The All India Drug Action Network has written to the government about the rapid coronavirus home screening testing kit, saying such “activities are a mockery of the government policy”. The drug watchdog wrote in connection with Bengaluru-based biotechnology startup Bione’s “simple point-of-care home screening kit”.
On Thursday, Bione in a statement said that the kit was approved by the Indian Council of Medical Research. However, Raman Gangakhedkar, the head of epidemiology and communicable diseases at ICMR, told Businessline that he was not aware of any such company selling kits online. “ICMR will look into the matter and will convey appropriate steps after discussing it,” he said.
Malini Aisola, the co-convener of the All India Drug Action Network, urged the Drug Controller General of India to make a list of approved testing kits available in the public domain. “In the absence of a public list of all Covid-19 test kits approved by DCGI, it is impossible for us to verify such claims,” she said in a statement.
The Central Drugs Standard Control Organisation uploaded the list of approved testing kits on its website after the statement was shared. It includes 25 RT-PCR or reverse transcriptase polymerase chain reaction test kits. However, it is not clear whether 29 rapid testing kits have final approval or if they need to get validated by the National Institute of Virology in Pune.
“The company’s strategy is clearly to exploit public anxiety around the pandemic in order to make a killing. It is selling kits to the general public even before the official directions regarding the use of rapid antibody tests have been issued, and even while the interim advisory of April 2, 2020, for use of antibody tests in hotspots does not support indiscriminate self-testing by the public,” said the All India Drug Action Network.
The drug watchdog said wrong coronavirus results could give individuals a false sense of comfort when used without proper clinical judgement. It added that public health risks with a self-test kit are also higher as Bione did not mention anything about further confirmation of the results, other than recommending that every person who tested positive contact a doctor.
“Unscrupulous activities need to be curbed as they could even run counter to the Covid-19 response,” the network said. “A publicly available list of approved test kits would help restrain exploitation and profiteering curing the public health crisis. Further, lack of information about the CDSCO [Central Drugs Standard Control Organisation] approved test kits undermines the ability of state governments to procure test kits to meet their testing needs. Transparency would also ensure that only approved test kits are used by private labs.”
Late Sunday evening, the Drug Controller General of India released a public notice saying it had not given a licence to Bione’s home testing kit.
Ruchi Dana, founding investor of Bione, claimed that they have sold their first batch of testing kits. “We are asking people to buy two of them, and retest themselves after seven days in case the first time around the result is negative,” she added. “These kits are available for screening online at between Rs 2,000 and Rs 3,000.”