Determinants of drug launch delay in pre-TRIPS India: A survival analysis approach

The dynamics of drug launch has been an under-researched area. Most of the studies in this field focus on developed countries, quite uniform in terms of disease profile and regulatory framework, and analyse whether stringency in regulation influences launch delay. Developing countries, in contrast, have diverse disease profiles and weaker forms of regulation. A limited set of studies, undertaken in recent years, on the diffusion of new drugs in developing countries indeed conjectures importance of such factors in shaping drug launch dynamics. We investigate the delay of new drug launch in India for drugs launched in the German market during 1990-2004, when, due to weak IPR, not only the innovators but also the domestic firms could launch new drug molecules in the country, making drug launch dynamics interesting to explore. The paper finds that global commercial success of a new drug, market share, first mover advantage, and the threat of imposition of strong IPR system shortens delay. Innovativeness of a new drug, surprisingly, does not have much significant impact on delay.