India
Central Drugs Standard Control Organization (CDSCO) · Asia-Pacific
Executive summary
India is the world's largest supplier of generic medicines by volume (~20% of global supply) and the third-largest pharmaceutical market by volume. The regulator is the Central Drugs Standard Control Organization (CDSCO), headed by the Drugs Controller General of India (DCGI), operating under the Ministry of Health and Family Welfare. Regulation is split between the central authority (CDSCO — new drugs, imports, biologics, clinical trials, large-volume parenterals) and State Drug Control Authorities (manufacturing licences, retail/wholesale, GMP for non-central categories). The principal legislation is the Drugs and Cosmetics Act 1940 and the New Drugs and Clinical Trials Rules 2019 (NDCTR 2019), which replaced Schedule Y and modernised India's regulatory framework. NDCTR 2019 introduced a 90-day default approval clock for clinical trials, a formal waiver of local clinical trials for products approved in reference countries (US, UK, Canada, EU, Japan, Australia), and structured pathways for compassionate use and orphan drugs. India is not yet ICH or PIC/S member but participates in WHO Prequalification (with the world's largest number of WHO-PQ approved generic suppliers). eCTD is not yet mandatory but increasingly accepted. The MA system uses Form CT-21 (new drug application by a foreign manufacturer) and Form CT-23 (new drug application by an Indian manufacturer). The Subject Expert Committee (SEC) review remains a defining feature, with discipline-specific committees evaluating each application before DCGI grants approval.
About the authority
CDSCO is headquartered in New Delhi with six zonal offices, four sub-zonal offices, 13 port offices, and seven laboratories. The Drugs Controller General of India (DCGI) is the apex authority for new drug approvals, clinical trials, biologics, large-volume parenterals, blood products, vaccines, sera, and imports. State Drug Control Authorities issue manufacturing and sale licences and conduct GMP inspections for state-controlled categories. Subject Expert Committees (SECs) — discipline-specific external advisory groups — review each new drug application and recommend approval/rejection to DCGI.
International affiliations
Reliance & recognition
Rule 101 of NDCTR 2019 codifies India's reliance framework: products approved by FDA, EMA, MHRA, Health Canada, TGA, or PMDA (and marketed for ≥4 years with no major safety signals) are eligible for waiver of local clinical trials and accelerated review. Reliance is also extended to GMP via WHO PQ inspections and selected foreign authority inspections.