NEW DELHI: India's drug regulator has suspended Mumbai-based Transasia Bio-Medicals' import license for COVID-19 IgG ELISA kit, saying the USFDA has removed the manufacturer from their list of coronavirus serology test kits.
The company was issued a show-cause notice on July 17 asking why its import license shall not be canceled 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 COVID-19 disease, according to an official order.
Transasia Bio-Medical was directed to submit its reply by July 20, failing which it would be presumed they have nothing to say in the matter and action deemed fit will be initiated against it under provisions of the Drugs and Cosmetics Act.
The July 21 order read, "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 not to cancel your said import license for the above product. Therefore, in the public interest, your import license for the above product becomes inoperative and stands suspended, till further orders," it stated.
The Drug Controller General of India (DCGI) directed that no batch of the diagnostic kit shall be imported for sale, stock, distribution, or sold or offered for sale.
According to an official source at the Central Drugs Standard Control Organisation (CDSCO), similar action was taken against 18 more firms with regard to their COVID-19 test kits.