No approval for COVID-19 rapid test given to Bione Venture: DCGI

The Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, has issued a public notice informing that the authority has not approved any license to Bengaluru-based firm Bione Venture for COVID-19 rapid single-use finger prick test.

Last week, the company had announced that its COVID-19 screening test kit is an IgG and IgM-based tool that delivers results within five to 10 minutes and is equipped to supply 20,000 kits per week. The company also revealed that it intends to build its manufacturing facilities in the next few months.

On 4^th April 2020, the Indian Council of Medical Research (ICMR) had issued an advisory, wherein it recommended to start a rapid antibody-based blood test for COVID-19. It had also issued the guidelines for the antibody test for negative as well as for antibody-positive cases. The test will help for areas reporting clusters (containment zone) and in large migration gatherings/evacuees centres cases of Influenza-Like Illness (ILI), which need to be monitored in health facilities. It also mentions that any surge in cases will be monitored and brought to the notice of Surveillance Officer/CMO for additional investigation.

As per the issued public notice 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 has not licensed the Bione Ventures COVID-19 test kits.

Commenting on the issued public notice by DCGI, a spokesperson from the company informed, “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 31^st March, 2020. With the sector constantly evolving and new regulatory standards coming into force all the time, Bione is studying the latest regulations in the ever-changing regulatory environment and is in the process of complying with all of them. Currently, Bione is reviewing the latest directive of ICMR released on 4^th 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.”

The public notice clearly mentions that all are advised to follow the guidelines issued by ICMR dated 4^th April, 2020, regarding the use of rapid antibody-based tests for coronavirus.

Antibody-based rapid tests validated at NIV, Pune and found to be satisfactory are:

• SARS-CoV-2 Antibody test (Lateral flow method): Guangzhou Wondfo Biotech,
• Mylan Laboratories Limited (CE-IVD)
• COVID-19 IgM IgG Rapid Test: BioMedomics (CE-IVD)
• COVID-19 IgM/IgG Antibody Rapid Test: ZHUHAI LIVZON DIAGNOSTICS (CE-IVD)
• New Coronavirus (COVID-19) IgG/IgM Rapid Test: Voxtur Bio Ltd, India
• COVID-19 IgM/IgG Antibody Detection card Test: VANGUARD Diagnostics, India
• Makesure COVID-19 Rapid test: HLL Lifecare Limited, India
• YHLO SARS-CoV-2 IgM and IgG detection kit (additional equipment required): CPC Diagnostics

The complete list of CE-marked rapid SARS-CoV-2 antibody tests is available at (https://www.finddx.org/covid-19/pipeline/).

[email protected]