DCGI revokes import licenses for rapid diagnostic units of Cadila Healthcare, two others; suspends 15
New Delhi: India's drug regulator has cancelled the rapid diagnostic kit import licences of 3 firms and suspended that of 15 other people saying the USFDA has eliminated the producers in their listing of coronavirus serology test kits using directions that they shouldn't be dispersed.The three firms are Cadila Healthcare, MDAAC International and N W Overseas while the 15 businesses...
New Delhi: India's drug regulator has cancelled the rapid diagnostic kit import licences of 3 firms and suspended that of 15 other people saying the USFDA has eliminated the producers in their listing of coronavirus serology test kits using directions that they shouldn't be dispersed.
The three firms are Cadila Healthcare, MDAAC International and N W Overseas while the 15 businesses comprise Transasia Bio-Medicals, Cosmic Scientific, Inbios India, S D Biosensor, Accurex Biomedicals, Biohouse Solutions and Trivitron Healthcare among others.
The companies were issued a show-cause notice on July 17 inquiring why their import licences will not be cancelled because the diagnostic kits of these producers are eliminated by USFDA with a direction that it should not be distributed from the list of merchandise of serology test kits for COVID-19 disease, based on an official order by the Drug Controller General of India (DCGI).
They were directed to submit their reply from July 20, failing that it could be presumed they have nothing to say in the issue and action deemed fit will be initiated under provisions of the Drugs and Cosmetics Act.
"Your reply to the show cause notice hasn't yet been found satisfactory with respect to the elimination of said kit, by USFDA from their list mentioning not to disperse," that the DCGI order issued to the 15 firms on July 21 said.
"However, it has been cited by you to not to cancel your stated import licence for the above item. Consequently, in the public interest, your import licence for the above product becomes inoperative and stands suspended, till further orders," it stated.
As for the three businesses whose licences were cancelled, the orders stated," Your response to the show cause notice has not been found satisfactory related to the removal of said kit, by USFDA from their listing mentioning not to disperse."
"Further, it has been mentioned by you that you mean to surrender your licence for the above product. Therefore, in the general interest, your import licence for preceding product becomes inoperative and stands with immediate effect," the order issued on July 21 read.
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