India Profile Updated

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

• 2024 Central Drugs Standard Control Organization (CDSCO) Notice on the National Single Window System (NSWS) online portal launch and related resources (See Regulatory Fees, Submission Process, and Manufacturing & Import)
• 2024 CDSCO Notice on submitting manufacturing and import applications via the NSWS portal (See Submission Process and Manufacturing & Import)
• 2024 CDSCO Notice on Subject Expert Committee (SEC) Division’s role in evaluating investigational new drug (IND) proposals (See Scope of Assessment and Submission Process)
• CDSCO Notice and related source from 2023 related to submission of regulatory documents in soft copy format (See Submission Process and Manufacturing & Import)
• Indian Council of Medical Research (ICMR) online portal for the transfer of human biological material (See Specimen Import & Export)
• 2023 ICMR guideline on the ethical application of artificial intelligence in biomedical research (See Scope of Review, Personal Data Protection, Participant Rights, and Vulnerable Populations)
• 2023 ICMR guideline on joint ethics review for ICMR-network multicenter research (See Scope of Review)
• February 2024 guidance on laboratory validation testing as it relates to personal data protection and related resource (See Personal Data Protection and Consent for Specimen)
• Additional information on ethics committee clinical trial record maintenance requirements (See Scope of Review)
• Additional information on participant/community post-trial access to research study findings and investigational drugs (See Insurance & Compensation)

Sources Added During this Update:

(Guidance) Guidance on Ethical Requirements for Laboratory Validation Testing (G-LabValidTest) (February 2024)
Indian Council of Medical Research

(Guidance) Guidelines for ICMR Network of Institutions: Joint Ethics Review of Multicentre Research (G-MultictrResRev) (March 17, 2023)
Indian Council of Medical Research

(Guidance) Ethical Guidelines for Application of Artificial Intelligence in Biomedical Research and Healthcare (G-AI-BiomedRes) (2023)
Indian Council of Medical Research

(Notice) Notice Regarding the Launch of the National Single Window System (NSWS) Portal (Notice1Jan24) (January 1, 2024)
Central Drugs Standard Control Organization

(Notice) Notice Regarding the Launch of Additional Forms on the National Single Window System (NSWS) Portal (Notice16Jan24) (January 16, 2024)
Central Drugs Standard Control Organization

(Notice) Notice Regarding CDSCO’s Clinical Research Unit (CRU) Request for Stakeholder Document Submission in Soft Copy Format (Notice12Oct23) (October 12, 2023)
Central Drugs Standard Control Organization

(Notice) Notice Regarding SEC Division’s Oversight of Investigational New Drugs (IND) Proposal Evaluation Meetings (Notice31Jan24) (January 31, 2024)
Central Drugs Standard Control Organization

(Notice) Amendment in Export Policy of Human Biological Samples under Chapter-30 of ITC HS Schedule-2 of Export Policy (Notice11Mar24) (March 11, 2024)
Directorate General of Foreign Trade, Ministry of Commerce & Industry

(Article) ICMR Issues Comprehensive Guidance on Ethical Requirements for Laboratory Validation Testing (IND-2) (February 9, 2024)
Nautiyal, Shardul; PharmaBiz.com

(Article) Efficiency Measures Implemented for Document Submission to CDSCO (IND-7) (October 13, 2023)
Legality Simplified

(Article) India Promulgates a National Single Window System (NSWS) to Ease Healthcare Information (IND-14) (February 12, 2024)
Gross, Ames; Regulatory Affairs Professionals Society (RAPS)

(International Guidance) Good Clinical Laboratory Practice (GCLP) (IND-76) (2009)
World Health Organization

(Webpage) Portal for Export of Human Biological Material (IND-77) (Last Updated April 3, 2024)
Indian Council of Medical Research

(Webpage) Transfer of Human Biological Material (THBM) Portal (IND-67) (Current as of May 24, 2024)
Indian Council of Medical Research

(Webpage) National Single Window System (NSWS) Portal (IND-3) (Current as of May 24, 2024)
Department of Promotion of Industry and Internal Trade, Ministry of Commerce & Industry, and Invest India

(Webpage) National Single Window System - User Guide: Document Containing Instructions to Properly Use the System (IND-4) (Current as of May 24, 2024)
Department of Promotion of Industry and Internal Trade, Ministry of Commerce & Industry, and Invest India

(Webpage) National Single Window System (NSWS) - Central Approvals (IND-23) (Current as of May 24, 2024)
Department of Promotion of Industry and Internal Trade, Ministry of Commerce & Industry, and Invest India

(Webpage) National Single Window System (NSWS) - Know Your Business Approvals (IND-12) (Current as of May 24, 2024)
Department of Promotion of Industry and Internal Trade, Ministry of Commerce & Industry, and Invest India

(Webpage) National Single Window System (NSWS) - FAQ (IND-24) (Current as of May 24, 2024)
Department of Promotion of Industry and Internal Trade, Ministry of Commerce & Industry, and Invest India

(Webpage) SUGAM - Frequently Asked Questions (FAQ) (IND-20) (Current as of May 24, 2024)
Central Drugs Standard Control Organization

(Webpage) Permanent Account Number (PAN) - Frequently Asked Questions (FAQs) - General (IND-33) (Last Updated May 24, 2024)
Tax Information Network of Income Tax Department, Ministry of Finance, Government of India

(Document) National Single Window System User Guide: How to Register, Sign in, Create Business Profile on NSWS (IND-61) (Last Updated January 13, 2023)
Department of Promotion of Industry and Internal Trade, Ministry of Commerce & Industry, and Invest India

(Document) National Single Window System User Guide: How to Verify PAN using Digital Signature Certificate (DSC) on NSWS (For New Users) (IND-62) (Last Updated November 16, 2023)
Department of Promotion of Industry and Internal Trade, Ministry of Commerce & Industry, and Invest India

(Document) National Single Window System User Guide: Add Digital Signature Certificate on NSWS (IND-64) (Last Updated May 4, 2022)
Department of Promotion of Industry and Internal Trade, Ministry of Commerce & Industry, and Invest India

(Document) National Single Window System User Guide: How to Apply for CDSCO Approval (IND-11) (Last Updated March 14, 2023)
Department for Promotion of Industry and Internal Trade, Ministry of Commerce & Industry; Invest India, National Investment Promotion and Facilitation Agency

(Document) National Single Window System – User Guide: How to View, Identify or Apply Central Approvals (IND-73) (Last Updated November 25, 2022)
Department for Promotion of Industry and Internal Trade, Ministry of Commerce & Industry; Invest India, National Investment Promotion and Facilitation Agency

Sources Revised During this Update:

(Article) India - Data Protection Overview (IND-65) (October 2023)
Chacko, Mathew and Misra, Aadya; OneTrust DataGuidance

(Webpage) Transfer of Biological Material (IND-55) (Last Updated March 20, 2024)
Indian Council of Medical Research