THOTA: India’s transplant law and its 2014 Rules

India’s transplant law and the THO Rules 2014 explained for foreign patients: near relatives, embassy Form 21, authorisation committees and payment bans.

Glossary term · Law & regulation

By Nikhil Sharma, Founder · Updated · How we write and check

Definition

Transplantation of Human Organs and Tissues Act (THOTA) (also: THOTA, THOA, Transplantation of Human Organs Act 1994, THO Rules 2014): THOTA is used here for India’s Transplantation of Human Organs Act 1994 and the Transplantation of Human Organs and Tissues Rules 2014 made under it.

India regulates organ transplants through the Transplantation of Human Organs Act 1994 and the Transplantation of Human Organs and Tissues Rules 2014. This page uses THOTA for both. For foreign patients the key points are simple. Living donation is allowed only from a near relative. The embassy certifies the relationship on Form 21. A hospital authorisation committee approves each case.

What does the law cover?

  • Who may donate and receive, and how relationships are proved.
  • Authorisation committees and how they decide.
  • Brain-stem death certification.
  • Registration of transplant hospitals, valid for five years.
  • Allocation of deceased-donor organs.

Key rules for foreign nationals

  • Transplants where the recipient is foreign and the donor is Indian are not permitted unless they are near relatives.
  • A senior embassy official of the country of origin must certify the relationship.
  • Cases of Indian donors consenting to donate to a foreign national are examined with extra care.
  • All cases involving a foreign donor or recipient go to the authorisation committee.

Safeguards against trade in organs

The Rules require the committee to confirm there is no commercial transaction between recipient and donor, no payment made or promised to the donor and no middleman or tout. Interviews are recorded on video.

What hospitals must have

Registered transplant centres must appoint a transplant coordinator and have HLA matching facilities. Hospital registration certificates are issued on Form 16.

Our position

IndiaMedica follows THOTA fully. We never source donors. We help families prepare documents and understand the process.

Questions people ask

Is the Act called THOA or THOTA?

The 2014 Rules refer to their parent law as the Transplantation of Human Organs Act 1994. The Rules themselves are titled the Transplantation of Human Organs and Tissues Rules 2014. You may see THOA, THOTA or THO Rules used for the same framework.

Where can I read the Rules?

The Rules are published by the Government of India. NOTTO, the national transplant body, provides information on organ donation. A transplant hospital’s coordinator can also explain which forms apply to your case.

Sources

General information, not medical or legal advice. Rules change: confirm with the official source. How we write and check.

More glossary

ART (Regulation) Act 2021

The ART (Regulation) Act 2021 is India’s law requiring registration of assisted reproduction clinics and banks and setting rules on consent, donors, embryos and sex selection.

Deceased organ donation

Deceased organ donation is the donation of organs after death, including after brain-stem death certified by a board of medical experts.

Digital Personal Data Protection Act 2023

The DPDP Act 2023 is India’s law governing how digital personal data is processed, setting consent rules, individual rights and duties for organisations that handle data.

Form 21 (transplant)

Form 21 is the certificate of relationship between donor and recipient in the case of foreigners, required under India’s Transplantation of Human Organs and Tissues Rules 2014.

Hospital authorisation committee

A hospital authorisation committee is the body set up under India’s THO Rules 2014 to approve or reject living-donor transplant applications.

Living organ donor

A living organ donor is a person who gives an organ, such as a kidney or part of the liver, while alive.

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