Union-State Division of Drug Regulation

India follows a shared system of drug regulation in which the Union establishes national standards and controls specified central matters, while States mainly regulate manufacture and market-level sale within their territories. The principal framework is the Drugs and Cosmetics Act, 1940 and the rules made under it, implemented through both Central and State authorities.

Constitutional basis

Under Article 246 and Entry 19 of the Concurrent List, both Parliament and State Legislatures may legislate on drugs and poisons. This entry is subject to Union List Entry 59, which covers the cultivation, manufacture and sale for export of opium.

• If Union and State laws on a Concurrent List matter conflict, Article 254 generally gives primacy to the parliamentary law, subject to its provisions concerning presidential assent to State laws.

Responsibilities of the Union

The Union functions mainly through the Central Drugs Standard Control Organisation, headed by the Drugs Controller General of India. It provides nationwide regulatory oversight and coordinates State regulators.

• It approves new drugs and regulates clinical trials under the applicable central rules.
• It lays down drug standards and controls the quality of imported drugs.
• It regulates imports through port offices and provides expert advice to promote uniform enforcement.
• It operates central testing and regulatory institutions under the national framework.

Responsibilities of the States

State Drug Control Administrations perform most field-level regulation under the central Act and rules. They are the principal authorities for licensing and monitoring manufacture, sale and distribution within their jurisdictions.

• State licensing authorities issue manufacturing and sale licences for most drugs and pharmaceutical establishments.
• State Drug Inspectors inspect premises, collect samples, investigate violations and initiate legal action.
• State laboratories and Government Analysts test samples for compliance with prescribed standards.
• For certain products and regulatory actions, State authorities work with CDSCO, making the division cooperative rather than watertight.