Tamil Nadu, Gujarat, Telangana, Maharashtra, Kerala, Chandigarh, Karnataka, National Capital Territory of Delhi, and Rajasthan are states and union territories having active deceased-donor organ transplant programs in India. Transplant data (2013-2018) have been collected by the National Organ and Tissue Transplant Organization from all states and union territories of India and submitted to the Global Observatory on Donation and Transplantation. From 2013 to 2018, 49 155 transplants were reported in India, including 39 000 living-donor organ recipients and 10 155 deceased-donor organ recipients. These transplants were for kidney (living donor = 32 584, deceased donor = 5748), liver (living donor = 6416, deceased donor = 2967), heart (deceased donor = 895), lung (deceased donor = 459), pancreas (deceased donor = 78), and small bowel (deceased donor = 8). According to 2018 data, India was the second largest transplanting country in the world in terms of the absolute number of transplants. Here, we discuss the status, progress, challenges, and solutions for deceased-donor organ transplantation. The plan to increase rates of organ donation in India include the following points: teamwork and focus by intensive care unit doctors; public education on organ donation using social media; professional education and family donation conversation programs for brain death declaration and donor management; organ procurement organizations; international collaboration and regular meetings and updates for organizations working in the field of organ transplantation; grief counseling and reporting of potential donation for families of recently deceased people; nonfinancial incentivization to families of potential organ donors; expert committees and standard operating protocols for use of marginal donor organs, donation after circulatory death programs, and machine perfusion; maintenance of transparency and ethics in organ donation, allocation, and transplantation as directed by governmental, nongovernmental, and intergovernmental entities; and regular audit of progress and registry data.

Key words : Global Observatory on Donation and Transplantation, National Organ and Tissue Transplant Organization

Introduction

Organ transplant is the best treatment for patients with end-stage organ failure. However, there is a gross discrepancy between supply and demand for organs worldwide, and the Indian subcontinent is no exception.¹ In addition to the low supply, there are other limitations and challenges for deceased-donor organ transplant (DDOT) in India. To streamline the organ donation and transplant process and to stop organ commerce, the Government of India passed the Transplantation of Human Organs Act in 1994,^2,3 which became effective in 1995. However, this law did not eradicate organ commerce. Organ commerce that was being practiced in the open before the law; was now being done with the help of false documentation. The concept of brain death was new to both the public and physicians, and there was a general lack of interest to promote this concept. From 1995 to 2000, there were only 35 hospitals that had attempted organ transplants from deceased donors, and, of these, only a handful of hospitals in states like Tamil Nadu and Maharashtra have regularly engaged in use of such donations.^4,5

In 2005, a national organ registry was established as a result of the efforts of the Indian Society of Organ Transplantation.⁶ The first 12 years of the program was sustained by efforts of the governments, nongovernmental organizations (NGOs), civil society, religious leaders, and other stakeholders in creating awareness, and this continued until 2010.⁷ In 2008 (effective 2009), the Tamil Nadu state passed 10 government orders to facilitate the program and defined all the procedures, including declaration of brain death and special cases (eg, medico-legal situations, such as a road traffic accident, for which postmortem procedures are required).⁸ This set forth the intent of the government to give a push to organ donation. The deceased-donor organ donation rate in the country increased from 0.27 per million inhabitants (pmp) in 2013 to 0.65 pmp in 2018. This is nearly a 2.4-fold increase in 5 years, whereas the deceased-donor kidney transplant rate doubled from 0.43 pmp to 0.86 pmp in the same period9 (although a much higher rate of donation will be required to obliterate the existing deficit). In 2019, the Transplantation of Human Organs Act in India reached its 25th anniversary, and the National Organ and Tissue Transplant Organization (NOTTO)10 celebrated this event with several activities, including press conferences and a meeting of anesthetists to discuss methods to improve brain death declarations. In 2011, the act underwent an amendment, and this resulted in the formation of NOTTO, charged with the main objectives of promoting the use of organs from deceased donors, preventing commercial trade, and creating a national registry.

The National Organ and Tissue Transplant Organization is a national networking organization established as a mandate of the Transplantation of Human Organs and Tissues Act10 in 1994 to perform the functions of the National Human Organs and Tissues Removal and Storage network. The National Organ and Tissue Transplant Organization also functions as the Indian national registry for organ donation and transplantation. The deceased-donor organ donation rate in India is less than 1 pmp, and the goal of NOTTO is to increase the number of donations. Nationwide and year-round awareness activities are conducted by NOTTO in coordination with regional organizations (ROTTOs) and state organizations (SOTTOs) and many NGOs to improve the number of donor pledges.

To promote the acceptance of declarations of brain death (in cases for which such a declaration are relevant) and to achieve a higher donor conversion rate (ie, from eligible to actual donor), training of intensivists and anesthetists is being undertaken to educate the medical community about the medical and legal provisions regarding declarations of brain death. To integrate organ donation in the process of end-of-life care, the Transplantation of Human Organs (Amendment) Act 201111 included a provision whereby patients and their families must be made aware of the “option to authorise or decline for donation of human organs or tissues” of their next of kin as part of the standard intensive care unit (ICU) care. Despite this effort, the organ donation rate remains proportionately low for a plethora of reasons. A brain death declaration by neurological criteria is not a routine or popular practice among medical professionals. Procedures that involve donations after cardiac death are performed in only 1 center in the country, in Chandigarh, as an effort to increase the deceased-donor organ donation rate. Issuance of government orders in different states like Tamil Nadu,¹² Kerala,¹³ Andhra Pradesh,¹⁴ and Maharashtra¹⁵ making declaration of brain death mandatory in all hospitals is another step in this direction. The use of the term “potential donors,” so that the full potential of patients who have a high probability of going into a state of brain death is tapped, is also being encouraged. Another strategy is the use of “expanded criteria donor” for increasing the donor pool. Also, increased use of split-grafting techniques (in cases of liver transplant) will make more organs available. The geographical differences in organ donation rates across a single nation are also noteworthy. Literacy rate, how long a transplant program has been established in government hospitals, cultural and religious practices, socioeconomic factors, access to health care, and ease of organ transport are just a few of many responsible factors for these differences in rates.

Role of Religious Beliefs Regarding Attitudes and Perceptions of Organ Donation^16-19
The Hindus believe in the concept of rebirth, whereas the Muslims believe that the human body should not be desecrated or tampered with after death. There is also a lack of trust in the health care system by some of the public. Many people also believe that, if consent is given to be an organ donor, then the doctors may not put their best efforts to save their lives, if endangered. These sorts of religious belief and public conceptions can impede efforts to improve donation rates. However, in some regions of India, it is not a major problem to counsel families on options for organ donation. “If we can save the lives of others, why not? It is a noble gesture and a gracious act,” is a thoughtful notion that prevails in the minds of many people. This is in keeping with teachings of Lord Krishna to Arjuna in the Bhagavad Gita, “yad yad ācharati śhreṣhṭhas tat tad evetaro janaḥ, sa yat pramāṇaṁ kurute lokas tad anuvartate,” which proposes that the common people will emulate the good actions of great leaders.²⁰

Religious beliefs play an important role in organ donation. Health care professionals are often unaware of religious beliefs and tend to avoid this sensitive issue in discussions with family members regarding organ donation. The major religions in the Indian subcontinent are Hinduism, Islam, Sikhism, and Christianity.

Hinduism
Hinduism is the major religion in the subcontinent with almost a billion followers. It has no founder and no universal authority. Hinduism believes in transmigration of the soul and reincarnation; that is, the deeds of an individual in this life will determine one’s fate in the next life. An important tenet of Hinduism is “daan,” or selfless giving to help someone who is suffering. The physical integrity of the dead body, although considered to be important by many people, is not seen as crucial to reincarnation. As a person puts on new garments and discards the old ones, the soul similarly accepts new material bodies, giving up the old bodies. In fact, one of the earliest depictions of xenotransplantation is in the case of Lord Ganesha, one of the best known and most widely worshipped deities in Hinduism, in whom the head of an elephant was transplanted on a human body by his father Lord Shiva.16,17 Various Hindu scholars have endorsed organ donation publicly. Hasmukh Velji Shah of the World Council of Hindus stated that “The important issue for a Hindu is that which sustains life should be accepted and promoted as Dharma (righteous living). Organ donation is an integral part of our living.”^18,19

Islam
Altruism is also an important principle of Islam, and saving a life is placed highly in the Quran: “Whosoever saves the life of one person would be considered as if he saved the life of all mankind.” The Islamic Jurisprudence Assembly Council in Saudi Arabia approved deceased donation and living donation in a landmark decision in 1988. Similar formal rulings are in place in India as well.^16,21

Sikhism
Sikhism is a monotheistic religion founded in 15th century India by Guru Nanak. Sikhs believe religion should be practiced by living in the world and coping with life’s everyday problems. Sikhism also stresses the importance of doing good actions. Sikhs believe in life after death, and a continuous cycle of rebirth. All Sikhs, apart from stillborn babies and infants dying within a few days of birth, are cremated after they die. Sikhism is similar to Hinduism in the belief that the physical body is not crucial to the cycle of rebirth, as the soul of a person is eternal while the body is simply flesh.^16,22

Religious concerns may be an underreported obstacle to deceased and living donations and/or the willingness to accept a transplant. Transplant teams, donation coordinators, intensivists, and nephrologists need to be more aware, and strategies to increase donation should consider religious concerns, although a proactive approach must be balanced against the patients’ rights to keep these topics confidential.

Deceased-Donor Organ Transplant in India
Deceased-donor organ transplant has seen a lot of ups and downs in India. With the establishment of NOTTO, with its first director taking charge, there have been a number of changes, and a dedicated attempt at transparency is being made in maintaining the national registry. Transplant data have been collected by NOTTO from all the states and union territories of India and submitted to the Global Observatory on Donation and Transplantation from 2013 to 2018. At the time of this writing, the 2019 data are currently being processed. According to the 2018 data, worldwide, India was the country with the second highest rate of organ transplant in terms of the absolute number of transplants (Tables 1 and 2).¹ Figure 1 shows the global data on donation and transplantation from India (2013-2018) for actual and utilized deceased donor (Figure 1A), kidney (Figure 1B), liver (Figure 1C), and other organs (heart, lung, and pancreas; Figure 1D).

Gujarat,^23-35 National Capital Territory of Delhi (Delhi NCT), Tamil Nadu, Telangana, Maharashtra, Kerala, Chandigarh, Karnataka, and Rajasthan are states and union territories having active DDOT programs in India. Programs for DDOT are underdeveloped in east India. Recently, Kolkata (West Bengal) and Bhubaneswar (Odisha) have started DDOT programs.

Gujarat
Up to February 2020, the Institute of Kidney Diseases and Research Centre, Institute of Transplantation Sciences (IKDRC-ITS), in Ahmedabad, India, has completed 386 liver transplants and 6008 kidney transplants, including 440 kidney exchange trans­plants, 523 robotic kidney transplants, and 937 deceased-donor kidney transplants. This is the largest public sector transplant hospital in India, and many transplants are funded under government plans. The IKDRC-ITS, in Ahmedabad, is also a SOTTO, to govern and regulate organ transplant activity in the state of Gujarat. Established in 2015 under the State University Act, the Gujarat University of Transplantation Sciences is the world’s first university for transplantation and allied sciences. The idea of setting up such a university was conceived in 1998, and the seed of its inception was laid down by Prof. H. L. Trivedi, the Founding Director of Smt. G. R. Doshi and Smt. K. M. Mehta IKDRC-ITS, Ahmedabad, Gujarat. Table 3^23-26 and Table 4^27-32 show DDOT outcome data from IKDRC-ITS, Ahmedabad; the IKDRC-ITS also reported successful renal transplant from brain-dead deceased donors who died from snakebite and head injury, disseminated intravascular coagulation, and deranged renal functions.^33-35 The Gujarat SOTTO is the first in India to approve living -donor and deceased-donor list exchange and is in the process of forming standard operating protocols. Table 5 shows DDOT outcome data from other centers in India.^36-41

Delhi National Capital Region
The Delhi National Capital Region (Delhi NCR) has had some of the firsts in DDOTs. The All India Institute of Medical Sciences (Delhi) conducted the first heart transplant in India in 1995.42 Small bowel transplant was conducted in Gurugram. Although there was a slow start, Delhi NCR has picked up rapid pace in performing transplants, with some of the centers offering transplant fellowships, training in organ retrieval, and transplant coordination. The National Organ and Tissue Transplant Organization, situated in Delhi, is a boost to this region and functions as the SOTTO for Delhi NCR. Delhi is credited with 198 actual donations from deceased donors, which translated into 156 utilized deceased donations from 2013 to 2018. An impressive 11 064 organ transplants have been done in Delhi alone in the above period, of which 414 were DDOT: 8218 kidney transplants, with 204 forming the DDKT component; 2779 liver transplants, 143 of these being DDLT; and 67 heart transplants. One small bowel transplant was also done (Table 6).⁴³ The National Organ and Tissue Transplant Organization organized the intensivist training program to increase the number of formal declarations of brain death, when brain death has occurred. The National Organ and Tissue Transplant Organization regularly conducts the transplant coordinator training course and organizes awareness activities for the public. Social media tools like Twitter are used to increase the awareness about organ donation and transplantation.

Tamil Nadu
Tamil Nadu was one of the first states to start DDOT after the rules were passed in 1995 and started an organ-sharing registry among 6 hospitals in the year 2000.44-45 In 2009, the Tamil Nadu government established a DDOT program in one of the major government hospitals in Chennai through a government order; originally known as the Cadaver Transplant Program, it was renamed as the Transplant Authority of Tamil Nadu (TRANSTAN) by government order.46 A ROTTO and a SOTTO have been sanctioned in Tamil Nadu by Government of India order. TRANSTAN reported 1338 deceased donors leading to transplants of kidneys (n = 2408), livers (n = 1222), hearts (n = 556), lungs (n = 496), pancreases (n = 29), and small intestines (n = 4) from January 2008 to December 2019 (Table 7).^47-49

Jeevandan, Telangana
In Andhra Pradesh, DDOT started in 2003, after the success in Tamil Nadu. In 2009, the government established (through a special order, as in Tamil Nadu) the Andhra Pradesh Network of Organ Sharing, and the program was promoted as “Jeevandan,” which gave a fillip to organ trans­plantation. Nizam’s Institute of Medical Sciences has been designated as the Appropriate Authority for Cadaver Transplantation; NGOs have also played an active role in promoting organ donation. There were 17 557 donor pledges as of May 2020. Registered recipients on wait lists numbered 7522, including 3966 for kidney and 3410 for liver. In total, 2885 organs (1191 kidneys, 712 livers, 102 hearts, 170 heart valves, 677 eyes, 23 lungs, 10 pancreases) were retrieved from 751 donors (Table 8).^50,51

Kerala
Kerala’s DDOT program reported 304 donors leading to transplants of kidney (n = 521), liver (n = 240), heart (n = 58), lung (n = 4), pancreas (n = 11), hand (n = 10), and small intestine (n = 3) from August 2012 to June 2020, with 1764 patients on wait lists for kidney transplant (Table 9).⁵²

Maharashtra
Zonal Transplant Coordination Centre, Mumbai, Maharashtra reported 505 donors leading to transplants of kidney (n = 822), liver (n = 344), heart (n = 77), lung (n = 18), and pancreas (n = 2) from 1997 to May 2019.⁵³

North India
Data on organ donation from deceased donors in India’s northern region, excluding Delhi NCR, from 2017 to September 30, 2019, reported 131 donors leading to transplants of kidney (n = 226), liver (n = 55), heart (n = 13), lung (n = 2), pancreas (n = 13), and small intestine (n = 0); in May 2020, there were 314 patients on wait lists for kidney transplant. There were 203 cumulative organs from deceased donors transplanted in 480 recipients from 1996 to 2019 at the Postgraduate Institute of Medical Education and Research, Chandigarh.⁵⁴

Karnataka
The Jeeva Sarthakathe has been constituted by the Government of Karnataka for a sustained DDOT program in the state of Karnataka. From 2011 to March 2020, there were 497 deceased organ donors reported.⁵⁵

Rajasthan
The Rajasthan Network for Organ Sharing reported 37 donors leading to transplants of kidney (n = 67), liver (n = 32), heart (n = 18), lung (n = 1), pancreas (n = 1), and small intestine (n = 0) from February 2015 to May 2020, with 314 patients on wait lists for kidney transplant.⁵⁶

Role of Media and Movies in Deceased-Donor Organ Donation
The media has played a key role in both increases and decreases in organ donation rates in India. The trust deficit has increased because of multiple kidney scams reported in the media, and this may have contributed to indifference among people regarding organ donation. However, in 2008, the donation by a doctor couple in Tamil Nadu of their son’s organs produced some extraordinary positive reports in the media, in the context of the extraordinary deeds of ordinary people.⁵⁷ The saving of multiple lives by a single donation may have had a positive effect on the social conscience, and subsequently a greater number of people opted for organ donation on behalf of a deceased family member.⁵⁷

Another potential project would be to facilitate transport of organs, such as hearts, from one part of the city to another through establishment of “green corridors” on roads where the traffic would be stopped to give acute priority to the transport of organs. Newspapers and television media, with the support of industry, corporate houses, and NGOs, have also helped in creating awareness about brain death and the positive social effect that may result from donations of multiple organs. The green corridors story caught the imagination of a cinema director who made the movie Traffic, which became a box office success; it was subsequently translated into many Indian languages. The dramatic theme of the movie was how a heart was moved over 100 miles through busy Indian roads.⁵⁸ This was followed by another movie, which repeated the plot of the English-language movie Coma (1978), with a plot that included a theme of donors being killed in a hospital for organs. Following this, more movies and television dramas were produced that contained themes focused on illegal organ commerce in India, which may have created fear among the public regarding organ donation and transplantation.⁵⁹ Such movies came up with plots that grossly distorted organ donation and transplantation, and some plots were downright ludicrous. More sinister plots were created in television series in different Indian languages, including the Amazon Prime series Breathe, in which the plot includes a father who is a policeman and is shown killing registered organ donors of a rare blood group because his son is in need of a lung transplant.⁶⁰ Worldwide, India produces the most movies in different Indian languages than any other country, and the visual media is considered a key influencer of peoples’ thought processes in the country. The law of the country that makes such acts of organ commerce a punishable offence through imprison­ment for up to 10 years and a fine of up to US $150 000 is disregarded and unknown to the movie directors.

General public distrust of transplantation and donation also made the print media hostile to the DDOT program, and some crime reporters have recently reported organ donation stories without any understanding, with distorted facts and sensational implications. Often the investigation from authorities would prove the stories to be wrong, but this was never reported or acknowledged in the press. Over the past several years, many people who pledged organs have withdrawn consent, and many families have simply refused donation fearing that organs would be sold. The NOTTO website, which has been functional since 2014, has witnessed to date (June 1, 2020) 210 incidents of withdrawal of consent for organ donation.⁶¹

The trust factor with the public that takes many years to build can easily be lost when the media depicts the topic of organ donation and trans­plantation in a negative manner. Organ donation has become a victim of media sensationalism, and, unless this is changed, it may be difficult to regain the confidence and trust of the people. Organ donation and transplantation myths in movies and television series have a negative impact on the progress of promoting organ donation.^62-67

Challenges and Solutions for Deceased-Donor Organ Transplant in India
Table 10 shows a proposed pathway to increase organ donation in India.

Socioeconomic factors
Public sector hospitals need to consider allocating greater resources to the field of organ transplantation so that clinical care for donors and recipients is affordable. Commencement of organ transplant programs in the public sector would help to facilitate and promote the field of transplantation.

Cultural and religious aspects
Widespread involvement of religious leaders to allay the fear of organ transplantation may facilitate an increase in the organ donation rate. Religious leaders need education on organ transplantation and brain death for a fruitful outcome.

Proper communication
Proper communication should involve volunteers trained in psychology to counsel the patient’s attendees regarding the details of a formal declaration of brain death. Brain death counseling should be part of end-of-life care, and the involvement of organ transplant coordinators and counselors should be ensured.

Organizational support
To promote the value of organ donation, organizational support is also needed. The staff and the coordinators need to be educated and trained to answer all probable questions that may be asked by the patient’s family and/or attendees. Well-nuanced counseling may help facilitate greater acceptance of organ donation. Hospitals should have a clear protocol for brain death declaration, and the doctors involved should not be stakeholders in the transplant team or posttransplant care.

Education of doctors
There is a need to educate doctors on organ donation. Dedicated training on organ donation and trans­plantation, including the Transplantation of Human Organs and Tissues Act 1994, has been incorporated by including this in the undergraduate curriculum created by the Medical Council of India in 2018. Medical graduates need training on the roles of doctors, nursing officers, and paramedics with regard to organ donation. In addition, the art of coordinated care with paramedical staff needs to be taught, as there have been differences in individual perspectives versus perspectives of the medical fraternity.

Suspicion of misuse
Up to 59% of the patients’ attendees believe that there was a potential misuse or misappropriation of a donated organ. Hence, it is vital to have complete transparency regarding the organ donation allocation system, with the details easily available to the public.

Organ transport
Creation of green corridors with the appropriation of stakeholders would reduce the risk of cold ischemia and thereby improve the longevity of the trans­planted organs. The creation of affordable air transport systems, particularly for transport of organs that require short cold ischemia time, such as heart and lung, is vital to ensure maximum utilization of organs from deceased donors.

Delays in procurement
A funeral is essential for the family. The undue delay in handing over the body discourages a patient’s attendees to engage with organ donation. The medical staff and paramedics need sensitization on this issue; also, the donor families need to be duly recognized.

Professional education family donation conversation
The Australian Government has developed a professional education family donation conversation program to increase organ donation rates; program includes introductory donation awareness training and an online learning family donation conversation workshop.⁶⁷

Coronavirus Disease 2019 and Organ Transplant
The points to consider before performing DDOT are the limitations in personal protective equipment, testing kits, asymptomatic infections, negative-pressure isolation rooms, ICU beds, ventilator support, telehealth, availability of trained healthcare workers, hospital beds, the changing dynamic of the current pandemic (corona virus disease 2019 [COVID-19]), the unwillingness of recipients, education updates, and the additional burden on the existing health care system. Most (up to 95%) nonurgent living-donor and DDOT programs were suspended in India from March 22, 2020, to May 31, 2020, in response to COVID-19; now, however, transplant programs are slowly restarting with safeguards.⁶⁸

Conclusions

To address the challenges in organ donation, established protocols should be implemented in all geographic areas. These can substantially ameliorate the disparity on the number of potential donors and the actual donation rate. There should be an emphasis on the importance of effective communication and humility of the stakeholders.

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