Medicines regulator suspends Mumbai-based company’s import license for COVID kit. (Representative)
New Delhi:
The Central Drugs Standard Control Organization (CDSCO) has suspended the import license of the Mumbai-based company – Transasia Bio-Medicals, which supplies the COVID-19 IgG ELISA kit.
The move comes when the USFDA removed the manufacturer from its list of serology test kits products for COVID-2019.
On July 17, the company received a show cause notice from the leading drug regulator asking why its import license should not be revoked since the manufacturer’s rapid diagnostic kit was withdrawn by the USFDA with the directive to do not distribute it. the list of products of the serological test kits for coronavirus disease.
“And although your response to the show cause notice was not deemed satisfactory with respect to the removal of said kit, by the USFDA from its list not to distribute. However, you mentioned not to cancel your import for the above product, ”said the order, a copy of which is with ANI.
“Therefore, in the public interest, your import license for the above product becomes inoperative and is suspended, until further orders,” the order reads.
Further, DCGI has ordered that no lot of said diagnostic kit be imported for sale / stock / distribution or sold or offered for sale, in the order listed.
Confirming the development to ANI, a top CDSCO government has informed that similar action against 19 other companies for their respective COVID19 test kits.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
