Bione’s virus test kit is yet to be approved: CDSCO1 min read . Updated: 06 Apr 2020, 11:29 PM IST
Bione removed the rapid testing kit from its website following the CDSCO notice
Central Drugs Standard Control Organisation (CDSCO) has warned against the use of the coronavirus testing kit made by Bengaluru-based Bione Ventures, as it has still not been approved by the regulator.
“It is hereby informed that CDSCO, the competent authority for approval and issuance of licence for importer/manufacturer for marketing of coronavirus diagnostics kits, has not licensed the aforesaid diagnostic kit by M/S Bione Ventures Pvt Ltd, Bengaluru," CDSCO chief and the Drug Controller General of India V.G. Somani said on Sunday.
CDSCO, the country’s drug and medical device regulator, also advised everyone to follow the Indian Council of Medical Research (ICMR)’s recommendations on testing protocols and use of the rapid antibody-based blood test.
Bione removed the rapid testing kit from its website following the CDSCO notice.
The company, in an emailed response to Mint’s queries, however, claimed that it had received a wholesale licence from the assistant drug controller and licensing authority of the Drug Control Department in Bengaluru. The kits can be sourced from ICMR-listed vendors, it said.
“We had applied for the licence in March itself and received the approval on 31 March. With the sector constantly evolving and new regulatory standards coming into force all the time, Bione is studying the latest regulations and is in the process of complying with all of them," the biotech company added.
Bione had started selling its test kits after claiming that it had received approvals.