1. Short title, application and commencement.—
Where does this law operate?Public health is a State matter. Therefore, this Act can apply to States only if they choose to adopt it. This law was originally valid in:
- All Union Territories under control of the Central Government
- Himachal Pradesh
- The Andhra Pradesh Transplantation of Human Organs Act, 1995
- Jammu and Kashmir Transplantation of Human Organs Act , 1997
2. Definitions.—In this Act, unless the context otherwise requires,— (a) “advertisement” includes any form of advertising whether to the public generally or to any section of the public or, individually to selected persons; (b) “Appropriate Authority” means the Appropriate Authority appointed under section 13; (c) “Authorisation Committee” means the committee constituted under clause (a) or clause (b) of sub-section (4) of section 9; (d) “brain-stem death” means the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified under sub-section (6) of section 3; (e) “deceased person” means a person in whom permanent disappearance of all evidence of life occurs, by reason of brain-stem death or in a cardio-pulmonary sense, at any time after live birth has taken place; (f) “donor” means any person, not less than eighteen years of age, who voluntarily authorises the removal of any of his human organs for therapeutic purposes under sub-section (1) or sub-section (2) of section 3; (g) “hospital” includes a nursing home, clinic, medical centre, medical or teaching institution for therapeutic purposes and other like institution; (h) “human organ” means any part of a human body consisting of a structured arrangement of tissues which, if wholly, removed, cannot be replicated by the body; (ha) “Human Organ Retrieval Centre” means a hospital,— (i) which has adequate facilities for treating seriously ill patients who can be potential donors of organs in the event of death; and (ii) which is registered under sub-section (1) of section 14 for retrieval of human organs; (hb) “minor” means a person who has not completed the age of eighteen years; (i) “near relative” means spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter; (j) “notification” means a notification published in the Official Gazette; (k) “payment” means payment in money or money’s worth but does not include any payment for defraying or reimbursing— (i) the cost of removing, transporting or preserving the human organ or tissue or both to be supplied; or (ii) any expenses or loss of earnings incurred by a person so far as reasonably and directly attributable to his supplying any human organ from his body; (l) “prescribed” means prescribed by rules made under this Act; (m) “recipient” means a person into whom any human organ or tissue or both is, or is proposed to be, transplanted; (n) “registered medical practitioner” means a medical practitioner who possesses any recognised medical qualification as defined in clause (h) of section 2 of the Indian Medical Council Act, 1956 (102 of 1956), and who is enrolled on a State Medical Register as defined in clause (k) of that section; (o) “therapeutic purposes” means systematic treatment of any disease or the measures to improve health according to any particular method or modality; (oa) “tissue” means a group of cells, except blood, performing a particular function in the human body; (ob) “Tissue Bank” means a facility registered under section 14A for carrying out any activity relating to the recovery, screening, testing, processing, storage and distribution of tissues, but does not include a Blood Bank; (p) “transplantation” means the grafting of any human organ from any living person or deceased person to some other living person for therapeutic purposes; (q) “transplant co-ordinator” means a person appointed by the hospital for co-ordinating all matters relating to removal or transplantation of human organs or tissues or both and for assisting the authority for removal of human organs in accordance with the provisions of sections 3.
What is the Authorisation Committee?The Authorisation Committee is a special group of medical experts. It exists in every State or Union Territory where this Act applies and oversees the process of organ transplantation. It grants the necessary permission for an organ transplantation to take place.
What is a brain-stem death?The brain-stem is the part of the brain where it connects with the spinal cord. The brain-stem regulates all activities that are essential for the continuation of life, such as breathing and swallowing.When the brain-stem stops performing its functions, the person is deemed to be brain-dead. The rest of his organs may continue to function thanks to the help of complex machinery, but a doctor can certify that for all practical purposes he is no longer alive.
In what circumstances would an individual be declared dead?There are broadly two types of death contemplated by this Act:1. Brain-stem death, which occurs when someone's brain stops working.2. Cardio-pulmonary death, which occurs when the heart stops beating and respiration ceases.
Who is a donor?An adult who of his own free will gives permission for his organs to be removed to further any medical purposes as provided under this law.
What is a human organ?Any part of the human body which cannot grow back once it is removed.For example, hair is not an organ because haircuts are not permanent. Kidneys do not replace themselves once removed, and hence fall under this definition.
Who is a registered medical practitioner?Someone who holds a legally valid qualification to be a medical doctor.
What are therapeutic purposes?It refers to any activity that has the objective of diagnosing a disease, treating and improving someone's health.
What are human tissues?Any group of cells that serve a particular function in the human body, excluding blood. Examples of human tissue would include nerves or muscular tissue.All human organs are made up of human tissues.
What is a tissue bank?It is a medical institution where human tissues are stored, screened, tested and distributed for scientific research, education, or medical needs.
What is transplantation?Transplantation occurs when you remove an organ from one person (who can either be dead or alive) and put said organ into the body of another living person for medical purposes.For example: Sheetal died in a car accident. Her liver is removed and put inside Rohan's body, who is suffering from liver failure. Transplantation can be said to occur when the liver has successfully been attached to Rohan's body.
3. Authority for removal of human organs or tissues or both.—
How do I become an organ donor?You have the right to become an organ donor, and allow your organs to be removed from your body and used for medical purposes after your death. You have to make a clear declaration about this in advance.You can do so:
- By registering online on the government site - http://notto.nic.in A guide to registration is here.
- By filling up Form 7, stating that you wish for your organs to be donated. Two witnesses have to sign this form, which should then be mailed to the National Organ And Tissue Transplant Organisation, 4th Floor, NIOP Building, Safdarjung Hospital Campus, New Delhi-110029
- For a person near-death, in the ICU, who has not made any such declaration, it will be the duty of the doctors to inform her of this option and find out from her or any near relative if she wants to donate her organs.
Can I change my mind about becoming an organ donor?Yes. An individual can at any time withdraw her consent to become a donor. Even if she never expressly revoked her permission in writing, if the person with legal possession of her body has good reason to believe that she may have changed her mind, he may refuse organ removal.
What if the deceased person never said anything about being an organ donor?The relative in charge can still allow organ donation, if it is clear that neither the deceased person nor any close relative objected to organ donation. However, if the person the person giving permission is someone who was only granted the limited responsibility of disposing of the body or performing last rites, then the organ removal must be refused.
Who can carry out the organ transplantation procedure?Only a registered medical practitioner has authority to carry out the procedure.
What are the duties of the doctors carrying out organ removal?Before initiating organ removal, the doctor has to ensure that:- The donor really is dead- The donor or the donor's representative has given permission to begin the organ removal.However, it is possible for a perfectly healthy individual to donate her organs under certain conditions. These conditions are laid down in Section 9.
How do we know that a brain-stem death has taken place?The body will have to first be inspected by a panel of medical specialists, If they are satisfied that brain-stem death has occurred, they will certify it so.
4. Removal of human organs or tissues or both not to be authorised in certain cases.—
Can a request for transplantation be refused even though the donor had consented to the organ removal?Yes. If there is reason to believe that the police or judicial system will need to inspect the body then the doctors are duty-bound to refuse to carry out organ removal.
5. Authority for removal of human organs or tissues or both in case of unclaimed bodies in hospital or prison.—
What about unclaimed bodies?In case the relatives of a dead person do not claim the body within 48 hours of death, then the hospital or prison administration will have the power to remove the organs or tissues from the body without seeking anyone's permission.However, if they have reason to believe that the dead person's relatives might eventually claim the body even though 48 hours have passed, then they must not remove any organs.
6. Authority for removal of human organs or tissues or both from bodies sent for post-mortem examination for medico-legal or pathological purposes.—Where the body of a person has been sent for post-mortem examination— (a) for medico-legal purposes by reason of the death of such person having been caused by accident or any other unnatural cause; or (b) for pathological purposes, the person competent under this Act to give authority for the removal of any human organ or tissue or both from such dead body may, if he has reason to believe that such human organ or tissue or both will not be required for the purpose for which such body has been sent for post-mortem examination, authorise the removal, for therapeutic purposes, of that human organ or tissue or both of the deceased person provided that he is satisfied that the deceased person had not expressed, before his death, any objection to any of his human organs or tissues or both being used, for therapeutic purposes after his death or, where he had granted an authority for the use of any of his human organs or tissues or both for therapeutic purposes, after his death, such authority had not been revoked by him before his death.
What is a post-mortem examination?Also known as an autopsy, it is when the authorities hand over a dead body to doctors or coroners so that they can determine what the cause and nature of death is.The body can be sent for post-mortem examination in two situations:
- Where someone has died in an accident or due to some other unnatural cause. An unnatural cause is one not connected to old age, a long-running disease, etc.
- To help diagnose and study a disease.
Can dead bodies sent for post-mortem examination be used for the purposes of organ removal?If the medical professionals believe that the organs they want to remove will not hinder the process of autopsy in any way, only then may they authorize the removal of the organs.Of course, all other conditions which are necessary for authorizing "normal" organ removal also have to be fulfilled.
7. Preservation of human organs or tissues or both.—After the removal of any human organ or tissue or both from the body of any person, the registered medical practitioner shall take such steps for the preservation of the human organ or tissue or both so removed as may be prescribed.
9. Restrictions on removal and transplantation of human organs or tissues or both.—
Can a healthy individual donate an organ that she can continue living without?Yes, a person is allowed to remove her organs even before her death, as long as she does it for therapeutic reasons only. People who do this are known as "living donors". However, there are certain restrictions:- A person suffering from a major mental disorder cannot be a living donor. - Children (below 18) cannot be living donors, except in extreme medical situations, where it has to be fully justified.- If a person, while alive, donates an organ to someone who is not a near relative, the Authorisation Committee has to approve.
Who can receive an organ or tissue transplant from a living donor?Normally, the recipient will have to be a near relative of the living donor. These are all the people that fall under the definition of "near relative":
Can someone who is not a near relative of the living donor also be a recipient?Yes, but this will require the approval of the Authorisation Committee.
Can a foreign national be a recipient of organ donation?Yes, but only if he is a near relative of the living donor. This will require the approval of the Authorisation Committee.
Can organ donors "swap" recipients?Yes. To understand how this works, consider the following scenario:-Jai has agreed to donate his liver to Veeru (who is his near relative) after he dies. In another family, Mario has also agreed to donate his liver to his brother Luigi. Now, the doctors find out that Jai and Veeru's bodies are incompatible, and Jai's liver cannot be safely transplanted into Veeru's body. They make a similar finding for Mario and Luigi.HOWEVER, it is also discovered that:- Jai's liver can safely be transplanted into Luigi's body- Mario's liver can safely be transplanted into Veeru's bodyAll four of them can then enter into an agreement that:- Upon Jai's death, his liver will be donated to Luigi- Upon Mario's death, his liver will be donated to VeeruIt is important that all four of them enter into this agreement for the swap to happen. The donations can also not happen in such a scenario without the approval of the Authorisation Committee.In case the Authorisation Committee believes that the people involved have not complied with the rules of this Act, it will be allowed to reject their application. However, the committee will have to give them an opportunity to be heard and record its reasons in writing.
10. Regulation of hospitals conducting the removal, storage or transplantation of human organs or tissues or both.—
Where can procedures related to organ donation take place?Removal, storage or transplantation of any organ or tissue may only take place at hospitals registered under this Act and only in the ways authorised by this Act.The only exception is the removal of eyes and ears from the dead body. These may take place by qualified doctors at any place.
Where may human tissues be stored, screened, or tested?Only at tissue banks registered as per the provisions of this Act.
11. Prohibition of removal or transplantation of human organs or tissues or both for any purpose other than therapeutic purposes.—No donor and no person empowered to give authority for the removal of any human organ shall authorise the removal of any human organ or tissue or both for any purpose other than therapeutic purposes.
Can human organs or tissues be removed from a body for any purpose other than therapeutic purposes?No. This is a punishable offence.
12. Explaining effects, etc., to donor and recipient.—No registered medical practitioner shall undertake the removal or transplantation of any human organ or tissue or both unless he has explained, in such manner as may be prescribed, all possible effects, complications and hazards connected with the removal and transplantation to the donor and the recipient respectively.
What information is the doctor duty-bound to disclose about organ transplantation?The doctor in charge of the operation will have to ensure that both the donor and the recipient understand the potential risks and complications that might arise out of this medical procedure. The organ removal cannot take place until he does so.
13. Appropriate Authority.—
How does the government enforce the provisions and rules of this Act?The government appoints certain officers to ensure that all the standards and guidelines are being followed by every hospital or other institution that is governed by this Act. These officers are referred to in this Act as the Appropriate Authority.They handle the registration of hospitals, investigate complaints against anyone violating this Act, inspect the quality of medical facilities, and exercise other such relevant functions in order to ensure that this law operates smoothly.This group of officers shall also be aided and advised by a committee of experts in the field of law, governance, social work, and medicine.
13A. Advisory Committees to advise Appropriate Authority.—
13B. Powers of Appropriate Authority.—The Appropriate Authority shall for the purposes of this Act have all the powers of a civil court trying a suit under the Code of Civil Procedure, 1908 (5 of 1908) and, in particular, in respect of the following matters, namely:— (a) summoning of any person who is in possession of any information relating to violation of the provisions of this Act or the rules made thereunder; (b) discovery and production of any document or material object; (c) issuing search warrant for any place suspected to be indulging in unauthorised removal, procurement or transplantation of human organs or tissues or both; and (d) any other matter which may be prescribed.
13C. National Human Organs and Tissues Removal and Storage Network.—The Central Government may, by notification, establish a National Human Organs and Tissues Removal and Storage Network at one or more places and Regional Network in such manner and to perform such functions, as may be prescribed.
13D. National registry.—The Central Government shall maintain a national registry of the donors and recipients of human organs and tissues and such registry shall have such information as may be prescribed to an ongoing evaluation of the scientific and clinical status of human organs and tissue.
14. Registration of hospitals engaged in removal, storage or transplantation of human organs or tissues or both.—
Is every hospital allowed to carry out organ and tissue transplantation procedures?No. Only a hospital or tissue bank which has been specially registered by the Appropriate Authority is allowed to undertake any activity in relation to the removal, storage, transport, transplantation, etc. of organs and tissues.
Why must hospitals be registered in order to carry out an organ transplantation?Organ transplantation is extremely specialized, risky business. Hospitals carrying out this procedure must be of the highest quality with expert staff, otherwise they might waste precious organs or put patients' lives in danger.
14A. Registration of Tissue Bank.—
Why must tissue banks be registered?They must be registered because they store sensitive biological substances, some of which may also turn out to be potentially hazardous to public health.
15. Certificate of registration.—
How are tissue banks and hospitals registered?The government holds an inquiry to decide if the tissue bank or hospital is following all the regulations. If they are satisfied, then they grant a certificate of registration.
What if the tissue bank or hospital cannot fulfil the regulations laid down by the government?The government will give the establishment an opportunity to put forward its case as to why it deserves to be registered. If the government officers are still not satisfied that the hospital or tissue bank is complying with the rules laid down under this Act, then they shall refuse to grant a certificate of registration.
16. Suspension or cancellation of registration.—
Can the registration of a hospital or tissue bank be suspended?Yes, if it is found out that they are violating the rules laid down under this Act. This is besides any criminal penalties they might face. They will, however, first be given an opportunity to argue why they don't deserve to have their registration suspended.
17. Appeals.—Any person aggrieved by an order of the Authorisation Committee rejecting an application for approval under sub-section (6) of section 9, or any hospital or Tissue Bank, as the case may be, aggrieved by an order of the Appropriate Authority rejecting an application for registration under sub-section (2) of section 15 or an order of suspension or cancellation of registration under sub-section (2) of section 16, may, within thirty days from the date of the receipt of the order, prefer an appeal, in such manner as may be prescribed, against such order to— (i) the Central Government where the appeal is against the order of the Authorisation Committee constituted under clause (a) of sub-section (4) of section 9 or against the order of the Appropriate Authority appointed under sub-section (1) of section 13; or (ii) the State Government, where the appeal is against the order of the Authorisation Committee constituted under clause (b) of sub-section (4) of section 9 or against the order of the Appropriate Authority appointed under sub-section (2) of section 13.
What can someone do if she has a problem with the Authorisation Committee refusing to allow a certain transplantation to go forward?She can complain to the government in charge of that particular State/Union Territory.
What can a hospital or tissue bank do if it has a problem with the Appropriate Authority refusing to register it in accordance with this Act?It can also complain to the government in charge of that particular State/Union Territory.
18. Punishment for removal of human organ without authority.—
What if someone removes an organ in violation of the rules and procedures laid down by this Act?He will be punished with both punishment that may last for upto ten years and have to pay a fine which may be as much as Rs. 20 lakhs.This same punishment will apply to anyone who was helping him or associated with the act in any way.In case he is a doctor, his license will be revoked for three years in case of the first violation, and permanently if he does the illegal act a second time.
What if someone removes a human tissue in violation of the rules and procedures laid down by this Act?He will be imprisoned for upto three years *and* will have to pay a fine which may be as much as Rs. 5 lakh.
19. Punishment for commercial dealings in human organs.—Whoever— (a) makes or receives any payment for the supply of, or for an offer to supply, any human organ; (b) seeks to find a person willing to supply for payment any human organ; (c) offers to supply any human organ for payment; or (d) initiates or negotiates any arrangement involving the making of any payment for the supply of, or for an offer to supply, any human organ; (e) takes part in the management or control of a body of persons, whether a society, firm or company, whose activities consist of or include the initiation or negotiation of any arrangement referred to in clause (d); or (f) publishes or distributes or causes to be published or distributed any advertisement,— (a) inviting persons to supply for payment of any human organ; (b) offering to supply any human organ for payment; or (c) indicating that the advertiser is willing to initiate or negotiate any arrangement referred to in clause (d); (g) abets in the preparation or submission of false documents including giving false affidavits to establish that the donor is making the donation of the human organs, as a near relative or by reason of affection or attachment towards the recipient,shall be punishable with imprisonment for a term which shall not be less than five years but which may extend to ten years and shall be liable to fine which shall not be less than twenty lakh rupees but may extend to one crore rupees.
What is the punishment for dealing commercially in human organs and tissues?Commercial dealings here refer to any business activity which involves money in exchange for human organs and tissues. Section 19 and 19A make these activities illegal.A person will be punished under Section 19 if he:
- Buys or sells organs
- Offers to buy or sell organs
- Advertises commercial dealings in relation to organs,
- Forges documents to make it seem like the donor wanted to give her organs to someone (but in reality didn't)
- Is a middleman who helps people participate in any of these banned acts
- Or is part of the management of an organization which was engaged in these activities
19A. Punishment for illegal dealings in human tissues.—Whoever— (a) makes or receives any payment for the supply of, or for an offer to supply, any human tissue; or (b) seeks to find a person willing to supply for payment and human tissue; or (c) offers to supply any human tissue for payment; or (d) initiates or negotiates any arrangement involving the making of any payment for the supply of, or for an offer to supply, any human tissue; or (e) takes part in the management or control of a body of persons, whether a society, firm or company, whose activities consist of or include the initiation or negotiation of any arrangement referred to in clause (d); or (f) publishes or distributes or causes to be published or distributed any advertisement— (i) inviting persons to supply for payment of any human tissue; or (ii) offering to supply any human tissue for payment; or (iii) indicating that the advertiser is willing to initiate or negotiate any arrangement referred to in clause (d); or (g) abets in the preparation or submission of false documents including giving false affidavits to establish that the donor is making the donation of the human tissues as a near relative or by reason of affection or attachment towards the recipient, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years and shall be liable to fine which shall not be less than five lakh rupees but which may extend to twenty-five lakh rupees.
What is the punishment for dealing commercially in human tissues?A person will be punished for all acts similar to those defined in Section 19 where the only difference is that the objects being commercially dealt with are human tissues instead of human organs.The main variation lies in the quantum of punishment, which, in the case of human tissues, will be imprisonment for 1-3 years and a fine ranging from Rs. 5 lakh to Rs. 25 lakh
20. Punishment for contravention of any other provision of this Act.—Whoever contravenes any provision of this Act or any rule made, or any condition of the registration granted, thereunder for which no punishment is separately provided in this Act, shall be punishable with imprisonment for a term which may extend to five years or with fine which may extend to twenty lakh rupees.
What is the punishment for violation of all other laws under this Act?The punishment for all other offences will be either imprisonment for a maximum limit of 5 years or a fine with a maximum limit of Rs. 25 lakh.
21. Offences by companies.—
Who will be punished in case a company or other such organization is found violating this Act?Every single person who is part of the company in a managerial capacity (or any other such capacity where he can be considered to be sufficiently responsible for the company's business decisions, like a Director or Chief Legal Officer) will be punished in case any law under this Act is violated.However, if he can prove that:
- The illegal action was committed without his knowledge, or
- He had done everything expected of him to prevent this illegal act from happening but it happened anyway,
22. Cognizance of offences.—
Can an individual approach the Court directly to complain about the violation of any law under this Act?No. An individual will first have to write a complaint to the government authority which is in charge of enforcing the rules of this Act, informing them that such a violation has taken place and he intends to approach the Court if action is not taken. In case no action is taken by the government authorities for 60 days after the complaint, only then may the individual may approach the Court.