coronavirus

licence

CoSara Diagnostics

Ambalal Sarabhai Enterprises

Kartikeya Sarabhai

Gandhinagar

Dwight Egan

The firm claims its reagent kits can givetest results in about 2.5 hrsAhmedabad based company has become the first in India to receive ato manufacture coronavirus test kits from the Central Drugs Standards Control Organisation (CDSCO). This makes the company the only one in the country so far to be able to manufacture reagent kits used in the rRT-PCR machines to test for coronavirus.Pvt Ltd, which is registered in Ahmedabad and has its manufacturing plant in Ranoli, Vadodara, received its licence on Tuesday, almost a month after its application was sent to the CDSCO for approval. The company is a joint venture between Co-Diagnostics Inc of Utah, USA, andof India.Co-Diagnostics had developed the test kit in the US and the company was trying to start manufacturing in India which has been importing the reagent test kits from other countries so far.Mohal, the CEO of CoSara Diagnostics, told Mirror, “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.”The company claims its reagent 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. Asked how his test kits give faster results, Sarabhai said, “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.”Even though the application for the manufacturing licence was submitted to the CSSCO in February, it is only now that it has finally been approved.Mirror has learnt that senior officers from the Health department and FDCA helped in expediting the process for the license after inspecting the file themselves. A representation was made to the Drugs Controller General of India (DCGI) during an event inon March 6-7. This test is designed to use nasopharyngeal, oro-pharyngeal swab and serum samples to detect the corona virus using a polymerase chain reaction (PCR) machine.“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,” said, CEO of Co-Diagnostics Inc, in a statement to the press.Asked at what price the test kits would be sold to the government, Sarabhai refused to divulge the same but said that it would definitely be cheaper than the cost at which the government is procuring the test kit from other countries at the moment.