Government of India has constituted a committee headed by Biocon Chairperson and Managing Director Kiran Mazumdar-Shaw to work out the modalities for private sector diagnostic labs to be involved in creating nationwide capacity for testing COVID-19. Business Today has learned that the process has gained momentum and there is a good chance that the private labs will be able to start testing from next week.
Currently, the kits used by the ICMR labs cost the government around Rs 5,000 per test, which is being absorbed by the government, and are offered free of charge to the patients. How this will be done in the private setting, is still not clear.
To begin with the testing is expected to be based on the well-established USFDA (US Food and Drug Administration) approved kits, which those in the private laboratory circles, read as kits made by companies like Roche Diagnostics and Thermo Fisher. However, it is likely that the list could perhaps be extended later to include other kit makers, including some domestic kit manufacturers.
Only NABL-accredited private laboratories in the country will be allowed to undertake COVID-19 tests. NABL is quickspeak for National Accreditation Board for Testing and Calibration Laboratories. Once identified, the private labs will wait for directions on the kits to be used. Most of these labs are already equipped with the first part of the test, which is RNA and genetic material extraction, and will need the go ahead on the kits/reagents to be used in the next stage to identify coronavirus.
Who can make the kit: Several companies have jumped into the fray and want to make the kits. Some have even been approaching entities like the CCMB for getting their kits evaluated. However, at the moment, Business Today learns, the CSIR (Council for Scientific and Industrial Research), the parent organisation of CCMB, is apparently, in talks with ICMR for getting CCMB to conduct testing and training for coronavirus detection. But as things stand, none of the kits can be used in the country until these are clinically validated by any of the ICMR labs and approved by the Drug Controller General of India (DCGI).
Which kits can be used and what is the process: Any kit to test for coronavirus has to be clinically validated by an ICMR laboratory or National Institute of Virology, Pune. After that, the DCGI will need to approve it for use and supply in the market. Right now, an official from the DCGI says, seven kits have been sent to NIV Pune for clinical validation. These include kits by companies like Roche Diagnostics, Thermo Fisher, and a few others.
What is stopping the government from roping in the CSIR laboratories from conducting the tests: An ICMR official says 49 CSIR labs have been identified and if there is a need, the will be put into action.