The Central Government has prohibited the manufacture, sale, distribution and supply of 16 fixed-dose combination (FDC) drugs across India, citing concerns over their safety, efficacy and therapeutic value.
The Union Health Ministry said the decision follows a scientific review that concluded the identified drug combinations offer little or no therapeutic benefit and may pose health risks to patients.
“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 stated.
According to officials, the banned formulations were found to lack therapeutic justification and were not considered beneficial when weighed against the potential risks associated with their use.
Fixed-dose combination drugs contain two or more active pharmaceutical ingredients combined in a predetermined ratio. The latest action comes after a review conducted in line with directions issued by the Supreme Court.
As part of the process, the Drugs Technical Advisory Board (DTAB) set up an expert committee to examine various drug combinations and identify formulations that were irrational, therapeutically unjustified or potentially harmful.
The banned products cover a range of therapeutic categories, including certain pain-relief medicines, antispasmodics, antibiotic combinations and dermatological formulations.
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-based 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.
The ban additionally extends to a number of skincare and dermatological products 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 orders have been issued under Section 26A of the Drugs and Cosmetics Act, 1940.
Officials said the move is part of the government’s ongoing efforts to promote the rational use of medicines, enhance patient safety and ensure that only scientifically validated and effective drugs remain available in the market.
The ministry noted that several irrational FDCs have been banned in previous years following detailed scientific evaluations. State drug controllers and enforcement agencies have been directed to strictly implement the latest order, while manufacturers, importers and distributors have been asked to take necessary steps to ensure compliance.