Stating that certain drug cocktails lack therapeutic justification and could pose risks to patients, the Union Ministry of Health and Family Welfare has banned 16 fixed dose combination medications in public interest.
The prohibited drugs include certain dermatological preparations, analgesic and antispasmodic medicines, and antibiotic-based formulations that have been deemed irrational or unsafe.
A fixed dose combination (FDC) is a medicine containing two or more active drugs combined in a fixed ratio in a single dosage form. While some FDCs improve treatment compliance and therapeutic effectiveness, irrational combinations may be ineffective or harmful.
The Ministry used its powers under Section 26A of the Drugs and Cosmetics Act to prohibit the manufacture, sale, and distribution of irrational FDCs after an expert review.
The order is effective immediately, and directs all State drug controllers, regulatory authorities, and enforcement agencies to ensure strict implementation and compliance. Manufacturers, importers, distributors, and other stakeholders have also been advised to take necessary corrective measures to comply with the provisions of the law.
This action is in line with the Centre’s continuing efforts to ensure that only safe, effective and scientifically validated medicines are available to the public, the Health Ministry said in a statement on Saturday (June 20, 2026). Earlier in the week, the Ministry had also banned the over-the-counter sale of all medicinal syrups, in the wake of multiple deaths in India and abroad linked to adulterated cough syrups.
“In previous instances as well, several irrational FDCs were prohibited following detailed scientific review, reinforcing the commitment of the Government towards patient safety and evidence-based healthcare. Accordingly, the manufacture for sale, distribution and supply of the identified 16 FDCs for human use shall stand prohibited with immediate effect across the country,’’ it said.
Published - June 20, 2026 03:53 pm IST
Source: The Hindu - India News
