LETTER TO THE EDITOR
Year : 2013 | Volume
: 6 | Issue : 5 | Page : 596--598
"Revised National Tuberculosis Control Programme" in India, a strong need to revise
Samir Anil Singru1, Anagha Samir Singru2,
1 Department of Community Medicine, Shrimati Kashibai Navale Medical College and General Hospital, Narhe, India
2 Medical Director, Reliable Pathology Laboratory, Nigdi, Pune, Maharashtra, India
Samir Anil Singru
Parveen Palace, Flat no 4, Plot No. 7, Sector 25(SDC), Pimpri Chinchwad New Township Development Area, Bhel Chowk, Nigdi, Pune - 411 044, Maharashtra
|How to cite this article:|
Singru SA, Singru AS. "Revised National Tuberculosis Control Programme" in India, a strong need to revise.Ann Trop Med Public Health 2013;6:596-598
|How to cite this URL:|
Singru SA, Singru AS. "Revised National Tuberculosis Control Programme" in India, a strong need to revise. Ann Trop Med Public Health [serial online] 2013 [cited 2019 Jul 17 ];6:596-598
Available from: http://www.atmph.org/text.asp?2013/6/5/596/133776
The World Health Organization (WHO)-recommended Directly Observed Treatment, Short Course (DOTS) strategy was launched formally as Revised National Tuberculosis Control programme (RNTCP) in India in 1997 after pilot testing from 1993 to 1996. WHO has recognized 58 countries, including India, in which extensively drug-resistant (XDR)-TB has been detected.  As per systematic review done from 16 publications (14 papers, one meeting abstract, and one institutional annual report) and after discounting all potential duplications a total of 598 cases of XDR-TB have been documented.  Estimated proportion of multidrug resistant (MDR)-TB in India is 2.1% (1.5%-2.7%) in New TB cases and 15% (13%-17%) in previously treated cases. As compared with global rates, the proportions of MDR-TB are lesser in India. 
We now wish to draw your attention to some very important basic issues.
Issue: 1. Are These TB Statistics Realistic?
One should not forget that these figures are based on the statistics provided mainly from treatment sites run under the RNTCP program. Of the 8 million doctors in India, about 6 million are engaged in private practice. Throughout India, most patients, including those with suspected TB, report first to private doctors.  In India, we have a wide range of private doctors ranging from general practitioners from allopathy, ayurveda, and homeopathy. We then also have general physicians who are postgraduates from specialities of general medicine, chest medicine, and other clinical specialities. Then, there are many self-proclaimed doctors or fake doctors who do not have any formal training but are very popular among the community. There is a definite need to involve all these private doctors in the national TB control program. Compulsory notification of TB cases, defaulters, relapse, and failure taking treatment under these private doctors should be made mandatory by legislative measures to the health authorities.
Issue: 2. What Are The Neglected Issues Responsible for The Risk of Drug Resistance in India?
As already stated most patients, including those with suspected TB, report first to private doctors. Not all private doctors are competent enough to handle TB patients. Prohibiting such incompetent/unauthorized doctors from treating TB patients is very essential for prevention of emergence of risk of drug resistance. Updating patient's details in term of address, mobile number, work place details, and similar details of their near relatives is another important measure for tracking defaulters in private setup. Chest physicians and other medical specialist in India have their own TB treatment regimen based on their experience, monetary gain, or other issues. A study conducted on 106 private practitioners from Mumbai urban slums found that when these private practitioners were asked to write a prescription for a patient with pulmonary TB, 63 different drug regimens were prescribed, and only 6 of these prescriptions were found to be appropriate.  Strict legal enforcement of WHO recommended standard regimen is very important measure to combat drug resistance. Strict adherence of fixed dose combinations, banning single drugs, prohibiting sale of anti-TB drugs over the counter without prescription from authorized doctors, use of anti-TB drugs for other medical conditions, and drug auditing by drug inspectors in pharmacy are other important steps to prevent drug resistance which are still not practiced in India.
Issue: 3. Why Intermittent Thrice a Week DOT Regimen?
Under RNTCP, thrice a week intermittent DOTS regimen is implemented. This was based on the theory of lag period and thrice a week intermittent regimen was believed to be more efficient than the conventional daily regimen containing the same drugs with approximately same doses taken daily for the same duration. The Cochrane database of systematic reviews, however, concludes that evidence for this is insufficient, with only one study fulfilling their selection criteria.  A more recent large case-control study from Hong Kong found intermittent (three times weekly) treatment to be significantly associated with recurrence when compared with daily treatment, whereas prolongation of treatment was protective.  In another systematic review of studies published regarding dosing frequency for human immunodeficiency virus-negative patients, the systematic review found little evidence of differences in failure or relapse rates with daily or three times weekly regimens. However, rates of acquired drug resistance were higher among patients receiving three times weekly dosing throughout therapy than among patients who received daily drug administration throughout treatment. Moreover, in patients with pretreatment isoniazid resistance, three times weekly dosing during the intensive phase was associated with significantly higher risks of failure and acquired drug resistance than daily dosing during the intensive phase.  Probable reason could be due to the fact that thrice a week regimen patients are receiving practically half the treatment than that of the daily regimen patients. It should be noted that only Isoniazid dose is doubled in thrice a week regimen and doses of other anti TB drugs increased slightly.
Another basis put forward in implementation of thrice a week intermittent regimen was that it was less toxic, less costly, requiring fewer visits by patients and logistically more feasible. Regarding toxicity, the medicines offered in both the regimens are the same with difference in frequency of dosing (higher in daily unsupervised) and dose per tablet (higher in thrice a week, intermittent directly observed). Adverse effects minimizes with the duration of the treatment, early recognition of adverse effects, and proper counselling. These interventions should reduce the toxicity issues. Thus, the thrice a week intermittent regimens are inferior to daily regimen based on scientific basis. The program should implement the daily regimen using the same drugs. WHO also recommends this in its publication: Treatment of tuberculosis: Guidelines, 4 th edition, WHO/HTM/TB/2009.420, recommendation 1.1, page 32. 
Issue: 4. Is There a Need for DOTS Provider from Treatment Centers?
In case of thrice a week intermittent DOTS regimen, the patient has to go to the treatment centre thrice in a week in intensive phase and once in a week in continuation phase. In contrast in daily unsupervised regimen he/she can collect the monthly medicines in a single visit. Also in the thrice a week intermittent DOTS regimen if the person misses one visit, he/she has not taken antitubercular medicines for 3 consecutive days. This can seriously increase the chances of drug resistance. As per various studies, the most likely reasons for patients to miss visits/medication were travelling back to the village, not being able to forgo their businesses for medication attendance, living far away, medication side-effects, attending family emergencies, and clashing of peak business time with hospital timings. ,,
Another important issue in case of the DOTS regimen is that the person has to swallow the medicines in the presence of the health staff. Initially, this was done by the health staff with great sincerity. However, with the continuation of the program, this motivation is slowly decreasing. This information is based on personal interviews with many hospital staff having DOTS centers and also various WHO TB consultants. As per 11 trials conducted in low-, middle-, and high-income countries with 5609 participants, no statistically significant difference was detected between DOT and self-administration in terms of cure with similar results for cure plus completion of treatment. When stratified by location, DOT provided at home compared with DOT provided at clinic suggests a possible small advantage with home-based DOT for cure. There was no significant difference detected in clinical outcomes between DOT at a clinic versus by a family member or community health worker or for DOT provided by a family member versus a community health worker. Two small trials of tuberculosis prophylaxis in intravenous drugs users found no statistically significant difference between DOT and self-administration (199 participants, 1 trial) or a choice of location for DOT for completion of treatment.  Thus, more money, time and energy is spent in case of thrice a week regimen than daily regimen. Family member or any community member selected by the patient if effectively counselled and if can be accountable can be used as DOT provider in home.
Issue: 5. What About Consuming Rifampicin After Food?
A study has showed significant reduction in absorption of rifampicin with respect to food.  Rifampicin should be taken ideally before food as food interferes with is absorption.  It is not possible for a TB patient to come to the treatment center empty stomach, wait till 10 am for the medical staff to come, swallow rifampicin, wait for another half hour, take breakfast/meals, and then consume the remaining medicines. Reduced absorption of rifampicin can contribute to increased drug resistance in future. Thus in our view, these are the important issues in the currently run RNTCP program in India. There is definitely a strong need to address these issues on urgent basis.
The authors acknowledge the inputs given by DOTS providers of various DOTS centers in Pune region, India.
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