India has approved the sale of 18 diagnostic kits made by private companies for coronavirus testing, a top official confirmed on Thursday. ...
India has approved the sale of 18 diagnostic kits made by private companies for coronavirus testing, a top official confirmed on Thursday. These include three kits made by Indian companies which have been evaluated by the National Institute of Virology in Pune, and 15 kits which have obtained fast-track approvals based on licences and certificates obtained in other countries.
“We have issued approvals for 18 kits,” VG Somani, the Drug Controller General of India, told Scroll.in on phone. “These include both manufacturing and marketing [import] approvals.”
The approvals were fast-tracked, said Somani, given the need to rapidly scale up coronavirus testing in India. Until March 26 evening, 633 cases had tested positive in the country for Covid-19, the disease caused by the novel coronavirus. Experts believe this is an undercount given India had tested only 25,254 people till March 25.
While public health activists have urged the government to expand testing, they say the country needs to maintain transparency in its regulatory process for the diagnostic kits.
When asked for the list of the 18 kits that have been granted licenses for import and manufacture, Somani said it was available on the Central Drugs Standard Control Organisation’s website. But Scroll.in was unable to find it. Somani did not respond to further messages.
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