India's 2024 Ban on Fixed-Dose Combinations: Implications for Safety, Efficacy, and Regulatory Policy

Introduction: Fixed-dose combination (FDC) drugs have emerged as a promising strategy to enhance patient compliance and simplify treatment regimens, especially in cases requiring multiple medications. Their growing use in clinical practice highlights their potential benefits in managing complex diseases. This review aims to evaluate the current challenges associated with FDCs, focusing on issues related to safety, efficacy, and regulatory oversight. Special attention is given to the recent ban on irrational FDCs by the Indian government. Methods: A comprehensive literature review was conducted using scientific databases and policy reports. The review analyzed pharmacokinetic and pharmacodynamic concerns, manufacturing challenges, and regulatory frameworks governing FDC development and approval. Results: FDCs reduce pill burden and improve adherence, but major concerns remain regarding dose inflexibility, adverse drug interactions, and the emergence of antimicrobial resistance. The 2024 ban on 156 FDCs in India underscores the need for rigorous safety evaluations and rational drug combinations. Technological advancements, such as 3D printing, show potential for producing personalized FDCs, but face limitations due to regulatory and material safety concerns. Discussion: The findings emphasize the critical need for rational FDC formulation, as many banned combinations lacked therapeutic justification and posed safety risks. This aligns with existing literature highlighting pharmacokinetic incompatibilities and adverse drug reactions. However, the study is limited by its reliance on secondary data and the exclusion of non-English publications, which may restrict broader applicability. Conclusion: To maximize the public health benefits of FDCs, stronger regulatory measures, evidence- based formulation practices, and pharmacogenetic screening are necessary. Incorporating FDC approval with WHO prequalification standards and implementing quality-by-design protocols can ensure the development of safe, effective, and patient-focused combination therapies.