Fight against coronavirus: Two test kits, 12 private labs added to India's arsenal

Indian Council of Medical Research (ICMR) on Monday, March 23, put out a list of 12 private testing laboratories that have now been allowed to test the COVID-19 samples. These include five in Maharashtra (four in Mumbai and one in Navi Mumbai) - SRL; Suburban Diagnostics; Sir H N Reliance Foundation Hospital and Research Centre; Metropolis Healthcare; and Throcare Technologies. Two each in Tamil Nadu and Haryana. The ones in Tamil Nadu are Department of Clinical Virology, CMC, Vellore; and Department of Laboratory Services, Apollo Hospitals Enterprise, Chennai. In Haryana, the approved laboratories are Strand Life Sciences; and SRL. The remaining private laboratories are Lal Path Labs in Delhi; Unipath Specialty laboratory in Ahmedabad; and Neuberg Anand Reference Laboratory in Bengaluru.

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In terms of the kits that have been approved, the RT-PCR kits from Altona Diagnostics and Mylab have been approved for use by the ICMR-recommended government and private laboratories.  These have been chosen after an evaluation of nine non-USFDA EUA/CE IVD kits. A ICMR note says that currently, RT-PCR probes for diagnosis of COVID-19 are procured from USA by ICMR-NIV and distributed to the testing laboratories across the country. However, it does also add that the USFDA EUA/CE IVD approved kits can be used directly after due approval from the Drug Controller General of India (DCGI) and after intimation to ICMR. Already, some of the labs have already put out videos with a telephone number where people could call for "safe and hygienic collection of sample at home".

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In this whole process, the story of Mylab is perhaps quite fascinating. This Pune-based six years old company that hopes to touch Rs 10 crore turnover this year, passed the ICMR evaluation exam with flying colours. With a palpable sense of pride, Dr Gautam Wankhede, a director in the company, told Business Today, "We have been developing the kit for the last two and a half months to three months and what is really big is that just this evening, we became the first Indian company to get the licence to manufacture and sell the kit." The kit, he says, is called 'Patho Detect COVID-19". He was particularly appreciative of the proactive government bodies, especially the Drug Controller General of India (DCGI). In less than 20 days, the company was able to get licence to get it evaluated by NIV, Pune and later the approval by the DCGI to make and sell in the local market. Mylab hopes to make the test available at nearly one-third of the current price cap per test, which is Rs 4,500.