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“Source;- Hindustan Times”
As India faces a severe shortage of coronavirus disease (Covid-19) testing kits, Mylab Discovery Solutions, the first Indian company whose testing kit was approved by the Indian Council of Medical Research (ICMR), has tied up with Serum Institute of India, world’s largest vaccine manufacturer by number of doses produced, to scale up the operations and escalate faster delivery of testing kits.

“…Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd has partnered with Serum Institute of India’s CEO Adar Poonawalla and Abhijit Pawar, Chairman of AP Globale. Funds invested will be used for scaling production of COVID-19 testing kits and expansion of molecular diagnostic solutions,” the company said in a statement on Thursday.

AP Globale, a positive impact business solutions company, will be helping Mylabs scale its operations within India and globally. Abhijit Pawar, chairman of APG, will be joining the board of the company.

Many of the 51 private labs approved by the ICMR for Covid-19 testing in the country have not been able to conduct tests as per their capacity and demand because of the shortage of kits.

“The kits are in short supply; the orders are getting delayed and, as a result, we are not able to conduct tests. The manufacturers are overburdened,” said Dr Naveen Dang, founder, Delhi’s Dr Dangs Lab, one of the first private labs to have received ICMR approval for testing.

From the day the first batch of private labs was given approval on March 21, all of them put together so far have done about 1500 tests.

With the tie-up, in the next few weeks, the production of kits is likely to be ramped up from the number that currently can perform about 150,000 test kits per week to at least 20 lakh tests per week.

“The shortage of testing kits will come to an end in a month or two,” said Serum Institute of India’s CEO Adar Poonawalla.

Mylab is the first Indian company to get commercial approval for its testing kits called Mylab PathoDetect COVID-19 Qualitative PCR kit.

The testing kits that get endorsed by the ICMR are further approved by Indian FDA or Central Drugs Standard Control Organisation (CDSCO) for manufacture, sale and distribution in India.

“Global innovation is the need of the hour to curb this pandemic that has affected millions across the world. The need for the maintenance and manufacturing of medical and healthcare equipment at the pace required to keep the numbers at bay has never been more important. Mylabs and their team have shown exceptionally innovative capabilities when they were able to develop a time-saving testing kit within 6-weeks of its outbreak. Keeping in mind their resilient approach and quick response, I am certain that the company has a variety of similar innovation-driven projects which will help bring drastic improvements in the healthcare sector. The investment towards Mylab will enable them to build their infrastructure and expand their capabilities further,” said Poonawalla.

“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,” said the company statement.

Sujit Jain, director, Mylab, said, “This will help Mylabs create a world class organization, which will help India become a leader in molecular diagnostics.’’

The ICMR has so far validated four PCR-based testing kits that have not had US FDA or European CE approvals. The US FDA and CE endorsed kits are already eligible for use. However, for the rest, ICMR recommends usage after thorough evaluation.