Overview
- The Union Health Ministry has prohibited the manufacture, sale, distribution and supply of 16 named fixed‑dose combination (FDC) medicines for human use with immediate effect across India.
- The banned products cover several categories, including analgesic and antispasmodic mixes, multiple antibiotic‑plus‑enzyme combinations, a diabetes adjunct and a range of Aloe‑based topical skin formulations; examples named by the ministry include Amoxicillin+Serratiopeptidase, Paracetamol+Lignocaine and Gliclazide+Chromium Picolinate.
- The decision follows a multi‑year scientific review ordered by the Supreme Court and led by a DTAB‑appointed expert committee whose process included public data submissions and a sub‑committee report that recommended prohibition in its final report dated December 28, 2024; the bans were issued in Section 26A notifications dated June 11 and published June 15.
- State drug controllers and enforcement agencies have been directed to implement immediate market withdrawal and manufacturers, importers and distributors must take corrective legal steps while patients are advised not to stop prescribed treatments without consulting clinicians.
- Regulators say the move aims to strengthen patient safety and rational prescribing by removing combinations the panel judged pharmacologically unjustified or likely to increase adverse reactions and antibiotic‑resistance risks, continuing a prior effort to eliminate irrational FDCs from the market.