The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for pharmaceuticals, medical devices, and cosmetics in India, functioning as an institution under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. Its origin is rooted in the Drugs and Cosmetics Act, 1940, which was introduced to prevent the circulation of substandard products and provides the legal framework for drug regulation in India. The CDSCO is headed by the Drugs Controller General of India (DCGI) and is tasked with ensuring the safety, efficacy, and quality of medical products.
The CDSCO's mechanism involves approving new drugs and clinical trials, laying down standards for drugs, controlling the quality of imported drugs, and coordinating with State Drug Control Organizations to ensure uniform enforcement of the Drugs and Cosmetics Act, 1940. It connects to several key concepts and institutions, including the Drugs and Cosmetics Rules, 1945, the Medical Devices Rules, 2017, and the New Drugs and Clinical Trials Rules, 2019. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
The CDSCO has undergone significant recent changes through the New Drugs and Clinical Trials (Amendment) Rules, 2026, which were notified in January 2026. This amendment introduced a prior intimation mechanism for certain low-risk activities, such as manufacturing new drugs for analytical and non-clinical testing or conducting specific bioavailability/bioequivalence (BA/BE) studies, replacing the need for a formal test license. This mechanism became effective on April 21, 2026, 90 days after its publication. For activities that still require permission, the statutory review timeline was reduced from 90 working days to 45 working days. Separately, a new fast-track system for issuing a No Objection Certificate (NOC) for drug testing at designated government laboratories, applicable to import or manufacture for sale, was introduced, effective from June 1, 2026. This reform allows testing to begin immediately upon application submission, with detailed scrutiny occurring in parallel or later.