E-Paper
No approval for Covid-19 testing kit that can be used at home
The notice was issued after allegations that a Bengaluru-based start-up was advertising a Covid-19 rapid testing kit on its website, and was offering the product directly to consumers.
The Drugs Controller General of India (DCGI) has issued a notice saying it has not approved any coronavirus disease (Covid-19) testing kit that can be used at home like a pregnancy kit to determine whether a person is Covid-19 positive.
The notice was issued after allegations that a Bengaluru-based start-up was advertising a Covid-19 rapid testing kit on its website, and was offering the product directly to consumers.
DCGI said the company was offering for sale a “rapid single use finger-prick test” for the Sars-CoV-2 virus that will give results in 5-10 minutes.
“...The product is also widely publicised in the media. In this regard it is hereby informed that Central Drugs Standard Organisation (CDSCO), the competent authority for the approval and issuance of license for import/ manufacturer for marketing of coronavirus diagnostic kit, has not licensed the aforesaid diagnostic kit by M/s Bione Ventures Private Limited,” the DCGI notice said, warning people against buying such a product online.
The drugs controller acted on a complaint by the All India Drug Action Network (AIDAN), which said the Bengaluru company provided no details on the foreign manufacturers of the kits, approval status in India or the test kit’s performance.
“The kit is being marketed as a single point-of-care home screening kit, and being sold directly to consumers through its website,” the complaint said.
There is no self-testing kit for Covid-19 approved for sale in India at present. All tests are to be conducted by trained health experts and after following the rules laid down by the country’s apex biomedical research organisation, Indian Council of Medical Research (ICMR).
