Indian Society of Organ Transplantation vs Union of India

WRIT PETITION (CIVIL) NO. 39 OF 2025

INDIAN SOCIETY OF ORGAN TRANSPLANTATION …..PETITIONER

VERSUS

UNION OF INDIA & ORS. …..RESPONDENTS

JUDGMENT

B.R. GAVAI, CJI.

1. The present Writ Petition has been filed at the instance of

the Indian Society of Organ Transplantation in order to highlight

the issues with regard to uniformity, equality and access in the

realm of organ donation for both the donors and the recipients.

2. The Transplantation of Human Organs Act, 1994 (for short,

“the 1994 Act”) was enacted pursuant to the resolutions passed

by various States under Article 252(1) of the Constitution of

India. The said legislation falls under Entry 6 of List II of the 7th

Schedule pertaining to “Public health and sanitation; hospitals Signature Not Verified Digitally signed by POOJA SHARMA Date: 2025.11.27 17:14:26 IST and dispensaries”. The 1994 Act was adopted by all the States. Reason: Page 1 of 14

3. Certain important amendments were made to the 1994 Act

in the year 2011, again pursuant to the resolutions passed by

the States under Article 252(1) of the Constitution of India. The

main purpose of the 2011 amendment was to include ‘tissue’

transplants within the scope of 1994 Act. The said amendment

also introduced Section 9(3A) enabling swap transplantation for

the first time. It also broadened the definition of ‘near relatives’,

set up the National Human Organs and Tissues Removal and

Storage Network, and established the National Registry for

Transplants. The Transplantation of Human Organs and Tissue

Rules, 2014 (for short, “the 2014 Rules”) were also brought into

force in line with the changes made in the 1994 Act.

4. It appears that one of the States, i.e., the State of Andhra

Pradesh has not yet adopted the 2011 amendment. It further

appears that the States of Karnataka, Telangana, Andhra

Pradesh and Manipur have not yet adopted the 2014 Rules. It

further appears that after the last affidavit was filed by the

Union of India, as per the directions issued by this Court, now

the State of Karnataka has passed a resolution dated

21.08.2025 adopting the 2011 amendment. Such a non-

Page 2 of 14 adoption till now, severely impedes the possibility of adoption of

a uniform national policy and national grid and reduces the

chances of transplantation in the concerned States as well as

the rest of the country.

5. We, therefore, request all the States/Union Territories,

who have not yet adopted the 2011 amendment and/or the

2014 Rules, to take into consideration the importance of the

issue and adopt the same.

6. It further appears that two north-eastern States i.e.,

Meghalaya and Nagaland and three Union Territories, i.e.,

Andaman and Nicobar Islands, Lakshadweep and Ladakh are

presently functioning without a State Organ and Tissue

Transplant Organization (for short, “SOTTO”).

Mr. K. Parameshwar learned senior counsel appearing on behalf

of the petitioner submits that unless the SOTTO is established

in the said States/Union Territories, the work of organ/tissue

transplant cannot be performed.

7. Learned senior counsel for the petitioner further states

that there is an acute shortage in the number of organ

donations in the country. He submits that in order to tackle the

Page 3 of 14 shortage, two policy measures need to be taken. First is linking

of brain-stem death certification with the death certification,

and the consequent option to donate organs. The second

suggestion of the learned senior counsel is development of a

national policy as well as national portal to operationalize swap

transplantation under Section 9(3A) of the 1994 Act.

8. Insofar as brain-stem death certification is concerned,

learned senior counsel submits that Form 4 and Form 4A of

Registration of Births and Deaths Rules, 1999 be amended

across the country to include a column on brain dead

certification and an option to donate organs. It is the contention

of the petitioner, which is working on the national level in the

field of organ transplantation, that such a measure would

exponentially increase awareness of possibility of the organ

donation in brain dead persons and will increase the number of

organ donations pursuant thereto.

9. The learned senior counsel for the petitioner has

highlighted that as per the National Organ and Tissue

Transplant Organization (for short, “NOTTO”), the importance of

donation by persons who are certified to be brain-stem dead is

Page 4 of 14 much more, as they can donate up to eight vital organs,

whereas the person who has suffered natural cardiac death can

only donate tissues.

10. Another issue highlighted by the learned senior counsel for

the petitioner is with regard to the swap transplantation, which

is permitted under Section 9(3A) of the 1994 Act. According to

the petitioner, on account of low deceased organ donation rates

and donor-recipient incompatibility, a national policy for swap

transplantation would go a long way in the matter of organ

donation/transplantation. It is submitted that in the absence of

a national policy coupled with the fact that different States have

either no policy, or an independent policy, the swap

transplantation is not being done though a large number of

donors are available. It is further submitted that a national grid

for swap transplantations and organ donations would enable

different donors and different recipients in various States across

the country to connect thereby increasing the number of

transplants. It is, therefore, submitted that the Union of India

through the NOTTO must formulate a national policy to ensure

equitable access to swap transplantation for addressing the

Page 5 of 14 existing inequalities in the healthcare system.

11. Learned senior counsel for the petitioner further submitted

that the capacity for organ transplantation must also take into

account the fact that the number of registered hospitals under

the 1994 Act and the 2014 Rules is abysmally low and almost

non-existent in some States. It is submitted that in some of the

States like the States of Jharkhand, Meghalaya, Mizoram,

Nagaland, Sikkim and Union Territories of Andaman and

Nicobar Islands, Ladakh and Lakshadweep, no government

hospital is available for carrying out organ transplantation. It is

accordingly suggested that the Union of India through the

NOTTO and in consultation with the States must evolve a five-

year plan to address these concerns and ensure that hospitals

are equipped with facilities and doctors, meeting the standards

as required under the 1994 Act and 2014 Rules in every State.

It is further stated that the said plan must also account for the

per capita transplantation requirements in larger States and

suggest measures for increasing the capacity as well as

awareness across the country regarding organ transplantation.

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12. We are also informed that the allocation criteria, which is

made by the States under Rule 31(4)(f) of the 2014 Rules differs

from State to State. It is submitted by the learned senior

counsel for the petitioner that while the criteria may be

reasonable in each State, the lack of a national policy allows for

“gaming of the system” by a select few who have the resources

and capability to register in different States. It is submitted that

the allocation criteria does not address concerns of gender,

class and region thereby resulting in discrimination, which is

impermissible. The learned senior counsel submitted that the

High Court of Gujarat has struck down the requirement of

domicile for registration for transplantation in the case of Vidya

Ramesh Chand Shah v. State of Gujarat1. It is further

submitted that a uniform national policy is imperative to secure

the substantial right to health. He submits that the Union of

India as well as the States/Union Territories should play a

cooperative role in facilitating organ donation/transplantation.

13. In response to the concern expressed by this Court when

the matter was heard yesterday that many a times the live

donors are left in the lurch after they donate their organs, 1 (2022) SCC OnLine Gug 2021

Page 7 of 14 learned senior counsel for the petitioner while referring to the

Guiding Principles for Organ Donation laid down by the World

Health Organization, submitted that the guiding principles

mandate that the donor’s concern is voluntary and informed.

He further submitted that the WHO’s guiding principle

(specifically No. 3) provides that live donations are acceptable,

when professional care of donors is ensured and follow-ups are

well organized. In this regard, he refers to the judgment passed

by the High Court of Kerala in the case of Moideen vs. State of

Kerala2 authored by one of us (K. Vinod Chandran, J., as he

then was), wherein the High Court observed thus:

“16...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. There is also an element of risk to the donor who is subjected to a surgical procedure and recovery therefrom. Quests in life are many and varied, for the haves, but for most; the have-nots, it is ‘a better tomorrow’. To loose hope in life and to sell ones own organ to achieve better living conditions is not a happy situation. Live organ transplantation for consideration, other than love, affection for a willing sacrifice, is abhorrent to the concept of a healthy, civilized society.”

2 (2017) SCC OnLine Ker 21219

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14. It is relevant to note that the Kerala High Court notices the

WHO’s Guiding Principles for Organ Donation and holds that

“Truly altruistic motives will also not be directed against an

individual and life of one is as precious of yet another”.

15. We concur with the view taken by the High Court of Kerala

and hold that though the life of a recipient is required to be

taken care of, equally the life of a live donor who parts with a

valuable part of his body should not be neglected and should be

adequately taken care of after the operation is carried out.

16. In that view of the matter, we find it appropriate that the

NOTTO must come forward with a national policy which also

addresses concerns with regard to the maintenance of the

health of a live donor after the operation is carried out.

17. We have also heard Mr. Tushar Mehta, learned Solicitor

General of India and Ms. Archana Pathak Dave, learned

Additional Solicitor General of India.

18. We must place on record our appreciation for the learned

Solicitor General of India as well as learned Additional Solicitor

General, who have assisted this Court by not treating the

present petition as an adversarial litigation. We must also

Page 9 of 14 place on record our appreciation for the Union of India as it has

acted in a collaborative manner with the petitioner to arrive at

practical solutions for the issues raised in the petition.

19. In light of the above, we issue the following directions:

i. We request the Union of India to persuade the State of

Andhra Pradesh through its Chief Secretary or the

Principal Secretary of Health to adopt the

Transplantation of Human Organs (Amendment) Act,

2011 by explaining to them the importance of such

adoption.

ii. We also request the Union of India to, in a similar

manner, persuade the States of Karnataka, Telangana,

Andhra Pradesh and Manipur to adopt the 2014 Rules.

iii. We direct the Secretary, Health and Family Welfare,

Union of India to personally monitor the aforesaid

points contained in sub-paragraphs (i) and (ii) of this

paragraph.

iv. The Union of India is directed to constitute a SOTTO for

the States of Meghalaya and Nagaland under the aegis

of National Organ Transplant Program after due

Page 10 of 14 consultation with the concerned States.

v. The Union of India through NOTTO is requested to

evolve model allocation criteria in consultation with all

the States so as to ensure a uniform national policy for

transplantation. The uniform national policy guidelines

must include provisions to alleviate the concerns with

respect to gender, class and regional discrimination and

provide appropriate remedial provisions for the same.

The policy must endeavor to have uniform criteria for

the registration of patients, donors and formats

throughout the country.

vi. We also request the Union of India through Ministry of

Home Affairs in consultation with NOTTO, Ministry of

Health and Family Welfare and the petitioner-

organization to consider amending Form 4 and Form 4A

of the Registration of Births and Deaths Rules, 1999 so

as to include a column on whether the deceased was a

case of brain-stem death and if that be the case to

indicate whether the option to donate organs was given

to the relatives of the deceased.

Page 11 of 14 vii. We further request the Union of India through NOTTO

to evolve national swap transplantation guidelines in

consultation with all States to implement Section 9(3) of

the 1994 Act. The swap transplantation guidelines

should be on a national level providing equal

opportunities to all the persons for swap and must be

done digitally through an accessible web portal.

viii. The Union of India through NOTTO in consultation with

all the States/Union Territories is requested to develop

transplantation facilities where there are inadequate

public health facilities. Further, the Union of India

through the NOTTO is requested to develop a five-year

plan mapping the course for development of

transplantation facilities in India.

ix. We further request the Union of India to take on board

all the States/Union Territories through the NOTTO and

evolve guidelines for welfare of live donors, including

measures to ensure an informed and voluntary consent,

maintenance of a portal, mandatory follow-up with the

doctors and to ensure they are cared for. This is to

Page 12 of 14 ensure that commercialization and exploitation of

donors is prevented.

x. We request all the States/Union Territories to ensure

that data related to organ donation and transplantation

along with the details of donors and recipients of organs

and tissues is reported by the concerned hospitals to

the national registry maintained by the NOTTO as

mandated under Section 13D of the

1994 Act.

xi. We further direct all the State Governments/Union

Territory Administrations to ensure that strict action is

taken against the defaulting hospitals, who fail to

furnish the data as has been directed by us in sub-

paragraph no. (x) of this paragraph.

20. We reiterate our appreciation for the Union of India, the

Solicitor General of India and the Additional Solicitor General

of India for not treating the present matter as an adversarial

litigation and assisting the Court in a collaborative manner. We

also place on record our appreciation for Mr. K. Parameshwar,

learned senior counsel, and his assisting counsel, who, despite

Page 13 of 14 not possessing any expertise in medical field, have assisted us

in passing the aforesaid judgment on the basis of their deep

research and dedication.

21. The matter be placed after six months, preferably before a

Bench of which K. Vinod Chandran, J., is a member.

.…………..................CJI.

(B.R. GAVAI)

.……………...................J. (K. VINOD CHANDRAN)

NEW DELHI 19th NOVEMBER, 2025

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