Drugs and Cosmetics Act, 1940

The Drugs and Cosmetics Act, 1940 is India’s principal law for regulating the import, manufacture, distribution and sale of drugs and cosmetics. Its central purpose is to protect public health by ensuring that regulated products meet prescribed standards of quality, safety and efficacy, read with the Drugs and Cosmetics Rules, 1945.

Scope and regulatory purpose

The Act creates controls across the supply chain so that drugs and cosmetics reaching consumers satisfy legally prescribed standards.

• It prohibits the import, manufacture, sale or distribution of drugs that are not of standard quality, misbranded, adulterated or spurious.
• It similarly regulates cosmetics and prohibits products falling within specified defective or deceptive categories.
• It enables licensing, product standards, labelling requirements and conditions governing manufacture, import, sale and distribution.
• Together with the Drugs and Cosmetics Rules, 1945, it provides for regulation of new drugs and clinical trials.

Regulatory institutions

Administration is shared broadly between the Union and state drug-control authorities, reflecting the different stages of regulation.

• The Central Drugs Standard Control Organisation, headed by the Drugs Controller General of India, performs central regulatory functions such as control over imported drugs, approval of new drugs and coordination with states.
• State drug-control authorities primarily license and inspect manufacturing and sale establishments within their jurisdiction.
• The Drugs Technical Advisory Board advises governments on technical matters, while the Drugs Consultative Committee promotes uniform administration.
• Government Analysts and designated laboratories examine samples to determine compliance with statutory standards.

Enforcement framework

The Act converts public-health standards into enforceable legal obligations rather than leaving quality assurance solely to manufacturers.

• Drug Inspectors may inspect premises, take samples and exercise statutory powers concerning suspected violations.
• Licences may be suspended or cancelled for non-compliance, subject to the applicable legal procedure.
• Contraventions involving prohibited or substandard products attract seizure, prosecution and statutory penalties.