Medical Innovation and Disease Burden Striking the right balance between public health priorities and medical innovation is a critical policy challenge for India, given their mutually conflicting nature and interests. On the one hand, the country has an expanding health industry with a strong presence of domestic and multinational private firms. The sector, with enormous state facilitation, could effectively position itself as the future engine of economic growth by rearranging itself to the new intellectual property and trade regimes. On the other hand, India has a huge burden of diseases implicated by a gamut of public health problems, including the uneven distribution of demographic and epidemiological transition, threat of new infectious diseases like COVID-19, increasing privatisation of healthcare, inadequately regulated pharmaceutical market, low affordability of life-saving medicines and, most importantly, escalating out-of-pocket healthcare expenditure coupled with poor financial risk protection. All these make the Indian healthscape not only diverse but also exceedingly complex. Given these, the central question that the book addresses is whether medical innovation in India is sensitive to public health needs and priorities. The book unearths a number of overriding issues related to responsiveness and equity in India’s health innovation and highlights the need for a responsible innovation framework for India that balances the priorities of public health and industry goals. Sobin George teaches at the Institute for Social and Economic Change, Bengaluru. His areas of research and writings are marginalities, social gradients of health, medical industry and labour rights. Medical Innovation and Disease Burden Conflicting Priorities and the Social Divide in India Sobin George University Printing House, Cambridge CB2 8BS, United Kingdom One Liberty Plaza, 20th Floor, New York, NY 10006, USA 477 Williamstown Road, Port Melbourne, vic 3207, Australia 314 to 321, 3rd Floor, Plot No.3, Splendor Forum, Jasola District Centre, New Delhi 110025, India 79 Anson Road, #06–04/06, Singapore 079906 Cambridge University Press is part of the University of Cambridge. It furthers the University’s mission by disseminating knowledge in the pursuit of education, learning and research at the highest international levels of excellence. www.cambridge.org Information on this title: www.cambridge.org/9781108832304 © Sobin George 2021 This publication is in copyright. Subject to statutory exception and to the provisions of relevant collective licensing agreements, no reproduction of any part may take place without the written permission of Cambridge University Press. First published 2021 Printed in India A catalogue record for this publication is available from the British Library Library of Congress Cataloging-in-Publication Data Names: George, Sobin, author. Title: Medical innovation and disease burden : conflicting priorities and the social divide in India / Sobin George. Description: Cambridge, United Kingdom ; New York, NY : Cambridge University Press, 2021. | Includes bibliographical references and index. Identifiers: LCCN 2020049872 (print) | LCCN 2020049873 (ebook) | ISBN 9781108832304 (hardback) | ISBN 9781108935838 (ebook) Subjects: LCSH: Public health--India. | Medical care--India. | Equality--Health aspects--India. | Health services accessibility--India. | Medical innovations--India. Classification: LCC RA529 .G46 2021 (print) | LCC RA529 (ebook) | DDC 362.10954--dc23 LC record available at https://lccn.loc.gov/2020049872 LC ebook record available at https://lccn.loc.gov/2020049873 ISBN 978-1-108-83230-4 Hardback Cambridge University Press has no responsibility for the persistence or accuracy of URLs for external or third-party internet websites referred to in this publication, and does not guarantee that any content on such websites is, or will remain, accurate or appropriate. Contents List of Tables vii List of Figures xi Acknowledgements xiii List of Abbreviations xv Introduction 1 1. Medical Innovation and Its Institutional Co-production in India 18 2. The Disease Focus of Health Research and Development 57 3. Drug Development and Responsiveness to Disease Burden 102 4. Affordability and the Social Divide 136 5. The Puzzle of Responsive and Responsible Medical Innovation 175 References 189 Index 205 Tables 1.1 Income, sales, R&D, export and import in Indian pharmaceutical sector (all) (INR million) 20 1.2 Income, sales, R&D, export and import, government enterprises (INR million) 21 1.3 Income, sales, R&D, export and import, Indian private enterprises 22 1.4 Income, sales, R&D, export and import, major 13 Indian private companies (INR million) 23 1.5 Income, sales, R&D, export and import, all foreign MNCs in Indian pharmaceutical sector (INR million) 24 1.6 Indian biotechnology industry, revenue of various sub-segments (INR crore) 28 1.7 Income, sales, R&D, export and import, major biopharma companies (INR million) 29 1.8 Income, sales, R&D, export and import, major biopharma government enterprises (INR million) 31 1.9 Income, sales, R&D, export and import, major Indian private sector biopharma (INR million) 33 1.10 Income, sales, R&D, export and import, major biopharma MNCs (INR million) 34 1.11 Market size, production, import and export of medical devices, India (USD million) 37 1A.1 Ongoing clinical trials by Indian pharmaceutical companies by disease focus by type of hospital 50 1A.2 Ongoing clinical trials by global pharmaceutical companies operating in India by disease focus by type of hospital 51 1A.3 Ongoing clinical trials by research institutes (Indian and foreign) by disease focus by type of hospital 53 viii Tables 1A.4 Ongoing clinical trials by research institutes cum hospitals (Indian and foreign) by disease focus by type of hospital 55 1A.5 Ongoing clinical trials by government funding agencies (Indian and foreign) by disease focus by type of hospital 56 2.1 Number of new drugs approved for marketing between 2000 and 2017 across disease conditions – 1 61 2.2 Number of new drugs approved for marketing between 2000 and 2017 across disease conditions – 2 64 2.3 Vaccine R&D pipelines of selected biopharmaceutical firms in India 66 2.4 Therapeutic R&D pipelines of selected biopharmaceutical firms in India 67 2.5 Research focus of selected biopharmaceutical start-ups in India 70 2.6 Medical technology requirement by disease/conditions in the Global South 77 2.7 Product and disease focus of selected medical device and technology firms in India 81 2A.1 Number of new drugs approved for marketing in India from 2000 to 2017 by indication 89 2A.2 Major biopharmaceutical companies in India and their product focus (as of February 2019) 91 3.1 Gender-wise distribution of causes of death 104 3.2 Causes of death, India: 0–4 age group 104 3.3 Causes of death, India: 5–14 age group 105 3.4 Causes of death, India: 15–29 age group 106 3.5 Causes of death, India: 30–49 age group 107 3.6 Causes of death, India: 50–59 age group 108 3.7 Causes of death, India: 60–69 age group 109 3.8 Causes of death, India: 70-plus age group 109 3.9 Deaths due to communicable, maternal, perinatal and nutritional conditions 111 3.10 Deaths due to non-communicable diseases 112 3.11 Deaths due to cardiovascular diseases 113 3.12 Deaths due to respiratory diseases 114 3.13 Deaths due to malignant neoplasms (cancer) 114 3.14 Deaths due to digestive diseases 117 3.15 Deaths due to genitourinary diseases 117 3.16 Deaths due to neurological conditions 118 3.17 Percentage distribution of reported morbidity in India by gender and sector 121 3.18 Contribution of disease categories to total deaths by age groups in states grouped by epidemiological transition level (ETL), 2016 122