Pharmacotherapy with fixed dose combination (FDC) drugs is becoming popular as evidence-based clinical guidelines recommend using multiple therapeutic agents in complex regimens for many chronic diseases including type 2 diabetes mellitus (T2DM). FDC formulations have unique advantages such as complementary mechanism of action, synergistic effects, better tolerability, elongated product life-cycle management, and cost savings. Polypharmacy is a frequent problem in T2DM patients having hypertension, dyslipidemia, and other comorbidities. Use of FDCs is a rational approach for achieving optimal therapeutic benefits while minimizing pill-burden. Greater convenience with decreased pill-burden leads to improved adherence, resulting in superior clinical outcomes and greater cost-effectiveness. However, the general guidance for the clinical development and approval of FDC drugs in India is not much standardized. For rationale approval, the central and state regulators must harmonize their procedures for licensing FDCs. Because regulatory approval of FDCs is based on bioavailability data, similar to the way generic medications are approved, the lack of prospective, randomized controlled trials directly comparing FDCs with their component drugs administered as separate pills should not be considered a limitation to their use. Nevertheless, all new and existing FDC products should be subjected to submission of longterm safety surveillance through closely monitored national level postmarketing studies.
© Journal of the Association of Physicians of India 2011.