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Cos with NIV validation to produce Corona testing kits

Amidst a surge of Covid-19 cases in the country (500 as on Tuesday morning), the government has expedited the mechanism to boost domestic manufacturing of testing kits for novel coronavirus infection by allowing validation by Pune-based National Institute of Virology.

Indian Council of Medical Research (ICMR) on Monday clarified that even if Indian companies can manufacture testing kits, even if they don’t have approval from the USFDA and European CE. ICMR director general Balram Bhargava told reporters, “Now kits manufactured in India need NIV validation and then apply to Drug Controller General of India (DCGI) for manufacturing licence.” Earlier, the research body had mandated that “commercial kits for real-time PCR based diagnosis of Covid-19 should be USFDA approved or European CE certified or both for in-vitro diagnosis of Covid-19 emergency use”.

The government has also scaled up the number of labs suitable for conducting these tests throughout India from only 50 government laboratories last week to about 111, with ICMR on Friday giving green chit to some private laboratories to start testing for the pernicious pandemic.