CDSCO Registration

Overview

The Central Drugs Standard Control Organisation (CDSCO) is India's central drug regulatory authority under the Directorate General of Health Services, Ministry of Health and Family Welfare. It regulates the import, manufacture and approval of drugs, cosmetics and medical devices, and grants registrations, import licences and approvals through its online SUGAM portal. CDSCO approval is commonly required for importing drugs, cosmetics and notified medical devices into India.

Objective

To obtain the CDSCO registration, licence or approval required to import or deal in regulated drugs, cosmetics or medical devices.

Characteristics

• CDSCO is the central regulator under the Ministry of Health and Family Welfare
• Covers drugs, cosmetics and medical devices
• Applications are filed through the CDSCO online (SUGAM) portal
• Import registration and licences are commonly required for foreign products
• Import of cosmetics generally requires CDSCO cosmetic registration

Eligibility

• Importers, manufacturers and authorised agents of regulated products
• Businesses handling drugs, cosmetics or notified medical devices
• Applicants with an Indian entity or authorised Indian agent for imports
• Entities able to meet the technical and documentation requirements of the applicable rules

Governing law

• Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945
• Cosmetics Rules, 2020
• Medical Devices Rules, 2017
• Central Drugs Standard Control Organisation (CDSCO)

The process

1. 1
   Scope assessment

   We identify the correct category and the specific CDSCO registration, licence or approval your product requires.

2. 2
   Dossier preparation

   We prepare the technical dossier and documents in the format required by CDSCO.

3. 3
   Application filing

   We file the application on the CDSCO SUGAM portal with the applicable fees.

4. 4
   Query handling and grant

   We respond to CDSCO queries and follow up until the registration or licence is granted.

Documents required

• Details and technical information of the product
• Manufacturer authorisation or power of attorney for imports
• Free sale certificate or regulatory approvals from the country of origin where applicable
• Details of the Indian entity or authorised agent
• Wholesale or manufacturing licence details where applicable
• Plant master file or device master file as required

Benefits

• Provides lawful authority to import or deal in regulated products
• Builds confidence among distributors, hospitals and buyers
• Supports smooth customs clearance of regulated imports
• Helps ensure compliance with Indian health regulations

Frequently asked questions