Tuberculosis is the leading cause of death in India, killing close to 500,000 people a year. A review of India's tuberculosis program in 1992 found that less than half of TB patients received an accurate diagnosis, and less than half of diagnosed cases received effective treatment.

The current study analyzed the effect of policies introduced in 1993, a pilot project called the Revised National Tuberculosis Control Program. The authors describe the first eight years of the program, including the years 1999 through 2001, during which the program was implemented on a large scale.

Begun on Oct. 2, 1993, the Indian TB control program is now one of the largest public health programs in the world. It has resulted in increased resources, improved laboratory-based diagnosis, direct observation of treatment, and the use of standardized anti-TB regimens and reporting methods. By September 2001 more than 200,000 health workers had been trained, and 430 million people, representing more than 40 percent of India's population, had access to services. Of the roughly 3.4 million patients tested for TB, nearly 800,000 had been treated, with an 80 percent success rate. More than half of the patients treated during the program's first eight years had been treated during the last twelve months.

The authors cited challenges India faced in implementing the program, among them an often dysfunctional general health service; an unregulated private health sector; varying levels of socioeconomic development that can affect program performance; the role and effectiveness of the state; difficulty in ensuring the quality of drugs; and the need to establish patient-friendly services, which sometimes contrasts with established patterns in Indian society.

The program was implemented for approximately $50 million over the eight-year period studied. Much of the initial expense was for one-time investments in infrastructure and capacity. Khatri and Frieden estimate that the program has prevented 200,000 deaths, with indirect savings of more than $400 million. It has also prevented the spread of TB, and reduced the disease's prevalence in some areas. Ongoing yearly project costs are approximately $0.05 per capita. At current rates of case detection, according to the authors, those costs correspond to less than $40 per patient treated, less than $50 per patient cured, and less than $200 per life saved.

The authors predicted that India will face a significant challenge in sustaining and expanding the program, for reasons listed above as well as two other factors: the threat of drug resistance and the HIV epidemic. Drug resistance, resulting from the inappropriate prescription or use of drugs, is associated with a higher failure rate among patients who are treated a second time. In some areas, from 1 percent to 3.4 percent of new patients had multidrug-resistant TB. The authors point out that if even 2 percent of new patients in India have multidrug-resistant TB, that represents 20,000 new infectious cases per year. The financial and human resources necessary to treat one patient with that strain of the disease are greater than the resources needed to treat 100 other patients. More than one million new TB patients still do not have access to basic program care.

Khatri and Frieden noted that about half of the estimated 4 million HIV-infected Indians are also infected with Mycobacterium tuberculosis. They predicted that active TB would develop each year in about 7 percent of coinfected patients, resulting in 400,000 cases of TB from reactivation disease alone. They wrote that, "given the experiences in other countries that 30 to 60 percent of tuberculosis in HIV-infected persons arise from recent infection, approximately 200,000 additional new cases will occur each year, representing a 10 percent increase in cases, even at the current relatively low rate of HIV infection."

Despite the obstacles the program has encountered, the researchers asserted that expansion plans to cover 80 percent of the country by 2004, and eventually cover the entire country, could possibly succeed, but success is far from assured. They noted that, "Continuing high-level commitment and technical rigor from the central and state governments of India and assistance from international organizations will be essential."

India's TB control program includes lessons for other programs, according to the authors. Those lessons include the use of well-tested standardized training modules, the application of strict criteria before allowing an area to begin services, intensive monitoring of and feedback on quarterly reports, and on-site supervision by specialized staff both from the program (contractual supervisors) and from outside the program (WHO consultants), and an information system that requires patient evaluation during and at the end of treatment.

"Tuberculosis control is a management problem; the disease itself is nearly 100 percent curable with interventions that are inexpensive and relatively simple," they said. "This program has shown that, with careful management, it is possible to provide high-quality treatment to large numbers of patients, even in the context of a suboptimally functioning health care system."

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