Central Drugs Standard Control Organization

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

Guidance documents

S.no Title Release Date Download Pdf Pdf Size
1 PAC Guidance for Biological Products - Quality Safety and Efficacy Document Version 1.2 2024-May-16 14186 KB
2 CDSCO Guidance for Industry Version 1.2 Biologicals 2024-May-15 1214 KB
3 Guidance document on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD) 2024-Apr-05 490 KB
4 Guidance Document on Risk Based Approach for Monitoring Quality at the Ports of Import 2024-Apr-02 1067 KB
5 Guidelines on good distribution practices for pharmaceutical Products 2024-Apr-02 783 KB
6 Guidance document on procedures to be followed For Evaluation of applications By The subject expert committees 2024-Apr-02 430 KB
7 Policy on Vaccine Approval 2024-Apr-02 390 KB