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Objectives: This study addresses the establishment of the National Organ and Tissue Transplant Organisation (NOTTO) and its impact on organ donation and transplantation in India., Methods: Yearly data, 2013 to 2018, from all the states and union territories of India as per the World Health Organization-Global Observatory on Donation and Transplantation (WHO-GODT) format, were analyzed and tabulated. The various national and international legislation, advisories, and reports that mandated establishment of national regulatory bodies were studied. Comparisons were drawn, noting points of similarity and contrast between analogous organizations., Results: In the WHO Madrid Report 2004, the international advisory highlighted the need for a national transplantation agency for effective integrated development of donation and transplantation. Its parallel in India was the 2011 Amendment of the Transplantation of Human Organs Act 1994 to set NOTTO up with its first director in 2014, and also with a national donor and recipient registry to achieve transparent allocation. A challenging task for NOTTO was to collect from all transplant and/or retrieval centers their real-time data of donors, recipients, and transplants in the National Organ and Tissue Transplant Registry (NOTTR). However, NOTTO succeeded in collecting data offline from all 29 states and 7 union territories and submitted to GODT in 2019. There was a greater than 2-fold increase of deceased organ donors from 340 in 2013 (pre-NOTTO) to 875 in 2018 (post-NOTTO). The deceased organ donation rate went up from 0.27 to 0.65, and the total number of transplants went up from 4990 to 10,340 in the same period. All the outcome measures doubled or tripled, establishing the role of NOTTO. Albeit having differences, NOTTO is analogous to the National Transplant Organization of Spain and United Network of Organ Sharing of the United States., Conclusion: The 2011 Amendment of THOA 1994 provided the basis for the establishment of NOTTO, which has been crucial in regulating organ donation and transplantation in India with the setting up of the NOTTR in 2015. NOTTO has been instrumental in augmenting all outcomes., (Copyright © 2020 Elsevier Inc. All rights reserved.)

The Organ Transplantation Act issued by the Government of India 1994 has undergone major and minor changes in the form of addition of rules and amendments in order to improve the Act to make it much acceptable legally. Over a period of time, with an increase in cadaver organ donations, the rules and policies with regard to the same have been defined and redefined over the years. In this article, the Act, the rules, the amendments, the quick essentials of approach, and the forms are reviewed.

Background: Legislation has made organ donation after brain death (DBD) possible in India since 1994. However, no organs are donated in most parts of the country; the national organ donation rate is estimated at between 0.08 and 0.34 donors per million population-one of the lowest in the world., Methods: A 350-bedded private hospital in Kochi started its DBD programme in September 2013 with a structured approach based on counselling of family members of critically ill individuals. A counsellor trained to diagnose family dynamics, and recognize different stages of the grieving process, chose the right time, and the correct family member to whom the donation request could be made. Regular debriefing sessions of the core team consisting of a transplant surgeon, a transplant coordinator, an ICU counsellor and a unit administrator resulted in setting up systems that supported families of patients with catastrophic brain injury, and created an environment conducive to obtaining consent., Results: A total of 85 organ donations took place in the first 24 months (September 2013 to September 2015) of instituting the programme., Conclusion: It is possible with hospital-based teamwork and a structured approach to consistently elicit organ donation., Competing Interests: None

Transplantation represents one of the best examples of the scientific achievements of medical science. However, its success has also led to some of the fiercest ethical challenges in modern medicine. Partly as a response to the uncovering of a flourishing clandestine kidney trade, the Central government promulgated the Human Organs Transplant Act (HOTA) in 1994. HOTA, along with its amendments, was a step forward in recognising concepts such as brain death. Nevertheless, there are numerous ethical challenges still to be resolved, particularly with regard to consent, incentives to donors and families, and equitable distribution of donated organs.

By 2005, human organ trafficking, commercialization, and transplant tourism had become a prominent and pervasive influence on transplantation therapy. The most common source of organs was impoverished people in India, Pakistan, Egypt, and the Philippines, deceased organ donors in Colombia, and executed prisoners in China. In response, in May 2008, The Transplantation Society and the International Society of Nephrology developed the Declaration of Istanbul on Organ Trafficking and Transplant Tourism consisting of a preamble, a set of principles, and a series of proposals. Promulgation of the Declaration of Istanbul and the formation of the Declaration of Istanbul Custodian Group to promote and uphold its principles have demonstrated that concerted, strategic, collaborative, and persistent actions by professionals can deliver tangible changes. Over the past 5 years, the Declaration of Istanbul Custodian Group organized and encouraged cooperation among professional bodies and relevant international, regional, and national governmental organizations, which has produced significant progress in combating organ trafficking and transplant tourism around the world. At a fifth anniversary meeting in Qatar in April 2013, the DICG took note of this progress and set forth in a Communiqué a number of specific activities and resolved to further engage groups from many sectors in working toward the Declaration's objectives.

: The Government of India has established laws to conduct organ transplantation in India. The Transplantation of Human Organ Act and rules in India were promulgated in 1994 and subsequently amended in 2008 and 2011 to promote organ transplantation, including deceased organ donation, commensurate with the highest ethical principles. We have reviewed in brief the origin and evolution of the Transplantation of Human Organ Act in India with the hope that our experience in developing the laws that govern organ transplantation may be of value for others undertaking or overseeing this life-giving advance.

In 1994, the Government of India enacted the Transplantation of Human Organs Act (THOA) to prevent commercial dealings in human organs. However, a greater number of scandals involving medical practitioners and others in the kidney trade has surfaced periodically in every state in India. The present regulatory system has failed mainly due to the misuse of Section 9(3) of the THOA, which approves the consent given by a live unrelated donor for the removal of organs for the reason of affection or attachment towards the recipient or for any other special reason. Currently in India, approximately 3500-4000 kidney transplants and 150-200 liver transplants are performed annually. However, the availability of organs from brain-dead persons is very low. As a result, live related or unrelated donors form the main source of organ transplantation. Therefore, physicians and policy-makers should re-examine the value of introducing regulated incentive-based organ donation to increase the supply of organs for transplantation and to end unlawful financial transaction.

Brainstem death and brain death although practically same with regards to the concept of organ donation, remain technically different. Brain death mandates irreversible cessation of all the functions of the entire brain and brainstem while brainstem death signifies irreversible damage to the brainstem. As per the Indian law, brainstem death is the legal requirement and not brain death.