Pharmaceutical Industry and Public Policy in Post-reform India

Abstract

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.

Pharmaceutical Market and Drug Price Policy in India

“…Such policy, since inception, has attracted criticism from opposite groups—industry bodies as well as those concerned with consumers’ access and affordability (Drug prices, 1965; Nair, 1965). Price control orders were criticised for their coverage, inclusion and exclusion in the list (span of control; Joseph, 2016; Rane, 1996, 2002; Srinivasan, 2001). In 1970, most drugs were under price control but the list was reduced to select 349 APIs in 1979, 142 in 1987 and to only 74 APIs in 1995 (GoI, 2005).…”

The Drug Discovery and Development Industry in India—Two Decades of Proprietary Small‐Molecule R&D

“…Initially dominated by major pharmacompanies, in particular DRL, Ranbaxya nd Glenmark, the out-licensing model experienced severalr esoundingf ailures, including in Phase 2s tudies, which led some analysts to claim the death of the Indian outlicensingm odel. [14] Whereas the steady decrease of licensed compounds appearst oc onfirmt his for large Indian pharma companies, the reversei st rue for biotech companiesw ith 10 licensing or option agreements since 2011, largely led by Aurigene, and illustrates the continuing attractiveness of Indiandevelopment compoundsf or global companies.…”

“…Drug discovery and pharmaceutical R&D in India has been reviewed and analyzed previously,b ut generally from specific points of view,s uch as its historical background, [6][7][8] the fate of the big pharma companies, [5,9] or the impact of process versus product patent output as ac onsequence of the Agreement on Trade-Related Aspects of Intellectual Property Rights( the socalled TRIPS agreement). [10] Other authors have analyzed its so-cioeconomic impact and public policy implicationsa nd recommendations, [11][12][13][14][15] drug development in India and in comparison with other emerging countries, [16,17] drug discovery in private companies and in publiclyf unded institutions, [18,19] current changes ando pportunities, [20,21] or out-licensing deals. [22] We recently reviewed contract and collaborative research alliances between Indiana nd globalp harmaceutical companies.…”

Therapies Out of Reach: Anticancer Drugs and Global Trade Regimes

“…Substantively, we offer an account of how such treaties effect the global market for anticancer drugs, a class of medication that has already come under intense scrutiny for their exorbitant pricing. In doing this, we build on scholarship that has critically examined the effects of the WTO agreement on pharmaceutical pricing, production and patenting in India (e.g., Chaudhuri, 2012; Chorev & Shadlen, 2015; Horner, 2013; Joseph, 2016; Sampat & Shadlen, 2015). Finally, we offer policy suggestions that could help curb the price increases in the anticancer drug market that make these drugs unaffordable to most cancer patients in the world.…”