Top drug regulator suspends import license of 19 firms for their COVID-19 test kit

The Central Drugs Standard Control Organisation (CDSCO) has suspended the import licenses of at least 19 firms for their respective COVID-19 test kits after USFDA removed the manufacturer from their list of the product of serology test kits for coronavirus.

“The top drug regulator has suspended the import license for about 16 companies and cancelled the license for three firms on similar grounds,” a senior health ministry official said to ANI while confirming the development.

“The import license has been suspended for companies like Aracion technology private limited, Diasys diagnostic India Private limited, Saffron Naturele Products Private Limited, Cosmic Scientific Technologies, SD Biosensors Healthcare Private Limited, Transasia Bio-Medicals has been cancelled whereas it has been cancelled for MDAAC International Private Limited, Cadila healthcare limited and NW Overseas Private Limited,” informed the official requesting anonymity.

On July 17, all the companies were issued a show-cause notice from the top drug controller asking why its import license shall not be cancelled since the rapid diagnostic kit of the manufacturer has been removed by US Food and Drug Administration (USFDA) with 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 notice, a copy of which is with ANI.

“Therefore in public interest your import license for the above product becomes inoperative and stands suspended, till further orders,” the notice read.

Further, the Drug Controller General of India (DCGI) directed that no batches of the said diagnostic kit shall be imported for sale/stock/distribution or sold or offered for sale, the notice stated.

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