Who can Apply for CDSCO License?| CDSCO Registration| SUGAM Portal| Corpbiz

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CDSCO or Central Drugs Standard Control Organisation, it is the National Regulatory Authority for Indian pharmaceutical & medical devices under the Directorate General of Health Services and Ministry of Health & Family Welfare in India. It is the responsibility of CDSCO to approve new drugs & conduct clinical trials in India under the Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules, 1945. It also lays down standards for drugs & control the quality of imported cosmetics & drugs in the country to bring about uniformity. The Act & Rules entrust several responsibilities to the Central & State Regulators for regulating Cosmetics & Drugs in India. CDSCO is the Central Drug Authority that discharges the functions assigned to the Central Government under this Act. It is also provides expert advice to State Drug Control Organisations and coordinates their activities. CDSCO and State regulators are jointly responsible for issuing CDSCO licenses for specific specialised categories of critical drugs like vaccines, IV fluids, sera, blood, and blood products.
The different objectives for which an applicant can register under the CDSCO portal are the following:
• Cosmetics Registration
• Export NOC (Zone);
• Ethics Committee Registration;
• Blood Bank Registration;
• Dual Use NOC (Trader);
• Blood Product Registration;
• Sponsors (BA/BE & CT)
• Manufacture or Import of Drugs;
• Test License;
• Formulation R&D Organisation;
• BA/BE Approved Sites.
Following is the list of applicants who can apply for CDSCO License:
• Importers
• Authorised Indian Representatives (AIR);
• Corporates;
• Foreign Enterprises were holding Indian Subsidiary.
Note: A manufacturing unit cannot register directly on the CDSCO portal. A corporate must create login credentials for the manufacturing unit by which they can log in on the CDSCO portal.
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