New Delhi: The Ministry of Health and Family Welfare has issued a ban on over 150 fixed-dose combination (FDC) drugs with immediate effect. The government has cited these combinations as irrational and posing a significant health risk to humans. This decision was made following recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB), which both deemed these FDCs to lack therapeutic justification and identified them as potential risks to public health. The ministry has issued a notification, necessitating a ban on the manufacture, sale, and distribution of FDC under section 26A of the Drugs and Cosmetics Act, 1940.
The crackdown comes after it was found that some state licensing authorities granted manufacturing licenses for several FDCs without prior approval from the Central Drugs Standard Control Organisation (CDSCO), leading to the circulation of untested and potentially unsafe drug combinations. This ban is part of a broader effort to regulate the pharmaceutical industry, following previous actions such as the prohibition of 344 combination drugs in March 2016 and 14 more in June 2023. Reports suggest that many of the products on the latest banned list had already been discontinued by several drug manufacturers. The impact of this ban is expected to be minimal for larger pharmaceutical companies, which have shifted focus towards safer and more rational drug combinations. However, smaller companies might feel the strain, as they have fewer resources to innovate and adapt to these regulatory changes.