THOTA-1994

THE TRANSPLANT of HUMAN ORGAN and TISSUE ACT 1994
(Revised in 2011 and Organ Transplant Rules 2014)

Brief History

In absence of regulations and rules there is chaos and in absence of law there are crimes.
This was the condition of Organ Transplantation before 1994. Human organ and tissue transplantation was started in India in 1962.
It is not the case that there was total absence of law. There were some scattered laws and regulations which were used for Organ Transplantation.

  1. Indian anatomy act 1919 and Indian Journal of Medical Ethics.
  2. Bombay Anotomy act 1949 and Bombay Anatomy Rules 1950..
  3. Bombay Corneal Grafting Act 1957
  4. Eyes act of 1982 and Ear drums and Ear bones Act 1982
  5. Maharashtra Kidney transplantation act 1982
    All these provisions were insufficient for regulation of organ transplantation. Such situation was beneficial to the criminals and the crimes in Organ Transplantation were beyond control.
    Realising the fact Government of Maharashtra first proposed the Transplantation of Human Organ Bill with support from Government of Goa and Government of Himachal Pradesh, to Loksabha on 20th August 1992. It was passed by Lok-Sabha on 8th July 1994 and published by Ministry of Law Justice and Company Affairs ( legislative department ) on 11th July 1994 as ‘Transplant of Human Organs Act 1994’. The act, by default made applicable from that day to proposing three states and obviously the union territories. Maharashtra, Himachal Pradesh, and Goa (who therefore adopted it by default) and was subsequently adopted by all states except Andhra Pradesh and Jammu and Kashmir.
    The Legislative Assembly of Andhra Pradesh had then adopted the aforesaid Central Act in the form of Andhra Pradesh Transplantation of Human Organs Act, 1995.
    The rules for implementation of the Act were made in force as Transplant of Human Organs Rules 1995 wef July 1995. The rules then further amended in 2008 and 2014.
    The act was further amended in 2011 and to the title of the act Tissues were introduced and the act now is known as ‘ Transplant of Human Organs and Tissue Act 1994 (Amendment 2011)’

It is a need of time that organ donation activists, persons in medical profession and specially persons in police department should know about the legal aspects of the organ transplantation.

The Act is to provide for the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in
human organs and for matters connected there with or incidental thereto.

The original act THOA 1994 called as principal act is divided in Seven Chapters and 25 Sections as follows.

CHAPTER I : Preliminary
1 Short title,application and commencement
2 Definitions
CHAPTER II : Authority for the removal of human organs
3 Authority for removal of human organs

  1. Removal of human organs not to be authorised in certain cases.
    5 Authority for removal of human organs in case of unclaimed bodies in hospital or prison
  2. Authority for removal of human organs from bodies sent for postmortem examination for medico-legal or pathological purposes.
  3. Preservation of human organs
  4. Savings
  5. Restrictions on removal and transplantation of human organs
    CHAPTER III : Regulation of hospitals
    10 Regulation of hospitals conducting the removal,storage or transplantation of human organs
    .11 Prohibition of removal or transplantation of human organs for any purpose other than therapeutic purposes.
    12 Explaining effects, etc., to donor and recipient.
    CHAPTER IV Appropriate Authority
    13 Appropriate Authority
    Chapter V : Registration of Hospitals
    14 Registration of hospitals engaged in removal,storage or transplantation of human organs.
    15 Certificate of registration
    16 Suspension or cancellation of registration
    17 Appeals
    Chapter VI : Offences and Penalties
    18 Punishment for removal of human organ without authority
    19 Punishment for commercial dealings in human organs
    20 Punishment for contravention of any other provision of this Act.
    21 Offences by companies
    22 Cognizance of offence
    Chapter VII : Miscellaneous
    23 Protection of action taken in good faith.
    24 Power to make rules.
    25 Repeal and saving

After fifteen years of the implementation of the act the need for amendment of this act became necessary. In view of the experience of some cases, incidents and other difficulties observed it was found that there was a nececity to amend the act to clarify some clauses.
An amendment to the act was then proposed by the States of Goa, Himachal Pradesh, and West Bengal in 2009 to address inadequacies in the efficacy, relevance, and impact of the act.