Centre Prohibits 16 Fixed-Dose Drug Combinations Over Safety Concerns
The central government has prohibited the manufacture, sale, and distribution of 16 fixed-dose combination (FDC) drugs, citing a lack of therapeutic justification and potential risks to public health. The Union Health Ministry announced the ban under Section 26A of the Drugs and Cosmetics Act, 1940, with immediate effect across the country.
FDC drugs contain two or more active pharmaceutical ingredients in a fixed ratio. The decision follows a review mandated by the Supreme Court, which led the Drugs Technical Advisory Board (DTAB) to form an expert committee. The committee examined various drug combinations and identified those deemed irrational, therapeutically unjustified, or potentially harmful.
The ministry stated that the banned FDCs 'lack therapeutic justification' and were 'not considered beneficial' relative to the risks involved. The prohibited list includes combinations spanning dermatological, analgesic, antispasmodic, and antibiotic categories. Examples include Acetyl Salicylic Acid with Ethoheptazine; Dicyclomine, Paracetamol, and Clidinium Bromide; Gliclazide with Chromium Picolinate; and Paracetamol with Lignocaine.
Several antibiotic-based combinations are also banned, such as Amoxicillin with Serratiopeptidase, Amoxicillin with Cloxacillin and Lactobacillus Sporogenes, and Cefuroxime with Serratiopeptidase. Additionally, dermatological formulations containing Aloe Vera or Aloe Extract combined with ingredients like Vitamin E, Jojoba Oil, and Tea Tree Oil are prohibited.
The ministry emphasised that the ban aims to promote rational medicine use and strengthen patient safety. It recalled previous prohibitions of irrational FDCs following scientific reviews. All state drug controllers, regulatory authorities, and enforcement agencies have been directed to ensure strict implementation. Manufacturers, importers, distributors, and other stakeholders are advised to comply with the law.
