Over 200 Human and Veterinary Drugs Banned Since 2023, Parliament Told
New Delhi: The central government intensified regulatory action against unsafe medicines, banning 172 drugs meant for human use and 39 veterinary drugs between 2023 and 2025, Parliament was informed.
Responding to a question in the Lok Sabha, Minister for Chemicals and Fertilizers Jagat Prakash Nadda stated that while no drugs were banned in 2021 and 2022, the government prohibited 14 human-use drugs and two veterinary drugs in 2023, followed by a sharp rise in 2024 with 157 drugs for human use and one animal drug. In 2025, one human-use drug and 36 veterinary drugs were banned under the provisions of the Drugs and Cosmetics Act, 1940.
During the session, Dr Anand Kumar raised concerns over the continued sale and purchase of banned medicines in the market despite regulatory prohibitions.
Acknowledging the issue, the government said that several writ petitions were filed in various High Courts across the country challenging the ban of the fixed-dose combinations (FDCs), and the court granted interim protection for the drugs already in the distribution network.
The minister clarified that the manufacture, sale, and distribution of banned drugs in the country is a punishable offense as per the Drugs and Cosmetics Act, 1940, and State Licensing Authorities (SLAs) appointed by respective State Governments are empowered to take action against such offenses.
The Minister further pointed out that as and when any such complaints/issues are received in the Central Drugs Standard Control Organisation (CDSCO) on the selling of banned drugs, the matter is taken up with State Drugs Controller for necessary action.
In addition, the Department of Health and Family Welfare has stated that the manufacture, sale, and distribution of drugs are regulated under the provisions of the Drugs and Cosmetics Act, 1940, and rules thereunder.
Any change in composition in respect of active ingredients of medicines requires new drug permission from CDSCO before obtaining the manufacturing license from SLA. Such applications are reviewed based on the provisions under New Drugs and Clinical Trial Rules, 2019.
Further, Drugs and Cosmetics Rules, 1945 was amended vide GSR no. 828(E) dated 06.11.2019, providing that in case an applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking in Form 51 to the licensing authority to the effect that to the best of his knowledge based on search in trademarks registry, central data base for brand name or trade name of drugs maintained by CDSCO, literature and reference books on details of drug formulations in India, and internet, such or similar brand name or trade name is not already in existence with respect to any drug in the country and the proposed brand name or trade name shall not lead to any confusion or deception in the market.
As and when any such complaints/issues regarding manufacturing/marketing of any medicine with a change in composition of active ingredients without CDSCO approval are taken up, the matter is with the concerned State Drugs Controller for necessary action under the provision of the Drugs Act and Rules.
