Regulatory aspects of tissue donation, banking and transplantation in India

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Regulatory aspects of tissue donation, banking and transplantation in India Astrid Lobo Gajiwala

Received: 28 August 2017 / Accepted: 19 February 2018 Ó Springer Science+Business Media B.V., part of Springer Nature 2018

Abstract Amendments to India’s Transplantation of Human Organs Act, 1994, have established the legality of tissue donation and transplantation from deceased donors and the conditions under which they are permitted. The amended Act, now known as The Transplantation of Human Organs and Tissues Act, 1994, seeks to prevent the commercialization of tissue donation and to guarantee the safety of indigenous allografts. Registration of tissue banks, compliance with national standards and the appointment of transplant co-ordinators in hospitals registered under the Act are now mandatory. A national registry and Regional and State networks for donation and transplantation of tissues have been introduced. Despite the amendments a few anomalies of the principal Act persist as some of the differences between tissue and organ donation and transplantation have been

overlooked. These include the possibility of skin donation in locations other than hospitals; the donation of medical and surgical tissue residues which does not pose any risk to the living donor; the non-requirement for compatibility between donor and recipient; the delayed time factor between tissue donation and transplantation which makes identification of a recipient at the time of donation impossible; and the easy availability of alternatives to tissues which make waiting lists redundant for many tissues. Rules for the implementation of the amended Act were framed in 2014 but like the Act must be adopted by the State health assemblies to become universally applicable in the country.

This article is dedicated to Professor Glyn Phillips to mark the occasion of his 90th birthday. Fondly referred to as the ‘‘Father of Tissue Banking,’’ he was the brain and the heart of the IAEA programme in Tissue Banking that helped set up tissue banks in more than 30 countries in the Asia–Pacific Region, Latin America, Africa and the Middle East. A visionary, he used the IAEA programme to bring together tissue bankers from around the globe making possible an exchange of expertise that led to the development of Standards for Tissue Banking, training programmes to implement the Standards, and an IAEA Code of Practice for the radiation sterilisation of tissues. Equally important he fostered a feeling of family across cultures, languages and religions that was palpable at the international conferences of the Asia Pacific Association of Surgical Tissue Banks which owes much of its early support from the IAEA, to his foresight. It was this network that enabled the IAEA project

to soar, resulting not only in financial gain for all the Member States, but also the creation of a knowledge bank that spanned tissue donation strategies, management and operation of tissue banks, legislation and regulatory systems, safe and effective use of ionising radiations, tracking and di