Adoption of Health Technologies in India: Implications for the AIDS Vaccine (Studies in Economic and Social Development)

Adoption of Health Technologies in India

Adoption of Health Technologies in India IMPLICATIONS FOR THE AIDS VACCINE

Indrani Gupta Mayur Trivedi Subodh Kandamuthan

Studies in Economic and Social Development No. 68 Institute of Economic Growth

SAGE Publications

Los Angeles/London/New Delhi/Singapore

Copyright © Institute of Economic Growth, 2007 Studies in Economic and Social Development No. 68 All rights reserved. No part of this book may be reproduced or utilised in any form or by any means, electronic or mechanical, including photocopying, recording or by any information storage or retrieval system, without permission in writing from the publisher. First published in 2007 by Sage Publications India Pvt Ltd B 1/I-1, Mohan Cooperative Industrial Area Mathura Road, New Delhi 110 044 www.sagepub.in Sage Publications Inc 2455 Teller Road Thousand Oaks, California 91320 Sage Publications Ltd 1 Oliver’s Yard, 55 City Road London EC1Y 1SP Sage Publications Asia-Pacific Pte Ltd 33 Pekin Street #02-01 Far East Square Singapore 048763 Published by Vivek Mehra for Sage Publications India Pvt Ltd, typeset in 10.5/13 GalliardBT at Excellent Laser Typesetters, Delhi, and printed at Chaman Enterprises, New Delhi. Library of Congress Cataloging-in-Publication Data Gupta, Indrani. Adoption of health technologies in India: implications for the AIDS vaccine/Indrani Gupta, Mayur Trivedi, Subodh Kandamuthan. p. cm.—(Studies in economic and social development; no. 68) Includes bibliographical references and index. 1. AIDS vaccines—India. 2. HIV infections—India. I. Trivedi, Mayur, 1976- II. Kandamuthan, Subodh, 1976- III. Title. IV. Series. [DNLM: 1. AIDS Vaccines—therapeutic use—India. 2. Disease Outbreaks— prevention & control—India. 3. HIV Infections—therapy—India. 4. Health Policy—India. 5. Health Services Accessibility—India. 6. Technology Transfer—India. WC 503.6 G9766a 2007] QR189.5.A33G87

615'.3720954—dc22

ISBN: 978–0–7619–3590–2 (PB)

2007

2007014171

978–81–7829–739–2 (India–PB)

The Sage Team: Sugata Ghosh, Gayatri E. Koshy and Mathew P.J.

To the memory of Sujata Mukherjee Ma, you are always with us.

Contents

Foreword by Kanchan Chopra Acknowledgements Executive Summary

11 14 16

PART I Adopting the AIDS Vaccine in India: Prognosis and Prospectus CHAPTER 1 1.1 1.2 1.3

INTRODUCTION AND RATIONALE FOR THE STUDY

21

Need for an AIDS Vaccine in India Access to a Health Technology Rationale and Conceptual Framework

21 24 27

CHAPTER 2 2.1 2.2 2.3 2.4 2.5

INTRODUCTION TO SELECTED HEALTH TECHNOLOGIES

37

Universal Immunisation Programme (UIP) Hepatitis B Vaccine (Hep B) No-Scalpel Vasectomy (NSV) Voluntary Counselling and Testing (VCT) Antiretroviral Therapy (ART)

37 39 41 43 45

8

Adoption of Health Technologies in India

CHAPTER 3

3.1 3.2 3.3 3.4 3.5 3.6

ADOPTION OF HEALTH TECHNOLOGIES IN INDIA: A SUMMARY OF MAJOR FINDINGS

Timing of Adoption Appropriateness and Adaptability Policy Framework of Adoption Supply Issues Distribution Issues Demand Issues

CHAPTER 4

LESSONS FOR THE ADOPTION AIDS VACCINE

OF THE

4.1 4.2 4.3 4.4 4.5 4.6

Timing of Adoption Appropriateness and Adaptability Policy Framework of Adoption Supply Issues Distribution Issues Demand Issues

CHAPTER 5

SUMMARY AND CONCLUSIONS

49 49 51 52 55 56 57 63 63 64 64 66 66 67 70

PART II Analysis: Selected Case Studies of Adoption of Health Technologies in India CHAPTER 6 6.1 6.2 6.3 6.4 6.5

UNIVERSAL IMMUNISATION PROGRAMME

77

Introduction Timing of Adoption Appropriateness and Adaptability Policy Framework of Adoption Supply Issues

77 78 79 79 82

Contents 9

6.6 6.7 6.8

Distribution Issues Demand Issues Overview and Lessons

CHAPTER 7 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8

Introduction Timing of Adoption Appropriateness and Adaptability Policy Framework of Adoption Supply Issues Distribution Issues Demand Issues Overview and Lessons

CHAPTER 8 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8

HEPATITIS B IMMUNISATION

NO-SCALPEL VASECTOMY

Introduction Timing of Adoption Appropriateness and Adaptability Policy Framework of Adoption Supply Issues Distribution Issues Demand Issues Overview and Lessons

CHAPTER 9

94 94 95 97 102 104 108 109 110 113 113 115 122 122 128 130 130 149

VOLUNTARY COUNSELLING TESTING

151

Introduction Timing of Adoption Appropriateness and Adaptability Policy Framework of Adoption Supply Issues Distribution Issues

151 154 155 157 161 168

AND

9.1 9.2 9.3 9.4 9.5 9.6

86 89 92

10 Adoption of Health Technologies in India

9.7 9.8

Demand Issues Overview and Lessons

168 179

CHAPTER 10 ANTIRETROVIRAL THERAPY

182

10.1 10.2 10.3 10.4 10.5 10.6 10.7 10.8

182 193 194 195 200 203 204 209

Introduction Timing of Adoption Appropriateness and Adaptability Policy Framework of Adoption Supply Issues Distribution Issues Demand Factors Overview and Lessons from ART

References Index About the Authors

212 229 236

Foreword

This volume is being published as part of the IEG series on ‘Studies in Economic and Social Development’ (Number 68 of the series earlier called Studies in Economic Development and Planning), being the outcome of research work undertaken by its authors at the Institute of Economic Growth. We at IEG welcome it, especially since this is the first volume in the series to come from the relatively new Health Policy Research Unit of the institute, a unit that has already contributed significantly to the world of health economics and policy research. It comes at a time when the world grapples with the question of how to contend with the spectre of HIV and AIDS, which is spreading in epidemic proportions in large parts of South Asia and Africa. It is also a time when a new health technology in the form of the AIDS vaccine is much awaited. The context and the juncture is appropriate for both looking back as also drawing lessons for the future from the manner in which health technologies were adopted in the past. This volume focusses on just such a ‘looking backward to look forward’, and is, therefore, a unique contribution to the ever-widening field of public policy in the health sector. It is also, arguably, among the first few to address this critical issue in this manner.

12 Adoption of Health Technologies in India

The book has two important messages: the first has to do with an often overlooked parameter in the launch of a technology, that is, evaluation. The need for the evaluation of a technology before scaling up or replicating cannot be emphasised enough. While this is generally true of all new technologies that countries plan to launch, it takes on greater importance in the context of health goods and services, where experiments and failures can have large associated human and social costs. The other message is for those who work on preventing HIV from becoming an epidemic, which still remains a fatal and catastrophic episode for households affected by it. The need for an AIDS vaccine remains as urgent now as before, if not more, because of the rapid spread of the virus around the globe. Developing countries, in particular, are the worst affected due to their inability to cope with an epidemic that has severe economic impact at every level of the economy. While the AIDS vaccine is still to be invented, there are encouraging signs that there may be a discovery around the corner. When this happens, a great deal of readiness to use it must be in place. It is not enough to merely have a potential vaccine, if one does not have a good plan on how to make it immediately reach those who need it the most. A careful planning for the launch of the AIDS vaccine in India would require a thorough study of past experiences with the launch of health technologies. This very opportune book attempts to understand the determinants of successful adoption of a health technology, based on in-depth analysis of four selected health technologies viz. Hepatitis B immunisation, No-Scalpel Vasectomy, Voluntary Counselling and Testing and Antiretroviral Therapy. The choice of the technologies was

Foreword

13

guided by the uniqueness of each and its appropriateness in throwing light on issues relevant for the AIDS vaccine. The technologies selected also represent a range, varying from the extremely service-oriented Voluntary Counselling and Training (VCT) to the more or less standardised Hepatitis B Immunisation. Further, the analyses are carried out through the prism of a few parameters: timing of adoption, appropriateness and adaptability of the technology, policy framework of adoption, supply and demand side issues and distributional factors. The authors find that continuous evolution and improvement is more possible in the case of service-oriented health technologies. The Universal Immunisation Programme, they feel, also offers valuable lessons to the planners on how best to prepare for the possible future adoption of the AIDS vaccine. This book is aimed at a wide audience both in the health sector as well as outside it. It offers a new methodology of preparing for the launch of a technology, adds new insights on existing health technologies, and presents in one place a vast amount of information on these technologies. Researchers stand to gain from its insights. Finally, it is unique in being forward looking and presenting a framework that may be used to prepare well in advance for the adoption of the AIDS vaccine as and when it becomes available. Decision makers and practitioners in charge of launching the AIDS vaccine stand to benefit a great deal from the analysis it contains. KANCHAN CHOPRA Director Institute of Economic Growth Delhi

Acknowledgements

The analysis in this book is based on secondary data, and on many rounds of talks, discussions, meetings and exchanges with several experts, academics, researchers, administrators, government officials, reviewers and well-wishers. Thus, the list of people to acknowledge is too long, and not attempted here; instead, we would like to sincerely thank all those who gave us their valuable time in various ways. Below, we mention names of those who reviewed the document and gave us inputs and comments on it. We would like to thank Dr M.S. Jayalakshmi, Dr Pem Namgyal, Dr R.K. Pal, Mr Balaji K. Ananth, Mr Binod Mahanty, Dr Po Lin Chan, Mr Christopher Skill, Ms Akhila Vasan and many individuals in IAVI, Delhi and New York (including those who are no longer in IAVI), for taking time to review the document and give us extensive comments. Also, we would like to take this opportunity to thank the International AIDS Vaccine Initiative (IAVI), New York and New Delhi, for having funded this project, which allowed us to work on a topic that we may not otherwise have taken up.

About IAVI The policy research for this publication was funded by the International AIDS Vaccine Initiative (IAVI). IAVI

Acknowledgements

15

is a global not-for-profit organisation whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996 and operational in 23 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI’s supporters—both financial and in-kind—include the Alfred P. Sloan Foundation; the Bill and Melinda Gates Foundation; the John D. Evans Foundation; the New York Community Trust; the Rockefeller Foundation; the Starr Foundation; the Governments of the Basque Countries, Canada, Denmark, the European Union, Ireland, the Netherlands, Norway, Sweden, the United Kingdom, and the United States; multilateral organisations such as the World Bank; corporate donors including BD (Becton, Dickinson & Co.), Continental Airlines, DHL, Merck & Co., Inc. and Pfizer Inc.; leading AIDS charities such as Broadway Cares/Equity Fights AIDS, Crusaid, Deutsche AIDS-Stiftung, and Until There’s A Cure Foundation; other private donors such as the Haas Charitable Trusts; and many generous individuals from around the world. For more information, see www.iavi.org.

Executive Summary

With more than 5 million reported cases of HIV positive individuals, India has the second highest number of infections in the world after South Africa. In response to the epidemic, various programmes on prevention, control and treatment have been implemented which have succeeded in breaking the momentum of the epidemic. Nevertheless, the size of the country, newer additions to the list of affected regions/states/districts and gender and ruralurban differentials point towards a scenario where India cannot be complacent about the future course of the epidemic. In this context, the potential of an AIDS vaccine to change the course of the epidemic is immense: a safe and effective AIDS vaccine is a potential health technology that can offer large and badly affected countries considerable benefits in a very short time. Since 2001, the International AIDS Vaccine Initiative (IAVI) has been partnering with the National AIDS Control Organisation (NACO) and the Indian Council for Medical Research (ICMR) for developing a vaccine to counter subtype C, the strain of HIV prevalent in India. While the world and India wait for the vaccine, which is being researched upon on a war footing in many parts of the world including India, it is important to put in place mechanisms that ensure that as and when the vaccine

Executive Summary

17

becomes available, it is accessible to all who ‘need’ it. Clearly, the mere theoretical availability of a health technology is not enough; ensuring access to such technologies is critical. Although relevant and effective technologies exist for many health problems, lack of accessibility and availability, limited acceptability and affordability, and inappropriate and inefficient delivery systems are some of the factors hindering access to those technologies. To set up a system that ensures rapid access to the AIDS vaccine requires an understanding of the domestic as well as global experiences in adoption and use of existing health technologies. There are several health technologies that have been introduced around the world and also in India, but very little on the process and success of the introduction of these technologies has, as yet, been documented. This study is an attempt to understand the various factors behind such success or failure, based on in-depth analysis of four selected health technologies with certain unique characteristics that make them interesting and useful to study in the context of the AIDS vaccine in India. These include Hepatitis B (Hep B) immunisation, No-Scalpel Vasectomy (NSV), Antiretroviral therapy (ART) and Voluntary Counselling and Testing (VCT) service. In addition, the Universal Immunisation Programme of India is also analysed to understand the experience of the first large-scale public health programme in the country, as also to understand better the Hep B experience which was introduced in the Universal Immunisation Programme (UIP). While it is somewhat difficult to squeeze out a set of pre-defined parameters from the rich and varied experiences of the various health technologies, the analysis uses the following parameters to look at the various dimensions of adoption of a technology: timing of adoption,

18 Adoption of Health Technologies in India

appropriateness and adaptability of the technology at point of initial adoption, policy framework of adoption, supply side issues, distribution issues and demand issues. The analysis indicated that, overall, India has a good record of timely adoption. While global directives or requests through international agencies were important catalysts, it does not necessarily mean that the issue of timing is irrelevant; rather, it means that India has been able to react more or less promptly to global initiatives. It does, however, also imply that India can be more pro-active on adoption of technologies if it has the requisite information and evidence. All the technologies considered seemed appropriate (except for Hep B, on which the opinions are divided) and adapted well by India, particularly VCT, which has continuously evolved over time, though it has taken somewhat longer to find its most appropriate form of delivery. In terms of the policy framework of adoption, there did not seem to be any major hurdles in terms of legal or legislative issues. However, depending on the type of technology, there did seem to be a weak link in the area of centre-state coordination. Also, the private sector participation was never visualised consciously by the government, which meant that a significant vehicle of diffusion of the technology remained untapped. On the supply side, procurement and distribution are areas where there is substantial scope for improvement, which would significantly increase the performance of these technologies. As for diffusion of these technologies, the analysis seemed to indicate that there is scope for improved and balanced spread of the health technologies in India, which is, to a large extent, possible with better data on surveillance and monitoring.

PART I Adopting the AIDS Vaccine in India: Prognosis and Prospectus

Chapter 1 Introduction and Rationale for Study

1.1 Need for an AIDS Vaccine in India India has the second highest number of infections in the world after South Africa, with 5.1 million HIV/AIDS cases reported by the National AIDS Control Organisation (NACO). The HIV/AIDS epidemic in India varies from state to state. States like Tamil Nadu, Andhra Pradesh, Maharashtra, Manipur and Goa are leading the rest of the country in terms of both AIDS cases and HIV prevalence. For example, the HIV prevalence in STD clinics in the states of Andhra Pradesh, Goa and Karnataka was 22.8 per cent, 14.01 per cent and 13.6 per cent respectively in 2005. The spread of the virus among the general population is often gleaned from its prevalence among Antenatal Clinic (ANC) attendees. The HIV prevalence among the ANC population in 2005 was 2 and 1.63 per cent in Andhra Pradesh and Nagaland respectively, and 1.25 per cent in the states of Manipur, Maharashtra, and Karnataka. This indicates not only the possibility of significant infection among the general population but also, especially, the vulnerability of

22 Adoption of Health Technologies in India

women. 86 per cent of all the infections in the country are reported to occur through sexual transmission, and the majority of these are through heterosexual transmission. The infections from infected blood and blood products comprise 3.6 per cent, and from Injecting Drug Use (IDU) 2.4 per cent of total reported HIV cases. Infection rates among the IDU, however, are much higher in the Northeastern states. For example, 21 per cent of total IDUs in Manipur were infected in 2004, and this increased to 24 per cent in 2005. The sentinel surveillance data also suggest that the epidemic is moving from urban to rural districts.1 In response to the gathering epidemic, the Indian government set up the National AIDS Control Programme (NACP) in 1987 and NACO in 1992. Initially, the emphasis of NACP was on prevention and control, to which has been added treatment, especially Antiretroviral Therapy (ART) in the recent past. While the various programmes that have been put in place have certainly made a huge difference in breaking the momentum of the epidemic, the size of the country, newer additions to the list of affected regions/states/ districts, gender and rural-urban differentials, all indicate that India cannot be complacent about the future course of the epidemic. In this context, the potential that an AIDS vaccine can offer to change the course of the epidemic is immense: a safe and effective AIDS vaccine is a potential health technology that can offer large and badly affected countries immense benefits in a very short time. The first generation of an AIDS vaccine might be partially 1 HIV/AIDS Epidemiological Surveillance and Estimation report for the year 2005.

Introduction and Rationale for Study 23

effective, multi-dose and expensive. Nevertheless, studies on the epidemiological impact of an AIDS vaccine show that a vaccine with partial effectiveness may still have substantial public health impact (Stover et al. 2002; Nagelkerke and De Vlas 2003). India is one of the developing countries that may potentially benefit from an AIDS vaccine. Since 2001, the International AIDS Vaccine Initiative (IAVI) has been partnering with NACO and the Indian Council for Medical Research (ICMR) for developing a vaccine to counter subtype C, the strain of HIV prevalent in India. The first phase of human clinical trials of an AIDS vaccine was to begin in 2004. While the world and India wait for the vaccine, which is being researched upon on a war footing in many parts of the world including India, it is important to put in place mechanisms that ensure that as and when the vaccine becomes available, it is accessible to all who ‘need’ it. India has had no serious discussions yet around targeting for an AIDS vaccine, but it is assumed that once the experts decide to adopt a need-based approach, there should be no delay in its access by these groups. As will be discussed in the following pages, the mere theoretical availability of a health technology is not enough; ensuring access to such technologies is critical. Although relevant and effective technologies exist for many health problems, limited acceptability and affordability, lack of accessibility and availability, and inappropriate and inefficient delivery systems are some of the factors hindering access to those technologies. To set up a system that ensures rapid access to the AIDS vaccine will require an understanding of the domestic as well as global experiences in adoption and use of existing health technologies.

24 Adoption of Health Technologies in India

1.2 Access to a Health Technology The Human Rights approach to health has increasingly found favour with international bodies like the UN, and in 2002, the UN Commission on Human Rights (UNHCR) appointed a Special Rapporteur with a mandate to focus on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. It is now universally agreed that increase in the physical and mental well-being of people would require access to, and optimal use of, available and new health technologies and medicines. For this, the WHO has constituted a Health Technology and Pharmaceuticals cluster, whose mission is to provide solutions to public health challenges by promoting tools that build good health—safe, effective medicines and health technologies. Health technologies are used at every level of a health system—from the most simple technology like medicines for common cold to the most complex of services like the package that can be defined as a heart surgery. Different forms of health technology are being accessed every time one seeks prevention, treatment or care services. An important element of a successful adoption is an approach that recognizes that a technology is much more than a simple technical tool. It comprises a complex set of factors: medicines, the actual scientific/clinical technology, equipment, devices and services. Although India has been somewhat successful both in making essential immunisation available in the country and in the production of many of the major vaccines, there are enough issues on both the demand and supply of routine immunisation and other health technologies, which continue to challenge policymakers. In many ways, the issues

Introduction and Rationale for Study 25

around adoption of the AIDS vaccine will be similar to any other health technology adoption. At the same time, the AIDS vaccine has some unique characteristics that make it somewhat different and the access issue is likely to become even more of a challenge to policymakers. Some of these reasons have to do with the stigma and sensitivity that still surround the infection, and with the issues around correct targeting, which raises the question of how best to target the vaccine for maximum effect. There are very few studies that have specifically looked at the possible distributional issues around an AIDS vaccine in India. For example, a study by Sheshadri et al. assessed the potential demand for and strategic use of HIV-1 vaccine in the four southern Indian states of Andhra Pradesh, Karnataka, Maharashtra, and Tamil Nadu (Seshadri et al. 2003). They described possible delivery channels for each population group2 and suggested that the HIV vaccine should be delivered through existing programmes to reach different population groups. The study mentioned that the key constraints in introducing an HIV vaccine could be, for example, stigma, low public awareness about the mode of HIV transmission, delivery infrastructure and public health delivery system. Supply or provision of technologies and demand or use of technologies influence access individually as well as in interaction with each other, making for complex adoption issues. For example, even in developed countries like Israel, rapid development of new and expensive health technologies as well as resource scarcity make it imperative to set priorities for the adoption of health technologies 2 The low-risk groups comprised children under 6, children between ages 11 and 14, pregnant women; the high-risk groups included commercial sex workers, truck drivers and STI patients.

26 Adoption of Health Technologies in India

(Shani et al. 2000). Funding and reimbursement systems can also create barriers for the adoption of new health technologies. Developed countries, like the UK and Australia, emphasise the role of economic evaluation in adoption process and require evidences for cost-effectiveness from manufacturers to support regulatory and reimbursement decisions. However, literature that document and explore the decision-making process in adopting health technologies in developing countries are rare. Experiences in developing countries reveal that there can be at least a decade or more of delay in the availability of new health technologies, such as the Hepatitis B vaccine, after they are approved for use in developed nations. The reasons have to do mainly with insufficient attention paid in the planning and implementation process to issues of procurement and access, in addition to cost concerns (Madhavi 2005). Approval and adoption process by governments can be as complex as the acceptance and use by individuals, and is often related to the latter. For example, Pakistan’s first five-year public sector development plan (1955–60) noted the importance of limiting population growth and recognised the need to limit the size of the Pakistani family in order to reduce the incidence of malnutrition and overcrowding. However, Islamic provisions in the constitution and diverse views of different religious groups pose a challenge to planners of family planning. As a result, the Pakistan government is said to be reluctant to aggressively promote the family planning programme (Khan 1996). Another study by Tran (1999) contends that the factors that contributed to a successful national population and family planning programme in Vietnam are political commitment, nationwide mobilisation of mass organisations, strong local leaders, strong advocacy and

Introduction and Rationale for Study 27

the Information, Education and Communication (IEC) programme, provision of various choices of contraceptives, effective programme management and support of the international community. Demand factors, such as health-seeking behaviour, price and acceptance also play major roles in determining the success in access to a health technology. A focus group study of 200 males and females in five locations of Kabarole district in Uganda revealed that the main barriers to condom use were low female acceptance, unavailability, societal attitudes and high cost (Kipp et al. 1992). Epidemiological models of data from Uttar Pradesh, India, collected by the National Family Health Survey (NFHS) from October 1992 to February 1993 showed that women exposed to TV messages, in ‘pucca’ (bricks and mortar) houses, with high school or higher levels of education, whose husbands were literate with schooling of 11 or more years, and who had 2 or more living sons were more likely to adopt contraception. It was also found that religion was an important determinant, and public health education is more effective among the less educated women (Dwivedi and Sundaram 2000). A similar study examined the factors associated with the use of maternal and child health (MCH) services in rural Ghana and documented that the level of education, religious background, region of residence, ethnicity and occupation determined the use of MCH services (Addai 2000).

1.3 Rationale and Conceptual Framework The discussion above reinforces the need to understand the factors that affect the successful adoption of a health

28 Adoption of Health Technologies in India

technology, which can best be done by studying the history of adoption of selected technologies in a country, as well as globally. Since the AIDS vaccine is still in the development phase, such information derived from existing health technologies can add valuable insights, and be used as a guide in formulating policy and strategies in order to prepare for access to the AIDS vaccine. There are several health technologies, which have been introduced around the world and also in India, but very little, as yet, has been documented on the process and success of introduction of these technologies. This study is an attempt to understand the various factors behind such success or failure, based on the in-depth analysis of four selected health technologies with certain unique characteristics that make them interesting and useful to study in the context of the AIDS vaccine in India. These include Hepatitis B (Hep B) immunisation, No-Scalpel Vascetomy (NSV), Antiretroviral therapy (ART), and Voluntary Counselling and Testing (VCT) service. In addition, the Universal Immunisation Programme of India is also discussed so as to understand the various dimensions of a large-scale programme, which also enhances one’s understanding of the Hep B vaccine programme in India. Despite the difficulties, this book is an attempt at extracting, from the rich and varied experiences of the various health technologies, a set of pre-defined parameters. The attempt is to understand the experiences with respect to the four technologies considered in this book by fitting in the various dimensions of a successful adoption into a set of parameters described in the framework, and to evaluate the performance of each of the technologies using these parameters. The evaluations are then discussed in the context of the AIDS vaccine, to better understand what lessons one can learn from past adoption.

Introduction and Rationale for Study 29

Before these are discussed in more detail, it is important to understand that in this book, adoption is considered from the government’s perspective. Governments generally take a deliberate policy decision to adopt a technology, though there are examples of technologies being adopted by the private sector before the government went in for national adoption. Since the analysis is being done in the context of the AIDS vaccine, with many governments and countries involved in the process, it is more relevant to talk about public policy around adoption. The conceptual framework for the analysis and a description of various parameters are given below: Review India’s experience on adoption of health technologies, which have potential implications on access to AIDS vaccine—UIP, Hep B vaccine, NSV, ARV and VCT services.

ƒ

Methodology Literature reviews of published and unpublished articles, secondary data, reports, research studies and journal articles related to adoption and use of selected health technologies. In-depth interviews and discussions with key representatives & stakeholders of different sectors (e.g. from Ministry of Health and Family Welfare and other relevant ministries, WHO, national and international NGOs etc.).

ƒ

(contd)

30 Adoption of Health Technologies in India

(contd) Critical assessment of adoption using the following parameters: – Timing of adoption – Appropriateness and adaptability of the technology at point of initial adoption – Policy framework of adoption – Approval and regulation – Roles of central/state/local governments – Role of private sector – Role of NGO/civil society – Supply side issues – Procurement – Infrastructure – Human resources – Distribution issues – Demand issues – Acceptability, and information & knowledge – Availability & accessibility – Affordability

ƒ

Lessons drawn and key messages on key process/ mechanism and factors contributing to success or failure in adoption.

ƒ

Identify challenges and recommend potential strategies for the AIDS vaccine and future research areas. We discuss each of these parameters in greater detail.

Introduction and Rationale for Study 31

1. Timing of Adoption A technology—if available in the world—should be adopted by the country at the earliest possible instance, if required. This means that if there is a recognised and evidence-based need for a technology that, it is believed, will make a significant difference to a large segment of the population, little time should elapse between the availability of the technology in the world and the adoption of it by a country. It also means that if the technology is available only in the private sector of the country and, therefore, not easily available and accessible to a large segment of the population that needs it, there has been a delay in its adoption in the country.

2. Appropriateness and Adaptability The technology, when being adopted, should be such that it is appropriate for the country and adaptable to suit local needs and conditions. In other words, a complicated technology, though required, may not be easily adopted on a large scale due to reasons that may have to do with the health system and infrastructure. Adopting a technology that is either unsuitable for local conditions or one that cannot be altered or adapted to suit local needs may create demand and supply barriers and, therefore, reduce the efficacy of adoption.

3. Policy Framework (a) Approval and Regulation How much time does it take for the government to take a decision about adoption at a national level and

32 Adoption of Health Technologies in India

pass/amend/create the necessary rules and regulations to implement its decision? In India, the situation is somewhat complicated by the federal structure of the country, that is to say, central and state policy environment may not always be the same. Also, the policy environment necessary for national adoption by the government cannot ignore the presence and use of the technology in the private sector. Thus, every action of the government would have implications for the private sector as well. An effective policy framework, therefore, is one that envisages roles, rules and regulations for all sectors that can offer the technology.

(b) Role of Central/State/Local Governments Once the decision to adopt a technology is taken, is there a structured implementation process put in place with roles of different players in the government charted out? In other words, one needs to consider whether the central government, while planning the roll out, decides a priori the roles of state and local governments, with their actual roles in the implementation clearly stated, or whether the adoption at the state and local levels takes place in a somewhat ad hoc fashion. (c) Role of Private Sector What role does the government visualise for the private sector? An omission to take into account the private sector or the failure to recognise that this sector is, and will continue to be an active player in making available many technologies and further in facilitating the access to publicly provided technologies, will be considered as a government decision to take a partial view of the adoption process.

Introduction and Rationale for Study 33

(d) Role of NGO/Civil Society Many health technologies need active participation from non-governmental and community-based organisations for their successful adoption, especially on the demand side, since these organisations work with communities and areas that are often not reached by many government programmes. The far-sightedness of the government adoption process will be evidenced if incentives are clearly built in to make these players active participants in the adoption process.

4. Supply Side Factors (a) Procurement and Distribution There are issues of procuring the intermediate as well as final products of a mostly product-based technology, and intermediate inputs if the technology has more characteristics of a service. A smooth adoption would critically depend on a reliable and smooth procurement process. Also, an efficient distribution chain of the procured materials is concomitant with an efficient supply system. (b) Human Resources The presence of adequate and quality human resources allows the transformation of a technology into a service. How well and how quickly the adoption process proceeds would depend critically on the availability of quality personnel. (c) Infrastructure The availability of suitable and adequate infrastructure for the various stages of transforming the technology into a service would determine to a great extent the quality of

34 Adoption of Health Technologies in India

the service. Whether it is to store materials, equipments or supplies or whether it is to offer a place where the service can be offered, infrastructure forms the backbone of any successful adoption. For technology that is directly given as a service, this takes on an even greater importance.

5. Distribution Once a technology is ready to be distributed, the issue of targeting becomes a critical one, and careful targeting determines to a great extent the equity and efficiency of the adoption process. A theoretically optimal distribution would be one that is determined by need, which may not always be the case with actual adoptions. The following parameters need to be paid attention to in the context of distribution:

(a) Targeted Groups Every adoption process is visualised with target populations in mind. At the very least, the adoption should be such that those who need the technology the most are targeted, and those that are targeted finally get the benefits of the technology. (b) States The other aspect of this for India is inter-state distribution, with the criterion of ‘need’ again being operative here. Inter-state differentials can be the result of calculations of requirements, and need not always imply inequities. (c) Rural-urban Dimension Another consideration from the equity perspective is the rural-urban spread of the technology—an important issue

Introduction and Rationale for Study 35

for India, where a majority of the population resides in the rural areas.

6. Demand Issues (a) Acceptability/Information and Knowledge A critical factor in adoption remains that of acceptance by those who need it the most. Acceptance depends on various factors, including beliefs, understanding and knowledge of the technology which in turn determine whether individuals feel the necessity to use the technology. Acceptability can be greatly enhanced by correct dissemination of information, education and communication (IEC). (b) Availability and Accessibility Once a country has declared a technology as adopted, its success would depend on whether it is available to all who need it. The availability may be constrained by a whole host of factors, ranging from poor distribution and supply to poor services offered at the point of use. The accessibility of a technology depends not only on physical access— ease of reaching the point where it is being delivered—but non-geographic access issues as well. The issues of acceptability on the one hand, and availability and accessibility on the other, are often interrelated and difficult to separate from each other. However, it is possible to have a highly accepted technology being poorly delivered and therefore not available, just as it is possible to have an illaccepted technology being easily available and accessible. (c) Affordability A critical role is played by price factors, not only of the final technology, but the intermediate or joint inputs that

36 Adoption of Health Technologies in India

need to be availed by the user to make it a complete package. If the final product is free but the accessories are costly, it may turn into a demand barrier. Thus, pricing of the final as well as complementary products/services would play an important role from the demand side of the adoption process. The study used data and information from all possible sources: literature reviews of published and unpublished articles, national data sets, other sources of data, reports, research studies and discussions/interviews with key individuals. Thus, in-depth interviews with individuals from the key ministries of the government, NGOs, WHO and other international organisations, physicians, programme managers, researchers and representatives of key sectors formed a major part of the inputs into the research. In the final stage, selected experts were given drafts of the reports for their feedback and inputs, and these were then incorporated in the final version of the book. Chapter 3 presents the major findings of the analyses, based on detailed research on each of the technologies. Chapter 4 presents the lessons that can be drawn from the analyses in the context of the AIDS vaccine. Summary and Conclusions are presented in Chapter 5. In Part II, Chapters 6–10 give the detailed analysis on each of the technologies, including the UIP.

Chapter 2 Introduction to Selected Health Technologies

Essentially, four health technologies have been analysed in this book, with a fifth one—universal immunisation programme—added, because of it being one of the first large-scale adoption of a health technology in the country, and also because it enables us to analyse another selected technology—Hepatitis B—better. We present below a brief introduction to each of the technologies discussed in this book, and the reason for their selection in the context of the AIDS vaccine.

2.1 Universal Immunisation Programme (UIP) ‘Essential immunisation service’ is defined as the ‘safe and timely delivery of effective vaccines of public health importance to those who need them’ (WHO 2001). WHO lists the following ‘essential’ vaccines for universal immunisation: BCG, Diphtheria, Hepatitis B, Measles, Pertussis, Oral Poliomyelitis and Tetanus; the list may,

38 Adoption of Health Technologies in India

however, vary depending on the disease burden in different countries. The UIP was launched in 1985 to provide universal coverage to pregnant women against Tetanus and to infants, in their first year of life, against six identified vaccine preventable diseases.1 The Pulse Polio Immunisation Programme was introduced in 1995. In 1992, the UIP became a part of the Child Survival and Safe Motherhood Programme (CSSM), and in 1997, it became an important component of the Reproductive and Child Health Programme (RCH). During the RCH programme, the cold-chain system was strengthened and training programmes were launched extensively throughout the country. The RCH Programme, which aims at the eradication of the polio virus, also incorporates selective introduction of the Hepatitis B (Hep B) vaccine in the UIP package, as will be explained in greater detail below. The UIP is till date the most comprehensive and extensive health technology launched by the public sector in India; it is also the first large-scale disease prevention initiative. The fairly long history of the UIP allows for the study of the various dimensions of this programme, thereby enhancing the understanding of the issues and concerns raised by such large-scale programmes against the backdrop of the health system set up of the country. Since the Hepatitis B pilot programme has been launched as part of the UIP, the analysis also helps in understanding the Hepatitis B programme. In the context of the AIDS vaccine, there could be important lessons learnt from the UIP analysis, especially the constraints that lend inertia to 1 Tuberculosis, Diphtheria, Whooping cough, Tetanus, Polio and Measles.

Introduction to Selected Health Technologies 39

such large-scale government programmes and prevent efficiency-enhancing changes to take place sooner rather than later.

2.2 Hepatitis B Vaccine The Hep B virus (HBV) is an important cause of acute and chronic morbidity and mortality in many parts of the world. It is estimated that about two billion people have the infection, and over 350 million people in the world are chronic carriers of the virus (Thyagarajan et al. 1996). However, there has been a lot of debate around the cost-effectiveness of introducing Hep B in national immunisation programmes, which continues to date. There are studies done in the international context, which have looked into different issues of Hep B immunisation in the UIP of countries. Beutels (2001) reviewed the major studies conducted between 1994 and 2000 and found that better understanding of the Hep B disease, more frequent use of expensive therapies with moderate effectiveness and a sharp decline in vaccination costs have made strategies for universal Hep B programme cost-effective all over the world. He argued, however, that this was not the case in countries with low endemicity. Macintyre (2001) corroborated this finding, but indicated that since selective vaccination may be difficult to implement due to logistical problems,2 the UIP remains the most effective way to eradicate Hep B. Edstam et al. (2002) and He argued that vaccination programmes targeting at-risk neonates are often poorly implemented and do not protect against horizontal transmission in early childhood. 2

40 Adoption of Health Technologies in India

Schoub et al. (2002) documented that in Mongolia and South Africa respectively, Hep B vaccination has successfully reduced the rate of chronic carriage in the immunised generation and concluded that Hep B in UIP was beneficial for developing countries. As for the cost issues, Edmunds et al. (2000) looked into the costs of integrating the Hep B vaccine in UIP in Addis Ababa. It was found that the type of vaccine (monovalent or tetravalent) did not really affect the costs, and, therefore, cost reduction should not determine which type of Hep B vaccine to introduce in UIP. In other words, the type of vaccine did not really matter and should not be a constraint for the introduction of Hep B in UIP. Van Damme and Vorsters (2002) argued that in European countries the Hep B prevalence had gone down due to the inclusion of Hep B immunisation in the UIP for 10 years. They argued that most of the countries had difficulties in incorporating the Hep B vaccine into universal childhood immunisation programmes because of economic constraints and the inability to procure a constant vaccine supply. Similarly, Namgyal (2003, 2005) looked into the impact of Hep B in Europe and also worldwide and concluded that including it in the UIP is the best way forward and financial sustainability is critical to ensure vaccine quality and good coverage. In 1992, the World Health Assembly recommended that all countries should introduce the Hep B vaccine by 1997 (WHA 1992). While over 40 million people in India are affected by Hep B, one in every 25 persons in the country is an HBV carrier. WHO classifies India as an intermediate category of country with a prevalence rate of 2–7 per cent. In 2002, the Government of India decided to implement a universal infant vaccination programme and the Hep B

Introduction to Selected Health Technologies 41

vaccine was introduced as part of the UIP for children in 15 cities and 33 districts as a pilot programme. The Hep B vaccination is different from routine immunisation due to the controversial and divided opinions on prevalence, modes of transmission and cost-effectiveness of alternative modes of delivery. While on the surface this technology does not seem to have anything in common with the AIDS vaccine, it, in fact, throws up interesting and critical issues around the need for data on disease burden, transmission route, cost-effectiveness and targeting that would be relevant for the AIDS vaccine as well.

2.3 No-Scalpel Vascetomy (NSV) No-Scalpel Vasectomy (NSV)—a simple surgical procedure, which as the name suggests, does not involve incisions and stitches—is an improvement on the conventional vasectomy with practically no side effects or complications.3 NSV was developed in 1974 by Dr Li Shunqiang of the ‘Chongqing Family Planning Research Institute’, at the Sichuan province in China. A team of international 3 Vasectomy is a simple operation that divides the tubes that carry the sperm in the body. These tubes arise from the testicles and go into the urinary passage, blocking off the passage of sperms into semen. This, therefore, makes unprotected intercourse safe, from the point of view of conception. This is a permanent method of contraception, and is generally recommended only when the desired family size has been achieved. In the new procedure, the vas is brought out through a tiny puncture, which does not require any stitches. The operation for NSV is much simpler than the conventional vasectomy. (www.cornellurology.com/uro/cornell/infertility/no_scalpel)

42 Adoption of Health Technologies in India

sterilisation experts from four countries visited the clinic to learn the newly developed Chinese NSV technique in 1985 and endorsed the technique as a standard approach for vasectomy. By the early 1990s, the NSV technique had been introduced in many countries of Asia, Africa and Latin America.4 Evidence from USA and Canada indicates that the NSV programme has been quite successful (Antarsh and Marston-Ainley 1993; Haws and Cullins 1999). The Association for Voluntary Surgical Contraception (AVSC)—which lately changed its name to ‘Engender Health’—played a significant role in popularising this method of male sterilisation. Approximately 48.2 per cent of couples from 15 to 49 years of age practice family planning methods in India. Female sterilisation accounts for 34.2 per cent, with male sterilisation declining from 3.4 per cent in 1992–93 to 1.9 per cent in 1998–99 (Sharma et al. 2001). In 1992, NSV was introduced in India, but it gathered momentum only when the government took a decision to collaborate with UNFPA to popularise this method as a tool to promote male participation in family welfare schemes. Despite being a relatively safer method of sterilisation, men in only a few countries worldwide have adopted vasectomy as their contraceptive method of choice (Finger 1997). NSV is a health technology for adults, closely related to sensitive issues like male sexuality, making ‘acceptability’ the heart of the adoption debate. Thus, insights into barriers to access and use of NSV are important in the context of the AIDS vaccine, and will help understand the ramifications of adopting a narrowly targeted technology, 4

http://www.cornel.edu/nsv

Introduction to Selected Health Technologies 43

which is implemented using standard public sector infrastructure without paying too much attention on the critical issue of acceptance.

2.4 Voluntary Counselling and Testing (VCT) VCT has been increasingly seen as an essential component of HIV prevention and control programmes. The global consensus is that pre- as well as post-test counselling should be ensured for all those coming in voluntarily to test for HIV. The concept of VCT has evolved over time. It started with the application of the indirect ELISA (Enzyme-linked Immmunosorbent Assay) to detect the antibodies to HTLV (HIV)—as an etiological agent causing AIDS—as early as in 1983 (Saxinger and Gallo 1983). Emphasis in the early use of these testing methods was restricted to the screening of blood and organ donors (WHO 1985, CDC 1985b). In 1986, the Centre for Disease Control (CDC) released a set of recommendations referring to counselling and voluntary serological testing for individuals at ‘increased risk’. A pilot project of establishing ‘alternate testing sites’ for the provision of HIV testing outside the blood-bank setting was put in place in USA during 1985–86. This can be thought of as the first VCT experiment for HIV interventions (CDC 1986b). As for the evolution of the testing methods, the first generation tests viz. ELISA and Western blot tests were utilised for HIV testing for a long period of time, despite cost and time (to reveal results) limitations (Branson 2000a, 2000b). As an alternative testing method, successful results using simple rapid tests were reported from different

44 Adoption of Health Technologies in India

countries of Europe, Africa and America (Constantine et al. 1989; Van Kerckhoven et al. 1991; Malone et al. 1993). The use of rapid tests made it possible to provide on-site results on the day of testing and, thus, improved the overall performance of VCT centres (McKenna et al. 1997; Kassler et al. 1998). The developments around the testing technologies and availability of Antiretroviral Therapy (ART) widened the scope of testing and counselling services. The objective and scope of VCT was revised from merely interrupting further transmission to the promotion of early knowledge of HIV status and provision of access to appropriate medical, preventive and psychosocial care services (CDC 1993, CDC 2001). India too has adopted this approach mid-way into the programme on prevention and control as an integral part of continuum of care, which is supposed to facilitate the early and appropriate uptake of HIV services for both HIV positive and negative individuals. HIV testing has become easier to perform with the advent of newer rapid and simple kits, and NACO plans on the expansion of testing facilities to all corners of the country in a phased manner. It envisages that within the next few years every district in the country will be equipped with HIV testing facilities, thereby ensuring that pre- and post-test quality counselling become critical. An analysis of VCT in the country helps in understanding a technology where human resources are critical, and which is delivered, unlike many other health technologies, as a somewhat personalised service. Availability and accessibility define quality in this case. A study of VCT, therefore, offers valuable insights into the possible pitfalls of such a human-intensive technology, the understanding

Introduction to Selected Health Technologies 45

of which is critical in the context of the AIDS vaccine as well.

2.5 Antiretroviral Therapy (ART) Effective ART has significantly reduced the morbidity and mortality among people living with HIV/AIDS. Until the development of Antiretrovirals (ARVs), AIDS was perceived as an untreatable condition. Prophylaxis and treatment of Opportunistic Infections (OIs) in the initial stages of infection and palliative care in the advanced stages were the only clinical components of care and support services to HIV positive people. It was only in March of 1987 that Zidovudine (AZT)—a drug that belongs to the group of Nucleoside Reverse Transcriptase Inhibitors (NRTIs)— became the first ARV approved for the treatment of HIV infection in the United States. By 1996, more drug molecules—from two additional category viz. Protease Inhibitors (PIs) and Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTIs)—were developed and approved for its clinical use in the treatment of HIV. The availability of different molecules and its combination therapy witnessed dramatic benefits, in terms of delays in HIV progression, improved survival and decreased hospitalisation for HIVinfected patients, resulting in HIV being transformed into a manageable chronic disease (Altice and Friedland 1998). The ideal treatment strategy then involved the use of a PI and two reverse transcriptase inhibitors. The combination of these three drugs has become known as ‘triple combination therapy’. While clinical advances were bringing down the AIDSrelated morbidity and mortality in the developed countries, the burden of HIV was increasing at an unprecedented

46 Adoption of Health Technologies in India

rate in the developing countries. Only a few pharmaceutical companies in the world were producing the ARV drugs, and this ‘monopolistic (or oligopolistic) market structure and asymmetries of information in favour of suppliers were the main reasons for price discrimination and high costs, which in turn were the major deterrents for accessing ARVs’ (Lucchini et al. 2003). Following the 12th World AIDS Conference on HIV/AIDS in Geneva with the theme of ‘Bridging the Gap’ in 1998—where several voices were raised to address the inequality of access to ART and the high prices charged for ART—many initiatives took place across the world to increase access to ARV for those who needed the drugs the most. In late 2000, amidst the oligopolistic market and increased negotiations with the patent holders, the downward spiral of price reduction started with the introduction of the first generic ARV by an Indian manufacturer called Cipla. Three major events that took place in 2001 are important to note in the context of ART: (i)

the United Nations General Assembly in its 26th Special Session (UNGASS) passed a resolution to declare global commitment to review and address the problem of HIV/AIDS in all it aspects; (ii) the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) was created to increase resources to fight three of the world’s most devastating diseases including HIV, and to direct those resources to areas of greatest need and (iii) generic versions of ARV drugs were offered to national governments at reduced rates. These three events resulted in further and dramatic price reductions. Along with the global initiatives and country

Introduction to Selected Health Technologies 47

specific movements for improved access (for example, Brazil), UNAIDS and WHO declared the lack of treatment in low- and middle-income countries a global public health emergency and launched the ‘3 by 5’ initiative in 2003, which aimed to put 3 million people on ART in these countries by the end of 2005 (WHO 2003). This amounted to about 50 per cent of all those who required treatment. In accordance with WHO’s intention, on 1 April 2004, NACO, India, launched the free ART programme, which assured availability of the fixed drug combination or cocktail of Zidovudine, Lamivudine, and Nevirapine to three categories viz. pregnant mothers, children below 15 years and those individuals with AIDS who seek care in government facilities at eight designated government hospitals. In the context of the AIDS vaccine, the ART programme can offer important lessons on a public-supported, specific group-targeted programme for treating a disease that is still surrounded by myths, stigma and discrimination. The already existing linkage of this programme with the VCT programme of the country leads to an important recommendation of this study: that the AIDS vaccine programme has the potential to be linked to both the ART and the VCT programmes in a three-way linkage to form a comprehensive programme on prevention, control and treatment. To sum up, the choice of the four (plus one) technologies was done carefully, keeping in mind the uniqueness of each, and whether or not it can add to the knowledge around adoption which would be relevant for the AIDS vaccine. Each of the four health technologies mentioned above yielded different insights into the AIDS vaccine issue. The Hep B experience helped in the understanding of

48 Adoption of Health Technologies in India

the issues around timing and targeting, and the pitfalls of integrating this with ongoing large programmes (UIP). A study of NSV yielded insights into the ramifications of a narrowly targeted health technology that deals with sensitive cultural issues and, in this context, the effectiveness of a largely public sector policy. The VCT and ART experiences helped in understanding the factors that determine the extent of success of a programme that is aimed at a vulnerable population that overlaps with the target group for the AIDS vaccine, and also the quality and supply concerns of a technology which needs to be offered as a personalised service with a human face. These two cases also help in the understanding of the possible pitfalls and challenges of rapid scaling up.

Chapter 3 Adoption of Health Technologies in India: A Summary of Major Findings

This chapter reports the major findings of an extensive analysis of the four technologies (and UIP), using the framework presented in the previous chapter. The detailed analyses of the technologies are given in Part II in Chapters 6–10 for easy reference. Here, we do not go into explanations of why a particular conclusion is presented; instead, each of the bullets of the framework is used for stating the conclusions. As mentioned before, the conclusions based on the research have also been discussed with various experts, including programme managers, and are based on as objective an analysis as was possible even with the constraints of data and time, though the conclusions remain those of the authors.

3.1 Timing of Adoption In 1992, the WHO recommended that Hep B be included in the UIP of countries by 1997. In India, the Hep B pilot

50 Adoption of Health Technologies in India

project was adopted on a large scale in 2002, which was about 5 years after the recommended year. The launch of the pilot project was not informed by analyses of disease burden, mode of transmission, or the most appropriate mode of delivery. These are, however, much debated issues in India and no consensus exists yet on the epidemiological situation with respect to Hep B. In the absence of firm evidence on these parameters, it can probably be concluded that an earlier adoption did not seem warranted. The timing of introduction of NSV has to be seen against the background of the ever-evolving family planning strategies in India. NSV was merely another method of male sterilisation, which was already very much a part of the family planning programme of the country. Thus, it was not a technology that addressed a new health need, but only a superior method of an existing method of family planning. NSV was introduced in India almost at the same time as it was being introduced in other developing countries. VCT has two parts: testing and counselling. The testing part was adopted in timely fashion, beginning with screening of blood, surveillance activities and evolution of HIV testing centres, which then logically converted into VCTC. This also implied that the counselling part evolved much later. VCT as a whole came to India almost a decade after testing for HIV was started in the country. As for ART, the timing of the public initiative in India was just about right. With increasing numbers needing treatment in the country, Indian pharmaceuticals offering generic cheaper drugs, global pressure and initiatives like ‘3 by 5’, and precedence of free ART in other countries, the timing of adoption of the free programme seemed appropriate.

Adoption of Health Technologies in India

51

Overall, looking at all the four technologies one can conclude that India has a good record of timely adoption. It is also true that global directive or requests through international agencies prompted most of these adoptions. This does not necessarily mean that the issue of timing is irrelevant; rather, it means that India has been able to react more or less promptly to global initiatives. However, it does imply that India can be more pro-active on adoption of technologies, if it has the requisite information and evidence. This, in turn, means that it must constantly endeavour to collect information and evidence on various diseases so that it can carry out timely adoption even on its own.

3.2 Appropriateness and Adaptability Appropriateness and adaptability are interesting issues in the context of transformation of the basic technology into a service. Different technologies have different service components. For example, Hep B is more or less a standard ‘product’, which can be transferred to the clients almost without further transformation, and adaptability is not an issue. The appropriateness in the case of Hep B has been debatable, since the adoption has not been based on evidence from within the country on the prevalence or mode of transmission. VCT is almost entirely service-oriented, and can, therefore, differ from country to country, and even within the country. The experience of VCT in India indicates that modifications to the programme were made often and productively, keeping in view local conditions. There are some issues around the suitability of the concept of counselling for India, but over time, it has evolved well.

52 Adoption of Health Technologies in India

NSV, is somewhere in-between: more service-oriented than Hep B, but less than ART and VCT. As a technology for male sterilisation, which has few options, it has been very appropriate. While considering appropriateness and adaptability in the context of ART, one has to look both at immediate technology (in this case, drugs given under strict medical supervision) itself, and the other parameters that need to be in place for it to work well. In India, these issues comprise drug procurement, physician training and health infrastructure. Interestingly, due to hasty initiation, the ART programme in many sites had to be modified and adapted to suit local realities without much problem with quality. The programme is as yet quite new, and it remains to be seen how it will evolve over time. Overall, all the technologies seemed appropriate (except Hep B, on which the opinions are divided) and adapted well by India, and VCT, in particular, has continuously evolved over time, though it has taken somewhat longer to find its most appropriate form of delivery.

3.3 Policy Framework of Adoption The policy framework was analysed using the following parameters:

Approval and Regulation Mechanisms It is interesting to note that it is fairly easy in India to adopt a technology, and the processes of approval and regulation do not seem to have ever delayed any adoption. The only exception to this has been VCT, which, due to

Adoption of Health Technologies in India

53

the sensitive nature of the disease/technology, had to go through a few legislative attempts that generated debate over mandatory versus voluntary HIV testing in the country. Also, it is important to note that from time to time directives are issued on a particular technology that is implemented through the various layers of the government. Often, as has been the case with NSV, directives, with fairly far reaching implications, are issued, which change the course and quality of the adoption.

Role of Central/State/Local Governments Since all the technologies considered were public sector ones, it is a given that different layers of the government would be involved in the implementation of the programmes. Thus, the centre and state governments have been involved for VCT and ART, whereas centre, state as well as local governments have been involved in Hep B and NSV. It should be noted that Hep B and NSV are within the RCH Programme of the government, which is implemented at the field level in collaboration with the local governments. On the other hand, ART and VCT are part of the NACP, which is implemented through state AIDS control societies, and do not need the local government machinery. The less-than-smooth implementation occurs because of imperfect coordination between the centre and the states on various issues. For example, procurement is done centrally and then distributed to peripherals. Any delay in this can cause a disruption to the programme. Also, centre-state financial arrangements have always been an issue in India, and delay in transfer of funds can hamper the efficiency of adoption. The centre-state coordination has been more of an issue with

54 Adoption of Health Technologies in India

the RCH-based Hep B/UIP and NSV programmes, but not for the VCT and ART programmes, which have benefited greatly by setting up a system that bypasses the need to deal with state health departments.

Role of Private Sector These are government programmes and to that extent the role of the private sector is, by definition, limited. However, the two technologies under the RCH programme have some components of public-private partnerships, whereas the NACP programmes do not. Overall, while the role of the private sector has been limited in practice, the government could have envisaged a much greater participation from the private players. This is especially true in the NACP supported technologies of ART and VCT, which have significant presence in the private sector, unlike Hep B and NSV.

Role of NGO/Civil Society NGOs have played a significant role in both VCT and ART, by forming linkages with government facilities. This is not surprising, given the nature of the HIV/AIDS epidemic. There are a large number of NGOs that are active in prevention, control and treatment. The partnerships have been productive and have helped the clients to a great extent, to avail of the services. On the other hand, in the cases of Hep B and NSV, NGOs have not had much of a role in the provision of services, but have played a limited role in IEC and other demand generation activities. This has not, however, been a significant component of these two programmes.

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3.4 Supply Issues Procurement and Distribution Procurement and distribution seem to have been somewhat of an issue for the ART programme, and in the recent past, there is evidence that it is affecting the volume of treatment being offered. On the other hand, NSV and VCT are, by their very nature, less dependent on input procurement, and this has, therefore, not been a bottleneck in their adoption. Distribution, however, continues to be an issue for the Hep B vaccine, and has affected the quality of the programme.

Infrastructure The two RCH programmes—NSV and Hep B—could use the existing government set up, and did not need additional infrastructure. However, to the extent that the NSV programme heavily depended on the camp approach, the quality of the camps has been an area of concern. VCT and ARV were both being implemented through the public sector hospitals, and while there have been issues initially about finding empty spaces for these programmes, these have been solved sooner and later. It does not, therefore, seem as though basic infrastructure has been an issue for any of these technologies.

Human Resources Most government programmes have elaborate training components, and all these technologies are no exceptions.

56 Adoption of Health Technologies in India

Trained doctors and other staff, including counsellors, have not been an issue in either of the NACO programmes. However, the RCH-based programmes are heavily dependent on the Auxiliary Nurse Midwife (ANM), and there is evidence that the Hep B programme has overburdened these village-level workers. Also, the Hep B programme has other personnel shortage, including competent personnel for management of the cold chain, and, to that extent, human resources have been an issue for this technology. For NSV, trained personnel have not been a bottleneck in its expansion.

3.5 Distribution Issues The Hep B programme was a pilot and has not been fully scaled up yet. However, the selection of sites for the pilot has been based only on the extent of coverage and not on any disease burden analyses. As for NSV, it seems that the selection of states was based on the performance of male sterilisations. For example, Andhra Pradesh received a significant percentage of the training courses, most probably because this state had shown very high male sterilisation rates. However, in this case, the request for training had to come from the states. Therefore, the onus was, to a large extent, on the states to demand NSV as a technology. VCT has been rolled out well all over the country, though there is scope of improvement in the vulnerable states and rural areas. As for ART, a majority of the centres and clients are in high prevalence states and are mostly in urban areas. Overall, it seems that there is scope for improved and balanced spread of the health technologies in India, which can be done, to a large extent, with better data on surveillance and monitoring.

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3.6 Demand Issues The demand issues discussed below are not mutually exclusive, but are being discussed under three separate heads, to bring out the distinct nature of each issue.

Acceptability/Information and Knowledge The acceptability of a technology by the population determines, to a great extent, its success. Acceptability has to do with correct information and knowledge, and a felt need for its use. The pilot Hep B project seems to have not done too well, due to both supply and demand factors. While documentation on Hep B is sparse, the evidence from the UIP experience indicates that the programme has suffered from low acceptability among mothers, and education and awareness of mothers have played a significant role in determining acceptance. As for NSV, the genuine demand for male sterilisation is sometimes difficult to separate from the demand that is generated through supply side measures like financial incentives given in mass camps or target-based approaches, which introduces elements of coerciveness in the programme. The possibility of low demand for family planning methods in general, and male sterilisation in particular, cannot be ruled out in the case of NSV. The VCT programme has benefited greatly from effective IEC. So has, to some extent, the ART programme, though in this case, the initial information about the programme resulted in higher demand than what could be sustained. In general, the NACP-supported technologies have done better than the RCH ones. It can be concluded

58 Adoption of Health Technologies in India

that demand generation with dissemination of correct information—which is the cornerstone of a successful adoption—has been somewhat of a weak area in the adoption of two of the technologies.

Availability and Accessibility The experience of UIP (and therefore Hep B) indicates that coverage has remained low in backward areas/states, tribal areas, small and inaccessible villages. Poor accessibility has, therefore, been a concern in the UIP programme. As for NSV, the approach has been state- and areaspecific and not really based on demand. It has been up to the states to decide where they wanted to launch the programme. In the recent past, with the renewed emphasis on male sterilisation, more areas are being targeted, including rural and backward areas. There is also some evidence of opposition to the sterilisation camps based on ideological and other concerns, which may have adversely affected accessibility. For VCT, the uneven quality of services, like ease of physical access of the centres and time taken to reveal test results, has been the main obstacle to a higher rate of adoption. The geographic spread of VCTCs has been more or less adequate and, in the recent past, districts are also being covered. In the case of ART, there is more demand than what can be met with the current supply. Constrained drug supply has affected availability in the case of the ART programme. On the surface, it does seem as though the quality of ART has been reasonable, though data for a much longer time span are required to really comment on the ‘structured’-ness of the ART programme.

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Affordability All the health technologies have been provided free. Therefore, affordability has not been a barrier to uptake. For NSV, the pricing is in fact negative, with financial incentives used as a method for attracting clients. ART, however, is an interesting case, since there are additional costs on other drugs, diagnostics, transport and other incidentals, which may become a barrier to adoption in some cases. Also, the government provides only 1st line drugs, and many experiencing treatment failure would require 2nd line drugs as well, which is currently prohibitively expensive in the private sector. Thus, in the case of ART, affordability remains a bit of an issue in its adoption. Table 3.1 sums up these findings across technologies and gives a summary of the results.

Role of private sector

Role of central/state/ local governments

Approval and regulation

Policy framework

All levels active; state governments’ decision staggered across states

Smooth

Yes

Timely

NSV

Limited role envisaged; some participation in IEC activities

All levels active; improved coordination possible

Smooth

Unsettled

Unsettled; earlier adoption not warranted

Timing of adoption1

Appropriateness/ adaptability

Hepatitis B

Parameters

Smooth

Yes

Timely

ARV

(contd)

Currently insignificant; can be expanded

Centre and state active; no local government role by design

Initially slow

Evolved positively

Testing timely Counselling delayed

VCT

TABLE 3.1 Adoption of health technologies in India: A review of key parameters

Insignificant; can be improved for demand generation

Role of NGO/civil society

Good

Not an issue generally, but occasionally in camps State responsible for training; geographic distribution of trained surgeons not optimal Skewed geographic distribution

Can be improved significantly

Can be improved significantly

Can be improved significantly

Infrastructure

Human resources

Distribution issues

Could be better for demand generation activities

NSV

Scope for improvement significant

Procurement and distribution

Supply issues

Hepatitis B

Parameters

(contd) ARV

Good

Average

Good

(contd)

Procurement & supply can be improved Not an issue

Moderate; rapid turnover of counsellors & uneven quality a concern

Good

Significant roles in demand generation and forming linkages with providers

VCT

Good

Good

Affordability

Note: 1 From the time of discovery of the technology to the felt need.

Source: Compiled by the authors.

Area specific; scope for improvement

Moderate

Availability/ accessibility

Low

NSV

Low

Hepatitis B

Acceptability/ knowledge

Demand issues

Parameters

(contd)

Good

Average

ARV

Good for 1st line, potential concern for 2nd line drugs

Good, increasing Good; Scope for improvement in voluntary access

VCT

Chapter 4 Lessons for the Adoption of the AIDS Vaccine

The above analysis was done mainly to understand the various issues to which policymakers need to be alert while planning to release the AIDS vaccine as and when it comes to India. The key to successful adoption is in prior planning which takes into account all the key parameters that go into adopting a technology. In this chapter, we highlight some of the main lessons learnt from a study of the four technologies in India.

4.1 Timing of Adoption This has, overall, been satisfactory and the gap between the ‘discovery’ or availability of the technology globally and India’s policy decision to adopt it has not been too much. It seems highly likely, therefore, that the AIDS vaccine, as and when it is available globally, will be adopted in India without too much delay. Since there is already a significant amount of global focus on the vaccine and since India has been a part of the global network on the AIDS

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vaccine, the adoption is predicted to be fairly quick in India. The aim should be to be pro-active in the process of adoption, rather than passive and to start processes that would facilitate rapid adoption.

4.2 Appropriateness and Adaptability The decisions around targeting and point of service delivery in the case of the AIDS vaccine will determine to a great extent the appropriateness and adaptability. The selected technologies studied here were, more or less, appropriate and were adapted to suit local needs sooner or later. If adequate planning is done, it is believed that the form in which the vaccine will be released in India would be such that it will be easy for the recipients to use it. The Hep B experience suggests that issues around selective vs universal adoption need to be dealt with as and when the government decides to introduce the AIDS vaccine. The evolution of VCT and the current experience with ART indicate that India has been good at adapting to constraints and bottlenecks and that there is not too much cause of worry on this account. This, of course, also means that earlier planning to ease such bottlenecks are required so that there are no efficiency losses even in the short run.

4.3 Policy Framework of Adoption None of the technologies needed drastic approval/regulation processes, except VCT to a certain extent. Given the sensitive nature of the AIDS vaccine, it is critical to plan early on the mode of its release, so that proper policies are put in place to deal with possible legal or ethical issues. It

Lessons for the Adoption of the AIDS Vaccine 65

is probably going to be the case that the AIDS vaccine will be released with much more control retained by the policymakers, given the issues around its efficacy and the possible impact of the presence of a vaccine on behaviour. How exactly the policy and regulation environment (for example, the question of whether a Bill will have to be introduced in the Parliament) will have to adjust, will need to be worked out much ahead of time. Like all the vaccines discussed here, the AIDS vaccine will need immense coordination between the layers of the government, as also between government and the private and NGO sectors. It does seem from the experience of UIP/Hep B, particularly, that coordination between centre and states has been less than optimal in India, and has affected a smoother adoption, especially for the RCHsupported technologies. However, the NACP technologies with relatively better performance indicate that having autonomous societies at state level may ensure smooth adoption. The planners will need to map out roles and responsibilities of the government layers sectors ahead of time and to think about whether it needs to create separate structures or use existing ones to facilitate release of the vaccine. There has also been no specific role envisaged for the private sector in any of these four technologies. Also, wherever the NGOs/civil societies have been co-opted, the adoption has been superior. The planners of the AIDS vaccine need to learn from the experiences of these technologies and plan out the roles of the private sector and NGO sector much ahead of time, especially since these sectors have been playing critical roles in the HIV/AIDS epidemic. In fact, the presence of both these sectors may be critical for a targeted release of the vaccine.

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4.4 Supply Issues Human resource continues to be a critical parameter. However, the case studies reveal that in the case of adoption, it has been weak. The release of the AIDS vaccine will have to be preceded by human resource planning, taking into account quantity and quality of personnel. The vaccine will need sensitive handling at the point of use and importantly, a stable and well-trained personnel backup, which has not always been the case with the technologies considered here. The extensive network of VCT and ART centres may be seen as entry points for the delivery of the AIDS vaccine, but would require trained health personnel and counsellors. While NSV and VCT are free from any procurement issues, the experience with product-based technologies, viz. Hep B and ART do indicate that ensuring smooth procurement and distribution will be key to smooth adoption. The requirement of infrastructure would depend to a great extent on how the AIDS vaccine is to be released, but the Hep B and the UIP experiences indicate an urgent need for prior planning around storage issues, which remains a weak spot of the vaccine programmes in India. Management issues around vaccine storage and distribution also need special focus and the UIP experience is key to understanding the various supply side problems a vast system of procurement and distribution can face.

4.5 Distribution Issues This has again been somewhat of a weak point in the adoption history in the country. This is mainly because of inadequate research and planning by the policymakers prior to

Lessons for the Adoption of the AIDS Vaccine 67

the release of a technology. Distribution will be one of the most critical issues in the case of the AIDS vaccine and is an area that will need to be worked out ahead with proper targets for groups, rural-urban areas and states. The history of adoption seems to indicate that distributional corrections are difficult to undertake midway, so planning has to be ahead of time. Much would, of course, depend on ‘to whom’ and ‘how and where’ the vaccine is going to be released. The Hep B experience indicates that proper understanding of the disease burden on different population groups is critical. In the case of the AIDS vaccine, this would translate into who (individuals as well as geographic entities) requires the vaccine and why, and where and how to make it accessible. A lot of operational research may be required ahead of time to take the decisions on how to distribute the vaccine well. Poor distribution would result in a very low rate of adoption and would, therefore, be cost-ineffective.

4.6 Demand Issues This is an area that has been weak especially for the sensitive health technologies like NSV and acceptance has been hindered by inadequate attention given to IEC. However, wherever NGOs have been involved in IEC, the adoption has been better, as in VCT and ARV. The status of the HIV/AIDS epidemic in India clearly indicates that it has spread to all corners and in all groups, and that prevention/control as well as treatment need to be handled with utmost sensitivity. Knowledge is the key and the release of the vaccine has to be done with proper and prior IEC activities targeted at areas and groups that need such knowledge the most. However, not only is

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proper knowledge about the vaccine critical, but also continuous messages about prevention. This may be the key to the success of the AIDS vaccine, since the availability of the vaccine could potentially cause some dis-inhibition. An IEC package on correct knowledge on the efficacy and quality of the vaccine combined with messages about prevention may have to be launched before the launch of the AIDS vaccine. Following are the additional messages that the planners of the AIDS vaccine can take away from this analysis: • The history of adoption of health technologies seems to indicate that it takes time to set up a foolproof system and it takes even longer to take corrective measures when required. • Heavily government-tilted health technology adoption may have its own problems, and further, may miss out on the strengths that the dynamism of the private and non-profit sectors provide. • Geographical and other distributional issues need to be given more attention since these could prove to be a weak link in the chain. • A health technology that is human resource intensive and deals with sensitive issues requires careful prior planning on the human resource front as this has also been a somewhat weak area in the adoption history in India. Cultural and social sensitivities need to be taken into account ahead of time and not left to the system to handle later as this could bring down the success of adoption considerably. • IEC activities remain the most important part of successful access to a technology, and in the context of sensitive issues like HIV and sexuality, it takes on an

Lessons for the Adoption of the AIDS Vaccine 69

even greater importance. Of utmost importance in the context of the AIDS vaccine will be proper dissemination of knowledge about the efficacy of the vaccine and prevention messages. The NGO/private sector could be potential partners in the process. • Rapid scaling up is fraught with pitfalls, and brings down quality. It should be avoided to the extent possible. • Technologies that are heavily resource intensive and need infrastructure as well as human resources, need prior and proper planning, which, in turn, is based on sound data, or else, there is the danger of scarce resources being wasted to a great extent. • Proper data and documentation should not only accompany a roll out but should precede such an intervention, since it could inform sound policymaking.

Chapter 5 Summary and Conclusions

There are several health technologies that have been introduced around the world and also in India, but very little on the processes and success of introduction of these technologies, has, as yet been documented. This study was an attempt to document and understand the various dimensions of adoption based on selected parameters through in-depth analyses of four selected health technologies with certain unique characteristics. These include Hepatitis B immunisation, No-Scalpel Vasectomy (NSV), Antiretroviral therapy (ART) and Voluntary Counselling and Testing (VCT) service. In addition, the Universal Immunisation Programme (UIP) of India was also looked at, as it is India’s first large-scale public health programme. The study indicates that despite some systemic problems with the health sector set up, India’s adoption experience has been quite encouraging. Every technology has thrown up a few important lessons that planners can use. The weakest parts of these programmes have had to do with imperfect coordination among the major stakeholders, inability to partner with private sector and use its dynamism in a productive way, inadequate planning of procurement, lack of attention paid to distributional issues

Summary and Conclusions 71

and low efforts at demand generation. The study concluded by presenting each of these findings in the context of the AIDS vaccine, and emphasised the need for proper and prior planning on these issues to make the adoption smoother for the AIDS vaccine. The AIDS vaccine is still a long way off for India and it is not entirely clear when one can expect to see a vaccine that is ready to be used. Nevertheless, issues around possibly a less-than 100 per cent efficacious vaccine raises questions about whether or not to adopt it, and if it is to be adopted, how best to adopt it. The lessons learnt from the adoption history of the four technologies discussed above bring home the point that if the aim of a vaccine is to reach those who need it the most, then prior and proper planning is essential. While most adoptions have evolved and learnt from past experiences, it may be costly to do course-corrections, especially in the context of the AIDS vaccine. It will be critical to plan ahead of time, on the following issues: • Target group: It is unlikely that the vaccine will be released for the general population. But it is not, as yet, clear who would be targeted. This is the key to the adoption of the AIDS vaccine, and will determine the extent of availability, accessibility and equitable distribution. • Point of service delivery: Where the vaccine will be given—in a facility or outside (in the field)—would determine requirements of infrastructure and, to some extent, personnel. A conclusion of this book is that there can be a three-way linkage between VCT, ART and the AIDS vaccine. Those who come in for testing will be sent to the ART clinic, if tested

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positive, and, if negative, can be counselled for the AIDS vaccine, and given the vaccine, if he/she agrees. This system can, therefore, save costs, by using an already existing system. A pre-condition of counselling and HIV testing at the time of vaccine delivery would not only ensure proper IEC, but ensure that it is given to those for whom it is meant, that is, HIV negative individuals. • Schedule of phased roll out: it is probably going to be costly, inefficient as well as counterproductive to release the vaccine all over the country. This is mainly because of the dis-inhibition issue. Therefore, a phased schedule of roll-out has to be planned out ahead of time, based on sound criteria for selection of the sites. Distribution has not been a strong point in India’s adoption history with health technologies, and will need special attention. • Approval/regulation: One unique feature that separates the AIDS vaccine from other health technologies is the following: its presence can affect behaviour with strong negative externalities. This may necessitate that control be kept in the hands of the policymakers so that it is not used sub-optimally. This may in turn require legislative or other regulatory processes that need to be planned ahead of time. • IEC: the key to an effective uptake will be messages on the vaccine accompanied by messages on prevention. The behaviour change that may occur due to the presence of the vaccine has to be strongly countered by proper, targeted and effective IEC. It is clear that poor IEC impacts strongly on acceptability and behaviour, and that it could be a potentially weak point in an adoption.

Summary and Conclusions 73

It is not clear yet when the AIDS vaccine will appear in the country. However, the analysis gives a framework for the planners to use and with which they can plan, and hopefully, will make the adoption process somewhat easier.

PART II Analysis: Selected Case Studies of Adoption of Health Technologies in India

Chapter 6 Universal Immunisation Programme

6.1

Introduction

Universal Immunisation Programme (UIP) has been introduced in every district of the country, and the target now is to achieve 100 per cent immunisation coverage. The impact of the programme in India is reflected in the significant reduction in the Infant Mortality Rate (IMR) from 129 per 1000 live births in 1976 to 63 per 1000 live births in 2002. Child mortality rate (calculated for ages 0–4) has declined from 26.5 per thousand in 1991 to 18 in 2002 (MOHFW Annual Report 2003–04). However, further improvements in the IMR are not forthcoming for sometime now, and the policymakers have been concerned about the inability of the UIP to really bring about faster reductions in infant and child mortality rates. The reasons for this could be many, and the discussion below is meant to bring out some of the constraints that face the programme today.

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6.2 Timing of Adoption Child immunisation was a priority of the government ever since independence, but the real impetus to universal immunisation came in the 1970s. The government could successfully eradicate Small Pox in 1975 and, thereafter, it turned its attention to other Vaccine Preventable Diseases (VPDs). In 1978, India launched the Expanded Programme on Immunisation (EPI) to control six VPDs like Diphtheria, Pertussis, Tetanus, Poliomyelitis, Typhoid and childhood Tuberculosis. The aim was to cover 80 per cent of all infants. Subsequently, the programme was universalised and renamed as Universal Immunisation Programme (UIP) in 1985. The inclusion of immunisation in India’s Technology Mission (one of five missions reporting directly to the Prime Minister) and the infusion of resources associated with the global Universal Childhood Immunisation (UCI) goal resulted in rapidly increasing the coverage in the late 1980s (WHO-UNICEF Coverage Review 2004). Measles vaccine was included in the programme and Typhoid vaccine was discontinued in 1985. The UIP was introduced in a phased manner from 1985 to cover all districts in the country by 1990, targeting all infants with the primary immunisation schedule and all pregnant women with Tetanus Toxoid (TT) immunisation. In 1992, the UIP became a part of the Child Survival and Safe Motherhood Programme (CSSM) and, in 1997, it became an important component of the Reproductive and Child Health Programme (RCH). During the RCH programme, the cold-chain system was strengthened and training programmes were launched extensively throughout the country. Intensified polio eradication activities were started in 1995–96 under the Polio Eradication Programme.

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WHO created the EPI in 1974. While India responded to WHO announcement of EPI almost after four years, measles introduction took a very long time. The WHO had recommended the Measles vaccine to be included in the EPI, but India could only include it into its national programme in 1985—almost 30 years after its global introduction. UIP is the culmination of a chain of interventions to prevent childhood diseases in India, and, except for measles, it does seem that the government acted as and when the need arose and vaccines became available globally.

6.3 Appropriateness and Adaptability The successive inclusion of the necessary and available vaccines in the UIP suggests a flexibility of framework and a willingness to adapt to changing needs. There is no doubt that the experience over the years has only helped to strengthen the administrative part of the programme and that policy issues have not been a major hurdle in the adoption of UIP. As will be seen later, the implementation of the UIP has, however, remained a major area of concern.

6.4 Policy Framework of Adoption Approval and Regulation Universal immunisation against six vaccine preventable diseases (VPD) by 2000 was one of the goals set in the National Health Policy of the government. In 1985, the UIP was started in India to achieve this objective. The UIP was taken up in 1986 as part of the National Technology

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Mission and became operational in all districts in the country during 1989–90. Currently, there is a National Technical Advisory Group on Immunisation (NTAGI), which advises the government on policies, practices and implementation of the national immunisation programme. The NTAGI held its first meeting on 19 December 2001 and, subsequently, it also coordinated the Immunisation Strengthening Project of the Ministry of Health and Family Welfare (MOHFW) with assistance from the World Bank (MOHFW 2002). The UIP currently envisages achieving and sustaining universal immunisation coverage in a target population of about 25 million infants with three doses of DPT and OPV and one dose each of the Measles vaccine and BCG, and, in pregnant women, with two primary doses or one booster dose of Tetanus Toxoid (TT).

Role of Central/State/Local Governments The government has the overall responsibility of the structure and management of the UIP in India. The administrative levels in India are national, state, district and block; the district is wholly responsible for service delivery in all of its blocks. The block includes the Primary Health Centres (PHC) and each PHC has several sub-centres. The District Immunisation Officer (DIO) reports to the District Medical Officer and also to the State Immunisation Officer. Each state is responsible for the monitoring, evaluation and supervision of the immunisation activities of the state. The state manages vaccine stocks received from the Central Government, delivers vaccines to the districts, compiles the reports of the districts and makes the state report which is then given to the centre. The Auxiliary

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Nurse Midwife (ANM) is in charge of a PHC and the sub-centres, and delivers comprehensive primary health care services, both curative and preventive, and is the key worker of the UIP.

Role of Private Sector With the government being the major immunisation provider in India, the role of the private sector in immunisation should be minimal. There are no statistics available about the extent of such coverage. However, the MOHFW (2005) indicates that an estimated 15–20 per cent of the total immunisation is currently being provided by the private sector, which is surprisingly high. It may indicate the failure of the public programme to reach all intended recipients, which will be discussed again below. The discussion with experts revealed that the private sector is playing a major role in the provision of (a) the child vaccines that are not yet fully covered in the UIP viz. Hep B, HiB, MMR and so on and (b) the adult vaccines. However, it was also learnt that some type of publicprivate partnership has been practised, wherein the DIO has the discretion to partner with private institutions. In this arrangement, only DTP vaccines are being provided free of cost to such institutions, who would, in turn, give it free to their clients. While it was learnt that the partnering institutions needed to report to the respective DIO about utilisation, it seemed that this information was not flowing beyond district level and, thus, no data is available around the extent of coverage through this kind of partnerships. The experts, however, also felt that it would take a long time before there could be an official impetus given to the public-private mix in the UIP in India.

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Role of NGO Sector While initially the NGO sector was not much involved in the RCH programme and the UIP, of late there has been a huge shift and partnership with NGOs is seen as an essential part of the RCH 2. The NGOs are now envisaged ‘to facilitate service delivery in addition to health education and awareness programmes’ (MOHFW 2006). The NGOs are now being seen as essential in reaching under-served and unserved areas, including Scheduled Caste/Scheduled Tribe (SC/ST) habitats, urban slums and other areas where the government facilities do not function well. This shift is a welcome step indeed. It shows the willingness of government to adapt to changing situations and to learn from experience.

6.5 Supply Issues Procurement and Distribution The UIP aims to achieve self-sufficiency in vaccine production and the manufacturing of cold-chain equipments. All the vaccines for the UIP are procured through Indian pharmaceutical companies, both public and private. The important public sector companies include Serum Institute of India and Central Research Institute (CRI), Kasauli. The major private sector suppliers are Biological Evans, Haffkine (HBPCL) and Pasteur Institute. The National Quality Control Laboratory at Kasauli does statutory testing of vaccines. The vaccines are released only after clearance by this laboratory. Only the Serum Institute has WHO pre-qualified vaccines, while all others do not meet

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the Good Management Practices (GMP) norms of WHO. However, in the wake of the new WTO regulations, all these enterprises have begun efforts to qualify for WHO pre-qualification. The manufacturers deliver vaccines directly to the Government Medical Stores Depots (GMSDs) or to the state EPI facilities, based on the supply orders from the central level. The vaccines are then distributed to the district level, and it reaches the sub-centres through the PHCs. Generally, this process takes about four to six months. When there is a shortage, a similar chain of communication is used to contact the central authorities. Discussions with the experts revealed that in the past few years there has been some logistical delays due to delayed orders from the state and centre. The MOHFW’s recent report admits logistical problems and states: often there is a delay in the procurement process resulting in acute as well as long-term shortages of vaccine, affecting the performance of the immunization programme. Feedback with regard to vaccine utilization and supply is also not accurate, complete and timely, resulting in overstocking and undersupply. There is also a need for strengthening planning and logistics of vaccine distribution at the state and district level with efficient feedback mechanisms on utilization and future demand.

Infrastructure Cold-Chain System A reliable cold-chain system is the backbone of any immunisation programme for storing and transporting all required

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vaccines, and attaining self-sufficiency in the production of all required vaccines. About 52,000 freezer refrigerators and about 140 walk-in-coolers (WICs) and walk-infreezers (WIFs) formed a part of the broad network of cold-chain network all over India. These equipments were supplied at various stages of the immunisation programme in the past, with funds from UNICEF and other foreign donor agencies. Additionally, there are eight WIFs in medical stores depots of the MOHFW, two each in Mumbai (Maharashtra), Kolkata (West Bengal), Chennai (Tamil Nadu) and Karnal (Haryana). The consensus seemed to be that despite this network of equipments, these were not sufficiently useful due to maintenance problems and delays in repairing them. This problem is more acute in the backward states like Uttar Pradesh and Bihar. The Midterm Review (MTR) of the UIP (MOHFW 2004) states that ‘there is lack of monitoring of the cold chain equipment breakdown rate and cold chain sickness rate, and the repairing status is a major area of concern’.

Logistical Issues Once the vaccines have been procured, the main issue is of distributing these to the concerned health functionary (in this case finally the ANMs), who would actually use the vaccines for immunisation. Needless to say, the efficiency of the cold-chain equipments would be crucial in this process. However, the UIP experience brings to light several logistical problems. The MTR states that ‘there is currently not enough human resource capacity at national level to attend to vaccine and vaccine supply procurement and distribution’, and that the ‘difference between reported and evaluated coverage is impacting on vaccine supply planning’. However, while the review team was of the opinion

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that the logistics system for managing and distributing vaccine stocks did not seem to be a major impediment to improving coverage, it did mention that ‘there were instances of shortages and stock-outs affecting different vaccines at different times, in different parts of the system, and affecting some immunization sessions’. Also, wastage rates were high, and generally vaccine supply did not match requirement. The review also mentioned that the calculation of vaccine requirements was not linked either to realistic coverage or wastage data, nor was it related to forecasts or actual use. Meetings with experts also re-confirmed the view that there was a worrying trend of unused vaccines going to waste due to bad planning.

Human Resources In India, immunisation in each district is under the purview of the district immunisation officer. However, there is evidence that in some of the major states, there is no such officer, due to the posts not being filled. The shortage of appropriately trained staff continues to plague the service delivery, which is key to improved access in the case of immunisation. The ANM has the responsibility to provide immunisation to the targeted number of infants in one sub-centre, which has around five villages. The ANM is supposed to visit one village every month on one particular day to immunise the children. The major burden of service delivery is, therefore, carried by the ANMs. There is a general view that the ANMs are overworked and also that the system is not efficient for meeting the coverage targets. To carry the vaccine in the vaccine carriers from the PHC to the village and back takes several hours and, in the process, the number of children actually

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immunised is often less than the target. In the absence of a fixed place where parents can bring their children, the chances of missing some children are quite high. Based on the 1991 census, it was decided that the ANM would cover 4–5 villages with around 5,000 children per village. However, after 15 years, the target population in each village has increased but not the staff, and one ANM continues to be incharge of the sub-centre. This has understandably put a serious workload on the ANMs. It also seems that lack of regular ongoing training and on-time payments of salaries are additional issues that ANMs have to deal with (Iyer and Jesani 1999; Dasgupta and Ritupriya 2002; Mohan et al. 2003). An efficient immunisation programme depends almost entirely on these individuals, who, along with other health functionaries, have a multiplicity of tasks that are not properly planned or coordinated. There seems to be a consensus that the human resource planning around immunisation services, which is an integral part of the service delivery, leaves a lot of scope for improvement. However, with a renewed political commitment towards immunisation, there are efforts now to deal with many of these issues, including efforts to reduce the burden on the ANMs by innovative strategies like providing vehicles to ANM for ease of travel.

6.6 Distribution Issues The main indicator of the success of the UIP as a heath technology is the extent of coverage. There are both government and other independent sources of data on immunisation coverage in India. The important data sources are the National Family Health Surveys (NFHS) in 1992–93

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(Phase 1) and 1998–99 (Phase 2), RCH surveys in 1997– 98 (Round 1) and 2002–03 (Round 2),1 National Sample Survey (NSS) (1995–96), the Multiple Indicator Cluster Survey (MICS) by UNICEF in 2000 and the data compiled by the MOHFW on a yearly basis in its Family Welfare Year book. There was also a coverage evaluation survey done by the Indian Council of Medical Research (ICMR) to assess the status of immunisation coverage across states in the year 1999. The following analysis is based on these various sources of data. The first impression from Table 6.1 is that of significant variations in the coverage rates across the different sources, even for the same time period. Even though NFHS 2 and RCH 1 were conducted during the same years, the coverage figures often vary for the same states. Except for a few states like Tamil Nadu, Goa and Haryana, the immunisation coverage figures are different between RCH 1 and NFHS 2, which were conducted in the same time period. In general, the RCH 1 figures were somewhat higher than the NFHS 2 figures. This could be due to different methodologies adopted in the different surveys. To control for these methodological variations, it would be appropriate to compare NFHS 1 and 2, especially when looking at temporal changes. It is clear that the immunisation coverage has increased over the years, except in states like Rajasthan, Madhya Pradesh, Bihar, Arunachal Pradesh and Meghalaya. The socio-demographic as well as economic indicators have traditionally been poor in what was earlier called the BIMARU states (which included the states of Bihar, Madhya Pradesh, Rajasthan, Uttar Pradesh); these states 1

The results of RCH Round 2 data for states are yet to be published.

88 Adoption of Health Technologies in India TABLE 6.1 State-wise coverage of the UIP in India (percentage of children fully immunised) States/UT India Andhra Pradesh Assam Bihar Gujarat Haryana Karnataka Kerala Madhya Pradesh Maharashtra Orissa Punjab Rajasthan Tamil Nadu Uttar Pradesh West Bengal Delhi Goa Himachal Pradesh Jammu and Kashmir Manipur Meghalaya Mizoram Nagaland Sikkim Tripura Arunachal Pradesh

NFHS 1 NFHS 2 RCH 1 ICMR 1992–93 1998–99 1998–99 1999 35.4 45.0 19.4 10.7 49.8 53.5 52.2 54.4 22.9 64.3 36.1 61.9 21.1 65.1 19.8 34.2 57.8 74.9 63.5 54.2 29.1 54.9 56.9 03.8 14.3 22.5

42.0 58.7 17.0 11.0 53.0 62.7 60.0 79.7 22.4 78.4 43.7 72.1 17.3 88.8 21.2 43.8 69.8 82.6 83.4 56.7 42.3 42.3 59.6 14.1 47.4 40.7 20.5

54.2 74.5 46.7 22.4 58.1 66.0 71.8 84.0 48.4 79.7 57.8 72.9 37.0 91.5 43.7 51.5 84.8 88.6 74.4 52.9 51.0 32.7 68.4 26.1 46.3 30.6

63.3 75.7 60.2 37.0 79.1 85.5 91.3 96.2 60.8 79.5 64.3 80.5 40.0 91.9 51.1 69.7 76.5 69.0 67.7 Total for NorthEast states 51.9

MICS 2000 37.9 46.1 22.2 12.6 43.9 33.5 68.0 76.9 30.1 63.7 45.7 43.5 24.2 80.8 16.6 57.2 54.6 86.2 71.1 54.9 57.1 30.2 37.5 23.4 60.7 32.9 28.6

Source: Complied from various sources including NFHS (1992–93) and NFHS (1998–99), RCH (1998), Singh and Yadav (2000) for the ICMR study and MICS (2001) for the MICS study.

along with Orissa are now called EAG or Empowered Action Group states. These EAG states were hovering

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around the 20 per cent mark for immunisation coverage, on an average, even after 5 years, though the RCH 1 numbers were somewhat higher. But even in the better performing states, coverage is uneven and not anywhere close to being ‘universal’. The MICS (2000) survey showed a national average of around 38 per cent immunisation coverage. This data also showed considerable differences with the NFHS 2 and RCH 1 except in the cases of Jammu and Kashmir and Goa. The coverage varied from as low as 16.6 per cent in Uttar Pradesh to 86 per cent in Goa. It is interesting to see that the ICMR sample survey done in the same years as RCH 1 and MICS show lot of differences across states in the coverage. The ICMR survey reported that the national coverage was 63 per cent, which was way above the MICS and RCH 1 surveys. The above discussion only makes obvious what the government has already admitted: the stagnating routine immunization coverage rates, high drop-out rates and declining trend in some of the districts in key states (UP, Bihar, Rajasthan, Jharkhand, West Bengal, AP and Assam) are issues of major concern. Even within states with high coverage rates, there is marked variation between districts. (MOHFW 2005).

6.7 Demand Issues Acceptability Information and Knowledge In addition to availability and accessibility, which are barriers that emerge from supply side issues, what prevents

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India from attaining a higher coverage rate in immunisation and why are the rates stagnating in many states? There are only a handful of studies on the reasons for poor coverage, but these do help in a greater understanding of the barriers to a faster and efficient adoption and performance. For example, Manjunath and Pareek (2003), in their study on children in Rajasthan, found that the major reason for lack of coverage was that the mothers were not well informed about immunisation details. The study recommended that in order to improve immunisation coverage, emphasis should be placed on maternal knowledge about vaccine preventable diseases and on the completion of the immunisation schedule. Singh and Yadav (2001) assessed the immunisation status of 6,300 children across 900 villages in 30 districts of the states of Bihar, Madhya Pradesh and Rajasthan. Only about 48 per cent of the children had received all the routine vaccines in these states, which was lower than the other national surveys like NFHS and RCH. The coverage levels were lower for children of illiterate mothers and children in small, inaccessible and tribal villages. Mother’s literacy was found to be a key variable for the success of the UIP. The study recommended that IEC activities should be targeted especially at mothers in rural areas and that more focus should be given to tribal, small and inaccessible villages. Other studies (Das and Dasgupta 2001; Ray et al. 2004; Dalal and Silveira 2005) also indicated that lack of awareness about immunisation and access problems were major reasons for low coverage. Studies from other parts of the world (Reichler et al. 1998; Browne et al. 2002; Harmanci et al. 2003) corroborate that lack of awareness, including social taboos and misconceptions and poor services are

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some of the major reasons for the lack of participation in immunisation programmes. The MOHFW (2004) also lists, as reasons for low demand and utilisation, lack of awareness as well as lack of motivation due to being unconvinced of the need for routine immunisation. This kind of attitude is reinforced by the poor quality of service delivery and, therefore, both demand and supply side issues need equal emphasis in the UIP in the country. Bhatia et al. (2004) attempted to find out the coverage of pulse polio immunisation among children on one of the national immunisation days in Chandigarh. They found that around 72 per cent of the children were fully immunised, and that there were no differences between the male and female immunisation rates. The study also documented the poor coverage among children in slums. The major reasons for low coverage were lack of monitoring, poor health infrastructure in slums and lack of IEC activities. Despite this, the pulse polio campaigns were relatively successful, and the study recommended that successful community involvement achieved in pulse polio campaigns could be a model for other vaccines of the routine immunisation programme.

Availability and Accessibility From the myriad problems of service delivery mentioned above, it does seem as though the service is neither available nor accessible to many parents of infants, especially in relatively backwards areas/states. The low coverage is certainly due to the limited reach of the services. Some studies (for example, Singh and Yadav 2001) show that coverage was low in small, inaccessible and tribal villages of backward states. Some other studies mentioned under the

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discussion on Hep B below also show poor accessibility to be a major reason for poor coverage, along with inadequate knowledge.

Affordability Since the government programme is free, price of the services is not an issue and not a barrier towards a better uptake.

6.8 Overview and Lessons The UIP is an essential component of the health policy of the country, for improving infant and child mortality as well as affecting maternal mortality to a certain extent. Given India’s recent lack of improvement on these indicators, the UIP takes on an even greater importance. The UIP has been able to penetrate into all the states and, therefore, coverage has improved. However, the increasing trend of coverage seems to have been arrested and there continue to be disparities between reported and evaluated coverage, and coverage rates continue to be an issue in backward states and many districts. Both demand and supply issues seem to plague the UIP in India. The initial progress made on increased coverage could have been maintained only by continuously focussing on and improving implementation bottlenecks. From the supply side, some of the major concerns like poor implementation and monitoring, human resource management, and maintenance of equipment needed early focus and correction. These are issues that were more under the control of the policy planners than demand

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issues. From the demand side, lack of awareness and the need for mothers’ involvement and commitment are areas that need specific and innovative IEC strategies as also more focussed campaigns like the Pulse Polio campaign. The main message from the UIP experience seems to be that the benefits from a good programme like the universal immunisation which has huge externalities can be forfeited unless a system of continuous course-correction is put in place and both demand and supply side issues are given equal importance. Since government machineries worldwide have in-built inertia, it is more important to consciously monitor and evaluate such programmes. Finally, since it is a government programme, the synergies with other interventions need to be focussed on, because the same system can be overstrained and overstretched if the planners think of programmes in a parallel, rather than holistic manner. Depending on how the AIDS vaccine is targeted, and whether or not such a comprehensive system would be required for its adoption, the UIP experience could offer valuable lessons to the planners on how best to prepare for it, and what areas of demand and supply should be focussed on.

Chapter 7 Hepatitis B Immunisation

7.1

Introduction

Hepatitis B (Hep B) is considered a major public health problem worldwide. Approximately 30 per cent of the world’s population, that is, about 2 billion persons, have serologic evidence of current or past Hepatitis B Virus (HBV) infection. Of these, an estimated 350 million have chronic HBV infection and at least one million persons die annually from HBV-related chronic liver disease, including cirrhosis and liver cancer.1 As per the WHO classification of Hep B prevalence, India is a country with intermediate endemicity, with Hep B surface antigen (HBsAg) prevalence being between 2 and 7 per cent of the populations studied. In 1991, the Global Advisory Group of the EPI of WHO recommended that Hep B vaccine be introduced into national immunisation programmes in all countries by the 1

www.who.int/hepatitisB

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year 1997. However, there has been a lot of debate around the cost-effectiveness of introducing Hep B in national immunisation programmes, which continues to date. A familiarity with some of these arguments on either side is important to fully understand the issues around adoption of Hep B. There are studies done in the international context, which have looked into different issues of Hep B immunisation in the UIP of countries. This brief review of the existing literature (some selected details have already been mentioned in Chapter 2) points to an emerging consensus that while the adoption of the Hep B vaccine may not require universal coverage, it has the highest chance of being a success only if it is incorporated in the UIP of the countries.

7.2 Timing of Adoption As mentioned above, the WHO in 1991 recommended that the Hep B vaccine should be introduced into national immunisation programmes in all countries by 1997. The World Health Assembly approved this in 1992 and, by the end of 2005, 168 countries worldwide had implemented this (Banatvala et al. 2006). Ever since Hep B immunisation was introduced in various developed countries, similar efforts have been initiated in India as well. The first attempt to introduce Hep B vaccination among children was made in 1996 and WHO provided the vaccines for a pilot project in East Delhi. The objective of the pilot project was to assess the feasibility of including the Hep B vaccine into the UIP and to assess the requirement for forms and educational materials. The

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resultant 60 per cent coverage was deemed a success and Hep B was introduced in the UIP for the entire city of Delhi. Subsequently, the Program for Appropriate Technology in Health (PATH) introduced Hep B vaccination in UIP in Andhra Pradesh. States like Kerala and Haryana also followed suit and introduced Hep B vaccination in their state-level programmes; however, both these states had to discontinue the programme due to operational difficulties (WHO 2002). Since then, till 2002, Hep B vaccine was available only in the private sector, mainly in urban areas, for those who could afford it. The Hep B vaccination programme in the public sector was launched with assistance from the Global Alliance for Vaccine and Immunization (GAVI) in 2002.2 This programme—started as a pilot project—was introduced in areas where the UIP coverage was around 80 per cent. In all, 15 cities3 and 33 districts were selected for the programme. The preliminary objective was to attempt a countrywide scaling based on the experience of the pilot Hep B vaccination. For ensuring maximum coverage, three doses of the vaccine were administered with DPT vaccine. Initially, the target was slum infants in the cities and all infants in the 33 districts. Later, for logistical reasons, the target group was increased to all infants of the selected cities and districts. Also, the government decided to continue with the existing areas, and did not scale up, as planned initially. However, the government has applied GAVI is a global body that comprises UNICEF, World Health Organization (WHO), Bill Gates Foundation and a vast number of organisations from developing and industrialized nations. 3 Greater Mumbai, Kolkata, Chennai, Delhi, Hyderabad, Bangalore, Kanpur, Ahmedabad, Pune, Lucknow, Vadodara, Jaipur, Indore, Patna and Bhopal. 2

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for additional funding from GAVI for the provision of vaccines and AD syringes for programme expansion to the additional states, the aim being to incorporate Hep B in around 11 selected states by 2006. In sum, it does not seem as though India delayed the introduction of Hep B too much, especially since the evidence on Hep B prevalence was not convincing enough to start an earlier initiation, as will be discussed below.

7.3 Appropriateness and Adaptability Whether and when to launch a new health technology should be evidence-based and driven by consensus of experts within the country. The inclusion of Hep B in the UIP has generated considerable debate around the usefulness of this policy, specifically in the context of prevalence of Hep B. The controversies are quite unique for Hep B and are relevant for questions around expansion and scaling up. The major debate was on the actual prevalence of Hep B in India. As mentioned above, the WHO classifies India as an intermediate country, with a prevalence rate of 4–7 per cent,4 whereas a review of studies on India by Lodha et al. (2001) seemed to indicate that the true prevalence of Hep B virus carriers in India is likely to be much lower, between 1 and 2 per cent. They concluded that the prevalence of HBsAg positivity and its associated diseases in India has probably been overestimated. Phadke and Kale (2000) argued that the prevalence estimates have not taken into account (a) the overestimation 4

www.who.int/hepatitis B

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due to inclusion of false positives; (b) the sampling bias due to the samples being of blood donors; and (c) the urban bias of the studies. The authors maintain that there has been no attempt in India to study the true prevelence of Hep B, which is esssential for a cost-effectiveness analysis, and which, in turn, is necessary for more effective planning around the Hep B vaccination programme. A WHO (2002) review of the studies on the prevalence of Hep B in India suggested that the prevalence of chronic HBV infection in different studies ranges from 2 to 10 per cent. Therefore, India has low to high endemicity, largely the former, for HBV infection. There has, however, been no evidence on the geographical variation in HBV prevalence. There is also a debate on the extent of mortality caused due to the prevalence of Hep B in India. While the international agencies contend that the mortality could be around 200,000 per year (WHO 2002), the estimates by some researchers (Mittal 2003; Sahni et al. 2004) indicate that the mortality figures will not be more than 5,000 per year in India. In order to identify the correct strategy for such an immunisation programme, there needs to be evidence-based consensus on the relative importance of perinatal and horizontal transmission. The meeting with various stakeholders revealed that if perinatal transmission is an important contributor to the carrier burden, then an early immunisation schedule—starting at the earliest after birth—has to be implemented; otherwise, it may be acceptable to defer the first dose till one and a half months of age, which is more feasible as one could merge it with the existing schedule. However, there is neither any major scientific study nor any consensus on the rate and magnitude of mother

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to child transmission of HBV in India. Some researchers, based on the extrapolation of Taiwanese data, argue that vertical transmission comprises at least 30–50 per cent of total transmission (Schoub et al. 2002). If the vertical transmission is high, and the Hep B vaccine is given along with DPT vaccine after 6 weeks, then at least 30–50 per cent ‘at-risk’ population will be left unvaccinated, making the programme extremely ineffective. However, the WHO maintains that the mother to child transmission of Hep B in India is less than 15 per cent, and providing the vaccine after six weeks will not make much of an impact. Moreover, there is some evidence (Dasgupta and Ritupriya 2002) to suggest that that administering birth doses has not been that successful, as the majority of births in India take place at homes.5 WHO (2002) concludes that the data on routes of transmission are insufficient to analyse the frequency of different routes of transmission of HBV infection in India. This, therefore, cannot inform the debate on when to administer the dose. However, it does encourage the adoption of a mixed strategy, where Hep B can be given as birth doses for institutional birth, or else along with DPT vaccine later. Finally, there is still no conclusive evidence on the extent of the various diseases related to HBV in India. The ‘whether’ is also linked closely with ‘how’ to introduce it. There are unresolved issues there as well, which are discussed below. The major concern raised against the universal immunisation of Hep B, keeping in consideration varying prevalence and mortality rates across different states in India, 5 Approximately only 33 per cent of the total births take place in a health facility/institution in India according to NFHS 2.

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is that the provision of the Hep B vaccine all over India may not be the cost-effective strategy. The countrywide expansion of the existing Hep B vaccination programme would require additional resources not only for the vaccines but also for the cold-chain equipments and additional infrastructure. With other diseases, like AIDS and tuberculosis, competing for scarce resources, it may be difficult for the government to support a nationwide Hep B programme. Hence, some authors like Dasgupta and Ritupriya (2002), Mittal (2003) and Mathew et al. (2004) have argued that selective Hep B vaccination—in high risk states—should be given priority. However, there are also contradictory views like that of Aggarwal and Ghoshal (2004), who advocate for routine Hep B immunisation programme. They argue that though the selective Hep B immunisation strategy of testing pregnant women for Hep B and limiting immunisation to children born to Hep B positive mothers may be cheaper than universal immunisation, it will be ineffective and difficult to administer, and will also pose logistic and ethical problems. An earlier study by Aggarwal and Naik (1994) had looked into the costeffective analysis of the Hep B immunisation in UIP vs selective immunisation of Hep B. They argued that selective immunisation of Hep B may not be able to reduce the overall disease burden, and that its inclusion into the UIP has significant benefits despite high costs. Other studies by Prakash (1999a, 1999b) and Aggarwal (2002) have also argued for the inclusion of Hep B in the UIP programme. WHO (2002) has, however, cautioned against the use of these cost-effectiveness study results. Some of the problems of these studies include (a) variability in data of the Hep B carrier rate, vaccine coverage and vaccine efficacy;

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(b) lack of focus on issues of perinatal transmission and birth dose; (c) varying vaccine costs in the analysis; (d) exclusion of vaccines for adults; and (e) the consideration of only one year birth cohorts in most of the studies. The literature review suggests that there is an urgent need for proper epidemiological studies to determine the true prevalence of HBV infection and associated morbidity/mortality in India. It is also important to have accurate baseline data, so that the impact of the Hep B vaccination programme can be judged objectively. Unfortunately, the pilot project has not thrown up answers to these questions of ‘whether’, ‘when’ and ‘how’ to introduce and scale up the programme. Thus, while India decided to go ahead with piloting Hep B in its UIP, the decision does not seem to be based on technical justifications on whether and when to introduce it in India. The selection of the sites for the pilot was based on coverage of routine immunisation and not on technical reasons. The question of appropriateness and adaptability are, therefore, answered depending on the perspective one takes on these issues. However, it does seem as though India is adapting well to changing scenarios and currently, discussions are on to replace the monovalent Hep B vaccine with the tetravalent, indicating its willingness to adapt to changing global availability of vaccines. Finally, as seems clear from the review of evidence from around the world and WHO’s recommendations, the consensus seems to be that the only channel to release Hep B is through country UIPs. The main issue around Hep B, once the decision to release it through UIP is taken, becomes that of implementation and the concerns are then the same ones raised in the discussion of the UIP in Chapter 6.

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7.4 Policy Framework of Adoption Approval and Regulation As has been the case with other childhood vaccination, India did not have to go through a prolonged process of approval, and it was fairly simple to implement the pilot project. GAVI was keen on supporting India to introduce Hep B vaccination in its UIP. The MOHFW after a series of discussions with different states and other stakeholders decided to apply for GAVI funding for Hep B immunisation in 15 urban slums and 32 districts. The Cabinet Committee on Economic Affairs of the Government of India gave its approval in August 2001 and the proposal to GAVI was submitted in November 2001. After acceptance by GAVI, the pilot project was finally launched by in June 2002.

Role of Central/State/Local Governments Although, Hep B is currently provided only in selected areas, the roles of national, state and local governments are quite substantial. The Central Government decides on the overall implementation and procurement of vaccines. The state governments play a role in the distribution of vaccines and the local governments in actually providing the vaccines as they do all the UIP vaccines. Thus, like other components of the UIP, Hep B also has to go through a similar system with different roles played by the various parts of the government machinery. The roles of all the three tiers of government would increase once the Hep B vaccine in the UIP is scaled up to more districts in different states. In states like Andhra Pradesh and Delhi, where

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Hep B immunisation is part of the UIP, the state governments are involved in the purchase and distribution of vaccines and the local governments in the actual provision.

Role of Private Sector Before the government decided to start Hep B immunisation in the UIP, it was the private sector that mostly provided Hep B vaccines, especially to adults. As of now, there are no clear guidelines regarding the participation of the private sector in the Hep B immunisation programme. Although the private sector is allowed to provide vaccines in the UIP with the permission of the district immunisation officer, Hep B immunisation has still not been included in this list of vaccines. However, it is anticipated that when the Hep B immunisation is scaled up, the private sector can play a greater role in provision, in partnership with the government. Unfortunately, there is no data on the extent of private sector participation in Hep B immunisation, and therefore, nothing much can be said about this aspect.

Role of NGOs There are not many NGOs that work on the Hep B immunisation in India. PATH—an international NGO—was instrumental in supporting the Hep B immunisation programme in Andhra Pradesh. Jointly with other organisations and the government, PATH has helped in monitoring Hep B immunisation in 15 cities and 33 districts. The Andhra Pradesh Immunisation Strengthening Project of the Andhra Pradesh government, in partnership with the Children’s Vaccine Program (CVP) at PATH, with

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support from the Bill and Melinda Gates Foundation, has helped in strengthening the immunisation services. Apart from this, the role of NGOs in Hep B immunisation has been limited.

7.5 Supply Issues Procurement and Distribution GAVI conferred a grant to India worth US $ 4.1 million for the 2002 pilot project. Despite the willingness of GAVI to let the government purchase vaccines, the latter requested GAVI to procure it through the United Nations Children Fund (UNICEF). UNICEF procured monovalent Hep B vaccines through a global tender, unlike in the case of the UIP, where the demand is met fully by the domestic companies. Seven domestic firms had received the ‘domestic’ quality certificate from the National Drug Regulatory Authority while only Shanta Biotech got the quality approval from WHO. Currently, the major share of the Hep B vaccine is procured from a Korean firm, and a small share is purchased from Shanta Biotech, an Indian firm. Even though it was procured through UNICEF, the price of the vaccine was slightly higher than the market price.6 Additionally, GAVI funded the provision of Auto Disabled (AD) syringes, with a renewed emphasis on maintenance of cold chain, safe injection practices, safe disposal of AD syringes and needles. These inputs were deemed vital to improve the UIP as a whole. With the introduction of Hep B immunisation in the UIP, the cost of the monovalent 6

The price was determined by a global bidding process.

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Hep B vaccine came down from Rs 100 per dose to Rs 15 per dose, easing the cost burden considerably. At the time of writing the book, many Indian companies like Serum institute and Shanta Biotech7 have introduced the tetravalent vaccine (DTP-Hep B). The government has yet to decide about the type of vaccine (monovalent or tetravalent) for the second phase of Hep B immunisation. Many countries have already started using the DTPHep B tetravalent vaccine in their UIP with GAVI financial assistance. While GAVI funds the newer vaccines, the sustainability of such vaccines in the long run would remain a major issue. When combined with other requirements of introducing a new vaccine like the tetravalent Hep B, the issues of financial feasibility become critical and require proper financial planning. Similarly, a mixed strategy of administering Hep B (with birth dose as well as with routine immunisation schedule) would require calculations of size of target population in the at-birth and after-6weeks group, if the procurement and distribution has to work smoothly. The issues around distribution of the Hep B vaccines are the same as in the case of the other vaccines in the UIP because, while the procurement is different, the vaccine is distributed using the same mechanisms as in the UIP. The Hep B vaccine supplies are given periodically—mostly in every quarter—to the cities and districts covered under the pilot project. The WHO evaluation study noted that the distribution of vaccines from districts/cities to hospitals and PHCs and further down the delivery system was in many locations 7 Now more companies in India like Ranbaxy are expecting WHO qualification for their tetravalent vaccines.

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based on previous indents and not on needs. Placing needbased indents after visual assessment of balance stock was being practised in relatively few locations. As for the actual delivery of the vaccines to different points in the delivery chain, it does not seem to be too much of an issue. From the manufacturers, the drugs and vaccine are sent first to the four Central Medical Store Depots (CMSD), and then to the 70 state depots and then finally to the specific district depots. The Chief Medical and Health Officer (CMHO) manages each district depot. The time taken for vaccines to reach the state and districts from the CMSD is around one week to one month. The discussion with the experts revealed that the delivery of vaccines has been on time from the CMSDs to the state depots and district deports. While no other information or evaluation is available, it does seem as though distribution of vaccines continues to be an issue, as is the case for routine immunisation. Basically, the vaccine supply planning continues to be plagued by the difference between reported and evaluated coverage, high wastage rates, mismatch of supply with requirement and lack of proper data on actual use. According to a few experts, there are issues of underutilisation of vaccines due to miscalculation of the demand for vaccines, including that of Hep B.

Infrastructure While the pilot introduction of Hep B has no major infrastructure implications, scaling up will require a strengthening of the immunisation system in the country as a whole. In particular, careful attention will need to be paid to the requirements of storage equipments and cold-chain

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system. These have proved to be major concerns in the case of UIP, and will therefore be the same for Hep B as well.

Human Resources The overburdened peripheral healthcare workers like the ANM, have always been an issue in the Indian healthcare delivery system. There is enough evidence now to indicate that these workers are overworked, and the introduction of a new vaccine is, therefore, likely to reduce their productivity. Logically, once introduced, the tetravalent vaccine (DPT-Hep B) will ease the burden somewhat, but till that time, this angle needs to be kept in mind while scaling up with monovalent vaccine. The only review available on Hep B vaccination by the Department of Family Welfare (2004) indicate some encouraging factors as well: • Satisfactory knowledge of Medical Officers and ANMs about Hep B vaccine, correct use of AD syringes and general cold-chain maintenance. • Auto-Disabled syringes and Hep B vaccines were very well accepted by health service personnel. The review recommended as an operational priority regular in-service training of district and facility-level staff on Injection Safety, with a focus on sharps waste management, in accordance with the policies of the government. On the negative side, the review also found that roles and responsibilities were inadequately defined, poorly understood and under-resourced. Overall, the other issues on personnel for Hep B immunisation are similar to those of the UIP, as discussed earlier.

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7.6 Distribution Issues How has Hep B fared in terms of reaching geographic groups and target groups? The discussion on this question is somewhat limited in scope since the programme is as yet not fully scaled up. The supply of vaccines is closely related to the calculation of the size of target groups. Hep B vaccine calculations and distribution suffer from similar limitations as in the case of UIP. The initial stages of the Hep B pilot, which included urban slum populations, probably had additional planning issues. From our discussions with experts and other stakeholders, we gathered that there were instances of centres giving the Hep B vaccines to older children and even adults who were not supposed to be covered under the programme. Now, with a more uniform vaccination schedule, which is aligned with routine immunisation, the problem is reduced significantly. As has been mentioned, the pilot project—started in 15 cities and 33 districts in India—is being continued even to date. The selection of states for the gradual expansion should be based on (a) more objective disease burden studies; (b) the ability of states to sustain such programmes; and (c) consultative collective decision making with an active involvement of states. This has not been the case for the pilot project. In the next application to GAVI, the government has recommended 11 states8 in India, where the DTP coverage is more than 75 per cent (Namgyal 2005). The states proposed to be included in the second phase are Delhi, West Bengal, Madhya Pradesh, Maharashtra, Andhra Pradesh, Tamil Nadu, Kerala, Chattisgarh, Jammu and Kashmir, Himachal Pradesh and Punjab. 8

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Although DTP3 coverage is a rough guide to select the states in which to introduce Hep B, it is unclear whether these are the states where the Hep B disease burden is the highest. The government officials maintained that introduction of Hep B in these states will ensure the utilisation of the vaccine more effectively and, thereby, a decrease in the disease burden over the years. While the governments’ commitment to expansion is very high, it also needs to carefully consider the various recommendations that have come out of the evaluation of the pilot phase.

7.7 Demand Issues Acceptability/Information and Knowledge Not much is known about the accessibility of the Hep B vaccine, but the lessons from UIP seem to indicate that one of the main reasons for low coverage is lack of information and knowledge, especially for parents. The east Delhi pilot project indicated that advocacy among the medical community, decision makers and public at large was crucial for the success of the project. (Addlakka and Grover 2000).

Availability and Accessibility WHO, in its evaluation, which was done at the behest of the Ministry of Health and Family Welfare, did not indicate a high success of the programme. Some of the results of the evaluation have already been mentioned above. The review reports lower coverage and higher drop-outs than what was targeted in many of the first phase sites. The

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review also mentioned the possibility of private practitioners administering state provided DPT vaccine without the Hep B vaccine, as a possible reason for lower coverage, and suggested that the government provide Hep B vaccines along with DPT to these providers, to reduce drop-outs. The UIP experience reveals that low coverage has been due both to poor knowledge among parents, particularly mothers, and inability to reach hard–to–reach populations in remote areas. Studies have emphasized the need for effective IEC to increase coverage of UIP. The same logic can be applied to Hep B as well.

Affordability From the perspective of the users, the vaccine continues to be free of charge in the public sector, and not a barrier to its uptake.

7.8 Overview and Lessons Much of the lessons learnt from the UIP are applicable in the case of Hep B as well. However, there are some additional points that may be worth mentioning. If the initial introduction of Hep B was really a pilot, the lessons learnt could have helped in further scaling up. The way the Hep B vaccine was introduced, it seemed as if it was not really a ‘pilot’, but, was in many ways, only a phased introduction of the vaccine. The government’s decision to expand Hep B vaccination to 11 states seemed independent of the ‘pilot’ project. While the government seems to have decided to go ahead with further expansion of Hep B immunisation in

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the UIP, it is safe to say that the launch of the programme and the plan to integrate it into the UIP has not been based on sound disease burden and epidemiological data viz. modes of transmission, magnitude of mortality and morbidity, and geographical spread. It may seem unnecessary now that the decision to launch Hep B immunisation through UIP has already been taken, but such data is still required for proper evaluation and midway corrections, if and when necessary. It is also important to have this information to select states/areas in a phased roll out, which is what the Hep B programme looks like. Proper evaluation of a programme can only be done if there is consensus and information on how the disease spreads and when best to prevent it. It is possible that the further adoption of Hep B, which is still not fully part of routine immunisation, can be done based on other evidence-based considerations. While from a purely logistical point of view, and given the nature of immunisation services, it does make a lot of sense to launch a Hep B programme along with the routine UPI, planners must anticipate the strengths and weaknesses of the programme ahead of time and plan accordingly. In a phased launch of a programme, distributional issues are critical and sound studies can inform better targeting. One issue that may be relevant in the case of the AIDS vaccine is the procurement of the vaccine. As noted, only one firm out of seven acquired WHO approval, which may restrict the supply of quality vaccines in the country. It is important for the government to align its standards to that of WHO so that the quality of vaccination does not suffer. At the same time, it is important for the global bodies to ensure that adequate volume of quality vaccine is available within the country.

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The access to the Hep B vaccine remains constrained by the weaknesses of the UIP machinery, and India still has not reached close to the target of universal immunisation. While the AIDS vaccine is unlikely to be distributed through the UIP apparatus and may need a different system altogether, the lessons learnt from the weaknesses of the Hep B/UIP would be important to bear in mind at the planning stage. There is an even greater need to plan around questions like ‘how, when and to whom’ with respect to the AIDS vaccine, ahead of time, given the sensitive aspects of the issue.

Chapter 8 No-Scalpel Vasectomy

8.1

Introduction

No-Scalpel Vasectomy (NSV)—a simple surgical procedure that does not, as the name suggests, involve incisions and stitches—is an improvement on the conventional vasectomy with practically no side effects or complications.1 While the conventional vasectomy is a full-fledged surgery using around 14 instruments, NSV require only 3 instruments and can be completed in less than 15 minutes. The procedure—which is generally painless, less invasive and faster—can take place in a small clinic or private room 1 Vasectomy is a simple operation, which divides the tubes that carry the sperm in the body. These tubes arise from the testicles and go into the urinary passage, blocking off the passage of sperms into semen. This, therefore, makes unprotected intercourse safe, from the point of view of conception. This is a permanent method of contraception, and is generally recommended only when the desired family size has been achieved. In the new procedure, the vas is brought out through a tiny puncture, which does not require any stitches. The operation for NSV is much simpler than the conventional vasectomy. (www.cornellurology. com/uro/cornell/infertility/no_scalpel)

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without any third party assistance,2 with minimal physical discomforts to the clients during the procedure as well as recovery. However, it warrants unique surgical skills, including the use and handling of special instruments. Thus, the role of physicians is of extreme importance in the successful adoption of the technique. During the 1970s, female sterilisation—tubal ligation to be specific—was the most commonly used method for voluntary sterilisation in China. NSV was developed in 1974 by Dr Li Shunqiang of the ‘Chongqing Family Planning Research Institute’, at the Sichuan province in China. NSV was a considerable improvement over the conventional vasectomy, especially in remote rural areas of China, with limited medical facilities. Overall, the acceptance of vasectomy improved in China, and certain provinces, including Sichuan, have shown tremendous acceptance (Zhang 1994). A team of international sterilisation experts from four countries visited the clinic to learn the newly developed Chinese NSV technique in 1985, and endorsed the technique as a standard approach for vasectomy. The visit was sponsored by the Association for Voluntary Surgical Contraception (AVSC), which later on supported the introduction and promotion of NSV in many parts of the world. The members of this review team then introduced the technique in Thailand and the United States. In China, the new technique was described as ‘ligation of vas deferens with clamp method under direct vision’ (AVSC 1993); AVSC (which lately changed its name to ‘Engender Health’) coined the term ‘no-scalpel’ after the technique’s most salient characteristic. It also supported 2

www.mohfw.nic.in/nsvindia

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the introduction of the NSV in many countries of Asia, Africa and Latin America.3 Evidence from USA and Canada indicates that the NSV programme has been quite successful (Antarsh and Marston-Ainley 1993; Haws and Cullins 1999).

8.2 Timing of Adoption To understand NSV in its proper context, it would be essential to review the Indian experience with ‘voluntary sterilisation’ as a method of family planning. India started its family planning programme in 1952, earlier than any other countries in the world. Despite having notions around its effects on virility and sexual performance, vasectomy was a dominant method of family planning during the 1960s and the 1970s in India (Cohen 1996). Till the mid 1970s, male sterilisation was the most important contraceptive method in many parts of India. Out of the 32.7 million sterilisations registered by the government’s family planning programme between 1956 and 1980, 65 per cent were vasectomies (Ross and Huber 1983; Srinivasan 1995). Figure 8.1 shows the details of total sterilisation operations done in the country till the 1979.4 The policy shift that took place during the mid 1960s with the introduction of target-based approach and the replacement of financial compensation with financial incentives resulted in the first wave of increased birth control practices, http://www.cornel.edu. The data to produce this graph was made available from Vicziany 1982. 3 4

1966–67

1964 Vasectomy

1970–71

1968–69

Tubectomy

1976–77

1974–75

1972–73

1962

1960

1958

1956

Thousands

Source: Various yearbooks of family welfare department of the Ministry of Health and Family Welfare.

0

3000

6000

9000

FIGURE 8.1 Sterilisations in India over time

1978–79

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including sterilisations. Cohen (1996) discussed four possible arguments for higher acceptance of vasectomy: (i) non-availability of laproscopic techniques for tubectomy resulting in female sterilisation becoming a major surgery to be performed under general anesthesia, while vasectomy was an outpatient procedure; (ii) limited options for permanent or semi-permanent methods of contraception (the Intra Uterine Devices (IUDs) were not adopted well in the mid 1960s); (iii) family planning and maternal and child health were treated separately, and, therefore, women were not the main focus for family planning intervention during pregnancy and delivery; and (iv) increasing incentives for male sterilisation operations. When the figures for vasectomy were seen to be going down in the late 1960s, an intensified approach was used in selected districts. The mass vasectomy camp approach— accompanied by generous financial incentives—introduced in the Ernakulam district5 in 1970, was repeated in other states and as can be seen from the graph, the number of vasectomies improved substantially during 1971–73. One reason for this dramatic increase can be attributed to the level of incentives that were provided to adopters as well as to the canvassers or the promoters. Till mid 1960s, the average compensation to the adopter and the canvasser Vicziany (1982) also discusses the role of the district collector in the Ernakulam camps, indicating the role that the bureaucracy may have played in its success. 5

118 Adoption of Health Technologies in India

was around Rs 20 and Rs 2 respectively. In Ernakulam, however, the amounts were more than Rs 100 and Rs 10 respectively. In many a case, the incentives comprised at least half of one month’s income and in some cases more than a month’s income of the acceptors. The skewed distribution of the vasectomies towards the lower socioeconomic classes (Vicziany 1982) is possibly explained by this feature of the camp approach. However, the practice of financial incentive was dropped in 1973–74 with the mistaken presumption that such a practice had played its role in the diffusion of the sterilisation techniques. It was also done away with because of budgetary constraints. The subsequent drop in the number of vasectomies in 1973–75 in turn can be attributed to this new change in policy. During these years, tubectomy operations were showing a moderately increasing trend. The conclusion from this brief analysis seems to be that during this period, vasectomies were popular mainly due to the target-based approach, which prompted bureaucratic efforts accompanied by financial incentives (Vicziany 1982). Thus, the voluntary nature of such adoption can be questioned, which could have come forth only through a change in attitude of the male participants. While so far, adoption of vasectomies was showing mixed results, it received a major setback during the ‘national emergency’6 period (June 1975–January 1977), The Emergency proclamation had suspended (a) all rights guaranteed by Article 19 of the Constitution of India, and (b) the right of a citizen to move any court for enforcement of Fundamental Rights guaranteed under the Constitution of India. The various amendments suspended various civil liberties and assured that the government retains absolute powers. The press was censored and any kinds of opposition including strikes were declared illegal. 6

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when the government took on extraordinary powers and implemented a series of strict measures. Family planning was given top-most priority in the government’s agenda for development. During this period, around 8–11 million sterilisations were performed (Gwatkin 1979; Soni 1983; Maharatna 2002), which not only exceeded the total numbers done in the previous five years, but was also more than the number done in any other country until that time. It was also reported that many adopters were either unmarried or over-age or had fewer than two children. Many sterlisation-attributed deaths were also reported (Soni 1983). Later on, the ‘family planning’ programme was renamed as ‘family welfare’ programme, and while initiatives were taken to reverse the negative image of sterlisation—which had resulted from the excesses of the Emergency—this was not much of a success. The use of coercive methods to increase vasectomy during the Emergency period ultimately reversed the trend, and female sterilisation became the most ‘preferred’ permanent method of sterilisation. Basu (1985) cited additional reasons for increased female sterilisation. These were: (i) availability of newer and simpler methods like laproscopic operations that made female sterilisation easier; (ii) increasing institutional deliveries, which provided an option of simultaneous sterilisation; and (iii) lack of promotion of vasectomies after Emergency. In the sixth Five-year plan [plan I (1978–80) and revised (1980–85)], several attempts were made to recover from the excesses of the Emergency. A health-based, timebound, target-oriented family welfare programme was advocated, with reduced emphasis on sterilisation. The

120 Adoption of Health Technologies in India

Sixth Five-year plan document did not even refer to mass camps but stated that ‘apart from sterilisation, the nonterminal methods like IUD, Conventional Contraceptives (CC) and Oral Pills have to be popularised, since a large number of young couples will prefer these methods’. The importance of spacing methods, on one hand, and child survival, on the other, were discussed, with a noticeable shift away from terminal methods of family planning. With changing views and aims of family planning (small family norm, freedom of choice), non-existence of camp approach, reluctance of men to come forward, the poor availability of spacing methods, and increased pool of infrastructure and trained personnel, female sterilisation became the preferred choice of contraception, during the Sixth plan period (Figure 8.2). The Seventh plan (1986–91) continued this low-key approach to sterilisations, with increased emphasis (with incentives) on spacing methods. As the name of the programme—Maternal and Child Health—indicated, the major emphasis was on the well-being of the mother and the child. The flip side of this was that men did not feature in this approach and were kept out of most of the IEC strategies. The Figure 8.2 bears this out: IUD and female sterilisation jointly contributed two-thirds of total use of contraception till early 1990s, and vasectomy was reduced to negligible levels. It was around this time that the first NSV operation was conducted in India.7 In its drive to popularise the technique in the developing world, AVSC sponsored the NSV training of two Indian doctors. They were trained in Thailand The Male Family Welfare Centre of the Lok Nayak Jai Prakash Hospital in New Delhi has been performing the new vasectomies since September 1991 (Das and Bhattacharjee 1993) 7

1982–83 IUD

1984–85

1983–84 Tubectomy

1985–86 Pills

1988–89

1987–88

1986–87

Vasectomy

1989–90

1981–82

1980–81

1979–80

1978–79

Source: Various yearbooks of family welfare department of the Ministry of Health and Family Welfare.

0%

20%

40%

60%

80%

100%

1990–91

FIGURE 8.2 Distribution of family planning acceptors across modern contraceptive methods in India

1991–92

122 Adoption of Health Technologies in India

in 1991. The first NSV training camp was organised in March 1992, and the procedure was officially introduced in India on 23 March 1992 (Das and Bhattacharjee 1993). Thus, as far as timing of introduction is concerned, NSV was introduced almost at the same time as it was being introduced in other developing countries. However, it was adopted on a large-scale with assistance from UNFPA (discussed below), a good 5–6 years later. There may be some disagreement, therefore, around the timing of adoption. Also, the timing has to be judged in the background of the various issues surrounding sterilisation in India, as discussed earlier, without which it may seem like NSV was a clean case of adoption at the right time. This was certainly not the case.

8.3 Appropriateness and Adaptability The lack of popularity of vasectomy gathered momentum after the Emergency period, and conventional sterilisation could no longer work as it did in the earlier period. The rate of female sterilisation was almost 90 per cent during the 1990s. NSV was aimed at reducing the huge dependence on female sterilisation, and given its simpler, inexpensive and risk-free nature, it was deemed also appropriate for a large country like India. Thus, in terms of appropriateness and adaptability, it was in a way a model health technology.

8.4 Policy Framework of Adoption Approval and Regulation The NSV technique was introduced under the UNFPAAVSC-GoI project entitled ‘Establishment of Centres of

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123

Excellence for Training in Sterilisation and Recanalisation’ (MOHFW 1992). The early years saw localised training programmes at an institution in Delhi, and, slowly, the volume of training was stepped up. NSV was introduced in the National Family Welfare programme in March 1994 (MOHFW 1995) and along with the training of more than 200 doctors, the technique spread in many parts of the country. Following the initial positive reaction to the introduction of the technique, a new UNFPA supported project to ‘popularise NSV and increase the male participation in family welfare’, was launched. This project aimed at training about 1500 doctors over a period of two and a half years (MOHFW 1997). This can be seen as an actual adoption of NSV in the public programme. The contribution of the Government of India was in the form of technical expertise provided by the Master Trainers and in making available the necessary infrastructure at the training cities. The UNFPA provided financial assistance of US$ 1,353,255 (MOHFW 1999). The total contribution of UNFPA was more than US$ 2,000,000 till 2003. A point to note is the adoption of the target-free approach in 1996 and the implementation of the Reproductive and Child Health (RCH) approach in 1997, which brought about another policy shift in India’s family welfare programme. The Ninth plan (1998–2001) document clearly indicated the need to re-popularise vasectomy8 If, over the next decade, attempts are made to re-popularise vasectomy so that this safe, simple procedure forms at least 50 per cent of all sterilisations, there will be a further substantial reduction both in morbidity/ mortality and in the cost of permanent methods of contraceptive care (Ninth Plan document accessed at http://planningcommission. nic.in/plans/planrel/fiveyr/9th/vol2/v2c3-5.htm). 8

124 Adoption of Health Technologies in India

and stated ‘promoting male participation in the Planned Parenthood movement and increasing the level of acceptance of vasectomy’ as an important strategy. This was the first evidence of the government’s renewed initiative to focus on vasectomy after the Emergency; the previous plans had discussed the importance of other methods. A separate line item for NSV was created in the plan allocation and a sum of Rs 30 million was allocated to NSV in the Ninth plan. The Tenth Plan (2002–07) also reiterated the government’s commitment to promote vasectomy. The 10th plan document states that: . . . every effort will be made to re-popularise vasectomy by improving access to vasectomy services. These services (conventional or no-scalpel) will be made readily available to all at convenient times as an outpatient procedure in all primary, secondary and tertiary care institutions . . . (and) follow up care will be provided to all taking into account the existing time constraints and the conveniences of men. The allocation to NSV was increased to Rs 80 million and a project called ‘Men in Planned Parenthood’ was launched, indicating the government’s support to this technology. The current government seems to be continuing this approach. While the stated aim continues to be male participation in family planning methods, there seems to be a parallel drive to step up sterlisations through directives to the various parastatal units. While the target-free approach continues on paper, the pressure to show success in family planning is likely to exert indirect pressure on various government bodies to show results, which can only be done

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125

through sterilisation.9 This trend—which is also reflected in the Population Policies of states like Madhya Pradesh, Maharashtra, Andhra Pradesh and Uttar Pradesh—is probably not a very welcome one, and may affect the uneducated vulnerable sections in an adverse way. While the initial adoption of NSV did not need any special legislation or regulatory mechanisms (except those on physicians to complete the training), there continue to be directives issued from time to time to various layers of the government machinery to encourage sterilisation in the country (Uttar Pradesh Population Policy 2002).

Role of Central/State/Local Governments The role of the different layers of government in NSV should not be seen in isolation, but as part of an ongoing, though often changing, set of initiatives around controlling the quality and quantity of population, which started soon after Independence. NSV is merely a part of the chain of events that were initiated around the government’s desire to control the family size. These events saw the family planning programme evolve, over the years, into a comprehensive reproductive and child health programme. NSV in that sense was merely an addition to the already existing programme and, to that extent, the roles of the various layers of government were no different. Specifically, the national government introduced NSV as a UNFPA supported special project. Its role was to provide training and improve the information and knowledge Please refer to: (i) http://www.expresshealthcaremgmt.com/ 200512/coverstory01.shtml and (ii) http://www.combatlaw.org/ information.php?issue_id=14&article_id=354. 9

126 Adoption of Health Technologies in India

about the technique. The actual implementation of NSV— as in other previous programmes around contraceptive use—was to be done by the states and local governments. The role of the local government was limited in the early years, but with the introduction of the RCH programme, the panchayats at the village level have been playing a crucial role in the planning as well as the implementation of the programme. Additionally, there are experiments for improving state level performance. The State Innovation in Family Planning Service Project Agency (SIFPFSA)—an implementing agency of a joint endeavour of the Government of India and the United States Agency for International Development (USAID)—implements a project called ‘Innovations in Family Planning Services (IFPS)’ in the state of Utter Pradesh. Along with a range of activities aiming at reducing fertility in the state, it has established NSV training and delivery centres. UNFPA is also promoting NSV techniques in its ‘Integrated Population and Development’ (IPD) project in states like Maharashtra.

Role of Private Sector The role of the private sector in the delivery of family welfare services has always been limited. It is estimated that while the private sector provides more than threefourths of all curative health care services, its contribution to maternal and child health and family planning services is less than one-third (Planning Commission 2002). However, there have been experiments to partner with the private sector for various family welfare initiatives, especially during RCH phase I (1997–2003), social marketing of contraceptives being the major one. There are also some

No-Scalpel Vasectomy

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public-private partnerships where private providers are given funding for providing sterilisation at the private facilities (Planning Commission 2004). In addition to government-backed institutions like the Employees State Insurance Corporation, a number of industrial concerns and public sector undertakings like TISCO, Escorts, SAIL and Larsen & Toubro have contributed to the family welfare programme. The Confederation of Indian Industries (CII) and the Federation of Indian Chambers of Commerce and Industries (FICCI) have been assisting various member industries to promote NSV by arranging camps for their workers. CII is also partnering with Family Planning Association of India (FPAI) under a project called male participation in sexual and reproductive health. Private sector has also been involved via training of private practitioners. The MOHFW Annual Report 2001–02 cites an example of training of physicians from industrial concerns.

Role of NGOs The role of NGOs to counterbalance the over-bureaucratisation of the programme, and to promote it, keeping in view the cultural sensitivity around family planning issues, has been advocated for a long time now (Pananidiker et al. 1987). The participation of voluntary organisations in India’s family welfare programme is not new and, since the beginning of the RCH programme, the NGOs have been active partners of the government in implementing various family planning activities, including sterilisation. In the context of NSV, however, the role of NGOs was limited at the time of introduction, but later on their participation increased. Engender Health, as discussed earlier,

128 Adoption of Health Technologies in India

was the first organisation to promote NSV in India by way of providing training. During the extensive training efforts under the GoI-UNFPA project, several NGOs were involved and their surgeons received training in the technique. A few Indian NGOs like the Family Planning Association of India (FPAI) and Population Foundation of India (PFI) are also extensively involved in NSV training. Other examples include NGOs like Janani, based in Bihar, which provides NSV operations from its clinics at a subsidised rate. Some experts that the authors had met, were, however, of the opinion that the role of NGOs was minimum as a whole, though there are some successful cases, as described above.

8.5 Supply Issues Procurement The two specially designed NSV instruments—extra cutaneous vas fixation forceps and vas dissection forceps— are being purchased by the Supply and Social Marketing division of the Health Ministry along with other contraceptives, through annual rate mechanism by advertised tenders. Apart from this, the other requirements are nominal (gloves, needles, etc.) and part of procurement of usual medical supplies at the facilities.

Infrastructure Given that it is a simple and quick procedure, no additional infrastructure is needed for NSV. However, the thrust

No-Scalpel Vasectomy

129

of NSV implementation has been through camps—the common approach to sterilisation in the country. Being a service-intensive technique, it was visualised that NSV camps will be organised to train surgeons and promote the technique. Thus, the infrastructure at the training as well as delivery camps is of interest in this context. There have been concerns over the infrastructure and quality of care being provided in the tubectomy and vasectomy camps (Mavalankar and Sharma 1999; Ramachander and Barge 1999; Townsend et al. 1999). While not much information is available on the level of infrastructure being ensured at various NSV delivery camps, the quality was found optimal during the NSV training camps in the first phase of introduction (Sinha and Rao 2001).

Human Resources An adequate number of trained surgeons/physicians is the key to a successful NSV programme, since the procedure needs more expertise than conventional sterilisation. As the case would be in any service-intensive technology, the demand and long-term success of NSV too depends a lot on the client-provider relationship. The major emphasis of NSV introduction, therefore, was on the training of surgeons. During the UNFPA-AVSC-GoI project (1992– 96) some 248 surgeons were trained and based on this experience the next UNFPA-GoI project was launched in last quarter of 1997 that aimed at training 1500 medical personnel in the country through 500 training sessions (MoHFW 1996 and MoHFW 1997).10

10

http://pib.nic.in/archieve/lreleng/l0599/r 210599.html

130 Adoption of Health Technologies in India

The various evaluation reports of the NSV project indicate a mixed response from the medical and para medical personnel who were trained during the drive; in many cases, the duration of three days was seen as inadequate (Sinha and Rao 2001). At the time of writing this book, NSV was being implemented in 22 states, with the target of (a) extending it to the entire country; and (b) having at least one NSV trained surgeon in each CHC/PHC (MOHFW 2004).

8.6 Distribution Issues As for geographic distribution, while the scheme may seem to be a centrally-sponsored one, the training programmes were, interestingly, being organised at the ‘request of the states’, and based on such requests, funds for training were to be released for each training session (Lok Sabha 2003). Thus, even though the states were not asked to implement the programme, the onus of adoption was left to the state governments. It is, therefore, not surprising that the training sessions are unevenly distributed across states; some states like Andhra Pradesh, conducted more than 25 per cent of total training courses, which ensured a superior performance.

8.7 Demand Issues Demand for various contraception methods seemed to be greatly influenced by the focus and the thrust of government strategies from time to time. To understand demand side issues, it is important to understand the experience of

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acceptance of different contraception methods over the time. For the ease of understanding, we have divided India’s adoption to modern methods of contraception in three distinct phases: origin till the Emergency (focus on sterilisation), post-Emergency till the early 1990s (focus on female methods) and from the early 1990s till date (focus on oral pills). As can be seen from the Figure 8.3, sterilisation has been at the forefront in the initial years of India’s family planning programme, mainly due to the non-availability of other options. Initially, tubectomy was the preferred method (over vasectomy), which was replaced by vasectomy in the early 1960s. The huge adoption of vasectomy during the 1960s can be attributed to HITTS (Health department operated, Incentive-based, Target-oriented, Time-bound and Sterilisation-focussed) programme (Srinivasan 1995). The IUD—whose introduction brought down the rate of vasectomy acceptors—failed to be a popular method and by the end of the 1960s, vasectomy was topping the chart. As discussed before, the decline in vasectomies during 1973–75 can be attributed to the withdrawal of monetary incentives. The post-Emergency phase saw a paradigm shift in access to modern methods, with a ‘basket approach’ to family planning, with choice being the operative word. The government, however, consciously promoted spacing methods, and it was around this time, that oral pills got its foothold in the programme. This phase saw, as Figure 8.4 indicates, the decline of tubectomy as well, alongside a negligible presence of vasectomy. The thrust on spacing method translated into increased demand for IUD and oral pills from merely 25 per cent acceptors in 1981–82 to 65 per cent acceptors in 1991–92.

1964

1962

Tubectomy

1968–69

1966– 67

Vasectomy

1970– 71

Pills

IUD

1972–73

1960

1958

1956

Source: Various yearbooks of family welfare department of the Ministry of Health and Family Welfare.

0%

20%

40%

60%

80%

100%

1974–75

FIGURE 8.3 Distribution of family planning acceptors by ‘modern’ methods in India—till the 1970s

1976– 77

1978–79

1980–81 Tubectomy

1982–83

Vasectomy

1984–85

Pills

1986–87 IUD

1988–89

1990–91

Source: Various yearbooks of family welfare department of the Ministry of Health and Family Welfare.

0%

20%

40%

60%

80%

100%

FIGURE 8.4 Distribution of family planning acceptors by ‘modern’ methods in India—post-Emergency phase

134 Adoption of Health Technologies in India

Since the last decade or so, while the thrust on spacing method continued, the oral pills became the preferred method of contraception. During this time, the government also attempted to re-popularise vasectomy, and this could account for the slight increase in sterilisation after 1998–99 (Figure 8.5). Figures 8.6 and 8.7 show the experience of targets vs achievements of terminal and spacing methods respectively. As can be seen, the changes in the relative performance of different methods mirror the changes in strategies adopted by the government. The result of the paradigm shift from the target-free approach in 1996 can be seen in the sudden reduction of almost all methods. Sterilisations (tubectomy and vasectomy)—apart from the Emergency period—more or less remained short of their targets over the years, while both IDU and oral pills have been performing relatively better. In the absence of targets, post-1996, pills and sterilisation have seen improvement, while IUD has stabilised. The fact that terminal methods of contraception have been performing poorly as compared to spacing methods, indicates that individuals, given a chance, will exercise their choice by adopting reversible methods.

Acceptability/Information and Knowledge While vasectomy still remains a very small part of total sterilisation, in absolute terms, both the methods are showing gradual upward trends over last five years. Figures 8.8 and 8.9 indicate the trends in male and female sterilisation over the years. With an annual growth rate of more than 12 per cent, vasectomy shows highest rate of increase over all other methods. This can be a result

1992–93

1994–95 Tubectomy

1996–97

Vasectomy

1998–99 Pills

IUD

2000–01

2002–03

Source: Various yearbooks of family welfare department of the Ministry of Health and Family Welfare.

0%

20%

40%

60%

80%

100%

FIGURE 8.5 Distribution of family planning acceptors by ‘modern’ methods in India—since the early 1990s

1956

1961

Achievement Sterilisation

Target Sterilisation

1966–67 1971–72 1976–77 1981–82 1986–87 1991–92 1996–97 2001–02

Source: Various yearbooks of family welfare department of the Ministry of Health and Family Welfare.

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

FIGURE 8.6 Targets and achievements of terminal methods of contraception

1966–67

1961

Achievement IUD

1976–77 Target IUD

1991–92

1986–87

Achievement Pills

Target Pills

1996–97

1981–82

1971–72

1956

Source: Various yearbooks of department of family welfare of the Ministry of Health and Family Welfare.

10000 9000 8000 7000 6000 5000 4000 3000 2000 1000 0

FIGURE 8.7 Targets and achievements of spacing methods of contraception

2001–02

138 Adoption of Health Technologies in India FIGURE 8.8 Vasectomies (in ‘000) over time

Source: Various yearbooks of department of family welfare of the Ministry of Health and Family Welfare.

FIGURE 8.9 Tubectomies (in ‘000) over time

Source: Various yearbooks of department of family welfare of the Ministry of Health and Family Welfare.

No-Scalpel Vasectomy

139

of what was emphasised in the Ninth plan and reinforced in the Tenth plan as the ‘Men in Planned Parenthood’ initiative: increasing thrust on re-popularising vasectomies. However, in relation to tubectomies, vasectomies have remained very low. The Lok Sabha (2003) report on the Committee for Empowerment of Women, states that the Committee are . . . constrained to note that the percentage of male sterilization has increased from 1.8% in 1997 to only 2.46% in 2002. The Committee feels that the pace of increase of male sterilisation is abysmally low and that at this rate it will take many years to achieve a substantial increase in male participation in the family planning exercise. This view can also be gleaned from the Common Minimum Programme (CMP) of the ruling United Progressive Alliance (UPA). The document states that ‘The UPA government is committed to replicating all over the country the success that some southern and other states have had in family planning. A sharply targeted population control programme will be launched in the 150-odd high-fertility districts’.11 The renewed reliance on such topdown, incentive and target-oriented approach to family planning in Empowered Action Group (EAG) or poor performing states may be misplaced, as past experience has shown (Rajalakshmi 2004). The role of NSV has been to hold up the male sterilisation figures, and though there is no data to bear this out, it is probably safe to say that a decline in male sterilisation is being delayed somewhat by the presence of NSV. National Common Minimum Programme of the Government of India, May 2004 can be accessed at http://pmindia.nic.in/cmp.pdf. 11

140 Adoption of Health Technologies in India

While at the national level the figures are improving, what has been the trend of performance of NSV at the state level? This is especially important to understand given the centralised nature of the programme. Table 8.1 indicates some of these figures. Andhra Pradesh seems to have done very well in the adoption of NSV; more than 83 per cent of total vasectomies in the country were done by the trained surgeons of that state, which comprised only 14 per cent of all trained surgeons till 2002. The rest of the 15 states, accounting for nearly two-thirds of trained surgeons, contribute to only 5 per cent of total NSV surgeries. Although it covers only 18 per cent of its total 45 districts, Madhya Pradesh has a large number of trained surgeons. Delhi has the highest number of trained surgeons per district, but this is not reflected in the performance of NSV surgeries. It is clear that the picture is uneven across states, with NSV having done much better in some states than in the others. The interesting question is how NSV has affected male and total sterilisations over the last five years. Table 8.2 indicates the state-level picture on the proportion of vasectomies to total sterilisations, which gives indirect evidence on the success of adoption. Sikkim seems to have had the most successful adoption, with a reversal of trend, from a total dependence on tubectomies to majority vasectomies in 2000–01. The states that have been done intensive training and delivery of NSV—Andhra Pradesh and Madhya Pradesh—are also showing an increasing trend in adoption. However, West Bengal and Orissa continue to show poor adoption to male sterilisation despite seemingly better performance in NSV. Gujarat, which is documented to be one of the wellperforming states, has also shown a decline. The same is

128393 10282 3341 2486 1171 7643 153316

No. 83.7 6.7 2.2 1.6 0.8 5.0 100.0

Proportion 168 59 51 66 73 770 1187

No. 14.2 5.0 4.3 5.6 6.1 64.9 100.0

Proportion

Total Trained NSV Surgeons

NSV

Acceptors

Proportion

130 18 106 44 100 41 49

Covered

of Districts

5 7 2 14 2 4 4

Covered

per District

Trained Surgeons

Source: Author’s calculation based on data available at http://mohFW.nic.in/doFW%20website/family%20welfare%20programme/ nsv/overview.htm.

Andhra Pradesh Madhya Pradesh West Bengal Delhi Orissa Others Total

State

TABLE 8.1 Performance of NSV across states till 2002

142 Adoption of Health Technologies in India TABLE 8.2 Trends in vasectomy as a proportion of total sterilisations in selected states over a five-year period States

1997–98

1998–99 1999–2000 2000–01

Highly performing states Sikkim Manipur Andhra Pradesh Delhi Madhya Pradesh Kerala Maharashtra

1.3 0.7 5.3 4.2 1.0 0.3 0.9

12.8 3.8 9.0 4.2 1.1 0.4 0.9

38.6 11.7 6.6 4.0 1.0 0.4 0.8

66.8 24.4 7.8 5.4 2.0 1.0 1.6

0.5 1.6 0.6 0.6 1.3 1.9 3.2

0.4 2.5 0.6 0.7 1.1 1.5 1.9

0.5 1.4 0.5 0.1 1.0 1.0 1.8

0.4 1.3 0.2 0.2 0.8 0.5 1.5

Poorly performing states West Bengal Orissa Bihar Arunachal Pradesh Gujarat Uttar Pradesh Jammu and Kashmir

Source: Various yearbooks of department of family welfare of the Ministry of Health and Family Welfare.

true of Bihar and Uttar Pradesh. The fact that vasectomies remain low or that their proportion to total sterilisations is reducing in some states, indicate that NSV may have just replaced traditional methods of male sterilisation and has, in fact, not really been able to stem the decline in demand for male sterilisations. These examples clearly indicate that the mere supply of a technology does not influence demand, unless there is a felt need for its adoption among the target population. The meeting with experts revealed that in many states where tubectomy is performing well, the authorities have not been willing to change the situation. Interestingly, even

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within states, there is variation, with some pockets performing better than others. For example, Vidharba in Maharashtra, Karim Nagar and Warrangal in Andhra Pradesh, Hubli in Karnataka, Amritsar in Punjab, and Khandwa, Ratlam and Satna districts in Madhya Pradesh have adopted well to NSV. In Punjab, although total vasectomies are increasing, more than 60 per cent of total operations, in 2005, were reported from only five out of 17 districts (Gayatri 2006). Similarly in Jharkhand, Kumar (2006) found that at least 250 NSVs each were done during three day camp at Bokaro and Ranchi districts. Thus, there is no uniformity of adoption even within states. This only reconfirms the previously mentioned point that the determinants of demand for male sterilisation and, therefore, NSV depend on many more factors besides supply parameters. There are very few micro-level studies that explain the relative demand for different methods of family planning. For example, a study by Rajoura et al. (2003) analysed data for 1994–95 to conclude that the average acceptor had at least a high school education, with the average age being 34. The study also concluded that newspapers contributed to the awareness about NSV, while television and radio did not make much impact. More such studies can certainly throw light on the profile of acceptors and the reasons for selecting a given method, and can help policymaking to a great extent, by alerting them to the limitations of supply side measures. The Andhra Pradesh case may bring home this point more forcefully, since it has one of the highest adoptions of NSV. During the three months period from July 1998 to September 1998, 27,661 males underwent NSV operations all over the country, out of which more than

144 Adoption of Health Technologies in India

75 per cent were in Andhra Pradesh, mainly Karim Nagar. A study conducted by Murthy and Rao (2003) in Andhra Pradesh showed that the reproductive problems associated with tubectomy were high, and nearly 50 per cent of the women who underwent tubectomy had problems. This was one reason for the increased acceptance of NSV in a few districts in that state.12 But the more important reasons seem to be the mass camp approach, as was the case with Ernakulam, discussed earlier. The District Medical Office, with the support of the NTPC (National Thermal Power Corporation) located there, organised mass sterilisation camps, and performed NSV for eligible men. The mass camps followed a strict schedule, which included pre-surgery counselling, surgery, post-surgery counselling, distribution of medicines and, finally, distribution of gifts and money. In these camps, all the expenses incurred— including the cost of infrastructure facilities, food, transport and accommodation for seven days for the clients— were shared between the District Medical Office and the NTPC. Only the best-trained surgeons conducted the camps. Karim Nagar still has 32 NSV surgeons trained under the MOHFW, which is the highest in India. The study also indicates that the monetary incentives were increased substantially, which may have greatly influenced the demand. As a result, the total number of sterilisations conducted in 1999 was 53,000, of which NSV accounted The experience of Karim Nagar in Andhra Pradesh is often mentioned as the only success story of the NSV programme in India. The NSV programme in Karim Nagar was started in 1997, and since then, till about recently, it has definitely been a showcase of a successful NSV programme. Since Karim Nagar seemed to be a unique success case, it was worth studying it in some detail to understand the reasons behind the success and the subsequent slow down of the programme. 12

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for 27,000 (51 per cent), slightly more than the tubectomy operations. Discussions held with key personnel indicate that the initial impetus—during 1998–99— was due to the enthusiasm and efforts of one individual, the District Collector of Karim Nagar. However, this initial success could not continue and there are reports that the proportion of NSVs in Karim Nagar is again declining. However, there is also evidence that, of late, many of the surgeons who were trained in NSV have left the programme, apparently due to lack of incentives and support. The lack of experienced surgeons in mass camps is likely to have affected the acceptance of NSV. For all these reasons, without any added impetus in the form of fresh ideas and innovations, there has been a slow down of the initial momentum, and a slow down in the rate of growth of NSVs. NSV—unlike many other health technologies—needs much stronger IEC activities so as to (a) dispel myths and misconceptions around its effect on sensitive issues like sexuality; and (b) to influence the strong gender bias in the family planning in India, and influence men to participate in family planning. China had demonstrated that strong IEC could improve the uptake significantly (Zhang 2004). In India, the myths and stigma that surrounds male sterilisation and sexuality seems to have prevented men from volunteering for this mode of family planning (Murthy and Rao 2003; Rao and Sinha 2004). The meetings with officials confirmed the view that the NSV programme would have benefited from intense and innovative IEC campaigns just as it had benefited programmes like the Pulse Polio Immunisation.

146 Adoption of Health Technologies in India

A related issue is the use of the ‘camp approach’ along with IEC. Camps are temporary sites outfitted as surgical facilities and heavily promoted to achieve a high flow of clients in a short period of time. As discussed earlier, the Ernakulam camps held in 1970 and 1971, achieved 78,000 male sterilisations, while the camps held in Gujarat in 1971 and 1972 sterilised over 200,000 men in two months (Ross and Huber 1985). In the first phase of NSV camps in Karim Nagar, a truly multi-sectoral approach was adopted by co-opting other departments. Imaginative and novel IEC activities like plays and magic shows were carried out, which seemed to have worked well for the cause of promoting NSV camp. The DWCRA (Development of Women and Child in Rural Areas) units of the district were also actively involved in providing publicity to the programme. Mobile theatres and trained surgeons were made available in all the villages and there were camps conducted in different parts of the district. However, one needs to draw a line between popularising the ‘camp’ and popularising the technique. It is evident from the series of studies done by Rao and Sinha (2004) that while introducing the NSV, the emphasis was much more on promoting the camps as compared to the IEC which promoted NSV as a superior technique. While the camp approach has its advantages, there are two drawbacks. One is the temporary nature of the IEC, which accompanies the delivery of services in the camp, and the other could be lack of efficiency and quality of services. Poor quality in mass camps would be an efficient way of achieving exactly the opposite effect and, therefore, it is imperative that mass camps not be undertaken without proper planning. Instead of mass camps, small

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mini camps are more efficient, according to an expert, who contended that around 500 NSVs conducted every year is much better than 1,500 NSVs done in a mass camp once in three years. MOHFW, 2006 however, indicates that a strategy of ‘advocacy and community mobilisation for increasing NSV acceptance through camps’ has been introduced (MOHFW 2006). Despite these views of reviewers, it is contended here that camps accompanied with incentives are not sustainable ways of increasing the demand for NSV, or any health technology for that matter, and that demand barriers need to be carefully considered prior to planning. The IEC in camps will have only limited long-term effect, but the monetary incentives are the main reason of high uptake. If one truly wants to influence male demand for sterilisation—of which NSV is just one method—then deeper changes in attitudes and awareness have to take place through well thought out IEC strategies. This has not really happened in India, though the concerned officials in the government maintain that steps are being taken to strengthen IEC so as to improve the results of the uptake on NSV. It must be mentioned here that there is always the slightly coercive route of increasing an adoption, which would bring in results, but at great costs to personal freedom. Any policy that promotes indirectly a target-oriented approach will perforce introduce elements of coercion into the programme, though it might seem as though it is happening naturally. One must exercise great caution to understand how central and state directives translate into actual implementation at the micro level, without hampering human rights and freedom of choice.

148 Adoption of Health Technologies in India

Availability and Accessibility As mentioned before, NSV is a simple procedure, which can be done even at a PHC. Also, the mass camps were conducted by the local governments at district levels, for ease of access. It does seem that the issues of availability and accessibility were secondary to the main issue of acceptance in India. Wherever there was a demand—like in the states of Andhra Pradesh, Madhya Pradesh and Punjab— availability and accessibility were not issues. The discussion with the surgeons in the Karim Nagar district revealed that availability of NSV surgeons in the district could be one additional reason for the higher success of NSV there (the main reason being the camp approach). The availability of good surgeons however reduced the failure rates of NSV. There is a debate on the failure rate of the NSV procedure in India even now. While international studies have estimated the failure rate to be more than 5 per cent, in India the figure varies from less than 2 per cent to more than 5 per cent. The failure rate is high in the mass camps of NSV, where non-experienced surgeons have been carrying out surgery for monetary benefit. A study by Kumar et al. (1999) in a hospital in Delhi found that out of the 4,253 NSV operations done till 1997, there were only seven complications, which was a very high success rate. However, no systematic or representative study exists on failure rates of NSV in India and, therefore, it is not easy to understand whether this has been a barrier to uptake.

Affordability It was offered free to the clients and sometimes even with an incentive during mass camps. Thus, not only was price

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not a constraint on demand, the incentives indicated almost a case of negative pricing.

8.8 Overview and Lessons Clearly, NSV has not been one of the success stories of the family planning programme in India. The experts within the government too endorse this view. This is despite the fact that sterilisation as a method of family planning has been popular with the government more often than not. This is true even currently as the government seems to push sterilisation all over again. The states have been attempting to popularise male sterilisation through the camp approach, which has worked only to a limited extent, and for a shorter time period. However, there are some states where male sterilisation continues to be the popular choice of family planning method. It is not clear what the ultimate objective is. If it is to make men take part in family planning methods, it does not seem to have worked. If NSV is merely a strategy to push permanent family planning methods, and is seen as a part of all methods including female sterilisation, then merely number of male vasectomies is not the right indicator. While the stated objective seems to be male participation, there seems to be a continued emphasis on sterilisation as a method of family planning. There are other ways of making the males partners in the family planning decisions, even if it is ultimately the woman who adopts the method. There has not been that much of an attempt to change male attitudes and make them partners in reproductive choices, which is understandably much harder to do. This inability

150 Adoption of Health Technologies in India

to influence male demand for family planning has been the major reason why NSV has not been a success in India. However, this seems to have changed in the recent past, and as the latest Annual Report of the Department of Family Welfare states four ways in which men can be involved in women’s reproductive health: (i) using male contraceptive methods; (ii) supporting partners’ contraceptive use by joint decision making; (iii) preventing the spread of STI/RTI; and (iv) promoting participation during pregnancy and delivery (MOHFW 2006). It remains to be seen how these aims actually translate into outcomes in a welfare-enhancing way. The NSV example also helps to reinforce the importance of a good system of monitoring and evaluation of programme so that corrective and timely steps could be taken. This has not happened for NSV, which is a much more complex technology from the demand perspective, than what it would seem at first sight. The experience of NSV adoption in India demonstrates the limitations of adopting a standard approach for initiating a technology which involves extremely sensitive, traditional and hard-to-change mindsets. If a government wants the success of such a technology, the approach has to go beyond the standard supply side models of government interventions that have the danger of reducing choices and, therefore, the welfare of individuals. In the context of the AIDS vaccine, these are valuable insights, since many of the issues around attitudes and awareness are likely to be equally sensitive and would need cautious handling and careful planning.

Chapter 9 Voluntary Counselling and Testing

9.1

Introduction

The concept of Voluntary Counselling and Testing (VCT) has evolved over time. It started as early as in 1983 with the application of the indirect ELISA to detect the antibodies to HTLV (now onwards to be referred as HIV), an etiological agent causing AIDS. In 1985, the Food and Drug Administration (FDA) in USA approved the ELISA test kit to detect HIV antibodies in the blood and thus, it became commercially available. Soon after that, in 1987, a more accurate testing method—the western blot test kit— was also approved.1 The early emphasis for the use of these testing methods was restricted to the screening of blood and organ donors (WHO 1985; CDC 1985b). It was in 1986 that CDC released a set of recommendations referring to counselling and voluntary serological testing for individuals at ‘increased risk’, which was the first of its kind. The objective of this 1

http://www.fda.gov/oashi/aids/miles81.html.

152 Adoption of Health Technologies in India

set of recommendations was to interrupt sexual and intravenous transmission, and a significant emphasis was given to confidentiality and anonymous testing. With an increased demand from the high-risk groups in USA, and with the availability of commercial kits to test HIV antibodies, a pilot project of establishing ‘alternate testing sites’ for the provision of HIV testing outside the blood-bank setting was put in place in during 1985– 86; this can be thought of as the first VCT experiment for HIV interventions (CDC 1986b). As for the evolution of the testing methods, the first generation tests viz. ELISA and the western blot tests were utilised for HIV testing for a long period of time, despite cost and time (to reveal results) limitations (Branson 2000a, 200b). It was also reported that these tests are costefficient only for high volumes (Tamashiro 1993). As the concept of voluntary counselling and testing evolved, the limitations of these methods were becoming clear, especially in resource-constrained settings, and at the sites where the testing load was low (Branson 2000b). The major implication of the long waiting time for the test results was on the ‘result seeking’ behaviour of individuals who got tested (Wilkinson and Habgood 1994; Tao et al. 1999; Branson 2003). As an alternative testing method, successful results using simple rapid tests were reported from different countries of Europe, Africa and America (Constantine et al. 1989; Van Kerckhoven et al. 1991; Malone J.D. et al. 1993). The use of rapid tests made it possible to provide on-site results on the day of testing and, thus, improved the overall performance of VCT centres (McKenna et al. 1997; Kassler et al. 1998). In 1997, WHO/UNAIDS specified different testing strategies according to the objective of testing (WHO/UNAIDS

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1997). In 1998, WHO/UNAIDS endorsed the costeffectiveness of rapid tests for scaling up to widen the access, and recommended the use of reliable simple/rapid tests (WHO/UNAIDS 1998). Currently, these recommendations are widely accepted and various national VCT guidelines, including that of India’s, follow it in their programmes. However, it was increasingly being recognised that the mere availability of testing services was not enough to ensure a wider uptake of the product. The lack of incentives—amidst stigma, discrimination and expensive treatment—was seen as a major reason for the slow uptake of the existing services, and thus, a three-pronged approach, including ‘Beneficial disclosure, Ethical partner counselling, and Appropriate use of HIV case-reporting’, was recommended to improve the uptake of VCT services. (UNAIDS 1999). The need for incentives that could have an impact on greater utilisation helped generate various models of VCT centres,2 many of which attempted to go beyond voluntary and confidential counselling and testing, and involved people living with HIV/AIDS (PLWHA) and NGOs in prevention and care activities (UNAIDS 1999; Vollmer and Valadez 1999). The developments around the testing technologies and availability of Antiretroviral Therapy (ART) widened the scope of testing and counselling services. The objective and scope of VCT was revised from merely interrupting further transmission to the promotion of early knowledge of HIV status and provision of access to appropriate Many of these models are discussed in UNAIDS (2001), which is a comprehensive account of VCT experiences across various target populations in different settings. 2

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medical, preventive and psychosocial care services (CDC 1993, 2001).

9.2 Timing of Adoption ICMR started the blood screening of certain pre-defined ‘high-risk’ groups, to determine the presence of HIV in India in 1985. Thus, the ‘testing’ part of VCT was adopted almost simultaneously in India as in other parts of the world. It was the ‘counselling’ part that entered the system much later. In fact, VCT as a whole came to India almost a decade after the country started testing for HIV. Following the detection of the first case of HIV in 1986, the surveillance activities were extended in a phased manner across the country to identify the modes of transmission, geographical spread and trend among special groups. Evidence suggests that during the early years of the epidemic, the emphasis was on mandatory testing. The proposed AIDS Prevention Bill 1989, the Railway Board Administrative Notification of 1989, the Goa Public Health Act Amendment of 1987 and an untitled bill introduced in the Maharashtra Legislative Council are examples of a few legislative attempts that generated debate over mandatory vs voluntary HIV testing in the country (Padmavati 1991; Matiharan 2002; World Bank 2003). The gathering epidemic in India and the rapid spread of the infection across groups, states and regions prompted the government to implement the National AIDS Control Programme (NACP) in 1992. The first phase (1992– 98) focussed essentially on prevention and control of the epidemic. The second phase of the NACP (1999–2006) envisaged the twin objectives of reducing the spread of

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HIV infection in India and strengthening India’s capacity to respond to HIV/AIDS on a long-term basis. The VCT service was then seen as a main activity of prevention among general communities in India. The emphasis on letting these services reach the ‘at-risk’ population was inherent in the vision of the National AIDS Control Organisation (NACO). VCT was visualised by NACO as an entry point into the ‘continuum of HIV/AIDS care’, which was to facilitate in the early and appropriate uptake of HIV services for both HIV positive and negative individuals (NACO 2004). Indian VCTC models—both public and private—can be broadly classified as integrated static sites or mobile/ outreach centres, depending upon its service delivery approach. Figure 9.1 shows the different models that exist in India, giving some insights into the relative place of the NACO-sponsored model in the entire country, which is the model under discussion in this book. Overall, it seems that the adoption of voluntary counselling came much later than testing in India and the entire model of VCT came later in India than in other countries.

9.3 Appropriateness and Adaptability Counselling techniques have been widely practiced in India’s family welfare programme for the promotion of contraceptive methods, and also for various mental health interventions, including de-addiction programmes. However, the strategy of ‘counselling for disease prevention’ is relatively new to India. Thus, VCT cannot be seen as an indigenous concept to Indian health care setting at the time of its adoption.

156 Adoption of Health Technologies in India FIGURE 9.1 Models of VCTCs in India VCT models

Mobile/outreach VCT service

Integrated VCT sites

PSI (Sadhan)

NACO sponsored VCTCs

Sites attached to research projects

VCTCs other than NACO sponsored

VCTCs at NARI

Functional in govt. hospital Funded by NACO

Functional in NGO hospital Funded by NACO

VCTCs in medical colleges, district hospitals, etc.

Sri Vivekananda Memorial Trust Hospital, Saragur, Karnataka

Employer sponsored VCTCs

NGOs

Railways, Defense, SAIL Only counselling Testing at NACO VCTC

Provision of Counselling and testing

Integrated with HIV care centre

Integrated with prevention activities in general community

Integrated with targeted intervention activities

Freedom Foundation YRG care

FHI

Humsafar Trust

Source: Generated by the authors.

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From the ‘testing’ perspective, the service providers— physicians—generally drive medical interventions in India with a somewhat passive health-seeking behaviour from the patients’ side. It is only on the recommendations of a physician that the patient gets the various diagnostic procedures done, including laboratory testing. Thus, voluntary testing, where individuals are expected to voluntarily visit a centre for laboratory tests without necessarily going to a physician first for a referral, is also a newer phenomenon. Given that counselling may often involve issues around sexuality, the implementation and acceptance of VCT services pose a serious challenge. Thus, while it was probably required in the context of the epidemic to have counselling and testing, the form in which it was started needed further adaptation and evolution. As will come out in subsequent discussions, India managed to do adapt the initial model quite well and, according to experts, the Indian VCT model in its current form is much superior than many global models.

9.4 Policy Framework of Adoption Approval and Regulation In the early years of the epidemic, the government established HIV testing laboratories across the country. The adoption of the sentinel surveillance strategy to widen the objective of monitoring the trend of the epidemic even in low-risk groups like ANC attendees was an important development. Various HIV testing laboratories were then restructured as surveillance centres, where HIV testing could be carried out for surveillance purposes.

158 Adoption of Health Technologies in India

In Phase I of the NACP, ‘Unlinked Anonymous’ testing method was adopted for surveillance purposes and HIV/AIDS counselling was discussed as an integral component for the ‘reduction of impact of HIV’ interventions. In 1993, a draft of Indian HIV/AIDS Counselling Training Module was developed and a three-level training programme was envisaged to train grass-roots workers for HIV counselling. In Phase I, the importance of counselling was emphasised mainly for care interventions. In the mid-term review of NACP Phase I (1995), the World Bank raised serious concerns over the relatively slow uptake of the programme, low performance of the states and the limited role of NGOs in various interventions. The year of 1996 brought about several landmark shifts in HIV interventions. While the debate over mandatory vs voluntary testing was on the rise, the Goa Public Health Act Amendment of 1985 and Railways Board Administrative Notification of 1989 were rescinded. Along with the recommendations of the mid-term review of the first phase of NACP, these developments brought about changes in the structure of the programme. The NACP, thus, gathered momentum towards a more comprehensive range of interventions. These developments culminated in the formulation of the national policy on HIV testing with emphasis on voluntary counselling in 1997. This started a new phase of VCT in India. The World Bank NACP Phase II project appraisal document (World Bank 1999) discussed VCT as an integral component of the prevention and control programme. A much greater emphasis was put on VCT in NACP Phase II and, in subsequent years, rapid geographic expansion of VCT centres ensued. What was called an HIV testing centre was renamed as VCT Centre (VCTC) and started being promoted as an entry point to prevention and care

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programmes. With the introduction of ‘rapid tests’—in addition to ELISA tests for confirmatory HIV testing— the testing procedures became quicker, resulting in increased efficiency. The details of the government models, and their quality and uptake, are discussed in detail later in the report.

Role of Central/State/Local Governments While the centre is responsible for procurement of test kits and training, the actual implementation of the VCT programme is done through the State AIDS Control Societies (SACS), which were set up for the smooth functioning of the NACP. To that extent, every state has a SACS, which coordinates prevention, control and treatment activities at the state level. Before the SACS structure was set up, the coordination between centre and state, especially in the devolution of funds, was a major issue. The current structure has made the process smoother, making the VCT adoption qualitatively better in the recent past. The VCT programme is implemented through the VCTCs set up in the different government-run facilities of the states. States have, therefore, a critical role to play in the adoption of this technology. The design of the programme does not so far include local governments. This may, however, change, with the aim of setting up VCTCs at the districts.

Role of Private Sector The presence and importance of private and commercial laboratories was recognised as early as in 1993, and it was deemed necessary to develop national guidelines for HIV testing in such establishments. National AIDS Control Policy states that ‘. . . In case of HIV testing facilities in the

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private sector hospitals, clinics, nursing homes and diagnostic centres, the state governments should adopt legislative and other measures to ensure that these testing centres conform to the national policy and guidelines relating to HIV testing’.3 However, neither was any substantial effort made to streamline testing and counselling practices in the private sector, nor were any linkages set up to partner with this huge and significant but under-recognized sector. Even after more than a decade, no guidelines exist for private sector testing. The issue of HIV testing in private settings, without necessary counselling, has been debated for a while now (Solomon and Ganesh 2002). The testing in private laboratories largely goes unrecognised, and in a majority of cases, it is unaccompanied with counselling. The instances of breaching confidentiality and routine HIV screening tests are also common, which is against the National policy guidelines (Sheikh et al. 2005). It can safely be said that only HIV testing is available in the private sector in India, and since the counselling component is not always ensured, the VCT as a technology is not yet fully adopted by the private providers. While there is no data available on this from the private sector, it is probably true that the share of this sector is shrinking due to the rapid expansion of government VCTCs.

Role of NGOs Counselling was incorporated as an IEC strategy in NACP Phase II, expanding its importance from providing only psychosocial support to a much more comprehensive National AIDS Control Policy (as accessed on the official website of NACO, http://www.nacoonline.org/policy. htm). 3

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attempt for prevention through VCT. NGOs were involved in the implementation of various HIV interventions, mainly Targeted Interventions (TI) among high-risk groups, and Care and Support services to HIV infected and affected individuals. In 1996, six Delhi-based NGOs, with the help of UNAIDS, and in partnership with NACO and the Delhi-based, government-owned and run Safdarjung Hospital, started a Model Counselling Centre (MCC) within its premises.4 This was the first ‘NGO initiated’ partnership experiment of its kind, which subsequently helped NACO to design its VCTC model. As can be gleaned from Figure 9.1, currently there are several NGO-run VCTC models that operate in India. In addition, the public sector VCT programme has close linkages with NGOs and community-based organisations, as well as with a network of people living with HIV and AIDS. Often, counsellors are selected from these various organisations and play a very important role in making the services accessible to those who need it.

9.5 Supply Issues Procurement and Distribution The NACO follows the mechanism of national as well as international comprehensive bidding for the annual 4 The stated objectives of the MCC were with the objectives of (a) providing pre-test, post-test, follow-up, general and family counselling to general public coming to the hospital; (b) bringing about behaviour and attitudinal change in people practicing high-risk behaviour; (c) providing support services and after-care services for HIV positive clients; and (d) disseminating information regarding STD, HIV/AIDS and condom use to a cross-section of society.

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purchase of HIV test kits and other supplies. Following the implementation of NACP Phase II, NACO appointed the National Thermal Power Corporation Limited (NTPC) in 1999 as the procurement agent for procurement of HIV test kits and other equipments. Both ELISA kits and Rapid test kits are in supply, and state governments are also advised to make local purchase in case of short supply. The procurement and supply issues remained more or less satisfactory, except for a few instances where defected ELISA kits were supplied to states (CAG 2004). In the context of distribution, as seen from Table 9.1, the highly vulnerable states have seen a rapid expansion in the establishment of VCTCs. As for the reach of the VCTCs, overall, India currently has 12 centres per 10 million adult population, which is a considerable improvement from the 8 per 10 million in 2002. However, there is significant variation across the four groups of states. In the case of the highly vulnerable states, although it has improved from 4 to 10 centres per 10 million adult TABLE 9.1 VCTCs and their reach—a comparison across state categories Adult Number Population of Existing (15–49) VCTC Years (in 10 State Groups High prevalence states Moderate prevalence states Highly vulnerable states Vulnerable states All India

VCTCs per 10 Million Adult Population

million)

2002

2005

2002

2005

15.70 2.90 31.40 2.10 52.10

218 27 134 35 414

241 40 308 42 631

14 9 4 17 8

15 14 10 20 12

Source: All tables were developed based on the data collected from the computerised Management Information System of the NACO.

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population, the reach of the VCTCs is less compared to other groups, and well below the national average. With a lower population base, vulnerable states have a better reach, with 20 centres per 10 million of adult population. NACO aims to expand VCTCs in such a way that each district throughout the country will have at least one centre. As of 2004, out of 593 districts, only 56 per cent of the districts were covered. Though 85 per cent of the districts in the high prevalence states had VCTCs, in the moderate and low prevalence states as many as 52 per cent of the districts still remained uncovered (CAG report, 2004). Table 9.2 shows that in the highly vulnerable and vulnerable states only 48 and 36 per cent of the districts are covered respectively. Out of the 263 uncovered districts,5 70 per cent were in the highly vulnerable states. Distribution issues are also linked closely with demand concerns. More on this will be discussed below.

Infrastructure In the last few years, India has seen a rapid expansion of VCTCs across the country. In the last three years alone, NACO has added more than 200 centres, reaching 631 VCTCs as of 2005.6 As can be seen in Figure 9.2, the number of VCTCs grew rapidly in the recent years. As of 2004, there are 628 Lok Sabha 2005. Nineteenth Report of Public Account Committee (2005–06) relating to ‘National AIDS Control Programme’ of the Ministry of Health and Family Welfare, New Delhi: Lok Sabha Secretariat. Lok Sabha 2005 states that 117 districts were uncovered and are in the process of initiating as on January 2005; the latest report seems to indicate that all the districts are covered. 6 http://www.nacoonline.org 5

132 31 354 76 593

100 22 116 24 265

Districts Providing VCT Facility (2002) 75.76 70.97 32.77 31.58 44.69

Districts Covered in 2002 (%) 112 24 170 27 333

Districts Providing VCT Facility (2004)

84.8 77.4 48.0 35.5 56.2

Districts Covered in 2004 (%)

7.7 2.7 70.8 18.8 100.0

Distribution of Districts Uncovered (%)

Source: All tables were developed based on the data collected from the Computerised Management Information System of the NACO.

High prevalence states Moderate prevalence states Highly vulnerable states Vulnerable states Total

Group of States

Districts (as per census 2001)

TABLE 9.2 Districts covered for VCTCs—a comparison across state categories

208

VCTCs in government healthcare set up

108

89

82

79

62

1997

353

445

542

VCTCs out side government

628

81

Source: All tables were developed based on the data collected from the Computerised Management Information System of the NACO.

0

100

1998

200

1999

300

2000

400

2001

500

April-02

600

August02

700

June-03

800

Novemb er-02

FIGURE 9.2 Growth of VCTCs in India

January04

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NACO supported centres located in various healthcare settings across the country. An additional 81 VCT centres have been set up outside the main government setup, which include seven by Employees State Insurance Corporation (ESIC), 32 by Steel Authority of India Ltd. (SAIL), seven by the Ministries of Defence and 35 by the Railways. As on January 2005, a total number of 709 VCTCs were functional in the country (Lok Sabha 2005). The infrastructure requirement for VCT is modest: it needs only one or at most two rooms. The rooms available for VCT have been initially an issue in some hospitals due to the space crunch, but have been resolved sooner or later.

Human Resources Availability of adequately trained counsellors is an important component of any counselling programme. In the context of HIV/AIDS in India, it becomes a critical issue because demand generation would depend, to a great extent, on the quality of counselling. Although there is a wide network of VCTC in place, there is not much information on the availability of trained counsellors at these VCTCs. Over the years, more than 90 per cent of VCTCs have not responded to the indicator that NACO uses for monitoring the availability of at least one male counsellor and one female counsellor (NACO CMIS 2005). NACO recommends comprehensive training for the counsellors.7 However, the CAG report mentioned that NACO VCT guidelines state that the identified VCTC counsellors need to undergo the required pre-placement training (based on modules developed by NACO at the local institutes identified by SACS), and also that they should participate in the refresher training (3–4 days) 7

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there is a shortfall of almost 57 per cent in the target of healthcare workers to be trained as of March 2003 (Table 9.3). The percentage of workers trained in HIV/AIDS counselling varied from as high as 99 per cent in Goa, 85 per cent in Pondicherry, 84 per cent in Uttar Pradesh and 76 per cent in Orissa to very low at 16 per cent in Gujarat, 5 per cent in Punjab, and less than 1 per cent in Uttaranchal. The NGO experts, who were part of the MCC, also raised the issue of inadequacy of training of NACO counsellors and laboratory technicians. As has been mentioned, the quality, rather than quantity, of training is of critical importance. The concerns over the rapid expansion of VCT services, and the consequent compromise on the adequacy of training of counsellors TABLE 9.3 Training of health workers— a comparison across state categories8

Group of States High prevalence states Moderate prevalence states Highly vulnerable states Vulnerable states Total

Health Workers Trained (in thousand) 47.1 6.0 89.2 21.7 164.0

Proportion of Total Health Workers Trained (%) 46.9 24.9 41.9 50.4 43.1

Source: All tables were developed based on the data collected from the Computerised Management Information System of the NACO. provided by SACS at least once a year to upgrade counselling skills. It also indicates that all the hospital staff should be given orientation and sensitisation training. 8 The estimates of Maharashtra, Manipur, Bihar, Chhatisgarh and union territories were not available. Thus, their figures were not taken into account.

168 Adoption of Health Technologies in India

and thus, the quality of counselling, were raised when NACO announced its aim of establishing a VCTC in every district. 9 The project performance assessment report of NACP Phase II—a mid-term review by the Word Bank—raised concerns over training of HIV counsellors and the poor client satisfaction among the users of VCTC (World Bank 2003). Additionally, the turnover of the counsellors also is high, mainly because of the low salary, and retaining trained and experienced counsellors is increasingly becoming difficult. This is a serious issue in the context of rapid scaling up. Inadequately trained health workers in VCTC may render the entire service almost irrelevant.

9.6 Distribution Issues Since VCT is mostly a service, with the main input being testing and counselling, there is very little distinction between the distribution of inputs and the final ‘product’. The decision to set up the centres and the distribution of VCTCs across states have already been addressed under supply issues of procurement and distribution, and will also be addressed to some extent under demand issues.

9.7 Demand Issues Acceptability/Information and Knowledge The VCT as a health technology is a perfect example of the importance of, as well as the tight link between, demand See http://archives.hst.org.za/sea-aids/msg00164.html, http:// health.groups.yahoo.com/group/AIDS-INDIA/message/1260 9

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and supply factors in improving access and utilisation. First of all, till now, it is still a derived demand, and influenced greatly by how the product is ‘advertised’. Second, the form in which this service is delivered influences demand significantly, and that is why discussion on ‘models’ is important. There are two prongs to VCT, if seen as a technology that hopes to prevent the spread HIV. In the first instance, the need for voluntary testing has to be instilled in the population. Second, once the awareness is created and potential demand is generated, the interest should be kept up by supplying the appropriate service, of which quality counselling is a key component. The supply of acceptable ‘physical setting’ and effective affordable ‘product’ is essential to make the target group utilise the technology fully, and for new entrants to feel encouraged to come forward as well. To understand these issues, reliable data on both demand and supply variables are required. However, very few scientific studies exist on the performance of VCTCs in India and, thus, the research had to rely on the very sparse literature existing on the subject, the existing CMIS data, and several meetings and discussions with experts on the subject to come up with some conclusions. The following analysis is based on this existing data. We use the categories of ‘high prevalence states’, ‘moderate prevalence states’, ‘highly vulnerable states’ and ‘vulnerable states’ (a re-classification as opposed to the earlier high, medium and low prevalence categories) to understand the access and distribution issues, and to make comparisons across various indicators.10 10 High prevalence states: Tamil Nadu, Maharashtra, Andhra Pradesh, Karnataka, Nagaland and Manipur.

170 Adoption of Health Technologies in India

Since VCT is about ‘voluntary’ access to counselling and testing, issues around acceptability have to do with not merely how many visited a centre, but how many visited it voluntarily. How ‘voluntary’ is the nature of demand of the voluntary counselling and testing services in India? To understand this, we need to understand the profile of those who access VCTC facilities in India. While the national policy on testing clearly mentions that ‘no individual should be made to undergo a mandatory testing for HIV’, there is some evidence of individuals being tested for HIV without their consent or knowledge. HIV testing is still performed, both in private and public hospitals, ‘as a differential diagnosis or in conjunction with surgery and obstetric care to provide reassurance for surgeons’. There are also instances of hospitals refusing to perform any invasive procedures on persons with HIV infection (Malavade J.A.B et al. 2002; Solomon and Ganesh 2002). Given this, it is important to understand the uptake of the service among its potential clientele. NACO CMIS maintains data on the proportion of voluntary walk-in individuals using VCTC services, which is calculated from (a) total number of voluntary walk-in people tested; and (b) the number of persons tested for HIV/AIDS at VCTCs. The indicator reflects the awareness of VCT services in general population. Moderate prevalence states: Gujarat, Goa and Pondicherry. Highly vulnerable states: Orissa, Jharkhand, Chhatisgarh, Assam, Rajasthan, Kerala, Himachal Pradesh, Punjab, West Bengal, Madhya Pradesh, Bihar, Uttar Pradesh, Uttaranchal, Delhi. Vulnerable states: Lakshadweep, Daman and Diu, Meghalaya, Tripura, Arunachal Pradesh, Dadra and Nagar Haveli, Sikkim, Jammu and Kashmir, Mizoram, Andaman and Nicobar Islands, Chandigarh, Haryana.

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Before looking at the actual variable, it is important to understand the extent of non-response from VCTCs across states. In 2002, only 53 per cent of the existing centres were reporting to the CMIS on this indicator, which has increased to about 88 per cent in 2004. The reporting is poor in vulnerable states, where 26 per cent of centres were not responding. The analysis below involves data from only the VCTCs that did report and should, thus, be used with caution. Table 9.4 presents an analysis across groups of states on walk-in individuals who got tested. In 2002, out of the 466,000 individuals who were tested at VCTCs, about 24 per cent were walk-in individuals. This proportion has increased to 31 per cent out of the 690,000 people tested in 2003, and to 37 per cent of the 836,000 people tested in 2004. These numbers are still quite low, indicating that the basic criterion of a good VCT system—voluntary testing—is still to be met in a serious fashion, raising doubts about its universal acceptability. While NACO has been able to achieve the target of bringing the proportion of walk-in persons to 30 per cent by 2004 (CAG 2004), the moderate prevalence states and highly vulnerable states are still grappling with high levels of mandatory testing. While it is important to understand the scenario within the state groups, it would also be interesting to know the distribution of voluntary clients across the state groups as presented in Table 9.5. A majority of the VCTC clients are from the high prevalence states and, over the last three years, it has increased from 52 per cent in 2002 to 61 per cent in 2004. The picture is no different for the walk-in clients, with almost two-thirds of the total walk-in clients being from these states. Low prevalence states contributed to about

247.0 105.1 87.4 26.6 466.1

High prevalence states Moderate prevalence states Highly vulnerable states Vulnerable states All India

407.0 119.1 126.9 36.1 689.1

2003 510.6 114.7 176.5 34.0 835.8

2004 83.3 6.8 14.6 6.8 111.5

2002 162.3 10.1 27.0 12.7 212.1

2003

229.0 27.5 42.0 12.5 310.9

2004

Walk-in People Tested (in thousand)

33.7 6.5 16.7 25.4 23.9

2002

39.9 8.5 21.3 35.2 30.8

2003

44.8 23.9 23.8 36.6 37.2

2004

Proportion of Walk-in People Tested

Source: All tables were developed based on the data collected from the Computerised Management Information System of the NACO.

2002

State Group

No. of People Tested (in thousand)

TABLE 9.4 Voluntary testing at VCTCs—a comparison across state categories

52.0 24.0 18.5 5.5

High prevalence states Moderate prevalence states Highly vulnerable states Vulnerable states

59.1 17.3 18.4 5.2

2003 61.06 13.72 21.16 4.06

2004

74.71 6.11 13.10 6.08

2002

76.52 4.76 12.72 6.00

2003

73.66 8.84 13.50 4.00

2004

Distribution of Walk-in People Tested for HIV/AIDS Across States (in percentage)

Source: All tables were developed based on the data collected from the Computerised Management Information System of the NACO.

2002

State Group

Distribution of People Tested for HIV/AIDS Across States (in percentage)

TABLE 9.5 Distribution of VCTC clients across state categories

174 Adoption of Health Technologies in India

one-fourth of the total testing and a little less than onefifth of voluntary testing. In 2004, highly vulnerable states, which comprise 44 per cent of total VCTCs, contributed only 21 per cent to the total testing and only 13 per cent of walk-in individuals were from these states. The analysis above does indicate that India still has a long way to go in making the VCT services truly voluntary, especially in the states with high vulnerability. This is the only way to make VCT useful in the prevention and control of the epidemic. The underlying reasons for its low voluntary uptake should be examined and steps should be taken to fill up gaps in information and knowledge.

Availability and Accessibility In addition to the mismatch between the need and the number of centres across states, there are also reports that a number of VCTCs are either not functional or not fully functional due to a variety of reasons like non-appointment of staff and non-availability of equipments (CAG 2004). The type of hospital where a VCTC is established, and also its location within the hospital, is of crucial importance from the point of view of access. NACO guidelines indicate that the sample collections are to be done at the counselling centre and that the clients do not have to go to the laboratory where the actual testing is to be carried out (generally in the microbiology/ pathology department) (NACO 2004). However, there is evidence to indicate that the sample collection is not always being done at the counselling room due to nonavailability of the requisite setup, and clients are required to walk down to the actual laboratory where the samples

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are collected and tested. As reiterated by the experts our team met, access could be substantially increased if these centres were located near the general OPD, in the vicinity of either the STI department and/or the antenatal clinic, so as to allow maximum access to the general public. Furthermore, there is the issue of the time taken to reveal results, which affects the return of clients to collect the test results and thus, post-test counselling. The discussions with experts revealed that there are centres where only ELISA tests are being done, thus, increasing the testing time, which ultimately affects the clients’ test-seeking, and, therefore, health-seeking behaviour. While NACO recommends Rapid tests, it is the SACS/testing centre that decides which technology is to be used. It was observed that well-established VCTCs in the tertiary care hospitals preferred ELISA tests over Rapid tests mainly because of the high client load. The newer VCTCs are more inclined towards Rapid tests, also because they do not have the ELISA readers. However, while no statistics are available to completely understand the trends in utilisation of HIV testing methods, it stands to reason that Rapid tests may be an integral part of an effective VCT system in the future. Quality and access issues are intertwined in the case of VCT, as has been mentioned many times earlier. Another insight into quality could be gleaned from pre- and posttest counselling numbers. As per the national policy on HIV testing, and also as mentioned in the VCT guidelines, pre-test and post-test counselling are essential parts of the HIV testing procedure. This implies that pre-test counselling, informed consent from the person being tested, and post-test counselling are usually the minimum requirements for an HIV test. The NACO CMIS variables that monitor counselling services are (a) the number

176 Adoption of Health Technologies in India

of persons given pre-test counselling; and (b) the number of HIV positive persons receiving test results.

Pre-test Counselling It is natural to expect that in the initial stages, the total individuals who undergo testing may be equal or less than those who were provided with pre-test counselling, but over time it should increase to 100 per cent or more (if the variable is constructed as the number of individuals given pre-test counselling to the proportion of those tested),11 indicating that some clients may opt not to go for the test after pre-test counselling. NACO CMIS does not give information on this indicator for walk-in clients and referred clients separately, and thus the analysis is for aggregate clients of VCTCs. As for the reporting scenario, more than 80 per cent of the VCTCs responded to this indicator in 2004, as compared to less than 50 per cent in 2002. Vulnerable states remain to be poor performers, where still 34 per cent of the total VCTCs do not respond. Of all the individuals tested, only 62 per cent were given pre-test counselling in 2002. This increased to 85 per cent in 2003 and almost 100 per cent in 2004. Moderate prevalence states have shown remarkable improvement reaching more than 90 per cent in 2004 from as low as 26 per cent in 2002. The low-prevalence states—both highly vulnerable and vulnerable states—are showing more pretest counselling than actual testing, indicating that around 12 per cent clients make informed decisions to not go for testing, in both the categories (Table 9.6). 11 The more logical way to construct the variable is to take it as the proportion of those tested to those who got pre-test counselling.

247.0 105.1 87.4 26.6 466.1

High prevalence states Moderate prevalence states Highly vulnerable states Vulnerable states All India

407.0 119.1 126.9 36.1 689.1

2003 510.6 114.7 176.5 34.0 835.8

2004 188.3 27.0 42.7 25.2 283.2

2002 377.7 44.3 130.9 33.4 586.4

2003

487.6 107.3 198.4 37.7 831.0

2004

People Imparted Pre-test Counselling (in thousand)

76.26 25.65 48.89 94.72 60.77

2002

92.80 37.24 103.18 92.41 85.09

2003

95.49 93.51 112.40 111.09 99.42

2004

Proportion of People Imparted Pre-test Counselling (in percentage)

Source: All tables were developed based on the data collected from the Computerised Management Information System of the NACO.

2002

State Group

People Tested for HIV/AIDS (in thousand)

TABLE 9.6 Pre-test counselling at VCTCs—a comparison across state categories

178 Adoption of Health Technologies in India

There is a wide inter-state variation for pre-test counselling, especially in the low prevalence states. Among the highly vulnerable states, the proportion varies from as low as 35 per cent in Himachal Pradesh to more than 200 per cent in states like Uttaranchal (226 per cent) and Orissa (438 per cent). Among the vulnerable states, except for Arunachal Pradesh (154 per cent) and Mizoram (194 per cent), for the rest of the states, the proportion was between 80 to 120 per cent. The significantly higher proportion (say beyond 120 per cent) of pre-test counselling, which indicated that some were not going in for testing after the pre-test counselling session, could be attributed to poor counselling, logistical issues around access to HIV kits, false reporting or merely erroneous data entry at VCTCs. It could also indicate that some people do not really need testing, and the counselling was good enough for them to understand that a test is unnecessary for them. While this is a possibility, it is not probable that this is happening, given other evidence on the quality of counselling.

Post-test Counselling We have used a CMIS indicator—proportion of HIV positive people receiving test results—which is derived from two variables viz. the number of HIV positives receiving test results as a numerator and total number of people tested for HIV/AIDS at a VCTC as a denominator. This indicator is misleading; since the denominator comprises total tested, the numerator should also be number of total tested individuals receiving test results, instead of only positive people. With an assumption that all those who come back to receive test results are being provided with post-test counselling, we present this variable (number of

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HIV positives receiving test results) as a proxy for analysing the trends in post-test counselling to positive clients (Table 9.7). In the high prevalence states, almost all the HIV positive people come back for their test results, indicating that they had an opportunity for post-test counselling that provides them with care and support linkages. The proportion decreases with HIV prevalence. For vulnerable states almost 30 per cent do not receive their test results, which has serious implications on the usefulness of the VCTCs as a part of the continuum of care.

Affordability The services of the VCTC are free. Therefore, affordability is not a barrier for client adoption.

9.8 Overview and Lessons The most common VCT model in India is that of the NACO. Better-integrated and more client-friendly models do, however, exist in the NGO sector. While India responded in quite a timely manner to the need of VCT, the ‘counselling’ part came later than ‘testing’, and, moreover, later in the country than in other parts of the world. The analysis does indicate that the very rapid scaling up of the government programme may have been at the cost of quality, without taking into consideration the needs of regions/ states. While high-prevalence states are performing well, it is the VCTCs of the currently low prevalence, but vulnerable, states that need to be strengthened. It may not be an easy task to improve the functioning of VCTCs in these

45.92 6.74 6.97 1.38 61.01

High prevalence states Moderate prevalence states Highly vulnerable states Vulnerable states India

74.02 8.00 8.69 1.57 92.29

2003 90.97 10.73 11.56 1.93 115.18

2004 41.41 5.82 5.71 1.13 54.07

2002 68.38 7.13 7.42 1.35 84.28

2003

90.81 9.93 10.12 1.38 112.23

2004

No. of HIV Positives Receiving Test Results (in thousand)

90.2 86.3 81.9 82.1 88.6

2002

92.4 89.1 85.3 85.8 91.3

2003

99.8 92.6 87.5 71.3 97.4

2004

Proportion of Positive People Receiving Test Results (in percentage)

Source: All tables were developed based on the data collected from the Computerised Management Information System of the NACO.

2002

States

No. of Persons Testing Sero-positive (in thousand)

TABLE 9.7 Positive people receiving test results—comparison across state categories

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states given that many of these are performing poorly across many developmental indicators as well. Much greater focus on human resources client-friendly environment is required to determine the quality of a client-oriented service like VCT. While these concerns are being recognised, it is never easy in a vast country like India to undertake corrective measures in government programmes. On the positive side, if one compares the situation over time, the availability of counselling along with testing itself is a huge improvement. While it offers individuals an inexpensive means of getting information and help, thereby impacting favourably on prevention efforts, it also coalesces well with the government’s free ART programme. Over time, India has learnt important lessons on how to introduce and adopt a service-intensive health technology like VCT. The need now is to capitalise on this experience and expand the services to un-reached areas and populations, as well as to tone up the quality of the services being offered. The other benefit of the VCT programme has been its integration with the ART programme in the country. Thus, while the VCT experience offers insights into the possible pitfalls of a rapid scaling up around a health technology, it also offers a model of a possible three-way integration of VCT, ART and the AIDS vaccine, which can be a unique way of bringing together prevention, control and treatment in the country.

Chapter 10 Antiretroviral Therapy

10.1 Introduction The adoption of a public policy of free provision of Antiretrovirals (ARVs) in India cannot be discussed without a brief introduction and history of the treatment with these drugs in the world. The short history of treatment with ARV, the increasing global context of such treatment, and the WHO’s role in its accelerated spread need to be understood so as to put India’s experience in its proper perspective. Until the development of Antiretrovirals (ARVs), AIDS was perceived as an untreatable condition. Prophylaxis and treatment of Opportunistic Infections (OIs) in the initial stages of infection, and palliative care in the advanced stages were the only clinical components of care and support services to HIV positive people. It was only in March 1987 that Zidovudine (AZT)—a drug that belongs to the group of Nucleoside Reverse Transcriptase Inhibitor (NRTI)— became the first ARV approved for the treatment of HIV infection in the United States. The next ARV, Didanosine (ddI), was approved in October 1991. It was initially used

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as mono-therapy for patients failing or intolerant to Zidovudine. In 1993, the expert panel of the National Institute of Health (NIH), USA, recommended the use of AZT as first-line therapy in patients with or without symptoms, with CD4+ T cell counts below 500/mm3, or to patients with severe AIDS-Related Complex or AIDS, regardless of their CD4+ T cell counts. The panel also mentioned that ‘combination therapy with AZT and ddI might also be considered, although clinical trials have not conclusively demonstrated clinical benefit to date’ (NIAID 1993). Subsequently, based on the results of the Delta Coordinating company, 1996 and the ‘AIDS Clinical Trials Group (ACTG) 175’ study (Hammer et al. 1996), the benefits of the combination therapy were established and thus, Didanosine was used in combination with Zidovudine. In 1994, Stavudine (d4T) was approved by the Food and Drug Administration (FDA) and, in 1995, two important molecules, Lamivudine (3CT) and the first Protease Inhibitor (PI)—Saquinavir (SQV), received approval from FDA. Thus, by then, two classes of ARV molecules viz. NRTIS and PIs were available. Following the advancement in knowledge about the disease progression and the development of newer ARV molecules, updated treatment guidelines were developed by the International AIDS Society USA (IAS USA) in mid 1996. The panel recommended two-drug therapy with nucleoside combinations and specified that the PIs should be reserved for patients at higher progression risk and that they can be selected primarily for antiretroviral potency, secondarily for safety, tolerability and drug resistance patterns (Carpenter et al. 1996). Nevirapine (NVP), the first Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), was approved around the

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same time in June 1996, making it the third category of the most effective ARV available till date. The availability of different molecules and its combination therapy witnessed dramatic benefits in terms of delays in HIV progression, improved survival and decreased hospitalisation for HIVinfected patients. HIV was, thus, transformed into a manageable chronic disease (Wainberg and Friedland 1998). The ideal treatment strategy then involved the use of a PI and two reverse transcriptase inhibitors. The combination of these three drugs has become known as ‘triple combination therapy’. While the expanded ARV options were raising hopes for effective treatment, instances of resistance and treatment failure were also being reported. As mentioned by Gulick (1997), ‘from the first approved antiretroviral agent, AZT, through two-drug nucleoside analogue regimens, to the current three-drug combination regimens with protease inhibitors, both the benefits of therapy and the complexities of therapy continue to increase’. Apprehensions about the spread of ART from a public health point of view, that is, preventing the development of HIV drug resistance and transmission of drug-resistant variants, were raised (Wainberg and Friedland 1998). The treatment guidelines were updated further, with increasing evidence on effectiveness of various combinations, the importance of adherence and adverse effects, the impact of ART on the quality of life and evolution of resistance (Carpenter et al. 1998). While clinical advances were bringing down the AIDSrelated morbidity and mortality in the developed countries, the burden of HIV was increasing at an unprecedented rate in the developing countries. Though a large proportion of people living with HIV/AIDS in many industrialised and some middle-income countries were able to benefit from

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this medical advance, only a few of those in developing countries could do so owing to its high cost. Only a few pharmaceutical companies in the world were producing these innovated molecules. This ‘monopolistic (or oligopolistic) market structure and asymmetries of information in favour of suppliers were the main reasons for price discrimination and high costs, which in turn were the major deterrents for accessing ARVs (Lucchini et al. 2003). While the basic treatment for the associated opportunistic infections was inaccessible in certain developing countries, making ARVs available to all who needed them was a distant dream. The next phase involved serious attempts to address these inequalities in the access to ART across the globe.

Global Access: An Overview The 12th World AIDS Conference on HIV/AIDS in Geneva in 1998 with the theme of ‘Bridging the Gap’ can be considered as an important milestone in the global access to ART. Several voices were raised to address the inequality of access to ART and the high prices that were being charged for ART. While AIDS had become a manageable chronic condition in the developed world, in the worst hit countries of Africa, Asia, and Latin America, AIDS mortality was on the rise mainly because of the lack of access to ART. Several initiatives took place in this period across the world to increase access to ARV for those who needed it the most. The early initiatives that took place to address high costs of ARVs were focussed on the process of negotiation with the few pharmaceuticals that were holding the patents. The emphasis was on convincing the pharma companies to have a ‘philanthropic’ approach, and provide subsidy

186 Adoption of Health Technologies in India

for national-level purchasing of ARVs (Lucchini et al. 2003). The early initiative, which was called Drug Access Initiative (DAI), demonstrated the feasibility of initiating delivery and monitoring of ART in the context of existing health care infrastructures and also reiterated the necessity of strong public control and support, which were essential for a successful diffusion of ART (Katzenstein 2003). Although the manufacturers provided the drugs at a reduced price, the costs were still high enough to restrict access to larger populations. The need to explore better and more feasible options laid the foundation for the next big initiative called Accelerating Access Initiative (AAI). AAI involved a ‘preferential pricing’ mechanism that was based on ‘a priori international price negotiation that were supposed to set a standard for procurement in all the countries that adhere to the initiative’ (Lucchini et al. 2003). Building on the results of the UNAIDS/WHO Drug Access Initiative, the experience of the AAI reinforced the feasibility of delivering ART in developing countries. By the end of 2002—with two years of interventions of AAI— the prices of drugs had reduced to a great extent. The following years saw various regional initiatives in Africa that further increased access in the region. Multicountry HIV/AIDS Programme for Africa (the MAP programme), and Treatment Acceleration Project (TAP) were the two major World Bank initiatives with the goals of increasing access to HIV/AIDS prevention, care, support and treatment as also to help mitigate the effects of the epidemic in the region. As a country level initiative, with the epidemic at its peak in Botswana, the Bill and Melinda Gates Foundation and the Merck Company Foundation/Merck and Co started The African Comprehensive HIV/AIDS Partnership (ACHAP).

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Amidst the oligopolistic market and increased negotiations with the patent holders, in late 2000, the downward spiral of price reduction started with the introduction of the first generic ARV by an Indian manufacturer Cipla. A revolution of sorts, thus, took place in the ARV access scenario. In the competition between branded vs generic ARVs, the prices of branded anti-HIV drugs were also reduced to $500 and $800 for low-income and middleincome countries respectively. The production of the generic version of ARVs not only reduced the cost, but also simplified the drug administration by introducing the single dose triple drug combination. The year of 2001 can be thought of as another landmark in access to ART for the three following events: (i) the United Nations General Assembly, in its 26th Special Session (UNGASS), passed a resolution to declare global commitment to review and address the problem of HIV/AIDS in all it aspects; (ii) the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) was created to increase resources to fight three of the world’s most devastating diseases including HIV, and to direct those resources to areas of greatest need; and (iii) generic versions of ARV drugs were offered to national governments at reduced rates, which would reduce the prices dramatically.1 In February 2001, Cipla further reduced its prices and offered to supply AIDS drugs ‘at a humanitarian price’ of $1 a day, and signed a deal of providing ARVs for $350 for donation and for US$ 600 for governments per patient per year. 1

188 Adoption of Health Technologies in India

While the UNGASS resolution propelled the international community towards the inequity in ‘treatment needs vs access’ and the GFATM raised hopes for greater resources, the reduction in cost of the medicine raised hopes for greater access. Along the sidelines of these global initiatives, a few country-level developments were also being carried out in Latin America and later in Thailand. Brazil has the distinction of being the first country to offer universal access to ART and in influencing the negotiations at the WTO in favour of the developing world. The Clinton Foundation initiative was the first kind of partnership with generic manufacturers to secure supply of ARVs at even further reduced rates. On 23 October 2003, the initiative announced an agreement with five suppliers (three of which were Indian) of generic ARV medications,2 which dramatically reduced the price of the most commonly used triple drug therapy combinations to less than $140 per person per year.3 This initiative aimed at providing ARVs to Africa and the Caribbean countries. Significantly, again, India was not one of the beneficiaries.

The ‘3 by 5’ Initiative At the second UN General Assembly Special Session on HIV/AIDS in September 2003, WHO and UNAIDS declared the lack of treatment in low- and middle-income 2 The Initiative’s cost experts worked with the companies—Aspen Pharmacare Holdings Ltd., Cipla Ltd., Hetero Drugs Ltd., Ranbaxy Laboratories Ltd., and Matrix Laboratories Ltd.— analysed the production chain and projected potential cost advantages that could result from higher volumes. 3 http://www.clintonfoundation.org/programs-hs-ai3.htm

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countries a global public health emergency. On World AIDS Day of the same year, the ‘3 by 5’ initiative was launched, which aimed to put 3 million people on ART by the end of 2005 (UNAIDS 2004). This amounted to about 50 per cent of all those who required treatment at that time. This announcement brought forth accolades and criticisms, mainly the latter, around issues of financial sustainability, ambitious target, equity, lack of health infrastructure in the targeted countries to deliver the complex therapy and risk of inconsistent governmental support (Kim and Ammann 2004; Logie 2004; Pau 2004). Till December 2004, the initiative seemed to be doing well and WHO was able to meet its predetermined objectives. However, the recent Global Progress Report (WHO 2006) suggests that in terms of coverage, the progress is far behind the target. The performance of the ‘3 by 5’ initiative till date can be seen from Figure 10.1.

People on ART

FIGURE 10.1 Progress and performance of WHO ‘3 by 5’ initiative 3500000 3000000 2500000 2000000 1500000 1000000 500000 0 Dec02

Jun03

3 by 5 target

Dec03

Jun04

Dec04

Jun05

Dec05

Number of people on treatment

Source: Various progress reports of ‘3 by 5’ initiatives, World Health Organization.

190 Adoption of Health Technologies in India

One of the most important outcomes of the 3 by 5 initiative was that it forced countries to acknowledge that treatment is essential. Further, the need to improve access to ART at an unprecedented speed was also realised. At the time of writing the book, 18 of the targeted developing countries provide treatment to half or more of the people living with HIV/AIDS (WHO 2006). Before discussing the Indian access initiative in detail, it is important to discuss the feature that played a vital role for the free ART initiative in India—the significant presence of Indian generic drugs. To understand this a bit more, it is important to understand the situation with domestic production of drugs and patents in India.

Indian Pharmaceutical Market At the time of independence, India had the patent system, which had been established by the then British government to secure the Indian market for the British industry under the Indian Patents and Design Act 1911. Till 1970, when India did away with the Patent Act 1911, various pharmaceuticals were largely imported from abroad and local production was minimal. This phase of negligible indigenous technological development in Indian pharmaceutical industry and, consequently, high drug prices compelled the Indian government in the late 1960s to shift to a soft patent regime (Pradhan 2004). The Indian Patent Act 19704 provided product patents for all inventions except food, medicine, drugs and substances produced by chemical processes. Various innovations in terms of reverse engineering and new process development resulted in 4

The Act came into force in 1972.

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technological advancement, thereby changing the trade scenario drastically. Not only did domestic production improve, but also the pharmaceutical exports from India grew consistently at a much higher rate than its imports since the 1970s (Figures 10.2 and 10.3).5 The major export destinations—accounting for more than half of the total export—were the developing countries in Africa, Latin America, Asia and the Pacific countries (Pradhan 2004). The fact that these developing countries, where HIV infection has been rampant since the 1990s, were importing generic Indian drugs makes the effect of TRIPs on the Indian patent regime an interesting case, and takes the issue beyond the domestic fore to the international arena. In the current context, since FIGURE 10.2 Pharmaceutical production over the years

Rs in 10 million

20000 16000 12000 8000 4000 0 1948

1982–83 1986–87 1990–91 1994–95 1998–99 Bulk drugs

Formulations

Sources of graphs include Pradhan 2004; Annual reports of the Department of Chemicals and Petrochemicals; Ministry of Chemicals and Fertilizers, Government of India and Handbook of Statistics on Indian Economy—2004, Bombay. 5

192 Adoption of Health Technologies in India FIGURE 10.3 Trade in pharmaceuticals over the years

approximately one-half of the 700,000 people currently receiving HIV treatment in developing countries depend on Indian pharmaceutical manufacturers, the adoption of TRIPs would not only affect the domestic Indian market but also its exports to AIDS-hit developing countries. Recently, amidst various protests, the Indian Parliament passed ‘The Patents (Amendment) Act, 2005 (No. 15 of 2005)’ on 4 April 2005. The preliminary analyses of the new patent Act indicate that the Act does not pose any ‘short-term danger’ to current efforts to expand access to ART (Havlir and Hammer 2005). Drugs discovered before 1995, including generic ARVs, that were being produced and marketed, are protected in the new patent amendments, through a mechanism called ‘automatic licensing’. The generic manufacturers may also continue to export it to various developing countries under the system of compulsory licensing (MSF 2005). However, this good news is restricted to existing drugs only, and the new regulations and its safeguards will not be applicable

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to (a) drugs whose patents were filed between 1995 and 2005 and are in the mailbox; and (b) the newly patented drugs (MSF 2005). For the drugs whose patents have been filed in the mailbox, generic manufacturers can continue producing them without any royalty only till they get formal patent. Thereafter, they can continue only after paying ‘reasonable royalty’ to the patent holder.6 In any case, the unique advantage of India in the ARV drugs market was, and continues to be, an important part of the ART scenario in India.

10.2 Timing of Adoption The access scenario in India was bleak till 2003. It was estimated that out of 750,000 ART eligible individuals, only 13,000 were on ART by the end of 2003. In other words, less than 2 per cent of the ART-eligible individuals were on ART in India. The corresponding global figure was around 8 per cent (Gupta et al. 2003). Till then, ART delivery was mainly through the private sector. ARVs were also being provided in the public sector through various government institutions like the Central Government Health Scheme (CGHS), Employees State Insurance Corporation (ESIC), the Armed Forces Medical Services and the Railways. These arrangements were neither systematic nor were they by design. They were in place mainly as part of a system of employer obligations in the government organisations. With domestic and international pressure to respond to the increasing treatment need, the government, on the eve http://www.aidsmap.com/en/news/B37B595E-09B6-4499-A93E9766C0F21AE8.asp. 6

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of World AIDS Day 2003, announced its programme for free distribution of ARVs in selected states, even though the ability of the health system to handle a complex therapy like ART was uncertain. As announced by the then health minister, the actual plan aimed at providing free antiretroviral treatment to 100,000 people living with HIV/AIDS by the end of 2005, and to provide treatment to an additional 15–20 per cent of AIDS cases each year thereafter, for a period of five years. The latest reports indicate that NACO is aiming to expand the ARV roll out to 100 centres—with at least one site in each state—by the end of the year 2005;7 at the time of writing the book, there were 60 centres in the public sector offering free ART. The programme is discussed in detail below in different sections. From the discussion above, it does seem as though the timing of the public initiative in India was just about right. With increasing numbers needing treatment in the country, Indian pharmaceuticals offering generic cheaper drugs, global pressure and initiatives like ‘3 by 5’, and precedence of free ART in other countries, the timing of adoption of the free programme seemed appropriate. Whether the planning around it was adequate is a question that will be addressed in discussions below.

10.3 Appropriateness and Adaptability The treatment with ARV, while simpler than many health technologies, is also one of the most rigorous ones, since 7 Answer of the minister of state in the Health Ministry to Lok Sabha’s unstarred question no. 454 to be answered on 27 July 2005.

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it entails life-long treatment without interruptions. Thus, while considering appropriateness and adaptability in the context of ART, one has to look both at the technology itself (in this case, drugs given under strict medical supervision) and the other parameters that need to be in place for it to work well. In the context of India, these issues comprise drugs procurement, physician training and health infrastructure. These will be discussed in more detail below; but at this juncture, it is sufficient to say that all these factors were not such as to pose serious concerns around appropriateness and adaptability. It can safely be said that the technology of giving ARV in perpetuity to individuals under strict medical supervision was an objective that India could in principle meet for a successful ART programme.

10.4 Policy Framework of Adoption Approval and Regulation Unlike many other technologies, the approval process in the ART programme was not a long drawn out one. The spate of Parliament questions around treatment especially in 2003–04 indicates that there was an increasing pressure on the government to take a decision on treatment. The possibility of giving ART through the public health system was also under discussion since the WHO announcement of 3 by 5, and the initiatives being taken by other countries like Brazil. Finally, the presence of Indian generic manufacturers added to the wave, and it was in a way inevitable that India joined the list of countries offering free ARV. However, it seemed as though the decision

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was taken very quickly, because subsequent events indicated that no proper financial or management planning was done before launching the programme. Till the announcement of the free programme, ART in India was pretty much left to the private sector as providers and drug manufactures. The free and unregulated provision of ART in the private sector as well as market driven movement of drug prices continued even after the launch, since there was no direct way of bringing the private sector under any regulatory purview. As for other regulations or systems, the patent system impacted directly on the pharmaceutical industry, but the changes in that system were to be brought out more through the WTO mechanisms than through this announcement. On the whole, it can safely be said that the free ART programme was not held back due to any delay in approval/regulatory mechanisms.

Role of Central/State/Local Governments Once the free ART programme was formulated, what were the roles assigned to the various government stakeholders, especially the states? Interestingly, the programme was put in place in government hospitals/medical colleges without much interaction with the state health departments. Since it was being run as a central programme, the state health departments were not actively taken on board for planning purposes, though the funding for the hospitals came from the health departments. Instead, only the State AIDS Control Societies (SACS), which were running the prevention and control programme in the states, were made the focal points of the treatment programme. The national guideline for

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implementation of ART was formulated and distributed across the ARV centres. Attempts were made to strengthen the health system through capacity-building measures for treating physicians. As described in the guideline, each ARV site was to receive (a) contingency grant of Rs 100,000 during the first year of the programme, and Rs 50,000 from the second year onwards; (b) a computer along with internet facility; and (c) funds for human resources.8 WHO has been assisting NACO, in various ways, in the implementation of the free ART initiatives. It is important to mention here that a few state-level free ART initiatives exist as well, some inspired by the national programme, and others in response to a felt need in these states. Kerala SACS started its own state-level free ART plan since December 2004, and now plans to provide treatment to an estimated 8,000–10,000 clients through four district hospitals. Two of these sites are now functioning as NACO-sponsored sites.

Role of Private Sector The free ART announcement did not mention anything about the role of the private sector or how private sector provision of ART was to be affected with the new programme. To that extent, the policy framework was incomplete and missed out on an important feature of the ART system in India—the significant existence of private providers in ART. Since ART was already being given by a large number of private physicians, it was Human Resources refers to two medical officers, one senior and one junior, one data entry operator (DEO), one counsellor, one lab technician and one record-keeper cum computer operator. 8

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important for the government to visualise a role for them, or improve their capacity to give structured ART. However, that has not happened till date in the ART programme planning. As for partnership with the other important private sector component—pharmaceutical companies—the situation was different. As has been discussed before, much of the price cuts offered by the manufacturers were happening due to global market and non-market pressures, and not due to active efforts of the government. The price dynamics of Indian pharmaceuticals is discussed in some detail below. Even when Cipla reduced the global prices of its ARV formulations, the Indian prices were still higher than its global offer (Shreedhar 2002). In the meantime, three more generic manufacturers came into the market that brought about further competition.9 Though the export base of ARVs increased, none of these resulted in drastic reduction of prices in the domestic market. While Indian manufacturers were exporting ARVs to various countries, the prices were still, ironically, high enough to act as a deterrent for improved access within the country. The reasons behind the high domestic prices were excise, sales and municipal taxes, which were adding up to almost 25 per cent of the price of the drug (Brown 2002). This was when the first pro-active policy came from the government. With a view to bring down the cost of treatment, in the 2001–02 Union budget, the government decided to exempt ARVs from central excise duties, which reduced the prices of various combinations from 9 to 25 9 Ranbaxy Pharmaceuticals, Aurobindo laboratories, and Hetero drugs.

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per cent (PIB release 2002). However, prices continued to be high enough due to the lack of bulk purchasing, and due to the non-existence of a government programme on ART (Brown 2002). Recently, after the Clinton Foundation agreement and the announcement of the free ARV initiatives, prices of ARVs have started falling. Since then, the prices have come in the range of affordability for many, and the access through private sector is also increasing. The 2nd round of the GFATM has also funded three Indian NGOs to provide ART on a cost recovery basis. More and more care and support centres are negotiating with pharmaceutical companies for reduced rates and are also trying out innovative financing schemes (Gupta and Trivedi 2004).

Role of NGOs The advocacy efforts of many NGOs working on HIV interventions, including the network of positive people greatly influenced the introduction of free antiretroviral programme of the government. Since the government’s programme is implemented from government hospitals, the NGOs are not really involved in the delivery of services; they, however, play a vital role in demand generation by establishing linkages with the ART clinics. The NGOs also step in whenever there is some issue with continuation of treatment, for instance when drugs are not available at the ART sites. The linkage between testing and treatment is being strengthened by counselling, including counselling for adherence. Additionally, the GFATM, through its second and fourth round of funding, provides treatment and care through partnership with

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selected NGOs. Three implementing NGOs viz. Y.R. Gaitonde Centre for AIDS Research and Education (YRG CARE) Chennai, Freedom Foundation, Bangalore and AIDS Research and Control Centre (ARCON), Mumbai are providing treatment under this programme.

10.5 Supply Issues Procurement and Distribution The GoI initiative is providing the first line regimen including combinations of Stavudine, Lamivudine, Zidovudine, Nevirapine and a small quantity of Efavirenz. In the first phase, WHO was responsible for procuring the medicines on behalf of NACO and supplying to the respective ART centres. From the second phase onwards, NACO—through a public sector firm called Hospital Services Consultancy Corporation Limited (HSCC)—has been procuring drugs from domestic manufacturers at the central level and supplying to these sites. The calculations of requirement of drugs still seem to be a bit fluid and evolving. It was also learnt that the Clinton Foundation is helping NACO in negotiations and also in streamlining the procurement and logistic issues. The visits to selected sites revealed that the supply of drugs from NACO has been more or less satisfactory, except in a few cases where there were complaints of irregular supply.10 Lately, there have been instances of instructions being sent to ‘high turnover’ sites to stop new recruitment and manage the already registered clients so as to streamline the logistic issues and short supply. http://health.groups.yahoo.com/group/AIDS-INDIA/message/ 4527. 10

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In the state-level initiative of Kerala, it was learnt, in meetings with the Kerala SACS officials, that the state government had sanctioned considerable amount of funds for the drugs, and could purchase drugs using the statelevel ‘Central Purchasing Committee’.

Infrastructure In terms of location, these free ART sites are situated in public hospitals, and mostly in the departments of medicine. Separate rooms have been allocated to these centres, though some hospitals may have faced initial problems in being able to make vacant rooms available at short notice, but NACO has provided adequate funds for setting up the clinic, once the rooms were available. The sites have been directed to distribute the ARV drugs from either a separate pharmacy or from the centre itself. Patients are only registered if they have come through any of the NACO VCTCs, which is an important element of the programme, one which tightens the links between the ART centre and the VCTC. The WHO emphasises measurement of CD4 count as a monitoring indicator, but test for viral load has not been mentioned as essential. However, till the programme started, the CD4/CD8 counter facility was available at only 30 apex medical institutions. It was also learnt from the visits to various ART sites that the waiting list for CD4 count is really long and, at certain sites, clients may need to wait more than a month for CD4 testing. The issues around the irregular supply of reagents were also raised at certain sites. Experts are of the opinion that many sites are not clear about the use of the CD4 machines, and are probably not using these optimally.

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This again brings up a training/management issue, which will be discussed below. While so far there have not been any major glitches in the free ART programme, it is not possible to fully understand all the supply side issues in the absence of data from all the centres. The various visits to the centres did indicate that many ad hoc systems have been put in place to temporarily solve a few operational issues, but that does not seem to have hampered the main treatment programme.

Human Resources A significant emphasis was put on strengthening the capacity of the health system to deliver a complex therapy like ART. The ART implementation guideline discusses the training component in great detail. At the central level, a multidisciplinary core national training team was envisaged that included physicians with extensive experience from both public and private sectors. This team was supposed to assist the states in the training of state-level training teams. The state societies were responsible for identifying training hospitals as well as state training teams— which in turn would train the ART teams at the hospital levels. The aim was to also include counsellors and to extend the training up to the level of CHC/PHCs. Based on the various discussions with experts and visits to some of the implementing ART sites, it seemed that the physicians and counsellors were adequately trained. In fact, the authors felt that the level and dedication of the treating physicians were, in many cases, exceptional and the main reason why the ART programme was doing well, despite many implementation bottlenecks.

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10.6 Distribution Issues The initial roll out took place only in six high-prevalence states and in Delhi. However, since then, more states have been added and at the time of writing the book, the 60 centres all over the country have the free ART programme. Understandably, the distributional issues are a bit difficult to analyse without proper criteria. The initial criterion was that it would be rolled out in areas that are currently experiencing, or will experience in the near future, a high demand for ART. Thus, it made sense to roll out the programme in high-prevalence states. But if the criterion is that it should be available to all those who need it, it is clearly not the case. Also, the programme remains more or less urban, with only a few sites now being opened at other areas besides cities—metros or otherwise. However, it is not clear if mass availability can be the criterion in a resource-poor setting and to that extent, the fast pace of roll out and the opening of centres in most of the significantly affected states is certainly a positive step towards a more regionally balanced picture. More on the distributional and access issues will be discussed below under demand side factors. Overall, on the supply side, the evidence seems to suggest that the ART programme has strained an already strained health care delivery system, and many of the health care staff have had to put in extra hours to ensure the smooth running of the programme. Clearly, the rapid scaling up did not allow the states and the sites to gear up in advance for the programme, and with further scaling up and expansion, the strains and stress on the system are likely to show up even more. The authorities will also need to ensure smooth procurement and distribution based on the needs of the

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states, tight monitoring, possibility of expansion of the programme beyond first-line drugs and stricter linkages with prevention activities. The pressure to offer 2nd line drugs through the public programme may mount. The government will need to do proper financial planning based on sound costing and cost-effectiveness analyses before taking a decision. However, in the current scenario of 1st line programme, with sufficient availability of funds, it may not be too difficult to tighten up the supply side loopholes. Whether and how the scenario will change with newer and better drugs and how India will cope with the WTO regulations remains to be seen. However, the experience so far indicates that there may be enough countervailing pressures to prevent a situation where India is unable to access these at reasonable prices, especially as a major player in the global pharmaceutical market.

10.7

Demand Factors

Acceptability/Information and Knowledge The public announcement of the free ART programme was strategically done to garner maximum attention. Also, due to the sensitive nature of the infection/disease, the networks for information dissemination are very effective in India, and the NGO sector—which has been in a productive partnership with the government—has helped greatly to make the programme more accessible to their clients. All this has resulted in a very quick spread of the information on the various dimensions of the programme. Thus, acceptability of the technology has not been an

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issue; rather, there is excess demand for it currently, which seems difficult to meet.

Availability and Accessibility As in the case of supply issues, no firm data is available to correctly assess the picture on uptake and utilisation of ART. Discussion with various stakeholders and visits to ART centres helped, to a certain extent, in the understanding of the demand side issues, and wherever necessary, secondary data was used to add to the analysis. By the end of the first year of roll out, 25 sites across 13 states were providing free ART to more than 7,000 patients. An additional 14 centres have been sanctioned to start ART programme by July 2005. As of July 2005, around 10,255 clients were on treatment through these 25 centres and, additionally, about 9,000 patients are taking ART from other government centres like Defence, Railways, ESIC and so on.11 After the reduction of prices based on the introduction of generic manufacturers, the access to ARVs has been steadily increasing in India, as can be seen from Figure 10.4. Earlier, ART was mainly available in the major cities of a few states. The government programme has boosted the geographical access, by providing drugs across more than 18 states, with a stated objective of reaching every state by the end of 2005. Many sites are reporting individuals coming from distant areas to access ART, even from outside the state. While travel costs and other incidental costs continue probably to be high, at least the option of free ART Answer of the minister of state in the Health ministry to Lok Sabha: Unstarred question no. 454 to be answered on 27 July 2005. 11

Dec-04

Oct-04

Aug-04 Private sector

Apr-05

Feb-05

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Jun-05

Jun-04

Apr-04

Feb-04

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Source: Various country profile report for India, World Health Organization.

0

5000

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FIGURE 10.4 Patients on ART in India over time

Dec-05

Oct-05 Aug-05

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is certainly a great improvement to the earlier situation. There are also reports from many private clinics and NGOs that clients are now switching over to the public distribution system, and many care organisations are actually encouraging their clients to avail of the free facilities.

Affordability The free programme has cut down costs of treatment drastically and made ARVs accessible to a great extent. Despite other costs like of tests and travel, the programme has changed the scenario on care of HIV/AIDS patients in India significantly. However, a worrying trend is the increasing number of cases of treatment failure, which necessitates in most cases a switch to the 2nd line drugs. The free ART programme of the government covers only 1st line drugs, and 2nd line drugs continue to be prohibitively expensive. Many of those who are currently accessing the free ART would sooner or later require 2nd line drugs as well, and it is not clear how the situation will develop, if there is no public policy on the 2nd line. If prices of 2nd line ARV come down further, it would also be more accessible outof-pocket. The key to affordable prices lie with the WTO conditions and how these are interpreted, because it is clear that new drugs may remain expensive in India, due to the patents that come into force after 1995. The Clinton Foundation is said to have reached an agreement with pharmaceutical companies that will allow the sale of antiretroviral drugs Efavirenz and Abacavir, as well as HIV tests, at a lower cost in developing countries.12 12 http://www.medicalnewstoday.com/medicalnews.php?newsid= 36094

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In case the government goes in for the 2nd line programme as well, such arrangements would certainly be helpful. For this, the government will need to partner with organisations like this for more financially feasible options. Before summing up the demand and supply issues, a word about overall quality is useful. In terms of quality, a rapid scaling up of a programme such as this always has the danger of slipping on the quality criterion. It does seem as though the programme is being sustained by a handful of extremely committed physicians who are able to ensure a fairly rigorous standard of treatment. NACO reports a satisfactory adherence rate13 of 96.1 per cent among those who have been placed on treatment in the Phase I sites at the end of first year,14 and only a small percentage of individuals are lost to follow up. This can partly be attributed to the strong linkages among and partnership with NGOs, network of positive people and various health providers at the ARV centres. But the quality of treatment can only be really understood with the passage of time, and through analyzing parameters like adherence, side effects, treatment failure, opportunistic illnesses and so on. NACO does collect some standard data on adherence and other parameters mainly from a programmatic perspective, but data on a more exhaustive list of parameters It was learnt from a meeting with an expert that while calculating adherence rate for NACO’s programme, the ‘Missed’ (Not showing up at the centre for three or less months) and ‘Lost to follow up’ (Not showing up at the centre for more than three months after starting the treatment) cases were excluded, and ‘pill count’ was used as a tool to measure the adherence. Thus, it can be safely said that the adherence rate here is ‘adherence to the programme’ rather than ‘adherence to treatment’. 14 www.nacoonline.org 13

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need to be collected to understand all the ‘long-term’ ramifications of the programme. A much more rigorous monitoring and evaluation system needs to be put in place that can yield valuable information on the extent of ‘structured’ ART in India and its effects on individuals who are accessing it. Till such time that data from all the centres on these parameters are available, it will be difficult to comment on the quality of the free programme. Finally, a word about the financial implications of the programme. The government has a grant of around US$ 122 million from the fourth round of GFATM, which aims to provide ART to 180,000 patients through 188 centres in 6 high prevalence states and in Delhi in a phased manner over a period of five years starting from August 2005. This support would help free up domestic funds for scaling up in the low/moderate prevalence states. It is not clear from the published information what exactly it is costing the NACO to run the free ART programme. However, the total costs of the programme are higher than what it might seem, since the costs incurred by the sites are not being taken into account. An initiative of the Institute of Economic Growth along the World Bank is now near completion, which would make it possible to understand the various sources of costs for the programme in the country and to, therefore, analyze issues of sustainability.

10.8 Overview and Lessons from ART An analysis of the free ART initiative of the government offers a unique opportunity to understand the issues and concerns of a rapidly scaled-up extensive programme. The sudden decision to launch this programme meant that

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systems had not been put in place prior to adoption. Also, adequate state-level planning did not take place, and the programme was put in place hastily with somewhat of a top-down approach, which meant that the brunt of management and programme issues had to be borne by the sites. This continues to be the case, with visible dissatisfaction among much of the staff at the sites. A more inclusive approach, with all the stakeholders being clear about their roles, would have helped the programme to a great extent. This programme also offers a lesson on the potential of a learn-and-correct approach, which can only be adopted when a strong Management Information System (MIS) with monitoring and evaluation is put in place, the omission of which makes the programme a bit dilute. At a more macro level, there has not been much discussion about the cost of the programme and the feasibility of it in the long run. A more scientific financial sustainability planning exercise would help the programme greatly, and also allay public fears about its feasibility. On the positive side, the links between VCTC and ART and the success of the programme for those who need ART indicate that it is possible to offer a safe technology to individuals, and combine a prevention and treatment programme that can bring together the different services being offered. The one-stop shop, discussed in the VCT chapter, visualises a programme that will offer (a) counselling and testing to all; (b) treatment to those who found positive; and (c) vaccines to those who are found to be negative. Overall, despite initial misgivings, the free ART programme seems to have helped many individuals to live a better and longer life. However, the supply side issues are critical and need more attention, especially around smooth supply of drugs, dosage/formulation, proper training, and

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maintenance of CD4 machines. If mid-course corrections can take place, the ART programme can easily qualify as one of the more successful adoptions in the recent history of the country. Finally, effective programme management and adoption of technology critically depends on proper data management and use. Unlike Brazil, which started the first free ART programme, data management is one possible area that can be substantially improved in India. Although the implementation guideline mentions the need for an MIS, it was learnt during the course of the research that data management—over and above the monthly reports that are being sent to NACO—is very poor across the sites. The free ART programme offered a unique opportunity to gather evidence on the clinical, epidemiological, economic and managerial parameters of a health technology like ARV, which could have served as a model for other such future technologies.

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Saha, M.K., S. Chakrabarti, S. Panda, T.N. Naik, B. Manna, A. Chatterjee, R. Detels and S.K. Bhattacharya. 2000. ‘Prevalence of HCV and HBV Infection amongst HIV Seropositive Intravenous Drug Users & their Non-injecting Wives in Manipur, India’, Indian Journal Medical Research, 111: 37–39. Sarkar, K., D.N. Ganguly, B. Bal, M.K. Saha, M.K. Bhattacharya and S.K. Bhattacharya. 2004. ‘Hepatitis B infection, Eastern India’, Letter to the Editor, Emerging Infectious Disease, 10(7), http:// www.cdc.gov/ncidod/EID/vol10no7/03-0766.htm Seshadri, R.S., P. Subramaniyam and P. Jha. 2003. ‘The Potential Demand for and Strategic Use of an HIV-1 Vaccine in Southern India’, World Bank Policy Research Working Paper 3066, Washington DC: The World Bank. Shani, S., I.M. Siebzhner, O. Luxenburg and J. Shemer. 2000. ‘Setting Priorities for the Adoption of Health Technologies on a National Level: the Israeli Experience’, Health Policy, 54: 169–85. Sharma, R.S., M. Rajalakshmi, R.S. Sharma and D.A. Jeyaraj. 2001. ‘Current Status on Fertility Control Methods in India’, Journal of Bioscience, 26(4): 391–405. Stover, J., G. Garnett, S. Seitz and S. Forsythe. 2002. ‘The Epidemiological Impact of an HIV/AIDS Vaccine in Developing Countries’, World Bank Policy Research Working Paper 2811, Washington DC: The World Bank. Tandon, B.N., M. Irshad, M. Raja, G.P. Mathur and M.N. Rao. 1991. ‘Prevalence of HBsAg and Anti HBs in Children and Strategy Suggested for Immunization in India’, Indian Journal Medical Research, 93: 337–39. Tandon, N. 1991. ‘Hepatitis B Vaccination and India’, Indian Journal of Medical Research, 4: 103–104. Thyagarajan, S.P., S. Jayaram and B. Mohanavalli. 1996. ‘Prevalence of HBV in the General Population in India’, in S.K. Sarin and A.K. Singhal (eds), Hepatitis B in India: Problems and Prevention, New Delhi: CBS Publishers. Tran Tien Duc. 1999. ‘Vietnam: Achievements and Challenges’, Integration, 62: 4–7. World Health Assembly. 1992. Resolution WHA 45.17, Immunization and Vaccine Quality, Geneva: World Health Assembly. World Health Organization, Regional Office for Southeast Asia, New Delhi. 2002. ‘Prevention of Hepatitis B in India: An Overview’, WHO document no. SEA-Hepat.-5/SEA-EPI-141.

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Selected References for Immunisation Bhatia, V., H.M. Swami, S.R. Rai, S. Gulati, A. Verma, A. Parashar and R. Kumari. 2004. ‘Immunization Status in Children’, Indian Journal of Pediatrics, 71(4): 313–15. Browne, E.N.L., A.A. Bonney, F.A. Agyapong and I.T. Essegbey. 2002. ‘Factors Influencing Participation in National Immunization Days in Kumasi, Ghana’, Annals of Tropical Medicine and Parasitology, 96(1): 93–104. Dalal, A. and M.P. Silveira. 2005. ‘Immunization Status of Children in Goa’, Indian Pediatrics, 42(4): 401–402. Das, R.K. and P. Dasgupta. 2001. ‘Child Health and Immunization: A Macro Perspective’, Economic and Political Weekly, 35(8 & 9): 19–26. Harmanci, H., Y. Gurbuz, S.D. Torun, N. Tumerdem, T. Erturk. 2003. ‘Reasons for non-Vaccination during National Immunization Days: A Case Study in Istanbul, Turkey’, Public Health, 117(1): 54–61. Iyer, Aditi and Amar Jesani. 1991. ‘Barriers to the Quality of Care: The Experience of Auxiliary Nurse-Midwives in Rural Maharashtra’, in A. Koenig, Michael and M.E. Khan (eds), Improving Quality of Care in India’s Family Welfare Programme: The Challenge Ahead, New York: Population Council. Lawate, D.W.W. 2004. ‘An Overview of Polio Vaccination in India’, Express Magazine, 16–31 October. Lodha, R., Y. Jain, K. Anand, S.K. Kabra and C.S. Pandav. 2001. ‘Hepatitis B in India: A Review of Disease Epidemiology’, Indian Pediatrics, 38(4): 349–71. Macintyre, C. 2001. ‘Hepatitis B: Risks and Benefits of Universal Neonatal Vaccination’, Journal of Pediatrics and Child Health, 37(3): 215–17. Manjunath, U. and R. Pareek. 2003. ‘Maternal Knowledge and Perceptions about the Routine Immunization Programme: A Study in a Semiurban Area in Rajasthan’, Indian Journal of Medical Sciences, 57(4): 58–63. Mohan, P., S.D. Iyengar, S. Brahmawar and K. Sen 2003. ‘Auxiliary Nurse Midwife: What Determines Her Place of Residence’, Journal of Health and Population in Developing Countries. Available at http://www.jhpdc.unc.edu/2003 papers/midmoh.pdf. MOHFW. 2002. Ministry of Health and Family Welfare Year Book 2001– 02. New Delhi: Government of India.

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Selected References for Hep B Addlakha, R. and A. Grover. 2000. ‘User Configuration and Perspective Hepatitis B Introductory Trial in East Delhi’, Economic and Political Weekly, 35(8 & 9): 736–44.

216 Adoption of Health Technologies in India Aggarwal, R. 2002. ‘Inclusion of Hepatitis B Vaccine in National Immunization Program in India: A Review of Economic Analyses. Report Undertaken for the WHO Regional Office for South East Asia’, New Delhi. Aggarwal R. and U.C. Ghoshal. 2004. ‘Hepatitis B Vaccination Policy for India: Is Selective Vaccination an Option?’, Indian Journal of Gastroenterology, 23: 2–4. Aggarwal R., U.C. Ghoshal and S.R. Naik. 2003. Assessment of costeffectiveness of Universal Hepatitis B Immunization in a LowIncome Country with Intermediate Endemicity using a Markov Model’, Journal of Hepatololgy, 38(2): 215–22. Aggarwal, R. and S.R. Naik. 1994. ‘Prevention of Hepatitis B Infection: The Appropriate Strategy for India’, National Medical Journal of India, 7(5): 216–20. Association for Voluntary Surgical Contraception (AVSC). 1993. ‘Summary of AVSC Supported Evaluation and Research Studies, 1988– 1993’, Internal Memorandum. Banatvala, P. Van Damme and N. Emiroglu. 2006. ‘Hepatitis B Immunization in Britain: Time to Change?’, British Medical Journal, 332 (7545): 804–805. Beutels, P. 2001. ‘Economic Evaluations of Hepatitis B Immunization: A Global Review of Recent Studies (1994–2000)’, Health Economics, 10(8): 751–74. Dasgupta, R. and R. Priya 2002. ‘The Sustainability of Hepatitis B Immunization within the Universal Immunization Programme in India’, Health Policy and Planning, 17(1): 99–105. Department of Family Welfare, New Delhi: WHO SEARO,WHO India, UNICEF and PATH. 2004. Rapid Assessment of Hepatitis B Vaccine Introduction in India, 1–6 August 2004. Edmunds, W., A. Dejene, Y. Mekonnen, M. Haile, W. Alemnu and D. Nokes. 2000. ‘The Cost of Integrating Hepatitis B Virus Vaccine into the National Immunization Programmes: A Case Study From Addis Ababa’, Health Policy and Planning, 15(4): 408–16. Edstam, J.S., N. Dulmaa, P. Nymadawa, A. Rinchin, J. Khulan and A.M. Kimball. 2002. ‘Comparison of Hepatitis B Vaccine Coverage and Effectiveness among Urban and Rural Mongolian 2-yearOlds’, Preventive Medicine, 34(2): 207–14. Griffiths U., K. Guy Hutlon and Eva Das Dores Pascoal. 2005. ‘The Cost-effectiveness of Introducing Hepatitis B Vaccine into Infant

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Immunization Services in Mozambique’, Health Policy and Planning, 20(1): 50–59. Lodha, R., Y. Jain, K. Anand, S.K. Kabra and C.S. Pandav. 2001. ‘Hepatitis B in India: A Review of Disease Epidemiology’, Indian Pediatrics, 38(4): 349–71. Macintyre, C. 2001. ‘Hepatitis B: Risks and Benefits of Universal Neonatal Vaccination’, Journal of Pediatrics and Child Health, 37(3): 215–17. Mathew, V., R. Abraham Jacob, James Jyotsna and M. Puliyel Jacob. 2004. ‘Determining the Point of Indifference: Where Costs of Selective and Universal Immunization against Hepatitis B are Identical, in a Cost-minimization Exercise’, Indian Journal of Gastroenterology, 23, 154–56. Mittal, S.K. 2003. ‘Hepatitis B Vaccination: Myths and Controversies’, Indian Journal of Pediatrics, 70(6): 499–502. MOHFW. 2006. Annual Report, Ministry of Health and Family Welfare, Government of India. ————. 2005. Multiyear Planning for Universal Immunization in India, 2005–2010, Government of India. Namgyal, Pem. 2003. ‘Impact of Hepatitis B Immunisation, Europe and Worldwide’, Journal of Hepatology, 39: S77–S82. ————. 2005. ‘Expansion of Hepatitis B (HepB) Vaccination in India: Options and Issues’, Discussion Paper, WHO. Phadke, A. and A. Kale. 2000. ‘Epidemiology and Ethics in the Hepatitis B Vaccine’, Indian Journal of Medical Ethics, 8(1): accessed at http://www.ijme.in/081mi008.html. Prakash, C. 1999a. ‘Universal Hepatitis B Immunization in India; Cost Effective Analysis’, Takemi Research Paper 147, Harvard School of Public Health. ————. 1999b. ‘Crucial Factors that Influence Cost Effectiveness of Universal Immunization in India’, Takemi Research Paper 152, Harvard School of Public Health. Puliyel, J.M., R. Mittal, V. Tyagi and S. Gupta. 2003. ‘Routine Hepatitis B Immunization in India: Cost Effectiveness Needs Reassessment’, Indian Journal of Pediatrics, 70(2): 188. Reichler, M.R., Ahmed Darwish, George Stroh, John Stevenson, Mahmoud Abu Al Nasr, Said Ali Oun and M.H. Wahdan. 1998. ‘Cluster Survey Evaluation of Coverage and Risk Factors for Failure to be Immunized during the 1995 National Immunization

218 Adoption of Health Technologies in India Days in Egypt’, International Journal of Epidemiology, 27(10): 83–89. Sahni, M., K. Jindal, N. Abraham, K. Aruldas and J. Puliyel. 2004. ‘Hepatitis B Immunization: Cost Calculation in a Communitybased Study in India’, Indian Journal of Gastroentrology, 23(1): 16–18. Schoub, B.D., U. Matai, B. Singh, N.K. Blackburn and J.B. Zevin. 2002. ‘Universal Immunization of Infants with Low Doses of a Low-Cost Plasma-derived Hepatitis B Vaccine in South Africa’, Bulletin of the World Health Organization, 80(4): 277–81. Singh, P. and R.J. Yadav. 2000. ‘Immunisation Status of Children of India’, Indian Journal of Paediatrics, 37(11): 1194–99. ————. 2001. ‘Immunisation Status of Children in BIMARU States’, Indian Journal of Paediatrics, 68(6): 495–500. Van Damme, Pierre and Alex Vorsters. 2002. ‘Hepatitis B Control in Europe by Universal Vaccination Programmes: The Situation in 2001’, Journal of Medical Virology, 67(3): 433–39. World Health Assembly. 1992. ‘Immunisation and Vaccine Quality’, Resolution WHA 45.17, Geneva. WHO. 2002. Prevention of Hepatitis B in India, An Overview. Regional Office for South Asia, New Delhi: World Health organization. ————. 2003. ‘Treating 3 Million by 2005: Making it Happen: The WHO Strategy.’

Selected References for NSV Altice F.L. and G.H. Friedland. 1998. The Era of Adherence to HIV Therapy. Annals of Internal Medicine, 129: 503–505. Antarsh, L. and S. Marston-Ainley. 1993. ‘The Introduction of NoScalpel Vasectomy in the United States (1988–1992),’ AVSC Working paper, 3, accessed at http://www.engenderhealth.org// pubs/workpap/wp3/wp_3.html. Basu, A.M. 1985. ‘Family Planning and the Emergency: An Unanticipated Consequence,’ Economic and Political Weekly, 20(10): 422–25. Cohen, S.L. 1996. Vasectomy and National Family Planning Programs in Asia and Latin America. Carolina Paper Series in International Health, Centre for Global Initiatives, North Carolina: University of North Carolina.

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Das, H.C. and J. Bhattacharjee. 1993. ‘No-Scalpel Vasectomy: Hope for the Future’, Journal of Family Welfare, 39: 14–16. Gayatri, Geetanjali. 2006. ‘Jalandhar, Amritsar Ahead in No-Scapel Vasectomy’, The Tribune, February 21, Chandigarh, India. Gwatkin, Davidson. 1979. ‘Political Will and Family Planning: The Implication of India’s Emergency Experience,’ Population and Development Review, 5(1): 29–59. Haws, J.M., Maureen McKenzie, Manisha Mehta, and Amy E. Pollock. 1997. ‘Increasing the Availability of Vasectomy in Public Sector Clinics’, Family Planning Perspectives, 29(4): 186–90. Haws J.M. and Vanessa Cullins. 1999. ‘No-Scalpel Vasectomy in the United States’, IPPF Medical Bulletin, 33(1): 2. Jezowski, T.W., F. Alarcon, C. Juárez, A. Estrada, F. Gomez. 1995. A Successful National Program for Expanding Vasectomy Services: The Experience of the Instituto Mexicano del Seguro Social, AVSC Working Paper No. 8, AVSC International, New York. Kumar, Navtan. 2006. ‘Cash Sop for Family Planning—No-Scapel Vasectomy, The Telegraph, February 16, Calcutta, India. Kumar, V., R.C.M. Kaza, I. Singh, S. Singhal and V. Kumaran. 1999. An Evaluation of the No-Scalpel Vasectomy Technique, British Journal of Urology, 83(3): 283–84. Lakshmi, R. and S. Barges. 1999. ‘Quality of Services at Laproscopic Camp in Madhya Pradesh’, Chapter 13, in Michael A. Koenig and M.E. Khan (eds), Improving Quality of Care in India’s Family Welfare Programme: The Challenge Ahead, New York: Population Council. Landry, E. and V. Ward. 1997. ‘Perspectives from Couples on the Vasectomy Decision: A Six-Country Study’. Reproductive Health Matters, Special Issue: 58–67. Lok Sabha. 2003. ‘Health and Family Welfare Programmes for Women— Action Taken on Fourth Report of Committee on Empowerment of Women’, Thirteenth Report, New Delhi: Lok Sabha Secretariat. Lynam, P., J. Dwyer, D. Wilkinson and E. Landry. 1993. ‘Vasectomy in Kenya: The First Steps’, AVSC Working Paper, 4. New York: AVSC. Maharatna, A. 2002. ‘India’s Family Planning Programme: An Unpleasant Essay’, Economic and Political Weekly, 37(10): 971–81. Martinez-Manautou, J., D. Hernandez, F. Alarcon and S. Correu. 1991. ‘Introduction of Non-Scalpel Vasectomy at the Mexican Social Security Institute Advances in Contraception’, 7(2–3): 193–201.

220 Adoption of Health Technologies in India Mavalankar, D.V., B. Sharma. 1999. ‘The Quality of Care in Sterilization Camps: Evidence from Gujarat’, Chapter 14, in Michael A. Koenig and M.E. Khan (eds), Improving Quality of Care in India’s Family Welfare Programme: The Challenge Ahead, New York: Population Council. Ministry of Health and Family Welfare (MOHFW). 1995. Annual Report, Government of India. ————. 1996. Annual Report, Government of India. ————. 1997. Annual Report, Government of India. ————. 2001. Ministry of Health and Family Welfare Annual Report. Government of India. ————. 2004. Annual Report, Government of India. ————. 2006. Annual Report, Government of India. Murthy, R.S. and Dharma Rao. 2002. ‘An Analysis of Factors Influencing the Acceptability of Vasectomy in Andhra Pradesh’, Health and Population—Perspectives and Issues, 26(4): 162–82. ————. 2003. ‘An Analysis of Factors Influencing the Acceptability of Vasectomy in Andhra Pradesh’, Health and Population—Perspectives and Issues, 26(4): 162–82. NIPORT and Population Council. 1998. Getting Men Involved in Family Planning; Experiences from an Innovative Programme, Final Report. Directorate of Family Planning and Population Council, Bangladesh. Nirapathpongporn, A. and C. Santati. 1989. ‘The Introduction and Use of Non-Scalpel Vasectomy in Thailand’, Presented at the International Symposium on the No-Scalpel Vasectomy Technique, Bangkok, Thailand, 4–6 December. Olaran, K. 1991. ‘Promotion of Vasectomy in Thailand’, Journal of the Medical Association of Thailand, 74(11): 518–21. Ozvaris, S.B., B.G. Dogan and A. Akin. 1998. ‘Male Involvement in Family Planning in Turkey’, World Health Forum, 19(1): 76–78. Pai Panandiker, V.A., A.K. Mehra and P.N. Chaudhuri. 1987. Peoples Participation in Family Planning, New Delhi: Uppal Publishing House. Penteado, L.G., Francisco Cabral, Margarita Díaz, Juan Díaz, Laura Ghiron and Ruth Simmons. 2001. ‘Organizing a Public-Sector Vasectomy Program in Brazil’, Studies in Family Planning, 32(4): 315–28. Pile, J.M., C. Bumin, A. Ciloglu and A. Akin. 1999. ‘Involving Men as Partners in Reproductive Health: Lessons Learned from Turkey’, AVSC Working Paper 12. New York: AVSC.

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222 Adoption of Health Technologies in India Vicziany, Marika. 1982. ‘Coercion in a Soft State: The Family Planning Programme of India: Part II: The Sources of Coercion,’ Pacific Affairs, 55(3): 557–92. Zhang, J. 1994. ‘A Good Example. Sichuan Province’, Integration, 39: 19. ————. 2004. ‘Does the Family Planning Program Affect Fertility Preferences? The Case of China’, Paper Prepared for the 12th Biennial Conference of the Australian Population Association, 15–17 September 2004, Canberra.

Selected Reference for VCT Bentley, M.E., Mary E. Shepherd, Raman R. Gangakhedkar, S. Thilikavathi, Robert C. Bollinger and Sanjay M. Mehendale. 1998. ‘HIV testing and counseling among men attending sexually transmitted disease clinics in Pune, India’, AIDS. 12(14): 1869– 77. Branson B. 2000a. ‘Rapid Tests for HIV Antibody’, AIDS Reviews. 2: 76–83. ————. 2000b. ‘Assessing Diagnostic Technologies Marketed to Less Industrialized Countries’, Journal of International Physicians in AIDS Care, 6(2): 56–58. ————. 2003. ‘Point-of-Care Rapid Tests for HIV Antibodies’, Journal of Laboratory Medicine, 27(7/8): 288–95. Comptroller and Auditor General of India. 2004. ‘Union Government (Civil) Performance Appraisal of National AIDS Control Programme’, Report on the Union Government for the Year Ended March 2003. Campbell C.H., M.E. Marum, M. Alwano-Edyegu, B.A. Dillon, M. Moore and E. Gumisiriza. 1997. ‘The Role of HIV Counseling and Testing in the Developing World’, AIDS Education and Prevention, 9 (Suppl B): 92–104. CDC. 1985a. ‘Provisional Public Health Service Inter-Agency Recommendations for Screening Donated Blood and Plasma for Antibody to the Virus Causing Acquired Immunodeficiency Syndrome’, Morbidity and Mortality Weekly Report, 34(1): 1–5. ————. 1985b. ‘Epidemiological Notes and Reports Testing Donors of Organs, Tissues, and Semen for Antibody to Human

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224 Adoption of Health Technologies in India Malone, J.D., E.S. Smith, J. Sheffield, D. Bigelow, K.C. Hyams, S.G. Beardsley, R.S. Lewis and C.R. Roberts. 1993. ‘Comparative Evaluation of Six Rapid Serological Tests for HIV-1 Antibody’. Journal of Acquired Immune Deficiency Syndromes, 6(2): 115–19. McKenna, S.L., G.K. Muyinda, D. Roth, M. Mwali, N. Ng'andu, A. Myrick, C. Luo, F.H. Priddy, V.M. Hall, A.A. von Lieven, J.R. Sabatino, K. Mark and S.A. Allen. 1997. ‘Rapid HIV Testing and Counseling for Voluntary Testing Centers in Africa’. AIDS, 11(suppl l): S103–S110. National AIDS Control Organisation. 2004. Voluntary Counseling and Testing-Operational Guidelines. Padmavati, A. 1991. ‘A Critical Analysis of the Law on AIDS in India’, Newsletter—Women’s Global Network on Reproductive Rights, 36: 61. Saxinger, C. and R.C. Gallo. 1983. ‘Application of the Indirect Enzyme-linked Immunosorbent Assay Microtest to the Detection and Surveillance of Human T Cell Leukemia-Lymphoma Virus’, Laboratory Investment, 49(3): 371–77. Sheikh, K., S. Rangan, S. Kielmann, S. Deshpande, V. Datye and J. Porter. 2005. ‘Private Providers and HIV Testing in Pune, India: Challenges and Opportunities’, AIDS Care, 17(6): 757–66. Solomon S. and A.K. Ganesh. 2002. ‘HIV in India’, Topics in HIV Medicine, 10(3): 19–24. Tao, G., B.M. Branson, William J. Kassler and Robin A. Cohen. 1999. ‘Rates of Receiving HIV Test Results: Data From the U.S. National Health Interview Survey for 1994 and 1995’, Journal of Acquired Immune Deficiency Syndrome, 22(4): 395. UNAIDS. 1999. ‘Knowledge is Power: Voluntary HIV Counselling and Testing in Uganda’, UNAIDS Case Study, Geneva UNAIDS. Van Kerchoven I, F. Vercauteren, P. Piot and G.V.D. Groen. 1991. ‘Comparative Evaluation of 36 Commercial Assays for Detecting Antibodies to HIV’, Bulletin of World Health Organisation, 69(6): 753–60. Vollmer, N. and J. Valadez. 1999. ‘A Psychological Epidemiology of People Seeking HIV/AIDS Counselling in Kenya: An Approach for Improving Counselling Training’, AIDS, 13(2): 1557–67. WHO. 1985. ‘Weekly Epidemiological Record 1985’, 60: 129–39. WHO/UNAIDS. 1997. ‘Revised Recommendations for the Selection and Use of HIV Antibody Tests’, Weekly Epidemiological Record, 72(12): 81–88.

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Selected Reference for ART Brown, D. 2002. ‘Survey Finds China’s AIDS Awareness is Lacking, Medicine Scarce in India, Conference is also Told’, Washington Post, 9 July 2002, http://www.thebody.com/cdc/news_updates_ archive/july11_02/china_aids.html. Carpenter, C.C., M.A. Sande, C.G. Cobbs, K.K. Holmes and J.P. Sandford. 1993. ‘Antiretroviral Therapy for Adult HIV-infected Patients: Recommendations from a State-of-the-art Conference’, National Institute of Allergy and Infectious Diseases, JAMA, 270 (21): 2583–89. Carpenter C.C.J., M.A. Fischl and S.M. Hammer for the International AIDS Society, USA. 1996, ‘Antiretroviral Therapy for HIV Infection in 1996: Recommendations of an International Panel’, JAMA, 276: 146–54. ————. 1996, ‘Consensus Statement: Antiretroviral Therapy for HIV Infection in 1996: Recommendations of an International Panel’. JAMA, 276: 146–54. ————. 1998. ‘Antiretroviral Therapy for HIV Infection in 1998: Undated Recommendation of the International AIDS Society— USA Panel’. JAMA, 280: 78–86.

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Index

ARCON (Aids Research and Control Centre), 200 accessibility, 17, 23, 30, 35, 44, 58, 71, 89, 91, 92, 109, 148, 174, 205 Addai, I., 27 Addis Ababa, 40 advocacy, 26, 109, 147, 199 Aggarwal, R., 100 Africa, 11, 16, 21, 40, 42, 44, 115, 152, 185, 186, 188, 191 Alfred P. Sloan Foundation, 15 Altice, Fred, 45 America, 44, 152 Amritsar, 143 Andhra Pradesh, 21, 25, 56, 88, 96, 102, 103, 108, 125, 130, 140, 142–44, 148, 169 Antarsh, L., 42, 115 Antenatal Clinic (ANC), 21, 157, 175 antibodies, 43, 151–52 Antiretroviral therapy (ART), 22, 28, 44–48, 50–59, 64–66, 70–71, 153, 181, 182–211

appropriate technology, 17, 30, 31, 44, 50, 52, 64, 96, 122, 194 Arunachal Pradesh, 87, 88, 142, 170, 178 Asia, 11, 42, 115, 185, 191 Auxiliary Nurse Midwife (ANM), 56, 80–81, 85, 86, 107 availability, 17, 23, 26, 30, 31, 33, 35, 63, 68, 71, 89, 91, 101, 109, 117, 119, 120, 131, 148, 152, 153, 166, 174, 181, 184, 203–5 Basque countries, 15 BCG, 37, 80 Becton, Dickinson & Co., 15 Barge, 129 Bhatia, V., 91 bloodbank, 43, 152 Bihar, 84, 87, 88, 89, 90, 128, 142, 170 Bill and Melinda Gates Foundation, 15, 96, 104, 186 Bimaru states, 87–88 Bokaro, 143

230 Adoption of Health Technologies in India bottleneck, 55, 56 Botswana, 186 Broadway Cares, 15 Brazil, 188 Brown, D., 198, 199 Browne, E.N.L., 90 CII (Confederation of Indian Industry), 127 Carpenter, C.C.J., 183 Caribbean countries, 188 Central Research Institute, Kasauli, 82 centre-state coordination, 53 Centre for Disease Control, 43 challenges, 24, 30, 48 Chandigarh, 91, 170 Chennai, 84, 96, 200 Child Survival and Safe Motherhood Programme (CSSM), 38, 78 children, 25, 27, 38, 41, 47, 77–81, 85, 86, 90, 91, 92, 99, 117 China, 41, 114, 145 Cipla, 46, 187, 188, 198 civil society, 30, 33, 54 Clinton Foundation, 188 community-based organizations, 33 condom, 27, 161 contraceptive, 42, 115, 121, 123, 126, 150, 155 cost, 26, 27, 39, 40, 41, 43, 67, 81, 95, 98, 100, 104, 105 counselling, 28, 43–44, 50, 51, 60, 70, 72, 144, 155–81, 199, 210

Crusaid, 15 Cullins, Vanessa, 42, 115 DWCRA, 146 Dalal, A., 90 Das, R.K., 90, 120, 122 Dasgupta, P., 86, 90, 99, 100 Data, 22, 27, 29, 36, 41, 197, 202, 205, 208, 209, 211 Delhi, 14, 88, 95, 96, 102, 108, 109, 120, 123, 140, 141, 142, 148, 161, 203, 209 Diphtheria, 37, 78 distribution, 18, 30, 33, 34, 35, 55, 56, 61, 66, 67, 71, 72, 200, 203, 207 delivery channels, 25 developing countries, 12, 23, 26, 40, 46, 50, 122, 184, 185, 186, 191, 192, 207 Didanosine, 182–83 Dwivedi, S.N., 27 education, 27, 57, 143 Efavirenz, 200, 207 ELISA, 43, 151, 152, 159, 162, 175 Emergency, 118–34 Engender Health, 42, 114, 127 epidemic, 21, 22, 186 Ernakulam, 117–18, 144, 146 Escorts, 127 ethnicity, 27 etiological, 43, 151 evaluation, 12, 26, 80, 87, 105, 106, 109, 111, 130, 150, 209, 210 Edstam, J., 39 equipment, 24, 84

Index evaluation, 12, 26, 80, 87, 105, 106, 109, 111, 130, 150, 209, 210 FICCI, 127 FPAI, 127, 128 family planning, 26, 41, 42, 50, 57, 114–50 family welfare, 29, 42, 80, 87, 107, 109, 116–50, 155, 163 Freedom Foundation, Bangalore, 156, 200 Friedland, G.H., 45, 184 funding, 26, 97, 102, 127, 196, 199 GAVI, 96, 97, 102, 104, 105, 108 Ganesh, A.K., 160, 170 Gayatri, Geetanjali, 143 gender, 16, 22, 145 generic, 46, 50, 187–205 Geneva, 46, 185 Ghana, 27 Ghoshal, U.C., 100 Goa, 21, 87, 88, 89, 154 Gulick, R.M., 184 Gujarat, 88, 140, 142, 146, 167, 170 Gupta, I. 193, 199 Gwatkin, D., 119 Haas Charitable Trusts, 15 Hammer, S.M., 183, 192 Haryana, 84, 87, 88, 96, 170 Havlir, D.V., 192 Haws, J.M., 42, 115 Health Policy Research Unit, 11 health sector, 11, 70

231

Hepatitis B, 17, 26, 28, 37–39, 60–62, 70, 94–111 Himachal Pradesh, 88, 108, 170, 178 HIV, 21–25, 43–46, 50, 53, 54, 65, 67, 68, 72, 151–207 Hubli, 143 human resources, 30, 33, 44, 107, 129, 166, 181, 197, 202 human rights, 24, 147 immunisation, 24, 28, 37–41, 70, 77–93, 94–112, 146 (see also Universal Immunisation Programme) Indian Council for Medical Research (ICMR), 16, 23, 87–89, 154 infection(s), 21, 22, 25, 39, 45, 94, 98, 99, 154, 155, 182, 191, 204 infertility, 41, 113 Information, Education and Communication (IEC), 27, 35, 54, 57, 60, 67, 68, 72, 90, 91, 110, 120, 145–47, 160 infrastructure, 25, 30, 31, 33, 34, 43, 52, 55, 61, 66, 69, 71, 163, 166, 189, 195, 201 Institute of Economic Growth, 11, 13, 209 International Aids Vaccine Initiative (IAVI), 14–16, 23 Intra Uterine Devices (IUD), 117, 120, 121, 131–37 Ireland, 15

232 Adoption of Health Technologies in India Islamic, 26 Iyer, Aditi, 86 Janani, 128 Jesani, 86 Jharkhand, 89, 143, 170 John D. Evans Foundation, 15 Kale, Ashok, 97 Karnal, 84 Karnataka, 21, 25, 88, 143, 156 Karim Nagar, 143–48 Kassler, W.J., 44, 152 Katzenstein, A., 186 Kerala, 88, 96, 108, 142, 170, 197, 201 Kerckhoven, Van, 44, 152 Khan, L.A., 26 Khandwa, 143 Kolkata, 84, 96 Kumar, N., 143 Larsen & Toubro, 127 Latin America, 42, 115, 185, 188, 191 legal issues, 18, 64 literate, literacy, 27, 90 legislation, 125 local needs, 31, 64 Lodha, R., 97 Lamivudine, 47, 183, 200 Lok Sabha, 130 Lucchini, 46, 185, 186 Macintyre, C., 39 Maharashtra, 21, 25, 84, 88, 108, 154, 167, 169 Maharatna, 119 Malavade, B., 170

Mavalankar, D.V., 129 Manipur, 21, 22, 88, 142, 167, 169 Manjunath, U., 90 Marston-Ainley, S., 42, 115 Maternal and Child Health (MCH), 27, 117 Mathew, V., 100 McKenna, S.L., 44, 152 measles, 37, 38, 78–80 Meghalaya, 87, 88, 170 Merck & Co., 15, 186 Ministry of Health and Family Welfare, 29, 80, 109, 116, 121, 132–38, 142, 163 Mittal, S.K., 98, 100 Mizoram, 88, 170, 178 Mohan, P., 86 Monitoring, 18, 56, 80, 84, 91, 92, 103, 150, 157, 166, 186, 201, 204, 209 mothers, 47, 57, 90, 92, 100, 110 morbidity, 39, 45, 101, 111, 123, 184 mortality, 39, 45, 77, 92, 98, 99, 101, 111, 123, 184, 185 Nagaland, 21, 88, 169 Namgyal, P., 14, 40 National Drug Regulatory Authority, 104 National Family Health Survey (NFHS), 27, 87, 88, 89, 90, 99 National Technology Mission, 79–80 Netherlands, 15

Index National Aids Control Organisation (NACO), 16, 21, 22, 23, 44, 47, 56, 145, 155–80, 194, 197–211 National Aids Control Programme (NACP), 22, 154, 163 Nevirapine, 47, 184, 200 New York Community Trust, 15 No-Scalpel Vasectomy, 41, 113–49 Non-Governmental Organisations (NGOs), 29, 30, 54, 61, 64, 65, 69, 82, 103, 204 Norway, 15 opportunistic infections, 45, 182 Orissa, 88, 140, 141, 142, 167 Pakistan, 26 Pareek, R., 90 Parliament, 65, 192, 195 Patent Act, 190, 192 Pertusis, 37 Phadke, A., 97 Pfizer Inc., 15 pharmaceutical, 46, 82, 185, 190–207 physicians, 36, 52, 157, 198, 202, 208 pilot, 38, 41, 43, 49, 50, 56, 57, 85–110, 152 Planned Parenthood, 124, 139 Planning Commission, 126–27 policymakers, 24, 25, 63, 65, 66, 72, 77 polio, 38, 78, 91, 146 Pondicherry, 167, 170

233

Poliomyelitis, 37, 78 population growth, 26; group, 25, 67; policies, 125 Pradhan, J.P., 190, 191 Prakash, C., 100 Programme for Appropriate Technology in Health (PATH), 96, 103 prevention, 16, 22, 24, 38, 43, 44, 47, 54, 67, 68, 69, 72, 153–181, 186, 196, 204, 210 private sector, 18, 29, 30, 31, 32, 54, 59, 60, 65, 69, 81, 82, 96, 103, 126–27, 159, 160, 193, 196, 197, 198, 199 public policy, 11, 29, 182, 207 public sector, 26, 38, 43, 48, 53, 82, 110, 127, 161, 193, 194, 200, 206 Rajasthan, 87, 88, 90, 170 Rajoura, 143 Ramachander, 129 Ratlam, 143 Rao, 129, 130, 144, 145, 146 Ray, 90 Reichler, Mary, 90 religion, 26, 27 Reproductive and Child Health (RCH) programme, 38, 53–57, 78, 82, 87, 123, 125, 126, 127 research, researchers, 13, 29, 30, 36, 49, 67, 98, 99, 200, 211 risk, 25, 39, 43, 151–61, 180, 189 Ritupriya, 86, 99, 100 Rockefeller Foundation, 15

234 Adoption of Health Technologies in India SAIL, 127, 156 STD (sexually transmitted disease), 21, 161 Sahni, M., 98 Saquinavir, 183 Satna, 143 Saxinger, C., 43, 151 Scheduled Castes/Scheduled Tribes, 82 Shanta Biotech, 104 Sharma, R.S., 42, 129 Shreedhar, Jaya, 198 Sichuan, 41, 114 Sikkim, 88, 140, 142, 170 Singh, P., 88, 90, 91 Silveira, M.P., 90 Sinha, R.K., 129, 130, 145, 146 Serological, 43, 151 Serum Institute of India, 82 sexuality, 42, 68, 145, 157 Sheshadri, 25 Schoub, B.D., 39, 99 Shunqiang, Li, 41, 114 Solomon, S., 170 Sony, 119 South Asia, 11 South Africa, 16, 21, 40 Srinivasan, K., 131 stakeholders, 29, 70, 98, 102, 108, 196, 205, 210 sterilisation, 41, 42, 50–58, 114–49 stigma, 25, 47, 145, 153 surgery, 24, 113, 117, 144, 148, 170 surveillance, 18, 22, 50, 56, 154–58 Sweden, 15

TISCO, 127 TRIPS, 191–92 targeting, target population, 25, 34, 48, 51, 57, 71, 80, 86, 96, 105, 108, 112, 115–47, 167–71, 189 Tamil Nadu, 21, 25, 84, 87, 88, 108, 169 test(ing), 28, 43–44, 50–60, 70–72, 82, 100, 151–81, 199, 201 tetanus, 37, 38, 78, 80 Thyagarajan, S.P., 39 Townsend, J.R., 129 Tran, Tien Duc, 26 Trivedi, Mayur, 199 tubectomy, 116–18, 121, 129, 131–45, 142–45 Uganda, 27 UNAIDS, 47, 152–61, 186–89 UNICEF, 78, 84, 96, 104 UNFPA, 42, 122–29 USA (also United States), 15, 42, 43, 45, 114, 115, 126, 152, 182, 183 United Nations, 46 Universal Immunisation Programme, 28, 37, 77–93 (see also Immunisation) Until There’s A Cure Foundation, 15 Uttar Pradesh, 27, 125, 142, 167, 170 Uttaranchal, 167, 170, 178 vaccine, 78, 79; AIDS, 3–17, 21–36, 37–48, 63–69, 71–73, 93, 111, 112,

Index 150–81; Hepatitis B, 26, 37–48, 55, 91–112; monovalent and tetravalent, 105 vasectomy, 28, 41, 42, 70, 113–49 (see also No-Scalpel Vasectomy) Voluntary Counselling and Training Service, 17, 28, 29 (see also Counselling) Van Damme, 40 Vicziany, Marika, 115–18 Vidarbha, 143 Vietnam, 26 Vorsters, 40 WHO, 24, 29, 36, 37, 40, 43, 47, 49, 78, 79, 82, 83,

235

94–100, 104, 105, 109, 111, 151–53, 195, 197, 200, 201 WTO, 83, 188, 196, 204, 207 Wainberg, M.A., 184 Warangal, 143 Western blot test, 43, 151 World Bank, 15, 80, 154, 158, 168, 186, 209 World Health Assembly, 40, 95 YRG CARE, 156, 200 Yadav, R.J., 88, 90, 91 Zhang, 114, 145 Zidovudine (AZT), 45, 47, 182, 183, 200

About the Authors

Indrani Gupta is Professor and Head, Health Policy Research Unit, Institute of Economic Growth, Delhi. She is a member of the Technical Review Panel of the Global Fund for AIDS, Tuberculosis and Malaria and the WHO South-East Asia Advisory Committee on Health Insurance. She has also been a consultant at the Policy Research Unit of the World Bank from 1991 to 1995, and a research analyst at the Bureau of Business and Economic Research, University of Maryland in 1991. She has written a number of reports and research papers on health and health technologies. Mayur Trivedi is Assistant Professor, Health Policy Research Unit, Institute of Economic Growth, Delhi. He has also worked as a consultant from 2003 to 2006 and as a project officer in 2003 at the Health Policy Research Unit of the Institute of Economic Growth. His main areas of interest being HIV/AIDS and health financing, he has written a number of papers and reports. Subodh Kandamuthan is faculty in Health Economics, Institute of Health Systems, Hyderabad. A Ph.D. in economics from the Institute of Economic and Social Change, Bangalore, he has co-written a number of papers for various journals.