Acts & Rules

Transplantation of Human Organs Act, 1994

The Transplantation of Human Organs Act (THOA), 1994 is the principal legislation governing the removal, storage and transplantation of human organs in India. It provides for the regulation of transplantation for therapeutic purposes and prohibits commercial dealings in human organs.

What the Act establishes

• Legal recognition of brain-stem death, and the procedure by which it must be certified by a board of medical experts
• Who may authorise the removal of organs — the donor during their lifetime, or the person lawfully in possession of the body
• Rules governing living donation, including the relationship categories permitted without additional approval
• Requirement for hospitals performing transplantation to be registered
• Prohibition of any commercial dealing in human organs, with defined penalties
• Constitution of Authorisation Committees and Appropriate Authorities to oversee approvals and compliance

The 2011 Amendment

The Act was amended in 2011 to broaden and strengthen the framework. The amendment extended the scope to tissues as well as organs, widened the definition of near relatives, provided for swap donation where a direct donor is incompatible, mandated the appointment of transplant coordinators in registered hospitals, introduced a requirement to enquire about donation in cases of brain-stem death, strengthened penalties for commercial dealing, and provided for a national registry and network.

Transplantation of Human Organs and Tissues Rules, 2014

The 2014 Rules set out the operational detail under the Act — the forms to be used for consent and authorisation, the composition and procedure of Authorisation Committees, the criteria and procedure for certifying brain-stem death, the standards required for hospital registration, the duties of transplant coordinators, and the structure of the national and state networks.

• Prescribed forms for donor consent, near-relative authorisation and brain-stem death certification
• Procedure and timelines for Authorisation Committee approval
• Composition of the board of medical experts certifying brain-stem death
• Registration requirements and standards for transplant hospitals
• Duties of transplant coordinators and requirement to counsel families
• Framework for NOTTO, ROTTO and SOTTO and for organ allocation and sharing

NOTTO, ROTTO and SOTTO

NOTTO

The National Organ and Tissue Transplant Organisation is the apex body under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. It coordinates procurement and distribution nationally, maintains the national registry of donors and recipients, sets networking and allocation policy, and operates the official donor pledge registry.

ROTTO

Regional Organ and Tissue Transplant Organisations coordinate across groups of states within a designated region and report to NOTTO.

SOTTO

State Organ and Tissue Transplant Organisations coordinate donation and transplantation within a state — registering hospitals and transplant centres, maintaining the state waiting list, and working with NOTTO when organs are shared across states. Members of SOTTO Odisha attended Sankalp, our launch programme.

What this means for you

• Pledging is free, voluntary and can be withdrawn at any time.
• A pledge records your intention. Your family will still be consulted at the time, which is why telling them matters.
• Buying or selling organs is a criminal offence. No legitimate transplant involves payment to a donor.
• Only registered hospitals may perform transplantation.
• Brain-stem death must be certified by a board of medical experts following the prescribed procedure.