Tuberculosis a major Public Health Problem

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3 Tuberculosis a major Public Health Problem (This report has been prepared on behalf of Independent Commission on Development and health in India, by Dr. L. M. Nath, Former Director, All India Institute of Medical Science, Delhi and Shri Deepak Gupta, former Additional Secretary, Ministry of Health &Family Welfare, GOI) 1. Background Tuberculosis is not a new disease. In India, it has been described since the time of the Vedas. Evidence of tuberculosis was also found in Neolithic bones and in Egyptian mummies. It has continued to be a scourge over the centuries. Even now, TB is a major health problem in India. As per latest WHO estimates, about 2.2 million new cases and 3 lakh deaths are occurring annually in India. Thus, about 3 people are dying of TB every 5 minutes. Modern India has a long history of scientific research on tuberculosis and was at one time a global leader of scientific thinking about this condition. The change of sanatoria based treatment to domiciliary management came about because of research in India from the TB Research Centre in Chennai. Unfortunately, the tempo of research and field action did not maintain the same intensity for half a century after independence. A national programme was started several decades ago. But poor implementation led to this disease becoming a severe problem. In the 90 s, the new global programme of DOTS, which changed the diagnosis and treatment, was started in India as the Revised National TB Control Programme (RNTCP), which had led to very good results. However, there are several existing challenges to run a good programme, along with the severe emerging threat of MDR and XDR, which has huge implications for public health. Therefore, the TB programme can no longer be treated like any other disease control programme. At the least, it now deserves as much attention as AIDS did, perhaps even more. 1.2 Characteristics of the disease At the outset, however, let us consider a few basic characteristics of the disease that have a deep impact upon the structuring of any programme to tackle the problem of TB as a public health concern. First, Tuberculosis exemplifies the difference between infection and disease. Infection with the organism responsible for TB does not mean that the person is suffering from the disease tuberculosis. The bacteria usually lie dormant until it activates and causes ill effects in the body. This is called Latent TB Infection (LTBI). The lifetime risk of developing disease following infection is estimated to be 10%. This risk is modified by various medical and social factors including HIV, silicosis, diabetes, immunosuppressant drug use, malnutrition, tobacco use, poverty, overcrowding etc. The risk has been found to be higher amongst prisoners, slum dwellers, and homeless and marginalised populations. It is estimated that 40% of the Indian population is infected i.e. ~400 million people. Even with a conservative estimate of 10% risk, nearly 40 million are likely to develop TB in their lifetime. However, there is presently no easy way to diagnose Latent TB Infection on a public health scale and there is no clear evidence demonstrating the benefit of treating LTBI in a high prevalence setting like India Second, Tuberculosis can affect any organ / system of the human body except the hair and the nail. The human is the primary reservoir for the organism and patients with disease in the lungs or pulmonary tuberculosis spread tuberculosis. Potential transmitters are persons who cough, persons with sputum positive 1

4 for AFB, persons not on chemotherapy, persons just started on chemotherapy and persons with a poor response to chemotherapy. Normally, TB infection can only be acquired by inhaling the bacteria coughed out by a person with pulmonary tuberculosis. Therefore, though tuberculosis is contagious, it can only be transmitted by a percentage of those suffering from pulmonary TB. It can be spread more easily in closed and densely populated surroundings. Even all pulmonary tuberculosis is not immediately contagious as in very early stage of the disease the individual does not have bacillus in the sputum and neither do those who have received effective treatment for some time. It is estimated that only 50-60% of persons with pulmonary tuberculosis are excreting M. tuberculosis and are thus potentially contagious. Third, there are effective drugs for treatment of persons with pulmonary tuberculosis which, when administered in an appropriate combination for the recommended duration, have high cure rates, provided the patient takes the prescribed drug regimen for the entire recommended duration. The problem is that treatment with the drugs currently in use makes even a rather ill patient feel much better in a relatively short period. Patients feel so well that they do not feel the need to continue treatment any longer and therefore discontinue taking the drugs. Inevitably the disease reappears in a short while and the patient starts the cycle of being ill, getting better, stopping treatment prematurely and so on. This is a recipe for serious problems as before long the M. TB in the person develops resistance to the drugs being given and we have another case of MDR tuberculosis! This situation is aggravated by patients going to private doctors where there is no system to ensure follow up or completion of the treatment. The DOT programme is a method of ensuring regular and effective treatment and should be rigorously followed to ensure adherence to the entire course prescribed. Fourth, in earlier years, a Mantoux test was used for detecting infection but it was found to be inefficient in diagnosing the disease, particularly after BCG immunisation at birth. Slowly, X-ray became the primary tool for diagnosis. However, studies established that this diagnostic procedure could lead to almost 50 % misdiagnosis! X rays also do not help in differentiating between active and healed TB lesions. Additionally studies showed that there were wide inter observer variation in reading of X-rays for diagnosis of TB thus limiting the use of this investigation. X-rays, therefore, now play only a supportive role in the diagnosis of pulmonary TB, mainly in cases where sputum smear result is negative. Currently smear microscopy is the primary diagnostic tool used to diagnose smear positive pulmonary TB in most national programmes. This tool is utilised within a diagnostic algorithm that evaluates any patient with tuberculosis of the lungs, quickly prioritises the most infectious patients for treatment and allows less infectious smear negative patients to also be diagnosed with the addition of other tools including radiography. Thus, smear microscopy is both easy to use, quality assured and cost effective. Newer point of care diagnostics are, however, now available that can diagnose tuberculosis with much greater sensitivity and specificity and can also be used to rule out resistance to the most important chemotherapeutic agents used to treat drug sensitive TB. It will be critical to deploy these new molecular tests strategically so that they are accessible in health facilities, which are frequented by patients this can be a game changer to TB control with the potential to diagnose more TB patients earlier and thus reduce / interrupt transmission in populations most at risk of TB infection and disease. The deployment of these rapid tests, which are also more expensive, cannot be along the same principles that guided the deployment of smear microscopy, nor should the deployment of these newer tests replace smear microscopy in the PHC in the immediate future. The new machine Xpert MTB/RIF is one such, which diagnoses positive pulmonary TB in 2 hours. It also simultaneously finds out resistance to rifampicin, thus allowing diagnosis of MDR TB. However, this is expensive. Each machine costs nearly US$ and each test currently costs US $ 10 at negotiated rates. 2

5 Fifth, because of the large pool of infected persons, control measures are not likely to have an overt shortterm impact in incidence and prevalence of TB disease and cases of the disease are likely to continue to surface for some time even with an effective and well-implemented control programme. Necessarily, therefore, the TB programme has to be a long term commitment of the Government and implemented rigorously over decades. Sometimes policy makers, or others, expect quick results. This will not happen. All must be prepared for the long haul. 1.3 TB and Poverty: Tuberculosis is often spoken of as a disease of the poor. While no section of society is free from or immune to this all too common condition, there are many factors that make poorer sections of society a higher incidence and prevalence of tuberculosis. (In fact this is true not only of TB but of all communicable disease and current evidence suggests that even the NCD are increasing in the poorer sections of our community). The reasons are clear overcrowding and poor sanitary living conditions especially in some urban slum areas, less access to public health facilities such as immunisation, literacy, health education, good water supply and sanitation and limited access to nutritious food - all form a vicious cycle that makes them more prone to ill health and a resultant decreased ability to resist disease. TB also contributes to poverty through the health and other ill effects caused by morbidity and mortality and costs of diagnosis and treatment. There are many studies which have shown the relationship between TB and poverty. A recent (2012) study by Oxlade and Murray 1 using the DHS data from India showed a positive correlation between poverty and the self-reported prevalence of TB in India and identified factors that appeared to play a direct role in this relationship. The studies across countries almost universally suggest that TB can cause catastrophic health expenditures catastrophic defined as more than 10% of the household annual income or more than 40% of annual non-food expenditure. Even in situations of free diagnosis and drugs there are huge indirect costs, of health care seeking, transportation, food, and loss of income. Many of the cases studied showed damaging indebtedness and/or sale of assets affecting future incomes. The problems are worst in urban slums, with Mumbai being possibly the worst example, also because of the huge dominance of the private sector. Since TB disproportionately affects the poor, reaching out to the poorer strata in different social conditions must become one of the primary objectives, as well as strategies, of the TB control programme. Proper control of tuberculosis, therefore, requires: 1. Early identification and diagnosis of pulmonary TB cases 2. Treatment should also be started early. The DOTS programme must be implemented rigorously. The ideal would be that the treatment is started the same day as diagnosis, particularly for MDR, if that cannot be achieved, the initiation of treatment must not be delayed beyond a week. 3. Treatment once started, must be carried on for the prescribed period without a break and completed. Effective supervision reinforcement of the message of complete treatment is the key to this. 4. Non-responders should be tested for resistance i.e., MDR as soon as possible and treated appropriately, with treatment starting immediately on diagnosis 5. A wide network of appropriate diagnostic facilities should be established 1 Oxlade O, Murray M (2012) Tuberculosis and Poverty: Why Are the Poor at Greater Risk in India? PLoS ONE 7(11): e doi: /journal.pone

6 6. Sufficient funds, adequate quantity of drugs, laboratory facilities at local level and proper staffing are necessary to ensure these. 7. Focussed efforts to reach out to special areas urban slums; tribal pockets; SC hamlets; identified other high-risk areas; HIV concentration areas. It is essential that TB control prioritise populations most at risk of infection and disease, 8. Strengthening of the public health system and involvement of all other sectors of health providers other public sector; NGO s; Medical Colleges; Private sector (which requires special attention) 9. Adequate supervision and monitoring is required at all levels starting from the top and extending to the community and periphery. 1.4 Revised National TB Control Programme In 1992, Government of India along with WHO, undertook a comprehensive evaluation of the existing NTP. It was found that though the NTP was technically sound, it suffered from managerial weaknesses, inadequate funding, over reliance on X-ray for diagnosis and frequent interruptions in drug supply resulting in unacceptably low rates of treatment completion. The presence of an unregulated private sector and free availability of drugs in the open market compounded the problem. These deficiencies were intended to be rectified in the revised programme, which was started as a pilot in 1993 and scaled up partly with World Bank assistance in 1996, and later with assistance from the Global Fund. India embarked upon a very ambitious expansion programme and the full country was covered by March The RNTCP included the following elements Adequacy of funds was assured through World Bank and Global Fund assistance. As we shall see, adequacy of funds will remain a critical factor, especially with MDR. Diagnosis was changed from x-ray to sputum microscopy. Microscopy labs were set up at health facilities including Primary, secondary and tertiary health centres, and many in other sectors, to provide free, quality assured, accessible and convenient TB services to the community. The daily drug regimen was changed to intermittent so that drugs were administered on alternate days. The efficacy remained the same but this significantly reduced incidence of adverse reactions. Moreover, because of the well - known tendency of patients not taking their drugs, now drugs had to be given in the presence of, and by, a provider to ensure that they were actually taken. This is called Direct Observation Treatment (DOT). Treatment centres were decentralised even further and made more accessible through engagement of community DOT providers. Core services, namely diagnosis and treatment, were delivered through the general health system. To facilitate this, implementation management units (TB Units) were set up per population of 500,000 (250,000 in tribal and difficult terrain). These were managed by RNTCP key staff, Senior Treatment Supervisors (STS) and Senior TB Lab Supervisors (STLS), and by the Medical Officer for TB Control (MOTC). In every unit, STS maintains the TB register and supervises grass root health workers and reporting procedures. STLS takes care of lab logistics and quality. These were contractual staff provided with mobility. This was a new and essential innovative addition. The District TB Officer, who also handles the compilation of TB unit reports and communicating these with the state and national governments, managed the District. The State TB Officer (STO) is overall in charge while the State TB Demonstration and Training Centre (STDC) is the technical wing) District TB Officers became District Programme Managers and were also provided vehicles, through hiring, for mobility. This was a small but crucial input. 4

7 There was a strong emphasis on supervision and monitoring. A separate RNTCP Supervision and Monitoring strategy was formulated as a tool for an objective review of the programme at all levels - from the peripheral health institutions to district, state and national levels. It also listed out detailed protocols for supervisory visits and reviews. Uninterrupted drug supply was ensured with a robust monitoring system. A great innovation was the patient-wise box which ensured that drugs for the complete treatment for every patient were ensured right from the beginning of the treatment. The patient also got this confidence apart from getting the message that he has to take all the drugs in the box for getting cured. Quality assurance of drugs was guaranteed through a variety of measures. A huge programme of training of all staff from top to bottom was implemented. Strong management programmes were also included. The idea was that the medical persons in charge also became programme managers and did not treat TB only as a clinical issue to be treated but as a public health problem to be managed. Strict financial control was exercised. There was a very robust system of recording all information; its collection; reporting; review; checking. It allowed in quick time to have information from bottom up. It also helped the monitoring process considerably. All this was designed to ensure that most people contracting the disease were actually detected; that both detection, and start of treatment, was initiated early to prevent transmission and treatment completion was facilitated. The focus was on sputum positive patients who spread infection. There were many important technical changes, but above all it was about political and administrative commitment, which was clearly lacking in the earlier decades. Adequacy of funding and proper management became the key. The design and implementation, therefore, took every possible step to prevent the normal inadequacies and weaknesses of our governance system, which have been the perpetual bane of our systems, including that of the health sector in general and over the years. This was a paradigm shift, which would result in the success of the programme as is quite evident years later. 1.5 Achievements of the RNTCP The key objectives of RNTCP were to achieve and maintain at least 85% cure rate among the new smear positive cases initiated on treatment, and thereafter, to have a case detection rate of at least 70% of such cases. Since 2007, the programme has been consistently achieving these targets. In 2011, RNTCP achieved the NSP CDR of 72% and treatment success rate of 88%. During the 11th Five Year Plan period ( ), the programme over-achieved all targets except number of MDR cases put on treatment. Every day In India more than chest symptomatic are examined for TB, more than 3000 smear-positive TB cases are detected, and more than 4800 TB cases of all forms are registered and put on treatment. Since implementation of RNTCP> 75 million TB suspects have been examined > 16 million patients placed on treatment and > 2.9 million lives saved In 1997, it used to be said that one person died per minute due to TB, now this has reduced to 3 persons dying every 5 minutes due to TB. As per the latest estimates of WHO (Global TB Report 2013) ever since the RNTCP started in 1997, it is estimated that prevalence has reduced from 465 cases per lakh population to 230, and incidence from 216 cases per lakh population to 180. The annual risk of TB infection is a measure of the risk of uninfected children being infected every year. The risk was about 1.5 a decade back. This risk has been reduced considerably. The reduction in annual risk of TB 5

8 infection between 1997 and 2007 is one of the key indicators that the newer infection rates are coming down. The position now should be even better. Survey I Survey II Change*/year ( ) All children 1.4% ( ) 1.1% ( ) -3.6% ( ). BCG- 1.5% ( ) 1.1% ( ) -3.5% ( ) This clearly indicated that the programme had impacted the TB epidemiology to a large extent and if the intensity of implementation continues, there would be substantial gains to be made. We are also on track to achieve the MDG so far as TB is concerned. Cost effectiveness: As per a study undertaken and published by Mark Goodchild et al A cost-benefit analysis of scaling up tuberculosis control in India Int J Tuberc Lung Dis 2011 Mar; 15(3):358-62, the scale-up of TB control in India has resulted in total health benefit of 29.2 million disability-adjusted life years (DALYs), including 1.3 million deaths averted. The study used the country level programme and epidemiological data from In 2006, the burden of TB measured in terms of DALYs lost would have been 1.8 times higher in the absence of the programme. The total gain in economic well-being from TB control is estimated at US $ 88.1 billion over the (a 10-year period). The study concluded that the scale-up of TB control has been a very cost-effective strategy for improving the health status of India's population, while the return on investment has been exceptional from a societal perspective. 1.6 National Strategic Plan ( ) Based on the experience of the RNTCP in the 11 th Plan and the emerging issues, and following a comprehensive consultation process, a National Strategic Plan for TB Control (NSP) , as part of the country s 12th Five Year Plan, has been prepared. Which commits to Universal access for quality diagnosis and treatment for all TB patients in the community focusing on early and complete detection of all TB cases, including drug resistant TB and HIV-associated TB, with greater engagement of private sector for improving care to all TB patients. The targets set are Detection & treatment of about 87 lakh Tuberculosis patients during 12th FYP Detection & treatment of at least 2 lakh MDR-TB patients during 12th FYP Reduction in delay in diagnosis and treatment of all types of TB cases Increase in access to services to marginalized and hard to reach populations and high. In line with the global targets the two main objectives of the programme are now 6

9 Early detection and treatment of at least 90% of estimated all type of TB cases in the community; including drug resistant and HIV associated TB. Successful treatment of at least 90% of new TB patients, and at least 85% of previously-treated TB patients Analyses in the last few years suggested that the earlier targets were insufficient to achieve predicted declines in TB incidence. Higher case detection was needed, accompanied by rapid diagnosis and correct treatment to sharply reduce TB prevalence, mortality and ultimately incidence. Essentially, this would require much greater attention to more and early case detection and much increased involvement of the private sector. However, though there is also an ambitious target for MDR cases, there is need for increase in the proposed number for detection of MDR patients. It would also require that patients and providers have access to state of the art diagnostic technologies including those for rapid drug susceptibility testing. Achieving this, and increased targets, will not be easy but is not impossible. However, it would require increased staffing, system changes; investment in new technologies, significantly increased funding from domestic sources for diagnosis and treatment, but above all, focused management attention, starting from the highest levels. It is estimated that, if successful, by 2017, India will have the ability to diagnose more than 1.8 million TB cases each year a 25% improvement compared to the present figure. This will also re-establish India as the global leader in TB control. 2. Current challenges While there have been many achievements there are some problems, which need to be addressed as we go forward. This strategic plan deals with the problems of TB Control in India quite comprehensively, identifying both the challenges and the new directions. We will refer to some of them, more so the managerial ones. 2.1 Case detection: Detection of new sputum positive pulmonary TB case has been above 70% of the estimated cases since 2006 onwards, but it seems to have plateaued. A greater matter of concern is that, in the year 2012, case detection declined to 68%. There could be several reasons, which need to be addressed. i) During discussions in some States regarding preparation of Results Framework Documents of Health Departments, it was worrying to find that this area was not being given much attention and easy targets were being proposed. It was evident that higherlevel attention was simply not being given. ii) iii) TB programme is now being implemented through the general health system in the States. Lack of human resources and physical infrastructure in the general health system adversely affects the services including diagnosis/treatment of TB patients. It was for this reason that provision of contractual work force was made in the programme to help the general health system. However, it appears that increasingly most of the time RNTCP work is being left only to the contractual staff and regular staff is not supporting at different levels. Moreover, if a contractual position falls vacant the services are affected adversely. At the same time, the full potential of the huge army of village level NRHM staff appears yet to be leveraged, not only for early case finding but for TB case finding. However, a large network of laboratories (Sputum Smear Microscopy Centre) has been established across the country under RNTCP based on population norms. Unfortunately, large number of such microscopy centres is under-utilized. A significant proportion of these Designated Microscopic Centres perform less than the minimum number of test (WHO recommends 500 slides annually) making them ineligible for EQA. There is an urgent need to review and revise this 7

10 strategy. While the number of diagnostic centres should be rationalized based on the workload, a strong sputum collection and transportation system should be established which links the PHCs, Sub-Centres and communities to the diagnostic facilities (Designated Microscopic Centres).This can be complemented by mobile technology based information system for rapid delivery of results. iv) Presently the procurement of reagents is decentralized to the states and districts. Thishas some disadvantages. The procurement process is dependent on the availability of funds with the state/district and the administrative procedures, both of which can seriously affect the timely availability of reagents. The decentralized procurement may also impact the quality of the reagents procured considering the wide variability in the capacity of the procurement officers. It is recommended that a central agency be identified for the procurement and supply of the reagents, which will address the above mentioned challenges. v) At present the case, detection is reported only from the public sector with very little i.e. 2% contribution from the private sector inspite of the fact that huge efforts have been made by the programme for involvement of private sector and corporate sector. New strategies are needed. Recent steps taken by the programme regarding notification of all TB cases perhaps may help in increasing the case detection provided extensive efforts are made at all levels for its implementation in its true spirit. Outside the Ministry of Health & Family Welfare there are large health delivery systems of other Ministries e.g. Railways, Labour (ESI), Defence, Home have their own health systems; large public sector like Coal India, SAIL etc.; large NGO/Trusts. TB patients treated in these systems need to be notified with RNTCP. This strategy was being followed diligently. It seems more needs to be done for enrolling more TB patients under RNTCP. vi) vii) viii) The progamme of involving medical colleges has paid rich dividends with 15 per cent of new cases being detected by the few participating Medical Colleges. Based on the good results shown so far, this programme needs to be expanded in both numbers and concepts. Special emphasis is needed for difficult to reach areas, vulnerable and marginalised populations.marginalized populations comprise of people who are having difficulty in accessing RNTCP services. Marginalization may be due to social, economic and/or geographical reasons. Vulnerable populations include people who are at higher risk of developing tuberculosis (e.g. Tribals, HIV+ persons, household contacts of sputum positive TB cases, people living in prisons, urban slum dwellers, workers exposed to silica dust, diabetic patients, tobacco smokers, etc.). Urban slums require much focussed attention because it is generally felt, and statistics support this, that the prevalence is much higher. The non-corporate and unorganised private sector is also active in such areas. A Report on Mumbai is annexed(iv) It would perhaps be a good idea of having special reports on what is happening in such areas in cities and towns across the country. In this connection, mapping of such Most At Risk Populations (MARP) needs to be prioritized and innovative intensified interventions customized for each of these groups developed and implemented. This will involve wide scale engagement with NGOs and CBOs for implementation of such community based activities. There is a need to do intensive microanalysis to identify all areas where there is likely to be much higher number of cases and those where the detection rate is poor. Both would require review, monitoring or additional measures. There is also perhaps scope of catching more at places where there is a huge caseload. ix) Sputum smear microscopy using Ziehl Nielsen staining technique only detects approximately 60-65% of patients who could be confirmed with TB. TB culture could do more, but it takes 6-8 weeks. Therefore, newer and more accurate diagnostic techniques have to be extensively utilised. A recent systematic review (published in PLoS One) has shown that the sensitivity and specificity 8

11 of Xpert MTB/RIF for diagnosis of PTB were 79.5% and 100% and for detection of rifampicin resistance were 57.1% and 100.0% respectively. The median time to treatment 7 (4 9) days in patients with Xpert MTB/RIF assay, and 21 (7 33.5) days in patients without Xpert MTB/RIF assay. It is also reported that detection rates have also increased with their use. x) There is also perhaps need for screening of vulnerable groups or active case detection in specialised situations/sites. Too much screening of course may have implications for management or cost burdens. Therefore, this has to be strategic in nature. xi) xii) xiii) This also means strategic deployment of new diagnostic tools. Where do we place the LED FM microscopes as they get installed? Where should the first instalment of Xpert MTB/RIF machines go? In addition, how should they be deployed as we go along. There is another problem of missing patients. In 2011, although 9, 53,032 patients were diagnosed as sputum smear positive, only 8, 44,920 were registered, missing over a lakh. This was always a challenge, but now we must have strategies to prevent this or to track them quickly. An additional point is regarding the current diagnostic algorithm under which the smear negative TB symptomatic are reviewed after a gap of 2 weeks during which they drop out of the system and venture out to the private sector. There is a need to review the algorithm and modify accordingly so that the Chest X ray is fast tracked. This means engaging private labs for this test where the government health centres do not have X- ray facilities. Trends in TB case detection and treatment success rates 120% 110% 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 84% 85% 87% 86% 86% 86% 86% 87% 87% 87% 88% 88% 51.6% 55.6% 61.5% 67.5% 62.8% 63.9% 66.9% 69.3% 71.1% 70.9% 70.5% 70.8% 68.4% Annualised New S+ve CDR Success rate The issue of the detection rate, however, requires a little more attention. The question is what should the denominator be? Essentially, it is the estimate of incidence. However, this is not really known except through the uncertain method of extrapolating ARTI. No countrywide prevalence survey has been done and this is an important reason for programme complacency about detection. If almost half of the incident TB cases at a point in time is being diagnosed and treated in the private sector, then the achievement of case detection no longer holds good! There are some studies, which show higher prevalence. Further, we know anecdotally and from some studies that urban slums show a very high prevalence. Therefore, it should be an important priority to estimate the prevalence disaggregated by geography, populations (urban, rural, slums tribal etc.), high-risk groups (HIV infected, diabetics etc.) This would give us a better picture of the number of patients, which need to be detected in different areas, and then draw up strategies to ensure that effective data is generated for evidence based action. It would help in this connection to look at trends in smear examination rates / 100,000 9

12 population (urban versus rural populations, and separately for populations attending tertiary facilities), trends in case finding within medical colleges and DTCs, trends in their contribution to regional / national notification, initial default by location of diagnosis. 2.2 Success rates: Though for many years, the programme was achieving treatment success rate of more than 85% among new sputum positive patients, for the last 2 years it is about 88%. This means good progress but we need to be cautious. Despite the persistent efforts of the programme to ensure patient friendly DOT services, the results have not been very satisfactory due to the variability of the health systems in respective states/districts. The Joint Monitoring Mission also noticed this. The health facilities open for a limited number of hours making it inconvenient for the patients to get DOT. The involvement of community DOT providers is guided by the efforts of the State and district programme managers and the timely disbursement of the incentives. The engagement of Community DOT Providers, monitoring and disbursement of incentives may be outsourced to an interface agency, which engages with this cadre through the available NGOs, CBOs and Self Help Groups. As noted elsewhere, there is a shortage of many staff, especially in the context of the need to increase the number of TUs, to give more attention to catch patients from the private sector. Further, in a programme where detection rates are falling, it is difficult to envisage rising success rates. The internal evaluation procedure needs to be very vigilant on this aspect so that actual progress is recorded. It may be useful to go through some of these reports of the recent past. Treatment success does not approximate to cure and this data needs validation. A special evaluation across different areas is recommended to follow up patients that have been reported as successfully completed treatment in a randomised manner. The fact that the case detection and other quoted rates shows a remarkable (and suspicious) consistency also needs to be investigated. Retreatment Cases: Retreatment cases include relapse, treatment after default, failure to treatment and others. Of the total 15, 15, 872 cases put on treatment, 20 % i.e , constituted the retreatment cases in the year 2011 for which treatment outcome is available. This has been the level of last 4-5 years. The treatment success rate among retreatment cases is less than 70% because of high default, death and failure rates. Default in treatment among retreatment cases has been 14% for the last two years at the national level, which is much higher than the 5% among new cases. Similarly, failure to treatment as well as death rate among retreatment cases is higher as compared to new cases. This category of patients need special attention of the programme as these patients are habitual defaulters and are irregular in their treatment and must be monitored separately. This needs to be considered, as a key quality issue and declining trend of retreatment cases should be taken as a mark of effective implementation of the programme in addition to reduction in default among these patients. This will also ensure better cure rate and reduction in failure to Category II treatment. By ensuring quality treatment through proper supervision and monitoring as per the programme guidelines one can reduce number of relapse cases (as irregular treatment among Category I patient is one of the important reasons for relapse as per studies). The programme needs to consider this also as key indicator. Both key indicators will help in reducing the MDR TB cases. It is noted, however, that much of the poor outcome in these groups is due to high rates of drug resistance. Currently all these cases are treated with a single standardised regimen. This leads to a situation where a patient who has failed a first line treatment is frequently given a single new drug, as part of the retreatment regimen violating the principle of not adding a single drug to a failing regimen. Therefore, a rapid increase in the use of drug susceptibility testing would be necessary to ensure that drug resistance is identified promptly and treated appropriately. Testing of all retreatment cases for DR-TB, at initiation of Cat II treatment, is now a 10

13 programme policy. The emphasis should be to strengthen this process and ensure all retreatment cases receive this test. 2.3 Drug supply: One of the critical requirements of RNTCP is to ensure uninterrupted supply of quality assured drugs at all times. Programme assures quality of drugs through variety of measures. All efforts to increase access of TB patients are bound to fail if the diagnosed patient is not initiated on treatment due to lack of drugs. A full-proof drug management system will help in ensuring sufficient buffer stock of drugs at all level as per the programme guidelines. Any laxity or complacency at any level of drug management may result in a situation of stock out of drugs. This cannot be allowed to happen, as the entire credibility of the programme will be affected. It is better if 1 to 2% of the total drugs procured is wasted rather than have a situation where stock out happens. As procurement is based on estimates of the patients to be put on treatment, we should procure keeping estimates on higher side to avoid stock out and following the principle of releasing those drugs with early expiry to avoid wastage (FEFO-First expiry, First Out). Further procurement must be planned well before requirements so that it caters to unexpected delays if any in the process. We have noticed a situation in the field where every time there is apprehension of drug stock out, local managers are arranging for putting two or more patients on one patient-wise box, which may result in irregular and incomplete treatment with at potential risk of amplification of resistance. Stock out of paediatric drugs has been observed in recent months. It should be examined how such a situation happened. Rather than blaming anybody, programme needs to improve its drug management systems at all levels to make it so robust that it becomes the strongest point of programme. Delays in central procurement have also been seen, leading to emergency procurements. There is even current apprehension of future large scale drug shortages because of continuing delays. This issue has in fact drawn worldwide attention with activists also loudly protesting during the India presentation at the recently concluded Union Conference in Paris. It is essential that the drug management system at all levels is urgently reviewed and necessary revisions including appropriate use of technology are made. 2.4 Human Resources: This has three aspects; I. Availability of trained work force at all levels is crucial: Vacancy positions of both regular and contractual positions and action on filling of the vacant positions needs to be reviewed at regular intervals. Training schedules (Induction training to new positions and re-training and update training of existing staff) needs to be drawn up annually and strictly followed ensuring availability of trained work force. However, there is a system of training under the programme but the same needs to be religiously followed and monitored. Training will ensure proper categorization of patients, initiation of early treatment after diagnosis, which is paramount for cure of the patient as well as making infectious patient non- infectious. It will ensure supervision and monitoring as per guidelines thus reducing the default in treatment. The patient satisfaction is directly related to the nature of interaction with the health staff. Many studies under the programme have cited dissatisfaction of the patient with health staff as one of the main reasons for seeking medical care from private sector despite availability of free services in the public health facilities. It is also one of the important reasons of default among TB patients taking DOTS at health facility. Thus, training of the staff in programme management as well as in interpersonal communication is essential for patient satisfaction to ensure adherence to treatment and raising the credibility of the programme in the public. There may be need for further decentralising DOTS provision and incentivising the providers. But clearly the NRHM staff needs to do more in the rural areas and we need to spread community DOTs providers in urban areas. High-risk urban slums would require special attention. The earlier strategy sought to involve grassroots organisations. Delhi was a success. We are told, however, that many have since left because of delayed payments etc. Programme needs to give attention to this. 11

14 II. III. Filling of contractual positions: These were specially created to cater to the needs of additional programmatic requirements and are critical to the success of the programme and its supervision. It is reported, however, that vacancies keep occurring regularly, and for long periods, at the lower levels, especially in some areas. The plan to increase the TUs is also suffering because of this. How is it possible to achieve high detection and success rates in such situations? This issue must be addressed and regularly reviewed, particularly for high-risk areas. As suggested elsewhere a TU wise analysis would be useful. Many states are defaulters in this regard. Absence of attention, delays in payments of salaries and lengthy administrative procedures for appointments are also reasons. Following the integration with the NRHM, at many places the regular staff are either not TB staff or have been given other work which is considered more important. As a result, there is neglect at district and higher levels. Supervision has suffered. The RNTCP requires attention, day after day. This aspect also needs to be reviewed district and state wise. There is need to identify certain areas where the increased number of TUs should be piloted. There careful training and monitoring of the proposed Block level supervision rather than a TU wise structure should be undertaken before a full scale roll out. Lower level involvement of NRHM staff has also to be studied and improved. Despite the availability of adequate funds, the utilisation remains low due to the delay in fund disbursement at all levels. Fund flow process, especially in light of the merging of the TB programme with NRHM, needs urgent review and modification. Perhaps mandating a RNTCP report long with every monthly NRHM report from every district will ensure that attention I paid to this disease. 2.5 Two major issues, which are partly inter-related, concern MDR and the Private Sector MDR & XDR (Multi Drug Resistant & Extra Drug Resistant) Tuberculosis Persons with tuberculosis disease who are found to not respond to treatment as effectively as the usual case may be caused by the organism resistant to the usual drugs. These non-responders need to be tested to see if the strain of M.TB found in their sputum are resistant to the common first-line drugs recommended for treating tuberculosis. If the test shows that, the strain is resistant to Isoniazid and Rifampicin, the patient is described as having Multi-Drug Resistant (MDR) tuberculosis. Such persons can be treated with second line drugs. However, not only are second line drugs more expensive-- about Rs1.5 to 2 lakhs (with procurement through Global Drug Facility perhaps being doubly expensive) in contrast to the less than a thousand Rupees for first line drugs, but also need a much longer treatment up to 24 months rather than the 6-8 months for non-resistant cases. In addition, only 50-60% MDR TB persons actually achieve cure. Sir John Crofton, who was one of the earliest persons to advocate multidrug therapy in tuberculosis, wrote in 1959 "The greatest disaster that can happen to a patient with tuberculosis is that his organisms become resistant to two or more of the standard drugs. The development of drug resistance may be a tragedy not only for the patient himself but also for others, for he can infect other people with his drug-resistant organisms 2.The public health consequence is frightening as persons with MDR tuberculosis cough out MDR bacteria and new infections arising from that case are drugresistant from the very beginning! Drug resistant tuberculosis is entirely a man-made phenomenon. It generally results when persons who are put on anti-tubercular treatment but do not take the drugs as prescribed for the period stipulated. Cessation of treatment before the infection has been effectively eliminated allow resistant 2 Crofton J. Chemotherapy of pulmonary tuberculosis. Br Med J. 1959;1: [PMC free article] [PubMed] 12

15 bacteria to proliferate and the individual develops the very difficult to treat MDR tuberculosis. The unfortunate consequence for the individual is that his or her disease may be difficult to diagnose, and treat. Only about half of the cases can be treated successfully. In the remaining, the disease is invariably fatal. In India, the usual figure quoted is that between 2 3% of new patients of tuberculosis are found to be MDR. There is a view that this may not be correct since this is the site-specific data from couple of sites in the country and should not be taken to be representative of the entire country. The state specific DRS studies done in Maharashtra, Gujarat and AP have shown the prevalence of MDR TB amongst new cases to be <3% and retreatment cases 12-18%.These figures may not be representative for other states, cities, and different populations groups. In 2008, WHO estimated over 99,000 MDR-TB cases in India, second only to China. This was revised to 64,000 incident cases annually amongst notified cases. Therefore, it can be safely estimated that India has between 60,000 to 1, 00, 000 incident patients with MDR annually. This is in the context of the fact that 22 Lakh patients with TB are detected and treated every year in India. Perhaps we should work on the assumption that the number of cases maybe a lakh annually. There is no data on prevalence of more severe forms of DR-TB like XDR TB. The programme needs to analyse the site-specific surveillance data and additionally undertake appropriate studies for realistic estimates of DR-TB. The Mumbai story already shows us the risk of this assumption. Among those patients who had earlier been treated for tuberculosis or had been irregular in their treatment, 12 to 18% are found to be MDR in India. Disturbingly, these figures are much higher for Mumbai, as shown by statistics from Dharavi. There is the emerging threat of X DR also, which is defined as MDR-TB resistant to both fluroquinolones and second-line injectable drugs. This requires a much more expensive regime of drugs. Their diagnosis also requires setting up of expensive labs and diagnostic facilities. Their rate of survival is even less. The State representative DRS Survey of Gujarat State showed 3.2% prevalence of X DR-TB among MDR-TB isolates. A precise estimate is not there, but surveillance in AP and Gujarat show an alarmingly high prevalence of fluroquinolone resistance (24%) Clearly, the situation is very serious and must be tackled urgently to stop this transmission effectively and quickly. Successful control of MDR TB requires prevention through effective TB control and private sector engagement to prevent generation of drug resistance in the first place. Simultaneously, the large number of MDR-TB patients currently present must also be diagnosed and treated effectively as early as possible to prevent transmission. The RNTCP has prepared a Strategy for Prevention and Control of MDR TB. The elements are enumerated below: Prevention of MDR TB Sustained high-quality DOTS implementation. This must remain the key. Promote rational use of anti-tb drugs. This involves increased engagement with the private sector. Implement infection control measures Stopping transmission of MDR TB Improve laboratory capacity for Rapid diagnosis of MDR-TB 13

16 Effective treatment of MDR-TB patients Initiation and rapid scale up of MDR-TB services Evaluate the extent of second-line anti-tb drug resistance and management strategies Expand diagnostic facilities for X DR. Progress made until date by RNTCP in scaling up services for Drug Resistant TB is given below: In March 2013, India completed geographical access to PMDT services in all 35 states across 692 districts covering 100% population of 1227 million. 48 laboratories (including 16 labs from other sectors) are currently offering quality diagnostic services for drug resistant TB with 38 labs equipped with rapid molecular diagnostic techniques (LPA) and an additional 30 sites offering Gene-Xpert tests under 2 different projects. 78 DR TB wards established with airborne infection control measures in place. Since the inception of PMDT services in India, as on December 2012, a cumulative total of o > MDR TB suspects have been examined for diagnosis o >21036 MDR TB cases have been put on regimen for MDR TB o >131 XDR TB Cases have been put on regimen for XDR TB The MDR problem raises four challenges immediately and several other issues. The first challenge is to detect all the cases. Only 21,000 cases have been initiated on treatment by 2012, and by 2017it is proposed, as per the Strategic Plan, to have the capacity to enrol MDR-TB patients annually. Therefore, many cases are being neglected and will be missed and will be mistreated in the private sector leading to additional drug resistance and XDR TB. Knowing that the prevalence/incidence is much higher, it is simply unacceptable that a conscious target be set up which would leave out probably more than half of estimated cases. It is essential that this strategy be revised immediately and a plan prepared which targets detection of all (or 90%) of estimated MDR-TB patients annually by This would mean a target of perhaps doing at least in 2014 and increasing by each year. It follows that the expected number of 4100 XDR-TB cases over years may also double. It consequently also means arranging for and funding a much higher requirement of diagnostic facilities, related consumables and drugs. Once detected it is important to put all such patients immediately on treatment. High turnaround time for diagnosis in solid C/DST (3.5-4 months) has led to attrition of diagnosed MDR TB cases to the tune of 30%. In a study in AP, only 66% cases were successfully initiated on treatment. Attrition was because of pre-treatment deaths, initiation of treatment in private sector and migration of patients. It has simply to be ensured that this is reduced to near zero (as some may die). How can we use ICT also should be examined. The second challenge is that this should not happen at the cost of DOTS programme, as sustained high quality DOTS implementation is critical to prevent the development of MDR-TB, which is a problem in view of high cost of management of MDR-TB, longer duration of treatment as well as poor outcomes of treatment and public health consequences. If management of MDR-TB is left with, the DOTS programme managers, these patients will consume a lot of their time and quality of basic DOTS will be affected. Thus, it would be in the interest of the programme if additional work force is immediately provided at state and district level which will be responsible to implement programmatic management of Drug Resistant TB (PMDT). This could start with the high-risk areas. The third challenge is to provide the funds. If the cost of treatment for an MDR case is Rs 1.5 lakhs, starting of treatment of 1 lakh cases in 2017 alone would require Rs 1500 crores, and in the next 3 years ( ) more money would be required. In addition, there would be increased XDR cases. Where will this money 14

17 come from? There must be clarity. The current plan allocation has consciously reduced this amount!! This has to change. We must argue for additional Global Fund money, while also planning for reduction in the cost of procurement through the Global Fund. Certainty of procurement of sufficient quantities by BRICS countries would ensure this immediately. This also suggests that these countries meet to prepare a medium term drug procurement programme. The fourth challenge is to find the right deployment strategy for the more sophisticated diagnostics, which will allow most of the MDR patients to be detected and have the necessary implementation framework and funds, both for the capital cost and the recurring testing costs. Other challenges include the sub optimal number and capacity of the clinicians managing MDR cases, which can be addresses through special training programmes. The programme also needs to encourage and promote active research for newer, shorter and more effective regimens to improve treatment outcomes and introduce socio-economic support packages (e.g. counselling, community support groups, incentives etc) for promoting adherence to treatment. There are reports that India is not participating in clinical trials for new drugs. If this is true, we would not be able to use such drugs if established. There is also need to discuss with Indian manufacturers how costs of drugs, diagnostics and consumables can be reduced. Future challenges We now come to the new challenges that have come about because of the threat of MDR, and even XDR, and the possibilities provided by new developments of diagnostics. This is exemplified by the situation in Mumbai, which is discussed in the annexed case study. In the past few years there has been a revolution in the field of TB diagnostics with the introduction of rapid and more reliable molecular tests. At least one of these tests (i.e. CBNAAT/Xpert) requires minimal infrastructure and minimally skilled human resource to perform, has high sensitivity and specificity and additionally informs about Rifampicin resistance. This test has the potential to become a point of care (POC) test and has been endorsed by WHO through a stringent grading mechanism. There is a need to review the programme policy on rapid adoption of the newer tests with several of them on the anvil. A brief discussion is given below: Current policy of PMDT treatment does not take into account the presence or absence of resistance to other drugs. Mono resistance to Rif is taken as a surrogate marker of MDR. Current RNTCP program policy is to do LPA (where available) or solid/liquid DST to diagnose DRTB. Performance of LPA and solid/liquid DST require special infrastructure and skilled human resource and hence are available only in the Intermediate Reference Laboratories. Xpert MTB/RIF does not have those special requirements and can be easily deployed in secondary health centres for providing decentralised diagnostic services. Solid/Liquid DST does diagnosis of XDRTB, which is suitable for second line drugs (Ofloxacin and Kanamycin). In the country, only the National Reference Labs (NTI, NIRT and LRS) are equipped for second line DST to diagnose XDR. However, 40 state level and private labs are in the process of upgrading/certification (it was not clear where and what is the timetable) Actually, Hinduja lab in Mumbai is also equipped, and is doing tests, but is yet to be certified under the programme. (Perhaps this has since been done in mid-december)there could be other such labs too, in the private sector. A limiting factor in engaging the private labs is the sub-optimal capacity to accredit the private labs. This could be addresses by relaxing the norms for labs, which are accredited by international 15

18 agencies like CAP. The accredited private labs can be engaged for accrediting other private labs. For the second line DST, capacity of the State IRLs can be built rapidly to perform DST for ofloxacin and Kanamycin and simultaneously the operational feasibility of LPA for second line DST can be undertaken. Ideally, all diagnosed TB patients should undergo DST before starting treatment. It means that 1.5 million cases should be tested annually. To keep a balance between the test need and the available lab capacity, program has taken a risk-based approach, by subjecting the TB patients with high risk for DST. The eligibility criteria for DST was initially only retreatment failures which has now been expanded to include all retreatment cases, failures of Cat 1 contacts of MDR TB cases, HIV positive and paediatric TB patients The PMDT vision is to include new cases in the current criteria. Despite the policy a significant proportion of the retreatment, cases do not get tested due to limited laboratory capacity and lack of follow up. This must be ensured for all retreatment cases forthwith where at least facilities exist (either in the public or even in the private sector). Mumbai Dharavi has shown almost 9% MDR in new cases and more than 25% in retreatment cases. The higher rates among retreatment cases may be due to two factors. This is because of poor DOT services in MMC as well as bad medical management of private cases. The higher rate among new cases does raise a concern. It is the evidence for primary transmission in the slum setting. The same could happen in any crowded settings with poorly managed basic DOTS and private treatment. On the one hand, it suggests special attention to urban slums, and, on the other, it suggests all retreatment cases be immediately subjected to DST. It appears that 5% of the MDR TB cases could be XDR. XDR TB is suspected on bacteriological non-response to the MDR treatment after six months or more. Isolates from culture thus found positive in state level labs are sent to NTI or other NRLs for second line DST. It has been suggested that the current delay in diagnosing XDR TB is due to Low index of suspicion and lack of certified lab capacity in the country. Due to the high workload in the 3 NRLs, the turnaround time is higher than the desired level. This is not true of Mumbai where a private lab exists and all retreatment cases could go straight for second line DST. It also implies that the load on NRLs be reduced by having more labs at different places based on case load and thereby reduce current delays of many months. More importantly it highlights the need to have such facilities in the public sector, especially in areas that suggest a higher that usual DR TB load in the community. Offering XDR test to Rif resistant Xpert MTB/RIF will require rapid capacity building beyond the planned 40 labs. However, it could start with where capacity exists. Annual cost of Diagnosis with this for retreatment cases alone would be 3, 00, per test means 30 Cr. To include new cases, it will be 1000 per test means 200 Cr. For XDR diagnosis, Liquid DST with four drugs for approximately 20,000 XDR TB 2000 INR per test will be 40 Cr. If extended to all Rif resistant cases diagnosed by Xpert MTB/RIF, it would be 1, 00, 2000 per test means 200 Cr annually. Cost of Liquid Culture Machine (MGIT-960) is approximately 25, 00,000 INR. We require 150 machines costing 38 Cr. These costs are indicated by the programme and our well worth incurring. Only ofloxacin and Kanamycin are sufficient for doing second line DST. This will also reduce the cost to about For MDRTB patient, a complete course costs lakhs. For approximately 1, 00,000 estimated MDR TB cases, it amounts to 1500 Cr annually. For XDRTB a complete course costs 3-4 lakh. For approximately 5000 XDRTB cases, this amounts to 200 Cr annually. The programme has to make provision of these additional funds. 16

19 There was talk of XDR patients getting individualised treatment regimen. This was specially argued by specialists in large hospitals and medical colleges. Individualised treatment regimen may be a good strategy. However, it offers challenges in drug forecasting, procurement and logistics management. For individualized treatment regime, the cost could fall between 3 and 4 lakh programme fears case to case procurement can result in long delays in treatment whereas procuring reserve stocks can result in expiry of costly drugs. This is the principle adopted in standardising the regime. RNTCP Program is perhaps planning to pilot individualized treatment regime in one or two tertiary care centres to gain initial experience with this strategy. It may be possible to have several identified courses based on the resistance patterns observed which could then be deemed partly individualised and partly standardised to provide for ease of procurement and could be then supplied in boxes, maybe a month at a time. It is essential that this matter be studied in depth and urgently. Given the small number of patients diagnosed with XDR-TB, States have been empowered to procure the additional drugs required for those cases. However, these drugs are exceptionally expensive and not easily procured in small quantities across all States. The lack of a secure drug supply for these drugs will become increasingly problematic for the programme as the number increases. Therefore, some central procurement system should be established asap. The programme is proposing to install 750 Xpert MTB/RIF machines in the next few years all over the country, one in every district. This is going to be costly. The problem is also that there is only one global manufacturer at present. Therefore, there is need for development of another manufacturer. Perhaps a strategy is needed where these are placed where needed most urgently because of high risks and to supply them there with a proper diagnostic strategy in place, even at the risk of some additional costs. Dharavi for example is a prime area even for a new diagnostic strategy. Here it has been suggested that we do xray for all new suspects, wherever some sign, take sputum sample to machine which will identify sp + and rifampicin resistance. Where resistant go straight to second line and then either treat MDR or personalised as per patterns? Perhaps there could be 50 such centres in first phase. MMC has already identified certain high-risk wards. Others such across urban slums in the country could also be identified. Here pilot projects of active case detection in vulnerable population can also be tried. The program policy allows this though its operationalization would need local micro-plans. It appears that for many years to come the program strategy will be to continue with sputum smear microscopy as the first tool. This is in view of not only the ease of deployment, operability, and cost, but also its relevance as a screening tool that can improve the cost-effectivity and test sensitivity of the machine and other tests to come. The rapid molecular tests like LPA and Xpert MTB/RIF will continue as a tool for diagnosis of Rifampicin Resistance among TB cases with higher risk of resistance. However, there should be better use of this tool in high-risk areas. The best strategy with currently available evidence suggested by the programme would be initial screening by smear microscopy, further screening of smear negatives by X-ray, those reporting a shadow on X-ray subjected to Xpert MTB/RIF/Culture DST. For Drug resistant cases, screening with Xpert MTB/RIF, further subjecting the Rif resistant cases to DST for at least 4 drugs (INH, Rifampicin, Ofloxacin and Kanamycin) and to treat the DRTB cases with DST driven individualized treatment regime. Thus the following issues need consideration regarding MDR and the situation seen in Mumbai I. Strategy for setting up of DST second line labs (or recognising others). 40 proposed. II. Strategy for setting up of Xpert MTB/RIF labs (or recognising others). 750 proposed III. For both time table; locations; costs 17

20 IV. No of tests likely, to be done annually in these labs/machines procurement of consumables can machines/consumables come from external support. V. Drugs required for MDR about Rs1.5 to 2 lakhs per patient for entire treatment course and for XDR Rs.3-4 Lakhper patient for entire treatment course. procurement/external funding support/domestic budget VI. If this is indeed current burden, how to detect and treat? VII. Any change in diagnostic processes? In high risk areas? VIII. Separate teams for MDR in high-risk areas urban slums. These exercises have been done, but the complete strategy and the higher targets are not fully in place or clearly identified Dealing with the private sector I. The private sector in India ranges from unqualified rural healthcare providers to the variety of small practitioners in urban areas and highly specialized corporate hospitals and medical colleges. The common factors across the spectrum of health care providers are the non-standardized and often irrational diagnostic and treatment practices for TB. This is particularly true as we step down the ladder. As an example Dr. Uplekar (v) had found many years ago in a follow up of the prescriptions issued by 100 doctors in private practice in Dharavi (Mumbai), that there were 80 different prescriptions. In a repeat survey two decades later, 106 practitioners used 63 different regimens. Of the 106 practitioners participating just 6 could write a standard prescription as per programme and only three could write a correct prescription for multi drug resistant TB. Unfortunately, they are likely to be the first point of contact/care when patients first experience symptoms of TB. Data shows that this could be upto70-80%. While most TB patients are ultimately treated by the RNTCP, most patients by then have already approached the private sector for diagnosis and treatment. The expectation that a well-functioning public sector providing free diagnosis and treatment over many years would attract more number of patients at the start itself has not materialised. As a result, there are delays in diagnosis, unnecessary patient expenditure and irrational or unsupervised treatment. These studies also point out that the longstanding programme of training private practitioners (especially those in the unorganised private sector) is not showing any measurable impact on the treatment regimen followed even by those trained. The area of practioner training has been proven to be ineffective and needs to be revisited. II. III. Some Medical College or Corporate Hospital doctors consider themselves too expert to be bound by programmatic guideline or restrictions. They prescribe what they consider the best treatment for their individual patients and naturally, their principal allegiance is to the individual while public health or national concerns are generally not considered. Perhaps the issue of individualised treatment for MDR cases can be a via media. Under RNTCP, successful efforts have been made to involve the Medical Colleges in the programme and most are part of it, and there has been some difference in attitude and approach. At the national level, medical colleges are contributing about 25% TB suspect referrals for diagnosis and 23% of new sputum positive diagnosis. 7% of patients are getting DOT within Medical Colleges. In 2011, 87,271 smear-positive TB cases, 49,031 smear-negative TB cases and 83,824 extra-pulmonary TB cases were diagnosed at Medical Colleges, which is 15% of all cases diagnosed and registered for treatment in the country. We have to see how to increase this since so many patients come there. Vigorous efforts to engage the private sector have been made over the years. They have revolved around outreach, directly via 16 public-private mix (PPM) schemes (about private providers and 1900 NGOs have signed MOU s to participate in these schemes and many are involved without them) and through intermediary groups such as the Indian Medical Association (IMA). In general, the efforts to engage private practitioners and sensitise them to generate referrals to RNTCP for diagnosis and/or 18