Regulatory role of CDSCO and State licensing authority.pptx

Role of cdsco and state licensing authority
and misconception about it

1. Regulatory role of CDSCO and State licensing authority in INDIA PRITAM PATEL (25PG230019) DEPARTMENT OF REGULATORY AFFARIS (M- PHARM) RLDC- (MRA-104T) 1

2. Contents : Introduction Cdsco and its organization Role and functions of cdsco in india responsibilities of cdsco State licensing authority Function Responsibility Misconception of cdsco and state licensing authority Conclusion Reference 2

3. Introduction Drug regulatory authority are the government authorities have responsibilities for granting licenses, approval, authorizations as like NDA/ANDA approvals necessary for the marketing and sale of pharmaceutical products. Different countries have his own regulatory authorities to ensure quality, safety and efficacy as per standards. For India : CDSCO (central drug standard control organization ) is responsible for protecting the public health by ensuring the quality , safety and efficacy for human and veterinary drugs. 3

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5. Central drug standard control organization (cdsco) Central Drugs Standard Control Organization (CDSC0) is a national regulatory body for pharmaceuticals, cosmetics, and medical devices in India. It functions under the Directorate General of Health Services, Ministry of Health and Family Welfare. It makes ensure safety, efficacy, and quallity of the products through its regulation of the imports, manufacturing, distribution, and sale . 5

6. Aim : TO protect and promote public health in India. Mission : To safeguard and enhance public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. 6

7. Role and function of cdsco in india : Regulatory authority control over : Approval of new drugs and clinical trails. License approving of blood banks, LVPs, vaccines, r-DNA products and some medical devices. Laying down the standards of drugs. Banning of drug and cosmetics. Amendment in D & C act and rules Control over the meetings of drug consultative committee (DCC) and drugs technical advisory board (DTAB) 7

8. Key responsibilities of cdsco : Authorization of clinical trials . Sets regulation of medical devices, cosmetics, and diagnostic. Pharmacovigilance oversight and adverse drug reporting. Granting of license for importing drugs and APIs. Issusance of NOC, form CT-21 and from CT-23 8

9. State licensing authority: The State Food and Drug Administration (State FDA) is a state-level government body responsible for enforcing central laws related to food, drugs, and cosmetics within its specific state . It operate under the guidance of the cdsco and the food safety and standard authority of india (FSSAI). The state licensing authority ensures safety, quality, and affordability of food products. 9

10. Organization and function of state licensing authority : 10

11. Roles and responsibility of state licensing authority : Issuance of the Manufacturing Licenses. Issuing the Sale and Distribution License. Conducting Inspections and Sampling. Enforcement and Recalls. Record-keeping and Reporting. Reporting to cdsco. 11

12. When State FDA Approval is Needed! Approved Drugs Manufacturing Licensing of Retail/ Wholesale Outlets GMP Site inspections Distribution and Recall Coordination 12

13. Misjudgement of cdsco and state licensing authority : Misconception : Many believe that once a product receives approval from the Central Drugs Standard Control Organization (CDSCO), no further regulatory approvals are needed for its manufacturing or distribution in India . REALITY :   While the CDSCO grants centralized marketing authorization, this approval does not  eliminate the need for a manufacturing license . This license must be obtained from the respective State Licensing Authority (State FDA) where the manufacturing facility is located 13

14. Conclusion : The CDSCO and State Licensing Authorities together form a dual-tiered regulatory framework in India, ensuring drug safety, efficacy, and quality across national and local levels . 14

15. Reference : Walter Healthcare. CDSCO vs State FDA: approval authority in India [Internet]. WalterHealthcare.co.in; [cited 2025 Oct 3]. Available from: https://www.walterhealthcare.co.in/post/cdsco-vs-state-fda-approval-authority-in-india SlideShare. Pharmaceutical licensing authorities of India [Internet]. [cited 2025 Oct 3]. Available from: https://image.slidesharecdn.com/licecnsingauthorites-210331035301/85/Pharmaceutical-Licecnsing-authorites-of-india-8-320.jpg International Journal of Pharmaceutical Sciences. CDSCO: pharmaceutical regulatory authority of India [Internet]. IJPS Journal; [cited 2025 Oct 3]. Available from: https://www.ijpsjournal.com/article/CDSCO%3A+pharmaceutical+regulatory+authority+of+India Scribd. CDSCO and State Licensing Authority [Internet]. Scribd; [cited 2025 Oct 3]. Available from: https://www.scribd.com/presentation/618352436/CDSCO-and-State-Licensing-Authority 15

16. THANK YOU! 16