Around the World
On the Way to Self-sufficiency: Improving
Deceased Organ Donation in India
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Vivek B. Kute, DM, FRCP,1 Vasanthi Ramesh, MS,2,3
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and Mohamed Rela, MS, FRCS, DSc4
HEALTHCARE STRUCTURE AND ECONOMICS
Organ transplantation in India to date relies predomi-
nantly (80.3%) on living donor procedures for kidney
and liver transplantation. Heart, lung, pancreas, and small
bowel transplants are therefore less frequent.1-4 There is
also a pronounced gender inequality with a majority of
male transplant recipients (81%), whereas most donors
(78%) are female. At this time, there are limited living
donor follow-up and variable recipient results. Most trans-
plants take place in private sector hospitals with costs that
nearly twice compared with those in the public sector.
India ranks 184 of 191 countries for the gross domestic
product (GDP) spent on healthcare. Based on the World
Health Organization National Health Profile, India spent
only 1.3%–1.4% of its GDP for public health expendi-
tures (2008–2020). In comparison, health expenditures
(% GDP) are significantly higher in developed coun-
tries, ranging from 17% in the United States to 9.2% in
Australia. Approximately 30% of healthcare in India is
funded by the government, whereas 70% is funded out-
of-pocket; 50% of healthcare in the country is provided
by private institutions. Ayushman Bharat Mission—
National Health Protection Mission or Pradhan Mantri
Jan Arogya Yojana has been launched in 2018, the
Received 23 December 2020.
Accepted 23 December 2020.
1
Department of Nephrology and Clinical Transplantation, Institute of Kidney
Diseases and Research Center, Dr HL Trivedi Institute of Transplantation
Sciences (IKDRC-ITS), Ahmedabad, India.
2
National Organ and Tissue Transplant Organization, New Delhi, India.
3 donor procedures in addition to 400 liver [362 deceased
The Department of Surgery, Vardhman Mahavir Medical College and Safdarjung
Hospital, New Delhi, India.
4
Department of Liver Transplantation and Hepatopancreatobiliary Surgery,
Institute of Liver Disease and Transplantation, Dr Rela Institute and Medical
Centre, Bharat Institute of Higher Education and Research, Chennai, India.
The authors declare no funding or conflicts of interest.
V.B.K., V.R., and M.R. have equal contribution to design of the work, acquisition,
analysis, data interpretation from Global Observatory on Donation and
Transplantation, drafting/revision of the work and final approval of the version
to be published.
Correspondence: Vivek B. Kute, DM, FRCP, Department of Nephrology and
Transplantation, Institute of Kidney Diseases and Research Center, Dr H L Trivedi
Institute of Transplantation Sciences (IKDRC-ITS), Ahmedabad 380016, India.
(drvivekkute@rediffmail.com).
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
ISSN: 0041-1337/21/1058-1625
DOI: 10.1097/TP.0000000000003677
Transplantation ■ August 2021 ■ Volume 105 ■ Number 8 www.transplantjournal.com 1625
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<zdoi;10.1097/TP.0000000000003677>
world’s largest healthcare plan, representing the path to
universal health coverage in India. Pradhan Mantri Jan
Arogya Yojana aims to provide health insurance in the
range of 6667 USD (5 lakh Indian rupees) to >100 mil-
lion families representing a population of 500 million
population, with secondary and tertiary care hospitaliza-
tion through a network of Healthcare Providers.5 This
approach may be life-saving for those without the means
unable to cover hospital treatment.
Healthcare plans supporting transplantation include the
Chief Minister Fund, Prime Minister Relief fund, Below
the Poverty Line Scheme, School Health Program, and
Mukhyamantri Amrutum Yojana in Gujarat.
Overall costs for kidney transplantation, including
donor/recipient evaluation and immunosuppression, range
from USD 5000 in the public sector hospital to USD
10  000–20  000 in private sector hospitals.2,6 The cost of
generic maintenance immunosuppression in public sector
hospital is 50% less expensive.6 Moreover, costs for liver
transplant range from USD 15  000 to 20  000 in public
compared with USD 30 000–USD40 000 in private sector
hospitals.2,6
Indeed, financial barriers are more prevalent than
ABO or HLA incompatibility in India.7 Thus, to facili-
tate access to transplantation to those with little financial
means, programs should be offered in each public sector
hospital using key features of other successful programs
such as Institute of Kidney Diseases and Research Center
and Institute of Transplantation Sciences, Ahmedabad,
India, a public sector hospital that has completed 5838
kidney transplants (942 deceased donor and 4895 living
donor and 38 living donor] transplants [1997 to March
2020]).2
TRANSPLANT RATES
Deceased organ donation rates have improved from
0.27 to 0.52 per million population (2013–2019) with an
overall increase of transplant rates from 4990 to 12 666
during the same time period.3-5 Deceased donor organ
transplantation (DDOT) contributed 19.7% of trans-
plants.1,4 Altough deceased donation rates have improved
in the West (Gujarat2 and Maharashtra), South (Tamil
Nadu, Telangana, Kerala, and Karnataka)7-10 and in the
North (Post Graduate Institute of Medical Education &
Research, Chandigarh),11 they remain poor in East and
Central India (Tables 1−3 and Figure 1). T1-T3,F1
 1626 Transplantation ■ August 2021 ■ Volume 105 ■ Number 8 www.transplantjournal.com

TABLE 1.
Global observatory on donation and transplantation: transplants in India (2013–2019)

Y 2019 2018 2017 2016 2015 2014 2013

Population million 1368.70 1354.10 1339.20 1326.80 1311.10 1267.40 1252.10
Actual DD 715 (0.52) 875 (0.65) 773 (0.58) 930 (0.7) 666 (0.51) 408 (0.32) 340 (0.27)
  Actual DBD 715 (0.52) 872 (0.64) 770 (0.57) 926 (0.7) 664 (0.51) 408 (0.32) 340 (0.27)
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  Actual DCD (–) 3 (0) 3 (0) 4 (0) 2 (0) (–) (–)

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Total KT 9751 (7.12) 7936 (5.86) 7334 (5.48) 6958 (5.24) 6555 (5) 5512 (4.35) 4037 (3.22)
 DDKT 1138 (0.83) 1164 (0.86) 1169 (0.87) 1261 (0.95) 984 (0.75) 628 (0.5) 542 (0.43)
 LDKT 8613 (6.29) 6772 (5) 6165 (4.6) 5697 (4.29) 5571 (4.25) 4884 (3.85) 3495 (2.79)
TOTAL LT 2592 (1.89) 1945 (1.44) 1843 (1.38) 1754 (1.32) 1616 (1.23) 1327 (1.05) 898 (0.72)
 DDLT 599 (0.44) 631 (0.47) 579 (0.43) 694 (0.52) 498 (0.38) 325 (0.26) 240 (0.19)
 LDLT 1991 (1.45) 1313 (0.97) 1264 (0.94) 1059 (0.8) 1118 (0.85) 1002 (0.79) 658 (0.53)
Heart 187 (0.14) 241 (0.18) 237 (0.18) 216 (0.16) 118 (0.09) 53 (0.04) 30 (0.02)
Lung 114 (0.08) 191 (0.14) 106 (0.08) 73 (0.06) 51 (0.04) 15 (0.01) 23 (0.02)
Pancreas 22 (0.02) 25 (0.02) 18 (0.01) 20 (0.02) 6 (0) 7 (0.01) 2 (0)
Small bowel (–) 2 (0) 1 (0) 1 (0) 2 (0) 2 (0) (–)
Total transplants 12 666 (9.25) 10 340 (7.64) 9539 (7.12) 9022 (6.8) 8348 (6.37) 6916 (5.46) 4990 (3.99)
Data are presented in absolute number (rate per million population). (–) represents data not available or not applicable.
DBD, donation after brain death; DCD, donation after circulatory death; DD, deceased donor; KT, kidney transplants; LD, living donor; LT, liver transplants.

TABLE 2.
Global observatory on donation and transplantation: DD in India (2013–2019)

Y Population Total actual DD Actual DBD Actual DCD Total utilized DD Utilized DBD Utilized DCD
2013 1252.10 340 340 0 319 319 0
2014 1267.40 408 408 0 385 385 0
2015 1311.10 666 664 2 604 602 2
2016 1326.80 930 926 4 759 755 4
2017 1339.20 773 770 3 725 722 3
2018 1354.10 875 872 3 712 709 3
2019 1368.70 715 715 0 712 712 0
DBD, donation after brain death, DCD, donation after circulatory death; DD, deceased donation.

TABLE 3.
Global observatory on donation and transplantation: transplant volume per organ

Kidney Liver Heart Lung Pancreas Small bowel

Y DD LD DD LD Domino DD Total
2013 542 3495 240 658 0 30 23 2 0 4990
2014 628 4884 325 1002 0 53 15 7 2 6916
2015 984 5571 498 1118 0 118 51 6 2 8348
2016 1261 5697 694 1059 1 216 73 20 1 9022
2017 1169 6165 579 1264 0 237 106 18 1 9539
2018 1164 6772 631 1313 1 241 191 25 2 10 340
2019 1138 8613 599 1991 2 187 114 22 0 12 666
2013–2019 6886 41 197 3566 8405 4 1082 573 100 8 61 821
DD, deceased donor; LD, living donor.

LEGAL FRAMEWORK AND CURRENT STRUCTURE (ROTTO) provide regulatory governmental oversight on
OF ORGAN DONATION: INVOLVEMENT AND the national level.3 SOTTO is responsible for organ allo-
OVERSIGHT OF GOVERNMENTAL AND cation and maintaining of the waitlist; transplant reg-
REGULATORY SYSTEMS istries are governed by the states in India. Organs are
The National Organ and Tissue Transplant allocated based on the following priorities: (1) by states,
Organization (NOTTO) together with the State Organ (2) by regions, and then (3) allocated to recipients of
and Tissue Transplant Organization (SOTTO) and Indian origin on the national list; subsequently, organs
Regional Organ and Tissue Transplant Organization will be allocated to foreigners. There are 28 states and

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 © 2021 Wolters Kluwer Kute et al 1627
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FIGURE 1.  State-wise distribution of DDOT in India. DDOT, deceased donor organ transplantation.

9 union territories in India with a total of 12 SOTTOs, CHALLENGES

5 ROTTO-SOTTOs, and NOTTO (that also operates
as SOTTO for the Delhi NCR). SOTTOs are not rep-
resented in 19 states and union territories. India has a
total of 550 organ transplant centers with the majority
(80%) in private sector hospitals and 140 nontransplant
organ retrieval centers (NTORC).3 To increase deceased
donor donation even in areas without transplant cent-
ers, NTORC can be registered for organ retrieval free
of cost. In general, requirements to establish a NTORC
are based on a 25-bed institution with operation theat-
ers in addition to an intensive care unit (ICU). NOTTO
will provide financial support of Rs 1 lakh (USD 1350)
for the management of potential deceased donors (for up
to 50 donations per year) if at least 1 organ is donated
to a government hospital. Moreover, there is provision
for financial assistance to transplant recipients below the
poverty line who have had a transplant in Government
hospitals at the rate of Rs 10 000 (USD 133) supporting
maintenance immunosuppression.12
Specific challenges include the high burden of patients with
end-stage organ failure, the limited availability of deceased
donors (demand versus supply gap), the inadequate aware-
ness in the general population as well as the medical com-
munity towards organ donation, limitations in accepting,
and declaring brain stem death (brain death declaration).
Notably, ignorance, misinformation, and anxiety on brain
death declaration and DDOT are also rampant in the medi-
cal community. Hurdles to be overcome include a limited
availability of infrastructure, particularly in the government
sector, high costs (especially for the uninsured and poor) in
absence of national healthcare insurance, a lack of a func-
tioning transportation of deceased donor organs, and gaps
in data reporting, especially online entry by hospitals/states
in national registry. Transplanting foreigners with deceased
donor organs continues to be viewed with great suspicion
linked to a lack of transparency on allocation.5 In addition,
inadequate training for grief counseling is an issue that needs
to be addressed.

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 1628 Transplantation ■ August 2021 ■ Volume 105 ■ Number 8 www.transplantjournal.com
BARRIERS TO DECEASED DONATION
Legal
Brain Death Declaration
The Transplantation of Human Organs Act (THOA),
India has been passed in 1994  and amended in 2011 and
2014 to promote deceased and paired kidney donations.13,14
Deceased donor transplantation predates THOA 1994,
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which had been implemented to combat paid organ dona-
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tion. Identification of organ donors, including the request to
donate, the support of transplant coordinators, and national
registries are mandated by law. Organ donations in medico-
legal cases have been simplified, and penalties increased for
any crime related to organ donation. THOA has been in place
now for >25 y, and additional clarifications and improve-
ments will need to be implemented. Moreover, it is relevant
to separate the diagnosis of brain death from the process of
organ donation. Brain death, at this time, is only mentioned
in the transplant law linked to organ donation but not in the
Registration of Births and Deaths Act of 1969. Moreover,
there is a need for a robust national protocol declaring brain
stem death. The World Brain Death Project recommends uni-
form practice by experienced physicians to avoid inconsist-
encies in the practice of brain death declaration performed
by 4 specialized physicians based on guidelines.13,14
Donor Pledge Form (Form 7) Requires a Legal Status
Based on THOA regulations, an organ or tissue donation
pledge needs to be signed by adults. This approach is fre-
quently challenged as close relatives do not necessarily accept
this agreement as legally binding, delaying or even prevent-
ing organ donation. This dilemma needs to be resolved.13,14
At this time, there are no dedicated grief counselors in the
ICU and emergency area. Educating ICU doctors on grief
counseling may increase trust and transparency between
relatives of the potential donor and organ retrieval team/
transplant team.
Cultural
Education and Awareness of Organ Donation
Although blood and cornea donations are well accepted,
most of the general population (75%) are not aware and
sufficiently educated on organ donation. Health workers,
part-time voluntary workers, social media, Information,
Education, and Communication  (ICE)  teams, religious
scholars/faith leaders, and key opinion leaders may have
an opportunity to address myths and misconceptions
related to organ donation. ICE activities include poster
competitions, broadcasting audio messages, video clips on
television channels, information kiosk during trade fair,
newspaper advertisements, and electronic communications
to mobile devices. Nevertheless, the success of educational
efforts will most likely only translate in increased dona-
tions after a prolonged period.
Potential Efforts on the Way to Increase Organ
Donation
Linking organ donation to the application of driver’s
license has been successful in many countries. For India, it
is suggested that all states should provide the opportunity
to pledge their organs while applying for a driving license.
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This effort has only been adapted by a few states, including
Rajasthan and Delhi.
To rapidly disseminate organ donation awareness in the
large population of India, it is suggested that the govern-
ment may request that telecom companies replace mobile
phone ringtones with default caller tune communicating
awareness on organ donation, an effort that has been suc-
cessful in communicating health awareness during coro-
navirus disease of 2019. Linking the celebration of the
Kite festival to organ donation theme is another example
of cost-effective strategy for increasing organ donation
awareness.
Nonfinancial Incentives
Publicly commemorating organ donation through and
offering healthcare to immediate relatives of deceased
organ donors may help increasing organ donation.
Educational
Multiorgan Retrieval Teams and Transplant
Procurement Managers
Transplant procurement managers are healthcare
professionals, mostly ICU doctors trained in facilitat-
ing the process of deceased organ donation. Early and
proactive donor identification management is a prereq-
uisite to improving donation rates. In attempt to meet
the transplantation needs, all intensive, emergency care
communities, and primary physicians should ensure
that their patients are always given the opportunity to
donate their organs after their death. The involvement
of transplant procurement managers is very limited at
present.
Organ Care and ICU Team
The Indian Society of Critical Care Medicine15 and
NOTTO position statement on management of potential
organ donor have laid out clear guidelines to improve
quality of organs before retrieval.5,16 Those guidelines
should be followed by all transplant centers.
Rapid Organ Transport
Each state/SOTTO should have access to a multiorgan
retrieval team facilitating a rapid transport of organs by
road using green corridor or by air thereby decreasing cold
ischemia time and leading to better long-term outcomes.
Transplantation Team
Waiting List, Registry, and Outcome
The organ allocation policy is variable as health care
is in the hands of the states in India. This approach is
challenging as a federal “One Nation and One Allocation
Policy” may allow to overcome any ambiguity. Digital
allocation should be used to avoid any man-made error to
avoid allegations of waiting list manipulation for foreign-
ers and VIP recipients. It is mandatory for hospitals to get
a license for organ donation and transplantation and to
share waiting list and outcome data with the authorities
(SOTTO, ROTTO, and NOTTO). A transparent commu-
nication could be a prerequisite when the hospital license
for transplants is being granted or renewed.
 © 2021 Wolters Kluwer Kute et al 1629

TABLE 4.
Challenges and opportunities1-10

Challenges Solutions for DDOT in India

Awareness Prime Minister highlighted DDOT in “Mann Ki Baat” radio program
“Mobile caller tune, festival celebration, walkathon” on organ donation theme
Religious/faith leaders and nongovernment organization support to overcome religious, sociocultural barriers
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Social media, TV, and digital reforms are quicker, easier, and cost-effective to disseminate DDOT in large
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population in India
Implementing options to organ pledge while applying for a driving license in all states
Include organ donation in the education system syllabus, developing IEC materials as per regional need
Facility for offline and online pledging for donation of organ
GC Mandatory dedicated grief counselors in emergency rooms and ICU
ICU doctors, treating, and primary care doctors should initiate GC/DDOT
BDD BDD needs to be separated from DDOT
Uniform guidelines for BDD by government authority
Mandatory BDD and reporting to state authority
Donor pledge form (form 7) requires a legal status
TPM, ICU doctors All transplant hospitals must have a TPM headed by an intensivist and supported by a team of ICU nurse,
counselor, coordinator, data manager
Early and proactive donor identification and management
Highest standard for donor care with no out-of-pocket expenditure
Increase donor conversion rate with regular e-learning modules
Rapid transport (eg, green corridor, airline, drone) to decrease cold ischemia time
Registry, allocation, Uniform data collection and data management system should be developed at the national level and state level
transplant team organization should have the admin access for state data
Government priority and support to develop self-sufficiency in transplant
Commitment of authorities, institutions, and individuals for pledge, waiting list, and transplant outcome registry
Nontransplant organ retrieval centers license on priority
Government guidelines for donation after circulatory death donors
“One Nation One Policy” for digital organ allocation: must be localized to the state and when the state declines,
it goes to region and national level
Nonfinancial incentives Allocation priority for registered donors and living donors
Honoring family members on organ donation day and world kidney day
Memory tree plantation in honoring organ donors
Social support (cremation rituals), government health card to dependent family members of organ donor
Collaboration, advisory Government authority, transplant collaboration with related national and international societies including
committees The Transplantation Society
State- and national-level advisory committees of experts and government officials and should be engaged in
policy making and revisions
A 24/7 call center has been made operational with provision of a toll-free helpline by NOTTO
NOTTO apex technical committees developed broad guiding principle for allocation
Expand DDOT in Leadership and dedicated transplant team
public sector hospitals Use key features of successful DDOT model (dark green states in Figure 1) to expand DDOT in emerging states
(light green, orange states in Figure 1)
Initiate and expand DDOT for heart, lung, and pancreas
Living and deceased donor advocates to decrease waiting time on DDOT
Training, capacity building Organ transplant fellowships
Local multiorgan retrieval team to avoid delay in multiorgan retrieval by multiple teams
Retrieval teams can be formed with general surgeons and they can be paid on case by case basis
Audit Audit of counseling, brain death declaration, organ donation, utilization rate, and transplant outcome
Accountability of hospitals getting license for organ donation and transplantation and outcome registry
Regulatory oversight of the entire transplant program is the responsibility of the state authority
Root cause analysis of social distrust and lack of awareness
Future Machine perfusion to reduce discard rates
Explicit opt-out laws (presumed consent) to achieve self-sufficiency
Deceased and living donor list exchange
BDD, brain death declaration; DDOT, deceased donor organ transplantation; GC, Grief counseling; ICU, intensive care unit; IEC, Information, Education, and Communication; NOTTO, National Organ and
Tissue Transplant Organization; TPM, transplant procurement manager.

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 1630 Transplantation ■ August 2021 ■ Volume 105 ■ Number 8 www.transplantjournal.com
Government Guidelines for Donation After Circulatory
Death
This rapidly increasing source of DDOT has been under-
utilized in India. The THOA recognizes and supports the
donation after circulatory death (DCD). There is a need to
implement guidelines for DCD donation with input from
professional experts and approval by the government.
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Ethics and Transplant
Organ transplantation should be “financially neu-
tral” in accordance with the Declaration of Istanbul
Custodian Group and World Health Organization prin-
ciples.17 Deceased donor advocates, nonprofit organiza-
tions, and local champions should be regularly trained and
supported.
Role of Nongovernment Organization
The Honorable President of India, Shri Ram Nath Kovind,
applauded Donate Life as an nongovernment organization
in 2018 that has facilitated 488 organ donations (kidney [n
= 320], liver [n = 137], heart [n = 27], pancreas [n = 2], lung
[n = 2]) in Gujarat, India. The Multi-Organ Harvesting Aid
Network foundation has facilitated DDOT in Tamil Nadu
and South India. Nongovernment organizations may be ini-
tiated in each district to increase DDOT.
Education, Collaboration, and Innovation
Regular meeting and updates on DDOT with national
(Indian Society of Organ Transplantation, Indian Society
of Nephrology, Indian Society of Critical Care Medicine)
and international societies (The Transplantation
Society, International Society for Organ Donation and
Procurement, World Health Organization, Declaration
of Istanbul Custodian Group, and International Society
of Nephrology), in addition to a close collaboration with
government authorities and transplant professionals, will
furthermore be necessary to move organ donation and
transplantation in India forward (Table  4). Moreover,
there is need of national standard operating procedures
for brain death declaration, retrieval, packaging, and labe-
ling of organs/tissues, digital allocation algorithms, and
DCD donation. Implementing machine perfusion could
help to utilize more expanded criteria donors. In addition,
list exchanges and national kidney exchange program are
ways to increase organ transplant in India.18,19
CONCLUSIONS
India has performed 12  666 transplants in 2019, the
second-largest volume by country worldwide. Although
most transplants have been from living donors, the coun-
try has made great strides. Main goals in the future will be
a close collaboration by all key players and the necessity
to increase the support of healthcare in the public sector.
Cultural and religious barriers to organ donation need to
be addressed, and educational efforts need to target both
medical professionals as well as the general population.
An expert infrastructure in hospitals needs to assure the
identification of donors and an optimized management.
The allocation of organs needs to be fair and transpar-
ent to assure public trust. The government will need
to prioritize the implementation of deceased donation
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policies. Opportunities of DDOT should be expanded
with dedicated team work. Cooperations with national
and international societies should be enforced to achieve a
self-sufficiency of organ transplantation in India.
ACKNOWLEDGMENTS
The authors are grateful for the editing support that they
have received from Stefan G. Tullius, MD, PhD, Harvard
Medical School, Boston, MA.
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