Rationality of Fixed Dose Combinations: Necessity to Weed out the Irrational Combinations Mushrooming in Pharmaceutical Industry

An innovation in drug therapy can take various forms, including new agents, new indications for existing drugs, and new dosage forms with improved pharmacological profiles.Combination therapy with two or more agents having complementary mechanisms of action represents a type of incremental innovation that has extended the range of therapeutic options in the treatment of almost every human disease. Combination products also known, as fixed-dose combinations are combinations of two or more active drugs produced in a single dosage form. They provide the advantages of combination therapy while reducing the number of prescriptions and the attendant administrative costs. The Indian laws have not been properly defined to grant marketing approvals of the fixed dose combinations (FDCs) by state or central drug controlling authorities. There is alarming increase in irrational FDCs in recent years and pharmaceutical companies manufacturing these FDCs are luring physicians to prescribe by unethical means. Unfortunately, the real contribution of combination products to therapeutics has been blurred by perceptions of inherent disadvantages. Considering these criteria it is essential to weed out the irrational combinations mushrooming in pharmaceutical industry at present.