#DrugImportLicense

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CDSCO Import License for Cosmetics & Medical Devices

Importers of cosmetics and medical devices must secure a CDSCO license. We streamline the entire process so you can start selling without compliance worries. Talk to our team now!

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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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Expert Solutions for CDSCO Registration and Import License

Are you looking to import medical products or drugs into India? Agile Regulatory can fast-track your CDSCO registration and import license approval. We ensure that all documentation is prepared accurately and in compliance with Indian drug regulations. Our experts work closely with you to navigate the approval process, ensuring a smooth and timely outcome.