Fixed-dose Combination

Health Ministry prohibits 16 fixed drug combinations, including antibiotic and cosmetic formulations, after an expert review found they lacked therapeutic justification and posed potential health risk

The Centre has prohibited the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs, saying they lack "therapeutic justification" and their continued use was not considered beneficial in relation to the potential risks involved. The move, the Union Health Ministry said, was to safeguard public health and promote rational use of medicines while ensuring only effective and scientifically validated medicines are available to the public. FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. The decision follows a review of FDCs undertaken in compliance with the Supreme Court's directions. The Drugs Technical Advisory Board (DTAB) had constituted an expert committee to examine various drug combinations and identify those that were irrational, therapeutically unjustified or potentially harmful. "The manufacture for sale, sale, distribution and supply of the identified 16 FDCs for human use shall sta

Sales declining anyway and there is no need to ban because of alleged misuse, say experts

The Centre had prohibited 344 FDCs from being produced and marketed in March

The decision comes in the back of a petition filed by South Indian Pharmaceutical manufacturers' federation