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Central Drugs Standard Control Organization

Central Drugs Standard Control Organization directorate General of Health Services, Ministry of Health and Family Welfare, government of india Central Drugs Standard Control Organization (Import & Registration Division). Guidance Document Document No. IMP/REG/200711. Title: Guidance document on Common Submission Format for Import and Registration of bulk Drugs and finished formulations in india . Guidance Document (Import and Registration Division) Document No. IMP/REG/200711 1|Page Central Drugs Standard Control Organization directorate General of Health Services, Ministry of Health and Family Welfare, government of india Table of Contents Sr. No. Content Page No. A Preface 4-9. B Requirements for Common Submission Format for 10-17.

Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India A. Preface In India import, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945 (hereinafter refer as Act) made there under.

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