VOLUME 18, NUMBER 5 |
SEPTEMBER/OCTOBER 2005 |
Editorials
The Revised National Tuberculosis Control Programme:
The gains and the future road map
As India has successfully completed the
first phase of the World Bank-assisted Revised National Tuberculosis
Control Programme (RNTCP) project in September 2005, it is time
to reflect on the achievements and experience gained over the
years, and plan for the challenges ahead so as to achieve the
Millennium Development Goals of halving by 2015 the 1990 levels
of mortality and prevalence of tuberculosis (TB) and effectively
controlling TB to a level where it ceases to be a public health
problem.1
Tuberculosis is one of the oldest diseases known to affect mankind.
It has been reported in the Vedas and Ayurvedic Samhitas as the
kshaya rog. Though an ancient disease, TB remains a major global
public health problem in much of the developing world. Globally,
it is estimated that 8–9 million people develop active
disease every year, of whom nearly 4 million are sputum smear-positive;
the majority live in developing countries.2 Of
an estimated 1.8 million new cases of TB every year in India,
about 0.8 million
are infectious new smear-positive pulmonary TB cases. More adults
die from TB than from any other infectious disease in India—more
than 1000 every day or 2 every 3 minutes. Deaths due to TB exceed
the combined deaths from all other communicable diseases and
account for 26% of all avoidable adult deaths. TB is also the
leading killer of women, causing more orphans than those produced
by all causes of maternal mortality combined. With nearly 40%
of the Indian population already infected with the TB bacillus,
constituting a large pool of infected people, TB will continue
to be a major problem in the foreseeable future.3 Besides
the disease burden, TB also causes an enormous socioeconomic
burden
on India. It is estimated that TB costs India more than US$ 300
million annually in direct costs alone.4 More than 300 000 children
may have left school permanently because of their parents’ TB,
and more than 100 000 women were rejected by their families because
they had TB.4
Globally, the HIV epidemic is worsening the TB situation, increasing
the number of TB cases and accelerating the spread of the disease.
One-third of the world’s AIDS patients are also suffering
from TB. HIV infection increases a person’s susceptibility
to TB and is now considered the most important risk factor for
the progression of TB infection to disease. With nearly 5.1 million
HIV-infected persons in India, the HIV epidemic has potential
implications for the epidemiology of TB in India.2,3
Effective antituberculosis drugs have been available for over
50 years. Different treatment regimens and combinations have
been practised over these years across the globe. Currently,
the internationally recommended Directly Observed Treatment,
Short-course (DOTS) strategy has been recognized as the most
cost-effective approach for the treatment of TB, to reduce the
disease burden and to control the spread of infection. Over 180
countries are implementing the DOTS programme and India’s
DOTS programme is now the largest globally in terms of the number
of patients being put on treatment—over 1.2 million cases
in 2004 alone, i.e. over 100 000 every month.3
Evolution of TB control activities in India5
Pioneering research by the Tuberculosis Research Centre, Chennai
and the National Tuberculosis Institute, Bangalore laid the foundation
and principles of the TB control programme in India and the world.
Research at these institutions in the 1950s and 1960s demonstrated
the effectiveness of domiciliary chemotherapy given under supervision.6,7 India
started the National TB Control Programme (NTCP) in 1962, based
on a District TB Centre Model. A review of the NTCP, after
nearly three decades of implementation, demonstrated that it
had failed to make any significant epidemiological impact. The
review, conducted by the Government of India (GoI) and the Swedish
International Development Agency (SIDA) in 1992 concluded that
the NTCP suffered from managerial weaknesses, inadequate funding,
over-reliance on X-ray for diagnosis, non-standard treatment
regimens, low rates of treatment completion, and lack of systematic
information on treatment outcomes. The programme review also
showed that only 30% of patients were diagnosed and, of these,
only 30% were successfully treated. Based on the findings and
recommendations of the 1992 review, the GoI evolved a revised
strategy and launched the Revised National TB Control Programme
(RNTCP) in the country based on the internationally recommended
DOTS strategy.
From October 1993 to 1996, the RNTCP was pilot-tested in a population
of nearly 20 million. Following the successful pilot implementation
of the programme, which demonstrated both technical and operational
feasibility, a credit agreement was signed with the World Bank
in 1996 to expand the programme in a phased manner. Support from
other international agencies such as the Department for International
Development (DFID) of the United Kingdom, Danish International
Development Agency (DANIDA), Global Fund for AIDS, TB and Malaria
(GFATM), United States Agency for International Development (USAID)
and Global Drug Facility (GDF) helped to expand and achieve universal
coverage.
A rapid scale-up of the programme began in late 1998, when another
100 million population was covered under the RNTCP. In the past
few years, the RNTCP has been expanding rapidly. By the end of
September 2005, over 1059 million people (95% of the population)
in more than 604 districts/reporting units were covered under
the programme and complete nationwide coverage is expected by
the end of 2005.
Gains and future road map of the programme
Over the past 8 years, the RNTCP has made rapid gains and, since
1999, progress in global TB control has been determined by India’s
success, which is expected to continue over the coming years.
Over 4.8 million patients have been put on treatment under the
RNTCP. Treatment success rates have more than tripled from 26%
in the earlier programme to 86% under the RNTCP. Death rates
have decreased from 29% to 4%, thereby saving over 800 000 additional
lives since the inception of the programme.
Over 600 District TB centres, nearly 11 000 microscopy centres
and 2150 Tuberculosis Units have been upgraded. The programme
has made provisions for contractual staff to ensure effective
programme implementation and monitoring. The establishment of
a sub-district level ‘Tuberculosis Unit’ covering
a population of 500 000 with provision for a dedicated contractual
Senior Treatment Supervisor and Senior Tuberculosis Laboratory
Supervisor has strengthened the programme at the field level.
These provisions will be continued in the next phase of the programme
to consolidate the gains achieved so far by the RNTCP.
The quality of diagnosis of TB patients under the RNTCP has improved
by giving the highest priority to the provision of quality assured
sputum smear microscopy services with RNTCP-designated microscopy
centres serving populations of 100 000. One of the unique innovations
under the RNTCP has been the development of ‘patient-wise
boxes’, which contain the full course of treatment for
one individual patient, ensuring that the treatment of that patient
cannot be interrupted due to a lack of drugs. The RNTCP has effectively
decentralized supervision via the sub-district TB Units, with
inbuilt systems for monitoring and evaluation.
The quality of diagnostic and treatment services is of utmost
priority under the programme. A quality assurance protocol was
initiated towards the end of phase I of the RNTCP and will be
further strengthened in the coming phase by building the capacity
of state-level laboratories to the level of an accredited RNTCP
Intermediate Reference Laboratory (IRL), capable of implementing
quality assurance protocol, and also perform quality assured
culture and drug sensitivity testing (DST). A new strategy document
for Supervision and Monitoring has laid down detailed guidelines,
checklists and indicators for monitoring the programme at the
Peripheral Health Institution (PHI)/ Designated Microcopy Centre
(DMC), TB Unit, District, State and National level. The quality
of DOTS implementation is already being monitored through select
indicators collected routinely.
The RNTCP has been successful in mobilizing political and administrative
commitment to ensure adequate funds, staff and other key inputs,
and in encouraging community participation at the grassroots
level. The RNTCP has forged participation with other stakeholders,
such as NGOs, private practitioners, medical colleges and other
ministries’ health facilities (Employees’ State Insurance
[ESI], Railways, Ports and Mines, Army, etc.), and the corporate
sector. Over 1600 NGOs, 9000 private practitioners and 100 corporate
houses are now involved in the programme. Guidelines for the
management of hospitalized TB patients have been developed, and
over 200 medical colleges have been involved. Medical colleges
have made an important contribution to case detection, 10%–15%
in some areas. With the establishment of a task force mechanism
for the involvement of medical colleges in the RNTCP and 5 zonal
nodal medical college centres, there is an increased professional
consensus, although still not universal, between public health
and medical opinion leaders on the appropriateness and feasibility
of the RNTCP for TB control in India. These partnerships are
constantly being reviewed to strengthen collaboration.
The RNTCP is a human resource-intensive programme. Human resource
development being the core for any successful programme, the
programme has developed standardized modular training material
for all levels of health staff. To date, over 420 000 personnel
have been trained. To build the capacity of the states, the State
TB Training and Demonstration Centres (STDCs), one in each of
the large states, have been strengthened. These centres have
a training unit, supervision and monitoring unit, and a laboratory
unit.
A systematic programme evaluation mechanism is in place, with
the responsibility of planning and implementation of such evaluations
decentralized to the state level. In 2004, internal evaluations
were planned and conducted in 47 selected districts to evaluate
the actual status of the RNTCP, including both the negative and
the positive aspects of programme implementation. Based on the
observations and recom-mendations of such evaluations, the programme
has taken steps to rectify any problems identified, so as to
continuously improve the performance of the RNTCP. These are
supplemented by Centrally-driven district-level evaluations,
regular programme review in the states by representatives from
the Centre and district reviews by state and district officials.
Under a joint National AIDS Control Programme (NACP)/RNTCP Action
Plan, since 2001, collaborative TB/HIV control activities and
coordination have been implemented by the RNTCP and the NACP.
As a result, coordination and service linkages have been established
between 242 voluntary counselling and testing centres (VCTCs)
and RNTCP diagnostic and treatment centres in the 6 high-prevalence
states of Andhra Pradesh, Karnataka, Maharashtra, Manipur, Nagaland
and Tamil Nadu.
TB/HIV activities are being scaled-up in 8 more states. HIV seroprevalence
surveys among TB patients are under way in selected sentinel
sites (4 districts) of Andhra Pradesh, Karnataka, Maharashtra
and Tamil Nadu.
The RNTCP with the Indian Academy of Pediatrics has developed
guidelines for the management of paediatric cases. During phase
II, it is planned to procure and supply paediatric drugs in patient-wise
boxes based on specific weight bands. Currently, nearly 6% of
new cases registered under the programme are in the paediatric
age group.
Today, with the greatly expanded efforts to strengthen TB prevention
and control programmes worldwide, there is growing concern about
the reported and potential future rates of multidrug-resistant
(MDR) TB (resistance to at least isoniazid and rifampicin). Though
the prevalence of MDR-TB in India is under 3% in new cases, when
translated into numbers, these cannot be ignored. The RNTCP views
the treatment of MDR-TB patients as a ‘standard of care’ issue.
However, recognizing that the treatment of MDR-TB cases is very
complex, an RNTCP standardized second-line drug regimen has been
developed following the internationally recommended DOTS Plus
guidelines and will be provided from designated RNTCP DOTS Plus
sites. In the initial years, these sites will be located in a
limited number of highly specialized centres, at least one in
each large state, and will have ready access to a state-level
accredited culture and DST laboratory, the IRL, under the RNTCP.
By 2010, these sites would be capable of registering 5000 patients
every year.8
Operational research is integral to the continued improvement
of the programme. In 2003, the RNTCP, successfully completed
a National Annual Risk of Tuberculosis Infection (ARTI) survey.
From the survey, the national ARTI was estimated at 1.5%.9 The
TB burden in India was estimated at 8.5 million cases of which
3.8 million were bacillary pulmonary TB cases.10 These surveys
have given, for the first time, true estimates of the disease
burden in India and repeat surveys planned in the next phase
of the programme will help to assess the impact of the RNTCP.
A detailed RNTCP operational research agenda has been prepared
and circulated for constant technical and operational inputs.11
The RNTCP has developed its own website (www.tbcindia.org) where
regularly updated information, RNTCP data, documents and training
manuals are readily accessible in the public domain. An interactive
bulletin board is operational on the website for the sharing
of ideas and experiences, and to seek and receive information.
State-wise and district-wise performance data are also posted
on the site. Each district has been electronically connected,
and quarterly programme reports are now routinely received electronically
from over 90% of the districts. A web-based information, education
and communication (IEC) resource centre has been developed and
is accessible on the RNTCP website.
CONCLUSION
As the programme moves from the preparatory and expansion phase
to the maintenance and consolidation phase, the RNTCP will endeavour
to continue providing high quality and cost-effective TB diagnostic
and treatment services. To further improve the quality of services,
earlier strategies have been fine-tuned and strengthened, and
several new initiatives have been taken.
To achieve the ultimate goal of TB control in India, the programme
will have to be sustained for many years to come. While implementing
the RNTCP since 1997 to date, nearly Rs 8.45 billion has been
spent and it has shown impressive gains. Further, planned investment
of over Rs 14.6 billion over the next 5 years is expected to
consolidate the gains achieved so far and yield better results,
and have a major impact on reducing the TB burden in India. Continued
decentralization of programme management and implementation,
ensuring financial support for the RNTCP, and mobilizing community
participation in TB control efforts will facilitate the process.
REFERENCES
- Human Development Report 2003. Millennium Development Goals—A
compact among nations to end human poverty. http://hdr.undp.org/reports/global/2003/
- World Health Organization. Global tuberculosis control—Surveillance,
planning, financing. WHO Report 2005. Geneva:WHO. WHO/HTM/TB/2005.349.
- TB India 2005: RNTCP Status Report. Central TB Division, Directorate
General of Health Services, Ministry of Health
and Family Welfare, Government of India, New Delhi, 2005.
http://www.tbcindia.org/documents.asp
- Rajeswari R, Balasubramanian R, Muniyandi M, Geetharamani S, Thresa
X, Venkatesan P.
Socio-economic impact of tuberculosis
on patients and family in India. Int J Tuberc Lung
Dis 1999;3:869–77.
- Agarwal SP, Chauhan LS. The Revised National Tuberculosis Control
Programme. In: Tuberculosis
control in India. New Delhi: Elsevier (India); 2005:23–4.
- Indian Council of Medical Research. Tuberculosis in
India—A
sample survey 1955–58, Special Report Series
No. 34. New Delhi:Indian Council of Medical Research;
1959:1–21.
- Tuberculosis Chemotherapy Centre. A concurrent comparison of home and
sanatorium treatment
of pulmonary
tuberculosis in south India. Bull World
Health Organ 1959;21:51–144.
- Central TB Division. Managing the Revised National Tuberculosis
Control Programme Phase II 2005. New Delhi:Directorate
General of
Health Services,
Ministry of
Health and Family Welfare; 2005.
- Directorate General of Health Services (DGHS), Government of India
(GoI), the National
Tuberculosis Institute (NTI), Bangalore
and the
Tuberculosis Research Centre, Chennai. Annual risk of tuberculosis
infection in different
zones of
India: A national sample survey 2000-2003. Bangalore:National
Tuberculosis Institute
(NTI); 2004.
- Central TB Division. Meeting of the Expert Committee to estimate
TB burden in India. 10-11 March 2005, New Delhi.
Directorate
of Health and
Family Welfare,
Government of India, 2005.
- Research in RNTCP. http://www.tbcindia.org/documents.asp# (accessed
on 6 September 2005).
S. P. AGARWAL
Director General Health Services
Ministry of Health and Family Welfare
Nirman Bhavan
New Delhi
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