Make-in-India: Indo-US firm gets nod to test Covid-19 Kit

BENGALURU: An Indo-US firm — CoSara Diagnostics — based out of Baroda and supported by Bengaluru-based Centre for Cellular And Molecular Platforms (CCAMP) has developed a diagnostic kit for Covid-19, which already has approval from the US Food and Drug Administration (FDA).
In India, the firm has received a research test licence from the Central Drugs Standard Control Organisation (CDSCO), and is in the process of obtaining a full-fledged manufacturing licence.
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CoSara, a joint venture between US firm Co-Diagnostics and India’s Sarabhai Group, already has a full-fledged manufacturing plant that was granted the licence in November 2019 where it makes kits for Malaria, Hepatitis-B, Hepatitis-C, Human papillomavirus (HPV), TB, etc.
Co-Diagnostics senior vice-president (Clinical Alliances) Dr Mayuranki Almaula told TOI: “Now, CoSara has got the test licence approval— research-use only test licence—from CDSCO for the Covid-19 diagnostic kit, which is the first step in the process of obtaining a full-fledged manufacturing licence.”
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She further said that the kit, which first received emergency use approval from the FDA for outside of the US, has already been shipped to Iran, Morocco, Italy and France, while the firm has received interest from places like Manila (Philippines), Dubai (UAE) too.
“...After that we received FDA approval to supply the kits to CLIA-approved labs in the US. CLIA is similar to India’s NABL. And now, in the past 48 hours, we’ve been told that anybody in the US can use our kit,” Almaula added.
Taslimarif Saiyed, CEO and director, CCAMP said: “We are excited that they have got the test licence and are in the process of getting a manufacturing licence as they will be able to bring the cost down to a fairly affordable rates.”
Almaula said designs kits on our own platform and we don’t have to pay licencing fees to any other company for our test design. Further elaborating, she said that while the firm has the research test licence now in India, it is only a matter of time before it gets the full-fledged licence given the nature of the virus and the way it is spreading.
“It is a matter of some validations before we get the licence in order to address the market needs. Also, the one thing we are really happy about is that this will be a complete Make in India product. While the initial designs would be from the US, the complete manufacturing will happen in India,” she added.