The Central government has banned the manufacture, sale and distribution of 16 Fixed Dose Combination (FDC) drugs across India with immediate effect, citing concerns over safety, effectiveness and lack of therapeutic justification. The decision was announced by the Ministry of Health and Family Welfare in a notification issued under Section 26A of the Drugs and Cosmetics Act.
The ministry’s notification stated, “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 move follows a scientific review of various FDCs marketed in India. The Drugs Technical Advisory Board (DTAB) set up an expert committee to assess whether these combinations were scientifically justified and safe for patients. Based on the committee’s recommendations, the government concluded that the 16 combinations were irrational and that their continued use posed potential risks without sufficient benefit.
The banned list covers several categories: antibiotic combinations, medicines used for pain relief and relief of abdominal cramps, and multiple aloe vera–based dermatological and skincare formulations. Named formulations include Acetyl Salicylic Acid with Ethoheptazine; Dicyclomine, Paracetamol and Clidinium Bromide; Dicyclomine, Paracetamol, Clidinium Bromide and Chlordiazepoxide; Gliclazide with Chromium Picolinate; and Paracetamol with Lignocaine.
Antibiotic combinations prohibited include 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 list also removes from the market several topical formulations combining 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.
Original Source: https://nenews.in/politics/centre-bans-16-fixed-dose-combination-drugs-cites-lack-of-therapeutic-justification/54706/
Category: Politics,banned products,Fixed Dose Combination,Ministry of Health and Family Welfare
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Publish Date: 2026-06-20 16:01:00
