Abstract: 
Fixed dose combination (FDC) are combinations of two or more active drugs in single dosage forms. It is the current hot topic of deliberation in the pharmaceutical industry, drug regulatory agency and pharmaceutical trade. It is not so among the doctor who prescribed the medicine or the patients who consume. Basically, it is increases the patients compliance but there are chances of consuming medicines, more than what is required. Reducing treatment complexity can be achieved through the use of single tablet fixed dose combinations of two active pharmaceutical ingredients. FDC’s improve patient compliance by reducing the number of pills. Clinical studies revealed that fixed dose combinations had many benefits compared to single entity and separate agents in terms of effects, convenience, compliance and cost. FDCs have become an important alternative to monotherapy in the treatment of diseases as hypertension, diabetes, cancer, tuberculosis, asthma and COPD by offering several advantages including patients compliance, simple dosage schedule, superior efficacy and tolerability, reduced risk of adverse events, cheaper shipment and packaging activities. In conclusion, FDCs had critical issues during evaluation such as safety efficacy, bioavailability and stability.

Keywords: Fixed Dose Combinations, Regulation of FDCs Products, India’s Regulatory Framework.