Private firm Roche Diagnostic gets FDA emergency approval for COVID-19 tests, Biomerieux in pipeline

New Delhi [India], Mar 18 (ANI): Amid coronavirus fears, international private diagnostic centres are coming forward to conduct the COVID-19 tests in India.

Roche Diagnostic, a Swiss private company, has got Food and Drug Administration (FDA) emergency approval for COVID-19 tests on Tuesday from Indian regulators, officials sources told ANI.

The Swiss company has received a license to conduct the COVID-19 diagnostic tests, sources said.

"Biomerieux Diagnostics, another private company, has also approached the Drug Controller General of India (DCGI). This will take 7 days to approve as officials are making an assessment," a top official requesting anonymity informed ANI.

"Once approved, Biomerieux Diagnostics company can do both the COVID-19 confirmatory tests," said the official adding that assessment of their diagnostic kits is being done.

"We want as many people as possible to come forward for medical solutions and diagnostics services at this time," said officials.

On Tuesday, the Union Health Ministry and Indian Council Of Medical Research (ICMR) constituted the guidelines for private laboratories to conduct COVID-19 tests.

These centres would work under the domain of ICMR.

ICMR has appealed to the private players to conduct the tests free of cost.

As of now, India has 72 laboratories across the country to test the samples. Also, ICMR is going to operationalise two Rapid Testing Laboratories (high throughput system) and 49 additional testing centers by the end of this week. The Rapid Testing Laboratories have a capacity to test 1400 samples each day.

According to Dr Balram Bhargava, Secretary, Department of Health Research & Director General, ICMR, "We are having a dialogue with high-quality private labs that are accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL). This is being done to understand the modalities of increasing access to the test in the endeavor to prepare for the future."

So far about 147 confirmed positive cases of COVID19 and three deaths have been reported in India.

The World Health Organisation (WHO) has declared it a pandemic. Globally, over 167,511 confirmed COVID-19 cases and 6,606 deaths across 152 countries have been reported.