In January 1997, at a small cardiac clinic in Sonapur, Assam, an ambitious Indian surgeon performed what he described as the first pig-to-human heart transplant. The patient, Purno Saikia, was a critically ill heart patient who had exhausted all conventional options. Dhaniram Baruah, a cardiac surgeon from Assam, completed the 15-hour surgery. Although the surgery was initially deemed successful, the patient passed away after seven days due to acute organ rejection.

Outrage followed. The transplant was performed without any prior approval or ethical oversight. Assam police arrested the surgeon on charges of culpable homicide and violations of the Transplantation of Human Organs and Tissues Act, 1994. He spent 40 days in jail before being released on bail. Protestors vandalised Baruah’s clinic, and a government committee condemned the transplant as unethical and unlawful.

This dramatic incident marked India’s first encounter with xenotransplantation, the transplantation of animal organs into humans. More importantly, it was a pivotal moment that highlighted gaps in India’s legal and regulatory frameworks for emerging biotechnologies. In the absence of a dedicated legal framework, authorities stretched the existing transplantation law and criminal laws to address this crisis. 

Xenotransplantation comes of age

Nearly three decades later, xenotransplantation is no longer a fringe experiment but an advancing clinical reality. 

Advances in genome-editing technologies, especially the development of CRISPR-Cas9, have made genome editing easier, more effective, and more economical. Scientists now edit donor animals’ DNA by switching off genes that trigger human immune rejection and reducing the risk of transmitting animal-borne viruses.

Since 2020, there have been multiple transplants of genetically altered pig kidneys, hearts and even lungs into humans. In 2022, a genetically edited pig heart was transplanted into a human. Although the heart only functioned for a few weeks, it demonstrated feasibility in human patients. 

The year 2025 saw significant developments in xenotransplantation. Scientists in China transplanted genetically modified pig lungs to a brain-dead human, who survived for nine days, showcasing viability. A United States national lived with a genetically altered kidney for 271 days before requiring dialysis, and a woman in China survived for 261 days before her body rejected it. Scientists now believe that patients’ survival durations may continue to extend.

Today, xenotransplantation is not limited to organ transplants. It also includes the use of animal skin grafts and pig heart valves as replacements for human heart valves.

This shift from an experimental option to a viable lifesaving procedure puts pressure on legislation worldwide, including India.

Organ scarcity, xenografts, and India’s regulatory shortcuts.

Xenotransplantation’s appeal lies in its potential as an alternative to human organ transplantation. India faces a high demand for organ transplants, with its organ donation rate being 0.86 per million population. Studies estimate that only 2 — 3 per cent of demand is met in the country. For thousands of patients, genetically modified animal organs could represent a new practical solution. 

While this shortage strengthens the case for alternative sources, India has taken a precautionary stand in the regulation and research of xenotransplantation. The country has not put in place any dedicated framework for the technology. Xenotransplantation was briefly addressed in the ICMR’s Ethical Guidelines for Biomedical Research on Human Participants, 2007. The guideline discussed the ethical and medical issues associated with the technology. It permitted only animal-to-animal experimental transplantation at the existing level of knowledge, while tasking ethics and advisory committees to oversee the experiments. However, the 2017 updated guidelines omit any reference to xenotransplantation.

India’s primary transplant legislation, the Transplantation of Human Organs and Tissues Act (THOTA), 1994, is similarly limited. It regulates only human-to-human transplantation and focuses on allocation ethics, prohibition of commercial organ trade and consent. It does not offer any meaningful tools to address issues arising from animal-to-human organ transplantation.

India’s drug law approach to xenografts

In the absence of a dedicated framework, India has attempted to govern xenografts through its drug approval régime. The New Drugs and Clinical Trials Rules, 2019 have categorised ​“xenografts intended for use as drugs” as a ​“New Drug”, thus subjecting them to rigorous clinical trial and approval processes. 

In October 2025, the government proposed a draft amendment to the Drugs and Cosmetics Rules, 1945. The amendments would add xenografts to its licensing and regulatory provisions. These Rules, along with the Drugs and Cosmetics Act of 1940, govern the manufacture, sale, and licensing of drugs. The proposed amendments seek to extend regulatory control beyond trials to market-stage production and commercialisation, which can be read as an indication that the government expects the technology to enter the market. 

The conceptual problem that arises in regulating xenotransplantation through drug laws is whether xenografts can appropriately be classified as drugs. On a literal reading, certain xenotransplantation procedures, especially skin grafts, can fall within the definition of drugs because they are therapeutic and alter bodily functions. However, this approach is conceptually strained when applied to organ transplantation. Entire organs like the heart and kidneys cannot be coherently categorised as ​‘drugs’.

Retrofitting this new technology into an existing régime provides a provisional regulatory pathway. However, this framework was originally designed for pharmaceutical drugs and is ill-equipped to address the novel challenges associated with interspecies organ transplantation, which involves the use of adaptive living organs.

What should xenotransplantation guidelines address?

The World Health Organisation (WHO) has adopted multiple resolutions regarding xenotransplantation. At the 57^th World Health Assembly in 2004, Resolution WHA57.18 called on member states to establish national regulatory mechanisms for xenogeneic transplantation. It also called for international cooperation in developing standards to mitigate the risks of secondary transmission of xenogeneic infections.

Like any new technology, xenotransplantation is accompanied by challenges unique to it. Primarily, xenotransplantation risks cross-species pathogen transmission, which may emerge even years after transplantation. This is categorised as a public health risk associated with the technology since the pathogen can transform into an infectious disease affecting third parties. 

Another major issue concerns animal governance. Safety in xenotransplantation is significantly enhanced by careful donor selection. Donor herds must undergo continuous pathogen monitoring and viral genome sequencing to detect emerging infections.

From an animal rights perspective, the country’s existing norms governing the use of animals are not designed to accommodate xenotransplantation. The process requires long-term breeding alongside genetic modification, raising ethical concerns. The issue of using animals as expendable sources of organs must also be addressed. A dedicated law should align with the Prevention of Cruelty against Animals Act, and incorporate the norms issued by the Committee for the Purpose of Control and Supervision of Experiments on Animals, while taking into account the requirements of xenotransplantation.

Having specific guidelines for new biotechnologies is a regulatory logic that India has followed in the past as well. ICMR guidelines for stem cell research, as well as guidelines for gene therapy product development, reflect this approach. 

Animal-to-human organ transplant is no longer science fiction; it is moving steadily towards clinical reality. Recent trials show patients surviving longer with gene-edited pig organs, yet India continues to rely on a patchwork of regulations rather than developing a dedicated, forward-looking framework. So, the question is no longer whether the technology will arrive in India, but whether India’s legal system will be ready when that moment arrives.