<h1>Indian IVD Manufacturers Face Challenges in WHO Prequalification Process Despite Opportunities for Global Market Entry</h1> Indian in-vitro diagnostic (IVD) manufacturers have a unique opportunity to enter international markets through the World Health Organization's (WHO) prequalification process. This process, launched in 2010, ensures a pool of prequalified suppliers offering quality IVDs to United Nations agencies and WHO member states. However, the stringent assessment, high costs, and complex regulatory requirements pose significant challenges. Indian manufacturers, despite having quality resources, often struggle due to poor understanding and lack of regulatory expertise. Financial support and specialized consultancy services from partnerships like I3CGLOBAL and IQZYME can help navigate these challenges and achieve global compliance.