The Union Government has issued a directive stating that from now on, every organ transplantation procedure conducted in India, whether involving living or deceased donors, will be assigned a unique identifier called the National Organ and Tissue Transplant Organisation (NOTTO) ID.
This measure, mandated through the NOTTO, aims to ensure transparency and regulate the process of organ donation and transplantation across the country. This new policy is designed to eliminate illicit commercial dealings in organ transplants and improve the monitoring and accountability of transplant activities, particularly in cases involving foreign nationals.
NOTTO (National Organ and Tissue Transplant Organization) under the Directorate General of Health Services functions as the apex centre for procurement, distribution and registry of organs and tissues. NOTTO has been empowered to do this under Transplantation of Human Organs & Tissues (Amendment) Act, 2011.
ORGAN TRANSPLANTATION:
Organ donation is the process of surgically removing an organ or tissue from one person (the organ donor) and placing it into another person (the recipient).
Transplantation is necessary because the recipient's organ has failed or has been damaged by disease or injury.
India is the world's third-largest country in terms of the number of transplants performed.
In 2022, the total number of organ transplants (including both deceased and living donors) stood at 15,561. Of this, organs from deceased donors accounted for almost 17.8%.( Source: National Organ and Tissue Transplant Organization (NOTTO))
Other than near relative donor: Such a donor can donate only for the reasons of affection and attachment or for any other special reason and that too with the approval of the authorisation committee.
By swapping of near relative donors between pairs of unmatched donor and recipient
Deceased donor Transplant:
Donor after Brain stem death
Donor after cardiac death
EXISTING REGULATIONS:
Transplantation of Human Organs Act, 1994 (THOA):
The Act regulates the removal and storage of human organs, as well as the transplantation of organs for therapeutic purposes and to prevent the illicit trade of human organs.
It contains provisions relating to the authority for removal of organs, preservation of organs, registration and regulation of hospitals conducting the removal, storage or transplantation of human organs, functions of appropriate authority and punishment for offences.
Brain Stem death is recognized as a legal death in India under the Act.
The Act has been adopted in all States except erstwhile State of J&K and Andhra Pradesh which have their own legislation in this regard.
Transplantation of Human Organs (Amendment) Act, 2011
The 1994 Act was amended in 2011 to allow swapping of organs and widen the donor pool by including grandparents and grandchildren in the list.
Transplantation of Human Organs and Tissues Rules (THOT), 2014
The rules have many provisions to remove the impediments to organ donation while curbing misuse/misinterpretation of the rules.
National Organ Transplant Programme (NOTP):
Government of India is implementing NOTP to promote organ donation and transplantation across the country.
Objectives of National Organ Transplant Programme:
To organize a system of organ and Tissue procurement & distribution for transplantation
To promote deceased organ and Tissue donation
To train required manpower
To protect vulnerable poor from organ trafficking
To monitor organ and tissue transplant services and bring about policy and programme corrections/ changes whenever needed
It establishes Organ and Tissue Transplant Organizations at the national, state and regional levels
National Organ Transplantation Guidelines:
Since the significant updates in February 2023, India's National Organ Transplantation Guidelines have included several key changes to enhance the accessibility and fairness of organ transplantation across the nation:
Age Limit Removal: Individuals older than 65 years can now register to receive organs from deceased donors. This adjustment acknowledges the increasing lifespan and health needs of the elderly population.Under the previous guidelines established by the National Organ and Tissue Transplant Organization (NOTTO), patients over the age of 65 suffering from end-stage organ failure were prohibited from registering to receive an organ for transplantation.
Elimination of Domicile Requirement: Previously, patients were required to register for transplants within their state of residence, which could limit their options and extend waiting periods. The new guidelines permit patients to register in any state, thus broadening their access to available organs and potentially shortening the time they wait for a transplant.
No Registration Fees: States have been advised to remove fees associated with registering for an organ transplant. This change is aimed at lowering the financial barriers for patients needing transplants. Certain states had previously charged a fee for registration, with some asking for as much as Rs 5,000 to Rs 10,000 to register a patient on the organ recipient waitlist.
Uniform Guidelines Across States: With the introduction of the "One Nation, One Policy" approach, there is a push towards a standardized protocol for organ donation and transplantation across all states. This seeks to ensure a consistent and equitable treatment of patients nationwide.
Promotion of Cadaver Donations: The guidelines emphasize increasing organ donations from deceased donors, coupled with public awareness campaigns to encourage more people to consider organ donation.
ISSUES AND CHALLENGES:
High Burden:
The number of people requiring transplants are far higher than the number of donors.
For instance, less than 3,000 liver transplants and only 250 heart transplants were performed in 2022, despite 80,000 people requiring a liver transplant and 10,000 needing a heart transplant.
Ensuring standards:
Since organs cannot be stored, they need to be retrieved and transplanted at the earliest. However, many states lack an organized system for organ procurement from the deceased, which makes maintenance of standards in transplantation, retrieval and tissue banking difficult.
Weak Infrastructure:
There is a sheer dearth of infrastructure and logistics for transferring an organ from one spot to another, especially in the Govt. sector.
Exploitation and illicit trade:
The shortage of organs has attracted a black market in organ trade. They rely on kidnapping, trafficking of humans for transplantation and preying on the poor to sell their organs for money, while disguising the transactions as altruistic.
Poor awareness and attitude:
Many people are unaware of theconcept of Brain Stem Death and the avenues available for donation of organs. There are also a lot of myths and religious rituals surrounding death that deter people from donating the organs of a loved one. This has resulted in poor deceased organ donation rate in India.
Low rate of brain stem death certification by hospitals:
In spite of medical and legal acceptance, the concept of brain death and brain-stem death is still unclear to many. Many brain dead patients are kept on life supporting systems and their death is not promptly declared due to lack of awareness and doubts about the legal procedure of certification.
High Cost:
The cost of transplantation and post-surgery care is high and often unaffordable for the uninsured and poor patients.
Bioethical concerns:
Owing to the shortage of organs, transplantation raises several ethical questions like how the organs should be distributed, who should be prioritized etc.
Medical Integrity and Ethics:
Recent incidents, such as those in Kerala where doctors prematurely declared donors brain-dead to harvest organs, violate medical ethics.
WAY FORWARD:
Uniformity: Currently, different states have different rules, and as health is a state subject, the Centre’s rules will not be binding on the states. So, the Centre needs to consult with the states to bring them on board on this.
Promote awareness: Efforts are needed to improve the awareness about organ donation and transplantation. In this regard, it is encouraging that the Health ministry, along with the ministry of education, has prepared a chapter on organ donation that is likely to be introduced in school curriculum in future.
Assess the feasibility of opt-out system: Government should assess the possibility of implementing the opt out system in India.Under the opt out system, if adults have not confirmed whether they want to be a donor, they will be considered to be willing to donate their organs and tissue when they die, unless they choose to opt out.
Public-Private Partnerships: Enhance infrastructure by promoting collaboration between government and private healthcare facilities.
Technology Implementation: Utilize advanced technology, such as blockchain, to ensure transparency and efficiency in organ tracking.
Support Services: Provide comprehensive support including counseling and financial assistance for donors and recipients.
Legal and Ethical Enforcement: Update legal frameworks and enforce strict regulations to prevent unethical practices.
Incentives for Donors: Offer non-financial incentives such as healthcare benefits and priority in future organ receipt.
Training and Capacity Building: Invest in training for medical professionals to improve care standards and efficiency in transplants.
International Collaborations: Partner with global networks to adopt best practices and expand the donor pool.
Periodic Policy Review: Regularly review and research policies and practices to enhance the effectiveness of organ transplantation.
PRACTICE QUESTION:
Q. Examine the challenges in India's organ transplantation sector and discuss how the recent updates to the National Organ Transplantation Guidelines can address these issues. Suggest measures to enhance the effectiveness and ethics of organ transplantation in India. (15 marks, 250 words)
