An Overview of CDSCO Registration

The Central Drugs Standard Control Organization (CDSCO) in India oversees the regulation and registration of pharmaceuticals, medical devices, cosmetics, and diagnostics under the Drugs and Cosmetics Act, of 1940. The CDSCO laid down the standards for Drugs, controlled the imported Drugs’ quality, coordinated the activities of SDCO (State Drug Control Organisation), and facilitated expert advice with an outlook of the regularity in the enforcement of the Drugs & Cosmetics Act. Any organization that manufactures imports or exports drugs & cosmetics conducts Research & Development activities regarding drugs, imports drugs to examine conducts BA (Bioavailability) & BE (Bioequivalence) studies in drugs for export purposes needs to obtain CDSCO Registration through its online registration portal.
Eligibility/Pre-Licensing/Mandatory Pre-Requisites
Legal Entity or Authorized Representative: Manufacturers or their authorized representatives intending to market pharmaceuticals, medical devices, cosmetics, or diagnostics in India are eligible.

Compliance with Quality Standards: Entities seeking registration must adhere to stringent quality management systems and standards specified by CDSCO. This includes compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other applicable norms.

Necessary Testing Data: Submission of comprehensive testing data and documentation verifying the safety, efficacy, and quality of the product is mandatory. This includes detailed information on formulation, manufacturing process, stability data, and clinical trial results, if applicable.

Conformity with Regulatory Norms: Demonstrating conformity with regulatory requirements specific to the category of the product (pharmaceuticals, medical devices, cosmetics, etc.) is essential. This involves compliance with relevant Drugs and Cosmetics Act provisions, Medical Device Rules, and other applicable guidelines.