Companies received justification notices on July 17 (representation)
New Delhi:
India’s drug regulator has canceled the import licenses for rapid diagnostic kits from three companies and suspended those for 16 others, saying the USFDA has removed the manufacturers from their list of coronavirus serology test kits with instructions according to which they should not be distributed.
The three companies are Cadila Healthcare, MDAAC International and N W Overseas, while the 16 companies include Transasia Bio-Medicals, Cosmic Scientific, Inbios India, S D Biosensor, Accurex Biomedicals, Biohouse Solutions, and Trivitron Healthcare, among others.
The companies received show cause notices on July 17 asking why their import licenses should not be revoked since manufacturers’ diagnostic kits have been removed by the USFDA with instructions not to distribute them from the list of products. Serological test kits for COVID -19 disease, according to an official order of the Drug Controller General of India (DCGI).
They were ordered to submit their response by July 20, failing which they would be presumed to have no say in the matter and action deemed appropriate will be taken under the provisions of the Medicines Act. and cosmetics.
“Your response to the show cause notice was not considered satisfactory with respect to the removal of said kit, by the USFDA from their list of not to distribute,” said the DCGI order issued to the 16 companies on July 21.
“However, it has been mentioned by you not to revoke said import license for the above product. Therefore, in the public interest, your import license for the above product becomes inoperative and is suspended , until new orders, “he said.
As for the three companies whose licenses were canceled, the orders stated: “Your response to the justification notice was not considered satisfactory with respect to the removal of said kit, by the USFDA from their list stating not to not distribute. “
“Additionally, you have mentioned that you intend to relinquish your license for the above product. Therefore, in the public interest, your import license for the above product becomes inoperative and is revoked. with immediate effect “, indicates the ordinance of July 21.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
