Race To The Generic Launch

Introduction

In a bid to delay the launching of generic drugs, the multinational drug manufacturers have recently asked the Indian government to develop a registry which will have all the collated information regarding drug applications pending manufacturing and marketing approval. This is not the first time that these pharma giants have tried hindering the process of generic drug development. Previously, there was an attempt to prevent generic drug players from conducting research and development during the life of the patent. This would in-turn lead to a delay in the marketing of the generic drug after the patent expiry of the brand company's drug. In the US, this is not possible because of the Hatch-Waxman provision which encourages competition and lower prices and allows generic companies to conduct experiments using safety and effectiveness studies of the innovator during the life of the patent. Furthermore, in the US there is an on-going effort to pass CREATES