Organ Transplantation in India | Organ Transplant Governing Laws

Laws and Rules Governing Organ Transplantation in India

The primary legislation related to organ donation and transplantation in India, Transplantation of Human Organs Act, was passed in 1994 and is aimed at regulation of removal, storage and transplantation of human organs for therapeutic purposes and for prevention of commercial dealings in human organs.

In India, matters related to health are governed by each state. The Act was initiated at the request of Maharashtra, Himachal Pradesh and Goa (who therefore adopted it by default) and was subsequently adopted by all states except Andhra Pradesh and Jammu & Kashmir. Despite a regulatory framework, cases of commercial dealings in human organs were reported in the media. An amendment to the act was 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. The amendment to the Act was passed by the parliament in 2011, and the rules were notified in 2014. The same is adopted by the proposing states and union territories by default and may be adopted by other states by passing a resolution.

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 the Embassy

The main provisions of the Act are as follows:

(including the amendments and rules of 2014)

Deceased Donor Transplant in India | Organ Donation After Death

The report was commissioned in September 2013 by the Parashar Foundation, an NGO based in Delhi in partnership with the MOHAN Foundation, and the survey was carried out by the research agency, Outline India.

The objective of the report was to understand the deceased organ donation and transplant environment in Delhi – facts, trends, processes, opportunities and challenges; conduct extensive research around historical developments; efforts made and lessons learnt; understand global systems and success stories in the field; come up with recommendations for action; plan future strategy for growth and effectiveness in Delhi/NCR and India.

A team of researchers from Outline India contacted Senior Medical Officers, doctors, transplant coordinators at 24 of the top hospitals/research centres in the Delhi/NCR region to gather information about the latest organ transplantation system in India of which 16 responded (In two cases, 2 interviews were conducted at two branches of the same group of hospitals, amounting to a total of 18 interviews overall, across 16 institutions).

Hospitals included in the scope of the research were Fortis (FMRI & Vasant Kunj), Max Patparganj, Max, Medanta, Gangaram, BLK, AIIMS, RML, Indraprastha Apollo, St Stephens, Primus Super-specialty Hospital, Jaipur Golden, Pushpawati Singhnia Research Institute, Safdarjung Hospital and Army Hospital R&R.

Some of the Doctors interviewed amongst others were Dr. Avnish Seth (Director FORT, FMRI), Dr. Ravi Mohanka (Fomerly Transplant Surgeon, Medanta), Dr. Aman Gupta (Fortis Vasant Kunj), Dr. PB Singh (Director, Institute of Urological Science, Max Patparganj), Dr Vijay Kher (Chairman Nephrology, Medanta The Medicity), Dr. Sangay Singh Negi (Director Hepatobilliary Surgery & Liver Transplantation, BLK), Dr. Sunil Prakash (Director Kidney Transplantation BLK) and Dr. Sudeep Naidu.

Recommendations of the Report:

It is only through awareness programmes that the number of deceased donations can be increased. Large-scale advertising campaigns should aim to educate people about the benefits of organ donation, clearing all prevalent myths and misconceptions about it. The concept of brain death needs to be adequately dealt with so that the organs of the deceased, which can be retrieved and utilised, do not go to waste.
What is needed is a large scale campaign, which only the government can undertake or fund. Clear messaging by the government will also add credibility to the cause. In fact all messaging in public places and hospitals in the form of standees, video spots etc. have to have the government logo along with that of the hospital in order to increase people’s trust.

A central organ sharing registry or a recipient registry is an absolute must, so that the donated organs can be shared in a fair and transparent manner. Apart from a few states, there are no sharing protocols in place. This leads to unethical and unhealthy practices. Further, it leads to wastage of organs which is a shame when a family has taken the courageous decision to donate. The sharing of cost between hospitals also has to be clearly defined.
This system, however, will not work in the current scenario with seemingly unhealthy and negative attitudes amongst the various stakeholders. There needs to be a spirit of cooperation, sharing and the willingness to adopt from successful practices in other parts of the country.

There was a near unanimous response from the medical fraternity that making the declaration of brain death mandatory will increase instances of organ donation. Making brain death declaration mandatory will help facilitate a discussion between the doctor/physicians and the relatives about brain death and organ donations. It would help Transplant Coordinators and personnel from other Departments to intervene and convince the relatives about organ donation.

It is imperative to understand and acknowledge the pivotal role that the Transplant coordinator plays in the entire process of organ donation and transplantation. It is only when the hospital is able to establish a personal rapport with the patient and the patient’s relatives, can it create a precondition necessary to establish talk regarding organ donation later on. An increased number of Transplant Coordinators would help in creating awareness and would also help in counselling the relatives to manage the system of organ donation. Higher numbers of Transplant Coordinators are required in a public set-up as the number of patients there are significantly higher.

Improve Infrastructure within public hospitals for transplantation. Transplantation as a service should be readily available in all Government hospitals as the majority of patients go there for treatment and many cannot afford treatment at private hospitals. The Government also needs to take the necessary steps to improve the infrastructural set-up at all public hospitals to store/transport organs, train the hospital staff/personnel for organ transplantation procedures and on the subject of brain death, and to increase awareness regarding the same.

Non-transplant hospitals need to be involved in organ retrieval. These medical centres (which have ICU’s but are not transplant centres) are crucial because a lot of accident victims are brought here for treatment. They should be geared up for brain death declaration. They need to be given an incentive to be participants in organ retrieval, and a system has to be worked out wherein they are compensated adequately for their active involvement in the Organ Donation programme.

Sensitization of police personnel and the forensic experts has to be taken up on a war footing to make all medico-legal cases smooth. Most brain death cases are accident cases and therefore medico legal cases. They usually are difficult to handle as they do not get cooperation from these quarters.

Provide the public with organ donor intent forms and brochures while issuing driving licences, Aadhar cards and college ID cards, so they can choose to express their intent on the cards.

Emulate successful practices from other states: States such as Tamil Nadu for instance have recorded an 80% conversion rate when it comes to donating the organs of one kin. The state has a record organ donation which is 15 times the national average. An important step in this direction was the creation of a network of hospitals for sharing organs. The same should be replicated in other cities, like Delhi.

The Maharashtra government made it compulsory for all non-transplant hospitals equipped with an ICU and operation theatre to retrieve organs for harvesting and made it mandatory for them to officially identify brain dead patients. This was a crucial point highlighted in the primary research as well and hence, needs to be implemented in the Delhi/NCR region.

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