← Policy & Regulation-Standards & approvals (all topics)
CDSCO
What it is
The Central Drugs Standard Control Organisation, under the Ministry of Health, is India's national regulator for drugs, medical devices, IVDs, vaccines and clinical trials, headed by the Drugs Controller General of India
It approves new drugs and trials, licenses imports and high-risk Class C/D devices, runs inspections and recalls, and shares jurisdiction with state authorities, which license most manufacturing and all Class A/B devices
Impact on industries
- Approval is the moat - registrations take years, so incumbents with a licensed portfolio are protected against fast entry by better-funded newcomers
- Reform has been real: the Sugam single-window portal, published SEC constitution guidelines and 2026 trial rules cutting some timelines from 90 to 45 working days
- Capacity is the constraint - too few inspectors for ~13,000 pharma plants makes enforcement uneven, and the failures behind DEG episodes sit here
- Split central-state jurisdiction makes standards inconsistent, so a licence revoked in one state has not always stopped distribution elsewhere