Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd, which specialises in molecular diagnostic kits, has developed first “Made in India” test kit for COVID-19 coronavirus disease.
The company on Monday said it has received commercial approval from the Central Drugs Standard Control Organisation (CDSCO) 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 a 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.
Besides, Mylab is the only Indian company to have achieved 100 per cent sensitivity and specificity in the ICMR evaluation.
The Government has fast-tracked the validation process for new testing kits for COVID-19 and granted approval to new commercial testing kits as total cases surged past 400 across the country.
ICMR Director General, Dr Balram Bhargava said the government has welcomed the use of indigenous diagnostic kits for COVID-19.
“A fast track mechanism has been set up for their validation at NIV, so that tests can be done quickly and we can confirm infections among people. And, it not mandatory that they be approved by US-based Food and Drug Administration (FDA), a validation from ICMR-NIV is adequate to give them a go-ahead,” Bhargava said on Monday.
Apart from government laboratories, as many as 12 private laboratories with 15,000 collection centres have also been permitted to conduct testing.
Swiss firm Roche Diagnostics India became the country’s first private firm to get COVID-19 test approval.
Roche Diagnostics India last week received the license for conducting Coronavirus tests after approval from drug regulator DCGI, making it the first private firm to get such permission after the government decided to allow accredited private labs to test for COVID-19.
(With agency inputs)