India Plans to Introduce a New Drugs, Medical Devices and Cosmetics Act

According to The Economic Times, India is preparing to replace its decades-old Drugs and Cosmetics Act, 1940 with a new Drugs, Medical Devices and Cosmetics Act, 2025. The current 1940 Act has long served as the foundation of India’s regulatory framework for drugs and cosmetics, defining key terms, specifying manufacturing and labeling standards, and setting rules to prevent misbranding and adulteration. The new legislation seeks to enhance quality control, strengthen market surveillance, and modernize the regulatory framework governing drugs, medical devices, and cosmetics.

The draft Act was presented by Drugs Controller General of India (DCGI) Dr. Rajeev Raghuvanshi during a high-level meeting chaired by Union Health Minister J.P. Nadda on October 14, 2025. It is expected to be tabled in the upcoming Winter Session of Parliament for discussion and approval.

Once enacted, the new law will grant the Central Drugs Standard Control Organization (CDSCO) with statutory authority to conduct strict quality checks and surveillance of drugs, medical devices and cosmetics manufactured in India for both domestic use and exports. For the first time, the CDSCO will also have the power to take immediate enforcement action against counterfeit or substandard drugs.

Additionally, the draft legislation includes provisions to digitize the licensing process, enhance coordination between central and state regulators, and upgrade the capacity of testing laboratories.

ChemLinked will continue to monitor the development of the Drugs, Medical Devices and Cosmetics Act, 2025, and provide timely updates once further details are released.