No license for Bione’s COVID-19 Test Kits

COVID-19 Test Kits

After the widespread news regarding Bione’s Rapid Test kit for COVID19, the Central Drugs Standard Control Organisation (CDSCO) came out with a public notice saying that the test kits have not been approved yet. Issued by Dr VG Somani, Drug Controller General of (India) (DCGI), the CDSCO, the competent authority for the approval and issuance of the license for import/manufacturer for the marketing of coronavirus diagnostic kits, the notice says that it has not licensed the Bione Ventures COVID-19 test kits. The public notice also mentions that all are advised to follow the guidelines issued by ICMR dated 4th April 2020, regarding the use of rapid antibody-based tests for coronavirus. Meanwhile, a spokesperson from Bione said, “Bione has a wholesale licence from Assistant Drug Controller and Licensing Authority, Drug Control Department, Bangalore Circle 6-ADC1. These kits would be sourced from ICMR-listed vendors. And we had applied for the license in March itself and received the approval on 31st March 2020.

Currently, Bione is reviewing the latest directive of ICMR released on 4th April 2020, regarding the use of rapid screening kits. We are very hopeful that we’ll get all the requisite compliance in place in the coming weeks with the help of the concerned departments.” Bione removed the test kits from its website after the notice was issued. Meanwhile, India is witnessing a spike in the number of confirmed Corona cases and the numbers now stand at above 4000.

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