Mumbai : The Drugs Controller General of India (DCGI) has directed all state licensing authorities (SLAs) to recall batches of rapid antigen in vitro diagnostic (IVD) kits of Gujarat-based manufacturer Labcare Diagnostics India Pvt Ltd and Haryana-based SD Biosensor Healthcare Pvt Ltd for non-compliance to the minimum acceptance criteria of sensitivity and specificity as stipulated by Indian Council of Medical Research (ICMR).
The said rapid antigen IVD kits have been found to be non-conforming to the requirements as prescribed under Rule 7 of Medical Device Rules (MDR)-2017 especially in COVID -19 pandemic situations.
Therefore, in public interest, SLAs have been directed to inform all to whom the batch manufactured by the two manufacturers has been distributed or supplied to stop further use of it and also to recall the same with immediate effect. Compliance in this regard shall be submitted to the DCGI office for the said lot.
Labcare and SD Biosensor are holding license to manufacture and sale and distribution of IVD Antigen Lateral Flow Test.
DCGI had on July 17, 2020 canceled kit import licences of three firms and suspended those of 15 others citing a ban by the US government due to quality compliance issues.
Companies go through three batches of ICMR trials before the agency sends their validation to the Director Controller General of India for final approval. If a test kit already has USFDA approval, it skips ICMR validation for DCGI approval.
In mid-March, the US FDA allowed test kits with external validation to bypass their validation process. After US Congress committee findings criticised their leniency, they began cracking down on “poor performance or misleading statements” and began publishing “removed” manufacturers on May 21, 2020.
When ICMR banned several Chinese antibody kits, the Indian Ambassador to South Korea visited SD Biosensor’s facility on April 22 to facilitate a shift to South Korean brands. Biosensor was also the first company to sell the heavily-used antigen test kits in India.