The government has banned the manufacture and sale of serodiagnostic tests (diagnosis based on blood serum) for tuberculosis. These tests are deemed to give ‘inaccurate results based on poor quality and grossly insufficient data’ by Dr Ashok Kumar, Deputy Director General of the Revised National Tuberculosis Control Programme (RNTCP).
In a strongly worded letter, Dr Kumar pointed out that 1.5 million people are subjected to these tests every year in the private sector which have cost them around US$ 15 million (Rs 839 cr). He said several meta analyses have proved the inaccuracy of these tests and wasn’t good enough to replace microbiological test. Inaccurate TB results leads to people who need treatment not getting it and unnecessary treatments for unaffected people which besides the cost also results in side-effects.
Earlier the Joint Secretary, Ministry of Health and Family Welfare, Arun Panda on June 7 stated that serodiagnostic test kits have led to imprecise results and inconsistent diagnosis of TB, leading to risk to human lives.
According to Section 26(A) of the Drugs and Cosmetic Act, 1940, the Centre has prohibited the manufacture, sale and distribution of the serodiagnostic test kits for diagnosis of tuberculosis.
It is estimated that due to high false positivity of commercially available serological tests, 1,57,000 false (non-diseased) cases may be wrongly treated in India alone. According to experts, billions of rupees are wasted because of wrongs treated TB cases.