Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

Stem Cells and Cell based products

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1 Clinical Trial Applications (Phase I, Il and III) for Cell and Gene Therapeutics Products through SUGAM Online portal system 2025-Jul-09 2877 KB
2 Stem Cell Treatment and Advertisements for various diseases 2023-Oct-12 1122 KB
3 Dircction under section 33P of the Drugs & Cosmetics Act, 1940 for issuance of clarification on stem cell derived products' as defined under New Drugs and Clinical Trials Rules, 2019 2021-Feb-09 928 KB
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1 2022.01.13_Final GSR 14(E)_To amend rule 2 to substitute cell or stem cell derived product under NDCTR 2019 2022-Jan-13 1169 KB
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1 Post Approval Changes for Clinical Trials (Form CT-06) For Form CТ04 for Cell and Gene Therapeutics Products through SUGAM Online portal system 2025-Oct-25 585 KB
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1 Details of manufacturing permissions of Cell and Gene Therapeutic Products till June 2026 2026-Jul-09 232 KB
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1 Details of Import permissions of Cell and Gene Therapeutic Products till June 2026 2026-Aug-14 76 KB
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1 Details of Clinical trial permissions (Form CT-06) of Cell and Gene Therapeutic Products from 2024 to till date 2026-Aug-06 141 KB