Syllabus: Mechanisms, laws, institutions and Bodies constituted for the protection and betterment of these vulnerable sections.
Legal Framework
- Organ transplantation in India is governed by the Transplantation of Human Organs and Tissues Act (THOTA), 1994.
- The Act regulates deceased donations and living donations, providing legal sanction for both.
- Brainstem Death (BSD) is legally recognised under the Act as a form of death.
Categories of Transplants
- Deceased Donation
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- Organs are retrieved from persons with irreversible brainstem damage while vital organs still function.
- The Act defines BSD and prescribes mandatory medical procedures for certification.
- Living Donation
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- A healthy organ is removed from a living person.
- Requires strict legal sanction, as doctors cannot remove normal organs without statutory approval.
Legal Ambiguities Hindering Organ Donation
- Confusion on BSD vs. Cardiac Death
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- BSD definition exists only in the 1994 Act, leading to doubts whether BSD is equivalent to cardio-pulmonary death legally.
- Families often refuse donation, raising questions on whether life support must continue despite BSD certification.
- Two Death Certificates Problem
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- Current practice issues a second cardiac-death certificate after organ retrieval, causing inconsistency.
- THOTA already clarifies that BSD constitutes “permanent disappearance of all evidence of life” and should suffice for registration under the Registration of Births and Deaths Act, 1969.
- Certification Issues
- Form 10 (BSD certification) does not record time of death, leading to incomplete documentation.
- Kerala resolved this by clarifying that time of death = time arterial pCO₂ reaches target in second apnoea test.
- Requirement that two of four certifying doctors be “Approved by Appropriate Authority (AA)” creates administrative hurdles with no clear eligibility criteria.
- Institutional Limitations
- BSD certification and organ retrieval allowed only in registered transplant hospitals or Non-Transplant Retrieval Centres.
- This contradicts Rule 5, which mandates BSD identification in any ICU-equipped hospital.
- Amendment is needed to allow BSD certification and retrieval in all ICU hospitals, while transplantation should remain restricted to registered centres.
- Consent-Related Legalities
- BSD must be certified before family consent is sought, as per Rule 5 and Form 8.
- Families may request continuation of life support even after BSD certification, but legally time and date of death remain final.
Conclusion
- Legal clarity on BSD equivalence, certification, documentation, and ICU-based identification is essential to expand India’s extremely low deceased donation rate. Empowering hospitals and removing procedural ambiguities will improve organ availability and uphold ethical medical practice.