Cells, tissues, and vigilance: navigating the complex landscape of biovigilance in India.

Biovigilance plays a crucial role in healthcare safety by monitoring and managing medical products of human origin (MPHO) to protect patient health. Initially centred on blood safety, known as haemovigilance, biovigilance has grown to cover a wide range of biological products, including tissues, organs, and cell-based therapies. The World Health Organization (WHO) has been a key in developing international standards and advocating for best practices in biovigilance. At a national level, programs such as India's Haemovigilance Programme (HvPI) work to increase transparency and improve reporting of adverse reactions. Today, biovigilance functions as an integrated safety system addressing ethical, regulatory, and clinical challenges linked to human-derived medical products, thus promoting safer global healthcare practices. This review presents a comprehensive overview of biovigilance, detailing its historical development, core areas, and current practices. Key initiatives, like the HvPI and Project Notify, exemplify effective approaches to adverse reaction monitoring and foster transparency in healthcare. Through these frameworks, biovigilance enhances patient safety, ensuring a more secure and trustworthy healthcare delivery worldwide.