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TB
is one of the most ancient diseases. It has been referred to in the Vedas and
Ayurvedic Samhitas. In India, the first open air sanatorium for treatment and
isolation of TB patients was founded in 1906 in Tiluania, near Ajmer, followed
by one in Almora two years later. In 1909, the first non-missionary sanatorium
was built near Shimla. Upon the earlier work done by Dr Louis Hart from 1908,
the United Mission Tuberculosis Sanatorium (UMTS) was built in 1912 at
Madanapalle, south India. Dr Frimodt Moller the first Medical Superintendent
played a large role in India’s fight against TB through the training of TB
workers, conducting TB surveys (1939) and introduction of BCG vaccination
(1948). In addition, the first TB dispensary was opened in Bombay in 1917,
followed by another in Madras. Soon anti-TB societies were formed in Lucknow
and Ajmer.
Dr
Lankaster, taking into cognizance the high incidence of TB infection,
recommended that the government should work closely with the non-governmental
organizations (NGOs) and support their activities. Following this suggestion,
India became a member of the International Union Against Tuberculosis (IUAT) in
1929. In 1937, Her Excellency Lady Linlithgow issued a public appeal for
anti-TB funds on behalf of the government. As a result, nearly a crore of
rupees was collected; 5% of this money was retained by the center and the
balance was distributed to the provinces and states. With the help of this 5%
direct donation and the King George V Thanksgiving (Anti-TB) Fund, The TB
Association of India (TAI) was formed in February, 1939. The provinces and
states which received money also started their TB associations. The Bengal TB
Association, however, had been functioning from 1929 and maintained
dispensaries in Calcutta and Howrah. Its activities were strengthened by this
funding. In 1946 there were only 6000 beds available for the treatment of TB
patients. The Bhore Committee estimated that there were about two and a half
million patients in need of treatment and half a million deaths annually. For a
huge country like India, which included Pakistan and Bangladesh in those days,
the sporadic efforts of NGOs were not adequate. The government had to
intervene. However, the issue of diagnosis, let alone treatment, remained
unresolved. Only by 1925, chest radiology could detect a deep-seated area of TB
consolidation and thoracic surgeons began to demand X-rays. By 1945, the
capability of the apparatus was enhanced to embody the MMR version.
As no
drug or combination of drugs were effective against TB till middle of the 20th
century, the main line of treatment was good food, open air and dry climate.
Till the advent of adequate chemotherapy, treatment took a second place to
diagnosis and prognosis. In 1939, the TAI recommended the Organized Home
Treatment Scheme as the best compromise under the prevailing circumstances.
Meanwhile,
the Second World War broke out. Fighting diseases took a back seat. However, a
TB Division in the Directorate General of Health Services (DGHS), was
established in New Delhi in 1946, with an Adviser in TB as its head. TB was
also given a prominent place in the planning. Since the government was not only
concerned with TB but with other diseases and health infrastructure, it
constituted a committee under the chairmanship of Sir Joseph Bhore. Its
secretary was Rao Bahadur KCKE Raja, who as the Director General of Health
Services (DGHS) played a dominant role in the TB field during his tenure. The
Bhore Committee, which published its report in 1946, placed organized
domiciliary service at the forefront of the programme. It recommended setting
up of a clinic for each district and the use of mobile clinics for rural areas.
BCG
vaccine, named after the two scientists who developed it, stands for Bacillus
Calmette Guerín.
BCG work started in India as a pilot project in two centers in 1948. In 1949,
it was extended to schools in almost all states of India. Under the aegis of
the International Tuberculosis Campaign, which had considerable experience in
BCG work in many countries, it was introduced in India on a small scale in
Madanapalle with Dr Frimodt Moller in the lead. India started a mass BCG
Campaign in 1951. A BCG Vaccine Production Center in Guindy, Madras was set up
in 1948. WHO and UNICEF provided support.
The very
notion that there could be effective drugs against the tubercle bacilli was so
revolutionary that researchers began to experiment on the effective dosages and
combinations of drugs to be used. The issue of affordability was also
considered. In the 1949 Annual TB Workers' Conference, several papers were
presented on the effects of PAS and SM on the patients and on the distribution
of SM in India. In 1952 Drs Robitzek and Selikoff revealed that INH is a
miracle drug against TB and it continues as such till date.
In 1953,
Frimodt Moller reported remarkable results with the regimen SM and INH, single
and combined, in the treatment of pulmonary TB in Indian patients. In 1956, Drs
Sikand and Pamra presented a paper on the “effect of SM, PAS and INH in 703
cases of pulmonary TB, diagnosed and treated during 1951-53”. They found that
the results of domiciliary treatment were encouraging enough to warrant a shift
of emphasis from hospitals and sanatoria to clinics without waiting for any
further trials.
These
studies would, in time, revolutionize the management of TB all over the world.
However, it soon became apparent that the tubercle bacilli could not be
destroyed easily even with drugs. The tubercle bacilli had powerful survival
techniques, besides developing resistance to drugs. Trials indicated that the
newly available drugs, when used singly, were effective only for short periods.
To be effective, conventional treatment had to be continued for at least 12-18
months. This brought with it several problems. How many patients would continue
to take medicines for such a long duration? How to keep track? Further research
was, therefore, needed to harness the potential of these newly discovered
drugs.
In the
mean time, the government in 1956 had established the Tuberculosis Chemotherapy
Center, later known as Tuberculosis Research Center (TRC) in Madras (Chennai),
under the auspices of the ICMR, Government of Madras, WHO, and the British
Medical Research Council (BMRC). This Center was to provide information on the
mass domiciliary application of chemotherapy in the treatment of pulmonary TB.
It demonstrated that the time-honoured virtues of sanatorium treatment such as
bed rest, well-balanced diet and good accommodation were remarkably unimportant
provided adequate chemotherapy was prescribed and taken. Further, there was no
evidence that close family contacts of patients treated at home incurred an
increased risk of contracting TB. Therefore, it would be appropriate to treat
infectious patients in their own homes. This finding revolutionized TB
treatment the world over.
National
Tuberculosis Institute (NTI) was established in 1959 to evolve through research
a practicable TB programme that could be applied in all parts of the country.
This Institute would train medical and para-medical workers to efficiently
apply proven methods in rural as well as urban areas.
In 1950,
Dr P V Benjamin reported that tuberculosis infection is so widespread that no
part of the country is free from it. The subsequent BCG campaigns revealed
similar findings. However, this needed to be checked by scientifically
conducted surveys.
For a
country as large as India, the sample of one area was inadequate. Reliable
information on the magnitude and extent of the disease in the various cross
sections of the population was required. This was not an easy task. Apart from
resources, trained personnel to conduct large- scale surveys was not readily
available. A special committee of the ICMR was set up to address the issue of
obtaining this information expeditiously and rationally. It decided that a
systematic survey on a countrywide basis should be undertaken.
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NTI
was also concerned with the efficacy of the BCG vaccine itself. BCG vaccination
was the only available protective measure against TB. Different trials had not
revealed credible proof of its efficacy. Many, including late Sri C
Rajagopalachari, even thought that its efficacy was not fully proven and
strongly advocated against its continued large-scale use. It would be in the
interest of the country to undertake a well designed trial to seek clear
answers to the major issues confronting it. Therefore, the NTI had been
vigorously planning to conduct a major BCG trial and had even reserved certain
areas in the country as vaccination-free zones. It was in touch with the
international scientific community, various vaccine production centres and in
the field. In January 1964, it initiated intensive discussions with the WHO
experts and representatives from United States Public Health Service (USPHS).
It was agreed that any trial undertaken must not interfere with the progress of
NTI and NTP; and because such a trial was expensive and prolonged, it would
have to be designed with utmost care and efficiency.
Ultimately,
the project named Feasibility Study for TB Prevention Trials became part of the
ICMR and moved out of the campus to its own building. In time, its studies
showed that the major BCG trial would be best if conducted in Chingleput
district of Tamil Nadu than in other areas reserved for the purpose. Field work
began and the office was moved to Madras. In spite of shifting of the project
camp to Madras, NTI continued to assist the BCG Trial by providing technical
guidance and replacement of staff. When Dr Raj Narain, Epidemiologist of NTI
retired, Dr Baily, TB Specialist of NTI joined as the Director of this study
and continued to serve till the first report was published.
The BCG
trial was completed as scheduled. After a period of twelve and a half years, it
brought out a revolutionary report. It showed that BCG vaccination did not
offer significant protection against TB of the lung. Several expert committees
appointed both by the authorities in India and by the WHO examined all the
procedures followed up in the study and came to the conclusion that the study
had been meticulously carried out and vaccine used in the trial were the best
available ones. The implications of this study was: Should BCG vaccination be
given up in India? Another committee appointed jointly by ICMR and the WHO went
into the epidemiological aspects of the causation of TB under Indian
conditions. It concluded that though BCG may not protect against TB of lung
which occurs mostly in adults, it could provide substantial protection against
childhood forms of TB such as tubercular meningitis, miliary TB. The protective
effect of BCG against these forms of TB was not studied in Chingleput Trial. In
India BCG vaccination policy was revised and it was recommended to be given at
an early age preferably before the end of the first year after birth by
integrating under UIP. BCG vaccination policies in many other countries were
also revised as a consequence of the Chingleput study findings.
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Chemotherapy
of TB underwent revolutionary changes in the seventies owing to the
availability of two well-tolerated and highly effective drugs – rifampicin and
pyrazinamide. These drugs allowed short course chemotherapy (SCC) and made it
possible to simplify treatment and reduce its duration. Discovery of rifampicin
in 1967 is considered as one of the greatest achievements in the history of
development of anti-TB drugs. After its discovery no new drug has been found.
Monitoring
of the programme It is not possible to measure disease burden accurately
through monitoring. However, it is an important tool to evaluate the
performance of the units of the DTPs in an ongoing manner and take corrective
action simultaneously. This would improve the programme efficiency on a regular
basis. Till 1978 monitoring of the programme was done by northern and southern
regional centres and from then by NTI only.
The
Evaluation of the NTP
The NTI had
believed in assessment and evaluation as an ongoing process. It welcomed the
idea of periodic assessment, especially from experts, on scientific lines as
they are vital to the growth and improvement in the programme.
The NTP
was evaluated by three agencies, ICMR, Institute of Communication, Operations
Research and Community Involvement (ICORCI) and WHO.
In 1992,
the Government of India, together with the World Health Organization (WHO) and
Swedish International Development Agency (SIDA), reviewed the national
programme and concluded that it suffered from managerial weakness, inadequate
funding, over-reliance on x-ray, non-standard treatment regimens, low rates of
treatment completion, and lack of systematic information on treatment outcomes.
As a result, a Revised National Tuberculosis Control Programme (RNTCP) was
designed.
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