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Gujarat Based Indo-US Firm Gets License To Manufacture COVID-19 Testing Kit
India, 20 March 2020 10:35 AM GMT
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By : Aditi Chattopadhyay
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The company claims its reagent kits can give test results in 2.5 hours as opposed to 5 hours taken by the kits being used by ICMR and its labs.
An Indo-US firm, CoSara Diagnostics Pvt Ltd, which is registered in Ahmedabad, has become the first in India to receive a licence to manufacture coronavirus test kits from the Central Drugs Standards Control Organisation (CDSCO) and is in the process of obtaining a full-fledged manufacturing licence.
Supported by Bengaluru-based Centre for Cellular And Molecular Platforms (CCAMP), the firm has developed a diagnostic kit for COVID-19, which already has an approval from the US Food and Drug Administration (FDA).
The Times of India reported that CoSara, which is a joint venture between US firm Co-Diagnostics and India's Sarabhai Group, has a full-fledged manufacturing plant that was granted the licence in November 2019 where it currently makes kits for Malaria, Hepatitis-B, Hepatitis-C, Human papillomavirus (HPV), TB, etc.
"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," Dr Mayuranki Almaula, Co-Diagnostics senior vice-president (Clinical Alliances) was quoted as saying.
The testing kit, after receiving approval for emergency use outside of the US from FDA, has already been shipped to Iran, Morocco, Italy and France. Other affected places like Manila (Philippines), Dubai (UAE) are also showing interest in these kits now.
"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," Almaula added.
The company claims its reagent kits can give test results in two to two-and-a-half hours as opposed to the five hours taken by the kits being used by ICMR and its labs.
According to Almaula, designing kits now will be cheaper since it is no longer a requirement to pay the licensing fees to any other company.
Also Read: Flattening The Coronavirus Curve: How Social Distancing Can Help Mitigate The Outbreak?
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