India Pharma Outlook Team | Friday, 30 January 2026
Healthcare major Cupid Limited has reached a major regulatory milestone after securing CE certification for its CupiKIT HIV 1&2 Antibody Test Kit and CupiKIT Hepatitis B Surface Antigen (HBsAg) Test Kit, marking a significant step in its global diagnostics expansion.
The certification is awarded according to the European Union In Vitro Diagnostic Regulation (EU 2017/746), which is one of the most effective regulatory frameworks in the world.
Using this authorization, Cupid CE certification enables the company to sell these diagnostic kits commercially to the European Economic Area (EEA), and other international markets that are recognized by the CE, which enhances its presence internationally.
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“These approvals expand our access to regulated international markets and enhance our ability to participate in large-scale screening and public health programs,” said Aditya Kumar Halwasiya, Chairman & Managing Director of Cupid Limited.
“The CE (EU IVDR) certification for our HIV 1&2 and Hepatitis B test kits is a meaningful step in strengthening our global diagnostics business. We continue to focus on building a reliable and affordable diagnostics portfolio while scaling our presence across key global regions to address growing healthcare needs.”
The new certified kits are tailored in supporting early diagnosis and mass screening programs particularly those that are under the public health programs and institutional purchase programs. Cupid CE certification will allow the company to enter the government tenders, multilateral agency programs, and controlled supply chains in healthcare where EU IVDR compliance is required.
The development supports the fact that Cupid Limited has become an innovative healthcare and diagnostics company. It also supplements its known maternal health and screening solutions and broaden its role in infectious disease diagnostics in Europe, Africa and other emerging markets of the world.