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, a public health advocacy group, 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 lack of such information in the public domain is “aiding such exploitation and profiteering during the public health crisis” stated the AIDAN complaint. However, by Sunday evening, the lists of kits for PCR tests and rapid tests that have been approved by the CDSCO were up on the website. Bione Ventures Pvt Ltd was not in the list of companies approved. Bione's COVID-19 rapid antibody test is being marketed as a “simple point-of-care home screening kit” and being sold directly to consumers through its website. In a press release issued on April 3, the company claimed that its test kits have received approval from the “requisite regulatory authorities”. The press release added that its “products have been sourced from our worldwide CE and FDA approved partners.” No details are available on the company website regarding the foreign manufacturer of the kits, approvals in India, or the test kit's performance. The kit is being sold online at a price of Rs 2,499 without the need for a physician's prescription. “The first batch has been sold out according to the company website and it is impossible to know about the genuineness of the test kit,” stated AIDAN“The company's strategy is clearly to exploit public anxiety around the pandemic in order to make a killing. It is selling kits to the general public even before official directions regarding the use of rapid antibody tests have been issued, and even the interim advisory of 2 April 2020 for use of antibody tests in hotspots does not support indiscriminate self-testing by the public,” pointed out the AIDAN letter.AIDAN has asked for an investigation into the claims being made by the company for their various tests related to Covid-19 and for greater transparency regarding names of companies that have got approval, the basis for approval and the information submitted by the applicant about the test kit's performance and pricing.Dr Surendra K Chikara, CEO, Bione's statementBione issued a statement that it has a wholesale license from the drug control department in Bangalore issued by March 30 and that the kits "would be sourced from ICMR approved vendors". "Bione is studying the latest regulations in the ever-changing regulatory environment and is in the process of complying with all of them," it stated adding that it was restudying the latest directive of the ICMR released on April 4 regarding the use of rapid screening kits.