Finally, Indian made COVID-19 Test kit gets commercial approval.

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 in a record time of six weeks. The kit — Mylab PathoDetect COVID-19 Qualitative PCR kit — is the first one to receive commercial approval from the Indian FDA/ Central Drugs Standard Control Organisation (CDSCO). Besides, Mylab is the only Indian company to have achieved 100 per cent sensitivity and specificity in the ICMR evaluation.

“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,” Hasmukh Rawal, Managing Director, Mylab Discovery Solutions said. 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.

Mylab has several years of experience in manufacturing RTPCR kits. It manufactures a range of kits at the facility approved by Indian FDA/CDSCO and is compliant with MDR 2017 regulation for manufacturing medical devices of Class C and D, the most stringent and regulated products by the government. Mylab currently manufactures ID-NAT screening kits for blood banks/hospitals, Quantitative HIV, HBV and HCV kits. Mylab has also received clearance from Drugs Controller General of India (DCGI) to manufacture the COVID-19 Qualitative kit, in the same facility. The Mylab COVID-19 kit had been evaluated at the Indian Council of Medical Research (ICMR).

“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 the sensitive 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 Shailendra Kawade, Executive Director at Mylab.

Currently, India ranks lowest in terms of testing done per million population. The number is as low as 6.8. Countries like South Korea and Singapore have been able to contain the growing number of Coronavirus cases by enhancing the number of testing.

So far the Indian government has been sourcing millions of testing kits from Germany to facilitate testing to diagnose Coronavirus patients PAN-India. However, the dependency on foreign kits has been troublesome and supply is getting blocked due to grounded airlines. This can change with the approval for made in India kits.

Mylab promised that it can manufacture up to 1 lakh tests in a week that can be further scaled up if needed. Further, the company claims that its test kits can test about 100 patients with one kit. An average lab with automated PCR can test more than 1000 patients a day.

With local sourcing of test kits, it will be a breakthrough for India as the testing kit by Mylab would cost nearly one-fourth of the current procurement cost. Moreover, Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the infection within 2.5 hours, compared to seven-plus hours taken by current protocols. This means that laboratories will be able to do twice the number of reactions at the same time on one machine.

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.