Import licenses for rapid diagnostic kits of 3 firms cancelled, 16 suspended by DCGI

India’s drug regulator has cancelled the rapid diagnostic kit import licenses of three firms and suspended that of 16 others saying the United States Food and Drug Administration (USFDA) has removed the manufacturers from their list of coronavirus serology test kits with directions that they should not be distributed.

The three firms 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 were issued show cause notices on 17^th July asking why their import licenses shall not be cancelled since the diagnostic kits of the manufacturers have 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 by the Drug Controller General of India (DCGI).

They were directed to submit their reply by 20^th July, failing which it would be presumed they have nothing to say in the matter and action deemed fit will be initiated under provisions of the Drugs and Cosmetics Act.

Also read: SII applies to DCGI for phase 2/3 clinical trial of COVID-19…

“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,” the DCGI order issued to the 16 companies on 21^st July stated.

“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 said.

As for the three companies whose licenses were cancelled, the orders said, “Your response to the show cause notice has not been found satisfactory with respect to the removal of said kit, by USFDA from their list mentioning not to distribute.”

“Further, it has been mentioned by you that you intend to surrender your license for the above product. Therefore, in public interest, your import license for above product becomes inoperative and stands cancelled with immediate effect,” the order issued on 21^st July read.

• Action against sale of habit-forming drugs without prescription: Tamil Nadu
• Gujarat’s Medical Device Park: A Game-Changer for India’s Healthcare Sector
• Key Notes on Revised Schedule M: Point No. 8 – Change Control
• Drug recall: Aurobindo Pharma, Glenmark, Zydus recall Drugs
• Hospitals can’t force Patients to buy medicines from their in house Medical Store
• FDA Haryana Organizes Workshop for Chemists: Yamunanagar

The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.