TB Week: Tuberculosis control in India — time to think beyond DOTS

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In the week leading up to International Tuberculosis Day, which commemorates the discovery by Robert Koch of the cause of the disease in 1882, Science Speaks will look at issues, events and efforts to confront this lasting and global health threat. Today’s guest post by Dr. Madhukar Pai looks at the need for an evolving approach to tuberculosis.

Madhukar Pai, MD, PhD is an associate professor of epidemiology at McGill University, Montreal, and an associate director of the McGill International TB Centre. He serves as a Consultant for the Bill & Melinda Gates Foundation. He has previously served as co-chair of the Stop TB Partnership’s Working Group on New Diagnostics. His research is mainly focused on improving the diagnosis of TB, with a special emphasis on India.

He wrote this post for Science Speaks. The views expressed in this post are those of Madhukar Pai, and they do not necessarily represent the views of any institution with which he is affiliated.

By Madhukar Pai

World TB Day is a good time to take stock of progress in global TB control. Unfortunately, TB continues to be major public health threat, with an estimated 8.7 million new cases per year, and an estimated 1.4 million deaths from TB. Early case detection and rapid treatment continues to remain the cornerstone of TB control strategy. With the incidence of TB declining very slowly, it is now obvious that TB cannot be eliminated by 2050.

India has the world’s highest burden of TB. TB kills one person every two minutes in India and 750 people every day.  Global TB control is unattainable without enhanced control of TB in India. India has been in the news lately because of the international attention around the emergence of “totally drug-resistant” TB in Mumbai and the growing concern that routine TB control (i.e. the DOTS strategy) may not be sufficient for reducing TB incidence in the country.

India’s Revised National TB Control Programme (RNTCP) has made great progress in the last decade, and free, quality-assured TB diagnosis and treatment is available to all patients who seek care in the public sector. Over the past year, laudable political and administrative commitment has been demonstrated by major increases in the RNTCP budget, a ban of inaccurate, antibody-based serological tests for TB, a national order for mandatory notification of all TB cases, and initiation of a national web-based case notification and tracking system.

The Government of India (GOI) recently approved the National Strategic Plan for 2012-2017 with an ambitious goal of universal access to quality TB diagnosis and treatment for all patients in India. This goal of universal access will mean increasing the capacity to manage and treat all forms of TB (including drug-resistant TB), as well as substantially great engagement of the private sector in India which manages nearly half of all TB cases.

The GOI is currently considering a simple National Standard Mechanism for universal access to quality assured free anti-TB drugs to all TB patients in the country, including those being treated in private sector. Furthermore, the RNTCP has also shown enthusiasm for scaling-up newer, WHO-endorsed molecular tests to enhance capacity for rapid detection of drug-resistance.

While these are positive developments, TB control in India is at a critical juncture. The routine, basic DOTS program has been scaled-up and may have reached its limits because TB incidence is not declining. Therefore, innovative solutions are needed to go beyond current gains and address the challenges of private sector engagement and drug-resistant TB, and leverage the potential of the private sector to help achieve the new goal of universal access.

We know that TB case finding has plateaued and many cases remain either undiagnosed or ineffectively treated. Delays in diagnosis or ineffective treatment lead to ongoing transmission, facilitating the spread of the disease. Patients often seek care in the informal and private sectors, and they remain outside the reach of the RNTCP.

Patients pay a lot for tests that are inaccurate, and treatment that is unsupervised, unsupported, and frequently far short of expected standards. Poor treatment practices drive the development of drug resistance, which endangers patients as well as the healthcare system. Without effective engagement of the private health sector, the new vision of TB control is unlikely to be achieved.

So, it is clear that India will need to invest in new diagnostics and drugs and scale them up to achieve impact. But technologies alone cannot solve the problem. Innovative delivery approaches and business models are needed, especially to engage the dominant Indian private sector.

Such innovative approaches are being tried out. For example, a new initiative is just being launched, to improve the affordability of WHO-endorsed TB tests. Initiated by a coalition of private labs in India, and supported by the industry, this project will make three WHO-approved tests available at affordable prices to patients in the private sector. These labs will have access to lower, negotiated prices for the quality tests in exchange of their commitment to pass on the benefits to patients.

Operating on a high-volume, low-margin model, the cost of GeneXpert will now be reduced to Rs 1700 (maximum price labs can charge patients). The line probe assay (Hain Genotype) will now be available at Rs 1600. Laboratories in the initiative will also offer other WHO-endorsed tests (e.g. MGIT, liquid culture) at transparently advertised ceiling prices. TB cases diagnosed will be notified to the RNTCP for linkages to free TB drugs, where necessary. The initiative can also be extended to include other new diagnostics in future, and cover other diseases of poverty.

Thus, this initiative is expected to greatly increase affordability for private sector patients, and improve the quality of TB care in the country. In the long run, removal of import duties for all TB tests along with encouraging domestic development of the same will be critical to achieving the RNTCP goal of universal access. India’s private sector has a responsibility and an obligation to make a contribution to TB control. Because TB is a huge economic drain on India and mostly affects young, productive adults, the private sector clearly stands to benefit from any initiative to reduce TB burden.

The National Strategic Plan, if fully implemented, can have a big impact. But it will require increased funding and a bold implementation plan.  For early detection and appropriate treatment of all TB patients, the RNTCP will need to engage the private sector, and support delivery innovations on a larger scale. That will be truly transformational.

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