The Center has banned 16 fixed-dose combination (FDC) medicines across India, stating that these drug formulations do not have adequate therapeutic justification and that the potential risks associated with their use outweigh any proven benefits.
The Union Health Ministry said the decision was taken in the interest of public health and forms part of the government’s broader effort to encourage the rational use of medicines while ensuring that only scientifically validated treatments remain available in the market.
Fixed-dose combination drugs contain two or more active pharmaceutical ingredients combined in predetermined proportions within a single formulation.
The prohibition follows a detailed review of such medicines conducted in line with directions issued by the Supreme Court. As part of the exercise, the Drugs Technical Advisory Board (DTAB) appointed an expert committee to assess various drug combinations and identify formulations considered irrational, therapeutically unjustified or potentially unsafe.
Following the committee’s recommendations, the ministry announced that the manufacture, sale, distribution and supply of the identified 16 FDC drugs for human use would be prohibited with immediate effect nationwide.
According to the ministry, the banned formulations were found to offer limited therapeutic value and were not considered appropriate when weighed against the associated health risks.
The list includes medicines from several treatment categories, such as pain-relief drugs, antispasmodics, antibiotics and dermatological products.
Among the combinations prohibited are Acetyl Salicylic Acid with Ethoheptazine, Dicyclomine with Paracetamol and Clidinium Bromide, Dicyclomine with Paracetamol, Clidinium Bromide and Chlordiazepoxide, Gliclazide with Chromium Picolinate, and Paracetamol with Lignocaine.
Several antibiotic combinations have also been barred, including formulations containing Amoxicillin and 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 covers a number of skincare and dermatological products that combine 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.
The ministry issued the notifications under Section 26A of the Drugs and Cosmetics Act, 1940.
Officials said the latest action is part of an ongoing initiative to strengthen patient safety and eliminate irrational drug combinations from the market. The ministry noted that several similar FDC formulations have been prohibited in recent years following scientific evaluation and regulatory review.
State drug regulators and enforcement authorities across the country have been instructed to ensure strict implementation of the ban. Manufacturers, distributors, importers and other stakeholders have also been directed to take the necessary steps to comply with the new regulations.
