Close to the heels of making tuberculosis a notifiable disease, the Government of India has now banned the import, sale, manufacture and use of serological test kits for diagnosis of tuberculosis (also known as blood test or antibody test for TB). A notification (no.X-11014/13/2011-DFQC) dated 7.6.2012, issued by the Ministry of Health and Family Welfare, prohibits with immediate effect the manufacture for sale, distribution, import and use of these serological test kits because 'the government is satisfied that it is necessary and expedient to prohibit the use of these test kits for diagnosis of TB in public interest as they are giving inconsistent and imprecise results leading to wrong diagnosis and their use is likely to involve risk to human beings and whereas safer alternatives are available.' Laudable sentiments indeed!
This much awaited and welcome order has come almost one year after the World Health Organization in July 2011 issued its first 'negative' policy recommendation on TB strongly recommending that 'commercial serodiagnostic tests not be used for the diagnosis of active pulmonary and extra-pulmonary TB, because (i)currently available commercial serodiagnostic/ serological tests provide inconsistent and imprecise findings, and (ii) there is no evidence that existing commercial serological assays improve patient outcomes, and high proportions of false-positive and false-negative results may have an adverse impact on the health of patients. Compared to appropriate diagnosis of TB through WHO-endorsed tests in a country like India, it is estimated that serological testing would result in 121,000 additional false-positive diagnoses. Research also suggests that for each additional smear-negative TB case found by serology, more than six additional false-positive cases would be inappropriately diagnosed.'
But merely passing laudable orders will not do. The morale of the Indian public is rather low regarding the morals of the powers that be. Past experiences suggest that in our country there is a wide chasm between enactment of laws and their implementation. I wonder if these tests have been banned overnight in the private medical sector across the country. And yet this is what the notification implies. Has the government made a reality check of the ground situation, at least in the better known private hospitals, even after almost a fortnight of passing this order? Are we to believe that that the existing test kits have been (or are being destroyed) by government agencies, even as new ones may not be imported or manufactured? The words 'with immediate effect' sound very hollow given the past inabilities of the government to ensure strict compliance of its orders. Perhaps it might have been more realistic for the government to have had some time frame (15 days or so) for the private sector to stop this faulty diagnostic practice before clamping the orders with ruthless rigidity.
The readymade TB kits are very popular in the private setup because these require very little expertise to operate. According to a paper in National Medical Journal of India, "every major private laboratory in India offers TB serological tests, mostly ELISA kits imported from countries such as France and the UK. Despite the evidence and lack of any supporting policies, 15 lakh (1.5 million) TB serological tests are estimated to be done in India and as a result patients end up spending an estimated Rs 75 crores (US$ 15 million) per year."
According to Dr Madhukar Pai, TB researcher and professor at McGill University –“It is well known that TB management practices in the private sector vary widely, often deviating from established standards. For example, inaccurate, blood-based, antibody tests are widely used, along with irrational drug regimens. Rampant use of antibiotics is another big concern. Indeed, since TB drugs are easy available over-the-counter, antibiotic resistance is a major threat for the control of TB.”
Despite the much publicised grandiose success of the DOTS (directly observed treatment short course) programme of India, our country continues to maintain its numero uno status among the highest TB burden countries in the world, housing one fifth of the world's TB patients. Also, more than 50% of these TB patients seek treatment in the private sector, which operates largely outside the confines of the Revised National TB Control Programme (RNTCP), with a total lack of regulation in diagnostics and treatment practices. There has to be a proper mechanism in place to put a curb to this. But alongside mending private fences, the government will have to set its own house in order too. Much more will have to be done than merely making TB a notifiable disease and banning inaccurate diagnostic tests. These paper measures have to be backed by a workable plan which helps the affected community of TB patients without violating their human rights. It is imperative not only to tighten the noose of control on the private sector, but the management and monitoring of the National TB control programme DOTS (directly observed treatment short course) has to improve too. Mismanagement of TB not only subjects the patients to unnecessary or incorrect treatment; it also results in creating new infections and fuelling drug resistant strains of the disease in the community. So, we need to have good diagnostics to detect TB earlier and faster and get more TB patients on regulated and appropriate treatment.
The Planning Commission has more than doubled the allocation to fight TB from Rs 400 crore in 2011--2012 to Rs 710 crore in 2012--2013. RNTCP 3 (for 2012–17) aims to provide universal access to quality diagnosis and treatment for the entire Indian population. Obviously, despite the increased budgets, RNTCP alone cannot meet this ambitious goal. India has one of the largest private health sectors in the world which, unfortunately, is largely unregulated. There has to be a robust mechanism to engage this sector meaningfully to join hands with the government, healthcare providers, civil society, donors, and affected communities to deliver the goods.
Let us hope that the government means business this time and has a proper surveillance system in place to fulfil its obligations for bringing all existing TB patients under the ambit of quality treatment and preventing new ones from harbouring the deadly bacteria.
Shobha Shukla - CNS
(The author is the Managing Editor of Citizen News Service (CNS). She is a J2J Fellow of National Press Foundation (NPF) USA. She has worked earlier with State Planning Institute, UP and taught physics at India's prestigious Loreto Convent. She also authored a book on childhood TB (2012), co-authored a book (translated in three languages) "Voices from the field on childhood pneumonia" and a report on Hepatitis C and HIV treatment access issues in 2011. Email: [email protected], website: http://www.citizen-news.org)