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 test license to the Roche Diagnostics India following successful completion of the evaluation of their testing kits.
"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.
Shravan Subramanyam, Managing Director, Roche Diagnostics India Pvt Ltd said the company has been accorded the test licence 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 commercialise the kits in India," Subramanyam said.
"We would like to thank the CDSCO for providing us the test license in record time, as it enables Roche Diagnostics India to initiate the process of bringing a world-class test to the country. Though this is the first step towards enabling access to the cobas SARS CoV-2 diagnostic test in India, it reinforces the government's intent to enable public-private partnership and improve patient access in a potentially serious healthcare situation," he added.
The Union health ministry had on Tuesday issued guidelines for private sector laboratories intending to initiate COVID-19 testing while the ICMR appealed them to conduct the tests free of cost.
Laboratory tests for coronavirus at private labs should be offered when prescribed by a qualified physician as per the ICMR guidelines for testing.
"Private labs testing is to ensure real time reporting to the Integrated Disease Surveillance Programme (IDSP) and the ICMR headquarters for timely initiation of contact tracing and research activities," the ministry said.
ICMR will share the standard operating procedure for laboratory testing and provide positive controls for establishing the test as soon as the private laboratory concerned has procured the primers, probes and reagents.
Adoption of commercial kits for testing should be based on validations conducted by the ICMR, National Institute of Virology (NIV) in Pune.
The ICMR has equipped 72 of its laboratories to test for the pandemic disease. In addition to these labs, 49 more under organisations like Council of Scientific & Industrial Research, Department of Biotechnology, and Defence Research, Development Organisation would be equipped to test for coronavirus by end of this week, ICMR Director General Balram Bhargava had said on Tuesday.
The ICMR will also be setting up two testing locations (NCR and Bhubaneswar) for high throughput diagnostic systems for exponentially increasing rapid diagnosing of the respiratory ailment, he said, adding each of these systems can test up to 1,400 samples daily.
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