The government has banned the manufacture, sale and distribution of drugs of 35 fixed dose combination (FDC). This decision is taken after cases of selling permission without these drugs, causing adverse effects to the health of the people. In this regard, the apex regulatory body (CDSCO) has written a letter to the drug controllers of all states and union territories instructing to ban, selling and distribution of 35 dislike fixed dose combination drugs. This includes pain relievers, nutritional and anti -diabetes drugs.
The CDSCO has asked all drug regulators to review the licensing process for fixed dose combination drugs (FDCs). Apart from this, the provisions of the Drugs and Cosmetics Act 1940 and the rules will also be strictly complied with. FDC medicines are those that contain two or more active pharmaceutical salts in a certain proportion. Recently, the top drug regulator has shown that some FDC drugs have been licensed for manufacturing, sales and distribution without safety and efficacy evaluation. This may pose a serious threat to public health and safety.
Drug Controller General of India (DCGI) Dr. Rajiv Raghuvanshi has expressed concern over the manufacture and sale of FDC medicines without permission to the drug controllers. He cited a letter issued in 2013. He said that several letters have been issued to the concerned state licensing officers, which allowed the construction and sale of unconcerned FDCs.
The letter issued in February 2025 also stated that it has come to the notice of the Directorate that under the Drugs and Cosmetics Act, 1940, some FDC medicines have been licensed for manufacturing, sales and distribution without prior evaluation of security and efficacy. This poses a serious threat to public health and safety. Approving such drugs compromise on the safety of patients. Lack of scientific authentication can cause adverse drug response, mutual activity between drugs and other health related threats.
He said that these licenses were provided by the related drug licensing authorities and no rules were violated in them. Therefore, the provisions of NDCT Rules 2019 are not equally applicable across the country under the Drugs and Cosmetics Act 1940. The letter states that drug controllers from all states and union territories should review their approval process for FDC and ensure strict compliance with the provisions of Act and rules. The letter also has a list of 35 rejected FDCs.
