First RT-PCR COVID-19 Test Made Domestically Approved by India’s Regulatory Authority

First RT-PCR COVID-19 Test Made by Domestically Approved by India’s Regulatory Authority

Mylab Discovery Solutions Pvt Ltd, a firm focusing considerable effort on sub-atomic analytic units is reported to have developed a COVID-19 test pack called PathoDetect COVID-19 Qualitative PCR Pack that has been approved by the Indian regulatory authority. It’s reverse transcription polymerase chain reaction (RT-PCR) test is purported to be the first such testing product made and approved in India as thus far the Asian nation has had to important all such products.

According to the Indian firm’s website, this is the first business to receive endorsement form the Indian drug regulatory authorities including approval from the CDSCO. The company reports that it has accomplished an Indian Council of Medica Assessment (ICMR) as well. The ICMR is the apex body in India for the formulation, coordination and promotion of biomedical research and is one of the oldest medical research bodies in the world.

National Race for Testing Device

As a matter of urgency and safety for the Indian people, as much as economics, an emphasis has been placed on the local development of COVID-19 testing products. The local press reports the Indian government primarily depends on imports from Germany but that this outside reliance is “problematic” and that supply chains are increasingly disrupted by grounded airplanes.

Mylab Discovery Solutions was up to the task reports Hasmukh Rawal, Managing Director, who noted they created the product “in record time.” Although India hasn’t experienced the pandemic with the severity of its neighbor to the north, or to the extent it would appear America now must react, nonetheless the nation of over 1.38 billion can’t afford to take chances. The company the new test costs one-fourth of the exported ones.

Support from Government Agencies & Regulators

Mylab Discovery Solutions reports it has significant support for its effort from the Central Drugs Standard Control Organization (CDSCO) as well as Indian FDA where its manufacturing facility has been purportedly reviewed and cleared.

Increase COVID-19 Testing Productivity

Purportedly, the new testing tool will not only reduce the costs to Indian government and private providers but also can perform accurate tests faster—within 2.5 hours contrasted with seven or more hours taken by existing tools.  Hence if accurate research centers will be able to double the quantity of responses simultaneously on one machine. The test kit can be applied to 1000 samples from large lab and 200 from smaller labs.

About Mylab Discovery Solutions Pvt Ltd

The firm develops and commercializes molecular diagnostic detection kits to empower labs to obtain reliable, timely and actionable answers. They serve multiple markets from clinical diagnostics, pharmaceutical drug discovery, biomedical research and others. The firm operates an ISO 9001, 1SO 13485 certified facility under 98/79/EC Full Quality Assurance Systems.