This book examines the impact of economic reforms in India on the pharmaceutical industry and access to medicines. It traces the changing production and trade pattern of the industry, research and development (R&D) preferences and strategies of Indian pharmaceutical firms, the patent system, pricing policy measures and their shortcomings. It also analyses the public health financing system in India driven largely by out-of-pocket expenditure -about 60 per cent -and characterised by a very high share of medicines in total health expenditure.A masterful insight into a topical area, the work will be indispensable to those working in the pharmaceutical industry and on public policy. It At a time when countries of the South Asian region are in a state of flux, reflected in far-reaching economic, political and social changes, this series aims to showcase critical analyses of some of the central questions relating to the direction and implications of those changes. Volumes in the series focus on economic issues and integrate these with incisive insights into historical, political and social contexts. Drawing on work by established scholars as well as younger researchers, they examine different aspects of political economy that are essential for understanding the present and have an important bearing on the future. The series will provide fresh analytical perspectives and empirical assessments that will be useful for students, researchers, policy makers and concerned citizens.The first books in the series cover themes such as the economic impact of new regimes of intellectual property rights, the trajectory of financial development in India, changing patterns of consumption expenditure and trends in poverty, health and human development in India, and land relations. Future volumes will deal with varying facets of economic processes and their consequences for the countries of South Asia.
India's generic pharmaceutical producers face numerous challenges after the country's patent law was amended to make it compatible with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Two amendments were significant: introduction of product patent regime covering the area of pharmaceuticals, replacing the process patent regime existing earlier, and increase in patent term for pharmaceutical patents to 20 years, from the earlier 5-7 years (5 years from sealing of patent or 7 years from the date of application, whichever was lower). India's pre-TRIPS patent regime that did not allow product patents in the pharmaceutical sector provided the impetus for the emergence of a generic pharmaceutical industry from the 1980s. How did the Indian pharmaceutical industry respond to the challenges posed by the TRIPS-consistent patent regime, in particular the product patent regime? This paper analysed a number of functional parameters to answer this question. Analysis of the parameters explaining the size and the operational strengths of the major companies in the industry did not suggest structural weaknesses in the generic companies. They continued to remain the leaders in the industry, both in terms of invested capital and size of operations. They remained viable: their profit rates were higher than those in most major manufacturing sectors in India. Although the major generic companies are all producers of generic medicines, they continued to invest sizeable shares of their sales turnover in research and development (R&D). They have been active in taking patents, but their filings in foreign jurisdictions were significantly higher.
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