Roche Diagnostics India on Tuesday received the test licence for SARS CoV-2 diagnostic test.Roche Diagnostics India — Indian subsidiary of Swiss multinational firm Roche — has been accorded the test licence by the CDSCO.

Meanwhile, two other Indian diagnostic firms — Trivitron Healthcare and Mylab Discovery Solutions — have said they are still awaiting approvals from the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) for the coronavirus testing kits developed by them.

A spokesperson of Roche Diagnostics India told the press that the test had received the United States Food and Drug Administration (USFDA) Emergency Use Authorisation a few days earlier.

“The test license accorded to Roche Diagnostics India allows us to import select quantities of the cobas SARS Cov-2 diagnostic test for product performance evaluation. Following successful completion of the evaluation, a decision from the authorities will enable us to commercialise the kits in India,” he said.

“We would like to thank the CDSCO for providing us the test license in record time, as it enables Roche Diagnostics India to initiate the process of bringing a world class test to the country. Though this is the first step towards enabling access to the cobas SARS CoV-2 diagnostic test in India, it reinforces the Government’s intent to enable public-private partnership and improve patient access in a potentially serious healthcare situation,” the spokesperson added.

The kits developed by the three firms will be sold to private diagnostic chains such as Dr Lal Path Labs, SRL Diagnostics and Metropolis Healthcare, among others, to start community testing to detect the virus that has claimed three lives and infected 126 people in India so far.

 

Once approved, these kits will be sold to private diagnostic chains such as Dr. Lal Path Labs, SRL Labs, Metropolis Healthcare among others to start community testing.