In the formulation and evolution of a National Tuberculosis Programme some assumptions are made which require to be tested under the normal administrative set up with minimum interference by the investigating team. The objectives of the study were to understand some operational aspects of Case-finding in the Peripheral Health Institutions (PHIs) in an integrated programme. First, what is the frequency of persons showing symptoms suggestive of pulmonary tuberculosis among the normal out patients attendance (OPA), how many cases can be found by direct microscopy of sputum of those symptomatics, what will be the workload of TB Case-finding at a PHI and, what proportion of symptomatics will be willing to and will actually attend the District TB Centre (DTC) when referred there for X-ray examination. The study was conducted in a district with a population of 1.5 million having one DTC and 55 PHIs. 15 PHIs were selected on the basis of stratified random sampling. At each PHI an National Tuberculosis Institute (NTI) investigator worked for a period of one month. All new out patients were questioned for symptoms (non- suggestive and suggestive) and any patient with chest symptoms mainly cough for more than one week fever, chest pain and haemoptysis was subjected to a sputum examination and also referred for X-ray examination at the DTC.

It was found that 381 (2.5%) of the 14881 total new out patients of all age groups complained of cough for 2 weeks and more. From these chest symptomatics, 11% were new cases of pulmonary tuberculosis. When the symptomatics were referred for X-ray examination, although 66% agreed to go for X-ray to DTC but only 16% (of the total referred) actually went for X-ray. Each PHI had to examine only one or two sputum specimens per working day. As the study was conducted in a representative sample of PHIs for a representative duration of time, the material permits the estimation of the potential yield of cases in a District TB Programme (DTP) during a period of time (say one year). It was estimated that about 45% of the total estimated prevalence cases in a district can be diagnosed in a DTP during a period of one year, if all PHIs function according to the programme recommendations. The workload due to tuberculosis Case-finding is small and can be managed with the existing staff and Case-finding by direct smear examination of sputum at the PHI has to be relied upon.

In 1975 recognising the importance of the TB problem, Govt. of India, Ministry of Health & FW, on suggestion of TB Association of India, requested ICMR to constitute an Assessment Committee who should evaluate the National Tuberculosis Programme (NTP) and submit a report. A committee consisting of five members reviewed the NTP in terms of i) aims & objectives of the programme, ii) implementation and iii) performance at various levels. Its shortcomings and various factors responsible were identified. Recommendations to improve the functioning of NTP in all the aspects were suggested. The country was divided into 5 zones; south, west, centre, north and east. Two District TB Centres (DTCs) from each zone were selected for the study. The data was collected by posting proformas to all the State and Union Territories and by visits of the expert committee members in groups to different regions in the country. The members obtained information from state headquarters, DTC, Primary Health Centre (PHC) and villages.

The committee observed that the general pattern of the District TB Programme (DTP) does not require any change; however, it requires strengthening in many ways. The performance of the DTC and Peripheral Health Institutions (PHIs) was found to be far from satisfactory in terms of Case-finding, case holding and BCG vaccination. Since the implementation and supervision of the programme was the responsibility of the State and which were found to be the weakest components of the programme, it was strongly felt by the committee that the programme should be made a truly national programme by making it centrally sponsored for the next 10 15 years and the centre should exert direct control over the programme instead of being left to the state for administering it. The committee observed that the programme has not been implemented in 57 districts in 15 States especially in Bihar where out of 31 districts only in 3 districts the programme has been implemented. Utmost priority should be given to implement the programme in the remaining districts especially in Bihar. The integration of programme with the General Health Services has not been satisfactory thus leading to poor functioning of Peripheral Health Institutions (PHIs). The poor performance of DTP was mainly due to limited contribution by the PHIs. The other shortfalls observed by the programme were lack of adequate supervision and control by the State TB Officer (STO), District TB Officer (DTO). Most of the centres including DTC were mainly serving the patients of the town in which they were situated. Thus, a large part of the rural area was not covered by the programme. The drug supply was adequate throughout the country except SM & PAS in some states where doctors were fond of using SM for every patient and preferred PAS to Thioacetazone as standard companion drug. There was shortage of MMR films and lab reagents in many of the DTCs. Equipments like MMR, microscopes, and vehicles were out of order for long periods for want of maintenance facilities. It was recommended that the Central Government should have equipment maintenance organisation and should be responsible for supply of the drugs, equipments, films and maintenance of the equipments. The status of the Tuberculosis Adviser should be of the rank of Deputy Director General, State TB Officer that of Deputy Director, Health Services and the DTO that of the DHO/DMO. There should be 5 Regional Centres with a Deputy Director In charge, supervisory staff and adequate funds. The functions of the Regional Centres will be to exercise supervisory control over the programme in the region. BCG vaccination coverage in the eligible population of 0 19 years age was found to be 10%. It was decided to change the strategy of BCG from mass approach to the integrated one i.e., with immunisation programme, for effective coverage. It is desirable to have periodic evaluation of the NTP. Therefore, there should be a permanent evaluation cell at the centre. There should be one TB worker and one microscopist exclusively for tuberculosis work at every PHC. There should be active community participation in the villages. The village headman and teachers should give adequate publicity for sputum examination and regular treatment. The TB workers at all levels should be debarred from private practice and should be given suitable non- practicing allowance. Active involvement of other governmental bodies like ESI, Army Health Services, CGHS, Railways etc., in the tuberculosis control by providing Case-finding and treatment facilities to all their beneficiaries and eligible patients as per the programme recommendation. Of the five State TB Demonstration Centres the work was found satisfactory only in Nagpur. Some training activity was going on there. Lack of political will and all pervading human apathy was visible at all levels. The committee felt that a strong 'political will' to give due priority to the programme was required.

The current National Tuberculosis Programme (NTP) was evolved by the NTI, Bangalore in 1962 after conducting a series of Epidemiological, Sociological and Operational Studies. The programme is integrated with the General Health Services (GHS). In spite of its sound conceptual and structural foundation, the programme performance was below expectation. Government of India had evaluated the reasons of low performance through a study group constituted by Indian Council of Medical Research (ICMR), in 1975 but the programme did not improve either due to non-implementation of the recommendations of the ICMR committee or they were not effective. The Institute of Communication, Operations Research And Community Involvement (ICORCI), an independent agency was asked by the Government of India to have an in depth evaluation of NTP. The terms of reference for this evaluation were to review the Objectives, Implementations & Expectations of the NTP along with various factors responsible for short fall and give recommendations to improve its performance. The evaluation was generally through routine quarterly reports received by NTI and information collected on the spot during the actual field visits made by the multi disciplinary expert group of ICORCI. A total of five states were selected. From among the total districts of these states, nine districts were picked up by composite index methodology and from each district, two PHCs were selected on the basis of performance.

OBSERVATIONS: About 15% of the districts are still without DTP. There was an increase of X-ray examinations per DTP by 1.4 times from 1981 to 1987, the percentage contribution of PHIs to new sputum examination increased from 34 in 1981 to 72 in 1987 leading to 1.44 increase in diagnosis of cases. Sputum positivity rate decreased from 13.6 in 1978 to 6.7 in 1987. The percentage contribution by PHI in case detection increased from 35 in 1981 to 40 in 1987. Number of suspect cases increased 1.8 times in 1987. There were wide variations in the X-ray positivity rates between the states, throwing doubt about the quality of X-ray reading. Suspect cases form 78% of all types of Tuberculosis cases diagnosed in 1987. This was much higher than the expected 43% according to NTI studies and indicates considerable over-diagnosis of suspect cases under NTP. From 1986 only 27% of Tuberculosis patients had made 12 or more monthly collections of Anti-TB drugs. It is a matter of serious concern and the reasons have to be investigated. In 1987, only 27% of the DTPs had a full DTC team and only 65% had DTC vehicle. This indicates deterioration in supervision. The other factors like lack of NTI training of DTC key personnel, Communication, Health Education, Community Involvement and contradictory instructions from the DTP manuals, central & state guidelines etc., influence the performance of the programme adversely. Most of the medical officers of the PHC wanted integration to continue. They only wanted that the additional inputs may be provided.

RECOMMENDATIONS: Most of the recommendations given are for improvement of the system which is essential for the success of NTP. Some specific recommendations for NTP are also given. Integration of health programme may be effected at district and state levels in a phased manner. It would be desirable to have integration with the central level also with one Director General of Health Services monitoring all programmes in one region of the country. A common budget for all health programmes/activities will solve many of the problems and will be in accordance with the principles of integration. Develop a proper two way referral system covering all programmes and activities. Orientation training may be given to all officers regarding budgeting, administration, monitoring and technical aspects. A vehicle pool may be maintained at the district level under the control of DCMO and monitored by CMO. The Central Government may supply microscopes of good quality instead of providing funds. Working facilities at DTCs and PHCs may be reviewed periodically to ensure good working conditions for efficient functioning. Local level recruitments may be made for Health Assistants and Health Workers. A careful review of the reasons for indiscipline, particularly at PHC level may be made before the situation deteriorates further. The entire staff structure and recruitment may be reviewed to provide promotional opportunities to all categories of staff. All suspect cases may be put under observation as per WHO recommendations instead of straight away giving them anti TB treatment for long periods. Sputum collection by Health Workers may be re introduced. Reasons for deviation from DTP manuals may be investigated, particularly in STCs which are required to train the staff as well as supervise the DTPs. Short Course Chemotherapy may be extended to all DTPs in the country. Steps may be taken to ensure that follow up examinations are carried out regularly and the results recorded on treatment cards. A drug testing laboratory may be set up in each state as proposed for the VIII plan. Procurement of drugs may be made only from reputed firms. In order to have a reliable monitoring, sample checks have to be carried out to ensure the validity of the records and reports. Targets for NTP may be withdrawn, particularly those regarding case detection to avoid over diagnosis. A monitoring and evaluation cell headed by a statistician may be created under the CMO to cater the needs of all programmes. The recommendations made for improvement may be introduced only after proper testing by field trials following operations research methodology. Changes introduced on adhoc basis may create more problems than are solved.

The review of the National Tuberculosis Programme (NTP) of India was carried out in 1992 by a team representing the Government of India (GOI), the World Health Organization and the Swedish International Development Agency (SIDA). The purpose of the review was to evaluate present policies and practices, analyse their adequacy to reduce the tuberculosis problem and recommend organizational, technical and administrative measures to improve the programme. The review team analysed the available documents including epidemiological data and reports of previous evaluations of the programme, discussed with officers of major institutions involved in disease control and in training, and made field visits in three States (Gujarat, Uttar Pradesh and Tamil Nadu) to assess the programme at the State, District and Peripheral levels. The National Tuberculosis Programme (NTP) was formulated in 1962 with major objectives of finding cases among the self reporting chest symptomatics, providing effective treatment near their homes, giving priority to smear positive patients and providing free diagnosis and treatment facilities. Human and financial resources are provided by Govt. of India and the States.

Situation Analysis: The constraints and shortcomings observed in the programme are giving low priority to NTP in allocation of funds and political commitment, wide gap between expectations and achievements, no change in the trend of tuberculosis, and threat of HIV infection aggravating the problem. The programme is integrated with General Health Services (GHS); however, the population growth and the proliferation of public health services has made the districts unwieldy for effective supervision by a single District TB Centre. The present management structure at national level requires strengthening, reorganisation and training at the state level. Improvement in the methods and management of Case-finding is needed as there is undue dependence on X-ray and clinical examinations. Standards of carrying out microscopy are low and laboratories are not well equipped. The treatment regimens are too many and standard regimens are ineffective and of long duration. Short Court Chemotherapy (SCC) implementation is very slow. The drug supplies are occasionally interrupted by lack of timely funding and of buffer stock. The Health Workers (HWs) are not utilised to prevent defaulting and to achieve treatment completion. The cure rate as the main indicator of programme efficiency is not available due to lack of followup examinations. The recording and reporting is complex and seriously deficient. Health infrastructure in metropolitan and urban areas is inadequate. The findings of previous programme evaluations have not been applied nor has adequate use of the results of operations research for the improvement of programme has been made.

However, the basic strengths of the India's TB Programme are considerable. The objectives on which the programme was established thirty years ago integration, decentralization, free services, priority to treatment of infectious cases are still valid today. They provide a sound revitalization of the national TB strategy. An updated and strengthened programme can expect to reduce the magnitude of the problem by about half in each 10-15 years. This will require political commitment, initial investment and strong leadership.

RECOMMENDATIONS Formulation of an executive task force at apex level, upgrading the central tuberculosis control unit in the Directorate to enhance the efficiency and effectiveness of the NTP. Quality of sputum examination to be improved by multiple smear examination, ensuring quality of microscope, training and quality control. Giving priority to smear positive cases, adopting SCC regimens, establishing criteria of treatment completion and cure. Ensuring an uninterrupted supply of drugs of good quality, revise the registration and notification system of NTP and giving due emphasis to cohort analysis. Policy of decentralization of treatment services closer to the community. Strengthening of administrative structure at the sub district level by providing Medical Officer, Treatment Organizer and Laboratory Supervisor to facilitate decentralization of supervision and tuberculosis programme. Development of training capabilities by utilizing state training facilities, medical colleges, public health institutes and voluntary agencies. In the light of the recommendations and concerns expressed by the Central Health Council, a revised strategy for NTP has been implemented in some selected areas of the country with the World Bank assistance. Operations Research must be carried out as an integral part of the revised NTP to evaluate performance and obtain baseline epidemiological information to measure reduction in the risk of infection.

District Tuberculosis Programme (DTP) was formulated in 1962 with one of the objectives of diagnosing maximum number of tuberculosis patients. The rural health institutions implemented as Peripheral Health Institutions (PHIs) are expected to play a major role. The PHIs according to the type of facilities available, are classified into X-ray Centres (XCs), Microscopy Centres (MCs) and Referring Centres (RCs). While all centres provide treatment, XCs offer chest X-ray and sputum microscopy examination; MCs offer only sputum microscopy and from RCs sputum slides are prepared and referred for further examination to DTC/XCs/MCs. The performance of DTP activities at PHIs are collectively reported. Hence, it was worth studying categorywise performance of PHIs, which may help in developing strategy for improvement in the performance of the National Tuberculosis Programme.

OBSERVATIONS : DTP is operational in 390 (89%), out of the 438 districts in the country. Of the 17,850 implemented PHIs, 2390 (13.7%), 8717 (48.8%) and 6740 (37.8%) are functioning as XCs, MCs and RCs respectively. In all, 208 DTP reports for October to December 1993 quarter received at National Tuberculosis Institute, were analysed. Reporting efficiency of XCs, & MCs was 85%, whereas of RCs, 54%. Of the 33.1 million self reporting outpatients belonging to various PHIs, 35% attended XCs, 43% MCs and 22% RCs. Of the total sputum examinations performed during the study period, XCs examined 39%, MCs 52% and RCs 9%. Selection of chest symptomatics worked out to 1.8% for XCs, 2.0% for MCs and 0.7% for RCs. Out of the total 28,654 smear positive cases diagnosed, 56% were detected by XCs, 37% by MCs and only 7% by RCs. It is seen that XCs diagnosed 56% of the total cases by doing 39% of the total sputum examinations. The sputum positivity rate at XCs is 7.8% which is almost double that of 3.8% at the MCs and 4.4% at RCs.

Sputum Examination Efficiency (SEE) and Case Detection Efficiency (CDE) (percentage of achievement compared with expectation) have also been compared according to the category of PHIs. SEE of XCs & MCs were 70% & 78% respectively as compared to only 26.5% in RCs. The CDE of XCs, MCs & RCs were 69.1%, 36.9% and 14.1% respectively. It is observed that XCs are working satisfactorily as 35% of the total out patients attend the XCs, their reporting efficiency being 85%, sputum examination efficiency 70% and sputum positivity rate 7.8%, indicating good performance, while MCs had a low sputum positivity rate of 3.8%, suggesting that there is a large scope for qualitative improvement in Case-finding activity. While RCs cater to about 20% of the total out patients had poor performance on all account and need a great deal of technical supervision.