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.
|District TB Programme|
Based on the findings of the operational studies conducted, a draft recommendation for the District Tuberculosis Programme was prepared in 1961, keeping in mind an average Indian district, its population and health facilities available. The national programme policy as enunciated in the introduction manual of DTP comprised:
|Anantapur: The first model DTC|
Anantapur district was chosen to establish the first model district TB centre (DTC). This programme aims at the integration of TB control schemes with the existing government health services to reduce the TB problem in the community as economically as possible. In the DTC, the X-ray examination facilities were provided on three days in a week and sputum examination daily.
Shortly after establishing the Anantapur DTC it became evident that case finding could be done at any place without difficulty but the major problem was that of keeping the patients on continuous treatment. Considerable time and effort was devoted to solve the problem of default. Only 66% of the TB patients were taking drugs regularly with a defaulter rate varying from 20% to 54%, with an overall average at 34%.
The Anantapur DTC became operational quickly and functioned well because, in addition to the state government’s component, NTI staff also worked. By October 1961, NTI trainers and trainees withdrew. From then on, there was a decline in the services of this DTP. The Anantapur programme suffered from not being recognized by the Andhra State government as essentially their responsibility.
|Controlled clinical trial for efficacy of BCG vaccine|
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.
|Era of short course chemotherapy|
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 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.