India authorises 18 private companies for conducting COVID-19 tests
Drug regulator DCGI has authorised 18 private companies for conducting COVID-19 tests in the country, reported ANI. Some of these companies are Cadila Healthcare Ltd, Zydus Healthcare Ltd, Medsource Healthcare Pvt Ltd, CoSara Diagnostics Pvt Ltd etc, an official told the news agency.
Drug regulator DCGI has authorised 18 private companies for conducting COVID-19 tests in the country, reported ANI. Some of these companies are Cadila Healthcare Ltd, Zydus Healthcare Ltd, Medsource Healthcare Pvt Ltd, CoSara Diagnostics Pvt Ltd etc, an official told the news agency.
Roche Diagnostics and bioMérieux had approached the Drug Controller General of India (DCGI) for allowing them to conduct coronavirus tests in the country, ANI had reported on Wednesday (March 18).
“Lot of companies have approached us (for conducting coronavirus tests in India). But only a few of them could fulfil the parameters. Since these are the test licences, first we will do an assessment. Then only, we will provide to our laboratory technicians in India,” said the official requesting anonymity.
So far, 223 COVID-19 cases have been reported in India with four death, according to the Union ministry of health and family welfare.
Meanwhile, the DCGI has provided with test licenses to 14 private companies, including Swiss firm Roche Diagnostics India, for evaluation of the quality of COVID-19 testing kits, a CDSCO official said.
Besides Roche Diagnostics India, rest of the firms are Indian firms, including CoSara Diagnostics from Ahmedabad and CPC Diagnostics from Chennai. All these companies will evaluate the quality of testing kits and submit their data to the DCGI.
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Roche Diagnostics India received the license from the country’s drug regulator DCGI for its ‘cobas SARS CoV-2’ diagnostic test kit on March 17.
“We are now assessing giving license to another private diagnostic firm, bioMérieux, which has also sought approval besides three other companies,” the official from Central Drugs Standard Control Organisation (CDSCO) said.
The development comes after the Indian Council of Medical Research (ICMR) announced that accredited private labs will conduct tests for COVID-19 to enhance capacity for diagnosis and detection of novel coronavirus amid rising cases in the country.
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.
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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 and National Institute of Virology (NIV) in Pune.
(With inputs from agencies)
