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Barely a day after India said it will return faulty Chinese rapid-test kits of two companies — Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics — back to the suppliers, the companies and their distributors have yet again found mention in the list of approved firms that can conduct business in India.
Rapid antibody test kits are finger-prick blood tests used for Covid-19 surveillance by the Centre and the States.
In the latest list of 100-odd firms released by the Centre, which have been approved to supply rapid antibody kits for Covid-19 from international companies, mostly Chinese, 13 Indian suppliers — Mylan Pharmaceuticals, Cadila Healthcare, Alere Medical, Rapid Diagnostics, Solumed India, Invex Healthcare, Bilcare, Archerchem Healthcare, Trivitron Healthcare, Core Diagnostics, Tata International, Sanya Hospitality, Matrix Lab — figure in the list of approved firms that have the licences to import Wondfo kits to India.
Shreya Pharmaceuticals, Genes 2 Me, Core Diagnostics and Renaissance Pharmaceuticals have been approved to import Zhuhai Livzon kits to India.
‘Under-performing’ kits
On April 27, the Indian Council of Medical Research, in a letter to States, said, on evaluating these kits, the results have shown wide variation in sensitivity. It added that the kits were found to be under-performing, subsequent to which orders have been cancelled for up to five-lakh kits that ICMR had procured from Wondfo and Zhuhai.
The latest list of approved firms implies that despite ICMR having asked States to stop using the Chinese kits in question, they can still be imported. “The customs department will check if the firms have requisite licences from the Drug Controller General of India (DCGI) to import, and if they do, as reflecting on the latest list, they will be allowed to bring these goods into India,” one of the distributors said, citing anonymity.
Malini Aisola, co-convenor of All India Drug Action Network, said the DCGI should clarify if it is reviewing licences of firms that are importing these Chinese kits. “The DCGI should make it clear whether it is allowing import of kits from companies in question, and what precautions are being taken to check their quality,” Aisola added.
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