FDC Drug Ban

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

The FDC is also effective in treating symptoms like watery eyes, runny nose, sneezing and other discomforts

In August, the government banned 156 FDCs, including antibiotics, antiallergics, pain relievers, multivitamins, and combination treatments for fever and hypertension, citing health risks

The list of FDCs banned includes antibiotics, anti-allergics, painkillers, multivitamins, and combination doses for fever and hypertension, among others

In a significant move to safeguard public health, the Indian government has banned 156 fixed-dose combination (FDC) drugs, citing concerns over their safety and efficacy. Watch the video to know more.

The government banned 14 FDCs in June that affected around Rs 824 crore of the domestic pharmaceuticals market

72 pharmaceutical companies have brands that fall under banned FDCs, says one expert

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

These drugs were found to be irrational and without therapeutic justification

Centre had notified a ban 344 fixed-dose combination drugs, impacting large pharma firms such as Pfizer, Abbott, GSK and Cipla

Around 400 companies and 2,000 drugs have been affected by the Centre's latest ban on 344 FDCs

Some of these companies happily pay millions in penalties in developed markets when their standards are exposed but are complaining when Indian regulators take similar measures