The Centre has banned the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs across India, saying these medicines lack therapeutic justification and may pose risks to patients, according to a report by PTI. 

The Union Health Ministry said the move is aimed at protecting public health and ensuring that only scientifically validated medicines remain available in the market.

Ban takes immediate effect

"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.

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FDC drugs contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.

According to the Ministry, the decision follows a review of FDCs carried out in compliance with directions from the Supreme Court. The Drugs Technical Advisory Board (DTAB) had formed an expert committee to examine various drug combinations and identify those considered irrational, therapeutically unjustified or potentially harmful.

Why the drugs were banned

The Ministry said the banned combinations were found to "lack therapeutic justification" and were "not considered beneficial" with respect to the risks involved.

It added that the prohibited formulations cover several therapeutic categories, including certain dermatological preparations, analgesic (painkiller) and antispasmodic (muscle relaxant) medicines, as well as antibiotic-based combinations.

Drugs on the banned list

Among the banned formulations are combinations such as 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 prohibited, 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 a number of 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.

Government cites patient safety

The Ministry issued the notifications under Section 26A of the Drugs and Cosmetics Act, 1940.

It noted that the action is part of the government's efforts to promote the rational use of medicines and strengthen patient safety. The Ministry also recalled that several irrational FDCs had been prohibited in previous years following detailed scientific reviews.

All state drug controllers, regulatory authorities and enforcement agencies have been directed to ensure strict implementation of the notifications.

Manufacturers, importers, distributors and other stakeholders have also been advised to take necessary corrective measures to comply with the law.

Published on: Jun 21, 2026 11:46 AM IST