#CDSCOApproval

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What is a "CDSCO Drugs Import License"?

The responsibility for issuing licenses for Specialized Categories of Critical Drugs, including blood and blood products, I.V. fluids, vaccines, and sera, lies with the Central Drugs Standard Control Organisation and state regulators. Importing drugs into India necessitates a Drugs Import License, which must adhere to government regulations.

CDSCO holds the designation of being the National Regulatory Authority (NRA) in India. The regulation of Import, Manufacturing, Sale, and Distribution of Drugs in India is governed by the Drugs & Cosmetics Act of 1940 and Rules of 1945.

Benefits of CDSCO Drugs Import License:

Legal Compliance

Quality Assurance

Consumer Safety

Business Credibility

Supply Chain Integrity

Customs Clearance

Marketing Authorization

Documents of CDSCO Drugs Import License:

Covering Letter

Form 8 or 8-A

TR6 Challan

Testing Protocol

Product Label and Brochures

FSC Certificate in the Country of Origin

Notarized Agreement

Ethics Committee Approval

Original Power of Attorney

Plant Master File

Drug Master File

Copy of BA/BE site registration (as approved by CDSCO in case of BA/BE approved sites)

Manufacturing License or Wholesale License (in the case of Import)

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CDSCO Registration — Online Procedure, Documentation, Benefits, Fee

The Central Drugs Standard and Control Organisation (CDSCO) is India’s foremost regulatory authority for overseeing Cosmetics, Pharmaceuticals, and Medical Devices. It wields significant influence within the country and operates under the Directorate General of Health Services, Ministry of Family Welfare & Health, and the Government of India.

To enhance regulatory oversight, the Indian Government has disclosed its intention to subject all medical devices, including implants and contraceptives, to CDSCO’s scrutiny. Additionally, CDSCO collaborates with state regulators to issue licenses for specific specialized categories of critical drugs, such as Blood and Blood Products, I.V. fluids, Vaccines, and Sera.

*If you want to know about EPR Registration, NGO Darpan Registration, GeM Registration, or APEDA Registration