Medication Safety in India and Southeast Asia: A SWOT Analysis of Policies and Practices.

Abstract

Medication safety is a critical component of patient care, yet fragmented regulations, under-reporting of adverse events, and resource constraints continue to pose risks in India and Southeast Asia. Addressing these challenges requires system-level interventions supported by robust policies and technology-driven solutions. This review analyzes medication safety frameworks in India and World Health Organization South-East Asia Region countries using a Strengths, Weaknesses, Opportunities, and Threats (SWOT) approach, identifying internal strengths and weaknesses alongside external opportunities and threats. The goal is to propose strategic actions that enhance regulatory oversight, capacity building, health-system resilience, and hospital-level practices. A comparative narrative review of national regulations, World Health Organization and Association of Southeast Asian Nations frameworks, policy documents, and published literature was conducted. Recurring themes were consolidated into four domains such as regulatory systems, health-system strengthening, workforce capacity building, and hospital-level strategies and synthesized using a SWOT-based analytical approach to identify shared gaps, contextual differences, and strategic priorities across India and South-East Asia Region countries. The SWOT analysis across four domains revealed shared patterns between India and World Health Organization South-East Asia Region countries. Regulatory frameworks show strong institutional structures in India and Association of Southeast Asian Nations Good Manufacturing Practices harmonization, but both lack centralized drug registries and face under-reporting of adverse events. Capacity building benefits from professional networks, yet rural workforce shortages and inconsistent training persist region wide. Health systems leverage multi-tiered structures and national programs, but fragmentation and weak digital infrastructure hinder medication error reporting. At the hospital level, limited resources, staff resistance, and complex policies restrict adoption of electronic health records and safety technologies. Opportunities include harmonizing Good Manufacturing Practice standards, scaling accreditation, and deploying digital tools, while threats such as counterfeit medicines, antimicrobial resistance, and punitive reporting cultures remain significant. Strategic priorities include establishing centralized drug registries, enforcing prescription-only rules, implementing QR codes for high-risk medicines, and promoting blame-free reporting. Medium-term actions involve expanding digital health solutions, integrating medication safety into curricula, and scaling accreditation. Long-term goals focus on regional harmonization, collaborative research, and cultural transformation toward safety. Leveraging India's regulatory strengths and lessons learned can accelerate medication safety improvements across Southeast.