The Union Government has imposed an immediate ban on 16 Fixed-Dose Combination (FDC) drugs, ordering the halt of their manufacture, sale and distribution across India. The Ministry of Health and Family Welfare issued the orders under Section 26A of the Drugs and Cosmetics Act, after a scientific review flagged that these formulations lacked therapeutic justification and could pose risks to public health.
A Fixed-Dose Combination drug contains two or more active pharmaceutical ingredients combined in a single dosage form. The ban followed a Supreme Court-mandated review of the Indian drug market. Acting on the court's orders, the Drugs Technical Advisory Board (DTAB) constituted an expert committee to remove potentially harmful formulations from circulation. After reviewing the clinical data, the panel concluded that these 16 specific combinations offered no real therapeutic value to patients, leading to their immediate prohibition.
The banned combinations include several antibiotic-enzyme pairings such as Amoxicillin with Serratiopeptidase, Cefuroxime with Serratiopeptidase and Cefadroxyl with Probenecid, along with formulations like Paracetamol with Lignocaine, Gliclazide with Chromium Picolinate, and various aloe-based skincare combinations. Some combinations paired antispasmodics such as Dicyclomine with Paracetamol and Clidinium Bromide.
The move reflects a continuing regulatory effort to weed out irrational drug combinations that may expose patients to unnecessary risk without delivering proven benefit. Section 26A empowers the central government to prohibit the manufacture and sale of a drug in the public interest. The decision strengthens drug safety oversight and aligns the Indian market with evidence-based prescribing standards.