Govt bans 156 combination drugs, mostly used for fever and pain
In a decisive effort to protect public health, the Ministry of Health and Family Welfare has banned the manufacture, sale, and distribution of 156 fixed-dose combination (FDC) drugs, which include widely used treatments for common conditions such as colds, fevers, and pain relief. The ban follows a thorough evaluation by an Expert Committee and the Drugs Technical Advisory Board, which found that these FDCs lacked therapeutic justification and posed potential health risks.
This sweeping action represents the most extensive crackdown on FDCs since 2016, when 344 such drugs were prohibited. Among the banned combinations are well-known drugs like mefenamic acid with paracetamol, used for pain and fever, and omeprazole magnesium with dicyclomine HCl, commonly prescribed for abdominal pain. The decision is expected to significantly impact major pharmaceutical companies, including Sun Pharmaceuticals, Cipla, Dr. Reddy's Laboratories, Torrent Pharmaceuticals, and Alkem Laboratories.
FDCs, often referred to as "cocktail drugs," combine two or more active pharmaceutical ingredients in fixed ratios. The government's move comes in response to concerns about the irrational use of these combinations and the availability of safer alternatives. The health ministry's notification emphasized that the use of these FDCs could pose risks to human health, making their prohibition necessary under Section 26A of the Drugs and Cosmetics Act, 1940.
A contributing factor to the crackdown was the issuance of manufacturing licenses for several FDCs by state authorities without the required approval from the Central Drugs Standard Control Organisation (CDSCO), resulting in the distribution of untested and potentially unsafe drugs. The ban aims to rectify these regulatory lapses and ensure the safety and efficacy of medications available in the market.
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