Pune-based Mylab gets approval for COVID-19 test kit commercial approval
New Delhi: Central Drugs Standard Control Organisation (CDSCO) has given commercial approval to Pune-based molecular diagnostics company Mylab Discovery Solutions for its COVID-19 test kit.
The test kit by the company is the first ‘Made in India’ kit to receive commercial approval from CDSCO, and is named as Mylab PathoDetect COVID-19 Qualitative PCR kit, the company said in a statement.
“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 record time,” Mylab Discovery Solutions MD Hasmukh Rawal 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, the company said.
Moreover, Mylab’s COVID-19 test kit screens and detects the infection within 2.5 hours as compared with over 7 hours taken by current protocols, it added.