Coronavirus Update in India

Mylab Discovery develops first Made in India Covid-19 test kit

Pune-based molecular diagnostics company, Mylab Discovery Solutions Pvt Ltd, has developed the first Made in India Covid-19 testing kit. On Wednesday, it announced that it is ready with the first batch of test kits and will start supplying to the government and private labs.

In the first batch, Mylab Discovery Solutions will supply testing kits to conduct 15,000 tests. The kit is the first one to receive commercial approval from Indian FDA/ Central Drugs Standard Control Organisation (CDSCO) and is developed in a record time of six weeks. Given the low testing rate in the country, India’s very own testing kit will help in fighting back the global pandemic Covid-19. Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the infection within 2.5 hours, compared to 7+ hours taken by current protocols.

“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.

Mylab test kits cost nearly one-third to one-fourth of the cost of the price cap provided by ICMR. But private and government labs approved by ICMR can conduct the tests for Covid-19. 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.

Hasmukh Rawal, MD, Mylab Discovery Solutions, said: “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”. He further added that the support and the immediate action from regulatory bodies (CDSCO/FDA), evaluation centre of ICMR, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments during this national emergency is commendable.

The Mylab manufacturing facility, approved by FDA/CDSCO is compliant with MDR 2017 regulation for Manufacturing Medical Device of Class A,B,C and D and ISO 13485: 2016 certification.

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