Days after the Union health ministry banned sero diagnostic test kits for diagnosis of tuberculosis (TB), the Drug Controller General of India (DCGI) has asked the state drug controllers to recall the kits from the market with immediate effect. He has asked the officials to ensure that the unused stocks are returned back to the manufacturers.
With a view to effectively implement the ban, the DCGI has also asked the state officials to ensure that the “licences granted in your state for manufacture of the serodiagnostic test kits for diagnostics of TB are cancelled with immediate effect and arrangement be made to recall the kits from the market on top priority,” said the DCGI recent letter.
The health ministry had recently banned the serological diagnostic test for tuberculosis, in line with a World Health Organisation recommendation. With this, India became the first country to execute the ban on the test, which is highly inaccurate but commonly used.
It is estimated that 1.5 million patients are subjected to the test every year in India for diagnosis of Mycobacterium tuberculosis and many of them are started on anti-TB treatment on the basis of the results.
In many cases, all it does is result in antibiotic resistance. These kits are popular in the private setup because these do not require much expertise to operate. Incidentally, another alternative — microscopic examination of sputum — involves kits that are less expensive but these require trained personnel.
A kit for the serological test costs an estimated Rs 800-Rs 1,000. It involves examination of blood serum, in contrast to tests like Elisa and Serum IgG. However, according to the recent notification, it was seen that the said test resulted in giving inconsistent and imprecise results leading to wrong diagnosis.
It was felt that their use was likely to involve risk to human being.
The health ministry finally decided to ban the test citing that safer alternatives were available.
India is estimated to have 75 new cases of TB (sputum positive) every year, of which an estimated 2 per cent are of the drug-resistant variety.