India Bans 16 Combination Drug Formulations Over Safety and Efficacy Concerns

By Mahima Katal

New Delhi, June 20 — India has banned the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs after health authorities concluded that the products lacked sufficient therapeutic justification and posed potential risks to public health.

The decision, announced by the Union Health Ministry on Saturday, takes immediate effect nationwide and follows a scientific review of combination medicines conducted in line with directions from the Supreme Court.

Fixed-dose combination drugs contain two or more active pharmaceutical ingredients in a single formulation. While such medicines can improve patient compliance and treatment outcomes when appropriately designed, regulators said the banned combinations failed to demonstrate clear medical benefits that outweighed their risks.

"The identified formulations lack therapeutic justification and are not considered beneficial in relation to the potential risks involved," the ministry said in a statement.

The review was carried out by an expert committee constituted by the Drugs Technical Advisory Board (DTAB), India's highest statutory body on technical matters related to drug regulation. The committee was tasked with identifying drug combinations that were irrational, medically unjustified or potentially harmful.

The banned formulations span several therapeutic categories, including pain-relief medications, muscle relaxants, antibiotics and dermatological products.

Among the prohibited combinations 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 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.

In addition, the government has prohibited a number of skincare and dermatological 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 ban was issued through notifications under Section 26A of India's Drugs and Cosmetics Act, 1940, which empowers the government to prohibit drugs deemed unsafe or lacking therapeutic value.

The Health Ministry said the action forms part of broader efforts to promote the rational use of medicines and strengthen patient safety. India has previously banned several fixed-dose combinations following scientific reviews that found them to be ineffective or potentially harmful.

State drug regulators and enforcement agencies have been directed to ensure strict implementation of the order, while manufacturers, importers and distributors have been asked to take immediate steps to comply with the new regulations.