Coronavirus Outbreak: Roche Diagnostics Gets FDA Approval From Indian Regulators, Receives Licence to Conduct COVID19 Diagnostic Test
In US, the FDA approved a new test from the Swiss pharmaceutical giant Roche that could represent a major breakthrough. The FDA issued an Emergency Use Authorization (EUA) for the company's SARS-CoV-2 Test.
New Delhi, March 18: As the number of COVID-19 cases continues to rise and create havoc across the world, Indian Health Ministry top officials have confirmed that Roche Diagnostics, a private company got Food and Drug Administration (FDA) emergency approval for coronavirus tests on Tuesday by Indian regulators. According to an ANI tweet, they have received the license to conduct the COVID19 Diagnostic test.
BioMerieux Diagnostics, another private company, has also approached Drug Controller General of India (DCGI). It will take seven days to get approved as officials are making an assessment. Reportedly, once approved, it can conduct the confirmatory test of COVID 19. Coronavirus Outbreak in India: Total Number of COVID-19 Positive Cases Rises to 147.
A few days earlier, in the US, the FDA approved a new test from pharmaceutical giant Roche that could represent a major breakthrough. The FDA issued an Emergency Use Authorization (EUA) for the company's SARS-CoV-2 Test.
Check ANI tweet:
According to a report on Print, two Indian diagnostic firms — Trivitron Healthcare and Mylab Discovery Solutions — are also waiting for 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.
Reportedly, the kits developed by these firms will be sold to diagnostic chains such as Dr Lal Path Labs, Metropolis Healthcare and others to start the process of community testing to detect the deadly virus that has claimed three lives and infected more than 147 people in India so far.
(The above story first appeared on LatestLY on Mar 18, 2020 03:57 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).