The Politics of the Pharmaceutical Industry and Access to Medicines : World Pharmacy and India book cover
1st Edition

The Politics of the Pharmaceutical Industry and Access to Medicines
World Pharmacy and India

Edited By

Hans Löfgren

ISBN 9781138103146
Published June 23, 2017 by Routledge
370 Pages

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Book Description

The book studies the pharmaceutical industry of India. It is one of the most successful stories of economic expansion and improvements in public health. Indian firms have made access to quality medicines possible and affordable in many developing countries. Indian pharmaceuticals are also exported on a large scale to the United States and other highly regulated markets. A wave of mergers, acquisitions and tie-ups point to growing integration between Indian firms and global pharma multinationals.

Please note: Taylor & Francis does not sell or distribute the Hardback in India, Pakistan, Nepal, Bhutan, Bangladesh and Sri Lanka

Table of Contents

1. The Pharmaceutical Industry and Access to Medicines in India

Hans Löfgren

The Pre-1972 Product Patent Period

The Process Patent Era 1972–2005

Full TRIPS-compliance from 2005

Financial and Economic Crisis and Access to Medicines for All

2. Challenges of Regulation of Medicines in India

S. Srinivasan and Anant Phadke

Price Regulation

Weeding Out of Irrational Medicines: A Necessary Complement to Price Control

Law on Banning Irrational Medicines

Towards Ethical Marketing and Promotion of Medicines

Promoting Transparency and Declarations of Conflict of Interest

General Review of all Legislations

Other Issues


3. CIPLA: Patients before Patents

Neelam Raaj

Modest Beginnings

Yusuf Hamied Living up to his Legacy

India’s Patent Law 1972

The Three Drug Combination: Potent Cocktail

A Life-saving Offer

Success Story

The Road Ahead

4. Systemic Failure of Regulation: The Political Economy of Pharmaceutical and Bulk Drug Manufacturing

G. Vijay

The Regulation of Industrial Pollution

Structure and Methodology

Structures of the Value Chains in the Rural Economy

Pathways of Pollution in the Dairy Industry

Regulatory Checks on Pathways in Value Chains

Final Observations

5. TRIPS Flexibilities and Access to Patented Medicines in India

Narayanan Lalitha

Use of Trips Flexibilities

Exemptions from Patentability

Future Options

6. India’s Free Trade Agreements: Implications for Access to Medicines in India and the Global South

Kajal Bhardwaj

Introduction 134

TRIPS Compliance: Using the Doha Declaration in India

India’s FTA Negotiations: An Overview

FTAs and Access to Medicines: Key Concerns

Intellectual Property Provisions

Investment (or Investor Protection) Measures

Regulatory Harmonization

Government of India’s Position

FTAs, TRIPS and the Right to Health


7. At any Price? Boehringer Ingelheim, Bayer HealthCare and Baxter in India

Christiane Fischer and Claudia Jenkes

The Examined Companies

How Good are the Drugs Supplied by these Companies?

What about Access?

Drug Treatment in the NGO, Private and Public Sectors

Research and Patents

Marketing and Business Behaviour


8. Trends and Prospects for India as a Global Generic Player

Deepak Kumar Jena and Poduri Balaram


Regulatory Status of India in World Generics Markets

India’s Bilateral Trade in Pharmaceutical Products

Outlook for the Indian Pharmaceutical Industry

TRIPS and the Future of the Indian Pharmaceutical Industry


9. The Indian Patent Law and Access to Antiretroviral Drugs in Sub-Saharan Africa

Christiane Fischer

TRIPS and Public Health

Compulsory Licensing

Parallel Imports

The Scope of Patentability

Indian Patent Law

African Patent Laws

The Impact of the Patent Status in India on Access in Sub-Saharan Africa

Lacking Access to Patented Radical Innovative Antiretrovirals

Patents Matter

10. Accessing Medicines in Developing Economies

Tu Thanh Nguyen

Intersection between IPRs and Competition Law

Refusal to Licence Pharmaceutical Patents in South Africa

Some Considerations

Abbott’s Withdrawal of Medicine Registration Applications in Thailand

Exclusive Distribution and the High Prices of Medicines in Vietnam

Indian Perspective

Concluding Remarks

11. The Politics of AIDS Treatment in Brazil

André de Mello e Souza


The Strategy of Local Generic Production

Challenges to the Sustainability of an Inclusive AIDS Treatment Policy

Restricting Patent Rights to Reduce ARV Costs


12. Financing Pharmaceutical Research and Development: Alternatives to the Patent System

Philip Soos and Hans Löfgren

Problems with the Patent System

Alternative Mechanisms for Financing R&D


13. Post-script

Hans Löfgren


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Hans Löfgren is Associate Professor in Politics and Policy Studies, Deakin University, Melbourne, Australia.