Regulatory
Central Drugs Standard Control Organisation — India's national regulatory body for pharmaceuticals and medical devices.
CDSCO states its own position plainly: it “is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act”. It sits under the Directorate General of Health Services in the Ministry of Health and Family Welfare, and operates six zonal offices, four sub-zonal offices, thirteen port offices and seven laboratories. The functions reserved to headquarters are the ones that matter to an importer or a sponsor: “regulatory control over the import of drugs, approval of new drugs and clinical trials”, the meetings of the Drugs Consultative Committee and the Drugs Technical Advisory Board, and approval of certain licences as Central Licence Approving Authority. The port offices are the practical gate for imported consignments; the central authority is where approval for the product itself is decided.
Sourced to the body itself. This entry cites the organisation’s own description of what it is and what it does, which is the right authority on its mandate and structure and the wrong one on its performance. Where a figure appears above it is the body’s own published figure. For statutory detail, the Act or notification named in the text governs, not the summary page.
CDSCO (Central Drugs Standard Control Organisation) issues a No Objection Certificate (NOC) for export of pharmaceutical products that are not approved for the Indian domestic market. NOC is required when the product formulation, dosage, or indication is only for export. Apply through SUGAM portal. NOC is typically issued within 30-45 working days.
From the AJG lexicon archive (July 2026).
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