SRINAGAR: The Government of India has recently imposed a ban on 156 fixed-dose combination (FDC) medicines, which include commonly used antibiotics, painkillers, and multivitamins. This decision comes after concerns over the safety and therapeutic justification of these medicines.
The ban, which was enacted in August 2024, aims to safeguard public health by addressing the risks posed by these drugs, some of which were found to have no valid therapeutic justification.
The Ministry of Chemicals and Fertilizers, responding to a Lok Sabha query, stated that the ban was initiated under the provisions of the Drugs and Cosmetics Act, of 1940. This law allows the government to regulate, restrict, or prohibit the manufacture and sale of any drug that may pose a risk to human health or animals. When concerns about certain drugs arise, they are examined by expert committees, including the Drugs Technical Advisory Board (DTAB), which make recommendations for action.
The ban follows the findings of an expert committee headed by Professor C.K. Kokate, which assessed the safety and efficacy of several FDCs. The committee identified various FDCs as irrational or being produced without proper licenses, leading to their prohibition.
The government has also emphasized that the manufacture, sale, or distribution of banned FDCs is a punishable offence, with state licensing authorities empowered to take legal action against offenders. The list of banned FDCs, including the 156 medicines, is available on the Central Drugs Standard Control Organisation (CDSCO) website.
These measures, the government said, are part of the government’s ongoing efforts to ensure that only safe and effective medicines are available to the public and to prevent the risks associated with irrational drug combinations.
