The Ministry of Health and Family Welfare (MoHFW) on February 08, 2024, issued steps taken to ensure the quality of medicines.
Central Drugs Standard Control Organization (CDSCO) and the Ministry of Health and Family Welfare have taken the following regulatory measures to ensure the quality of medicines in the country:
- The Drugs and Cosmetics Act, of 1940 was amended under the Drugs & Cosmetics (Amendment) Act of 2008 to provide stringent penalties for the manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable.
- States and UTs have set up special Courts for the trial of offences under the Drugs and Cosmetics Act for speedy disposal.
- The number of sanctioned posts in CDSCO has been increased from 111 in 2008 to 931 till date.
- To ensure the efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing that the applicant shall submit the result of a bioequivalence study along with the application for a grant of manufacturing license of the oral dosage form of some drugs.
- The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of a manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government.
- The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before granting of manufacturing license by the Authority.
- CDSCO coordinates activities of State Drug Control Organisations and provides expert advice through the Drugs Consultative Committee (DCC) meetings held with State drug controllers for uniformity in the administration of the Drugs and Cosmetics Act.
- Central Government has amended the Drugs Rules 1945 vide G.S.R. 922 (E) dated 28.12.2023 to revise the schedule M to the said rules related to Good Manufacturing Practices and requirements of premises, plant and equipment for pharmaceutical products.
CDSCO, Ministry of Health and Family Welfare regulates the quality, safety and efficacy of Drugs, Medical Devices and Cosmetics in the country under the provisions of the Drugs & Cosmetics Act, 1940 and its Rules.
[Notification No. 2004361]
