Laws in India

Healthcare
208 Authority
the makes
or the Appropriate cognizance
Government take if
can likewise the
io orState The Court or social organization who
complaint.
is made
by any personabout the offence, to the
objection the
prior-notice the
a 15-days mentioned
and has also intention
on
Yn i Appropriate Authority
b gives
If the Appropriate
Authority
failsto
od to the Court. can
person move
days, the the
02o to complain
within fifteen complaint, ma
BA s take any action receipt of such alI may
The Court on to submit the
Court hinmself. relevant
Authority
the Appropriate
direct the Court.
them to the
records available with
Rules, 2014
PC&PNDT (Amendment) by the PC&PNr
1996 have been amended
The PC & PNDT Rules, of sex selection
fortheprohibition
2014 to provide
(Amendment)Rules, of pre-natal diagnostic
and for regulation
before or after conception, abnormalities or
the purposes of detecting genetic
techniques for orcertain congenital
disorders or chromosomal abnormalities
metabolic etc.
linked disorders
malformations of sex
Court, while
In FOGSI v. Union of India
Ors.", The Supreme & &
Federation of Obstetrics
the writ petition filed by
dismissing the constitutional
of India (FOGSI) upheld
Gynaecological Societies for penalties
the PC&PNDT Act which provides
validityof Section 23 of
errors regulating the provisions
for anomalies in record keeping/clerical of the Act
of the Act. The Court held that
any dilution of the provisions
of the Act to prevent
or the Rules would only defeat the purpose 21 of
of life of a girlchild under Article
foeticide,and relegate the right
Court further observed that
the Constitution to a mere formality. The
non-maintenance of records is notmerely a technical
or procedural lapse
significant piece of
in the context of sex deternmination;it is the most
record is not
evidence for identifying the accused. If a detailed
maintained, then the violations can never be detected and it
will,

therefore,defeat thepurpose of the whole Act.

Transplantation of Human Organs

commonly that thousands die in
It is seen of healthypeersons
accidents, while a comparable number of patients die in hospitals
waiting for health organs that they are to receive via transplant. Win
thedevelopment of scienceand technology, themedical sector hasmade
tremendous advancement and organ transplantation has evolved as

an established technique to save the lives of

people
who would

89. Federation &

of Obstetrics & Gynaecological Societies of India(FOGSI) 7
Union ofIndia
v.
leiOrs., MANU/SC/0663/2019
 The
transplantationof
human organs andtissues
die act, 1994 209
due to
therwise and organ
the last failure.
Many people
failure0 option of suffer from organ
The treatmnent for
transplantation. Governments
laws as to of them is organ
different different
encourage and countries has adopted
and permit organ
transformation effective
stepsare donation and
misused. takento ensurethat
is not People suffering
from organ the system
benefitted
through organ failureare
transplant immensely
ofhealthy
transplantableorgansis [Link] the availability
scarceas
the Governments aretaking compared I with the demand,
effective steps to
ever- increasing demand by regulate and meet this
adequate legislation.
Organ Transplantation Law in India
In India,
organ transplantation
technique developed
the past century
of during the
Jast quarter around 1970's and eversince then,
a demand from various there
has been
quarters such as social workers,
national
bodies. and medical as
well as legal
expertsforra
a comprehensive
legislation on organ transplant especially with a view to prevent its
misuse by commercialisation

Asheld by the Supreme Court in a number of cases?", 'right to

health' is an integral
part of right to life' under Article 21 of the
[Link] of human life is of paramount importance.

Organ transplant technology has emerged as a gift of life to people

suffering from organ failures. It has enhanced chances of survival and

ability to lead a healthy and prolonged life.

Organ transplantation is a surgical device by which the diseased

organ of the person is removed and
replaced with a healthy organ. The

healthy organ may have been donated

by a live person or it may also
a dead donor. The law relating to transplant of human organs
to
be of
inthe Human Organs and Tissues Act, 1994.
needypatients is contained

of Human Organs and Tissues Act, 1994

Ihe Transplantation
(THOTA) of
for the transplantation
Prior to 1994,there
was no legislation of

The Bill on Transplantation

human Organs and tissues in India. May, 1994 an
by Parliament on 5th
Human
man Organs% was passed 25
1994. It is an Act comprising
received President's assent
on 8th July contents
Chapters. The break-up of the
sections spread over Seven
ailmernts.
failure are
common
Santha, AIR
pancreas and
intestine V.P.
90. v.
liver, lungs, heart, Medical Assn
1978 SC597,
Kidney,) Indian
91.
Maneka Gandhi v. UOI, AR Human Organ
1996 550 of
etc. asthe Transplantation of Human
92.
The Rules under the Act were framed by the Transplantation of the Act.
replaced
implementation
Rules, 1995 which were subsequently the effective
& Tissues Rules,2014to facilitate
Organs
 Healthcare
Lawsin India
210
and
follows - (title,
commencement definitions;
- Preliminary 2)
Chapter I 1 and
Sections of Human
for the Removal Organs
II - Authority to 9)
Chapter
(Sections3
(Sections
10 to 12)
of Hospital
Chapter II -
Regulation
(Section 13)
Authority
Chapter IV
-
Appropriate
(Section 14
to 17)
of Hospitals
Chapter V -
Registration
18 to 22)
-Offences &
Penalties (Section
Chapter VI 23 to 25)
(Sections
Chapter VII
-
Miscellaneous
or removal, storage and
regulation
The Act provides for and tissuesfor therapeutic purposes
of human organs and tissues
transplantation in human orgarns
dealings
ofcommercial
and forprevention organ donation and
the Act is to streamline
The main objective of
activities.
transplantation death thoueh
brain death as a form of neurological
The Act accepts of his organs is permissible
isnot really [Link] donation
the person donation by brain-dead
Act. The only change in the organ
under the of death before the
the absence of declaration
organ donor would be
organs are recovered.
of organs as punishable
The Act makes the sale and purchase in the Act to curb illegal
controlmechanismn
[Link] is an effective
The main features of the
and 'unrelated' donation activities. are as follows
organs & Tissues Act, 1994
Transplantation of Human
donate organ Person who can donate
-
(i) Persons who can
include near relatives,
organs without any legal formality
son, daughter and
namely, mother, father, brothers, sisters
are also included in the
spouse. More recently,grandparents
nod list of close relatives.
eer ot so

(ii) Brain death declaration - It needs certification from two

nominated by the appropriate authority (AA)
ofthe
doctors
Government, one of them must be an expert in neurologY.

(iii)Authorization Committee to Regulate Transplant Activite

The Appropriate Authority (AA)in each state or unio
-
territory would form an Authorization Committee (AC).The
role of this Committee
is to regulate the process
the
and
nossl o authorization approve or reject transplant betweenThe
A stlo recipient and donor other than the first relatives.
 The
transplantation of human organs and tissues act, 1994 211

Committee has to
ensure that the
monetary coonsideration donor is not exploited for
or
application submitted pressurised in any way. The joint
by the
scrutinised by holding recipient and the donor is
personal interview and
about the potential risk explaining them
involved in transplant Such
information about approval surgery. 5ucn
or rejection issent to the
concerned by the Authorization hospital
Committee.
iv) Role of Appropriate
Authority (AA)- The Appropriate
Authority under section 13of the
Act has an imnportantrole in
regulating the removal, storage and
transplantationof human
organs and [Link] is only after getting
clearance from the
Appropriate Authority (AA), that a hospital can
perform
dntransplantation surgery and treatment.
However, theremoval of eyesfrom a dead body of a donor
does not require such licensing or permission from the
Appropriate Authority.

The Appropriate Authority (AA)is empowered to inspect

Oand grant registrationto [Link]
license so issued by the Appropriate Authority (AA)shall be
valid for five years. It can however, be renewed on expiry.

Most importantly transplant of each organ requiresa

separated license.

(v) Procedural formalities - The transplantation of the Human

and the
Organs & Tissues Act, 1994 lays down the procedure
entire formality requires filling up of as
many asthirteen forms
Organs Rules, 1995 as
as per the Transplantation of Human
amended in 2008.
rejection - The Authorization
(vi) Reasons for approval or reasons forrejecting
Committee (AC)should statein writing its

donor and all

the application of the proposed
or approving conditions -
subject to following
approvals should be to
proposed donor would be subjected
(a) The approved stages of the
tests as required at relevant
medical fitness and capacity
procedure to determine his biological
Done
in question.
to donate the organ
thepsychiatrist who
to seek clearance from
(b) Itismandatory awareness,
0
sisitig would certify donor's
absence of any overt
mental condition,
diseases and
or latent psychiatric
of organ.
consent for donation
give free
abilityto
 212 Healthcare Laws8 in India

The
final decision
law expects that the Authorization Committee (AC)must
as to rejection/ approval of organ transplantation
) take

Every Authorization centre must 1 have within

24 hours of its meeting. its
The decision of the AC must be displayed on the notice own

.
website.
board
of the hospital concerned within 24 hours of making the decision.

Authorization Committees may be set up at various levels.

In big

)
cities they may be hospital-based Authorization
Committee
whichshal
consist of

Medical Director/Superintendent of the Hospital;

(ii) Two medical from the same hospital who are not
practitioners

part of the transplantation-surgery

team.
o

(ii) Two members of social standing, credibility and integrity; and

(iv) Secretary, Health or his nominee and Director Health Services

or his nominee

Commercial Dealings in Human Organs Transplantation

Commercial dealings in human organs has been made a punishable
offence under Section 19 of the Transplantation of the Human Organ
Act, 1994 which provides that whoever -
(a) makes or receives any payment for thesupply of, or for an offer
to supply any human organs; or

(b) seeks to find person willing to supply for payment any human
sSE organ; or

(c) supply any human organ for payment; initiates or

offers to
negotiatesany arrangement involving the making of any
payment for thesupply of or for an offer to supply,any human
organ; or

(d) takes part in themanagement or control of a body of persons,

ls bos whether a society,firm or a company, whose activities consist
of or include the initiation or negotiation of any
arrangement
referred to in clause(d);or

)
(e) publishes or distributes or causes to be published or distributed
any advertisement

invitingpersons to supply forpayment of any human organ

orlw te (ii) offering to supply any human organ for payment;

(ii)indicating that the advertiser is willing to initiate o

negotiate any arrangement referred to in clause (d).

recipie and conor other thon celative

 Donor's
consent for
organ
removal forimplantation • 213
shall be punishable with
punishment for a
five years but which term which shall not be less
than may extend
to ten
Provided that Court
years.
may, for
in the adequate and special reasons to be
mentioned judgment, impose a
sentence of less than five years
imprisonnent.
Section 21 provides
punishment where the offence
is committed
bya company or a corporate body.
The director,
other officer shall be liable for manager, secretary or
to him. any connivance or negligernce if
attributable

Grtion 22of the Act lays

down that (1) no Court shall
offence take cognizance
of any under this Act except
on a complain made
byi
(a) the Appropriate
Authority (AA)concerned, or any
authorised in this behalf by other
theCentral Government orthe
Government, as the case may be; State
or
(b) a person who has given notice of not
less than 60 days, in a
manneras prescribed, to theAppropriate
Authority concerned,
of the alleged offence and
of his intentionto make a
to the Court. complaint

The offence under theAct istriable only by the

Court of theJudicial
Magistrate of the First Class.

The earlier two enactments,namely, theEar Drums and Ear Bones

(Authorityfor use for Therapeutic Purposes) Act, 1989 and the Eyes
(Authority for use for therapeuticpurposes) Act, 1982 are hereby

repealed by Section 25 of the Transplantation of Human Organs &

Tissues Act, 1994.

Donor's Consent for Organ Removal for Implantation

The Transplantation of Human Organs Act, 1994 recognises the
brain-stemndeath, facilitating cadaver-based» kidney transplant
procedure after obtaining proper consent. The law permits organ
donation for transplantation by two categories of donors, namely-

(1) Donor who is close relative such as spouse, parents, siblings

etc., and
(2) Donor by reason of
who is not a relative but consents to donate
the recipientor for any other
affection, or attachment towards
deal, provided prior
Special reason, except a commercial
Committee has duly been
permission from the Authorization
obtained.
93. It is
known as Shav Adharit Kidney Pratyarapan (d
 Healthcare Laws in India
214
Advisory Committee and
constituting
The Act also provides
for and Storage Network
and Tissues Removal
prohibited under the
'National Human Organs organ isstrictly
human a duty on
t he Appropriate
Trading kidney or any
of
and imparts
offence organ transplant
law and it issa cognizable or unauthorised
that no illegal
Authority to ensure

takes place. of the deceased (dead

the consent
In case cadaver donation,
of
forremoval of his/her organs
person) before his death is a prerequisite

after his death.

of organ transplantation
may be either "on
consent' in the context
in" or 'opt-out' or 'mnandated'.
giving explicit consent
by the donorbefore
Tot opt-in'consent implies for transplantation. On
the
in the activity of organ donation
engaging donor
consernt by default, unless the
other hand, 'opt-ou' consent is
rejects the request
and withdraws the consent later.
consent requires an
In the context of organ donation, 'mandated
or not he/she
individual to make on advance decision as to whether
death.
wishes to donate his organs in the event of his/her

However, in India, only 'opt-in' form of consent for retrieval of

organs from the deceased is needed. It simply means authorization to

removean organ of a deceased person.

Restrictions on Removal and Transplantation of Human Organs
Section 9 of the Act sets out the procedure and norms for
transplantation of human organs and regulating the procurement of
organs for transplantation. It also provides curbs on organ sale.
However, the restrictions under section 9 for
procurement of organs
for transplant do not entitle all the End-Stage
Organ Failure (ESOF)
patients to procure an organ donor. This
category of patients is excluded
from transplant treatment by virtue of provisions of
Act. Therefore
section of the 9
ESOF
category of patients have solely
to depend on
cadaver organ donation and if such
donor is not timely available,the
ESOF patientisbound to die waiting for
the transplantable organ. Thus
it seriously
contravenes thewell settled
Article21)ensures 'right principle thatright to life
to health and (under
self preservation
healthcare as also the right to
to everyone.

d vinb
eaitsorityhoo oleeieg
94. Section 3(1) of the
Transportation of Human Organs & Tissues Act, 1994 (
(THOTA)
 The THOTA (Amendment)act,
2011effective from january2014
215
t Co-ordinators
and
Organ retrieval
Transplant
The hospitals engaged in organ
transplants and related activities
with organ donation/retrievalcentres
along las per Section 14 of the sare required to be registered
hospitals or centrescan be
Act. Such
as mandated
only if they have who
registered
appointed Transplantt Co-ordinators",
work forincreasing the
would cadaver donor organ pol.
Section 14(3) of the THOTA,1994
specifically
those hospitals//centres
provaich
would beregistered under the Act, which have
have
Iservices and facilities and
adequate skilled man-power and
specialised
ofthe prescribed standard
equipments necessary forremoval, storage
ttransplantationof any human n organ or tissue or both fortherapeutic

purposes.
The National Organ and Tissue Transplant Organisation
India, the Transplantation of Human Organs and Tissues

THOTA) was enacted with the intentto provide a snmooth procedure

for organ and tissue transplant so that patientssuffering from organ

failure could be saved. Butthelaw has not been able to fill up thehuge

gap between the demand and supply of organs donors. Every year
thousands of patients die of end-stage organ failure (ESOF).Taking
note of this factual situation, the Directorate-General of the Health
Ministry of the Government of India has set up a National Organ and

Tissue Transplant Organisation (NOTTO)

in November 2015 in Delhi
with a view to ensuring that ESOF patients do not die for want of a
transplantable organ.

The THOTA (Amendment) Act,2011 Effective from January 2014

Act, 1994 was
The Transplantation of Human Organs and Tissues
2011 (Act 16 of 2011) with effect
amended by the Amendment Act of
trom 10th January 2014,which
provides that human organ or tissue or
without the prior approval
both shall not be removed and transplanted
f the Authorisation Committee (AC).

theperson competent under

The Amendment Act furtherstates that
of any human organ or tissue
this Act
to give authority for the removal
or both, he has reason to believe that such
from dead-body, may if
be required for the purpose for
human organ or tissue or both will not withdraw
post mortem examination,
which such
body has been sentfor done from
transplant can be
The cadaveric organ donor
Such co
consent.
'brain before heartstops
beating. solssss&
stem dead' persons

[Link] 14(4) of THTA, 1994

 Z16 Healtheare Laws in India

Transplant Scandals
Some Intriguing Human Organ
Uttar Pradesh Police on 24
The Joint-teamnof Haryana and January
house at Gurgaon
2008raided a residential building and guest owned
unearthed an illegal kidney racket. at a
by one Amit Kumar and local

clinic which was going on for the

past seven years. The donors were
for kidney removal. The
lured with an offer of 30,000 rupees doctors
transplanted nearly 500 kidneys. Tha
involved in the racket illegally

donor was paid$ 1000for the kidney which

was sold and
transplanted
|
in the recipient fora charge of $ 37500 from him. The culprits wera
booked under various provisions of the Transplantation of Human
fiveot
Organs Act, 1994and theSpecial Court convicted and sentenced
the accused persons on March 22,2013. The kingpin of the Scandal, Dr
Amit Kumar and Dr. Upendra Kumar were sentenced to seven years
rigorous imprisonment and a fineof rupees six lakhs each.

India'sslum dwellers are the easy targetsfor organ traders as they

agree to sell theirorgans under the compulsion of poverty. Surveys
show that a healthy kidney is sold for Rs. 50,000/- for transplantation.

Similarly,thePunjab police unearthed whatthey called the"mother

of all scandals in human organ trafficking in India"and arrested several
doctors, middlemen and donors, the kingpin of which was transplant
surgeon Dr Praveen Kumar Sareen who was running a private charitable
clinic. The Chairman of theAuthorisation Committee Dr.0.P. Mahajan
who was the Principal of the Government Medical College, Amritsar
was also involved in the scandal. He issued certificates that no
commercial transaction was taking place. The scandal was operative
for nearly 5 years from 1997 to 2002 and nearly fifty
millions rupees
changed hands between the accused doctors, middlemen and donors.
Investigationinto thecase revealed that most of the addresses of donors
and recipientsin the records were fake.

Though Section 18 of theAct provides stringent

punishment forthe
offence under the Act which may extend to
ten years of imprisonment
and finewhich may extend to 20 lakh rupeesfor
illegal removal of human
organ without lawful authority,but the
illegal trading in human
still continues because
organs
more than 90 per cent of the donors
fighting
poverty are lured into donating their
organs for fat the
amount.
Yet another kidney racket was
reported on 4h January 2013
Dharmapuri district of Tamil Nadu when the n
Kumalgod Police of
Bangalore registered a complaint
againstthe accused persons who
carrying on the illegal were
kidney trade for years. Five in
this racket were arrested on June 11, 2013. persons involved
Investigationsshowed that
 Judicial
decisions on THOTA • 217
were exploiting the
they poor and
trade. The racket unemployed persons to sell kidney
for organ was allegedto
be
idney sellers
andl aroun75 were lured by theoperating for eight years
Decisions on racketeers
Judicial
THOTA
The Judiciary, on its part,is
offillegal making all out efforts to curbthe
menace human organ trading
writ
writ [Link] through its juudgments and public
interest many of thejudgments,
for the abuse Courts
Courts have expressed
disapprobation the medical of
technique for organ
transplantation which was developed to
save lives of people suffering
from end stage organ failure leading
ultimately tothe
exploitation the
poor.
In Balbir Singhv. Authorisation
Court held that
Committee
Delhi High & Ors,%, the
particularlyin kidney (rend)
transplant cases,the poor
personssare
exploited either inthe garb of donation, affection
or special
ircumstances with active
connivance and involvement of medical
practitioners, and organ transplantationis done formoney
in a consideration
clandestine manner. There are even
cases where gullible
are become victims of donors
deception in the name of treatment. The
held that the
Court
judiciary through its decisions has to
stop this misuse of
the THOTA Act by awarding stringentpunishment to the
culprits.
The SupremeCourt in Kuldeep Singh v. State
TamilNadu", iterated of

that the intriguing question of

genuineness of the donor's willingness
to donate theorgan
mustbe thoroughly examined by the Authorisation
Committee before grant of permission for
organ transplantation,The
Court held that the Judiciary should
also intervene effectively in matters
relating to grant of approval by the
Authorisation Committee and
whethertheCommittee had complied with the
provisions of processing
the applicationfor donation of organ 98
in case of emergency.
In Marium Nathira v. Union f India Ors.9 the petitioner wife &
Wanted to undergo kidney transplant operation with the help of her
husband who was prepared to donate one of his kidneys and
prayed
tnat the Authorization Committee be directed to permit the
petitioner
to undergo
Renal Transplant. It was also submitted thatthe petitioner
and her
husband had undergone all the requiredtests and tissues
Ching
a
kidney. .
and the doctor had
The documentary evidence
ascertained thather husband could donate
of relationship as husband and

96. AIR 2004

Del 413
,AIR 2005SC 2106
98.S.
M Karnataka, AIR 2005 Kant 74
E
Maligamma alias Malligavva & Anr v. State
of
9.
MANU/TN/2786/2013
 218 Healthcare Laws in India

argued that sections 9(2)

wife wassubmitted. It was further
also
and
clear that only in case i
9(3) of theTHOTA (Act) make it amply
involving
recipient, there is need to go
'non-near related' donor and through the
from the
process of obtaining requisite approval
Committee. Similarly,clause 6B of Transplantation
Authorisation
of Human On
Organs
Rules, 2008 applicable only
is to unrelated donors and all
foreigners
but not for the cases involving near
relative donor/recipient, asin
the
present case.

In view of these facts,the Court directed the Authorisation

Committee to expedite the process of approval enabling the petitioner
the undergo Renal (Kidney) transplant operation within a period of
one week. The process of approval must be expedited. The petition was
accordingly,allowed.

important decision handed down by theHigh Court of Kerals

in Moideen E. [Link] of Kerala & Ors.10, it was held that "sacrifice" is

profoundest of all human emotionswhich is innate in every living being,

to live on. The petitioners in these 16 writ petitions were persons who
were disabled with renal (kidney) complaints and needed kidney
transplant according to their doctors. The petitioners wee seeking
permission to make publicationsin print media, seeking a kidney from
willing altruisticdonors from [Link] Court permitted such
publications and held that the THOTA (Act) did not prohibit such
publication solong as it does not invite'supply for payment or offers
such supply' or indicate willingness to initiate or negotiate any
arrangement, in view of Section 19(1)(f) of the Act.

The Gujarat High Court in Vidya Ramesh Chand Shah v. State of

Gujaratio1held that the law giving preference to persons who are

domiciled in the statefor cadaveric organ transplant (transplantafter
death of donor) is illegal and arbitrary.

In this case, the petitioner was an Indian Citizen brought up in

Madhya Pradesh but was Gujarati by descent. She was sufferingfrom

'CIRRHOSIS which had reached end stage and required immediate
transplantation on urgent basis. Her son and daughter both were
rejected as donors on medical grounds. Therefore, the petitioner was
left with no alternativebut to go forcadaver donation. When she applied
for registrationunder the THOTA (Act) she was registered in the
non
domicile list asper Gujarat Guidelines, which said priority will be given
to the domicile residents and it is only after that list is exhausted, the

100. MANU/KE/2257/2018
101. MANU/GJ/2361/2022 2013 inveceeseeskds
 Judicial decision8on THOTA 219
be offered
will to
organ non-domicile list. Being
Guidelines, she moved the aggrieved by these
Gujarat Court for a writ of mandamus.
The Court allowed the petition and held the Guidelines
and discretionary, which
Gujarat
arbitrary deserved to be set aside as modified.

contended
In Jagat
Narain
that his wife who
Choube
was
& Ors. v.
Achal
Sepaha & Ors. ,the appellant
undergoing dialysis sat Gandhi Medical
,
Bhopal, had been advised
College, idney transplantation to be done
but prior to this,
in Chennai several tests such as HLA
typing tissue-
had to be done for
cross matching which she was referred to Dr. Achal
Sepaha
and Choithram Hospital, Indore
(Respondents 1 and 2), which
testing
had these facilities. The
respondents, aftertesting advised the
aetitioner's kidney transplantationcould be done at Choithram
Hospital
and there was no need to go
itself to Chennai for this purpose.
Respondent, Dr. Sepaha further advised the petitioner
that as per
statutory provisions pertaining to organ
transplants,only a relative
coulddonate the kidney and that the blood group of his ailing wife
matched only with that of her son who was too young to donate
his
kidney. He was also told that his wife could be cured through regular
treatment and she might not need dialysis or kidney transplantation.

She was accordingly admitted to Choitram Hospital, Indorewhereshe

died allegedly due to gross negligence of the respondents.

The petitioner moved the State Consumer Disputes Redressal

Commission, Madhya Pradesh (SCDRC)which dismissed thecomplaint
as the opposite parties (respondentdoctor and thehospital)successfully
proved that it was a terminal or end-stage case and the patient could
not be saved despite due attention and care.
Aggrieved by the order of the State Commission,the appellant
found
moved the High Court. The High Court after perusal of records
that it was fully established that the complainant's wife was a patient of

Chronic Renal Failurewith Pleural effusion. When

she came to Choithram

Hospital, Indore, and her kidney was totally

[Link] such a
case of end may die even with dialysis as it
stage renal failure, a patent
ls its own effect. had treated the patient with all possible
Dr. Sepaha
circumstances, therespondents,
areand attention and therefore,in these
in any way.
1&2(opposite parties) cannot be held negligent
of Delhi,the petitioner
sought
InNeha Devi [Link] of NCT medical
to relevant
donate her to her ailing fatherand presented
kidney

102.

103. MANU/CE /0129/ /2013els sse 81SSNKAMSSros 0E

MANU/DE/2300/2022
 Laws in India
Healthcare
220 is recommended.
that a transplant to donate Butshe
which suggested ready and willing her
records she is
being processed
that although was not organ
contended since
the application of no the
to her father, on a submission
is insisting objection
which was not
hospital practicable or
respondent her husband, possible
from were estranged.
certificate with husband sheTherefore,
becauseher
relationship
her kidney
to father without
give
permitted to and the obtairing
should be from her hhusband hospital be
and authorisation at the
permission of her father earliest as
operation any
directed to
conduct the
be fatalto the patient.

.
in operation could
further delay
was whether the act of
question before the Court the
The from petitioner's
on authorization husband was
respondentininsisting Rules, 2014.
per Rule 18
as of the THOTA
valid
a
THOTA (Rules) 2014 does not require
Held, Rule 22 of
to be sought from the husband, the
objection certificate'

requirement in case of married

woman donor is that her independont
other than the beneficiary.
consent be verified by someone

since delay
Moreover, operation was likely to cause loss of life
in

of the petitioner's father, the respondent

(hospital)should not dismissed
her prayer only for the reason that the spouse's no objection
certificate

was not produced.

The observationmade by the Supreme Court in the landmark case
Common Cause (A Regd Society) v. Union ofIndia and Others", deserve
special mention in the context of saving life through the technique of

organ transplantations.

The Court observed:

"Modern medical science has contributed in a

significant way to enhancing the expectancy of

life. Equipped with the tools of knowledge,

medical sciencehas shownthe ability to
reduce
or prolong life. Yet, in its ability to
extend life,
medical sciencehasan impact on
quality of lite
ason the nature and extentof
human suffering.
The ability of science
to prolong life mustface
an equally important concern
over the ability
of its impact on quality of
life. While medical
sciencehas extended
longevity, it has come with

104.2018/
INSC/223
Maharashtra
:
& Ors.,MANU/SC/2032/2018,see also Ganpatrao
State
and otherssv.
of

MANU/MH/3430/2017
 Judicial decisions on THOTA 221
associated costs of
medical care and
which accompanies theagony
on artificially
Medical ethics must sustained life.
grapple with the need
bring about a to
balanced ability of
extend life with science to
need for science to
allknowledge
must enhance a recognise
existence"105 meaningful
The Court in case noted that Rules
this
have been framed under
Rule
24 of THOTA Rules, 2014 where form of
FORM authorisationfor organ
or tissue pledging
is
7, which
provides that an authorisation by
of two
donorin presence witnessesis also
o required to be registered
The statutory by
Donor Organ Registry.
is recognition of this authorisation
statute clear indication of
in the
acceptance of the concept of advance
medical
directive in this countryl,
In Siya Omar & Ors v. Union of India & Ors. the petitioner
107
the High Court of Delhi for
approached grant of direction to the
respondent (Government) grantpetitioner, thenecessary permission to
donate a part of her liver to her ailing
fatherwho needed liver
She was a minor
daughter aged 17 years on the day of 2 transplant.
petition.
The petitionersfather was admitted to Dr.
Rela Institute of Medical
Centre,Chennai and was diagnosed
with prolonged liver disease, namely
Non-alcoholic SteatochepatitisCirhosis
(NASH). The end stage of the
disease requires urgent liver transplantation.
The daughter was found
suitable for this purpose. The hesitationon the
part of theGovernment
to grant her permission was her age of
minority.

Since no response was coming from the Government, the

petitioners a writ petition under Art 226 before the High Court.
filed
The petition was however withdrawn as thepetitionerwas desirous of
getting the liver transplant conducted in New Delhi since the Court
had no jurisdictionover Government of NCT, Delhi.

The High Court of Delhi, however, held the screening of petitioner.

And it showed that she could donate part of her liver to her father
Within the criterion prescribed. But theCourt ordered that the
petitioner
AIundergo
AlIMS
liver transplant in a high
volume specialised centre or
where all workup of petitioner may be done in view of
detailed

hsaltety. She could do ather own risk. The petition was thusallowed
holding it was a fit case
to permit organ transplant.

105.
TbidPara
106.
343
Para 569
U.
MANU/DE/0671/2024
222 HealthcareLaws in India

In Modh. Aslam v. State Madhya Pradesh108 a writ

of
petition
Art. 226 of the
Constitution was filed beforethe High Courtcof under
Pradesh, seeking mandamus directing the respondent Madhya
instruct hospitalto immediately perform kidney transplant oper
(Government)
of the petitionertaking into consideration his critical health coperation
cond
condition.
in this case was a patient of chronic
The petitioner
kidney
Iwas required to undergo kidney
transplant operation. For failure th
had already obtained permission under the
THOTA Act, [Link]
transplant operation was required to be performed at
T
Apollo
Hospital. The son of the petitioner named Mohd Aman was Sage
regularly
persuading thegovernment forperforming kidney transplant.
However
the respondent was not giving any positive
response to the petitioner
and his family members.
The High Court held that thesaid hospitalbeing
was not covered under the writ jurisdictionand asa private hospital
such, the Cort
cannot issue any mandamus to the hospital in any
manner. The Court
also cannot issue any suggestion to the
treating doctors to take a decision
contrary to their satisfaction. The writ
accordingly, failed and the
petition was accordingly, dismissed.

In the case of Lata &

Ors v. State o Maharas}htraand othhers1",
the
respondent hospital is a multi-speciality
hospital providing
comprehensive medical services in the city of
Aurangabad
(Maharashtra)across various fields of healthcare. It
strictly observes
laws, rules and regulations and is a
part of 'Medicover group of
companies which isa European healthcaregroup
providing world-class
medical servicesto millionsof people
world-wide. It has successfully
conducted thousands of organ transplant
in India. surgeries across its hospitals

The Medicover Hospital Aurangabad,

successfully performed a
Swap Kidney organ transplantwhen there was no compatible
donor
without the patient's [Link]
they exchanged kidneys where
the kidneys of the donors and
recipient familiesmatched.
In theinstantcase the
transplantoperation took place in
2023 in which there was hyper November
acute rejection of transplant.
The Court held that in view of the facts
and
circumstances of he
case,thecharge against
respondent Hospital was wholly
and therefore,liable to be unsustainable
quashed. The patient's
lymphocyte cros
108. MANU/MP/0608/2024
109. MANU/MH/1322//2024; See also Mulkh Raj & &Ors
MANU/CF/0321/ 2018 Ors. v. Jaipur Golden Hospital
 Surrogacy 2021 223
(regulation) act,

match
test reportindicated
doubtful negative
results which posed risks
transplant and
forsuccessful possibility of hyper acute rejection.
the rejection and refusal
of transplant
Therefore, operation was based
on medical grounds arnd therefore the
respondent hospital was
solely in not proceeding with renal
justified
transplant in the backdrop of
cross-match.
Inegative
doubtful
Organ Transplantation
National Programme!" (NOTP)
Under the National Organ Transplant Programme (NOTP), a
Level Tissue Bank
(Bio-Material Centre) for storing tissues
National

has
been established at the National Organs & Tissue Transplant
(NOTP)at Delhi. Further, under NOTP, a provision has
Orngarnisation
also been made for providing financial support to the states for setting
of Bio-Material Centre. A newsuchcentre is established at Chennai
up
(Tamil Nadu).
Government of India is implementing National Organ
The
TransplantationProgramme (NOTP) to promote organ donation and
ransplantationacross the country. The provision under theProgramme

include
(1) Setting up of National/Regional/State level Bio-material
Centres;

(2) Financial support for establishing new organ Transplant/

Retrieval facilities and strengthening the existing ones;
Surgeons,
(3) Training to orgarn transplantationexperts including
Physicians, Transplant Co-ordinators.

(4) Financial support for

hiring of Transplantation Co-ordinators

(5) Post-transplant immune-

suppressant drugs to below poverty

line (BPL).
Act, 2021
Surrogacy (Regulation) 2021 to
the Surrogacy (Regulation)Act,
Parliament introduced the rules and
law outlines
surrogacy in the country. The
gulate and aims atprotecting
arrangements in India
egulations for surrogacy the child born through
intended parents, and
e interests of surrogates,
Act criminalises commercial surrogacy
and provides
sUrTogacy. The or intended parent(s).
a surrogate
restrictions as to who can become
Act 2021 consists
of The Act: The Surrogacy (Regulation)
Outline Act are outlined
The contents of the
54sections
of 8 chapters.
spread over
as
follows:

10.
MANU/PIBU/3003/2021