DCGI suspends Mumbai-based firm's import license for COVID-19 ELISA kit

The company was issued a show cause notice on July 17 asking why its import licence shall not be cancelled since the rapid diagnostic kit of the manufacturer has been removed by USFDA with direction that it should not be distributed from the list of product of serology test kits for COVID-19 disease, according to an official order.

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 licence shall not be cancelled since the rapid diagnostic kit of the manufacturer has been removed by USFDA with direction that it should not be distributed from the list of 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 to not to cancel your said import license for the above product. Therefore, in public interest, your import license for 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 Central Drugs Standard Control Organisation (CDSCO), similar action was taken against 18 more firms with regard to their COVID-19 test kits..