Medicines regulation in India

The national authority

The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. It sits under the Directorate General of Health Services in the Ministry of Health and Family Welfare, and the Drugs Controller General of India (DCGI) heads it. Its legal base is the Drugs and Cosmetics Act, 1940 and the rules made under it.

CDSCO handles approval of new drugs, clinical trial permissions, import and manufacturing licences for products under central control, vaccine and biologics oversight, and medical device regulation under the Medical Device Rules, 2017.

The federal split

Drug regulation in India is shared. The central authority approves new drugs and clinical trials and sets national standards, while state drug control authorities license most manufacturing and sales within their states and run local inspection and enforcement. A product's path therefore often involves both levels.

Public records and registries

The Clinical Trials Registry - India (CTRI) is a free public register of clinical trials conducted in India, run by the National Institute of Medical Statistics of the Indian Council of Medical Research; registration of trials is mandatory before enrolling participants. The national pharmacovigilance programme (PvPI) collects adverse drug reaction reports. CDSCO's portal publishes approvals, alerts and guidance.

Using this profile

This is a structural orientation, not legal or regulatory advice. Rules, forms and procedures change; anyone acting on a real application, import or trial should work from the authority's current publications or a qualified regulatory professional.