Fourteen private companies including Swiss firm Roche Diagnostics India have been given test licenses by the drug regulator DCGI for evaluation of the quality of COVID-19 testing kits, a CDSCO official said.
Apart from Roche Diagnostics India, the rest of the 13 are Indian firms include 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 Drug Controller General of India.
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 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.
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.
The adoption of commercial kits for testing should be based on validations conducted by the ICMR and National Institute of Virology (NIV) in Pune.