CDSCO (Central Drugs Standard Control Organization) Registration is a mandatory regulatory approval required for the import, manufacture, sale, and distribution of drugs, cosmetics, and notified medical devices in India. It ensures compliance with the Drugs and Cosmetics Act, 1940, and confirms product safety, quality, and regulatory approval.
Mandatory approval for manufacturing or importing regulated medical products in India.
Ensures adherence to Indian quality and safety standards.
Essential for customs clearance of medical devices and drugs.
Avoids penalties, product recalls, and license suspension.
Enhances trust among hospitals, distributors, and healthcare institutions.
Required for supplying products to public healthcare departments.
Enables lawful marketing and interstate supply of regulated products.
Ensures business continuity through proper regulatory adherence.
The following documents are generally required:
Manufacturing license (if applicable)
Import Export Code (for importers)
Wholesale drug license
Power of Attorney (for authorized agent)
Free Sale Certificate (for imported products)
Product technical details and specifications
Device Master File (for medical devices)
Plant Master File (for manufacturers)
ISO Certificate (e.g., ISO 13485 for medical devices)
Test reports and quality certificates
Covering letter and prescribed application forms
