GOOD NEWS: First ‘Made in India’ Test Kit for COVID-19 by Mylab Gets Commercial Approval from CDSCO

Amid the coronavirus outbreak, good news has come from a Pune-based molecular diagnostics company, Mylab Discovery Solutions. The company has received commercial approval from the Central Drugs Standard Control Organisation or CDSCO for its COVID-19 test kit.

What is ‘Made in India’ test kit?

Interestingly, the test kit by the company is the first ''Made in India'' kit that has received commercial approval from CDSCO. It is named as Mylab Patho Detect COVID-19 Qualitative PCR kit, the company informed in a statement.

Mylab Discovery Solutions MD Hasmukh Rawal said, "With emphasis on ''Make in India'' and support from local & central government, the COVID- 19 kit has been made according to the 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 company said, “Local sourcing of test kits will be a major breakthrough for India as the testing kit by Mylab would cost nearly one-fourth of the current procurement cost.”

Adding to it, Mylab's COVID-19 test kit screens & detects the infection within 2.5 hours as compared with over 7 hours taken by current protocols, statement mentioned.

About Mylab Discovery Solutions:

Mylab Discovery Solutions specializes in molecular diagnostic kits. It is the only Indian company to have achieved 100 percent sensitivity and specifity in the ICMR evaluation.