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CDSCO Registration
Central Drugs Standard Control Organisation is, known as CDSCO, is a regulatory body for the Indian medical devices industry, under the provisions of the Drugs & Cosmetics Rules, 1945 and Drugs & Cosmetics Act, 1940 and it’s the national regulatory body for Indian pharmaceutical and medical devices. Team Corpbiz will assist you in CDSCO Registration or DCGI approval for your products as per the guidelines of CDSCO.
CDSCO Registration can be obtained for various purposes and the purposes for which an applicant can register under the portal of CDSCO:
- Test License;
- Dual Use NOC (Trader);
- Blood Bank Registration;
- Cosmetics Registration;
- BA or BE Approved Sites;
- Import or Manufacture of Drugs;
- Ethics Committee Registration;
- Formulation of Research and Development Organisation;
- Sponsors (BA or BE and CT);
- Export NOC (Zone);
- Blood Product Registration.
The CDSCO stands for Central Drugs Standard Control Organisation is the NRA Or National Regulatory Authority under the Directorate General of Health Services, Government of India, and Ministry of Health and Family Welfare. The CDSCO is responsible for the regulation & approval of New Drugs and Clinical Trials in the country under the Drugs & Cosmetics Rules, 1945 And Drugs & Cosmetics Act, 1940. The CDSCO laid down the standards for Drugs, control over the imported Drugs’ quality, coordination of the activities of SDCO (State Drug Control Organisation) and facilitating expert advice with an outlook of the regularity in the enforcement of the Drugs & Cosmetics Act.
Any organisation that manufacturers or imports or exports drugs & cosmetics conducts Research & Development activities regarding drugs, imports drugs for the purpose of examining conducts BA (Bioavailability) & BE (Bioequivalence) studies in drugs for export purposes need to obtain CDSCO Registration through its online registration portal.