Co-Diagnostics, a Utah-based molecular diagnostics company, says its joint venture for manufacturing, CoSara Diagnostics Pvt Ltd has obtained regulatory clearance for five tests in India. The clearance obtained is to manufacture and sell in the form of in vitro diagnostics (“IVDs”) from their facility in Ranoli, India.
“India is soon to become the largest healthcare market on the planet and the best place for CoPrimer-powered products to be manufactured and distributed is from within the country itself. Being able to sell fully approved IVDs to this market represents the next stage in our growth as we establish Co-Diagnostics to be a leading innovator of high-quality, affordable diagnostics solutions. We are excited to be taking this next step in our growth with such a distinguished partner and are eager to see returns on the time and effort we have spent to get to this point,” says Dwight Egan, CEO of Co-Diagnostics.
The Saragene tests for malaria, mycobacterium tuberculosis, hepatitis B, hepatitis C and human papillomavirus (HPV) meet the requirements of the Central Drug Standard Control Organization (“CDSCO”) Medical Device Rules (MDR) 2017. CDSCO has approved after completely inspecting the CoSara manufacturing facility and its location, technology presentation, quality system, product validation data, procedures, and performance evaluation by an independent NABL & CAP-accredited laboratory. The licenses and regulatory clearance would permit CoSara to produce and sell the tests for the detection of the respective pathogen and microorganisms for the first time.
The joint venture holds the exclusive manufacturing rights in India for the infectious disease molecular diagnostics kits, specially designed by the Co-Diagnostic using their CoPrimer technology platform. Alongside, certain tests are to be sent to the CDSCO for approval that includes drug-resistant tuberculosis, HIV and more.
“We are honored to be the manufacturer of the first indigenous PCR-based diagnostic kits in India. Our team has worked tirelessly this year, ensuring the facility and procedures meet or exceed the requirements to fulfil our mandate of providing cutting-edge molecular diagnostics technology to India. The goals of the ‘Make in India’ initiative aligns perfectly with those of CoSara, and we look forward to serving not only the Indian market but to receiving the CE markings and other necessary regulatory approvals that will allow CoSara Diagnostics to expand on a global scale,” says Mohal Sarabhai, CEO of Synbiotics.
