New Delhi: The Modi government has asked states and union territories to stop purchasing rapid antibody diagnostic kits from two Chinese firms, citing “public interest”, ThePrint has learnt.
The message was conveyed in a letter dated 28 April from V.G. Somani, the drug controller general of India (DCGI), addressed to drug controllers across states and union territories. The ban pertains to rapid antibody tests — that claim to offer quick diagnosis — sold by the Chinese firms Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics.
India had earlier this month received 5.5 lakh rapid antibody test kits from the two firms. In the letter, the DCGI has said that the Indian importers through whom the tests were being purchased had been asked to stop the imports.
“It is to communicate for your information and necessary action that the import licence holders of Covid19 rapid diagnostic kits from the sites (of) Guangzhou Wondfo Biotech, China and Zhuhai Livzon Diagnostics, China, have been asked to stop import of the said kits in public interest,” it states.
The move comes days after the Indian Council of Medical Research (ICMR), the country’s apex health research body, asked states and union territories (UTs) to stop using testing kits procured from China on account of a “wide variation” in their performance.
According to the DCGI’s letter, which has been accessed by ThePrint, show-cause notices have been issued to the importers “in light of information from ICMR that these kits have shown wide variation in their sensitivity in the field”.
The DCGI has also cancelled the import licences issued to the Indian importers for the kits, it is learnt. “After writing the letter, we also cancelled the licences of these firms to avoid further confusion,” said a senior official from the Ministry of Health and Family Welfare.
‘Faulty antibody testing kits’
Rapid antibody tests are prick-based tests that can detect the presence of coronavirus antibodies. They claim to provide quick results and don’t require a laboratory setting.
On 4 April, the ICMR had approved the use of rapid antibody tests in Covid-19 clusters (areas with a high number of cases).
However, Monday, the government asked states and UTs to withdraw rapid antibody kits acquired from the two aforementioned Chinese firms.
The ICMR said it had evaluated the testing kits procured from these two firms “in field conditions” and the results showed “wide variation”.
The states were advised to send the tests back to the suppliers. The ICMR also reiterated that states employ RT-PCR (real time reverse transcription polymerase chain reaction) throat/nasal swab tests, claiming they were the “best” for Covid-19 diagnosis and detect the virus early.
Complaints about rapid antibody testing kits, including those from China, have also come from other countries such as the UK.