Apart from approval for new manufacturers of COVID19 test kits, the government has also allowed 12 laboratory chains with 15,000 collection centers all over the country to carry out the necessary tests.
In a significant development which will enhance the readiness of India in fighting COVID19, MyLab, a Pune based molecular diagnostic company has become the first Indian company to received the validation for its Covid-19 diagnostic test kits by the National Institute of Virology (NIV). The COVID19 diagnostic test kits made by MyLab has a around time of 2 1/2 hours compared to the four hours taken by the current lab tests.
The information about the path-breaking COVID19 test kits was provided to ET by Dr Gautam Wankhde, Medical Director of Mylab. He also informed that the company’s kits can study 1000 samples from large labs and 200 from smaller labs. Mylabs is looking to price its kits around INR 1200 which is 1/3rd of the price of the kits available in the market now. Mylab has promised that it can manufacture up to 1 lakh tests in a week which can be further scaled up if needed.
To further aid the readiness and improve the testing record, Indian Council of Medical Research (ICMR) on Monday said that Indian manufacturers can produce testing kits and supply to private and government laboratories with NIV validation. The ICMR also stated that a NIV validation is enough for these kits and they do not immediately require the approval from the USFDA and European CE, in order to fast track approval system.
Another German manufacturer, Altona Diagnostics, has also got the approval from NIV for their COVID19 test kits. Till last week, COVID19 confirmatory tests were conducted in about 50 government laboratories. The number was increased to 111 on Friday with ICMR allowing private laboratories to start testing for the pandemic. Along with the new approval for low cost diagnostic kits, the government has also allowed 12 laboratory chains with 15,000 collection centers all over the country to carry out COVID19 tests.