India bans 16 fixed-dose combination drugs effective now

The Indian government has banned the manufacture, sale, and distribution of 16 fixed-dose combination (FDC) drugs with immediate effect, citing a lack of therapeutic justification and potential health risks. The nationwide prohibition, announced on June 20, 2026, by the Ministry of Health and Family Welfare, follows a Supreme Court-mandated review of such drug combinations.

The decision was implemented under Section 26A of the Drugs and Cosmetics Act, 1940, after an expert committee concluded the banned formulations offered no significant benefit over separate medicines and their risks outweighed any potential advantages. The committee was constituted by the Drugs Technical Advisory Board (DTAB) in compliance with the Supreme Court's directions for a comprehensive review of FDCs available in the country.

Officials stated the action is part of ongoing efforts to ensure only safe, effective, and scientifically validated medicines are available to the public. They noted that similar bans on irrational drug combinations have been enacted in the past following detailed scientific reviews, reinforcing a commitment to evidence-based healthcare and patient safety.