Xenotransplantation in India: Ethical challenges, historical lessons, and future prospects

• India has no existing clinical research or regulatory policy on xenotransplantation. • Religious sensitivities toward pigs pose unique sociocultural barriers in India. • The 1997 unauthorized pig heart transplant by Dr. Baruah still influences public trust. • India's bioethics and trial approval systems are unprepared for interspecies grafts. • A context-specific roadmap is proposed for India including legal and institutional reforms. • Global advances, like China’s pig liver transplant, offer relevant models for India. • Public engagement, interfaith dialogue, and targeted policy are essential for India’s entry. India faces an acute shortfall in organ donations, with a deceased donor rate of approximately 0.5 per million population—one of the lowest globally. Xenotransplantation—the transplantation of organs or tissues across species—has re-emerged internationally as a viable solution to organ shortages, particularly with advances in genetic engineering of pigs. However, its application in India is fraught with ethical complexities, religious sensitivities, biosafety concerns, and regulatory limitations. A pivotal moment in Indian medical history occurred in 1997 when Dr. Dhaniram Baruah conducted an unauthorized pig-to-human heart transplant in Assam. The operation ended in the patient's death and raised serious ethical and legal questions, shaping the Indian public and institutional attitude toward xenotransplantation. This review examines India’s current position in the global xenotransplantation landscape by critically analyzing historical precedents, sociocultural dynamics, ethical imperatives, infrastructural readiness, and regulatory gaps. It argues for a measured and inclusive approach involving the reform of legal frameworks, scientific infrastructure development, and public engagement through culturally sensitive discourse. Drawing on international guidelines and experiences, the article proposes a detailed roadmap for India’s preparedness to responsibly embrace xenotransplantation. Ethical and scientific vigilance, alongside cross-sectoral cooperation, will be key to ensuring that this frontier of medicine serves public health without compromising safety, equity, or public trust.