A Review on Regulatory Aspects of Generic Dru...

A Review on Regulatory Aspects of Generic Drug Development Process, Their Challenges & Current Scenario

Author Name : Mr. N. C. Chavan, Dr. H. D. Mahajan, Dr. T. J. Shaikh, Mr. R. S. Patil, Mr. A. A. Chaudhari, Miss. H. Y. Bhadane

ABSTRACT Generic drug product development approach is scientifically and technically totally different by the branded product produced by pharma industry. In the current Scenario generic drug plays an important role in pharmaceutical market. By minimum marketing expenses and no R&D cost generic drug are available in cheaper price and bioequivalent to branded drugs. They have to in development process will be Regulatory aspect are give in there approval process This study will be discuss on various challenges occurred in generic drug development process and current scenario in generic medicines.