Towards a Uniform National Framework for Organ Transplantation and Donor Protection
Commentary on Indian Society of Organ Transplantation v. Union of India, 2025 INSC 1361 (Supreme Court of India)

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1. Introduction

The judgment in Indian Society of Organ Transplantation v. Union of India (W.P. (C) No. 39 of 2025, decided on 19 November 2025) marks a significant development in Indian health law and constitutional governance. Decided by a Bench headed by the Chief Justice of India, B.R. Gavai, with Justice K. Vinod Chandran concurring, the decision addresses systemic problems in the legal and institutional framework for organ donation and transplantation in India.

The petitioner, the Indian Society of Organ Transplantation (a national-level professional body), approached the Supreme Court under its original writ jurisdiction, highlighting:

• the lack of uniformity in the legal framework governing organ transplantation across States and Union Territories (UTs),
• inequalities in access to organs and transplantation services, and
• serious gaps in donor and recipient protection, especially for live donors and brain-stem death donations.

The Court does not strike down any statutory provision. Instead, it exercises its constitutional jurisdiction in a structural and supervisory manner, issuing wide-ranging directions to:

• the Union of India,
• State Governments, and
• Union Territory Administrations,

aimed at:

• achieving a uniform national policy on organ allocation and swap transplantation,
• enhancing institutional capacity (via SOTTOs and public hospitals),
• improving data and transparency in organ donation and transplantation, and
• institutionalizing welfare and follow-up for live organ donors.

The Court keeps the matter pending for further monitoring, signalling a form of continuing mandamus. The judgment thus operates simultaneously as a constitutional directive, a health policy catalyst, and a precedent on the right to health and donor protection.

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2. Background and Legal Framework

2.1 The Statute: Transplantation of Human Organs Act, 1994

The core enactment is the Transplantation of Human Organs Act, 1994 (“1994 Act”), enacted by Parliament pursuant to Article 252(1) of the Constitution, after several States passed resolutions empowering Parliament to legislate in a State List subject.

Key features of the 1994 Act (as relevant here) include:

• regulation of removal, storage and transplantation of human organs,
• definitions of “near relatives” and circumstances in which live donations are permissible,
• authorization of cadaveric (deceased) donations, particularly after brain-stem death, and
• structures for authorization committees and hospital registration.

Under the Seventh Schedule, organ transplantation falls within Entry 6 of List II (“Public health and sanitation; hospitals and dispensaries”), ordinarily a State subject. Article 252(1) provides the constitutional bridge that allowed Parliament to legislate once States resolved to that effect.

2.2 The 2011 Amendment and 2014 Rules

The Transplantation of Human Organs (Amendment) Act, 2011 substantially expanded the 1994 framework. As the Court notes, its principal objectives were:

• to bring “tissues” within the regulatory framework of the 1994 Act,
• to introduce swap transplantation through Section 9(3A),
• to broaden the definition of “near relatives”,
• to establish a National Human Organs and Tissues Removal and Storage Network, and
• to create a National Registry for Transplants.

The corresponding Transplantation of Human Organs and Tissues Rules, 2014 (“2014 Rules”) operationalize the Act, including:

• hospital registration norms,
• allocation criteria (notably Rule 31(4)(f)),
• standardization of forms and procedures, and
• institutional arrangements like State Organ and Tissue Transplant Organizations (SOTTOs).

The judgment reveals a key structural problem: non-uniform adoption of the 2011 Amendment and 2014 Rules by some States, despite the Act being originally a product of the Article 252 process. This asymmetry directly undermines the creation of a national organ-sharing grid.

2.3 Institutional Architecture: NOTTO, SOTTO, National Registry

The judgment relies heavily on the institutional framework contemplated by the 2011 amendment and 2014 Rules:

• National Organ and Tissue Transplant Organization (NOTTO) – a central coordinating body for:
  • maintaining the national registry,
  • developing model policies and allocation criteria,
  • coordinating interstate allocation and swap transplantation, and
  • assisting in capacity-building and awareness.
• State Organ and Tissue Transplant Organizations (SOTTOs) – intended as state-level nodal entities for implementing the national framework.
• National Registry under Section 13D – a centralized database where hospitals must report transplant-related data.

However, the Court notes that:

• some States and UTs (Meghalaya, Nagaland, Andaman and Nicobar Islands, Lakshadweep, Ladakh) function without SOTTOs, and
• some lack even a single government hospital registered to perform transplants.

The case thus arises in a context where the statutory and institutional architecture exists on paper but is patchy, incomplete and unevenly implemented across the country.

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3. Summary of the Judgment

3.1 Key Concerns Raised by the Petitioner

The petitioner highlighted four main problem-areas:

1. Non-adoption of the 2011 Amendment and 2014 Rules by some States, impeding a uniform policy and national grid.
2. Inadequate institutional capacity, including absence of SOTTOs in some States/UTs and lack of registered government hospitals for transplantation.
3. Policy gaps in:
   • brain-stem death certification and linkage to organ donation, and
   • swap transplantation, especially lack of a national, digital system under Section 9(3A).
4. Inequitable allocation criteria under Rule 31(4)(f) of the 2014 Rules, varying across States, enabling “gaming the system” and discriminating on grounds of gender, class and region.

Additional emphasis was placed on the welfare of live donors, including the risk that, after donation, they are “left in the lurch” without proper follow-up, and are vulnerable to exploitation and commercialization.

3.2 Court’s Principal Findings

While not formally declaring new constitutional rights in abstract terms, the Court:

• Recognizes organ transplantation and organ donation as integrally linked to the right to health and equality, noting concerns of discrimination and access.
• Emphasizes the equal value of the donor’s life relative to that of the recipient and the need for post-donation care.
• Affirms the relevance of WHO Guiding Principles on organ donation, particularly on voluntariness, informed consent, and post-donation care for live donors.
• Endorses High Court jurisprudence (Kerala and Gujarat) advancing donor protection and non-discriminatory access.

3.3 Directions Issued

The operative part of the judgment (para 19) contains an 11-point set of directions and “requests” to different authorities. Key directions include:

1. Adoption of Central Amendments and Rules
   • Union to persuade Andhra Pradesh to adopt the 2011 Amendment Act.
   • Union to persuade Karnataka, Telangana, Andhra Pradesh and Manipur to adopt the 2014 Rules.
   • Secretary, Health and Family Welfare (Union) is directed to personally monitor these efforts.
2. Creation of SOTTOs
   • Union of India is directed to constitute SOTTOs for Meghalaya and Nagaland under the National Organ Transplant Program, after consultation with those States.
3. Uniform Allocation Policy and Anti-Discrimination Safeguards
   • NOTTO is requested to evolve model allocation criteria, in consultation with all States, to achieve a uniform national policy for transplantation.
   • This policy must:
     • address gender, class and regional discrimination, and
     • provide remedial provisions for inequities.
   • The policy should standardize registration criteria and formats for patients and donors nationwide.
4. Brain-Stem Death Certification and Organ Donation
   • Union (through Ministry of Home Affairs in consultation with NOTTO, MoHFW and the petitioner) is requested to consider amending Form 4 and 4A of the Registration of Births and Deaths Rules, 1999.
   • Amendment should:
     • introduce a column indicating whether the deceased was a case of brain-stem death, and
     • record whether the option to donate organs was offered to the relatives.
5. National Swap Transplantation Guidelines
   • NOTTO is requested to evolve national swap transplantation guidelines under Section 9(3A).
   • These guidelines must:
     • operate at a national level,
     • ensure equal opportunities for all eligible persons, and
     • be implemented through an accessible digital web portal.
6. Capacity Building and Five-Year Plan
   • NOTTO, with States/UTs, is requested to develop transplantation facilities where public health infrastructure is inadequate.
   • NOTTO is also requested to design a five-year plan that:
     • maps the development of transplantation facilities across India, and
     • accounts for per capita transplantation requirements in larger States.
7. Welfare of Live Donors
   • Union (through NOTTO) is requested to evolve guidelines for live donor welfare, including:
     • ensuring informed and voluntary consent,
     • maintenance of a donor portal,
     • mandatory medical follow-up, and
     • measures to prevent commercialization and exploitation.
8. Data Reporting and Enforcement
   • States/UTs are requested to ensure that hospitals report data on organ donations and transplants, as mandated by Section 13D of the 1994 Act, to NOTTO’s national registry.
   • All State Governments/UT Administrations are directed to take strict action against defaulting hospitals that fail to furnish data.

Finally, the Court keeps the matter alive and directs that it be listed after six months, preferably before a Bench including Justice K. Vinod Chandran, underscoring continuing oversight.

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4. Analysis of the Judgment

4.1 Precedents and Authorities Cited

4.1.1 Vidya Ramesh Chand Shah v. State Of Gujarat¹

The Supreme Court notes that the Gujarat High Court in Vidya Ramesh Chand Shah v. State Of Gujarat (2022 SCC OnLine Guj 2021) struck down a domicile requirement for registration for organ transplantation. This precedent is important for two reasons:

• It affirms that access to organ transplantation cannot be restricted by domicile criteria once the statutory framework permits donation and transplantation.
• It directly supports the petitioner’s contention that state-specific allocation criteria may lead to discrimination and “gaming of the system” by those with resources to register in multiple States.

By invoking this case, the Supreme Court strengthens the argument that organ allocation and registration must be non-discriminatory and nationally coherent, and that regional barriers are constitutionally suspect when they impair access to life-saving treatment.

4.1.2 Moideen v. State of Kerala²

The decision in Moideen v. State of Kerala (2017 SCC OnLine Ker 21219), authored by Justice K. Vinod Chandran (now on the Supreme Court Bench), is relied upon to foreground live donor protection.

The Kerala High Court had observed:

“The renal parameters of a donor are assessed at the time of transplant and it does not take into account the medical complications that may arise in future due to the stress on the remaining organ… Live organ transplantation for consideration, other than love, affection for a willing sacrifice, is abhorrent to the concept of a healthy, civilized society.”

and further that:

“Truly altruistic motives will also not be directed against an individual and life of one is as precious of yet another.”

The Supreme Court:

• expressly concurs with this reasoning, and
• builds on it to hold that the life and post-operative health of the live donor must be “equally” taken care of.

This marks an explicit elevation of donor welfare from a policy desideratum to a judicially recognized obligation, which NOTTO and States must now concretize into guidelines and practices.

4.1.3 WHO Guiding Principles on Organ Donation

The petitioner and the Court rely on the World Health Organization (WHO) Guiding Principles on Human Cell, Tissue and Organ Transplantation, particularly Guiding Principle 3, which requires:

• voluntary and informed consent of donors, and
• professional care and organized follow-up for live donors.

While international norms are not binding per se, Indian courts frequently draw upon them as persuasive authority consistent with the Constitution’s commitment to human dignity and health. Here, they serve as a global benchmark reinforcing:

• the ethical prohibition on commercialization and coercion in organ donation, and
• the need for structured post-donation care.

The Supreme Court uses these principles to justify its direction that NOTTO must develop national guidelines for live donor welfare, including a follow-up mechanism.

4.2 Legal Reasoning and Constitutional Underpinnings

4.2.1 Cooperative Federalism in a State-List Subject (Article 252)

The Court recognizes that organ transplantation falls under Entry 6 of List II, but that the 1994 Act and its amendments were enacted using Article 252(1), based on State resolutions. The reasoning implicitly rests on:

• States having formally ceded legislative field to Parliament for this subject, and
• a consequent expectation of uniformity in regulation across those States.

However, post-enactment, further steps like adoption of Amendments and Rules still require State action. The non-adoption by Andhra Pradesh (2011 Amendment) and by several States (2014 Rules) fragments the statutory regime.

The Court uses the language of “request” and “persuade” rather than “mandate” when dealing with State adoption, respecting the formal division of powers. Yet:

• These directions emanate from the apex constitutional court in a reportable judgment,
• the Union Secretary is explicitly directed to monitor the process, and
• the matter is kept pending for compliance review.

In substance, this constructs a model of cooperative federalism: the Supreme Court nudges the Union to use persuasion, coordination, and monitoring to secure nationwide uptake of health regulations critical to the right to health.

4.2.2 Right to Health and Non-Discrimination

Although the judgment does not explicitly recite Articles 14, 21 or 47, its logic is anchored in:

• Right to health and life (Article 21) – transplantation is a life-saving procedure, and obstacles to access (e.g., lack of facilities, non-uniform allocation rules, low organ availability) trench on this right.
• Equality and non-discrimination (Article 14) – the Court explicitly flags concerns of:
  • gender-based disparities,
  • class-based inequities, and
  • regional imbalances,
  in access to organs and placements on waiting lists.
• Directive Principles (Article 47) – establishing transplantation facilities and organ-sharing systems advances the State’s duty to improve public health.

The insistence on:

• a uniform national allocation framework,
• remedial provisions for disadvantaged categories, and
• a ban on domicile-based discrimination (consistent with the Gujarat High Court),

places this judgment squarely within the line of decisions that read the right to health as a justiciable component of Article 21, with an overlay of substantive equality.

4.2.3 Organ Donation: Balancing Recipient’s Life and Donor’s Dignity

A notable aspect of the reasoning is its insistence that the life of a live donor is as precious as that of the recipient. The Court:

• approves the Kerala High Court’s moral and legal stance that commercial or coerced live donations are “abhorrent to a healthy, civilized society”,
• notes that donor evaluation typically focuses on short-term renal parameters without systematically addressing long-term risks, and
• frames a positive obligation to “adequately take care of” the donor post-operation.

This effectively reconfigures donors from being mere “sources” of organs to rights-bearing subjects entitled to:

• information,
• voluntariness,
• long-term medical follow-up, and
• protection against exploitation.

In doctrinal terms, it aligns donor welfare with:

• right to bodily integrity and autonomy, and
• right to dignity, both subsumed within Article 21.

4.2.4 Brain-Stem Death and Maximizing Cadaveric Donation

The Court gives weight to the petitioner’s submission that:

• brain-stem dead donors can provide up to eight vital organs,
• whereas cardiac-death donors primarily supply tissues only.

The recommendation to amend Form 4 and 4A (Registration of Births and Deaths Rules, 1999) to record:

• whether the deceased was brain-stem dead, and
• whether relatives were given an option of organ donation,

serves multiple purposes:

• Data capture – systematically identifying brain-stem death cases nationwide.
• Public awareness and nudging – making organ donation a structured part of end-of-life decision-making.
• Accountability – allowing future audits on whether hospitals and officials offer the organ donation option in appropriate cases.

Though couched as a “request” to “consider” the amendment, the Supreme Court’s imprimatur will have strong persuasive weight in regulatory practice and future litigation.

4.2.5 Swap Transplantation as a Tool of Equity

Swap transplantation under Section 9(3A) allows two or more donor–recipient pairs, where each donor is incompatible with their intended recipient but compatible with the other, to exchange donors. The Court recognizes:

• India’s low deceased donation rates,
• high incidence of donor-recipient incompatibility, and
• the potential of swap programmes to dramatically increase transplant opportunities.

But in the absence of:

• a national swap policy, and
• a digital, cross-State matching platform,

swap potential remains underutilized and fragmented. The Court therefore:

• assigns NOTTO the task of designing national swap transplantation guidelines,
• mandates that these operate through a web portal,
• stresses the need for equal opportunities nationwide, thus pre-empting regional monopolies or inequitable access.

Doctrinally, this expands the understanding of the State’s duty: not merely to refrain from arbitrary denials, but to proactively create enabling systems and platforms for life-saving treatment.

4.2.6 Data, Transparency, and Regulatory Compliance

Section 13D of the 1994 Act mandates the creation of a national registry for organ and tissue transplants. The Court leverages this provision to:

• require States/UTs to ensure compulsory reporting of data by hospitals, and
• direct State Governments/UT Administrations to take “strict action” against defaulting hospitals.

This is one of the few directions framed unequivocally as a binding mandate (“direct”) rather than a “request,” signalling:

• the centrality of data to regulatory oversight and equity, and
• a willingness to treat non-reporting as a serious regulatory breach.

Over time, this emphasis on data is likely to:

• enable monitoring for discrimination,
• facilitate research and policy planning, and
• support judicial scrutiny in future cases of alleged arbitrariness or malpractice.

4.3 Impact and Significance

4.3.1 Towards a De Facto National Organ Allocation and Swap System

This judgment does not itself enact a national grid, but it lays down the judicial blueprint

• NOTTO must:
  • standardize allocation criteria,
  • address discrimination factors (gender, class, region),
  • standardize registration criteria and formats, and
  • build a national swap portal.
• States are encouraged (and structurally pressured) to:
  • adopt the 2011 Amendment and 2014 Rules,
  • constitute SOTTOs, and
  • expand hospital capacity under a five-year plan.

Practically, these steps will move India from a largely State-centric, fragmented system to a nationally integrated organ sharing and swap network, akin to mature global systems.

4.3.2 Donor-Centric Shift in Organ Transplant Ethics

By formally recognizing donor welfare as a central concern, and by directing guidelines for:

• informed and voluntary consent,
• donor tracking portals, and
• mandatory medical follow-up,

the Court triggers a shift from a purely recipient-centric framework to one where:

• donors are rights-holders, and
• donor exploitation is a regulatory and constitutional wrong, not merely a moral failing.

This will influence:

• hospital protocols,
• incidental regulatory rules, and
• evaluation of cases concerning alleged coercion or trafficking.

4.3.3 Brain-Death Awareness and Normalization of Cadaveric Donation

Linking death certificates to:

• brain-stem death status, and
• whether organ donation was offered or considered,

will, over time:

• normalize the conversation around organ donation at the point of end-of-life care,
• increase awareness among families and medical staff, and
• provide a feedback mechanism to identify where the system fails to capture donation opportunities.

If implemented effectively, this single change can substantially increase the pool of available organs, mitigating waiting times and mortality on transplant lists.

4.3.4 Reinforcing Cooperative Federalism in Health Governance

The judgment illustrates a sophisticated judicial approach to a politically sensitive subject:

• It respects the State’s constitutional domain in health and the formalities of Article 252.
• It uses requests and persuasion rather than blanket mandates where competence is shared or politically sensitive.
• It nonetheless imposes hard obligations (e.g., data reporting, enforcement against hospitals, SOTTO establishment for certain States) where the statutory framework already authorizes uniformity.

This will likely serve as a template for future health-related PILs involving:

• vaccination policies,
• public health emergencies,
• rare disease treatment, and
• other areas requiring coordinated national and State action.

4.3.5 Judicial Oversight and Continuing Mandamus

By listing the matter after six months before (if possible) a Bench that includes Justice K. Vinod Chandran, the Court signals:

• a longitudinal engagement with the issue, and
• an expectation that the Union and States will show concrete progress on each direction.

This is typical of continuing mandamus in public interest litigation, where courts supervise systemic reform rather than issue a one-time order. The impact is twofold:

• Administrative – executives are under pressure to deliver time-bound policy and institutional changes.
• Normative – health governance becomes a shared responsibility under the Court’s watchful eye.

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5. Complex Legal and Medical Concepts Simplified

5.1 Article 252(1) of the Constitution

Normally, subjects in the State List (like public health) are legislated upon by State Legislatures. Article 252(1) provides that:

• if two or more State Legislatures pass resolutions asking Parliament to make a law on a State List subject,
• Parliament may enact such a law,
• and that law then applies to those States (and any other State that later adopts it via resolution).

The 1994 Act and its 2011 amendment are created under this mechanism. States that have not yet “adopted” the 2011 amendment or the 2014 Rules remain out of full alignment, hence the Court’s push for adoption.

5.2 Brain-Stem Death vs Cardiac Death

• Cardiac Death – the heart irreversibly stops beating. Organs quickly deteriorate, but some tissues (e.g., corneas, skin) can still be donated.
• Brain-Stem Death – the brain-stem (which controls basic functions like breathing and consciousness) irreversibly ceases to function, but the heart can continue beating for some time with ventilatory support.

Under Indian law, brain-stem death is recognized as a form of legal death. In such cases, many vital organs (heart, lungs, liver, kidneys, pancreas, intestines) can be retrieved and transplanted, potentially saving multiple lives. Hence, the Court’s focus on:

• certifying brain-stem death, and
• linking that certification with organ donation discussions and documentation.

5.3 Swap Transplantation (Paired Kidney Exchange)

Swap transplantation (under Section 9(3A)) typically applies to kidney transplants. Imagine:

• Pair 1: Donor A and Recipient A – medically incompatible.
• Pair 2: Donor B and Recipient B – medically incompatible.

But:

• Donor A is compatible with Recipient B,
• Donor B is compatible with Recipient A.

By “swapping” the donors, both recipients can receive compatible kidneys in a lawful and ethically regulated manner. Larger swap networks (including chains) vastly increase the chances of finding a match, particularly in countries with low deceased donation rates.

5.4 NOTTO and SOTTO

• NOTTO (National Organ and Tissue Transplant Organization) – central body under the Union Ministry of Health:
  • central registry maintenance,
  • policy formulation,
  • coordination among States and hospitals.
• SOTTO (State Organ and Tissue Transplant Organization) – State-level nodes:
  • implement and adapt national policies,
  • coordinate within the State’s hospitals,
  • liaise with NOTTO for interstate organ sharing and data reporting.

Without a SOTTO, a State lacks a dedicated institutional mechanism to run its organ transplant program effectively, which is why the Court directs SOTTO creation for certain States.

5.5 Continuing Mandamus

In complex public interest cases, Indian courts sometimes:

• issue interim and final directions,
• keep the matter on the court’s docket, and
• periodically monitor compliance through status reports and hearings.

This practice is called continuing mandamus. It allows courts to oversee systemic reforms that cannot be achieved by a single order. By scheduling a hearing after six months, the Supreme Court uses this technique to ensure its directions on organ transplantation are not merely paper directives.

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6. Conclusion: Key Takeaways and Broader Significance

The decision in Indian Society of Organ Transplantation v. Union of India establishes a significant structural precedent in Indian health law and constitutional governance. Its key contributions can be synthesized as follows:

1. Implicit Constitutionalization of Organ Transplantation
   The Court treats access to organ transplantation as an integral part of the right to health under Article 21, intertwined with equality under Article 14. By focusing on discrimination (gender, class, region) and access barriers, it moves transplantation from the margins of medical regulation into the core of constitutional scrutiny.
2. From Fragmentation to a Uniform National Framework
   Through directions on:
   • adoption of the 2011 Amendment and 2014 Rules,
   • model allocation criteria,
   • national swap guidelines and portal,
   • standardized registration formats, and
   • data reporting to the national registry,
   the Court lays down the blueprint for a de facto national organ allocation and swap system, implemented via NOTTO and SOTTOs in a cooperative federal model.
3. Centrality of Donor Welfare and Anti-Exploitation Safeguards
   By endorsing Moideen and WHO Guiding Principles, and directing the creation of donor welfare guidelines, the Court recasts donors as rights-bearing subjects entitled to:
   • voluntary and informed consent,
   • systematic medical follow-up, and
   • protection from commercialization and coercion.
   This donor-centric repositioning is a major normative advance.
4. Leveraging Brain-Stem Death and Registry Data
   The Court’s push to:
   • link brain-stem death certification with death registration and donation options, and
   • enforce mandatory reporting to the national registry,
   lays foundations for:
   • increased cadaveric organ availability,
   • better planning and oversight, and
   • future legal challenges based on empirical data, not anecdote.
5. Model of Judicially Supervised Cooperative Federalism
   By respecting State autonomy where constitutionally required, using persuasion for adoption of amendments, and issuing firm directions where statute already mandates uniformity (e.g., registry data, SOTTOs), the Court offers a template for health governance litigation that is:
   • collaborative rather than confrontational,
   • yet rights-focused and enforceable.

Going forward, this judgment will serve as a critical reference point for:

• policy-makers designing organ transplant programs and laws,
• courts adjudicating disputes on allocation, donor exploitation, and access, and
• civil society and medical professionals advocating for an ethical and equitable transplantation system.

In substance, the Supreme Court has transformed a set of fragmented statutory provisions into a coherent constitutional project: to build a uniform, equitable, and donor-sensitive organ transplantation framework for India, underpinned by data, transparency, and cooperative federalism.

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¹ Vidya Ramesh Chand Shah v. State Of Gujarat, 2022 SCC OnLine Guj 2021.
² Moideen v. State of Kerala, 2017 SCC OnLine Ker 21219.