The Drugs and Cosmetics Act, 1940 is a central legislative Act that provides the statutory framework for regulating the import, manufacture, distribution, and sale of drugs and cosmetics in India. Enacted on April 10, 1940, its primary purpose was to ensure that the public has access to drugs and cosmetics that are safe, effective, and of the requisite quality. The Act, which comprises five chapters and two schedules, was created to solve the problem of unregulated and potentially harmful substances being sold to consumers.
The Act works by establishing regulatory control over the entire supply chain, from import to sale. It mandates that all drugs and cosmetics must meet prescribed standards of quality and purity. A key mechanism is the regulation of clinical trials, which must be registered with the Central Drug Authority (CDA) and approved by a registered Ethics Committee. The Act also covers medical devices, which were historically included under the definition of 'drugs'.
The Act is closely connected to the Central Drug Standards Control Organization and the Ministry of Health and Family Welfare, which are the competent authorities for its implementation. It also connects to the Drugs and Cosmetics Rules, 1945, which provide detailed rules for its enforcement. A significant recent change occurred with the passage of the Jan Vishwas (Amendment of Provisions) Bill, 2026, which operationalized reforms to promote the Ease of Doing Business. This amendment replaced criminal penalties, particularly imprisonment, with graded monetary and administrative penalties for minor procedural violations, such as those under Section 28A concerning record-keeping. However, stringent penal provisions remain in force for serious offences like the manufacture or sale of spurious or adulterated products that pose a risk to public health. The proposed Drugs, Cosmetics and Medical Devices Act, 1940 (as per the 2013 Bill) aims to replace the current Act and formally add a separate definition for medical devices.