drugs Standard Control Organization
(Guidance) The Subject Expert Committees Guidance Document (G-SECs) (Ver. 1.0) (2025)
Central Drugs Standard Control Organization
(Document) Ethics Committee Registration Check List (IND-21) (Date Unavailable)
Central Drugs Standard Control Organization
(Document) Inspection Checklist for Ethics Committee (IND-81) (May 29, 2025)
Central Drugs Standard Control Organization
(Article) A Comparison of Regulatory Approval of Clinical Trial Protocol with Different Countries (IND-82) (August 2021)
Amaresh, K. et al; International Journal of Clinical Trials
(Article) Digital Personal Data Protection Rules, 2025 (IND-85) (Last Updated May 7, 2025)
Bhatt, Shubhankar and Jain, Sourabh; Lawrbit
(Article) India’s DPDP Act Explained: The Latest Guide for Compliance (IND-84) (June 17, 2025)
Safna; CookieYes
(Article) Regulation of Clinical Research Organisations (IND-83) (September 27, 2024)
Cyril Amarchand Mangaldas; Client Alert
(Webpage) Central Drugs Standard Control Organization (IND-80) (Current as of September 23, 2025)
Central Drugs Standard Control Organization
(Webpage) Central Drugs Standard Control Organization - Functions (IND-79) (Current as of September 23, 2025)
Central Drugs Standard Control Organization