The Union ministry of health and family welfare has banned 16 more fixed dose combinations (FDC), including skin medications, painkillers and muscle relaxants, that it felt had limited therapeutic use, according to people familiar with the matter.
“The health ministry has issued notifications under Section 26A of the Drugs and Cosmetics Act, 1940, prohibiting the manufacture for sale, sale and distribution for human use of 16 FDCs. The notifications have come into force with immediate effect,” read the health ministry statement.
FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also referred to as “cocktail” drugs.
According to the health ministry, the decision followed directions of the Supreme Court, which mandated a comprehensive review of FDCs available in the country. In compliance with these directions, the Drugs Technical Advisory Board (DTAB) constituted an expert committee to examine various FDCs and identify those that are “irrational, lack therapeutic justification or may pose risks to human health.”
“Based on the scientific assessment and recommendations of the expert committee, the government has taken action against 16 FDCs that were found to lack therapeutic justification and whose continued use was not considered beneficial in relation to the potential risks involved,” read the health ministry statement
The prohibited FDCs belong to various therapeutic categories, including certain dermatological preparations, analgesic and antispasmodic medicines and antibiotic-based formulations.
Among the FDCs banned are the combinations of aloe extract, allantoin , alphatocopherol acetate, D-penthenol and vitamin A; aloe extract, vitamin E, dimethicone and glycerine; aloe vera , jojoba oil, wheat germ oil and tea tree oil; dicyclomine, paracetamol and clidinium bromide; dicyclomine, paracetamol and clidinium bromide; paracetamol and lignocaine; amoxicillin, serratiopeptidase and lactobacillus sporogenes; amoxicillin, cloxacillin, lactic acid bacillus and serratiopeptidase; cefadroxyl and probenecid; cefuroxime and Serratiopeptidase.
“The ministry noted that this action is in line with the government’s continuing efforts to ensure that only safe, effective and scientifically validated medicines are available to the public. In previous instances as well, several irrational FDCs were prohibited following detailed scientific review, reinforcing the commitment of the government towards patient safety and evidence-based healthcare,” read the health ministry statement.
“Accordingly, the manufacture, sale, distribution and supply of the identified 16 FDCs for human use shall stand prohibited with immediate effect across the country,” the statement read.
All state drug controllers, regulatory authorities and enforcement agencies have been directed to ensure strict implementation and compliance with the notifications. Manufacturers, importers, distributors and other stakeholders have also been advised to take necessary corrective measures to comply with the provisions of the law.
The government in 2016 announced ban on 344 FDCs after an expert panel’s recommendations.
Between 2023 and 2025, a total of 205 FDCs have been banned as part of the exercise to phase out unapproved fixed dose combination drugs from Indian market. Many of the FDCs banned over the years were also from those 344 drug combinations.
