India’s First Homemade COVID-19 PCR Kit Commercially Approved by Government

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

Pune-based Mylab Discovery Solutions Pvt Ltd. announces the commercial approval of the first, made in India COVID-19 test kit which it developed in a record span of just six weeks.

The COVID-19 pandemic which originated in Wuhan, China has spread to different corners of the world and several countries, previously less or unaffected have begun to feel its wrath. Since a viral outbreak of this scale was unanticipated, health systems around the globe have been caught off-guard. Among other things, the biggest issue that cripples people is the shortage of medical supplies and diagnostic tests. Given the circumstances, India has been one of the countries which have handled the situation reasonably well, inviting praise from the World Health Organization (WHO). Starting tonight, a nationwide lockdown will be imposed for three weeks as the current reported cases spiked to over 500 with 10 deaths, at the time of writing.

However, as compared to Singapore or South Korea, India ranks lowest at 6.8 in terms of testing done per million population. The Indian government has been taking measures to import kits from manufacturers in Germany, but the current crisis in airline services has dented that cause. The logical solution is to manufacture homemade test kits which will give the country a shot in the arm with a freedom to scale up production and also lower procurement costs.


First Home-made COVID-19 Test

In order to combat the rising demand for COVID diagnostics, Pune-based Mylab Discovery Solutions, a private company that specializes in molecular diagnostic kits has developed India’s first homemade COVID-19 kits in six weeks. Yesterday it announced the commercial approval of its Mylab PathoDetect COVID-19 Qualitative PCR kit by the Central Drugs Standard Control Organisation (CDSCO). With this, the kit becomes the first one to receive commercial approval from the drug regulatory body of India.

Hasmukh Rawal, Managing Director of Mylab commended the immediate action by the agency and other regulatory bodies such as the Indian Council of Medical Research (ICMR), National Institute of Virology (NIV) and Biotechnology Industry Research Assistance Council (BIRAC). “With emphasis on ‘Make in India’ and support from local and central government, the COVID-19 kit, has been made as per WHO/CDC guidelines. It was developed and evaluated in a record time” said Rawal in a company statement.

“We have been trying hard to make cutting edge technology available to our country at a reasonable and affordable price. Since this test is based on PCR technology, even early stage infection can be detected, with highest accuracy as has been seen during tests at ICMR. The ICMR tested, CDSCO approved kit makes detection faster too”, said Mrs. Shailendra Kawade, Executive Director at Mylab.

Mylab has promised to manufacture around 1,00,000 tests each week with plans of scaling up. Each kit has the capacity to test 100 patients and labs with PCR facilities could now serve more than 1000 patients a day. The kit screens and detects COVID-19 infection within 2.5 hours.

Related Article: QuarkBio Announces a COVID-19 Test Kit, 10 Times More Sensitive than Existing Kits



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