Home Test Kit’ Sold Online, Regulator Says Not Approved

The Central Drug Standards Control Organisation (CDSCO) told TOI on Sunday that no home test kits for Covid-19 have been approved. The regulator also issued a public notice clarifying that it had not licensed a home test kit being sold online by Bione Ventures Pvt Ltd.

The notice followed a complaint by All India Drug Action Network (AIDAN) about online marketing of Covid-19 rapid antibody test kits for home use and false marketing of products claiming to be Covid-19 related.

AIDAN had pointed out in its complaint that there was no way to check the claims of Bione Ventures Pvt Ltd that it had the required approvals for its home test kit because the CDSCO was yet to make public the list of test kits approved for sale in India. The lists of kits for PCR tests and rapid tests that have been approved by the CDSCO were up by Sunday and Bione Ventures Pvt Ltd was not in the list. Bione’s kit is being sold online at a price of Rs 2,499 without the need for a physician’s prescription.

Bione’s public relations firm told TOI that it was not possible to get a comment from the company’s promoters on the issue on a Sunday.-Times Of India