WHY IN NEWS ?
- Renewed debate on legal ambiguities in Brain-Stem Death (BSD) certification under the Transplantation of Human Organs and Tissues Act, 1994.
- India’s deceased organ donation rate remains critically low:
- India (2023): 0.77 donors per million
- Spain (2023): 49.38 donors per million
- ~5 lakh Indians die annually while waiting for organ transplants.
- Demand rising to:
- Expand the donor pool
- Remove legal-bureaucratic bottlenecks
- Clarify death certification & consent protocols
Relevance :
GS Paper III – Health Sector & Human Resource Development
- Public health system capacity: ICU infrastructure & trained transplant coordinators
- Organ donation as a resource optimisation strategy in healthcare
- Demand–supply gap in transplants and mortality burden
- Health system efficiency and end-of-life care management
- Medical technology, ventilator dependence and ICU rationing
WHAT IS ORGAN TRANSPLANTATION LAW IN INDIA?
- Governed by:
- Transplantation of Human Organs and Tissues Act, 1994
- Covers two types of transplants:
(A) Deceased Donor Transplant
- Organs retrieved from a person with certified Brain-Stem Death (BSD).
- Heart may still beat with ventilator support.
- Law legally recognises BSD as death.
(B) Living Donor Transplant
- Organ removed from a healthy living person.
- Needs legal sanction because:
- Doctors are otherwise prohibited from removing healthy organs.
WHAT IS BRAIN-STEM DEATH (BSD)?
- Defined under the 1994 Act as:
- “Permanent and irreversible cessation of all functions of the brain-stem.”
- Brain-stem controls:
- Breathing
- Consciousness
- Vital reflexes
- BSD = irreversible biological death, even if heart is artificially supported.
WHY INDIA’S ORGAN TRANSPLANT PERFORMANCE IS POOR
- Extreme shortage of:
- ICU infrastructure
- BSD-certified hospitals
- Trained transplant coordinators
- Major bottlenecks:
- Legal confusion
- Bureaucratic controls
- Family consent delays
- Low public awareness
- Result:
- Massive organ-demand vs supply gap
KEY LEGAL CONFUSIONS AROUND BSD
Q1. Is BSD legally equivalent to cardiac death?
Yes, under the 1994 Act:
- “Deceased person” includes:
- Death by brain-stem death
- Death by cardio-pulmonary failure
- Core legal phrase:
- “Permanent disappearance of all evidence of life”
- Therefore:
- BSD has full legal recognition as death
Q2. Should life support continue if family refuses organ donation?
- Law:
- Only defines death
- Does not dictate post-death hospital actions
- Ethical-legal position:
- If no consent:
- Life support may be continued on family request
- But death certificate time is final
- If consent exists:
- Life support must continue temporarily to preserve organs
- If no consent:
Q3. Are two death certificates required?
- Current practice:
- BSD certificate issued first
- Fresh death certificate issued after organ harvest
- Legal position:
- Unnecessary duplication
- BSD certificate alone is sufficient for legal death registration
LINK WITH DEATH REGISTRATION LAW
- Registration of Births and Deaths Act, 1969
- Definition of death:
- “Permanent disappearance of all evidence of life.”
- Same core definition as 1994 Act.
- Form 4 (Death Registration Form):
- Separates:
- Cause of death
- Mode of death (heart failure, respiratory failure, etc.)
- Separates:
- BSD is interpreted as:
- Respiratory failure due to brain-stem damage
- Conclusion:
- No new amendment needed to register BSD legally.
MAJOR LEGAL CONTRADICTION NEEDING AMENDMENT
Section 14(1) of 1994 Act:
- BSD certification & organ retrieval allowed only in registered hospitals.
Rule 5(1) & 5(2):
- BSD certification mandatory in every hospital with ICU, including:
- Non-transplant hospitals
| Provision | What it Allows |
| Section 14 | Only registered hospitals |
| Rule 5 | All ICU hospitals |
Resulting Contradiction:
This legally blocks universal BSD identification.
CRITICAL NEED FOR LEGISLATIVE AMENDMENT
Reform Required:
- Allow BSD certification and organ retrieval in all ICU-equipped hospitals.
- Restrict actual transplant surgery to:
- Registered transplant centres only.
Why Essential:
- BSD commonly occurs in:
- Trauma
- Stroke
- Brain haemorrhage cases
- Most such deaths occur in:
- District hospitals
- Medical colleges
- Current law artificially shrinks the donor pool.
BUREAUCRATIC BOTTLENECKS IN BSD CERTIFICATION
Problem 1: Doctor Approval by Appropriate Authority (AA)
- Form 10 requires:
- 2 of the 4 certifying doctors to be AA-approved
- Issues:
- No special qualification criteria
- Cumbersome approval process
- Doctors reluctant to apply
- Effect:
- BSD certification gets delayed or avoided
- Reform Needed:
- Allow any registered specialist medical practitioner to certify BSD.
Problem 2: No “Time of Death” in Form 10
- A death certificate without time = legally incomplete
- Kerala Government (2020) solved this by:
- Defining time of death as:
- “Time when arterial pCO₂ reaches target value in second apnoea test”
- Defining time of death as:
- Other States still lack this clarity.
- Result:
- Legal uncertainty in death registration.
CONSENT PROCESS: LEGAL SEQUENCING
When should consent be sought?
- As per law:
- First → BSD must be diagnosed & certified
- Then only → Family approached for consent
Legal tools:
- Form 8 (Declaration & Consent Form):
- Starts with:
- “Has been declared brain-stem dead/dead…”
- Confirms:
- Authorisation for organ removal after BSD certification
- Starts with:
Consent before BSD certification is legally incorrect.
POLICY IMPORTANCE OF CLEAR BSD LAW
- Addresses three national priorities:
- Public health → Organ availability
- Medical ethics → End-of-life clarity
- Resource efficiency → ICU & ventilator optimisation
- Prevents:
- Indefinite ventilator occupation
- Medico-legal hesitation
- Family-doctor conflict


