After Chinese mobile phones and toys, it’s the serological test kits from the Dragon that are flooding the Indian market. But more importantly, they are being commercially used rampantly by private medical practitioners to diagnose tuberculosis (TB) in violation of WHO guidelines.
Intriguingly, while one wing of the Health Ministry, Indian Council for Medical Research (ICMR), has sought a ban on these test kits because of their unreliable diagnostic of the infectious disease, its other wing, Drug Controller of India, has been giving licences to firms to import and manufacture these equipments.
As per ICMR, there are more than 73 manufacturers of TB serology and evaluation of enzyme-linked immunosorbent assay (ELISA) test kits in the country with China taking the lead for rapid test marketing. There are, at least, 23 TB rapid test kit makers from China alone followed by USA (16) and India (12m).
Though the WHO has banned serology and ELISA tests for detecting TB because of their inaccurate findings adversely impacting patient safety, unfortunately, unethical medical practices have ensured these kits are sold freely, said VM Katoch, ICMR chief. Each manufacturer claims its product is better, which is misguiding, he pointed out.
Katoch lamented that despite WHO guidelines endorsed by Health Ministry’s TB Control Division banning these serological tests, not much is expected. “It is mainly because the Division has no control over the import or manufacturing of these kits in Indian market which are licensed for marketing by DCGI.
“Hence, until the import and manufacturing of these kits is banned, these kits will continue to confuse the Indian market and interested parties will make huge profits.”
In a joint editorial published in the latest issue of the Indian Journal of Medical Research, Katoch and Sarman Singh from Department of Laboratory Medicine in AIIMS, have highlighted the issue ruing that medical experts have not even bothered much on quality of tests and implications of false-positive and false-negative results.
India accounts for one fifth of the global TB burden — a total of 9.2 million new cases and 1.7 million deaths every year. Rapid and sensitive diagnosis of the disease and containment of its spread to the uninfected population remain two main strategies for effective TB control programme.
The non-availability of affordable, rapid and precise diagnostic tools at peripheral level has led to mushrooming of commercial serological tests which are developed in unaccredited basic biology laboratories with little cross-validation by third parties, the editorial maintained.
The sputum smear microscopy remains a backbone of TB diagnosis despite its limitation, said the editorial titled ‘Commercial serological tests for the diagnosis of active tuberculosis in India: Time for introspection’.
By Archana Jyoti
The Pionner
http://www.dailypioneer.com/nation/24160-illegal-tb-kits-get-legal-push-in-india.html