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Guest Lecture

JOURNEY OF TUBERCULOSIS CONTROL MOVEMENT IN INDIA: NATIONAL TUBERCULOSIS PROGRAMME TO REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAMME* Prahlad Kumar** Summary: The presentation passes through the saga of important landmarks of the past dealing with Era of prechemotherapy, Conventional and Short Course Chemotherapy (SCC) over two decades and the present era of Directly Observed Treatment Short course (DOTS) spanning more than a decade. It also touches upon the likely challenges to be faced in the near future for Tuberculosis (TB) control. [Indian J Tuberc 2005; 52:63-71] Key Words: Tuberculosis, Revised National Tuberculosis Control Programme, Chemotherapy

INTRODUCTION It is indeed a great honour showered upon me by the Tuberculosis Association of India (TAI) to deliver the prestigious Dr. O.A. Sarma, Guest Lecture in the 59th National Conference on Tuberculosis & Chest Diseases being held at New Delhi. I thank the TAI, New Delhi for having selected me for presenting this oration. Era of Pre-chemotherapy

many facets of research in prevention, control and therapeutic aspects of the disease. He was awarded the Nobel prize in 1905. Unfortunately, there was no breakthrough in the treatment of TB for a long time to come. The only available mode of treatment was isolation, providing good food and ventilation in a sanatorium. This used to be a common practice in Europe during prechemotherapeutic era. •

In India, the first open-air sanatorium was established during the year 1906 at Tilonia near Ajmer. The second came up at Almora in 1908 for isolation and treatment of TB patients. In south India, United Mission Tuberculosis Sanatorium was established in the year 1912 at Madanapalle.

•

The Tuberculosis Association of India was started in February 1939. Dr. C Frimodt Moller and Dr. B.K. Sikand took a lead in starting the Association1.

Tuberculosis has been recognized as one of the most ancient diseases which finds a place in the works of Ancient Ayurvedic System practised by Sushrutha, Charaka and others around 2500 BC. It is stated in the literature that the disease process can result from imbalance in the homeostasis which can be due to variation in Vata (combination of Air & Earth), Pitta (Fire) and Kapha (Water & Earth). It has also been documented in the Vedas and Ayurvedic Samhitas as early as 2000 BC. There are archaeological evidences of spinal TB in the Egyptian mummies dating back to 1000 BC.

BCG Campaign in India

As we all know, 24th March 1882 is a landmark day, as on this day, Robert Koch announced the discovery of causative organism of TB. This brought to the forefront, a totally new era in the struggle against TB. Its relevance continues till date. Koch’s discovery inspired

Bacillus Calmette Guerin (BCG) vaccination was the only avenue for protection and prevention of tuberculosis. As a preventive measure, it was extensively used in most of the European countries 2 in 1920s. Dr. J. Frimodt Moller introduced BCG vaccination in India for

* Dr. O.A. Sarma’s Guest Lecture delivered at the 59th National Conference on TB and Chest Diseases held in New Delhi from 3rd to 6th January, 2005 ** Director, National Tuberculosis Institute, No.8, Bellary Road, Bangalore 560 003 email: [email protected]

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the first time in the year 1948. Around the same time, BCG vaccine production centre was also established in Guindy, Chennai with the assistance of WHO and UNICEF. Mass BCG vaccination took off on a large scale in India in early 50s. The development of anti-TB drugs was chequered and sporadic over a period of two decades starting from 1940s. Streptomycin and Para-Amino Salicylic Acid (PAS) were first introduced in 40s followed by Thioacetazone and Isonicotinic Acid Hydrazide (INH) in 50s. This gave a global impetus for treatment and control of TB. In 1951, these drugs were tried out on smaller scale in a limited number of patients in India by Dr. Sikand from New Delhi TB Centre3, Dr. Sen from Calcutta in 1952, Dr. Frimodt Moller from Madanapalle4 in 1953, and Dr. Sikand & Dr. Pamra from Delhi5 in 1956. The Bhore Committee report in 1946 had come out with an estimate that there were about 2.5 million patients requiring treatment in the country and only a few thousand beds were available which indicated a wide gap that had to be bridged 6. The committee recommended establishment of an organized domiciliary service by setting up of TB clinics in the districts and mobile TB clinics for rural areas. Around the same time, a TB Division was set up under the Directorate General of Health Services, New Delhi. With this turn of events and keeping in view the sheer magnitude of the disease, it was felt that the government should be a key player in initiating measures to control the disease. The following steps were taken in that direction. n

Dr. P. V. Benjamin, as a member of the Health Planning Cell in the Planning Commission, was instrumental in initiating the Indian Council of Medical Research (ICMR) sponsored National Sample Survey (NSS). The NSS (1955 to 1958) was an eye opener, which revealed that the problem of TB was uniformly distributed, both in the urban and rural population of the country 7. On an average, the bacillary cases were 4/1000

Indian Journal of Tuberculosis

and X-ray active cases 16/ 1000. n

Dr Benjamin was also a driving force for establishment of the Tuberculosis Research Centre (TRC) at Madras, earlier known as Tuberculosis Chemotherapy Centre (TCC). The TCC carried out an epoch-making study in 1956 which indicated that domiciliary treatment for pulmonary tuberculosis was as effective as treatment in sanatorium. Bed rest and balanced diet contributed very little in the final treatment outcome 8.

With the path-breaking findings of the above studies, it was logical to formulate a nationally applicable TB control programme in the country. This process was initiated under the dynamic leadership of Dr. P. V. Benjamin, by establishing National Tuberculosis Institute (NTI), Bangalore 9 in the year 1959. The primary purpose of establishing the NTI was to formulate a nationally applicable programme for TB control, training of district TB key personnel and orientation training for medical officers and paramedical TB workers. The National TB Control Programme (NTCP) formulated in 1962 and implemented throughout the country with limited resources was to create a good infrastructure in most parts of our country. A large number of key personnel of District TB Centres were trained in carrying out NTCP activities. It was also engaged in monitoring the TB control programme and providing feedback from time to time both to the central and state authorities. National Tuberculosis Institute has conducted several important studies on different aspects of TB disease: epidemiological, operational, sociological and bacteriological studies. These findings have been found useful in improving the TB control strategies. Of the several breakthrough studies carried out during this period, the following need special mention as they formed the foundation for the programme: –

The sociological study of awareness of symptoms suggestive of pulmonary TB

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–

study by Dr. D. Banerji et al10. Tuberculosis in a rural population of South India: A five-year Epidemiological study 11.

Era of Conventional Chemotherapy (1961 1986) An integrated NTP was pilot tested in Ananthpur district of Andhra Pradesh during 1961 and thereafter the programme was launched in a phased manner throughout the country. It would not be out of place to discuss the use of BCG for protection against pulmonary tuberculosis. Controversy of protective effect of BCG lingered as the studies carried out in different countries showed the protective effect of BCG to vary from 0-80%. A decision was taken by Government of India (GOI) to carry out a meticulously designed controlled trial for testing the efficacy of BCG vaccination12 in 1968. Dr. Raj Narain, Epidemiologist of NTI, was instrumental in organizing and conducting the field work for this study in Chingleput district of

Tamilnadu. After 12 years of follow-up, the study revealed that BCG was not affording protection against pulmonary TB. After an indepth review, it was decided to continue with BCG vaccination in children as it was observed to substantially protect against childhood forms of TB. He was also responsible for many classical morbidity surveys. He can rightly be called the father of Epidemiology among the TB workers. This had wide implications as mass BCG campaign had already taken roots and was in full swing. The programme was expanded in a phased manner to cover 364 districts using R1 to R5 regimen and monitoring being taken up on a regional basis initially and thereafter NTI took up the monitoring work for the entire country 13 . From the analysis of monitoring reports and the observations made in a number of studies, it stood out prominently that the compliance with anti-TB treatment for 12 to 18 months was a big problem under field conditions. Researchers had already demonstrated that the duration of treatment could be brought down to 6-8 months.

DRUG REGIMENS IN NTP Code No. R1 R2

R3 R4 R5

Mode & Rhythm of administration

Drugs & Dosage

Isoniazid 300 mg + Thioacetazone 150 mg.

Both drugs in a single dose or in two divided doses orally, daily

Bi-weekly regimen Inj. Sterptomycin 0.75 g / 1 g. + Isoniazid 600 to 700 mg, Pyrodoxine 10 mg.

Intramuscularly orally

Isoniazid 300 mg + PAS 10 g. Isoniazid 300 mg + Ethambutol 800 mg. Bi-phasic regimen Intensive phase Inj. Streptomycin 0.75 g / 1 g. + Isoniazid 300 mg + Thioacetazone 150 mg or Ethambutol 800 mg. Or PAS 10 g. Followed by continuation phase of 10 – 16 months duration

In a single dose or in two divided doses. Both drugs orally, daily Both drugs in a single dose, daily, orally First two months Intramuscularly daily In single dose orally, daily, (Thioacetazone and PAS may be given in two divided doses)

Total duration of treatment = 12 to 18 months

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SHORT COURSE CHEMOTHERAPY REGIMENS UNDER NTP DTP Code

RA

RB

Drug Regimen with Dosage

Category of patient

2EHRZ/6TH a) Intensive Phase EHRZ (2 months) b) Continuation Phase HT (6 months) H=300 mg & T=150 mg

All new smear positive patients and seriously ill extra-pulmonary TB cases

2SHRZ/2S2H2R2 a) Intensive Phase (2 months) S=0.75g, H=300mg, R=450mg & Z=1.5g b) Continuation Phase (4 months) S=0.75 g, H=600 mg & R=600 mg

Failures and relapses

Era of Short course chemotherapy (1986 -1993) At this juncture, the name that first strikes the mind is that of Dr. Wallace Fox who, through British Medical Research Council units in East Africa, India, Hongkong and Singapore, handed over the greatest gift to the world i.e., SCC. He is considered as the father of clinical trials for chemotherapy of TB. It takes decades for a dedicated and devoted researcher engaged in research to come to a logical conclusion. With the introduction of Rifampicin and Pyrazinamide in the developed countries in early 1960s, a new era started in the battle against TB. This has been a very important milestone in the fight against TB on a global scale which brought enormous hope of early TB control. This finding enabled to cut down the duration of treatment to 6 -8 months.

reviews were carried out in India18,19. However, there was no concrete follow-up action on the recommendations of these committees. Following the global review of the programme 20, WHO in 1993 declared TB as a global emergency. Era of Directly Observed Treatment Shortcourse (DOTS) -1993 -2005 In 1992, GOI-WHO carried out an indepth review of TB programme in India as a part of global review and observed glaring deficiencies viz.: < < < <