Regulatory Challenges in Approval and Control of Fixed Dose Combinations (FDCs) in India

Fixed Dose Combinations (FDCs) are medicines containing two or more active pharmaceutical ingredients in a single dosage form. India is one of the largest producers and consumers of FDCs globally. While rational FDCs improve patient compliance and therapeutic outcomes, irrational combinations pose serious public health risks including adverse drug reactions, therapeutic failure, and antimicrobial resistance. The Central Drugs Standard Control Organization (CDSCO) governs FDC regulation under the Drugs and Cosmetics Act, 1940. Despite regulatory reforms, approval inconsistencies, weak pharmacovigilance, and enforcement gaps remain. This paper examines regulatory challenges associated with FDC approval and control in India, including the 2016 ban on over 300 irrational combinations, and provides recommendations for strengthening the regulatory framework.