First made-in-India Covid-19 test kit gets commercial approval

Indian Council Medical Research on Tuesday approved Covid-19 test kits manufactured by Pune-based private lab “Mylab Discovery Solution”. The first batch of test kits is expected to be out on Wednesday. The private lab has managed to produce test kits in a record time of six weeks following the WHO guidelines.

Amidst the outbreak of coronavirus, the ICMR recently gave green signal to 16 private laboratories across the country to conduct Covid-19 tests. In this hour of need, the Pune-based lab received commercial approval from the Central Drugs Standard Control Organisation (CDSCO) for Covid-19 test kit.

The company said the kit will cost nearly one-fourth of the current procurement cost.

The test kit has been named as “MyLab PathoDetect Covid-19 Qualitative PCR” kit. The Pune-based firm is the first Indian company to get commercial approval from the national regulatory body.  Besides, Mylab is the only Indian company to have achieved 100 per cent sensitivity and specificity in the ICMR evaluation.

The Indian government till now has been importing RT-PCR kits from Germany and Switzerland. This approval will help the government to reduce the burden of procurement.

Medical affairs officer director Gautam Wankhede said, “We should be able to ship out the first few kits maybe tomorrow early morning. The lab can manufacture up to 1 lakh tests in a week that can be further scaled up if needed.” According to the company nearly 100 patients can be tested using one kit. The kit will screen and detect Covd-19 infection within two and half hours.