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Judgment
V. Dhanapalan, J.—By consent of the learned counsel on either side, the writ petition itself is taken up for final disposal at the stage of
admission itself. Heard Mr. John Zacharia, learned counsel appearing for the petitioner, Mr. C. Kanagaraj, learned counsel for R1 and also Mr.
P.H. Aravind Pandian, learned Additional Advocate General, assisted by Mr. V. Jayaprakash Narayanan, Special Government Pleader appearing
for R2.
The petitioner has filed this writ petition seeking to quash the List D.M.E. Ref. No. 8810/MEII/2/07 of the 2nd respondent dated 07.02.2007
with a consequential prayer to direct the 2nd respondent to permit the petitioner to undergo the Renal Transplant Operation at the 3rd respondent
hospital, by receiving the organ from the husband of petitioner/donor Mr. Kaja Salaudin in terms of the letter dated 01.11.2011 of the 1st
respondent without insisting on the documents set out in the List D.M.E. Ref. No. 8810/MEII/2/07 dated 07.02.2007.
According to the petitioner, she is a house wife and her husband is working as System Administrator at Kuwait. Their marriage was solemnized
17 years ago and have one daughter and two sons. She has kidney problem since 2007 and due to diabetes and hypertension, her kidney
condition has become worst and has been taking treatment with a nephrologists at Kovai Medical Centre and Hospital. On account of sudden
complications, she was admitted in the ICU as an inpatient from 24.06.2013 and was discharged on 09.10.2013. The petitioner was advised to
undergo kidney transplantation. As her condition became more worst, she was put on haemodialysis. Since her Doctor insisted to got for
immediate kidney transplantation, her husband came forward to donate one of his kidneys to her and he was fit enough to donate the same also.
3a. It is submitted by the petitioner that her husband underwent all the required tests and tissue matching and it was ascertained by the Doctors that
her husband could donate a kidney. Therefore, the petitioner and her husband approached the Authorisation Committee of the 3rd respondent
Hospital on 07.11.2013 with all relevant documents to accord such approval. However, the 3rd respondent, by referring to a list issued by the 2nd
respondent in the year 2007, called upon her to produce further documents, which has no relevance as of today due to the amendment being
brought in to the Act of 1994 on 27.09.2011. It was informed to her that 3rd respondent Hospital has been registered u/s 14 of the
Transplantation of Human Organs Act, 1994 and the registration has been renewed periodically and the same is being certified by the Inspecting
Team, nominated by the 2nd respondent. It was further informed to her that 2nd respondent has laid down certain conditions as per an order
dated 11.01.2011, wherein under Clause 2(d)(02), it has been stipulated that approval is required from the Authorization Committee even for near
relative patients and as per Clause 2(d)(05), the 3rd respondent hospital was directed to produce all the donors in non-near relative cases within
90 days after surgery before the Authorization Committee, Chennai or Coimbatore. The 3rd respondent hospital has also been directed to
produce donors in all cases within 90 days after the surgery in a local medical college, but these conditions are not provided under the Act and her
husband is unwilling to undergo any medical test either after operation, having spent more money. It was informed to her that a person with one
kidney can also lead a normal life as that of person having both. In view of the conditions set out by the 1st respondent, she has been facing
problems, though such provisions have not been incorporated in the Act or Rules.
3b. Section 9 of the Act, which requires necessary approval, reads as under:
Section 9: (1) Save as otherwise provided in sub-section (3), no human organ removed from the body of a donor before his death shall be
transplanted into a recipient unless the donor is a near relative of the recipient.
(1A) Where the donor or the recipient being near relative is a foreign national, prior approval of the Authorisation Committee shall be required
before removing or transplanting human organ or tissue or both:
Provided that the Authorisation Committee shall not approve such removal on transplantation if the recipient is a foreign national and the donor is
an Indian National unless they are near relatives.
(4)(a) The composition of the Authorisation Committees shall be such as may be prescribed by the Central Government from time to time.
(b) The State Government and the Union territories shall constitute, by notification, one or more Authorisation Committees consisting of such
members as may be nominated by the State Government and the Union territories, on such terms and conditions as may be specified in the
notification for the purposes of this section.
(5) On an application jointly made, in such form and in such manner as may be prescribed, by the donor and the recipient, the Authorisation
Committee shall, after holding an inquiry and after satisfying itself that the applicants have complied with all the requirements of this Act and the
rules made thereunder, grant to the applicants approval for the removal and transplantation of the human organs.
(6) If, after the inquiry and after giving an opportunity to the applicants of being heard, the Authorisation Committee is satisfied that the applicants
have not complied with the requirements of this Act and the rules made thereunder, it shall, for reasons to be recorded in writing, reject the
application for approval.
3c. It is stated by the petitioner that the definition of near relative has also been amended as under:
Section 2(i): near relative means spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter.
Therefore, according to the petitioner, even grandparents or grandchildren are near relatives and can donate organ and thus as per Section 9 and
Section 2(i), there is no necessity to obtain approval from the Authorisation Committee in cases of near relatives. It is different in case of a
transplant between a foreign national and an Indian, who are near relatives.
3d. The submission of petitioner is that as per the Transplantation of Human Organs Rules, 1995, amended as on 31.07.2008, the Rules have cast
certain duties on the Medical Practitioner under Rule 4, as per which, the Medical Practitioner has to satisfy himself of certain aspects. Under Rule
4A(2), the Medical Practitioner is to evaluate the factum of marriage and ensure that documents in this regard are kept for records. Under Clause
6F(a), the Authorisation Committee can only focus on the following, namely,
(a) Where the proposed transplant is between persons related genetically, Mother, Father, Brother, Sister, Son or Daughter above the age of 18
years, the concerned competent authority shall evaluate:
(i) Results of tissue typing and other basic tests;
(ii) Documentary evidence of relationship e.g. Relevant birth certificates and marriage certificate, certificate from Sub-divisional
Magistrate/Metropolitan Magistrate/or Sarpanch of the Panchayat;
(iii) Documentary evidence of Identify and residence of the proposed donor e.g. Ration Card or Voters Identity Card or Passport or Driving
Licence or PAN card or Bank Account and family photograph depicting the proposed donor and the proposed recipient along with another near
relative;
(iv) If in his opinion, the relationship is not conclusively established after evaluating the above evidence, it may in its discretion direct further medical
tests as prescribed as below:
(a) ----
(b) ----
(c) ----
(d) ----
Rule 6F(b) The papers for approval of transplantation would be processed by the Registered Medical Practitioner and administrative division of
the Institution for transplantation, while the approval will be granted by the Authorisation Committee.
(c) Where the proposed transplant is between a married couple (except foreigners, whose cases should be dealt with by Authorisation
Committee), the concerned Competent Authority or Authorisation Committee, as the case may be, must evaluate all available evidence to establish
the factum and duration of marriage and ensure that documents such as marriage certificate, marriage photograph is placed before the Committee
along with the information on the number and age of children and a family photograph depicting the entire immediate family, birth certificates of
children containing the particulars of parents.
3e. The further submission of the petitioner is that Rule 6F(i) provides that the Authorisation Committee shall expedite its decision making process
and use its discretion judiciously and pragmatically in all such cases where the patient requires immediate transplantation. Thus, the above said
Sections and Rules make it very clear that insofar as transplants among genetically near relatives are concerned, the Medical Practitioner is the only
competent authority to decide the issue and the Authorisation Committee will, once the required documents are sent to them, expeditiously pass
necessary orders. However, insofar as married couples are concerned, the requirement of even going to the Authorisation Committee does not
arise, except in the case of foreigners and the Competent Authority that is the Hospital Committee can decide the issue, after going through the
documents and relevant details submitted by the donor and recipient and therefore, it would be pertinent to state that insofar as transplants among
near relatives are concerned, the Approval of the committee is only a mere formality and it is only so, that they are informed of the same and
insofar as married couples are concerned, the records are to be maintained by the competent authority, namely the Hospital Committee.
3f. The contention of the petitioner is that the procedure contemplated for genetically near relatives and of married couples differ, which is a
conscious decision taken by the law makers. However, when such terminally ill patients apply for approval of the transplant from near relatives
under the said Act, the application submitted ought to be considered and dealt with expeditiously. But to the contrary, it was informed to the
petitioner that it would take 2 to 3 months for consideration in the case of local patients and 4 to 5 months for outside the State patients. That once
approval is obtained from the native State, then the second approval is not required and the necessity for such voluminous documents should be
done away with. It is submitted that in Delhi, transplants are done within 15 days of the submission of documents in near relative cases.
3g. It is also submitted that in view of the fact that the Competent Authority/Authorised Committee deals with the lives of human beings, Rule 6A
prescribes that an Authorisation Committee is to be formed in metros and big cities, which is hospital based and Authorisation Committee should
be formed in every hospital, if the number of transplants exceeds 25 in a year at the respective transplantation centres. The delay in granting
approval causes huge financial implications on the patient, as it is mandatory to undergo dialysis, which amounts to Rs. 30,000/- to Rs. 40,000/-
per month besides other incidental expenses, such as boarding, lodging, travel etc In fact, the Hon''ble Union Minister of Health Mr. Gulam Nabi
Azad also insisted the need for simplifying the formalities in cases of blood relatives. It is stated that this Court and other High Courts had held in
respect of lacunas in the rules. This Court, in the case of Dr. M. Anoop v. State of Tamilnadu in W.P. No. 18657 of 2009 dated 15.09.2009,
referred to a decision of the Hon''ble High Court of Andhra Pradesh in Smt. Kamal Devi v. Director of Medical Education in W.P. No. 5618 of
2009 dated 30.03.2009 and found that certain lacunas exist in the rules, besides holding that the Authorisation Committee of Tamilnadu has no
jurisdiction to call upon persons, who have already undergone the verification in another State and obtained NOC from that State, to go through
the process again. In fact, in a recent judgment of the Bombay High Court in Miss. Sonia Ajit Vayklip and Another Vs. Hospital Committee,
Lilavati Hospital and Research Centre and Others, , by clearly defining the scope of Authorisation committee, it has been held in Para 19 as
follows:
All the observations, therefore, pertain to a case where the donor and recipient are not near relatives. Therefore, in cases where donor and
recipient are near relatives as defined by the Act, there need be no enquiry by the Authorisation Committee to ascertain whether there is any
commercial element. Such enquiry is therefore, not at all required to be held in the case of near relatives.
Further, in a case in Kuldeep Singh and Another Vs. State of Tamil Nadu and Others, , the Hon''ble Supreme Court held that Authorisation
Committee is to satisfy itself that removal is not for commercial considerations and that expeditious disposal of the application would be
appropriate and also in an unreported judgment dated 18.12.2012 in the case of Rekha Agarwal v. Union of India, W.P. No. 29840 of 2012, the
Hon''ble Supreme Court in a similar issue had directed the Authorisation Committee, the Hospital to consider the case on submission of the
necessary documents, wherein too, the State to which the petitioner therein had provided NOC.
3h. It is the case of the petitioner that though Act, Rules and the law laid down do not prescribe any condition for obtaining approval of the
Authorisation Committee, in view of the conditions laid down by the 2nd respondent on the 3rd respondent hospital, there arose necessity to seek
such approval from the committee and produce many more documents. The petitioner had requested the hospital vide letter dated 07.11.2013 to
permit her to receive kidney from her husband, but however, she was informed that the 3rd respondent is bound by the order of the Health
Secretary of the Government of Tamil Nadu, whereunder approval from the Tamil Nadu Authorisation Committee is mandatory even in case of
kidney transplantation between near relatives and the 2nd respondent had also set impugned list of documents for production, due to which, the
3rd respondent directed her to furnish all the certificates/documents for forwarding the same to the Authorisation Committee.
3i. It is further case of the petitioner that in view of the problems faced by the patients like that of her, the Hon''ble Delhi High Court had taken note
of the same vide order dated 01.09.2011 passed in W.P. No. 6105 of 2011 in Sadhana Bharadwaj v. Department of Health and Family Welfare
and observed that in case of organ transplantation, a donor has to be present before his native State''s authorities, then present himself before the
State from which the Organ recipient hails, which leads to a long delay in granting NOC and proves to be fatal for the patients. In view of the said
order of the Hon''ble Delhi High Court, the 1st respondent vide letter dated 01.11.2011 stated that NOC is not granted on the basis that there is
no love and affection between the donor and the recipient inspite of a valid domicile legal status obtained by the recipient/donor in their respective
states. The 1st respondent therefore clarified that the Authorisation Committee of the hospital/institutions, where the transplantation is going to take
place, only has to establish the reasons for affection and attachment and that the State Government, namely, Authorisation Committee, need not go
into the relationship and reasons of donation. The 1st respondent vide another letter of even date, had clarified the issue about ""near relatives"". The
relevant portion of the letter is extracted hereunder:
...it has come to notice that in many instances, the cases involving ''near relative'' as defined under the Act, are also routed through the
Authorization Committees. In this regard, Sections 9(2) and 9(3) of the Act make it amply clear that the cases involving non-''near related'' donor
and recipient only need to go through the process of obtaining requisite approval from the Authorization Committee.
The above matter has been examined in this Ministry and it is hereby clarified that clause 6B of Transplantation of Human Organs Rules, 2008 is
applicable only for unrelated cases (and all foreigners) but not for the cases involving ''near relative'' donor/recipient.
I, therefore, request you to issue necessary instructions to all concerned to follow the law as laid down in the Transplantation of Human Organs
Act, 1994 and Rules, 1995 (as amended in 2008) in both letter and spirit.
3j. It is also the case of the petitioner that in a recent judgment of the Hon''ble Bombay High Court dated 05.03.2013, the Hon''ble High Court
held that organ transplant of near relatives of donors and donees, coming from outside the State, could be done without NOC from the State from
which they hail. It is stated that because of the misreading of the Act and Rules by the 2nd respondent, patients like petitioner are made to suffer.
The 1st respondent, having considered this, has directed the Government of Tamilnadu vide letter dated 01.11.2011 to do away with such archaic
and resolute practice.
I have heard the rival submissions perused the material documents and various provisions of law placed on record.
It is the case of the wife that she wants to undergo immediate kidney transplant operation with the help of her husband, who is prepared to
donate one of his kidneys to her out of his utmost love and affection. The issue involved in this writ petition as to whether the approval of the
Authorisation Committee is absolutely required in the case of ''near relative'' has to be examined in detail. In this regard, learned Additional
Advocate General on earlier occasion has produced a Position Note, stating the following instructions:
It is submitted that the Union Government of India in their letter D.O. No. S-12011/1/2011-MS(pt) dated 01.11.2011 addressed the Principal
Secretary to Government, Health and Family Welfare Department, Government of Tamil Nadu, Secretariat, Chennai has stated that sections 9(2)
and 9(3) of the THOT Act make it amply clear that the cases involving non-''near related'' donor and recipient only need to go through the process
of obtaining requisite approval from the Authorization Committee.
Rule 6B of the Transplantation of Human Organ Rules, 2008 (as amended) has been reproduced as stated below:
The State level committee shall be formed for the purpose of providing approval or no objection certificate to the respective donor and recipient to
establish the legal and residential status as a domicile state. It is mandatory that if donor, recipient and place of transplantation are from different
states, then the approval or no objection certificate from the respective domicile State Government should be necessary. The institution where the
transplant is to be undertaken in such case the approval of Authorization Committee is mandatory.
It is submitted that the draft amendment on the above Central Government instructions have been sent to Government of Tamil Nadu in this office
letter Ref. No. 92780/MEII(2)/2012 dated 17.01.2013 requesting to issue necessary amendment to Transplantation of Human Organs Rules,
2008 with regard to the cases involving near relatives'' as defined under the Act to exempt them to routed through the Authorisation Committees as
per the clarification issued by Ministry of Health and Family Welfare, New Delhi, Government of India. The same is under process in Government.
A glossarial look at the above instructions would reveal that though a number of amendments on the Central Government instructions have been
sent to the Government of Tamil Nadu, for issuance of necessary amendment in the Transplantation of Human Organs Rules with regard to the
cases involved in ""near relatives"" as defined under the Act, exempting to obtain approval from the Authorisation Committee, the State of Tamil
Nadu has not taken any firm decision on this yet. Learned Additional Advocate General on instructions from the Health Secretary, has informed to
this Court that the Government of Tamil Nadu will issue necessary notification of amendment to the Rules shortly.
On noticing the above submission of the learned Additional Advocate General, learned counsel for the petitioner retaliates that there is an urgent
need for the petitioner to undergo transplant operation in time for her survival and awaiting the amendment will definitely cause serious prejudice to
the petitioner.
It is also seen that the petitioner has produced voluminous document in support of her contention. But, the third respondent was of the view that
the petitioner should produce all the documents as per the format prescribed by the 2nd respondent. The format contains certain documents, which
would be applicable in case the donor is not closely related to the patient on whom transplantation should be made. The donor, being the husband
of the petitioner, no such documents are necessary in this case.
Taking into account the submissions made by the learned Additional Advocate General that there will be a notification in this regard shortly and
also considering the crucial stage of the petitioner, who is longing for her survival as well as kidney transplantation, I am of the considered opinion
that the matter has to be urgently looked into by the Authorisation Committee for according approval to the petitioner. At this stage, it is informed
across the bar that the second respondent is the Chairman of the Authorisation Committee, who is also a party to this writ petition. Therefore, this
Court is of the view that it is fit and appropriate for this Court to direct the second respondent to expedite the process for approval enabling the
petitioner to undergo transplant operation. Accordingly, this writ petition stands disposed of, directing the 2nd respondent to take note of the entire
situation as stated above and accord permission to the petitioner to undergo Renal Transplant Operation at the 3rd respondent hospital within a
period of one week from today. The parties on either side involved in this process shall extend their fullest co-operation to expedite the process for
approval. No costs. Consequently, connected miscellaneous petition is closed.