Overview
- The Health Ministry on Saturday issued notifications under Section 26A of the Drugs and Cosmetics Act that prohibit the manufacture, sale, distribution and supply of 16 named fixed‑dose combination (FDC) medicines with immediate effect across India.
- The banned products cover several categories, including antibiotic combinations, painkillers and antispasmodics, and multiple topical skin formulations; named examples reported include paracetamol with lignocaine, several amoxicillin‑serratiopeptidase mixes, and Aloe‑based topical blends.
- The move follows a Supreme Court‑mandated review by the Drugs Technical Advisory Board and its expert committee, which concluded these FDCs lack therapeutic justification, offer no proven added benefit and may raise risks such as adverse reactions and antibiotic resistance.
- The ministry has directed state drug controllers and enforcement agencies to implement the ban immediately and told manufacturers, importers and distributors to take corrective measures while advising patients not to stop prescribed medicines without consulting a clinician.
- The action continues a multi‑year effort to remove irrational FDCs from the market after earlier rounds of prohibitions, including a 2016 ban on 344 FDCs and further removals between 2023 and 2025, and it raises questions about how quickly clinicians and pharmacies will shift prescriptions and supply chains.