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India Bans 35 Unapproved Fixed-Dose Combination Drugs

The CDSCO has directed state authorities to halt the production, sale, and distribution of these FDCs over safety concerns and enforce stricter compliance with drug regulations.

The approval of such unapproved FDCs compromises patient safety and may lead to adverse drug reactions.
FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also referred to as “cocktail” drugs. (REUTERS)

Overview

  • The Central Drugs Standard Control Organisation (CDSCO) has ordered the prohibition of 35 unapproved fixed-dose combination (FDC) drugs, including painkillers, nutritional supplements, and anti-diabetics.
  • The directive mandates state and union territory drug controllers to treat FDCs as new drugs, requiring rigorous safety and efficacy evaluations before approval.
  • The banned FDCs were previously licensed by state authorities without central clearance, compromising patient safety and increasing risks of adverse reactions and drug interactions.
  • Manufacturers have either voluntarily surrendered licenses or had them canceled by state drug authorities following show cause notices issued by the CDSCO.
  • This action is part of an ongoing crackdown on unapproved FDCs, with earlier bans in 2016, June 2023, and October 2024 targeting hundreds of unsafe combinations.