Organ & Tissue Transplant- Policies, Technologies, etc.
Kidney Transplants in India: Law, Demand and Alleged Rackets
Note4Students
From UPSC perspective, the following things are important :
Prelims level: Transplantation of Human Organs and Tissues Act, 1994
Mains level: Read the attached story
Central Idea
- The government has initiated an investigation into allegations that poor villagers from Myanmar were coerced into selling their kidneys to wealthy patients, with Delhi’s Apollo hospital implicated in the scheme.
India’s Transplant Law and Kidney Scams
- India’s Transplantation Law: The Transplantation of Human Organs and Tissues Act, 1994, in India allows organ donations from living persons, primarily close relatives, and deceased donors.
- Curb on organ trade: It strictly prohibits organ trade to prevent exploitation of the poor.
- Previous Allegations: This isn’t the first instance of alleged kidney scams in India, with most rackets reportedly using forged documents to establish fake donor-recipient relationships.
Procedure for Legal Transplants
- Documentation for Close Relatives: For living donations involving close relatives, both Indian and foreign nationals must submit identity proofs, family trees, relationship evidence, and financial status documents.
- Scrutiny for Unrelated Donors: Donations from non-relatives require additional evidence of long-term association and undergo rigorous examination by an external committee to prevent illegal transactions.
- Penalties for Illegal Organ Trade: The law imposes severe punishments, including imprisonment and hefty fines, for any involvement in organ trade or related illegal activities.
Kidney Transplants: High Demand and Target for Illegal Trade
- High Demand: Approximately 2 lakh Indians annually reach end-stage kidney failure, necessitating transplants or dialysis, but only about 12,000 transplants occur each year.
- Low Risk and Accessibility: Kidney transplants pose the least risk to donors and are relatively affordable and widely available in India, making kidneys a common target for illegal trade.
- Organ Viability: Kidneys can survive outside the body for 24-36 hours, longer than lungs or liver, increasing their viability for transplants.
Addressing the Organ Supply Gap
- Promoting Deceased Donations: Increasing awareness and promoting donations from brain-dead individuals can significantly enhance the organ pool.
- Government Initiatives: The government has introduced an Aadhaar-linked donor registry to encourage deceased donations, which currently constitute only 16% of total transplants in India.
- Reducing Transplant Necessity: Efforts are also needed to decrease the number of people requiring organ transplants.
Conclusion
- Combating Illegal Organ Trade: The ongoing investigation into the alleged kidney racket highlights the need for stringent vigilance and adherence to legal procedures in organ transplants.
- Enhancing Legal Organ Donation: Increasing public awareness and promoting legal avenues for organ donation are crucial steps in addressing the organ supply-demand gap and preventing exploitation in organ trade.
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Organ & Tissue Transplant- Policies, Technologies, etc.
Govt. to release Manual for Organ Donation & Transplantation
Note4Students
From UPSC perspective, the following things are important :
Prelims level: NOTTO
Mains level: Liberalizing organ transplant rules in India
Central Idea: The National Organ and Tissue Transplant Organisation (NOTTO) is working on a transplant manual as a step-by-step guide for the implementation of organ donation and transplantation programmes in hospitals and a standard course for training transplant coordinators.
Organ transplant in India: Key statistics
- According to data accessed from the Health Ministry, the number of organ transplants has increased by over three times from 4,990 in 2013 to 15,561 in 2022.
- Of the 15,561 transplants, a majority — 12,791 (82%) — are from live donors and 2,765 (18%) are from cadavers (the dead).
- Up to 11,423 of the 15,561 organ transplants are for the kidney, followed by liver (766), heart (250), lung (138), pancreas (24) and small bowel transplants (3).
- Most of these transplants occur in private hospitals, the numbers in government hospitals are relatively lower.
About National Organ Transplant Programme (NOTP)
- In 2019, the GoI implemented the NOTP for promoting deceased organ donation.
- Organ donation in India is regulated by the Transplantation of Human Organs and Tissues Act, 1994.
Types of Organ Donations
- The law allows both deceased and living donors to donate their organs.
- It also identifies brain death as a form of death.
- Living donors must be over 18 years of age and are limited to donating only to their immediate blood relatives or, in some special cases, out of affection and attachment towards the recipient.
(1) Deceased donors:
- They may donate six life-saving organs: kidneys, liver, heart, lungs, pancreas, and intestine.
- Uterus transplant is also performed, but it is not regarded as a life-saving organ.
- Organs and tissues from a person declared legally dead can be donated after consent from the family has been obtained.
- Brainstem death is also recognized as a form of death in India, as in many other countries.
- After a natural cardiac death, organs that can be donated are cornea, bone, skin, and blood vessels, whereas after brainstem death about 37 different organs and tissues can be donated, including the above six life-saving organs
(2) Living donors:
They are permitted to donate the following:
- one of their kidneys
- portion of pancreas
- part of the liver
Features of the NOTP
- Under the NOTP a National Level Tissue Bank (Biomaterial Centre) for storing tissues has been established at National Organ and Tissue Transplant Organization (NOTTO), New Delhi.
- Further, under the NOTP, a provision has also been made for providing financial support to the States for setting up of Bio-material centre.
- As of now a Regional Bio-material centre has been established at Regional Organ and Tissue Transplant Organization (ROTTO), Chennai, Tamil Nadu.
More moves for facilitation: Green Corridors
- Studies have suggested that the chances of transplantation being successful are enhanced by reducing the time delay between harvest and transplant of the organ.
- Therefore, the transportation of the organ is a critical factor. For this purpose, “green corridors” have been created in many parts of India.
- A “green corridor” refers to a route that is cleared out for an ambulance carrying the harvested organs to ensure its delivery at the destination in the shortest time possible.
Recent amendments
(1) No Age Bar
- Now an individual of any age can register for organ transplant.
- People beyond 65 years in need of an organ donation will also be eligible to get one.
- The government has decided to do away with a clause in the National Organ and Tissue Transplant Organisation (NOTTO) guidelines as the clause violates the Right to Life.
(2) Doing away with domicile compulsion
- Earlier an organ recipient could register for a prospective transplant in domicile State.
- States like Gujarat had made it mandatory for registered patients to furnish a domicile certificate to be eligible for a transplant.
- In November last year, the Gujarat High Court quashed the discriminatory policy of the State government.
About NOTTO
National Organ and Tissue Transplant Organization (NOTTO) is a national level organization set up under the Directorate General of Health Services, Ministry of Health and Family Welfare.
- National Human Organ and Tissue Removal and Storage Network
- National Biomaterial Centre (National Tissue Bank)
[I] National Human Organ and Tissue Removal and Storage Network
- This has been mandated as per the Transplantation of Human Organs (Amendment) Act 2011.
- The network will be established initially for Delhi and gradually expanded to include other States and Regions of the country.
- Thus, this division of the NOTTO is the nodal networking agency for Delhi and shall network for Procurement Allocation and Distribution of Organs and Tissues in Delhi.
- It functions as apex centre for All India activities of coordination and networking for procurement and distribution of Organs and Tissues and registry of Organs and Tissues Donation and Transplantation in the country.
[II] National Biomaterial Centre (National Tissue Bank)
- The Transplantation of Human Organs (Amendment) Act 2011 has included the component of tissue donation and registration of tissue Banks.
- It becomes imperative under the changed circumstances to establish National level Tissue Bank to fulfill the demands of tissue transplantation including activities for procurement, storage and fulfil distribution of biomaterials.
- The main thrust & objective of establishing the centre is to fill up the gap between ‘Demand’ and ‘Supply’ as well as ‘Quality Assurance’ in the availability of various tissues.
The centre will take care of the following Tissue allografts:
- Bone and bone products
- Skin graft
- Cornea
- Heart valves and vessels
Various issues involved
- Lack of awareness: Lack of awareness leads to myths and misconceptions about organ donation, which further discourages people from donating organs.
- Religious and cultural beliefs: Some religious and cultural beliefs view organ donation as a desecration of the body, which hinders organ donation.
- Lack of infrastructure: India faces a shortage of medical infrastructure and facilities for organ donation.
- Legal and regulatory challenges: India’s organ donation system is heavily regulated by the Transplantation of Human Organs and Tissues Act, 1994.
- Socioeconomic factors: Poverty and lack of education can lead to reduced access to information and medical services, making it difficult for people to donate organs.
- Organized crime: Organized criminal networks involved in organ trafficking and commercialization also create challenges for organ donation in India.
- Stigma and Discrimination: Stigma against organ recipients, particularly those who receive transplants from other communities or castes, is also a challenge in promoting organ donation in India.
Way forward
- Developing a National Organ and Tissue Donation Registry: The registry could maintain a database of donors and recipients, along with their medical history and compatibility information.
- Setting up Mobile Organ Donation Units: These units could be equipped with medical personnel and equipment to conduct donation procedures in remote areas.
- Crowdfunding for Organ Transplant Surgeries: This could be used as a means to raise funds for organ transplant surgeries, especially for underprivileged individuals who cannot afford the cost of treatment.
- Promoting Living Donor Transplants: Living donor transplants can help increase the number of organs available for transplantation.
- Incentivizing for Organ Donation: Incentives could be introduced to encourage more people to donate organs. This could include tax breaks, priority access to medical treatment, and other benefits.
- Leveraging Technology: Technology could be used to develop better donor and recipient matching algorithms, create virtual waiting lists, and streamline the donation and transplantation process.
- International Collaboration: India could collaborate with other countries to share best practices, leverage technology, and develop new approaches to organ donation and transplantation.
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Organ & Tissue Transplant- Policies, Technologies, etc.
Organ on a chip: New setup for lab testing
Note4Students
From UPSC perspective, the following things are important :
Prelims level: Organ as a chip
Mains level: Not Much
Central idea: Organ-on-a-chip technology has emerged as a new laboratory setup that scientists are using instead of animals to test new drugs.
What is Organ-on-a-Chip?
- Organ-on-a-chip is a microfluidic device that aims to mimic the structure and function of specific human organs or tissues in vitro.
- It is a small, transparent chip made of biocompatible materials such as silicon, glass, or polymers, and contains tiny channels lined with living cells.
- The living cells are derived from human tissues and can be cultured to replicate the microenvironment of the specific organ being modelled.
How does Organ-on-a-Chip work?
- Microfluidic channels simulation: Each organ-on-a-chip contains a complex network of microfluidic channels and chambers that can simulate the mechanical and chemical environment of a specific organ.
- Mimics the blood flow: The microfluidic channels can mimic the flow of blood and air, while the living cells provide a realistic environment for drug testing and disease modelling.
Potential applications of organ-on-a-chip
- Organ-on-a-chip technology has numerous potential applications, including drug development, disease modelling, and toxicity testing.
- By replicating the structure and function of human organs, researchers can study how organs interact with drugs and other compounds.
- This could lead to the development of more effective and personalized treatments for a variety of diseases.
- Additionally, organ-on-a-chip technology provides a more ethical and effective approach to testing drugs and other compounds, reducing the reliance on animal testing.
Examples of Organ-on-a-Chip
Several examples of organ-on-a-chip technology have been developed, including-
- Lung-on-a-chip mimics the air-blood interface in the lungs
- Heart-on-a-chip mimics the mechanical and electrical properties of the heart
- Liver-on-a-chip replicates the metabolic activity of the liver
- Brain-on-a-chip models the blood-brain barrier and neural activity in the brain
Future prospects
- Organ-on-a-chip technology is a promising and rapidly evolving field that offers numerous advantages over traditional drug development and testing methods.
- It provides a more ethical and effective approach to testing drugs and other compounds, reducing the reliance on animal testing.
- Furthermore, it has the potential to revolutionize the field of drug development by enabling more personalized and effective treatments for a variety of diseases.
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Organ & Tissue Transplant- Policies, Technologies, etc.
Organ transplant rules In India: A Significant Step
Note4Students
From UPSC perspective, the following things are important :
Prelims level: NA
Mains level: Liberalizing organ transplant rules in India
Central Idea
- The changes to the organ transplant rules announced by the Union health ministry last week, are small, but significant, steps towards giving a new lease of life to many people with failing organs. Despite of performing the third-the greatest number of transplants in the world, only about 0.01 percent of Indians donate their organs after death, according to the World Health Organization.
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What are the changes introduced?
- No age ceiling for organ receivers: With the new changes, patients who are 65 years and older can now register for receiving organs from a deceased donor. Now an individual of any age can register for organ transplant.
- Previously: Previously, the upper age limit for registering patients requiring organs from deceased donors was 65 years, but this ceiling has now been removed.
- No domicile criteria for receivers: Eliminate the domicile criterion for registering to receive organs, so that patients in need can register in any state.
- Previously: Currently, certain states restrict registration for deceased organ donors to only those who are domiciled in the state or give them preference. Organs harvested in one state are first shared with other hospitals within the same state, then in the region and then share nationally on the occasion that no match was found.
- No registration fees: The ministry has also requested that states not impose any fees on patients seeking registration for organ transplantation, as it violates the 2014 Transplantation of Human Organs and Tissues Rules.
- Previously: States such as Maharashtra, Kerala, Gujarat, and Telangana charge between Rs 5,000 and Rs 10,000 to register patients who need an organ replacement. The health ministry has rightly directed these states to stop charging this fee.
Where does India stand?
- Third Highest number of transplants in the world: India conducts the third highest number of transplants in the world every year. Yet barely four per cent of the patients who require a liver, heart or kidney transplant manage to get one.
- Organ transplants has significantly increased over the past decade: According to latest available official data, the number of organ transplants has significantly increased over the past decade. In 2013, there were 4,990 organ transplants, whereas in 2022, there were 15,561 a jump of 211 percent.
- Kidney transplants: Specifically, the number of kidney transplants from living donors increased by approximately 181 percent from 3,495 in 2013 to 9,834 in 2022. The number of kidney transplants from deceased donors increased by approximately 193 percent from 542 in 2013 to 1,589 in 2022.
- Liver transplants: The total number of liver transplants from living donors increased by approximately 350 percent from 658 in 2013 to 2,957 in 2022, and from deceased donors, it increased by approximately 217 percent from 240 in 2013 to 761 in 2022. Deceased donors account for nearly 17 percent of all transplants in India.
- Heart and Lung transplants: The total number of heart transplants increased by approximately 733 percent from 30 in 2013 to 250 in 2022, while lung transplants increased by approximately 500 percent from 23 to 138.
- Government hospitals fall behind: Furthermore, private hospitals lead in organ transplants while numbers in government hospitals remain relatively low, sources said.
Challenges to Organ Donation in India
- Lack of awareness: There is a lack of awareness among the general public about the importance of organ donation, the legal framework governing it, and the procedures involved. This can limit the number of potential donors.
- Cultural beliefs and superstitions: In India, there are several cultural beliefs and superstitions that discourage organ donation. Some people believe that organ donation is against religious beliefs, or that it can impact the soul or afterlife.
- Lack of infrastructure: India faces a shortage of hospitals and medical facilities that are equipped to handle organ transplantation. This can limit the availability of organs for transplantation.
- Regulatory bottlenecks: While the legal framework exists, there is a lack of implementation and enforcement of the law. This can lead to issues such as organ trafficking and black-market activities.
Did you know?
- NOTTO Scientific Dialogue 2023 was organized to bring all the stakeholders under one roof to brainstorm ideas about interventions and best practices in the organ and tissue transplant field that can be taken up for saving lives.
What is National Organ and Tissue Transplant Organization (NOTTO)?
- NOTTO is a national level organization set up under Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
- It has following two divisions:
- National Human Organ and Tissue Removal and Storage Network: It functions as apex Centre for All India activities of coordination and networking for procurement and distribution of Organs and Tissues and registry of Organs and Tissues Donation and Transplantation in the country
- National Biomaterial Centre: The main thrust & objective of establishing the centre is to fill up the gap between ‘Demand’ and ‘Supply’ as well as ‘Quality Assurance’ in the availability of various tissues. The centre will take care of the Tissue allografts such as Bone and bone products, Skin graft, Cornea and Heart valves and vessel.
Conclusion
- The percentages are very likely to go up once the changes in the rules announced last week take effect. The organ shortage problem is, however, a complex one, that continues to confound planners, even in nations whose healthcare systems are far better equipped than that of India’s. There is a need to expand the number of institutions where surgeries and transplants are undertaken. A uniform policy, will help patients in seeking transplant from deceased donors at any hospital in the country, giving them a lot of flexibility.
Mains Question
Q. Despite of performing the third-the greatest number of transplants in the world, only about 0.01 percent of Indians donate their organs after death. Discuss the recent changes in the rules of transplantation suggested by Union Health Ministry.
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Organ & Tissue Transplant- Policies, Technologies, etc.
Amendments to Organ Transplant Rules
Note4Students
From UPSC perspective, the following things are important :
Prelims level: NTTO
Mains level: Liberalizing organ transplant rules in India
In a major tweak to the organ donation policy, the Union Ministry of Health and Family Welfare said that the clause that people beyond 65 years could not receive cadaver organ transplants had been removed.
What are the changes introduced?
(1) No Age Bar
- Now an individual of any age can register for organ transplant.
- People beyond 65 years in need of an organ donation will also be eligible to get one.
- The government has decided to do away with a clause in the National Organ and Tissue Transplant Organisation (NOTTO) guidelines as the clause violates the Right to Life.
(2) Doing away with domicile compulsion
- Earlier an organ recipient could register for a prospective transplant in domicile State.
- States like Gujarat had made it mandatory for registered patients to furnish a domicile certificate to be eligible for a transplant.
- In November last year, the Gujarat High Court quashed the discriminatory policy of the State government.
Organ transplant in India: Key statistics
- According to data accessed from the Health Ministry, the number of organ transplants have increased by over three times from 4,990 in 2013 to 15,561 in 2022.
- Of the 15,561 transplants, a majority — 12,791 (82%) — are from live donors and 2,765 (18%) are from cadavers (the dead).
- Up to 11,423 of the 15,561 organ transplants are for the kidney, followed by liver (766), heart (250), lung (138), pancreas (24) and small bowel transplants (3).
- Most of these transplants occur in private hospitals, the numbers in government hospitals are relatively lower.
Challenges to Organ Donation in India
- Lack of awareness: There is a lack of awareness among the general public about the importance of organ donation, the legal framework governing it, and the procedures involved. This can limit the number of potential donors.
- Cultural beliefs and superstitions: In India, there are several cultural beliefs and superstitions that discourage organ donation. Some people believe that organ donation is against religious beliefs, or that it can impact the soul or afterlife.
- Lack of infrastructure: India faces a shortage of hospitals and medical facilities that are equipped to handle organ transplantation. This can limit the availability of organs for transplantation.
- Regulatory bottlenecks: While the legal framework exists, there is a lack of implementation and enforcement of the law. This can lead to issues such as organ trafficking and black market activities.
Way ahead
- To address these challenges, the government and other stakeholders are working to raise awareness, improve infrastructure, and strengthen the legal framework governing organ donation.
- Campaigns and initiatives are being undertaken to educate the public and healthcare professionals about the importance of organ donation, and to dispel myths and misconceptions.
- Efforts are also being made to improve the infrastructure and facilities for organ transplantation, and to enhance the regulatory framework to prevent illegal activities.
- These steps are aimed at promoting organ donation and increasing the availability of organs for transplantation, which can save lives and improve the quality of life for many people in India.
About National Organ Transplant Programme (NOTP)
- In 2019, the GoI implemented the NOTP for promoting deceased organ donation.
- Organ donation in India is regulated by the Transplantation of Human Organs and Tissues Act, 1994.
Types of Organ Donations
- The law allows both deceased and living donors to donate their organs.
- It also identifies brain death as a form of death.
- Living donors must be over 18 years of age and are limited to donating only to their immediate blood relatives or, in some special cases, out of affection and attachment towards the recipient.
(1) Deceased donors:
- They may donate six life-saving organs: kidneys, liver, heart, lungs, pancreas, and intestine.
- Uterus transplant is also performed, but it is not regarded as a life-saving organ.
- Organs and tissues from a person declared legally dead can be donated after consent from the family has been obtained.
- Brainstem death is also recognized as a form of death in India, as in many other countries.
- After a natural cardiac death, organs that can be donated are cornea, bone, skin, and blood vessels, whereas after brainstem death about 37 different organs and tissues can be donated, including the above six life-saving organs
(2) Living donors:
They are permitted to donate the following:
- one of their kidneys
- portion of pancreas
- part of the liver
Features of the NOTP
- Under the NOTP a National Level Tissue Bank (Biomaterial Centre) for storing tissues has been established at National Organ and Tissue Transplant Organization (NOTTO), New Delhi.
- Further, under the NOTP, a provision has also been made for providing financial support to the States for setting up of Bio- material centre.
- As of now a Regional Bio-material centre has been established at Regional Organ and Tissue Transplant Organization (ROTTO), Chennai, Tamil Nadu.
Back2Basics: National Organ and Tissue Transplant Organization (NOTTO)NOTTO is a national-level organization set up under the Directorate General of Health Services, Ministry of Health and Family Welfare. 1. National Human Organ and Tissue Removal and Storage Network 2. National Biomaterial Centre (National Tissue Bank) [I] National Human Organ and Tissue Removal and Storage Network
[II] National Biomaterial Centre (National Tissue Bank)
The centre will take care of the following Tissue allografts: 1. Bone and bone products 2. Skin graft 3. Cornea 4. Heart valves and vessels |
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