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On the Way to Self-sufficiency: Improving Deceased Organ Donation in India

Kute, Vivek B. DM, FRCP1; Ramesh, Vasanthi MS2,3; Rela, Mohamed MS, FRCS, DSc4

Author Information
doi: 10.1097/TP.0000000000003677
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HEALTHCARE STRUCTURE AND ECONOMICS

Organ transplantation in India to date relies predominantly (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 transplants 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 expenditures (2008–2020). In comparison, health expenditures (% GDP) are significantly higher in developed countries, 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 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 million families representing a population of 500 million population, with secondary and tertiary care hospitalization 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 facilitate 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 procedures in addition to 400 liver [362 deceased 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 transplants.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).

FIGURE 1.
FIGURE 1.:
State-wise distribution of DDOT in India. DDOT, deceased donor organ transplantation.

LEGAL FRAMEWORK AND CURRENT STRUCTURE OF ORGAN DONATION: INVOLVEMENT AND OVERSIGHT OF GOVERNMENTAL AND REGULATORY SYSTEMS

The National Organ and Tissue Transplant Organization (NOTTO) together with the State Organ and Tissue Transplant Organization (SOTTO) and Regional Organ and Tissue Transplant Organization (ROTTO) provide regulatory governmental oversight on the national level.3 SOTTO is responsible for organ allocation and maintaining of the waitlist; transplant registries are governed by the states in India. Organs are allocated based on the following priorities: (1) by states, (2) by regions, and then (3) allocated to recipients of Indian origin on the national list; subsequently, organs will be allocated to foreigners. There are 28 states and 9 union territories in India with a total of 12 SOTTOs, 5 ROTTO-SOTTOs, and NOTTO (that also operates as SOTTO for the Delhi NCR). SOTTOs are not represented 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 centers, 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 theaters 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

CHALLENGES

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 awareness in the general population as well as the medical community 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 medical 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 functioning 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.

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, which had been implemented to combat paid organ donation. Identification of organ donors, including the request to donate, the support of transplant coordinators, and national registries are mandated by law. Organ donations in medicolegal 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 improvements 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 uniform practice by experienced physicians to avoid inconsistencies 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 frequently challenged as close relatives do not necessarily accept this agreement as legally binding, delaying or even preventing 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 donations 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. 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 government may request that telecom companies replace mobile phone ringtones with default caller tune communicating awareness on organ donation, an effort that has been successful in communicating health awareness during coronavirus 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 facilitating the process of deceased organ donation. Early and proactive donor identification management is a prerequisite 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 foreigners 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 communication could be a prerequisite when the hospital license for transplants is being granted or renewed.

Government Guidelines for Donation After Circulatory Death

This rapidly increasing source of DDOT has been underutilized 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.

Ethics and Transplant

Organ transplantation should be “financially neutral” in accordance with the Declaration of Istanbul Custodian Group and World Health Organization principles.17 Deceased donor advocates, nonprofit organizations, 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 initiated 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 labeling 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 country 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 transparent to assure public trust. The government will need to prioritize the implementation of deceased donation 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.

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)
 Actual DCD (–) 3 (0) 3 (0) 4 (0) 2 (0) (–) (–)
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
Y Kidney Liver Heart Lung Pancreas Small bowel Total
DD LD DD LD Domino DD
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.

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
Social media, TV, and digital reforms are quicker, easier, and cost-effective to disseminate DDOT in large 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 ICUICU 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, transplant team Uniform data collection and data management system should be developed at the national level and state level 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 committees Government authority, transplant collaboration with related national and international societies including 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 public sector hospitals Leadership and dedicated transplant team
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.

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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