DISCREPANCY BETWEEN LIVE AND DECEASED DONOR TRANSPLANTS IN INDIA
We intend to elaborate on the current status, diversity in access, equity, and economics of solid organ transplantation (SOT) in India. Currently, India performs the third largest volume of organ transplants after the United States and China.1-3 Notably, <10% of patients with organ failure have access to SOT worldwide. The Indian Ministry of Health estimates a gap of approximately 175 000 kidneys, 50 000 livers, hearts, and lungs in addition to 2500 pancreas. TheNewsletter Transplant (2018 data) reported on 12 758 patients wait-listed for kidneys, 4173 for liver, 425 for heart, 75 for lung, 48 for pancreas, and 6 for small bowel transplants (SBTs) for in India.4 Deceased donation rates have remained stable and <1 per million population from 2013 to 2021. To achieve self-sufficiency in organ donation, the estimated deceased donation rate in India will need to achieve a rate of 62 per million population. The distinguishing feature of Indian transplant programs is their predominant reliance on living donation (87%), with only 13% of the kidney transplant volume deriving from deceased donors (DD).1-3 There are also stark geographic differences in India with active DD programs in South and West India, whereas DD has not been initiated in Northeast India. Moreover, donation after the circulatory determination of death and kidney-paired exchange programs are still underdeveloped in India (<1%) and should be promoted.
HISTORY AND TRANSPLANT VOLUMES OF LIVE AND DECEASED DONOR TRANSPLANTS IN INDIA
Kidney and Liver Transplants
Kidney (8232 DD, 54 442 living donor, and 62 674 total) and liver (4339 DD, 12 255 living donor, 8 domino, and 16 602 total) are the predominantly transplanted organs in India and only 1322 heart transplants, 773 lung transplants, 133 pancreas transplants, 75 kidney–pancreas transplants, and 19 SBTs have been performed from 2013 to 2021 (Figure 1). There has been growth in successful outcomes of extrarenal transplants during the past decade, and deceased donation rates have increased since 2007/2008, which was probably the watershed moment in deceased donation in the country. Figure 1 shows transplant activities in India (2013–2021) as listed in the GODT with data on access to non–kidney organ transplants in India shown in Figure 2A–G). GODT: Donation and transplantation in India, Southeast Asia region, and Global (2019–2021) are shown in Table 1. During the coronavirus disease 2019 (COVID-19) pandemic, transplantation rates initially declined in India5 and gradually recovered with the implementation of National Organ and Tissue Transplant Organization transplant guidelines6,7 and the ability to cope with the pandemic. Table 2 summarizes milestones in SOT in India8-19
TABLE 1. -
Donation and transplantation activities in 2019 versus 2020 versus 2021, according to data derived from the GODT
1-3
|
2019 |
2020 |
2021 |
| No. countries contributing with data |
|
n = 3 |
n = 84 |
|
n = 4 |
n = 93 |
|
n = 3 |
n = 79 |
| Data presented in absolute number and pmp |
India |
SEAR |
Global |
India |
SEAR |
Global |
India |
SEAR |
Global |
| Actual DDs |
715 (0.52) |
1016 (0.63) |
41 686 (7.00) |
351 (0.25) |
764 (0.47) |
36 100 (5.8) |
552 (0.4) |
742 (0.46) |
37 653 (6.86) |
| Actual DBD |
715 (0.52) |
1016 (0.63) |
32 444 (5.45) |
347 (0.25) |
760 (0.46) |
27 934 (4.49) |
552 (0.4) |
742 (0.46) |
29 111 (5.31) |
| Actual DCD |
(–) |
(–) |
8999 (1.51) |
4 (0) |
4(0) |
8166 (1.31) |
(–) |
(–) |
8503 (1.55) |
| Total kidney transplants |
9751 (7.12) |
10 635 (6.62) |
102 403 (17.18) |
5486 (3.98) |
6661 (4.07) |
80 926 (13) |
9105 (6.53) |
9767 (5.99) |
89 244 (16.27) |
| Deceased kidney transplants |
1138 (0.83) |
1698 (1.06) |
64 091 (10.75) |
516 (0.37) |
1192 (0.73) |
55 258 (8.88) |
830 (0.6) |
1181 (0.72) |
56 487 (10.30) |
| Living kidney transplants |
8613 (6.29) |
8937 (5.56) |
38 312 (6.43) |
4970 (3.6) |
5469 (3.34) |
25 668 (4.12) |
8275 (5.94) |
8584 (5.27) |
32 755 (5.97) |
| Total liver transplants |
2592 (1.89) |
2708 (1.69) |
36 745 (6.16) |
1780 (1.29) |
1916 (1.17) |
32 586 (5.24) |
2847 (2.04) |
2936 (1.80) |
33 105 (6.03) |
| Deceased liver transplants |
599 (0.44) |
697 (0.43) |
28 131 (4.72) |
291 (0.21) |
396 (0.24) |
25 285 (4.06) |
482 (0.35) |
539 (0.33) |
26 333 (4.80) |
| Living liver transplants |
1991 (1.45) |
2009 (1.25) |
7610 (1.28) |
1487 (1.08) |
1518 (0.93) |
6663 (1.07) |
2363 (1.7) |
2395 (1.47) |
6748 (1.23) |
| Heart transplants |
187 (0.14) |
218 (0.14) |
8848 (1.48) |
89 (0.06) |
122 (0.07) |
8101 (1.3) |
151 (0.11) |
175 (0.11) |
8232 (1.50) |
| Lung transplants |
114 (0.08) |
114 (0.07) |
6807 (1.14) |
67 (0.05) |
68 (0.04) |
5940 (0.95) |
133 (0.1) |
134 (0.08) |
6301 (1.15) |
| Pancreas transplants |
22 (0.02) |
25 (0.02) |
2352 (0.39) |
14 (0.01) |
15 (0.01) |
1970 (0.32) |
19 (0.01) |
20 (0.01) |
1986 (0.36) |
| Small bowel transplants |
(–) |
(–) |
146 (0.02) |
7 (0.01) |
7 (0) |
158 (0.03) |
4 (0) |
5 (0) |
172 (0.03) |
| Total organ transplants |
12 666 (9.25) |
13 700 (8.53) |
157 301 (26.39) |
7443 (5.39) |
8789 (5.37) |
129 681 (20.84) |
12 259 (8.8) |
23 037 (8.00) |
139 040
(25.34) |
COVID-19 first wave, March–December 2020 with a peak in September; COVID-19 Second wave, February–July 2021 with peak in May; DBD, deceased donation after brain death; DCD, deceased donation after circulatory death; DD, deceased donor; (–), data not available or not applicable; GDOT, Global Observatory on Donation and Transplantation; PMP, per million population; SEAR, Southeast Asia region.
TABLE 2. -
Milestone in solid organ transplantation in India
| Milestone in India |
Hospital name |
Year |
| First DD kidney Tx
8
|
King Edward Memorial Hospital, Mumbai |
May 1965 |
| First successful LD kidney Tx
8
|
CMC Hospital, Vellore |
January 1971 |
| First successful DD liver Tx
9
|
Apollo Hospital, Delhi |
November 5, 1998 |
| First successful LD liver Tx
9
|
Apollo Hospital, Delhi |
November 15, 1998 |
| First successful DD heart Tx
10
|
AIIMS, Delhi |
August 3, 1994 |
| First DD double-lung and first combined heart–lung Tx
11
|
Madras Medical Mission, Chennai |
May 1999 |
| First DD double-lung Tx in a government hospital (unsuccessful)
12
|
PGIMER, Chandigarh (n = 1) |
July 11, 2017 |
| First DD SBT
13
|
Chennai Transplant Center and Research Foundation, Madras Medical Mission, Chennai |
Before 2007 |
| First successful DD SBT
14
|
Medanta Hospital, New Delhi |
November 24, 2012 |
| Combined DD small bowel and abdominal wall Tx
15
|
Apollo Hospital in Chennai |
March 2020 |
| Pediatric successful living donor SBT after recovering from COVID-19
16
|
Global Hospital, Mumbai |
November 5, 2020 |
| First DD simultaneous pancreas kidney Tx |
IKDRC-ITS, Ahmedabad (n = 19) |
July 17, 1999 |
| DD hand Tx
17
|
Amrita Institute of Medical Sciences, Kochi (n = 12) |
January 13, 2015 |
| LD uterus Tx |
Galaxy Care Private Hospital, Pune (n = 9) |
May 18, 2017 |
| First LD uterus Tx in public sector hospital |
IKDRC-ITS, Ahmedabad (n = 2) |
September 25, 2022 |
| Milestone in region |
| First DD small-bowel Tx in Maharashtra |
Jupiter Hospital Pune |
March 4, 2020 |
| First SPKT in |
AIIMS Delhi
18
|
March 9, 2004 |
| First SPKT in |
PGIMER, Chandigarh (n = 38)
19
|
December 10, 2014 |
AIIMS, All India Institute of Medical Sciences; COVID-19, coronavirus disease 2019; DD, deceased donor; IKDRC-ITS, Institute of Kidney Diseases and Research Center and Dr H L Trivedi Institute of Transplantation Sciences; LD, living donor; PGIMER, Postgraduate Institute of Medical Education and Research; SBT, small-bowel transplant; SPKT, simultaneous pancreas kidney transplantation; Tx, transplant.
;)
FIGURE 1.: Global observatory on donation and transplantation: transplants in India (2013–2021).
1-3 DBD, deceased donation after brain death; DCD, deceased donation after circulatory death; DD, deceased donation; LD, living donor; TX, transplant.
A–H, Extrarenal organ transplants in green shade. H, SOTTO status (states without SOTTO in red and orange shade). I, THOTA status (7 states in red shade yet to adopt THOTA). J, State-wise transplant centers numbers per million population in India as per the 2011 Census. SOTTO, State Organ and Tissue Transplant Organization; THOTA, Transplantation of Human Organs Act.
Heart–Lung Transplants
At the time of this report, there were <10 government institutions performing heart transplant (Figure 2B), and only 3 government hospitals (Postgraduate Institute of Medical Education and Research, Chandigarh; All India Institute of Medical Sciences, New Delhi; and Rajiv Gandhi Government General Hospital, Chennai) have an established lung transplant (LT) program in India. Until now, Rajiv Gandhi Government General Hospital, Chennai, has been performing combined heart–lung transplant among government hospitals. A total of 441 transplants LTs (Figure 2C; isolated LT, n = 339 and combined heart–lung transplant, n = 102) have been done in India until March 2021 (Tamil Nadu, n = 340; Telangana, n = 45; Karnataka, n = 29; Maharashtra, n = 23; Punjab, n = 1; Rajasthan = 1; Kerala, n = 1; and Delhi n = 1 have been performed in India). Twenty-five LTs have been done in India for COVID-19–affected lungs.20
Small Bowel Transplants
The majority of SBTs (>50%) are currently performed in Maharashtra (Jupiter Hospital Pune, Jupiter Hospital, Mumbai, and Global Hospital, Mumbai) with additional activities at Medanta Hospital, Delhi, Apollo Hospital and Dr Rela Institute, Chennai, Osmania General Hospital, Hyderabad, and Apollo and Fortis Hospital, Bangalore (Figure 2D).
Pancreas Transplants
Pancreas procurement rates remain low, partly related to strict acceptance criteria.19 At present, only a few centers across the country with trained surgeons offer pancreas transplants. These centers include Postgraduate Institute of Medical Education and Research, Chandigarh (n = 38), Institute of Kidney Diseases and Research Center and Dr H L Trivedi Institute of Transplantation Sciences (IKDRC-ITS), Ahmedabad (n = 19), AIIMS, Delhi, Sahyadri Super Speciality Hospital and Ruby Hall in Pune, Apollo Hospital, Global Hospitals, Dr Rela Institute in Chennai, Global Hospitals and Apollo Hospitals, Bangalore, Jubilee Hills and Yashoda Hyderabad, Amrita Institute of Medical Sciences, Kochi, and Kovai Medical Centre and Hospital, Coimbatore (Figure 2E).
Composite Tissue Allotransplantation
Hand Transplants
At present, only a few centers across the country with trained surgeons offer this procedure; 26 hand transplants have been performed at the time of this report. Centers include Amrita Institute of Medical Sciences, Kochi, Global hospital, Mumbai, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry,21 Global hospital, Chennai, KEM hospital, Mumbai, and Stanley Medical College, Chennai (Figure 2F).
Uterus Transplants
More than 90 UTs have been done worldwide. India has been an early adapter of this novel approach. Two live births occurred from a total of 11 living donor UTs in India (9 UTs at Galaxy Care Private Hospital, Pune, and 2 UTs at IKDRC-ITS, Ahmedabad; Figure 2G).
OVERSIGHT OF GOVERNMENTAL AND REGULATORY SYSTEMS IN INDIA
The Government of India enacted the Transplantation of Human Organs Act (THOTA) in 1994 to curb organ trading and to promote deceased organ donation. Seven states in India (Andhra Pradesh, Telengana, Karnataka, Uttarakhand, Mizoram, Meghalaya, and Tripura) are yet to adopt the THOTA (Figure 2H). Seven North-eastern states (Sikkim, Mizoram, Meghalaya, Manipur, Arunachal Pradesh, Tripura, and Nagaland) and 3 union territories (Andaman and Nicobar Lakshadweep, and Ladakh) do not have a State Organ and Tissue Transplant Organization (SOTTO; Figure 2I). Three large states (Chhattisgarh, Telangana, and Uttarakhand) are currently in the process to implement a SOTTO. The North-eastern states, including Arunachal Pradesh, Mizoram, Meghalaya, Nagaland, Sikkim, and Tripura, in addition to the union territories Andaman and Nicobar, Dadra and Nagar, Haveli and Daman, Diu, and Lakshadweep do not have transplant centers, even after 75 y of India’s independence (Figure 2J). Organ Transplantation task force of National Academy of Medical Sciences pointed out that Organ Transplantation task force of National Academy of Medical Sciences pointed out that the financial grant under the National Organ Transplantation Program22 is underused because of the lack of sufficient staffing in the National Organ and Tissue Transplant Organization, the Regional Organ and Tissue Transplant Organization, and SOTTO. Clearly, more support of full-time staff focusing on organ donation and transplantation without giving additional charges to these posts will need to be allocated. Documenting outcome data will be critical for policy decisions. There is also insufficient documentation on transplant recipients and the long-term health of live donors. Compliance in these areas is lacking, although documentation is mandated by the THOTA.
DISPARITY IN ACCESS TO AFFORDABLE TRANSPLANTS
Only 20% of kidney and <5% of liver, heart, lung, and multiorgan transplants are performed in government hospitals.23 High costs of transplants at private hospitals are, in general, not affordable for most patients in the absence of governmental healthcare plans. To improve the current status of organ transplantation in government hospitals in India, there is a need for improved infrastructure, funding mechanisms, effective policies, trained personnel, a better networking and organ allocation system, a unified approach for organ procurement and transport, and a nationwide registry, governed by effective and integrating leadership.24 Moreover, there is an urgent need to make organ donation and transplantation affordable in India, including the coverage of immunosuppressants, organ preservation, and required consumables. Each SOT should be covered under Governmental healthcare plans adapted to local needs. The inclusion of organ transplantation under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana health plan represents a step forward in providing Government support for SOT. Dedicated infrastructure and organ transplant departments/units staffed by trained dedicated faculty will ideally be implemented in at least 1 public sector hospital per state. Multiorgan retrieval teams should be established in all general surgery departments in parallel to educated and trained intensivists and trauma units in institutions that can initially operate as non-Transplant Organ Retrieval Centers and, if needed, be transformed into transplant centers.
Today, <10% of patients with end-stage kidney failure in India have access to transplantation. Mortality because of limited access and high costs of dialysis is therefore high. IKDRC-ITS, Ahmedabad and the Gujarat Dialysis Program have provided effective examples that may serve as models in each state, providing free-of-charge dialysis and transplants. Those efforts have recently been recognized by the opening of an additional 850-bed unit at IKDRC Ahmedabad for multiorgan transplants in addition to 188 satellite dialysis centers under the One Gujarat, One Dialysis program by Prime Minister Narendra Modi. This initiative aims to provide free of charge or subsidized kidney and transplant care providing Gujarat Government supported universal health.
CONCLUSION
The clinical implementation of SOT in India has been laborious and great disparities in access to transplantation remain. Transplant activities rest largely on living donation, an approach that will not be sustainable for kidney and liver transplantation and also not available for most other organs. Moreover, there is disproportionate focus on kidney transplantation with a lack of progress for extrarenal organ transplants in addition to tissue or cell transplantation. The lack of a solid DD transplant system also comes with increased potential for organ trafficking, coercion, and transplant tourism that will need to be closely monitored and prevented. Moreover, there is a strong necessity for documenting national data to improve safety, quality, efficacy, epidemiology, and ethics. We therefore urge the government to take actions addressing transparency, allocation, policies, oversight, and safety of organ transplantation. India has an opportunity to use its full potential to expand transplantation in accordance with World Health Organization Guiding Principles on human cell, tissue, and organ transplantation.
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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