Licences of two importers supplying COVID-19 rapid antibody test kits cancelled

The Central Drugs Standard Control Organisation (CDSCO) has cancelled the licenses granted to two importers who supplied COVID-19 rapid antibody test kits made by Guangzhou Wandfo Biotech and Zhuhai Livzon Diagnostics in China.

The central drug regulator has issued show cause notices to these two importers and asked to stop the import of rapid test kits based on the observation by the apex health research body ICMR.

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"The CDSCO has cancelled the licenses of two importers who imported COVID-19 rapid antibody test kits made by Guangzhou Wandfo Biotech and Zhuhai Livzon Diagnostics in China," a senior government official said.

In a letter to drug controllers in all states and Union territories, the central drug regulator on April 28 had said that the license holders of COVID-rapid diagnostic kits from two sites in China have been asked to stop import of the said equipment in public interest.

"It is to communicate for your information and necessary that the import license holders of COVID-rapid diagnostic kits from the sites (Guangzhou Wandfo Biotech, China and Zhuhai Livzon Diagnostics, China) have been asked to stop import of the said kits in public interest and issued show cause notices in light of information of ICMR that these kits have shown wide-variation in their sensitivity in the field," the Drug Controller General of India (DCGI) said in the letter.

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The Indian Council of Medical Research (ICMR) on Monday asked states to stop using the COVID-19 rapid antibody test kits procured from the two Chinese companies and return them to be sent back to the suppliers.

In an advisory sent to chief secretaries of all states and UTs recently, the ICMR said it "evaluated the kits of Guangzhou Wondfo Biotech and Zhuhai Livson Diagnostics in field conditions. The results have shown wide variation in their sensitivity, despite early promise of good performance for surveillance purpose".

The Union Health Ministry also issued a statement saying it has "not lost a single rupee" with respect to the supplies of the COVID-19 rapid antibody test kits.

"It needs to be stressed that the ICMR has not made any payment whatsoever in respect of these supplies. Because of the due process followed (not going for procurement with 100 per cent advance amount), the Government of India does not stand to lose a single rupee," the health ministry said while issuing a fact sheet to clear controversies surrounding prices of rapid antibody test kits.

India recently had procured five lakh rapid antibody test kits from the two Chinese firms and they were distributed to states for districts with high burden of COVID-19 infection.

Some states, including Rajasthan, had complained that the rapid testing kits for coronavirus were giving out inaccurate results.