India’s challenges in regulating unproven stem cell interventions: Recommendations to strengthen adverse event reporting

Abstract Stem cell interventions (SCIs) hold great promise, but there is little international scientific evidence to support their clinical use, and there are several critical issues persist that need to be resolved. However, many of these clinics operate outside the boundaries of scientific evidence and ethical standards, putting vulnerable patients at risk. India has emerged as a global hub for stem cell-based therapies due to the global surge in stem cell and regenerative therapies, but there is still a need for robust regulation. A critical component in ensuring the safety and efficacy of SCIs is the diligent reporting of adverse drug reactions (ADRs) and adverse events (AEs). Adverse event reporting is a crucial tool to mitigate the risks of unproven SCIs and ensuring their safe and effective use. This review examines the specific factors contributing to the underreporting of ADRs related to SCIs in India and suggests appropriate recommendations based on the study’s findings. Strengthening AE data collection and analysis will enable regulatory authorities to identify risks, implement safeguards, and inform healthcare professionals and the public, ultimately fostering safer, evidence-based adoption of SCIs.