More vigilance on generic drugs are necessary

The results of PK/PD studies, the toxicity studies, phase I-III clinical trials, and studies in special populations like elderly and in renal and hepatic dysfunction are available in public domain. API of the branded drug may differ from generic in terms of various synthesis related (e.g., starting material, impurities, residual solvents, polymorphism, isomerism, and manufacturing process) and formulation related factors (solubility, particle size, bulk density, polymorphism, and flowability). [...]in fixed drug combinations (e.g., Vildagliptin+ Metformin), various technologies like monolithic, bilayered, hot-melt extrusion, etc. may differ between the brand and generic products.