#PharmaceuticalImports
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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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