India’s 1st Made In India Testing Kit For #Coronavirus Get Approved; Price Will Be 76% Less!

A molecular diagnostics company Mylab Discovery Solutions Pvt Ltd, based in Pune has developed the first made-in-India test kit for COVID-19 in a record time of six weeks, as per the reports. 

How Did This Happen?

Basically this company specializes in molecular diagnostic kits.

Also, this 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). 

Apart from that, Mylab is the only Indian company to have achieved 100 percent sensitivity and specificity in the ICMR evaluation.

What Does Mylab Discovery Solutions Say?

The Managing Director, Mylab Discovery Solutions, Hasmukh Rawal said “With the emphasis on ‘Make in India’ and support from local and central government, the COVID- 19 kits have been made as per WHO/CDC guidelines. It was developed and evaluated in record time,”.

Further, he added that the support and the immediate action from regulatory bodies (CDSCO/FDA), evaluation center of ICMR, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments during this national emergency is commendable.

The molecular diagnostics company has several years of experience in manufacturing RTPCR kits.

Mylab 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. 

Currently, Mylab manufactures ID-NAT screening kits for blood banks/hospitals, Quantitative HIV, HBV and HCV kits. 

Also, the company has received clearance from the Drugs Controller General of India (DCGI) to manufacture the COVID-19 Qualitative kit, in the same facility.

Further, the Mylab COVID-19 kit had been evaluated at the Indian Council of Medical Research (ICMR).

The Executive Director at Mylab, Shailendra Kawade said”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 sensitive PCR technology, even early-stage infection can be detected, with the highest accuracy as has been seen during tests at ICMR. The ICMR tested, CDSCO approved kit makes detection faster too,”.

How Will This Help?

So far, India ranks lowest in terms of testing done per million population. 

Currently, 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.

Till now the Indian government has been sourcing millions of testing kits from Germany to facilitate testing to diagnose Coronavirus patients PAN-India.

 Although, the dependency on foreign kits has been troublesome and supply is getting blocked due to grounded airlines. 

But this picture will change with the approval for made in India kits.

Further, Mylab promised that it can manufacture up to 1 lakh tests in a week that can be further scaled up if needed.

Also, the company claims that its test kits can test about 100 patients with one kit. 

While an average lab with automated PCR can test more than 1000 patients a day.

This will affect the cost too, as local sourcing of test kits will be a breakthrough for India as the testing kit by Mylab would cost nearly one-fourth of the current procurement cost.

How Does It Work?

Normally, 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.

Moreover, 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.