Global Expansion Strategy of Plasma-Derived Medicine Products Supply through Changes in India's Plasma Management System

Abstract

This research explores strategies to improve India's plasma management system and, consequently, expands the supply of plasma-derived medicine products on an international scale. With a population of 1.43 billion as of 2022, India holds the highest potential globally to significantly alleviate the shortage of plasma-derived medicines by enhancing its plasma management system. Therefore, India's policies and current status in plasma management play a crucial role in the global plasma-derived medicine industry. Efficient operation of the plasma collection and management system, the primary raw material for this industry, is imperative for its sustained growth. This research provides a comprehensive analysis of India's plasma management system, exploring regulatory frameworks, economic capacities, and healthcare dynamics. Through a SWOT analysis, the research identified the system's strengths, weaknesses, opportunities, and threats. Regulatory constraints, such as export limitations and the absence of mandatory Nucleic Acid Testing (NAT), pose hurdles to international collaboration, demanding a delicate balance between safety measures and economic considerations. Economic challenges, including budget constraints and healthcare expenditure disparities, highlight the need for strategic planning and collaboration with foreign entities. India's plasma fractionation capacity falls significantly short of the EU's, necessitating strategic alliances and addressing deficiencies in the plasma management system, notably the absence of mandatory NAT. The health insurance system in India faces challenges in supporting plasma-derived medicine products due to the limited budget. For example, balancing the allocation of resources between rare diseases and prevalent health concerns emerges as a critical consideration. In response, this research proposes collaborative strategies to enhance plasma collection centers and strengthen India's health insurance system through partnerships with foreign companies. In recommendations from this research, focusing on the establishment of collaborative plasma collection centers and collaboration to strengthen India's health insurance, aim to navigate regulatory complexities, overcome economic barriers, and enhance healthcare infrastructure. If implemented, these strategies are anticipated to foster successful collaboration between foreign companies and the Indian government, meeting global demand for plasma-derived medicine products sustainably and ethically.