Kolkata: Swiss firm Roche Diagnostics India received the licence 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.
Dr Shravan Subramanyam, managing director of Roche Diagnostics India, told News18, "Our company has been accorded the test licence for Cobas SARS CoV-2 by the Central Drugs Standard Control Organisation (CDSCO). A few days ago, this test received the United States Food and Drug Administration (USFDA) Emergency Use Authorisation.”
“The licence will allow 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.”
A senior official said the Drug Controller General of India (DCGI) is now assessing giving the licence to another private diagnostic firm, bioMérieux, which has also sought approval to conduct tests for coronavirus.
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.
Stating that the licence was granted in record time, Subramanyam said 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 appealing them to conduct the tests free of cost.
(With inputs from PTI)