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Drug Controller General of India (DCGI) has slapped show-cause notices on firms that hold import licences for rapid antibody kits of Chinese companies - Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics.
The national drug watchdog’s action follows Indian Council of Medical Research’s (ICMR) finding that these kits of Chinese make have shown wide variation in their sensitivity in the field. While up to five lakh kits estimated to cost nearly ₹ 30 crore were distributed to various States for ramping up Covid-19 surveillance, within two days of disbursing them, ICMR asked the States to return the ‘faulty,’ kits. ICMR also said that these would be returned to the suppliers.
VG Somani, DCGI in a letter to drug regulators in all States and Union Territories has emphasised that import licence holders of the Chinese companies have been asked to stop import of the said kits in public interest.
Before such a clarification was issued by DCGI, it was uncertain whether any action would be taken on importers, as despite ICMR’s appeal to return the kits on April 27, up to 13 Indian firms later found mention in the list maintained by Central officials who can still import Wondfo kits, while four firms were still holding import licenses for Livzon kits.
DCGI cleared the air in the matter by instructing the States to stop import of kits from the Chinese companies in question.
Rapid antibody kits are finger-prick blood tests which are being planned to be used for Covid-19 surveillance. Till date, no company has demonstrated accuracy in detection as has been claimed, which has led ICMR to ask States to stop using them..
The inaccurate results of these kits has led to a delay in mass surveillance of Covid-19 cases in communities as had earlier been envisioned in the containment strategy. Currently, only RT-PCR method is being considered as gold standard for testing. ICMR has tested 8,30,201 samples using RT-PCR till date and is nearing an average of testing 50,000 samples per day, over the past five days, Lav Agarwal, joint secretary, Ministry of Health said.
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