Central Drugs Standard Control Organisation
Indian regulator; administers GMP under Schedule M of the Drugs and Cosmetics Rules.
WHAT CDSCO COVERS
The Central Drugs Standard Control Organisation is India’s national drug regulator, headed by the Drugs Controller General of India, operating under the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945. India is one of the largest suppliers of generic medicines globally, so its GMP standards carry weight well beyond the domestic market.
WHERE IT SITS INTERNATIONALLY
India adopts many international technical standards in practice, particularly at export-oriented sites built to FDA or EU expectations, and the revised Schedule M moves the domestic baseline closer to WHO GMP.
HOW ITS REQUIREMENTS BITE
Regulatory authority is shared: CDSCO handles new drug approval, imports, clinical trials, and central licensing functions, while State Licensing Authorities license and inspect most manufacturing sites. That split is the defining feature of the system — a manufacturer typically deals with a state authority for its licence and with CDSCO for product approval and export-related matters.
WHAT CDSCO PUBLISHES
- 01Schedule M of the Drugs and Cosmetics Rules — the GMP requirements (substantially revised, with phased implementation)
- 02Schedule Y for clinical trial and import requirements, alongside the New Drugs and Clinical Trials Rules 2019
- 03Indian Pharmacopoeia (published by the Indian Pharmacopoeia Commission)
- 04Guidance documents and circulars from the DCGI
- 05Alerts on spurious or not-of-standard-quality drugs
WHAT PRACTITIONERS GET WRONG
- ›Central and state responsibilities are split — know which authority owns which decision before you need it.
- ›The revised Schedule M raises GMP requirements substantially, with phased timelines by manufacturer size.
- ›Sites exporting to the US or EU are typically built to those standards, which can exceed the domestic baseline.
- ›India is not a PIC/S participating authority, so no reliance route exists on that basis.
CDSCO STANDARDS SPEQ DECODES · 1
DISCIPLINES IN CDSCO’S REMIT
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