century, TB could be diagnosed microbiologically, but there was no
anti-TB drug. For rest and fresh air, sanatoria were established in
Europe. India’s early TB sanatoria were in Tiluania (near Ajmer, 1906),
Almora (1908), Shimla (1909) and Madanapalle (Andhra Pradesh, 1914)
[15-17]. Johannes Frimodt-Moller became medical superintendent in
Madanapalle in 1940 [15-17]. He introduced BCG vaccination in 1948; the
Government of India (GoI) established a BCG production unit in Chennai
[15-17]. One of us (TJJ) learned TB epidemiology from Frimodt-Moller
BCG was believed to prevent MTb infection [7,15, 16].
The Indian Council of Medical Research (ICMR) and Government of India
(GoI) had conducted country-wide surveys and found TB rampant
everywhere. In 1951 mass BCG campaign was begun. During 1949-1952, soon
after their discovery, Para amino salicylic acid (PAS), streptomycin
(SM) and isoniazid (INH) were introduced in India and GoI established a
TB Chemotherapy Centre (renamed TB Research Centre and today National
Institute for Research in TB) in Chennai in 1956 [15-17]. In 1961 a
district TB diagnosis and treatment Programme was designed, using which
NTCP was launched in 1962 [15-17].
Post-independence, GoI re-designed health ministry
abolishing the posts of Public Health Commissioner at GoI and Directors
of Public Health in most States . Public Health functions were
assigned to Directorate of Health Services (DHS) . Thus, disease
control, including NTCP, came under DHS as vertical and single-disease
oriented [4,18]. Since then, attempts to re-establish a Public Health
Service in India have been unsuccessful [14,18,19]. National leaders
understand biomedical advances, not the value of Public Health [14,
National TB Control Project (NTCP)
NTCP was designed for a two pronged attack on TB –
BCG vaccination and TB treatment. State government (responsible for
healthcare) and GoI (responsible for disease control) had to be full
partners. The policy was to give treatment free of charge.
Chemoprophylaxis (for latent TB) was considered impractical because of
the massive numbers of subjects, and non-essential as BCG was believed
sufficient to control MTb infection . To measure vaccine efficacy of
BCG, a large trial was designed in Chingleput District (Tamil Nadu)
under the TB Research Centre [16,20].
In 1961, treatment demonstration was established in
Anantapur district (Andhra Pradesh) . "The Anantapur DTC
[district TB control] became operational quickly and functioned well
because, in addition to the state government’s component, NTI [National
TB Institute, Bangalore] staff also worked. By October 1961 the NTI
trainers and trainees withdrew. From then on, there was a decline in the
services of this DTP. The Anantapur project suffered from not being
recognized by the Andhra State government as essentially their
Yet, unmodified NTCP was launched nationally in 1962.
Retrospectively, TB treatment in project mode, separated from
healthcare, was not optimal for success. This flaw, recognized in 1961,
has not been rectified, for which the sharing of health management
responsibilities between GoI and State governments must be re-designed
[14, 18, 19].
Tuberculosis Control in Crisis, 1980s and 1990s
In 1978, BCG vaccination was shifted under the
Expanded Programme on Immunisation. In 1979, preliminary results of the
BCG trial showed no protection against MTb infection [20, 21]. This
unexpected finding evoked scientific discussion but no GoI response
[20-22]. NTCP was now without an effective vaccine to control TB. The
HIV pandemic of early 1980s also did not evoke GoI response until
academic investigators detected it in India in 1986 [13,23,24]. These
glaring omissions of non-response to two major factors adversely
affecting TB control illustrate why Public Health infrastructure,
capable of recognition of all diseases, is unavoidable for their
HIV infection was spreading in India since 1984 [13,
23,24]. Volunteer blood donors, and even pregnant women without
behavioral risk factors, were found infected in 1988/89–the epidemic was
getting into general population [24,25]. West was by then aware of
HIV-TB synergy; in 1992 the first report of clinical profile of AIDS in
India showed TB as the commonest secondary infectious disease .
In 1992, the Swedish International Development
Agency, WHO and GoI evaluated NTCP and found reduction in mortality, but
no reduction of TB burden . Also multi-drug resistance (MDR) in TB
was widely recognized in India [11, 27]
Thus, 5 factors signaled crisis – (i) BCG
without role in TB control; (ii) no alternate primary prevention
tool; (iii) failure of NTCP in reducing TB burden; (iv)
HIV pandemic; and (v) increasing prevalence of drug resistance.
Revised NTCP (RNTCP)
In 1993, the WHO declared TB as a global emergency,
devised the directly observed treatment – short course (DOTS), and
recommended it for all countries [1,7,17]. The NTCP evaluation partners
jointly designed RNTCP the same year. The objectives of RNTCP were to
achieve at least 85% cure rate among the new smear-positive (NSP) cases
of pulmonary TB, and a case detection rate of at least 70% [1,7]. NTCP
had created wide public awareness of TB, 446 district TB centres, 330 TB
clinics and 47,600 hospital beds for TB, treating over 1.3 million cases
annually . In spite of these advantages, there was delay in achieving
RNTCP and DOTS coverage throughout the country–piloted in 1993, launched
in 1997, 50% districts covered in 2003 and all districts covered by 24
March 2006 [1,7, 16,17]. The opportunity of WHO declaring TB as
emergency was not used to put RNTCP on war footing. Instead it took 13
years to build up; meanwhile HIV was spreading; drug resistance was
increasing; and NSP cases were not declining.
The Current Status of TB Situation in India
RNTCP has achieved very high cure rates. For those
diagnosed as NSP TB at the designated microscopy centres (DMS) and put
on DOTS, case fatality has dropped to 4.2 to 4.7% during 2000 to 2003
. Without treatment the case fatality is believed to be about 80%,
suggesting 90% reduction in case fatality. Thus the first objective of
RNTCP is being achieved. WHO estimates overall TB mortality of 26 and
24/100,000 in 2010 and 2011, respectively [2,3]. This translates to
about 1000 deaths a day, or 2 deaths every 3 minutes. TB accounts for
17.6% of all deaths from communicable disease, and for 3.5% of all
cause-mortality, in India . TB continues as India’s public health
The proportion of persons with pulmonary TB getting
treatment is between 59% (WHO) and 70% (RNTCP) [7, 3]. The WHO estimates
that annually there are 2.2 million cases (181/100,000 population),
without appreciable decline over the years . An estimated 40-50% of
those with pulmonary TB seek care in private sector healthcare clinics
[7,3]. They pay for diagnosis and treatment, but get non-standard drug
regimen for less than recommended duration and are believed to
contribute to high case fatality and drug resistance .
The current estimates are that at least 3% NSP cases
and 12% those with relapse have MDR TB [11,29]. Only after failure of
DOTS to cure TB is sputum cultured for drug sensitivity test (DST) under
RNTCP, thus delaying detecting drug resistance. Recently extensively
drug resistant (XDR) TB has been detected in several tertiary care
institutions in India .
The current annual economic loss to the country on
account of TB is estimated to be Rs. one lakh and two thousand crores ($
23.7 billion) . But India had been spending only about Rs. 500
crores ($ 100 million) on TB control [5, 30] which was raised to around
$ 200 million recently . Independent assessment puts the requirement
for effective TB control as over Rs. 3000 crores ($ 600 million) .
Thus TB acts as a spotlight on several deficiencies of the health
management system: the lack of public health infrastructure; failure to
apply epidemiology in disease control; the neglect of health economics
resulting in unwillingness to allocate sufficient funds to face a
national health emergency like TB.
Pediatric TB, the Achilles Heel of TB Control
When RNTCP was designed, the final result of the
15-year Chingleput BCG trial had not been fully analyzed and published
. There was lingering hope that the interim data analysis (1978-79)
was incomplete and that the final results would prove BCG a tool of
primary prevention. However, BCG showed no efficacy against MTb
infection or reactivation of latent infection . Thus, TB control had
to be re-designed . The objective of 70% case detection and 85% cure
were set on modeling but not field evaluation . We do not believe
DOTS alone will control TB, even if rates of case detection and cure
increased further [8,10]. Addressing childhood MTb infection is key to
TB control [8-10].
Recognizing this need, a workshop on childhood TB was
organized in 2003 by TB experts of RNTCP and Indian Academy of
Pediatrics. Its recommendation was: "Asymptomatic children under 6
years of age, exposed to an adult with infectious (smear positive)
tuberculosis, from the same household, will be given 6 months of
isoniazid (5 mg per kg daily) chemoprophylaxis" . It was agreed
that "pediatric-focused monitoring may preferably be an integral part
of the programme" and that "A revision of the RNTCP training
modules will be undertaken to include pediatric TB issues" .
Thus, tracing of household contacts of NSP cases is
an added intervention; all under-6 children are to be screened for
symptomatic TB and treated if so diagnosed. All others ought to be
offered INH preventive treatment. The underlying assumption is that all
such children would already have been infected by the NSP case of
pulmonary TB. In a study with careful search, 100 at-risk children were
screened; 99 were infected, among whom 55 had chest radiographic signs
of TB [33,34]. The assumption that all <6 children would have been
infected may reflect reality . If given prophylaxis, they will be
cured of infection. The critical value of this intervention has not been
widely appreciated . In Krishna district (Andhra Pradesh), among 825
NSP case households 172 contacts <6 were enumerated; two-thirds had been
screened for TB disease and none found . Ninety seven children (84%)
were initiated on Isoniazid preventive therapy but the remaining 16
children were not treated for want of drugs at the health centre .
In the former study pediatricians, and in the latter paramedical workers
screened children for symptomatic TB. The contrast is striking;
unfortunately RNTCP does not have sufficient medical officers to do
follow-up in families of NSP TB patients. These two studies illustrate
the complexity of contact tracing, screening, and preventive therapy.
Currently coverage is less than optimal. About half of TB cases are seen
in private sector and lost from TB Registry; children in such households
are not even identified. If screening is suboptimal, children with early
TB disease may receive INH monotherapy, which is unsound medical care
Preventive treatment can sterilize latent infection.
From this viewpoint, preventive chemotherapy is the only biomedical TB
control intervention we have, while DOTS is the mortality reduction
intervention that will enable the buy-in of TB control by the public.
Detection of pediatric MTb infection has to be brought under systematic
management; pediatric TB disease has to be kept under close clinical
scrutiny. In countries practicing Public Health surveillance, 20-25% of
all TB is in children. In India the proportion of childhood TB is a mere
2%, illustrating its gross neglect .
The magnitude of childhood TB disease is unknown in
India. Regional data from the WHO in 2007 showed that smear-positive TB
in children aged <14 years accounted for 0.6%–3.6% of reported cases.
However, because <95% of cases in children <12 years of age are smear
negative, these data underestimate the true burden of TB . It is
estimated that in developing countries, nearly 8-20% of the deaths are
caused by pediatric TB .
Infected children accumulate in the ‘pool’ of latent
infection, from which individuals exit with disease . TB control
requires shrinking of the magnitude of the pool. If detection of
pediatric MTb infection has to be brought under systematic management,
pediatric TB disease has to be kept under close clinical scrutiny. Only
in May 2012 has TB been made "notifiable," endorsing the arguments about
the critical need for complete data on TB cases [8, 40].
We have proposed the definition of TB control as 5-
10% annual reduction of the incidence of MTb infection in children,
monitored through tuberculin skin testing [9, 10]. This is realistically
achievable. A nation-wide survey in India among young children showed
very high figures of annual risk of MTb infection (ARTI) in almost all
the regions- highest in north zone (1.9%) followed by west zone (1.8%),
east zone (1.3%) and lowest in the south zone (1.0-1.1%) . Under
NTCP the goal of achieving a level of ARTI of 1% during the first 14
years of life had been mooted . That translates as ARTI of 0.07% from
infancy till 14 years. Reduction by 5% annually will result in 0.07%
incidence of infection in 20 years; reduction by 10% will achieve it in
10 years [9,10].
The Way Forward for TB Control In India
Controlling TB is an extremely complex task but it is
extremely urgent also. Under India’s Constitution, responsibility for
disease control belongs to GoI and healthcare to State. Although TB
control is a GoI project, the tool of intervention is healthcare– case
diagnosis and treatment. All healthcares are shared between public and
private sectors; hence the success of TB control will depend upon how
well these 3 partners cooperate in managing and monitoring TB in a
seamless manner. Thus, TB control is in urgent need of re-design.
Healthcare functions on the basis of personal demand.
TB treatment also, if in healthcare, is demand-driven. In RNTCP the
intention is to shift it to project-driven, free, full course treatment,
for which supervisory responsibility is assumed. Yet, half of lung TB
cases and the lion’s share of extra-pulmonary and pediatric TB cases are
managed outside RNTCP ; if we should bring protocol-based diagnosis
and treatment, healthcare has to be supervised, regulated and also
helped by locally present and overarching Public Health. Public Health
laboratories must be equipped and ready to assist with control of TB and
The obvious way to achieve this is to reinstate
Public Health department under GoI with functional presence and mandate
in all States and districts [14,19]. All vertical disease control
projects should then be shifted under Public Health. We do not see any
alternative to such re-engineering of health management in India for not
only efficient TB control but also control of all diseases.
Public participation needs to be built into TB
control. Innovative ways of public education and empowerment are
essential. Citizens should know TB is infectious and treatment is of
long duration; completion of treatment is in the interests of all –
affected and unaffected individuals including children. We must educate
the public to adopt hygienic behaviours – of not spitting in public
spaces and observing cough/sneeze etiquette.
Case detection has to reach as near 100% as possible;
for this, innovative ways of building public-private partnering has to
be accomplished in every community, especially in sub-districts, under
supervision of the district RNTCP unit. Anti-TB drugs should be
restricted from over-the-counter dispensing; alternatively such
prescriptions should be notified on par with TB cases.
TB may affect any organ system; therefore, all
medical and surgical subspecialties that treat TB must be brought under
Public Health surveillance. Such gathering of information is not
realistic for just one pathogen; all pathogens under Public Health
purview must be made notifiable. A model for decentralized and
response-demanding disease surveillance has been tested successfully in
India . The Integrated Disease Surveillance Project, as currently
conducted, unfortunately, does not satisfy the definition or
requirements of Public Health surveillance or of disease control .
TB diagnosis and treatment in the private sector
ought to be registered with RNTCP and monitored for quality and
outcomes. Around every diagnosed person with TB, adult and child, active
search and standard management for latently infected and symptomatic
cases must be enforced. All data should be supported by information
technology for ready access and follow up.
Currently there are built-in delays in TB diagnosis
and also detection of MDR TB. There are newer techniques available to
shorten such intervals and they should be systematically included in
RNTCP. Under RNTCP, a second sputum screening to detect treatment
failure (for MDR TB) is collected after 2 months of therapy. This
interval ought to be reduced to 2 weeks to detect MDR status at the
earliest. Healthcare deserves assistance in access to diagnostics – both
classical and modern. GoI ought to invest at least $ 600 million, if not
1 billion, annually for TB control as we are losing >23 billion from
national wealth. Budgeting 100-200 million appears to be indicative of
inadequate seriousness given for TB control .
All pediatric clinics should be linked to RNTCP so
that case-detection rate is increased. As part of ‘well baby’ checks,
all children ought to be tuberculin tested at 5 and 10 years and
appropriate management applied if found positive. Until this
intervention becomes operational, annual skin test surveys should be
conducted to document and monitor ARTI and its annual decline.
TB control is both a means to, and a measure of,
economic and social development. These many additions to the DOTS
strategy require a reorganization of the health management approach in
India. TB control must be owned by States and Districts – for which
flexibility in interventions and freedom to innovate must be given to
them, while regularly auditing the performances at the district level.
Such external auditing should be in addition to internal (within
district) auditing of the performance by the district RNTCP staff
themselves. All tools and parameters for auditing have to be developed
To conclude, there is an urgent need to relook at the
strategies of TB control in India with openness to accept the need for
redesigning, particularly the way pediatric TB is dealt with. The
efforts to control TB must be comprehensive, addressing all the elements
necessary in this national massive initiative. They include effective
health education, strong Public Health, functional surveillance, sound
public-private partnership, and more liberal financial support.
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