Disposed

Dr. Bharat Shah v. Union of India and 3 Ors.

Bombay HC5 Mar 2013PIL/26/2013

Case brief

AI extract

What is this about?

In PIL matter concerning organ transplantation regulations, the Bombay High Court examined discrepancies between State checklist requirements and judicial pronouncements on near-relative donations, ordering the relevant authorities to seek Central Government clarification by a specific timeline before disposing of the petition.

What did the court decide?

Directions to the Central Government to issue necessary clarification on the applicability of NOC requirements for related donor/recipient cases across State lines.

Dr. Bharat Shah Vs Union of India and 3 Ors. — Medical Negligence | Bombay HC (2013)

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IN THE HIGH COURT OF JUDICATURE AT BOMBAY ORDINARY ORIGINAL CIVIL JURISDICTION

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PUBLIC INTEREST LITIGATION LODGING NO.5 OF 2013

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Dr. Bharat Shah ...Petitioner

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Versus Union of India through its Ministry of Health & Family Welfare & Ors. ...Respondents

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Mr. Venkatesh Dhond, Senior Advocate with Rashmin Khandekar i/b. Sita Kapadia Associates for petitioner. Mr. Parag Vyas for respondent-Union of India Mr. G.W. Mattos, AGP for respondent-State.

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CORAM : MOHIT S. SHAH, C.J. & ANOOP V. MOHTA, J. DATE : 05 March 2013

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P .C.

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In this Public Interest Litigation, the petitioner who himself is a Nephrologist Surgeon, has prayed for a direction to the respondent authorities to issue clarification to the checklist circulated by the Deputy Director of Health Services, Bombay Circle, Thane under the Transplantation of Human Organs and Tissues Act, 1994 and also to the form/s under the Transplantation of Human Organs Rules, 1995. The controversy arises in the following background.

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In Miss Sonia Ajit Vayklip & Anr. vs. Hospital Committee, Lilavati Hospital & Research Centre, 2012 (2) All M.R. 926 , this Court had an occasion to deal with the issue whether the approval of the Authorisation Committee constituted under Section 9(4) of the

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Transplantation of Human Organs and Tissues Act, 1994 is required when the donor as well as donee of the kidney are near relatives e.g. brother and sister. In the context of that controversy, this Court examined the Legislative scheme and held as under:-

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“11. The Legislative scheme therefore, is that two types of cases are contemplated:

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(i) donor to stranger:-

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As far as this category is concerned i.e. when the donor and the recipient are not near relatives as defined by the Act, the removal and transplantation of human organ or tissue cannot be done without the prior approval of the Authorisation Committee appointed under sub-section (4) of Section 9 of the Act.

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(ii) from donor to near relative:-

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“near relative” means spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter”.

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Subject to the following three exceptions, no such approval is required from the Authorisation Committee for donation of a human organ or tissue to a near relative, because there would be no commercial element for such donations.

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Even the donation to a near relative, there are three restrictions :-

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(A) where either the donor or the recipient is a foreign national, prior approval of the Authorisation Committee is required.

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(B) in case of a minor, no organ or tissue can be removed from the body of the minor before his death for the purpose of transplantation except in the manner as prescribed;

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(C) in case of mentally challenged person, no organ or tissue can be removed from the body of the mentally challenged person before his death for the purpose of transplantation” .

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This Court accordingly held that in case of both donor and donee being near relatives, no approval of the Authorization Committee is required as contemplated under Section 9 of the Transplantation of Human Organs and Tissues Act, 1994. It is not necessary to refer to the definition of mentally challenged person which is to be found in Section 9 of the Act.

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Rule 6B of the Transplantation of Human Organs Rules, 1995 inserted by the Transplantation of Human Organs (Amendment) Rules, 2008 reads as under:-

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“6B. The State level committees 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 Authorisation Committee is mandatory”.

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Our attention is invited to the letter dated November 1, 2011 from the Government of India in the Ministry of Health and Family Welfare to the Principal Secretary (H & FW), Government of NCT of Delhi Secretariat, I.P. Estate, New Delhi containing the following clarification:-

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“It is hereby clarified that clause 6B of Transplantation of Human Organs Rules, 2008 is applicable for unrelated cases (and all foreigners) but not for the cases involving 'near relative' donor/recipient.”

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The learned counsel for the petitioner has submitted that inspite of the above clear pronouncement of this Court, the respondents have in their checklist dated 30 November 2011 issued by the Deputy

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Director of Health Services, Mumbai Circle, Thane (Exhibit “B”) stated in Clauses 15 and 16 as under:-

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“15. If patient or donor or both are not domicile of Maharashtra, then approval/N.O.C. of concerned State Authorization Committee be obtained. (As per Judgment of Supreme Court of India, New Delhi in W.P. No.256/05, dated March 31, 2005.

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In case of foreign nationals of transplant case attach Consulate's No Objection Certificate and certificate stating that the donation is free, voluntary and without any transaction. It should also indicate relation between recipient & donor in related cases.”

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It is submitted that the petitioner has no grievance about Clause 16 of the checklist, but Clause 15 is not in consonance with the principles laid down by this Court. As far as judgment of the Supreme Court dated March 31, 2005 in Kuldeep Singh & Anr. vs. State of T.N. & Ors., (2005) 11 SCC 122 is concerned, the same has already been referred to in paragraph 17 of the judgment of this Court in Ms. Sonia A. Vayklip (supra).

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In response to the notice issued by this Court, affidavit in reply has been filed by Dr. Bhausaheb Chanagouda Kempipatil, Assistant Director of Health Services and it is stated, inter alia, as under:-

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“6. I say that the prescribed forms and/or applications including Form 10 to be submitted required for the transplantation of the Human Organs are prescribed by the Central Government under the Transplantation of Human Organ Rules, 1995 as amended in 2008. I say that the amendment in the said forms would have to be carried by the Central Government. I say that the State Government would take up the said matter with the Central Government. However, it is humbly submitted that necessary Orders be passed by this Hon'ble Court directing the Central Government to take necessary steps in respect thereof.

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However, during the interregnum period, the State Authorization Committee would in pursuance to the said Order passed by this Hon'ble Court, a copy whereof is annexed and marked as Exhibit -C to the Petition, would permit organ transplant of “near relatives” without the NOC from the Authorization Committee of the State from which the donor and/or the donee hail.

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I say that in cases where the donor and donee are related, and are residing in the State of Maharashtra, the decision in respect thereof is taken by the Hospital based (Local) Authorization Committee constituted in each of the registered hospitals headed by the Medical Director/Superintendent of the said hospital. However, cases;

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where the donor and/or donee who are unrelated but who hail from Maharashtra,

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all related and unrelated cases from outside the State of Maharashtra

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and

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all related and unrelated cases of foreigners are decided by the State Authorization Committee.

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While deciding the cases of transplant of organs of related donor and donee hailing from outside the State of Maharashtra, it shall not insist upon the NOC from the concerned State Authorization Committee.”

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(emphasis supplied)

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Mr.Mattos, learned A.G.P., appearing for the respondent authorities on instructions from the Assistant Director of Health Services states that the State Government will take up the matter with the Central Government within two weeks from today for issuing necessary clarification.

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The learned counsel for the Central Government also states that the concerned Ministry will be informed about this order within two weeks from today. Thereafter the Central Government will take necessary action as expeditiously as possible and preferably within three months from the date of receipt of the letter from the Assistant Director of Health Services.

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In view of the above clarifications and statements, nothing further survives in this Public Interest Litigation. The PIL accordingly stands disposed of.

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CHIEF JUSTICE

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ANOOP V. MOHTA , J .

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Dr. Bharat Shah v. Union of India and 3 Ors.

Case brief

What is this about?

What did the court decide?

Dr. Bharat Shah v. Union of India and 3 Ors.

Case brief

What is this about?

What did the court decide?

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