India’s drug regulator revoked the importation of immediate diagnostic kits from 3 corporations and suspended those of 16 others, saying that the USFDA had disposed of the marks from its list of coronavirus serological verification kits with orders not to be distributed.
The 3 corporations are Cadila Healthcare, MDAAC International and N W Overseas, while the 16 corporations come with Transasia Bio-Medicals, Cosmic Scientific, Inbios India, S D Biosensor, Accurex Biomedicals, Biohouse Solutions and Trivitron Healthcare, among others. The companies obtained a justification recognition on July 17 by asking why their import licenses were not cancelled, as manufacturers’ diagnostic kits were removed through the USFDA with orders not to distribute them from the product list in Covid-19 disease serological test kits. according to an official order of the Comptroller General of Drugs of India (DCGI).
They were asked to submit their reaction until 20 July, otherwise they would be supposed to have nothing to say about the case and actions deemed appropriate under the provisions of the Medicines and Cosmetics Act will be taken.
“Your reaction to realizing that the justification is not acceptable regarding the removal of the kit through the USFDA from its no-distribution list,” the DCGI order issued to all 16 corporations said on July 21.
“However, you discussed not canceling your import license for the previous product. Therefore, in the public interest, your import license for the previous product becomes inoperative and is suspended until new orders are placed,” he said. With respect to the 3 corporations whose licenses have been cancelled, the orders state: “Your reaction to the realization of the justification was not discovered passable with respect to the removal of that kit through the USFDA from its list by mentioning not distributing”. , you commented that you intend to waive your license for the previous product. Therefore, in the public interest, your import license for the previous product stops working and is cancelled with immediate effect,” the July 21 order states.
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