Every year, approximately 2 million persons in India develop tuberculosis (TB), accounting for one-fourth of the world's new TB cases. Organized TB control activities have existed in India for 40 years; however, the quality of diagnosis and treatment of TB in the public and private sectors has been variable, and TB incidence and prevalence trends have not changed substantially over this time. In 1992, the Indian government established a Revised National Tuberculosis Control Programme (RNTCP) using the directly observed treatment, short-course (DOTS) strategy recommended by the World Health Organization (WHO). The DOTS strategy consists of sustained government commitment, effective laboratory-based diagnosis, standard treatment given under direct observation, secure drug supply, and systematic monitoring and evaluation. RNTCP was implemented in pilot areas beginning in 1993; large-scale implementation of the program began in late 1998. This report summarizes the process, outcomes, and challenges of RNTCP in India. RNTCP has implemented DOTS rapidly and has yielded positive results in TB control; however, continued commitment from Indian government authorities and the international community is needed to sustain and expand this ongoing program.

During 1993-2001, under RNTCP, patients diagnosed in health- care facilities with coughs lasting >3 weeks underwent three sputum smear examinations over a 2-day period. If all three acid- fast bacilli (AFB) smears were negative, 1-2 weeks of broad- spectrum antibiotics were prescribed. If some but not all of the specimens were positive, or if a patient with negative smears continued to have symptoms after 1-2 weeks of broad-spectrum antibiotics, a chest radiograph was taken, and if indicative of disease, the patient was treated for TB. All TB treatment was given three times weekly on alternate days; the diagnostic evaluation and the entire course of treatment were free of charge. During the first 2 months of treatment (intensive phase), patients were treated with isoniazid, rifampin, pyrazinamide, and ethambutol (streptomycin was added for re-treatment patients, and ethambutol was omitted for smear-negative, nonseriously ill patients); every dose was observed directly by either a health-care provider or a non-family community member. For the remaining 4-6 months of treatment (continuation phase), either isoniazid and rifampin or isonizaid, rifampin, and ethambutol were prepared into weekly packs, and at least the first dose each week was observed directly. To prevent drug shortages during TB therapy, medications for both phases of treatment were maintained in individualized patient boxes containing the entire course of treatment for a given patient at the health facility or residence of the community volunteer providing DOTS. Recording and reporting of case detection and treatment outcomes were conducted according to WHO recommendations.

As of November 2001, RNTCP offered TB control services to regions comprising >40 percent of the country's population (>440 million persons), compared with <2 percent in mid-1998. To prepare for service delivery under RNTCP, since 1998, approximately 3,000 small laboratories have been upgraded for smear microscopy, 2,000 contractual staff hired, approximately 200,000 health-care workers trained in different aspects of DOTS service provision, and approximately 500 million tablets of anti-TB medication distributed.

During 2001, approximately 300,000 adult outpatient visits were recorded per day in facilities covered by RNTCP, with approximately 5,000 patients examined for TB and approximately 1,300 patients started on treatment each day of operation. Indicators of the quality of case-detection activities include the proportion of patients with newly diagnosed pulmonary TB who are sputum smear-positive for AFB (which should be >50 percent in a well-functioning program). During April-June 2001, 179 (95%) of 189 districts reported that >50 percent of all new pulmonary TB patients were diagnosed as sputum smear-positive for AFB, indicating high diagnostic quality in these districts.

One year following the start of treatment, 256,621 (80%) patients had been treated successfully, and 98,302 (81%) patients who were initially sputum smear-positive had laboratory evidence of sputum conversion to negative. During April-June 2000, 77 (75%) districts had treatment success rates of >80 percent. However, previously treated patients had outcomes that were slightly less favorable than new TB patients (71 percent versus 83 percent treatment success). Patients who had previously failed treatment (those who were sputum smear-positive at 5 months or later during an earlier course of treatment) had a significantly higher risk for remaining smear-positive when treated again than did other types of re-treatment patients, such as successfully treated patients that relapsed or those who prematurely discontinued treatment (12.9% versus 5.8% and 5.2% respectively, p<0.001).

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