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India bans Serological TB Tests , a step in right direction

Cell culture plates

Cell culture plates (Photo credit: Sanofi Pasteur)

In a welcome step, a gazette notification by the Ministry of Health & Family Welfare banning serological test (commonly referred to as blood or antibody test) for TB, under the Drugs & Cosmetic Act, has finally been made public today. This gazette notification also, in particular bans the importation of the serological test kits.

The serological test for TB is widely used in the private sector, even though they are known to be inaccurate, inconsistent and with no clinical value for TB diagnosis. The World Health Organization (WHO) in its first-ever negative policy recommendation recently called on governments to immediately ban blood tests prescribed and used to detect TB. See WHO Factsheet on TB serological tests: http://www.who.int/tb/features_archive/factsheet_serodiagnostic_test.pdf

The Revised National TB Control Programme (RNTCP) has never recommended these tests. In fact, guidelines such as the International Standards for TB Care and those by the Indian Academy of Pediatrics actually discourage their use. According to a paper in National Medical Journal of India, “Despite the evidence and lack of any supporting policies, 15 lakh (1.5 million) TB serological tests are estimated to be done in and as a result patients end up spending an estimated INR 75 crores (US$ 15 million) per year.” See attached paper published in National Medical Journal of : “Tuberculosis Control in India: Time to get dangerously ambitious?”

As per this paper, “every major private laboratory in India offers TB serological tests, mostly ELISA kits imported from countries such as France and the UK. These countries, apparently, do not approve the same tests for clinical use on their own TB patients!”

Last year ’s committee on diagnosis asked the Drug Controller General of India (DCGI)’s office to investigate and if necessary ban the serological tests conducted by the private sector.

An expert group set up by the DGCI found that blood tests are mostly inaccurate for TB detection. It had recommended to the Union health ministry to immediately ban them. (Report of the expert committee is not publicly available).

What do treatment and health activists working on TB feel about this regulation: A welcome move to check irrational practices on TB diagnosis in the private sector. But it needs strict implementation across the country to check this practice among doctors who prescribe and labs who conduct these tests. The import of serological test kits should be immediately stopped, which will improve the implementation of this government notification. At the same time, it is also equally important to increase access to accurate culture and drug sensitivity testing (DST) for drug-resistant TB (DR-TB) in the public sector. A large number of patients with extra-pulmonary and drug resistant TB are pushed into the private sector when their TB is left undiagnosed in the public sector.

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