Why India should become a global leader in high-quality, affordable TB diagnostics.

The scale up of DOTS in India is one of the greatest public health accomplishments, and yet undiagnosed and poorly managed TB continues to fuel the epidemic such that India continues to have the highest number of TB cases in the world. Recognizing these challenges, the Government of India has set an ambitious goal of providing universal access to quality diagnosis and treatment for all TB patients in the country. Innovative tools and delivery systems in both the public and private sectors are essential for reaching this goal. Fortunately, India has the potential to solve its TB problem with "home-grown" solutions. Just as Indian pharmaceutical companies revolutionized access to high-quality, affordable AIDS drugs through generic production, Indian diagnostic companies could also become the world's hub for high-quality generic diagnostics. In the long term, India has the potential to lead the world in developing innovative TB diagnostics. For this to happen, Indian industry must move from the import and imitation approach to genuine innovation in both product development as well as delivery. This must be supported by permissive policies and enhanced funding by the Indian government and the private sector. Strict regulation of diagnostics, increased attention to quality assurance in laboratories, and greater engagement of the private health care providers are also needed to effectively deliver innovative products and approaches.