MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES

Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers otherthan the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost savingmeasure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Theobjective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory andlegislative level, from originator medicines. It describes the current and historical regulation of medicines in theworld’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between genericsand their originator equivalents including the reasons for the cost differences seen between originator and genericmedicines. This article refers to the general generic drug approval process in India, USA, and Japan. They havedifferent regulation and approval process.