The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body, an institution operating under the Directorate General of Health Services in the Ministry of Health and Family Welfare. Its establishment traces back to the Drugs and Cosmetics Act, 1940, which was enacted to ensure that drugs and cosmetics manufactured, distributed, and sold in India were safe, efficacious, and of high quality. The CDSCO functions as the Central Drug Authority, discharging the responsibilities assigned to the Central Government under the Drugs and Cosmetics Act, 1940, and its subsequent rules.
The mechanism of the CDSCO involves several key functions, including the approval of new drugs and clinical trials, laying down standards for drugs, and controlling the quality of imported drugs. It is headed by the Drugs Controller General of India (DCGI). The CDSCO connects to the State Drug Control Organisations, coordinating their activities to ensure uniform enforcement of the Act across the country. The regulatory framework is governed by the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and the New Drugs and Clinical Trials Rules, 2019.
Recently, the CDSCO has focused on modernization and streamlining processes, such as enhancing the SUGAM portal for digital compliance and reducing regulatory timelines. For instance, in 2026, the regulator amended the New Drugs and Clinical Trials Rules, 2019, to reduce approval timelines for certain manufacturers from 90 working days to 45 working days. Furthermore, the CDSCO has been undergoing structural changes to support the transition of the Indian pharmaceutical industry towards value-led innovation, particularly in biologics and biosimilars.