Unlocking Global Markets: The Role of WHO Prequalification for Indian IVD Manufacturers

WHO Prequalification offers a strategic gateway for Indian IVD manufacturers to compete globally, with compliance challenges mitigated by partnerships like I3CGLOBAL-IQZYME. Although costly, WHO PQ ensures high-quality IVD access, enabling Indian firms to leverage it for international market success and highlight the need for governmental financial support.

Ensuring early disease diagnosis is critical for mitigating societal health impacts, with affordable in-vitro diagnostics (IVDs) playing a key role. The WHO prequalification process provides a strategic entry into global markets for Indian IVD manufacturers, offering an opportunity to amplify their international presence.

The WHO has a stringent prequalification process that has been in place since 2010. It allows only original IVD manufacturers with previously marketed IVDs to qualify, bypassing rebranded products. Mr. Sinto Poulose from IQZYME Medtech highlights the complexities and financial challenges in the process.

Governmental support is essential as costs soar, impeding many manufacturers. Partnerships, like those formed by I3CGLOBAL and IQZYME, provide crucial guidance. Their collaboration aims to assist manufacturers with dossier preparation, performance evaluation, and quality system implementation, helping them navigate WHO PQ and IVDR CE Marking efficiently.

(With inputs from agencies.)