Central Drugs Standard Control Organisation

The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority for drugs, functioning under the Directorate General of Health Services in the Union Ministry of Health and Family Welfare. Headed by the Drugs Controller General of India (DCGI), it performs the regulatory responsibilities assigned to the Central Government and coordinates drug regulation across states.

Legal and institutional basis

The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 provide the principal framework for regulating the import, manufacture, distribution and sale of drugs. Drugs and poisons are placed in Entry 19 of the Concurrent List, allowing both Parliament and state legislatures to make laws on the subject.

• The New Drugs and Clinical Trials Rules, 2019 govern new drugs, clinical trials and related approvals.
• The Medical Devices Rules, 2017 provide the regulatory framework for medical devices covered under drugs law.

Core regulatory functions

CDSCO exercises central oversight where national evaluation, import control or uniform standards are required.

• It evaluates and approves new drugs and grants permissions for clinical trials according to the applicable rules.
• It controls the quality of imported drugs and performs central licensing functions assigned under drugs law.
• It lays down drug standards and provides expert advice to support consistent regulatory decisions.
• It regulates notified medical devices through the central licensing and oversight arrangements prescribed by law.

Coordination with state regulators

Drug regulation is a shared administrative responsibility rather than a completely centralised system. State drug control authorities primarily license and supervise manufacture, sale and distribution within their jurisdictions, while CDSCO coordinates their activities and promotes uniform enforcement of national law.

• Central and state regulators jointly oversee certain specialised and safety-critical categories where the rules require shared responsibility.
• CDSCO supports coordination through inspections, technical guidance, regulatory communication and expert advice.