Kidney Transplant in India
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Everything you need to know about Kidney Transplant in India
First kidney transplants in India was initiated in the 1970’s and since that time, India has been a leading country in this field on the Asian sub-continent.
Transplantation of Human Organ Act (THO) was passed in India in 1994 to streamline organ donation and transplantation activities. Broadly, the act accepted brain death as a form of death and made the sale of organs a punishable offence.
Legal Procedure for Kidney Transplant in India
- Living donation
- Who can donate – mother, father, brothers, sisters, son, daughter, spouse and grandparents
- Brain-death and its declaration –Three certifications are required:
- One certification from treating doctors
- Two more certifications from the doctors nominated by the appropriate authority of the government with one of the two being an expert in the field of neurology.
- Regulation of transplant activities
- Role of Authorization Committee (AC) –
- to regulate the process of authorization to approve or reject transplants between the recipient and donors other than a first relative.
- to ensure that the donor is not being exploited for monetary consideration to donate their
- Information about approval or rejection is sent by mail to the concerned hospitals
- Role of Appropriate Authority (AA) –
- to regulate the removal, storage, and transplantation of human organs.
- inspecting and granting registration to the hospitals for transplant surgery, enforcing the required standards for hospitals, conducting regular inspections of the hospitals to examine the quality of transplantation and follow-up medical care of donors and
- Role of Authorization Committee (AC) –
- Authority for removal of human organ
- Any donor may authorize the removal, before his death, of any human organ of his body for therapeutic purposes as specified in Forms 1(A), 1(B), and 1(C), to be submitted with proof of identity and address, marriage registration certificate, family photographs, etc. with attestation by a Notary Public
Things a medical practitioner should verify before transplant –
- Before removing a human organ from the body of a donor before his death, a medical practitioner should verify that the donor has given authorization in Form 1(A) if the relative is a close relative i.e., a mother, father, brother, sister, son, or daughter
- The donor is in a proper state of health and is fit to donate the organ. The registered medical practitioner should then sign a certificate as specified in Form 2.
- The donor is a close relative of the recipient as certified in Form 3 and has signed Form 1(A).
- The donor has submitted an application in Form 10 jointly with the recipient and the proposed donation has been approved by the concerned competent authority.
- Cost of donor management, retrieval, transportation and preservation to be borne by the recipient, institution, government, NGO or society, and not by the donor family.
Things a medical practitioner confirm before removing an organ from a dead body –
- The donor had, in the presence of two or more witnesses (at least one of whom is a close relative of the recipient), unequivocally authorized as specified in Form 5 before his death,
- the removal of the human organ of his body after his death for therapeutic purposes and there is no reason to believe that the donor had subsequently revoked the authority.
- The person lawfully in possession of the dead body has signed a certificate as specified in Form 6
In the event of brain-stem death, confirm the following –
- A certificate as specified in Form 8 has been signed by all the members of the Board of Medical Experts.
- In the case of brain-stem death of a person of less than 18 years of age, a certificate specified in Form 8 has been signed by all the members of the Board of Medical Experts and an authority as specified in Form 9 has been signed by either of the parents the person.
If the transplant is between persons related genetically & above the age of 18 years old, the following shall be evaluated –
- Results of tissue typing and other basic tests
- Documentary evidence of relationship e.g., relevant birth certificates and marriage certificate
- Documentary evidence of identity and residence of the proposed donor e.g., Ration Card or Voters Identity Card, Passport, Driving License, PAN Card, or Bank Account and family photograph depicting the proposed donor and the proposed recipient along with another near relative
- If the relationship is not conclusively established after evaluating the above evidence, direct further medical tests may be given as described follows.
- Test for Human Leukocyte Antigen (HLA), human leukocyte antigen-B alleles to be performed by the serological and /or polymerase chain reaction (PCR) based Deoxyribonucleic Acid (DNA) methods
- Test for human leukocyte antigen-Dr beta genes to be performed using PCR-based DNA methods
When the proposed donor and the recipient are not close relatives, the Authorization Committee shall evaluate the following –
- An explanation of the link between them and the circumstances that led to the offer being made
- Reasons why the donor wishes to donate
- Documentary evidence of the link, e.g., proof that they have lived together
- Old photographs showing the donor and recipient together
- There is no middleman or tout involved
- The financial status of the donor and the recipient.
- The donor is not a drug addict or known person with criminal record
- The next of kin of the proposed unrelated donor is interviewed regarding awareness about his or her intention to donate an organ, the authenticity of the link between the donor and the recipient and the reasons for donation.
Process followed after donor matching –
- The approved proposed donor would be subjected to all medical tests as required at relevant stages to determine his biological capacity and compatibility to donate the organ in question.
- Psychiatrist’s clearance in such cases is deemed mandatory to certify the donor’s mental condition, awareness, absence of any overt or latent psychiatric disease, and ability to give free consent.
- All prescribed forms have been completed by all relevant persons involved in the process of the transplantation.
- All interviews should be video recorded.
The various forms outlined in the rules are as follows:
- Form 1: Near-relative consent
- Form 2: Spouse consent
- Form 3: Other than near-relative donor consent
- Form 4: Psychiatrist evaluation of the donor
- Form 5: HLA DNA profiling report
- Form 7: Self consent for deceased donation
- Form 8: Consent for organ donation from family (also applicable for minors)
- Form 9: Consent for organ donation from unclaimed bodies
- Form 10: Brain death declaration form
- Form 11: Joint transplant application by donor / recipient
- Form 12: Registration of hospital for organ transplantation
- Form 13: Registration of hospital for organ retrieval
- Form 16: Grant of registration
- Form 17: Renewal of registration
- Form 18: Decision by hospital authorization committee
- Form 19: Decision by district authorization committee
- Form 20: Verification of Domicile for non-near-relative
- Form 21: Letter from Embassy
Penalties for removal of organ without authority, making or receiving payment for supplying human organs or contravening any other provisions of the Act have been made very stringent in order to serve as a deterrent for such activities.