Some years ago, a patient with a failed liver was given a genetically modified liver of a pig. The patient passed away after 171 days. However, the case held out the promise of extended survival rates. The cross-species organ transplantation — xenotransplantation — was discussed in a paper published in the Journal of Hepatology.
Research into xenotransplantation holds hope for patients who require transplants but have too few human donor options. India faces a severe crisis in organ availability.
More than half a million people are estimated to need organ transplantation annually. However, the country has one of the lowest rates of deceased donors globally — about 0.5 per million population.
Xenotransplantation is seen as one way to solve organ shortages.
Advances in the genetic engineering of pigs have made this process more feasible internationally.
In another paper, published in the journal Transplantation Reports and titled ‘Xenotransplantation in India: Ethical challenges, historical lessons, and future prospects’, the authors (Soumyadip Sain and Trisha Chattoraj) highlight examples of US surgeons who successfully implanted gene-edited pig kidneys into patients. China has also performed a gene-edited pig liver transplant.
They point out that India’s context is unique due to a historical event that continues to influence public trust. In January 1997, Dr Dhaniram Baruah attempted a pig-to-human heart transplant in Assam. The recipient, a 32-year-old man, died within a week due to organ failure.
This transplant was unauthorised. It lacked ethical approval, governmental authorisation, and institutional oversight. Dr Baruah was arrested under the Transplantation of Human Organs and Tissues Act (THOTA), 1994, and his licence was later revoked. This episode established xenotransplantation in the Indian public consciousness as ‘controversial’.
Missing policy
India has no existing clinical research or regulatory policy on transplantation of organs from animals to humans. THOTA, too, does not address cross-species transplants.
Neither the Central Drugs Standard Control Organisation (CDSCO) nor the Indian Council of Medical Research (ICMR) have published any related guidelines, unlike their US and European counterparts.
The paper also points to India’s lack of regulatory preparedness for interspecies grafts, and the absence of a national registry to enable follow-ups on xenograft recipients or track long-term outcomes, which are critical to estimate safety for prospective patients. A new ‘Xenotransplantation Act’ or major amendments to THOTA are needed to address these gaps.
The use of animal, particularly pig, organs poses significant challenges in India’s multi-religious society. While some Indians could consider xenografts unacceptable due to religious beliefs, others could view porcine sources as unclean, not to mention viewing the killing of animals for organ transplant as an act of violence. Introducing pig organs into clinical use requires transparent communication and careful religious consultation.
Reinforcing equity
Critical, and as a prerequisite to cross-species transplants, are trials that help estimate efficacy.
The paper asserts that India lacks the infrastructure to begin trials. Currently, the country does not have ‘specific pathogen-free’ (SPF) pig colonies, which are essential for xenograft suitability. “Establishing these colonies requires extensive bio-secure facilities and specialised genetic engineering capabilities.”
Xenotransplantation could also prove expensive — $300,000 to $1 million per organ, according to US estimates. In India, where more than 70 per cent of health expenditure is out of pocket, this technology risks widening existing healthcare inequities.
The authors argue that, to move forward, India needs to fund SPF animal facilities, establish dedicated research centres, and initiate a public dialogue involving religious scholars and ethicists. The country, they say, must also establish centralised ethical oversight and incorporate xenotransplantation in the ICMR’s priority research agenda.
As important and urgent would be the establishment of a legal framework addressing animal rights, zoonotic risk, and trial safety; centralised ethical oversight panels and biosafety committees; and fast-track research pathways within ICMR and CDSCO.
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Published on November 17, 2025