India Profile Updated

The India profile in ClinRegs has been updated with the following information:

• Reforms to India’s personal data protection framework and related requirements resulting from the implementation of the Digital Personal Data Protection Act, 2023 and Digital Personal Data Protection Rules, 2025 (See Personal Data Protection)
• 2026 Central Drugs Standard Control Organization (CDSCO) guidance on parallel submission of clinical trial protocols to CDSCO and registered ethics committees (ECs) (See Scope of Assessment, Scope of Review, and Submission Process)
• 2026 requirements and additional resources for a new prior intimation mechanism for certain bioavailability/bioequivalence studies and manufacturing small quantities of new drugs or investigational products for analytical and non-clinical testing (See Scope of Assessment, Submission Process, and Manufacturing & Import)
• Details on CDSCO application reminder/rejection process and timeline (See Submission Process and Timeline of Review)
• Reference to 2025 notice regarding the submission of post approval changes to cell and gene therapeutic product clinical trials (See Submission Process)

Sources Added During This Update:

(Advisory) Advisory Regarding Parallel Submission and Processing of Clinical Trial Applications by CDSCO and Ethics Committees Registered under New Drugs and Clinical Trials Rules, 2019 (A-ParallelSbmiss) (May 11, 2026)
Central Drugs Standard Control Organization

(Corrigendum) Corrigendum to Digital Personal Data Protection Rules (Corrig-DPDPR) (December 10, 2025)
Ministry of Electronics and Information Technology

(Guidance) FAQs on Prior Intimation Application for BA/BE study for Export Purpose under the New Drugs and Clinical Trial Rules, 2019 Amended as per G.S.R 50(E) Dated 21.01.2026 (G-PriorIntimBA-BE-FAQs) (Date Unavailable)
BA/BE Division for Export, Central Drugs Standard Control Organization

(Legislation) Constitution of India (IndiaCon - Hindi and English) (Up to Date as of May 1, 2024)
Ministry of Law and Justice

(Legislation) Digital Personal Data Protection Act, 2023 (DPDPA - Hindi and English) (August 11, 2023)
Ministry of Electronics and Information Technology

(Legislation) Digital Personal Data Protection Rules, 2025 (DPDPR - Hindi and English) (November 13, 2025)
Ministry of Electronics and Information Technology

(Notice) Notice Regarding BE-NOC Prior Intimation (System of Notification for Certain Category of New Drugs for Conduct of "BA-BE Studies" for Export Purpose under Chapter V, NDCT Rule, 2019) and Procedure for Obtaining CT-16 Application on NSWS Portal (Notice22May26) (May 22, 2026)
Central Drugs Standard Control Organization

(Notice) Notice Regarding Disposal/Rejection of Long-Pending Applications on SUGAM Portal Awaiting Query Response (Notice4May26) (May 4, 2026)
Central Drugs Standard Control Organization

(Notice) Notice Regarding Post Approval Changes for Clinical Trials (Form CT-06) for Form CТ-04 for Cell and Gene Therapeutics Products through SUGAM Online Portal System (Notice27Oct25) (October 27, 2025)
Central Drugs Standard Control Organization

(Notification) Decision Regarding the Number of Members in the Data Protection Board of India (DPBMem - Hindi and English) (November 13, 2025)
Ministry of Electronics and Information Technology

(Notification) Enforcement Timeline for the Digital Personal Data Protection Act, 2023 (Enforce-DPDPA - Hindi and English) (November 13, 2025)
Ministry of Electronics and Information Technology

(Notification) Establishment of the Data Protection Board of India (Estab-DPB - Hindi and English) (November 13, 2025)
Ministry of Electronics and Information Technology

(Circular) Circular Regarding Implementation of Prior Intimation System for BA/BE Studies of Unapproved Drugs Using Form CT-05 Application (for Export Purpose Only) w.e.f 21.04.2026 in Pursuance of G.S.R 50(E) (Circular20Apr26) (April 20, 2026)
Central Drugs Standard Control Organization

(Circular) Circular Regarding Implementation of Prior Intimation System for Forms CT-10, CT-12 and CT-13 in Pursuance of G.S.R. 46(E) Dated 20.01.2026 (Circular6Mar26) (March 6, 2026)
Central Drugs Standard Control Organization

(Regulation) New Drugs and Clinical Trials (Amendment) Rules, 2026 (2026-CTRules - Hindi and English) (Effective March 7, 2026)
Ministry of Health and Family Welfare

(Regulation) New Drugs and Clinical Trials (Second Amendment) Rules, 2026 (2026-CTRules-2ndAmdt - Hindi and English) (Effective April 21, 2026)
Ministry of Health and Family Welfare

(Article) Amendments to the Clinical Trial Rules, a Welcome Shift in the Current Regulatory Landscape (IND-78) (March 13, 2026)
Martin, Ananda Malhotra and Pirani, Taskeen; Chamber and Partners

(Article) Govt Notifies Rules for DPDP Act, Putting India’s First Digital Privacy Law into Effect (IND-88) (November 14, 2025)
The New Indian Express

(Article) India’s Digital Personal Data Protection Act 2023 Brought into Force (IND-89) (November 17, 2025)
Aw, Charmian and O'Leary, Ciara; Hogan Lovells

(Press Release) Union Health Ministry Notifies Key Amendments to NDCT Rules, 2019 to Reduce Regulatory Burden and Promote Ease of Doing Business (IND-86) (January 28, 2026)
Ministry of Health and Family Welfare

(Press Release) Government Notifies DPDP Rules to Empower Citizens and Protect Privacy (IND-87) (November 14, 2025)
Ministry of Health and Family Welfare