The Central Drugs Standard Control Organisation (CDSCO) has suspended the import license of Mumbai-based company–Transasia Bio-Medicals which is providing COVID-19 IgG ELISA kit.
The move comes when the USFDA removed the manufacturer from their list of the product of serology test kits for COVID- 2019.
On July 17, the company was issued a show-cause notice from the top drug regulator asking why its import licence shall not be cancelled since the rapid diagnostic kit of the manufacturer has been removed by USFDA with the direction that it should not be distributed from the list of the product of serology test kits for coronavirus disease.
“And whereas your response to the show-cause notice has not been found satisfactory with respect to removal of said kit, by USFDA from their list mentioning not to distribute. However, it has been mentioned by you to not to cancel your said import for the above product,” stated the order, a copy of which is with ANI.
“Therefore in the public interest, your import license for the above product becomes inoperative and stands suspended, till further orders,” the order read.
Further, the DCGI directed that no batches of the said diagnostic kit shall be imported for sale/stock/distribution or sold or offered for sale, the order stated.
Confirming the development to ANI, a senior government at CDSCO informed that similar action against 19 more firms for their respective COVID19 test kits.
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