Drivers and strategies to combat substandard and falsified medicines in low- and middle-income countries: A systematic review of qualitative evidence.

Substandard and falsified (SF) medicines pose a significant global public health threat, disproportionately affecting low- and middle-income countries (LMICs). While quantitative studies have documented their prevalence, a gap exists in the systematic synthesis of qualitative evidence exploring the underlying contextual, systemic, and behavioral drivers of the burden of SF medicines. A systematic review of qualitative studies was conducted. The study used PubMed and Google Scholar as databases, which were searched from June to October 30 for literature published between 2012 and 2025. The methodological quality of included studies was evaluated as per eight criteria of the Critical Appraisal Skills Program (CASP) qualitative checklist. Studies exploring drivers or mitigation strategies for SF medicines were included. Two reviewers conducted the study selection, quality appraisal, and thematic analysis. The thematic analysis in this review was conducted systematically and iteratively, following a well-established qualitative synthesis approach. After data extraction, the included studies were organized based on the review questions. Through collaborative discussion among authors, the evidence categories were refined and grouped into two overarching themes: drivers and mitigation strategies. A total of 19 studies were included. The review identified four key thematic drivers, such as market and economic drivers (profit-driven cost cutting and price arbitrage), weak regulatory and legal enforcement (inadequate oversight, corruption, and lenient penalties), complex supply chain and demand issues, and critical gaps in knowledge and perception (public and professional misconceptions, particularly regarding generic medicines). In addition, the review identified that emphasizing the need for strengthening regulatory systems, technological innovations (track and trace), public and professional education, and addressing underlying socioeconomic drivers are among the main actions used as mitigation strategies. This qualitative systematic review concluded that interconnected market pressures, weak regulation, fragile supply chains, and knowledge gaps are significant issues. Hence, effective action requires integrated policies that strengthen enforcement capacity, secure supply chains through affordable track-and-trace technologies, and launch context-specific education campaigns to combat public mistrust in quality-assured generics. These lead to translating systemic insights into practical policy implementation for medicine quality and positive public health outcomes.