Organ Donation- Rules and Regulation

By- Komal Pandey

Introduction

Medical science has so far done a very tremendous job in the field of organ donation and transplantation.  One person donating her/his organs is capable of saving up to 9 lives and improving the lives of quite a few others too.

However, due to the lack of awareness and prevalence of myths around organ donation in India majority of people do not take up this noble cause.

What is organ donation?

The complete process of retrieving a human organ from a deceased or living person referred to as a donor, and transplanting it into a recipient is known as organ donation. A patient who is suffering from organ failure and will not survive unless she/ he receives an organ replacement is the recipient and the process of recovering an organ is called retrieval. 

 Which organs can be donated?

Organ donation can take place when the donor is alive as well as after the death of the donor. There are eight organs that can be donated or transplanted:

1. Kidneys: the demand for the kidney is highest and they are the most frequently donated organs. A deceased donor can donate both kidneys. The average lifespan of a transplanted kidney is approximately 9 years and varies from person to person. A living donor can donate one kidney and can live on one kidney for the rest of their life.
2. Heart: after retrieving a donor’s heart it can survive for 4-6 hours only.
3. Liver: the only human organ that can grow cells and regenerate is the liver. A deceased donor’s liver can save two lives by splitting it into two pieces and transplanting it to two different patients. a living donor can have a portion of the liver removed and can be donated to someone, her/his liver will regenerate.
4. Lungs: living donor can give a single lobe from the lungs. While a deceased donor can donate single or double-lungs but it will not regenerate.
5. Pancreas: a deceased donor’s pancreas can be transplanted to the patient and a living donor can also give a portion and can function on the rest of the pancreas.
6. Intestine: a deceased donor can donate their intestine and very rare can a living donor can donate a portion of their intestine.

Apart from organs, tissues like corneas, skin, bones, ligaments, heart valves, etc can be donated. Within 6 hours of the donor’s death, most tissues should be donated.

1. Cornea: eye donation or cornea donation is the most known tissue donation. The eye’s primary focusing element and the transparent covering over the eye is the cornea. Patients with blindness because of an accident, infection, or some disease can opt for a corneal transplant. Donors can be of any age group.
2. Bones: whose bones are cancerous can get bones replaced by the donor’s bones without amputating the cancerous bone.
3. Skin: used for burn victims, acid attack victims or post-mastectomy breast reconstruction, etc.
4. Veins: veins donation is generally used for cardiac bypass surgeries.   

Tissues like tendons, muscles, ligaments, and cartilage can also be donated.

Types of organ donation

There are two types of organ donation- living and deceased organ donations.

Living organ donation: a healthy living person can transplant an organ to someone who is suffering from end-stage organ failure. This can be done mostly in the case of liver or kidney failure.

Near relatives or distant relatives/friends etc can be classified as a living donor. A near relative is a spouse, children, siblings, parents, grandparents, and grandchildren. Distant relatives and friends will need the permission of the State Authorization Committee to donate organs. The patient can send legal notice to the hospital for not following the Transplant Act if they do not entertain their case.

Deceased organ donation: organ donation after death or pledging for organ donation is called deceased organ donation. A person who has been declared brain stem dead can donate their organs. When there is an irreversible loss of consciousness, absence of reflexes and irreversible loss of capacity to breathe then the person is said to be brain stem dead. In India, organ donation can only be possible in case of brain stem death.  It is common in the west to carry the donation after cardiac death but in India, it is rare for donation to take place after cardiac death.

Process of organ donation

 The living donation process:

1. The living donor will undergo some medical procedures and evaluations to confirm her/his medical compatibility with the recipient.
2. The organ retrieved surgically by the doctors will be stored in special chemical solutions until they are transplanted into the recipient.
3. The living donor will be in observation for a few days until the doctor declares them fit.

The deceased donation process:

1. A person who has suffered a fatal head injury or had a brain hemorrhage and declared brain stem dead can be a group of medical experts in a hospital who can be a deceased donor.
2. The donor’s family has to give consent before organ retrieval takes place. In the meantime, doctors will keep the donor on life-support until the organ retrieval is allowed to carry forward.
3. All the suitable recipients will be identified from a waiting list and will be notified to reach their respective hospitals.
4. After the retrieval of all the organs, the donor will be respectfully handed over to the family.

Law regulating organ donation in India

Transportation of Human Organs & Tissues Act, passed in the year 1994 is the primary legislation related to organ donation in India. It aims to regulate of removal, storage, and transplantation of human organs for medicinal purposes and horse trading in human organs.

Some main provisions of the act are:

• The form of death should be identified as brain stem death. The process and criteria for brain stem death certification are also defined.
• Allowing transplantation of organs from living donors and cadavers.
• Regulatory and advisory body.
• Monitoring transplantation activity and its constitution.

Procedure for death declaration

According to the Transplantation of Human Organs & Tissues Act, THOTA 1994:

A panel of 4 doctors should be made and approved by the government. Among 4, two doctors must declare brain stem death. This test has to be performed twice with a gap of 6 hours between them. 

The panel includes:

1. A registered medical practitioner- is in charge of the hospital where the brain stem death patient is admitted.
2. A registered medical practitioner approved by the authority.
3. A neurologist/neuro-surgeon (any surgeon or physician and Anesthetist or Intensivist who is nominated by a medical administrator in charge approved by authority can also perform the test if a neurologist is not available).
4. Test results are recorded on Form 10 of the THOT act 2014 and the family’s consent is obtained on Form 8.

There must be no interest or benefit for the certifying clinicians from the transplantation of cadaver donor organs. The certification should be done as per the act and the medical superintendent of the hospital should crosscheck and sign the form.

An initiative by the Indian government  

The Ministry of Health and Family Welfare launched its first organ donation day world’s 6^th organ donation congress 2010 in New Delhi. Every year India celebrates its organ donation day on the 27^th of November. World Organ Donation day is celebrated on 13 August and aims at encouraging people to pledge to donate their organs.  The objective of celebrating organ donation day is to address the myths around organ donation and debunk them due to unawareness that there is always a huge shortage of donors and the organ that is to be transplanted.

Situation in India

In India, only those who have been declared brain dead can donate their organs but the relatives are mostly reluctant to donate the organs of their loved ones

The transplant coordinator approaches the family of the brain-dead patient to inform them about the procedures and formalities they perform for the organ transplant. The coordinator will first educate the family about organ donation it is always encouraged to donate so that it can save someone’s life. In a time of their loss, it is not always welcomed by the family therefore complete knowledge and every possibility is presented before them.

According to a 2017 report, there was a total of 905 deceased donors in India, and nearly 1.5 lacks people died of brain death mostly due to accidents. The organ donation rate in India is 0.86 per million population. The demand for organ donation is nearly 5lakh organs annually and barely 2-3 percent of the demand can be fulfilled.

There are two government agencies that regulate organ donation in India. NOTTO- National Organ and Tissue Transplant Organization, and ROTTO- Regional Organ Donation and Tissue Transplant Organization.

NOTTO- National Organ Donation and Tissues Transplant Organization

It is a national-level organization. It is established under the Transplantation of Organs and Tissues (Amendment) Act of 2011. It comes under the Ministry of Health and family welfare and is headed by the Directorate General of Health Services. It is the apex body and checks the activity of organ donation all over India. Apart from its national role, it is also the nodal networking agency for Delhi and the national capital region. It looks for the procurement, allocation, and distribution of organs and tissues.

ROTTO- Regional Organ and tissues Transplant Organization

There is a total of five regional government organizations in India. They ensure the protocols amongst them mentioned under state organization and function as a separate regional branch. They are based in Government Hospitals under the state. Each ROTTO is managing 5-7 states and is responsible for the activities like procurement, network, distribution, and coordination of the transplantation of organs and tissues between their respective states.

References

1. https://www.nhp.gov.in/Organ-Donation-Day_pg
2. https://www.organindia.org/

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