Roche Diagnostics Is India’s First Private Firm To Get Regulatory Approval For COVID-19 Testing In India

Swiss firm Roche Diagnostics India received the license for conducting coronavirus tests after approval from drug regulator DCGI, making it the first private firm to get such permission after the government decided to allow accredited private labs to test for COVID-19.

According to a senior official, the Drug Controller General of India (DCGI) is now assessing giving license to another private diagnostic firm, bioMérieux, which has also sought approval to conduct tests for coronavirus. It will take 7 days to get approved as officials are making assessment. Once approved, it can conduct the confirmatory test of COVID19

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 costs

Professor Balram Bhargava, Secretary, Department of Health Research and Director General, ICMR stated, "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 increased access to the test in an endeavour to prepare for future."

Last Friday, Roche received the US regulator FDA’s first emergency use authorization for a commercially developed COVID-19 test. The agency said it cleared the diagnostic within 24 hours of receiving the company’s application, and that it did not object to Roche shipping the kits to labs ahead of time to prepare for the launch.