The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority for pharmaceuticals, medical devices, and cosmetics in India, functioning as an institution under the Directorate General of Health Services, which is part of the Ministry of Health and Family Welfare. Its origin is rooted in the need to combat substandard products, leading to the enactment of the Drugs and Cosmetics Act, 1940. The CDSCO is the Central Drug Authority responsible for discharging the functions assigned to the Central Government under this Act.
The mechanism of the CDSCO involves establishing standards, granting licenses, performing inspections, and enforcing quality control to ensure that products are safe, effective, and of high quality. It regulates the import, manufacture, distribution, and sale of drugs, cosmetics, and medical equipment. The organization is headed by the Drugs Controller General of India (DCGI), who is responsible for the approval of licenses for specific categories of drugs, such as vaccines and blood products. The CDSCO works in coordination with State Drugs Control Authorities, which regulate manufacturing, distribution, and sale within their respective states, ensuring a uniform implementation of the legislation.
The CDSCO's work is intrinsically connected to the Drugs and Cosmetics Act, 1940, and the subsequent Drugs and Cosmetics Rules, 1945, which provide the legal framework for its operations. A significant recent change involves the revision of Schedule M under the Rules in 2023, which introduced internationally accepted concepts like Pharmaceutical Quality System (PQS) and Quality Risk Management (QRM) to strengthen Good Manufacturing Practices (GMP). Furthermore, the CDSCO is implementing a new fast-track system from June 1, 2026, for drug testing approvals, where a No Objection Certificate (NOC) is issued upon application submission, reducing the initial review time. Another recent development is the Drugs (Fifth Amendment) Rules, 2026, which removed the over-the-counter status for liquid oral syrups, mandating their sale only on prescription and subjecting them to the full rigors of Chapter IV of the Act.