The Central government has issued a ban on the manufacture, sale, and distribution of the fixed-dose combination (FDC) drug containing Etodolac and Paracetamol, citing the lack of therapeutic justification and potential risks to human health. The decision follows a recommendation by the Drugs Technical Advisory Board (DTAB), which found the combination to be “irrational.” This ban, effective immediately, was first notified in 2018 but was challenged in court, leading to a reassessment that confirmed the prohibition.
In addition to the ban, the government has imposed restrictions on the use of two other FDC drugs that combine Naproxen with antacids, specifically Naproxen IP 375mg with Esomeprazole Magnesium Trihydrate IP 20mg, and Naproxen IP 250/500mg with Pantoprazole IP 20mg. These drugs, used primarily for treating conditions like osteoarthritis and rheumatoid arthritis, will be allowed under strict conditions to minimize the risk of developing NSAID-associated gastric or duodenal ulcers. Manufacturers are required to demonstrate the bioequivalence of these drugs with international standards within one year.
This move is part of the government’s ongoing efforts to regulate the safety and efficacy of FDC drugs. In recent years, the Central government has banned several other FDCs, including a significant ban on 344 drug combinations in 2016, due to concerns over their safety and the lack of scientific data supporting their use. The government continues to monitor and review the usage of such drugs to ensure patient safety.
Post Your Comments