PUNE: Pune-based Mylab Discovery Solutions, a specialist in molecular diagnostic kits, has become the first biotechnology company in the country to receive commercial approval to manufacture and sell its novel coronavirus testing kits in the country.
The testing tool named as Mylab PathoDetect COVID-19 Qualitative PCR kit was developed in a record time of six weeks.
Till date the Indian government has been sourcing millions of testing kits from Germany to facilitate testing of Coronavirus patients in the country.
The dependency on foreign kits has been troublesome as the supply had got blocked due to curbs on international flights. The locally made testing kit could also allow healthcare professionals to test more number of suspected patients.
The testing kit has been approved by the Indian FDA/Central Drugs Standard Control Organisation (CDSCO), after being validated by Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research.
"We are the first one in India to receive approval to manufacture and sell Covid-19 testing kits from the Indian FDA/Central Drugs Standard Control Organisation (CDSCO), the licensing authority, under the Union Ministry of Health," said Dr Gautam Wankhede, medical affairs director at Mylab Discovery Solutions.
He said the new COVID-19 test kit screens and detects the infection within 2.5 hours, compared to seven-plus hours taken by current protocols. This means that laboratories will be able to do twice the number of reactions at the same time on one machine.
He said the ballpark figure of testing labs in the country would be in the region of 3,000 units who would order its kits. "At present, we can produce 150 kits a day and ramp up production as per demand," Wankhede said.