First 'Made-in-India' Coronavirus test kit gets government approval; to start supply soon

Mylab Discovery Solutions Pvt Ltd, a Pune based molecular diagnostics company which specialises in molecular diagnostic kits, has developed the first Made-in-India test kit for COVID-19 in a record time of six weeks. The kit 'Mylab PathoDetect COVID-19 Qualitative PCR kit' is the first one to receive commercial approval from the Indian FDA/Central Drugs Standard Control Organisation (CDSCO). 

'The company can ramp-up its capacity'

In the first batch, the company will supply testing kits for 15,000 tests. The kit costs around one-third to one-fourth of the price cap mandated by the government's guidelines, the company said in a release. “At present, Mylab can produce kits to test for 20,000 samples per day. However, in case of an adverse situation, the company can ramp-up its capacity to ship kits to conduct 50,000 tests per day.”, said, Rahul Patil, Executive Director and Operations Head, Mylab Discovery Solutions.

According to Mylab, the test kit 'Mylab PathoDetect COVID-19 Qualitative PCR kit' will give results in 2.5 hours as against the prevalent 6-8 hours because its team has created a solution that does both the screening and confirmation

As of 25th March, ICMR has approved more than 100 government labs and 29 private labs across the country for testing. “We are continuously working with all the testing labs to predict the demand and schedule the supplies of the testing kits. We are letting them know of supply schedules ahead of time”, said Sujit Jain, Advisor and Mentor on Corporate Strategy, Mylab Discovery Solutions.

'In no way, we are relaxed about anything at this point' 

Globally, the Coronavirus has infected 532,120 and 24,084 people have died so far, while in India, 694 cases have emerged with the death toll rising to 16.  Lav Agarwal, Joint Secretary in the ministry of health, told a press conference that while the "numbers of COVID-19 cases are increasing, there appears to be relatively a stable trend or even little bit reduction in the rate at which they are increasing".

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"This, however, does not establish a clear trend and in no way are we relaxed about anything at this point," he added. The government on Thursday announced Rs 1.7 lakh crore worth package for poor people, health workers, employees and poor women to mitigate the crisis that has emerged due to the pandemic outbreak.

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