Organ donation in India has considerably evolved in last 25 years since THOA was passed into a law in 1994

Dr Ravi Mohanka, Chief Surgeon and Head of Department of Liver Transplant and Hepato-Biliary Surgery at Global Hospitals, Mumbai

Organ donation in India has considerably evolved and matured in the last 25 years since the Transplantation of Human Organs Act (THOA) was passed into a law in 1994. THOA laid down the process for brain death declaration enabling organ donation from deceased people. It also laid down the criteria for living donation giving a major boost to living donor kidney and liver transplantation and prohibiting organ trading.

In an exclusive interview with Financial Express Online, Dr Ravi Mohanka, Chief Surgeon and Head of Department of Liver Transplant and Hepato-Biliary Surgery at Global Hospitals, Mumbai shares the evolving status of organ donation in India while also giving a low down on the scenario of organ donation registry in India to increase its outreach and accessibility.

How evolved is organ donation in India vis-a-vis globally?

Over the last 25 years, organ donations rates in India have increased from 0.08 PMP to 0.6 per million population (PMP), although there are large geographical variations across states. However, these are very low compared to some of the leading countries with organ donation rates of 25 to 35 PMP such as USA and Spain.

India currently performs the 2nd largest number of transplants in the world, majority of them being living donor transplants. Organ donation rates across the world are compared using organ donations per million population (PMP).

Some of the most successful organ donation programs, such as in USA, UK, Australia, and some European countries, are enabled and supported by the government and run by professionals. In India, the 2011 amendment of THOA, 1994 mandated establishing the National Organ Transplant Program (NOTP), with administrative and regulatory statuary bodies at national, regional and state levels i.e. NOTTO, ROTTO and SOTTO, respectively.

Does India have an organ donation registry?

Transplantation of Human Organs (Amendment) Act (THOTA – 2011) which came into force on January 10, 2014 mandated establishing making a government sponsored and run organ donation registry.

National Organ and Tissue Transplant Organisation (NOTTO) maintains a pledge registry on its website (in addition to the NGOs). The same could be done in conjunction with vital identity documents such as the driving license, Aadhaar card or PAN card, one of which is always carried by most people, making them available at the time of death. Doctors and hospitals should be given secure access to the registry to enable verification of the organ donation pledge status of any individual.

Each State Organ and Tissue Transplant Organisation (SOTTO) (and their NGO partners) maintain a registry of patients waiting for a deceased donor transplant, which is used for organ allocation locally. A national waiting list could be maintained and used by various SOTTOs for organ allocation.

Each transplant hospital is mandated to send a monthly report of number of organ donations and transplants (both deceased donor and living donor transplants) to DHS. This could be complied into a registry to probably form the most accurate registry of the number of transplants. NOTTO and Directorate of Health Services (DHS) in different states also collect outcome data (survival, rejection, etc.) from transplant hospitals at variable frequencies using variable formats in different states. If the data collection formats and frequency of outcome data collection could be standardized and mandated, with a penalty clause for non-compliance or falsification, it may help establish a robust outcome registry.

What kinds of organ donations are successful in India?

Living donations i.e. one kidney or a part of the liver enable about 70% of transplants in India. The success of these transplants is at par with international standards. India is therefore fast becoming a hub for ethical transplant tourism.

Each deceased donation allows about 8 life-saving organ donations and donations of many tissues. Most commonly donations are kidney and liver, followed by heart and lungs (as the donor selection criteria for them are more stringent) and less commonly pancreas, intestines and hands.Tissue donations such as cornea, bones and skin are also uncommon.

What are government and private players’ interventions in helping organ donations in India?

The government has launched the National Organ Transplant Programme (NOTP) NOTP and setup NOTTO, ROTTO and SOTTO, which in turn collaborate with state level NGOs to enable various registries, training programs, organ retrievals and transplants. NOTTO coordinates inter-state organ sharing.

Directorate of Health Services (DHS) is responsible for registration and regulation of transplant centres. Directorate of Medical Education and Research (DMER) is responsible for scrutiny and approval of each living donor transplant. Mostly NGOs, have taken initiatives for organ donation awareness amongst public and professionals, prominent ones being MOHAN foundation, DONATE Life and others

State level NGOs have been authorized by the respective SOTTO which maintain waiting list and allocate organs for deceased donor transplants e.g. ZTCC in Mumbai, TRANSTAN in Tamil Nadu, JeevanDan in Telangana and ZCCK in Karnataka among others.

How is the regulatory and legal scenario? Who are the stakeholders?

Transplants in India are regulated as per THOA, 1994 with THOTA 2011 amendment and rules published in 1995 and 2014. Registration, renewal and deregistration of hospitals for transplant is done by the Directorate of Health Services (DHS) which has the powers of a civil court in these matters. Living donor approvals are done by the Authorization Committee chaired by the DMER. NOTTO with its network of ROTTOs and SOTTOs is responsible for deceased organ donation, waiting list maintenance and organ allocation, which is most commonly done by them either directly or in partnership with local NGOs. The penalties for any act of organ trading are fines upto 5 crores with jail and cancellation of licence for doctors.