What Government Said About Fixed Dose Combination (FDC) Antibiotics

The Minister of State in the Ministry of Health and Family Welfare, Anupriya Patel, addressed concerns in the Rajya Sabha today regarding the regulation of Fixed Dose Combination (FDC) antibiotics. Responding to questions raised by MP Kanimozhi, she detailed the government’s actions in monitoring and controlling the manufacture and sale of these drugs.

Patel explained that the manufacture, sale, and distribution of drugs in India are governed by the Drugs & Cosmetics Act, 1940, and its accompanying rules. These regulations ensure that all drugs, including FDCs, undergo a licensing and inspection process overseen by State Licensing Authorities (SLAs), which operate under respective state governments. She highlighted that any FDC classified as a “new drug” requires prior approval from the Central Drugs Standard Control Organisation (CDSCO) before a state authority can grant a manufacturing licence.

The Minister acknowledged that certain State Licensing Authorities had issued manufacturing licences for new drugs, including FDCs, without the necessary approval from the Drugs Controller General of India (DCGI). In response to such instances, the Central Government has taken decisive action to regulate the market and prevent the uncontrolled proliferation of these drug combinations.

Patel outlined a series of government measures restricting the manufacture, sale, and distribution of specific FDCs over the years. The government had already prohibited 328 FDCs, including 63 antibiotic combinations, through a notification issued on 7 September 2018. Further restrictions were placed on six additional FDCs with specific conditions. Subsequently, on 11 January 2019, another notification led to the ban of 80 more FDCs, including 12 antibiotic combinations.

Most recently, the Central Government issued notifications on 2 June 2023 and 2 August 2024, banning 14 and 156 FDCs, respectively. Among these, 15 antibiotic combinations have been prohibited from manufacture, sale, or distribution in India. A complete list of banned FDCs is available on the Central Drugs Standard Control Organisation (CDSCO) website.

Patel also reminded the Rajya Sabha that under the Drugs & Cosmetics Act, 1940, the manufacture, sale, or distribution of banned drugs is a punishable offence. State Licensing Authorities have been given the power to take necessary action against those violating these regulations.