Adoption of Health Technologies in India

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
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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 vaccinesIndia. 2. HIV infectionsIndia. I. Trivedi, Mayur,
1976- II. Kandamuthan, Subodh, 1976- III. Title. IV. Series.
[DNLM: 1. AIDS Vaccinestherapeutic useIndia. 2. Disease Outbreaks
prevention & controlIndia. 3. HIV InfectionstherapyIndia. 4. Health
PolicyIndia. 5. Health Services AccessibilityIndia. 6. Technology
TransferIndia. WC 503.6 G9766a 2007]
QR189.5.A33G87
615'.3720954dc22
ISBN: 9780761935902 (PB)
2007
2007014171
9788178297392 (IndiaPB)
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
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
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
CHAPTER 6
6.1
6.2
6.3
6.4
6.5
UNIVERSAL IMMUNISATION
PROGRAMME
77
Introduction
Timing 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
Supply Issues
Distribution Issues
Demand Issues
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
Supply Issues
Distribution Issues
Demand Issues
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
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
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
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.
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. IAVIs supportersboth financial and
in-kindinclude 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 Theres 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,
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
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.
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 healthsafe,
effective medicines and health technologies.
Health technologies are used at every level of a health
systemfrom 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
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.
(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, Pakistans
first five-year public sector development plan (195560)
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
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
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 ones 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.
Before these are discussed in more detail, it is important to understand that in this book, adoption is considered from the governments 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
Indias experience on adoption of health technologies, which have potential implications on access to
AIDS vaccineUIP, Hep B vaccine, NSV, ARV and
VCT services.
Methodology
Literature reviews of published and unpublished
articles, secondary data, reports, research studies and
journal articles related to adoption and use of selected
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.).
(contd)
(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
Lessons drawn and key messages on key process/

mechanism and factors contributing to success or
failure in adoption.
Identify challenges and recommend potential strategies for the AIDS vaccine and future research areas.
We discuss each of these parameters in greater detail.
1. Timing of Adoption
A technologyif available in the worldshould 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
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.
(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
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 technologyan important issue
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 deliveredbut
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
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 610 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 oneuniversal immunisation
programmeadded, 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
technologyHepatitis Bbetter. 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,
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
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 27 per cent.
In 2002, the Government of India decided to implement
a universal infant vaccination programme and the Hep B
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 stitchesis 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)
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 Healthplayed 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 199293 to
1.9 per cent in 199899 (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
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 AIDSas
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
198586. 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
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
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
moleculesfrom 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
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 1998where several voices were
raised to address the inequality of access to ART and the
high prices charged for ARTmany 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 worlds 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
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 WHOs 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
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 610 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
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.
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.
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
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
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.
55
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 programmesNSV and Hep Bcould 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.
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.
57
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
that demand generation with dissemination of correct

informationwhich is the cornerstone of a successful adoptionhas 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.
59
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.

This has, overall, been satisfactory and the gap between
the discovery or availability of the technology globally
and Indias 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
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.

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.

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.
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.

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
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
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
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 Indias first large-scale public health programme.
The study indicates that despite some systemic problems with the health sector set up, Indias 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
givenin 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
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 Indias 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
04) has declined from 26.5 per thousand in 1991 to 18
in 2002 (MOHFW Annual Report 200304). 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.

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 Indias
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 199596 under the Polio Eradication Programme.
Universal Immunisation Programme 79
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 1985almost 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.

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.

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
Mission and became operational in all districts in the country during 198990. 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).

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
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.

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 1520 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.
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

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
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 MOHFWs 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
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
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
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
45 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.

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 199293
(Phase 1) and 199899 (Phase 2), RCH surveys in 1997

98 (Round 1) and 200203 (Round 2),1 National Sample
Survey (NSS) (199596), 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.

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

199293 199899 199899 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 (199293)

and NFHS (199899), 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
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
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.
Mothers 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
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.

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
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 Indias 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
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
worlds 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
Hepatitis B Immunisation
95
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.

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
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
programmestarted as a pilot projectwas 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
97
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.

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 47 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
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 schedulestarting at the earliest after birthhas
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
99
to child transmission of HBV in India. Some researchers,

based on the extrapolation of Taiwanese data, argue that
vertical transmission comprises at least 3050 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 3050 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.
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 vaccinationin high risk
statesshould 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;
101
(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 WHOs 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.

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.

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
103
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.

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. PATHan international NGOwas
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 Childrens Vaccine Program (CVP) at PATH, with
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

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.
105
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 periodicallymostly in
every quarterto 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.
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
107
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.

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 projectstarted in 15
cities and 33 districts in Indiais 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
109
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

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).

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
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 hardtoreach 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.

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 governments
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
111
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.
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 stitchesis 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
procedurewhich is generally painless, less invasive and
fastercan 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)
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 sterilisationtubal ligation
to be specificwas 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
techniques most salient characteristic. It also supported
2
www.mohfw.nic.in/nsvindia
115
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).

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
governments 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
196667
1964
Vasectomy
197071
196869
Tubectomy
197677
197475
197273
1962
1960
1958
1956
Thousands
Source: Various yearbooks of family welfare department of the Ministry of Health and Family Welfare.
3000
6000
9000
FIGURE 8.1
Sterilisations in India over time
197879
117
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 incentivesintroduced
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 197173. 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
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 months income and in some cases more
than a months 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 197374 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 197375 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 emergency6 period (June 1975January 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
119
when the government took on extraordinary powers and

implemented a series of strict measures. Family planning
was given top-most priority in the governments agenda
for development. During this period, around 811 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
sterlisationwhich had resulted from the excesses of the
Emergencythis 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 (197880) and revised (198085)], 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
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 (198691) continued
this low-key approach to sterilisations, with increased emphasis (with incentives) on spacing methods. As the name
of the programmeMaternal and Child Healthindicated, 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
198283
IUD
198485
198384
Tubectomy
198586
Pills
198889
198788
198687
Vasectomy
198990
198182
198081
197980
197879
0%
20%
40%
60%
80%
100%
199091
FIGURE 8.2
Distribution of family planning acceptors across modern contraceptive methods in India
199192
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 56 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.

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.

The NSV technique was introduced under the UNFPAAVSC-GoI project entitled Establishment of Centres of
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 Indias family
welfare programme. The Ninth plan (19982001) 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
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 governments 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 (200207) also reiterated the
governments 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 governments 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
125
through sterilisation.9 This trendwhich is also reflected

in the Population Policies of states like Madhya Pradesh,
Maharashtra, Andhra Pradesh and Uttar Pradeshis 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).

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 governments
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
about the technique. The actual implementation of NSV

as in other previous programmes around contraceptive
usewas 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.

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 (19972003), social marketing of
contraceptives being the major one. There are also some
127
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 200102 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 Indias 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,
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 instrumentsextra
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
129
of NSV implementation has been through campsthe

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
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).

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
131
acceptance of different contraception methods over the

time. For the ease of understanding, we have divided Indias
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 Indias 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 IUDwhose introduction brought
down the rate of vasectomy acceptorsfailed 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 197375 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 198182
to 65 per cent acceptors in 199192.
1964
1962
Tubectomy
196869
1966 67
Vasectomy
1970 71
Pills
IUD
197273
1960
1958
1956
0%
20%
40%
60%
80%
100%
197475
FIGURE 8.3
Distribution of family planning acceptors by modern methods in Indiatill the 1970s
1976 77
197879
198081
Tubectomy
198283
Vasectomy
198485
Pills
198687
IUD
198889
199091
0%
20%
40%
60%
80%
100%
FIGURE 8.4
Distribution of family planning acceptors by modern methods in Indiapost-Emergency phase
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
199899 (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 periodmore 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.

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
199293
199495
Tubectomy
199697
Vasectomy
199899
Pills
IUD
200001
200203
0%
20%
40%
60%
80%
100%
FIGURE 8.5
Distribution of family planning acceptors by modern methods in Indiasince the early 1990s
1956
1961
Achievement Sterilisation
Target Sterilisation
196667 197172 197677 198182 198687 199192 199697 200102
1000
2000
3000
4000
5000
6000
7000
8000
9000
FIGURE 8.6
Targets and achievements of terminal methods of contraception
196667
1961
Achievement IUD
197677
Target IUD
199192
198687
Achievement Pills
Target Pills
199697
198182
197172
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
200102

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.
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
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 200001. The
states that have been done intensive training and delivery
of NSVAndhra Pradesh and Madhya Pradeshare 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: Authors 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

TABLE 8.2
Trends in vasectomy as a proportion of total
sterilisations in selected states over a five-year period
States
199798
199899 19992000 200001
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
143
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 199495 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
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
145
for 27,000 (51 per cent), slightly more than the tubectomy operations. Discussions held with key personnel
indicate that the initial impetusduring 199899
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.
NSVunlike many other health technologiesneeds
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.
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
147
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 sterilisationof which NSV is just one methodthen 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.

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 demandlike 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
149
not a constraint on demand, the incentives indicated almost a case of negative pricing.

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
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 womens 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 methodthe 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.
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
Voluntary Counselling and Testing
153
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 Indias, 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 incentivesamidst stigma, discrimination and expensive treatmentwas 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
medical, preventive and psychosocial care services (CDC

1993, 2001).

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 (19992006)
envisaged the twin objectives of reducing the spread of
155
HIV infection in India and strengthening Indias 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 modelsboth public and privatecan
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.

Counselling techniques have been widely practiced in
Indias 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.

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.
157
From the testing perspective, the service providers

physiciansgenerally 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.

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.
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
159
programmes. With the introduction of rapid testsin

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.

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.

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
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
161
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

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.
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 reacha comparison across state categories
Adult
Number
Population of Existing
(1549)
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.
163
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 (200506) 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.

Vulnerable states
Total
Group of States
Districts
(as per
census
2001)
TABLE 9.2
Districts covered for VCTCsa 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.
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
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 (34 days)
7
167
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
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.
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 IIa mid-term review by the
Word Bankraised 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.

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

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
169
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.
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.
171
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 systemvoluntary
testingis 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

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
NACO.
2002
State Group
No. of People Tested

(in thousand)
TABLE 9.4
Voluntary testing at VCTCsa comparison across state categories
52.0
24.0
18.5
5.5

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)
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
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.

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
175
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
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 statesboth highly
vulnerable and vulnerable statesare 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

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)
NACO.
2002
State Group
People Tested
for HIV/AIDS
(in thousand)
TABLE 9.6
Pre-test counselling at VCTCsa comparison across state categories
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 indicatorproportion of HIV positive people receiving test resultswhich 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
179
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.

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

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)
NACO.
2002
States
No. of Persons
Testing Sero-positive
(in thousand)
TABLE 9.7
Positive people receiving test resultscomparison across state categories
181
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 governments 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 WHOs role in its accelerated spread need to be
understood so as to put Indias 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
183
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
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
185
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
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 2002with 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).
187
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 worlds 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
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 Initiatives cost experts worked with the companiesAspen
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
189
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.
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 Indiathe 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.
191
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 destinationsaccounting for more
than half of the total exportwere 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
198283 198687 199091 199495 199899

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 Economy2004, Bombay.
5

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
193
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.

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
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 1520
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 centreswith
at least one site in each stateby 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.

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 Sabhas
unstarred question no. 454 to be answered on 27 July 2005.
195
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.

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 200304 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
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.

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
197
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 8,00010,000 clients
through four district hospitals. Two of these sites are now
functioning as NACO-sponsored sites.

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 Indiathe 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
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 componentpharmaceutical companiesthe 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 200102 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.
199
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 governments
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
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

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, NACOthrough
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
201
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.
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.
203

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 citiesmetros 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
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

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 sectorwhich has been in a productive partnership with the governmenthas 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
205
issue; rather, there is excess demand for it currently, which

seems difficult to meet.

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
Public sector
Jun-05
Jun-04
Apr-04
Feb-04
Dec-03
Source: Various country profile report for India, World Health Organization.
5000
10000
15000
20000
25000
30000
35000
40000
FIGURE 10.4
Patients on ART in India over time
Dec-05
Oct-05
Aug-05
207
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
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 NACOs 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
209
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
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
211
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
managementover and above the monthly reports that
are being sent to NACOis 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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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, 14244,
148, 169
Antarsh, L., 42, 115
Antenatal Clinic (ANC), 21,
157, 175
antibodies, 43, 15152
Antiretroviral therapy (ART),
22, 28, 4448, 5059,
6466, 7071, 153, 181,
182211
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, 8081, 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, 2035
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, 8788
Bokaro, 143

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,
7781, 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, 4344, 50, 51,
60, 70, 72, 144, 15581,
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, 18283
Dwivedi, S.N., 27
education, 27, 57, 143
Efavirenz, 200, 207
ELISA, 43, 151, 152, 159,
162, 175
Emergency, 11834
Engender Health, 42, 114, 127
epidemic, 21, 22, 186
Ernakulam, 11718, 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, 11450
family welfare, 29, 42, 80, 87,
107, 109, 11650, 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, 187205
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, 3739,

6062, 70, 94111
Himachal Pradesh, 88, 108,
170, 178
HIV, 2125, 4346, 50, 53, 54,
65, 67, 68, 72, 151207
Hubli, 143
human resources, 30, 33, 44,
107, 129, 166, 181, 197,
202
human rights, 24, 147
immunisation, 24, 28, 3741,
70, 7793, 94112, 146
(see also Universal
Immunisation Programme)
Indian Council for Medical
Research (ICMR), 16, 23,
8789, 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, 14547,
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), 1416, 23
Intra Uterine Devices (IUD),
117, 120, 121, 13137
Ireland, 15

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, 14348
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, 7880
Meghalaya, 87, 88, 170
Merck & Co., 15, 186
Ministry of Health and Family
Welfare, 29, 80, 109, 116,
121, 13238, 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,
7980
Netherlands, 15
Index
National Aids Control
Organisation (NACO), 16,
21, 22, 23, 44, 47, 56, 145,
15580, 194, 197211
National Aids Control
Programme (NACP), 22,
154, 163
Nevirapine, 47, 184, 200
New York Community Trust, 15
No-Scalpel Vasectomy, 41,
11349
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,
190207
physicians, 36, 52, 157, 198,
202, 208
pilot, 38, 41, 43, 49, 50, 56, 57,
85110, 152
Planned Parenthood, 124, 139
Planning Commission, 12627
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,
153181, 186, 196, 204, 210
private sector, 18, 29, 30, 31,
32, 54, 59, 60, 65, 69, 81,
82, 96, 103, 12627, 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,
5357, 78, 82, 87, 123,
125, 126, 127
research, researchers, 13, 29, 30,
36, 49, 67, 98, 99, 200, 211
risk, 25, 39, 43, 15161, 180,
189
Ritupriya, 86, 99, 100
Rockefeller Foundation, 15

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, 5058,
11449
stigma, 25, 47, 145, 153
surgery, 24, 113, 117, 144,
148, 170
surveillance, 18, 22, 50, 56,
15458
Sweden, 15
TISCO, 127
TRIPS, 19192
targeting, target population, 25,
34, 48, 51, 57, 71, 80, 86,
96, 105, 108, 112, 11547,
16771, 189
Tamil Nadu, 21, 25, 84, 87, 88,
108, 169
test(ing), 28, 4344, 5060,
7072, 82, 100, 15181,
199, 201
tetanus, 37, 38, 78, 80
Thyagarajan, S.P., 39
Townsend, J.R., 129
Tran, Tien Duc, 26
Trivedi, Mayur, 199
tubectomy, 11618, 121, 129,
13145, 14245
Uganda, 27
UNAIDS, 47, 15261, 18689
UNICEF, 78, 84, 96, 104
UNFPA, 42, 12229
USA (also United States), 15,
42, 43, 45, 114, 115, 126,
152, 182, 183
United Nations, 46
Universal Immunisation
Programme, 28, 37, 7793
(see also Immunisation)
Until Theres A Cure
Foundation, 15
Uttar Pradesh, 27, 125, 142,
167, 170
Uttaranchal, 167, 170, 178
vaccine, 78, 79; AIDS, 317,
2136, 3748, 6369,
7173, 93, 111, 112,
Index
15081; Hepatitis B, 26,
3748, 55, 91112;
monovalent and tetravalent,
105
vasectomy, 28, 41, 42, 70,
11349 (see also No-Scalpel
Vasectomy)
Voluntary Counselling and
Training Service, 17, 28, 29
(see also Counselling)
Van Damme, 40
Vicziany, Marika, 11518
Vidarbha, 143
Vietnam, 26
Vorsters, 40
WHO, 24, 29, 36, 37, 40, 43,
47, 49, 78, 79, 82, 83,
235
94100, 104, 105, 109,

111, 15153, 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
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.

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Adoption of Health

Studies in Economic and Social Development No. 68

Los Angeles/London/New Delhi/Singapore

Copyright Institute of Economic Growth, 2007

ISBN: 9780761935902 (PB)

Foreword by Kanchan Chopra

INTRODUCTION AND RATIONALE

Need for an AIDS Vaccine in India

Universal Immunisation Programme (UIP)

ADOPTION OF HEALTH TECHNOLOGIES

LESSONS FOR THE ADOPTION

SUMMARY AND CONCLUSIONS

10 Adoption of Health Technologies in India

CHAPTER 10 ANTIRETROVIRAL THERAPY

This volume is being published as part of the IEG

12 Adoption of Health Technologies in India

The book has two important messages: the first has to

guided by the uniqueness of each and its appropriateness

The analysis in this book is based on secondary data, and

is a global not-for-profit organisation whose mission is to

With more than 5 million reported cases of HIV positive

becomes available, it is accessible to all who need it. Clearly,

18 Adoption of Health Technologies in India

appropriateness and adaptability of the technology at point

1.1 Need for an AIDS Vaccine in India

22 Adoption of Health Technologies in India

women. 86 per cent of all the infections in the country are

Introduction and Rationale for Study 23

effective, multi-dose and expensive. Nevertheless, studies

24 Adoption of Health Technologies in India

1.2 Access to a Health Technology

Introduction and Rationale for Study 25

around adoption of the AIDS vaccine will be similar to

26 Adoption of Health Technologies in India

(Shani et al. 2000). Funding and reimbursement systems

Introduction and Rationale for Study 27

the Information, Education and Communication (IEC)

1.3 Rationale and Conceptual

28 Adoption of Health Technologies in India

Introduction and Rationale for Study 29

30 Adoption of Health Technologies in India

Lessons drawn and key messages on key process/

Introduction and Rationale for Study 31

2. Appropriateness and Adaptability

32 Adoption of Health Technologies in India

pass/amend/create the necessary rules and regulations to

(b) Role of Central/State/Local Governments

Introduction and Rationale for Study 33

(d) Role of NGO/Civil Society

4. Supply Side Factors

34 Adoption of Health Technologies in India

the service. Whether it is to store materials, equipments or

(a) Targeted Groups

Introduction and Rationale for Study 35

for India, where a majority of the population resides in

36 Adoption of Health Technologies in India

Essentially, four health technologies have been analysed in

2.1 Universal Immunisation

38 Adoption of Health Technologies in India

however, vary depending on the disease burden in different countries.

Introduction to Selected Health Technologies 39

such large-scale government programmes and prevent