Faulty kits: Import licences of two Chinese companies cancelled

NEW DELHI: The Drugs Controller General of India (DCGI) has banned the import of antibody kits from Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics, the two Chinese companies that have been implicated for quality issues.

“The licences of both the Chinese companies and their importers have been cancelled,” the DCGI VG Somani told ET on Thursday.

The DCGI has communicated to the state drug controllers that licence holders of Covid-19 rapid diagnostic kits from the two Chinese firms have been asked to stop import of the kits in public interest and issued show cause notices in light of information from the Indian Council of Medical Research (ICMR) that these kits have shown wide variation in sensitivity in the field.

ET had reported on Wednesday that more than a dozen importers held a valid licence to procure and import rapid testing kits from both the Chinese companies, even as the ICMR had implicated them for quality issues after the kits failed to give accurate results.

The ICMR had decided on Tuesday not to use the antibody test kits.

According to the DCGI, licences were granted to 13 importers which could supply Guangzhou Wondfo Biotech antibody kits and there were four importers that could supply Zhuhai Livzon Diagnostics rapid testing kits in India. “The ICMR has found quality issues with the kits and we have accordingly taken action,” said Somani.

The government had decided to withdraw the “faulty” rapid testing kits from use and cancelled all procurement orders on Monday after it emerged that the kits from China were showing inaccurate results. The ICMR said it would return the antibody test kits to the suppliers as the results showed “wide variation” in sensitivity.

While the ICMR has received its first set of 500,000 kits, the government has cancelled the pending orders from the companies. “Orders of two million test kits pending with two Chinese firms have also been cancelled,” a senior official said on condition of anonymity. “The ICMR will not place fresh orders for antibody rapid testing kits. Instead, it has asked manufacturers of RT-PCR (reverse transcription polymerase chain reaction) kits to ramp up production.”

The ICMR said despite early promise of good performance for surveillance purposes, kits of Guangzhou Wondfo and Zhuhai Livzon were found to give wide variation in sensitivity in field conditions.