COVID19 Test Kit By Mylab Gets Commercial Approval From CDSCO
The first made-in-India test kit for Covid-19 developed by a Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd has received commercial approval from the Indian FDA/ Central Drugs Standard Control Organisation (CDSCO).
It took only six weeks to develop the ‘Mylab PathoDetect COVID-19 Qualitative PCR kit’. This would be the first kit to receive approval from CDSCO. In ICMR evaluation, Mylab is the only Indian company to have achieved 100 percent specificity and sensitivity.
The kit is made as per the WHO/CDC guidelines, with support from the local and central governments and an emphasis on ‘Make in India.’
The Managing Director of Mylab Discovery Solutions, Hasmukh Rawal, said that the kit was developed and evaluated in a record time of six weeks. He also commented on the support and immediate action received from NIV, regulatory bodies (CDSCO/FDA), Biotechnology Industry Research Assistance Council (BIRAC), evaluation center of ICMR, and the state and central governments during this emergency situation.
At present, most of the pandemic-prone diseases, including the Covid-19, are diagnosed accurately using the Polymerase Chain Reaction (PCR) only. Mylab has been manufacturing RTPCR kits for several years. The company manufactures a range of kits approved by Indian FDA/CDSCO and is compliant with MDR 2017 regulation for manufacturing the most stringent and regulated products like the medical devices of Class C and D. Currently, Mylab manufactures Quantitative HBV, HIV, and HCV kits as well as the ID-NAT screening kits for hospitals/blood banks.
The Drugs Controller General of India (DCGI) has approved the company to manufacture COVID-19 Qualitative kits in the same facility. The Indian Council of Medical Research (ICMR) evaluated Mylab’s COVID-19 kit.
Shailendra Kawade, Executive Director at Mylab, said that the sensitive PCR technology employed in the kit could be used to detect even early-stage infection with high accuracy. The CDSCO approved, ICMR tested kit is faster too, he said.
In terms of testing done per million population, India is currently ranking the lowest. It is as low as 6.8. It is by enhancing the number of testing, countries like Singapore and South Korea succeeded in containing the disease.
Millions of testing kits from Germany are being sourced by the Indian Government to diagnose Covid-19 patients in India. But the grounded airlines, blocking the supply and troublesome dependency on foreign kits remain to be the major challenges. However, kits made in India could change the situation.
Up to 1 lack test kits can be manufactured in a week, promised Mylab. The number will be increased if needed. Moreover, the company claims that samples of about 100 patients can be tested using a single kit. An automated PCR in an average lab can test more than 1000 samples in a day.
The new COVID19 testing kit by Mylab will be a great advancement for India as the kit will cost only one-fourth of the current procurement cost. Further, Mylab’s COVID19 test kit can detect the infection within 2.5 hours compared to the current kits that take more than seven hours for detection. Therefore, twice the number of reactions can be done by laboratories in one machine.