Diagnosis of drug-resistant TB and provision of second-line TB treatment in India: some ethical considerations.

BACKGROUND: The GeneXpert® MTB/RIF (hereinafter Xpert) test has demonstrated sensitive detection of tuberculosis (TB) and Rifampicin resistance directly from untreated sputum in less than two hours. India is currently drafting the third phase of its Revised National Tuberculosis Control Programme (RNTCP). This process provides the country's health authorities with an ideal opportunity to revolutionise TB management in the country. The RNTCP is currently conducting a multi-site demonstration study to gather operational evidence to scale up the Xpert test under Indian programme conditions. DISCUSSION: With the impending publication of RNTCP's third phase, we consider the obligations of India's RNTCP in the light of the World Health Organization's Guidance on ethics of tuberculosis prevention, care and control, published in November 2010. SUMMARY: India is ethically obliged to phase-in the nationwide deployment of Xpert, a generic equivalent, or a quality lower-cost molecular diagnostic alternative, preferably made in India, as soon as reasonably possible. Further, India is ethically obliged to provide those diagnosed with first-line drug resistance universal access to second-line TB drugs. Doing so will reduce India's morbidity and mortality associated with diagnostic delay, dropout, and mistreatment of TB, and help stem the country's growing TB crisis.