Fixed Dose Combination Productsof Anti-hypertensive’sand Anti-diabetic’s - Indian Regulatory Perspective against Usa and Eu

Fixed dose combination (FDC) products are gaining more interest by pharma companies worldwide considering their importance in treating the disease and the increased safety/efficacy profile. Very few general guidelines are available with respect to FDCs in USA whereas Europe has some guidelines while India has just started developing such guidelines. Indian market is flooded with several irrational formulations / combinations, and western markets such as USA and Europe are still very cautious in giving approvals for FDCs. Lack of stringent guidelines, proper approval processes and the strict oversight can be considered as major reasons for such irrational drugs in Indian market.