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Coronavirus outbreak: First private company gets FDA emergency approval for COVID-19 tests

A private company has received Food and Drug Administration (FDA) emergency approval for COVID-19 tests by Indian regulators. The company, Roche Diagnostics, has received the license to conduct the COVID-19 diagnostic test.

Edited by: India TV News Desk New Delhi Updated on: March 18, 2020 15:56 IST
Coronavirus outbreak, Covid-19 tests, private company FDA approval, FDA emergency approval, COVID-19
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A private company has received Food and Drug Administration (FDA) emergency approval for COVID-19 tests by Indian regulators. The company, Roche Diagnostics, has received the license to conduct the COVID-19 diagnostic test, making it the first private firm to get such permission after the government decided to allow accredited private labs to test for COVID-19. With 147 Coronavirus positive cases, India has reported 3 deaths so far. 

 

Meanwhile, another private company, BioMerieux Diagnostics, approached the Drug Controller General of India (DCGI). It will take a period of seven days to get approved as officials are making an assessment. Once approved, it can conduct the confirmatory test of COVID-19.

The official said two Indian diagnostic companies-- Trivitron Healthcare and Mylab Discovery Solution-- have also sought approval from the DCGI for the coronavirus testing kits developed by them.

The Union health ministry had on Tuesday issued guidelines for private sector laboratories intending to initiate COVID-19 testing while appealing them to conduct the tests free of cost.

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