The following three centres were selected for the visit and intensive study:

1. Gulabi Bagh in North Delhi, which is being flaunted as the most successful pilot project in the entire country. The study was done on 29 Jan. & 19 Feb. 1998.
2. Mahesana district of Gujarat, which was the only rural area chosen under the pilot
   phase programme. The study was conducted on 10 and 11 Feb. 1998.
3. Jaipur, which was taken up in the second phase and could represent the BIMAROU (Bihar, MP, Assam, Rajasthan, Orissa, UP) area. The study was conducted from 09 to 11 March 1998.

The questions to start with were the following:

• Is DOTS really directly observed, because the revision revolves around this and the investment is being justified on this ground alone?
• What is the universe of patients against which the cure and compliance rates are being calculated?
• What is the detection rate and does it come anywhere near the expected incidence of TB (0.2%) in their populations?

Is a strict vigil being maintained on the compliance because, if not, the programme would indeed be disastrously increasing the incidence of MDRTB?

• What are the patients’ reactions?
• How strictly are the technical guidelines for case detection and treatment being met?

Note : Data received from the three project areas may not be comparable as the data sheets handed over to the author have been at the discretion of the projects. These data are the property of the World Bank; one project officer confided.

Background
In 1992, a nation wide survey was conducted by the Government of India to review the National Tuberculosis Programme (NTP) with assistance from WHO and SIDA. Based on the various findings, a Revised National Tuberculosis Control Programme (RNTCP) was launched in the country in 1993 with an emphasis on DOTS - Directly Observed Treatment - Short Course in five pilot projects in different parts of the country.

The Strategy

• use of sputum testing as the primary method of diagnosis among self-reporting patients.
• standardize treatment regimens.
• augmentation of the peripheral level supervision through the creation of a sub-district supervisory unit.
• ensuring a regular, uninterrupted supply of drugs unto the most peripheral level.
• augmentation of organizational support at central and state levels for meaningful coordination.
• emphasize training, IEC, operational research and NGO involvement in the programme.
• increase the budgetary outlay.

The successful implementation of the revised strategy is expected to achieve:

• a) a cure rate of at least 85%.
• b) case detection of at least 70% of the expected.
• c) the reduction in the annual rateof infection from the current 2 - 2.5% to 8 - 10%.
• d) reduction in mortality to about 20 per 1,00,000 population.
• e) reduction in relapse to less than 5% from current figure of 20%.

After the GOI was convinced of the efficacy of the approach, the project area was progressively increased with an aim to cover 271.21 million population by the end of phase III of the programme, i.e., by 1998. The idea of DOTS was to ensure that each and every dose of medicine was supervised from a centre close to the patient. This would help the patient to ‘remember the intake, cut down cost of default, cut down incidence of Multidrug Drug Resistance to TB (MDRTB) and is reassuring to the patient.’ During the Intensive Phase (IP), the patient has to come to the centre for the thrice weekly intake of drugs in single daily dose blister combi-pack, but during the Continuation Phase (CP) the patient has to collect the drug only once a week in weekly blister combi-pack dosages of which s/he has to take only the first of the three doses in front of the TB worker. In toto, of the 24 IP doses and 18 CP doses, 24 IP and 6 CP doses require observation.

By the time this study was underway, the programme has already been termed unofficially as POTS, i.e. Partially Observed Treatment Short Course.

Delhi - Chest Clinic, Gulabi Bagh Population of project area - 1 million, Field centres - 10 and Microscopy centres 3, Pilot-project started in October 1993.
It was found that there was only a passive surveillance for newer cases. Initially, there was a problem in getting patients, and the project resorted to active case finding. Each case of sputum positive TB attracted an incentive of hundred rupees and the health workers spent a lot of energy in urging all ‘TB looking people’ to cough out their sputum and in making slides on the spot. The scheme fizzled out because finally the promised incentive was never paid to the workers.
Drug supplies have been regular and have never failed. In both the TB centres there were no water sources. The drugs which were swallowed by the patients were not under direct observation of the health workers. I noticed two relatives coming to collect the drugs and they were given medicine which was definitely against the DOTS concept! I could observe only one patient swallowing the drug in front of the DOTS worker. All the patients interviewed while taking the DOTS dose had taken at least some kind of food in the last one hour ‘to avoid vomiting’. A few jaundice cases and several temporary gastritis were recorded.
The two medical officers seemed to be very enthusiastic about the DOTS regimen. Most of the workers were sensitive to the problems faced by the patients and their relations in attending the DOTS clinic and were strident in their criticism. Two of them even told me that the doctors also were unhappy about it but have to follow the system because of pressure from above. The patient compliance was generally good. However, the workers felt there may be 25 - 30% left out on reasons of unlikely compliance of DOTS. The record maintenance done is of an exceptionally high quality. There is a shortage of laboratory staff, but the medical officers and the supervisors have been doing reasonably well.

Gujarat - Mahesana District RNTCP
Population of project area - 1490076 since 1995, No. of villages 580, Health centres/dispensaries/hospital - 59, Microscopic centres 36 and X-ray centres 3. The DOTS Project started in Oct. 1993 as a pilot project for the RNTCP with an initial population of five lakh.
The entire project has been handled by the existing government health service functionaries, by retraining and reorienting them to the DOTS and RNTCP ideology. Initially, the project had difficulty in identifying new cases. But over the years, the programme has built up a formidable reputation in the rural areas and the moment patients come to know that they may have symptoms suggestive of TB, they may even directly report to the PHC/Mahesana DTC for a correct evaluation before starting treatment. But the majority still reach private practitioners, before switching over to the Govt. system. The expertise of microscopists at CHC/PHC were doubtful. None of the sputum positive patients are X-rayed even once, neither before nor after.
There is no overlap of regimens in the project area. However, of the patients taking drugs from the DTC itself, only 50 of the approx. 500 patients are on the RNTCP regimen. Those reporting for the first time from outside the district and those who get transferred from some other district are kept on NTP regimens.
Once the patient is registered, the first DOTS is given immediately. Depending on the time expected for the drug - box to reach the DOTS/alternative DOTS worker, the patient is given one or two more doses in his or her charge. The TB drugs supply has never broken down completely.
By and large, the doctors at the CHC and the pharmacist were well conversant with the new changes in the RNTCP. The level of recording accuracy was also very high. Most patients when questioned, were taking their drugs empty stomach first thing in the morning. However, about 30% had problems taking the Rifampicin and had to resort to taking it after breakfast. Few cases of gastritis and jaundice cases were noticed. However supervisory staff did not know how to handle the reactions. Drug administration directly under observation was not a problem because all the centres have only three to five patients staggered over a few hours of time. The general patient compliance was good. All the staff swore by DOTS. The DOTS programme has been successfully mounted on the government health system in Gujarat.

Jaipur - District TB Programme (Urban)
Population of project area - 1.5 million, Field centres 13, Microscopy centres 8, TB units 2, project started in 1995. Although the programme is working entirely through Government hospitals and dispensaries, special DOTS workers have been employed for the project. Curiously, the Rajasthan Government has decided to employ retired Government personnel, not necessarily from the health department. hence the project is saddled by old people who do not have adequate energy levels to cycle down their areas to follow-up defaulters, besides their lack of technical knowledge. The staff is inadequate. All Government hospitals and dispensaries have been asked to allot a room for the DOTS centre.

There is gross deficiency of laboratory technicians, as many of the vacancies are yet to be filled up. DOTS and RNTCP get a step-motherly treatment and the stigma of TB still seems to exist.

There is only a passive surveillance for case finding, so the number of new sputum positive detected by the microscopy centres are very few. Most hospitals are not meeting the targets of TB detection. Percentage of initial defaulters was found to be 10%. There has been no shortage of drugs ever. Only one out of the five DOTS workers was really diligent enough to ensure swallowing of the doses in front of him. Others either asked the patient to go to the next tap or handed over the complete weekly pack in the hand of the patient. Record keeping was found fairely good, but authenticity was questionable. There was no formal records of adverse drug reactions, except few cases of jaundice, and gastritis to Rifampicin. Defaulter rates were said to be very high. The confidence of DOTS workers varied from place to place. Some had no faith in the DOTS. There was a very poor response to the programme from almost all hospitals where the DOTS centres were running.

Discussion
At the end of the observations, let us examine the RNTCP as it is seen to be on ground vis-a-vis the revisions for which it was launched. To begin with, what are the answers to the questions that we started off with?

Is DOTS really directly observed?
No. At most centres, the programme could be called KNOTS — Knowing but Not Observing Treatment - Short course. From the DOTS envisaged, the RNTCP guidelines had anyway diluted the scheme to POTS - Partially Observed Treatment Short course. The ground realities have taken it to KNOTS. Even when the majority of the patients are coming to the DOTS Centre they are not exactly swallowing the drug in front of the DOTS workers. If so, what is the point in making the patients travel a distance wasting time and money.

What is the universe of patients against which all the cure and compliance rates are being calculated?
Although the area has been demarcated quite clearly for the three projects, patients from outside also report to the centres knowing that these centres have drugs available regularly. However, because the project does not have sufficient coverage - only 16 districts have been covered as of December 1997 against the target of 102 districts - a 41.47% patients get THROWN OUT of the system due to its coditionalities.
There are lot of inconsistencies in the figures handed out, with no one really monitoring the records at all. There is no believable uniformity for seeing the denominator for the treatment results. We are not sure if records are being fudged by corrupt staff to suit the numerator requirements being stressed on in the programme.

What is the rate of TB detection against expected incidence?
Considering the fact that there is roughly a 0.2% annual incidence of TB in India - agreed that it may not hold out for each individual district - the expected registration vis-a- vis the actual number of patients registered in each of the projects areas in 1996 would have been: Delhi 2000, Mahesana 3000 and Jaipur 3000 as against actual registration 1177, 717 and 910 respectively. Infact the case detection in all the projects is far below expectations.

What is the status of the case holding?
By and large, one felt happy with the amount of pains being taken to motivate patients to complete the treatment once started. The efforts by the medical officers and senior doctors need to be appreciated. Case holding was 92% in Delhi, 87% in Mahesana and 88.8% in Jaipur.

What are the patients' reactions?
Most patients were not bothered about travelling one or two kilometres to get their drugs thrice a week, as they had no alternative. Barring a couple of people, no one had experienced any side-effects and were quite comfortable with the drugs.

How strictly are the guidelines for case detection and treatment being followed?
The case detection is good wherever the sputum is checked centrally, like the CCGB. Wherever the job is delegated to people outside the programme, the case finding seems to drop. There are details of the treatment which need to be strengthened. The overall cure rates need to be kept under surveillance. The rates are not satisfactory which is 89.32% in CCGB, 78.52 in Mahesana and 70.57 in Jaipur.

Is there an epidemic of TB?
Not in India at least. There may have been an upsurge of the disease in the US, the CIS states, and all the countries hit by the HIV epidemic, but no such epidemic in India, nor is there any evidence to prove that the incidence or prevalence of TB has increased over the past decade or so. Not even from the states of Manipur and Maharashtra, which report 14% and 10% HIV seropositivity these days. However, India needs to be alert.

Was a revision necessary in the TB programme?
was definitely a need of a revision in 1993, and the reasons for them continue to exist in 90% of the areas of India even today. As Dr. D. Banerji, Professor Emeritus, JNU often repeats, "the TB Control ship needs to sink or sail with the primary health care system or else the remedy may be worse than the disease itself".

Is DOTS necessary keeping in mind the ailments of the NTP?
The principle behind DOTS is agreeable but not the method. With frontline drugs being available universally, there is no reserve worth its name to delve into. Hence it is imperative that patients take anti-TB drugs correctly, regularly and for the complete duration.
DOTS aims at policing the wrong people in the crime of non-compliance. The overwhelming reasons of patients not completing their treatment are a lack of regular drug supply, lack of faith in the treating physician/institution/diagnosis, or due to intolerance but never because of cheating.

How effective is the thrice weekly regimen for a country like India?
There are very few trials on thrice weekly regimens lasting for 6 months or 8 months as approved in the RNTCP, with very little knowledge about it among the medical fraternity. If the GOI had wider debates on the DOTS, lot of resistance from the doctors and delay in expanding the programme would have been avoided.

How affordable are the RNTCP regiments?
At two millions cases every year, at an average cost of Rs. 1000/- per patient, an amount of Rs. 200 crores is required for the drugs annually. It is a cost which India can afford if there is a political will. Money can be raised innovatively from within the country as well.

How can the private sector be involved?
Presuming that 50% of all TB patients remain with the private sector till the end of treatment, it is essential that the Indian Medical Association and reputed NGOs must be involved in the task ahead. Notification of TB and prescription audit by Distirct-level communities may be required.

Conclusion
After the small observational study, one thing which comes out clearly is the need for a wider debate to clear the intellectual cobwebs. It is necessary because TB as disease and the patients suffering from it are more important than our viewpoints. There is a need to present experiences of successful models, and to involve medical college professors, teachers, IMA and NGOs in the programme from the planning stage itself. There is also a need to utilize the attention which has been generated in a proper, rational and cost-effective manner for the sake of TB, and the faster this gets done, the better would be the outcome in the long run.

Note: Non-availability of anti-TB drugs continues to be a major bottle-neck in TB care. The increasing cost of TB drugs, failure in effective communication and emergence of drug resistance have made the complicated TB situation worse. Readers are requested to share their views, experiences and concerns in working among TB patients. This will be valuable in making a joint effort in addressing the problem of TB.

Copy of the full report is available from:
Public Policy Division
Voluntary Health Association of India
New Delhi 110 016.

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