Ahmedabad based company gets green signal first in India to receive a licence for manufacturing coronavirus test kits from the Central Drugs Standards Control Organisation (CDSCO). CoSara Diagnostics Pvt Ltd, which is registered in Ahmedabad and has its manufacturing plant in Ranoli, Vadodara, received its licence on Tuesday, a month after an application was sent to the CDSCO for approval.
The company is a joint venture between Co-Diagnostics Inc of Utah, USA, and Ambalal Sarabhai Enterprises of India. The licence will enable the company the country to manufacture reagent kits used in the rRT-PCR machines for testing coronavirus.
The company had developed the test kit in the US and was trying manufacturing in India which has been importing the reagent test kits from other countries.
“We have received the licence from the CDSCO and will begin manufacturing shortly. We have ordered raw materials from our partner in the US and they will be arriving soon.” said Mohal Kartikeya Sarabhai, the CEO of CoSara Diagnostics.
According to the company, “kits can give test results in two to two-and-a-half hours as against five hours taken by the kits being used by ICMR and its labs.
“We have a patented software to be used in the PCR machines that has a faster diagnostic time frame than the ones currently being used.” Sarabhai said as to how it will perform faster tests.
Senior officers from the Health department and FDCA helped in the process for giving license after inspecting the file. A representation was also made to the Drugs Controller General of India (DCGI) during an event in Gandhinagar on March 6-7.
The test is designed to use nasopharyngeal, oro-pharyngeal swab and serum samples to detect the corona virus using a polymerase chain reaction (PCR) machine.
Dwight Egan, CEO of Co-Diagnostics Inc, said that, “With no known treatment or approved vaccine for the highlyinfectious Covid-19, the need for accurate and rapid diagnoses has never been greater. Our costeffective Covid-19 test has been designed to run on a variety of commercially available platforms. We are confident in our ability to meet the growing demand for this diagnostic kit,”