The Centre has prohibited the manufacture, sale and distribution of 16 fixed-dose combination (FDC) medicines, stating that these formulations do not have adequate therapeutic justification and may pose potential health risks. The Union Health Ministry said the move is aimed at protecting public health, promoting the rational use of medicines and ensuring that only scientifically validated and effective drugs are available in the market.
FDC drugs contain two or more active pharmaceutical ingredients combined in fixed proportions. The latest decision follows a review undertaken in compliance with directions from the Supreme Court. The Drugs Technical Advisory Board (DTAB) had constituted an expert committee to evaluate various FDCs and identify those considered irrational, therapeutically unjustified or potentially harmful.
Acting on the panel’s recommendations, the Ministry announced that the manufacture, sale, distribution and supply of the 16 identified FDCs for human use stand banned with immediate effect across the country. It noted that the potential risks associated with these combinations outweighed any expected benefits.
The prohibited formulations span multiple therapeutic categories, including certain dermatological products, pain-relief and antispasmodic medicines, as well as antibiotic combinations. Among those banned 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 combinations have also been barred, 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.
Additionally, the ban covers a number of dermatological and skincare formulations containing Aloe Vera or Aloe Extract combined with ingredients such as Vitamin E, Jojoba Oil, Orange Oil, Wheat Germ Oil, Tea Tree Oil, Allantoin and D-Panthenol.
The prohibition has been enforced through notifications issued under Section 26A of the Drugs and Cosmetics Act, 1940. The Health Ministry said the action is part of the government’s ongoing efforts to strengthen patient safety and encourage evidence-based prescribing practices. State drug regulators and enforcement agencies have been directed to ensure strict implementation, while manufacturers, importers and distributors have been advised to take immediate corrective measures to comply with the new regulations.
