Roche Diagnostics is India’s first private firm to get COVID
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Roche Diagnostics India has received the license from the country's drug regulator DCGI for its 'cobas SARS CoV-2' diagnostic test kit, making it the first private firm to get permission to conduct coronavirus tests.

The development comes after the Indian Council of Medical Research (ICMR) permitted accredited private labs to conduct tests for COVID-19 to enhance capacity for diagnosis and detection of novel coronavirus amid rising cases in the country.

According to a senior official, the Drug Controller General of India (DCGI) has given a test license to the Roche Diagnostics India following the successful completion of the evaluation of their testing kits.

Shravan Subramanyam, Managing Director, Roche Diagnostics India Pvt Ltd said the company has been accorded the test license for cobas SARS CoV-2 diagnostic test by the Central Drugs Standard Control Organisation (CDSCO). "It may be noteworthy that this test received the United States Food and Drug Administration (USFDA) Emergency Use Authorisation a few days earlier," he said.

"The test license accorded to Roche Diagnostics India allows us to initiate steps 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 commercialize the kits in India," Subramanyam said.

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. "We are now assessing giving license to another private diagnostic firm, bioMérieux, which has also sought approval to conduct tests for coronavirus," the official said.

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