They lack therapeutic justification: Centre bans 16 fixed-dose combination drugs

Published 20 June 2026 · india

The Centre has prohibited the manufacture, sale, distribution and supply of 16 fixed-dose combination, or FDC, drugs for human use across the country with immediate

The Centre has prohibited the manufacture, sale, distribution and supply of 16 fixed-dose combination, or FDC, drugs for human use across the country with immediate effect, saying they lack "therapeutic justification" and that their continued use is "not considered beneficial" in relation to the risks involved. The Union Health Ministry said the step was taken to safeguard public health, promote the rational use of medicines and ensure that only effective and scientifically validated medicines are available to the public. FDC drugs are medicines that contain two or more active pharmaceutical ingredients in a fixed ratio. Read Full Story The decision follows a review of FDCs carried out in line with the Supreme Court's directions.

The Drugs Technical Advisory Board had set up an expert committee to examine various drug combinations and identify those that were irrational, therapeutically unjustified or potentially harmful. In a notification issued under Section 26A of the Drugs and Cosmetics Act, 1940, the ministry said, "The manufacture for sale, sale, distribution and supply of the identified 16 FDCs for human use shall stand prohibited with immediate effect across the country." The ministry said the banned formulations cover a range of therapeutic categories, including certain dermatological preparations, analgesic and antispasmodic medicines, and antibiotic-based combinations. Among the prohibited formulations are Acetyl Salicylic Acid with Ethoheptazine; Dicyclomine, Paracetamol and Clidinium Bromide; Dicyclomine, Paracetamol, Clidinium Bromide and Chlordiazepoxide; Gliclazide with Chromium Picolinate; and Paracetamol with Lignocaine.

Several antibiotic-based combinations have also been banned, including Amoxicillin with Serratiopeptidase, Amoxicillin with Serratiopeptidase and Lactobacillus Sporogenes, Amoxicillin with Cloxacillin, Lactic Acid Bacillus and Serratiopeptidase, Cefadroxyl with Probenecid, and Cefuroxime with Serratiopeptidase. The banned list also includes several dermatological and skincare formulations containing combinations of Aloe Vera or Aloe Extract with ingredients such as Vitamin E, Jojoba Oil, Orange Oil, Wheat Germ Oil, Tea Tree Oil, Allantoin and D-Panthenol. The ministry said the action is part of the government's efforts to promote the rational use of medicines and strengthen patient safety, and noted that several irrational FDCs had been prohibited in previous years after detailed scientific reviews.