Central Drugs Standard Control Organisation
Indian regulator; administers GMP under Schedule M of the Drugs and Cosmetics Rules.
What this page does not claim
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
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.
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
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 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.
What an inspection under this authority actually probes
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.
CDSCO STANDARDS SPEQ DECODES · 1
DISCIPLINES IN CDSCO’S REMIT
CDSCO: frequently asked questions
Reference answers on Central Drugs Standard Control Organisation’s mandate, what it publishes, and how its requirements acquire force.
What is CDSCO?
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.
Who inspects manufacturing sites in India?
Authority is shared. CDSCO handles new drug approval, imports, clinical trials, and central licensing, while State Licensing Authorities license and inspect most manufacturing sites. A manufacturer typically deals with a state authority for its licence and CDSCO for product approval.
What is Schedule M?
Schedule M of the Drugs and Cosmetics Rules sets India’s GMP requirements. It has been substantially revised, raising requirements with phased timelines by manufacturer size. India is not a PIC/S participating authority, so no reliance route exists on that basis.