Bengaluru-based Bione Ventures Pvt Ltd's coronavirus testing kit, which it claimed can give results within 10 minutes, has not yet been approved by the Central Drugs Standard Control Organisation (CDSCO).
In a notice issued to the company, CDSCO, the drug and medical devices regulator, has warned against the use of the home kit for the self-testing of coronavirus. Several media houses had earlier reported that the Bengaluru based company "Bione" has launched a new home testing kit of COVID-19.
"CDSCO, the competent authority for coronavirus diagnostic kits, has not licensed the diagnostic kit by Bione," stated Drugs Comptroller of India, Dr VG Somani.
According to Firstpost article, Bione's test kit requires blood from a prick of the finger and promises to give a result within 5-10 minutes.
The price of the kit could range from ₹2,000-3,000. The company is expected to manufacture 20,000 kits per week. They will be available for sale on the company's platform and delivered in 2-3 days of placing an order, according to a company
The notice further advised everyone to follow the advice of the Indian Council of Medical Research (ICMR) on testing protocols and use of rapid antibody-based blood test for use against coronavirus.
Earlier the All India Drug Action Network (AIDAN) had written to the Drugs Comptroller of India asking if the government had approved the kits which Bione was marketing.
"Bione's activities are a mockery of the government policy of clinical judgement and physician's prescription for COVID19 testing. 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 while the interim advisory of 2 April 2020 for use of antibody tests in hotspots does not support indiscriminate self-testing by the public," AIDAN saying in their letter.
The letter also stated that the first batch was sold out on the company's website. However, the company website no longer lists the test kit for coronavirus.
Bione continues to sell other two kits -- MyMicrobiome and Genetic Susceptibility -- at a price of ₹14,999 and ₹7,999 respectively.
Bione in a statement on April 2 had said that the kit was approved by the Indian Council of Medical Research. However, Raman Gangakhedkar, the head of epidemiology and communicable diseases at ICMR, told Businessline that he was not aware of any such company selling kits online. "ICMR will look into the matter and will convey appropriate steps after discussing it," he said.
According to an article by The Times of India, Bione issued a statement stating 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.
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