“9. Conditions for grant of Certificate of Registration:
No hospital shall be granted a certificate of registration under this Act unless it fulfils the following requirement of manpower, equipment, specialized services and facilities as laid down'below:- A General Manpower Requirement Specialised Services and Facilities:
(1) 24 hours availability of medical and surgical, (senior and junior) staff.
(2) 24 hours availability of nursing staff, (general and speciality trained).
(3) 24 hours availability of Intensive Care Units with adequate equipments, staff and support system, including specialists in anaesthesiology, intensive care.
(4) 24 hours availability of laboratory with multiple discipline testing facilities including but not limited to Microbiology, Bio-Chemistry, Pathology and* Hematology and Radiology departments with trained staff.
(5) 24 hours availability of Operation Theater facilities (OT facilities) for planned and emergency procedures with adequate staff, support system and equipments.
(6) 24 hours availability of communication system, with power backup, including but not limited to multiple line telephones, public telephone systems, fax, computers and paper photo-imaging machine.
(7) Experts (Other than the experts required for the relevant transplantation) of relevant and associated specialties including but not limited to and depending upon the requirements, the experts in internal medicine, diabetology, GiXjOf,-4 26 B C (A) (B) (C) Note:
THE GAZETTE OF INDIA: EXTRAORDINARY [Part II—Sec. 3(i)] gastroenterology, nephrology, neurology, paediatrics, gynaecology immunology and cardiology etc. should be available to the transplantation centre.
Equipments:
Equipments as per current and expected scientific requirements specific to organ or organs being transplanted. The transplant centre should ensure the availability of the accessories, spare-parts and back-up/maintenance/service support system in relation to all relevant equipments.
Experts and their qualifications:- Kidney Transplantation:
M.S. (Gen.) Surgery or equivalent qualification with three years post M.S. training in a recognised center in India or abroad and having attended to adequate number of renal transplantation as an active member of team.
) . .
Transplantation of liver and other abdominal organs M.S. (Gen.) Surgery or equivalent qualification with adequate post M.S. training in an established center with a reasonable experience of performing liver transplantation as an active member of team.- Cardiac, Pulmonary, Cardio-Pulmonary Transplantation:
M.Ch. Cardio-thoracic and vascular surgery or equivalent qualification in India or abroad with at least 3 years experience as an active member of the team ■* performing an adequate number of open heart operations per year and well-versed with Coronary by-pass surgery and Heart-valve surgery.
Cornea Transplantation:
M.D./M.S. ophthalmology or equivalent qualification with one year post M.D./M.S training in a recognised hospital carrying out Corneal transplant operations.
[F.No. S-12011/12/2007-MS] VINEET CHAWDHRY, Jt.Secy.
The principal rules were published in the Gazette of India vide notification No. S-12011/2/1994-MS, dated the 4th February, 1995, Extraordinary, under G.S.R. No. 51(E).
[wn—tsPS3(i)] FORM KA) (Pagel of2) (To be completed by the prospective related donor) (See Rule 3) My full name is..... ...........
and this is my photograph To be affixed and attested by Notary Photograph of the Donor Public after it is (A5ested by Notary Public) affixed.
My permanent home address is ........................................................................ ..........................................Tel:................................
My present home address is ....................................................................... ...........................................Tel:................................. , Date of birth ............................... ................ .............................................(day/month/year) • Ration/Consumer Card niimber and Date of issue & place:......... ..........................
(Photocopy attached) and/or • Voter’s l-Card number, date of issue, Assembly constituency......... ............................
(Photocopy attached) and/or • Passport number and country of issue..........
(Photocopy attached) and/or • Driving Licence number, Date of issue, licensing authority.......... ......................... ..........
(Photocopy attached) and/or • PAN...................................... ’......... :...............................................................................
and/or • Other proof of identity and address ............................................................................
I hereby authorize removal for therapeutic purposes/consent to donate my..............................
(state which organ) to my relative...... ......................... (specify son/daughter/father/mother/ brother/sister), whose name is ..................................................................... ...................... and who was bom on.............................................(day/month/year) and whose particulars are as follows:
Photograph of the Recipient (Attested by Notary Public) To be affixed and attested by Notary Public after it is affixed.
28 _________ __ _______________ THE GAZETTE OF INDIA: EXTRAORDINARY [PartII—SECjfffl FORM 1(A) (Page-21 • Ration/Consumer Card number and Date of issue & place:.......... >........................
(Photocopy attached) and/or • Voter’s l-Card number, date of issue, Assembly constituency....;........................
(Photocopy attached) and/or • Passport number and country of issue................ ........................................ ..................
(Photocopy attached) and/ or • Driving Licence number, Date of issue, licensing authority.............................................
(photocopy attached) and/or • PAN........................ ......................................................................................................
and/or • Other proof of identity and address...............................................................................
I solemnly affirm and declare that:
Sections 2, 9 and 19 of The Transplantation of Human Organs Act 1994 have been explained to me and I confirm that:
1. I understand the nature of criminal offences referred to in the sections.
2. No payment of money or money’s worth as referred to in the sections of the Act has been made to me or will be made to me or any other person.
3. I am giving the consent and authorisation to remove my..........................................
(organ) of my own free will without any undue pressure, inducement, influence or allurement.
4. I have been given a full explanation of the nature of the medical procedure involved and the risks involved for me in the removal of my.......................................(organ).
That explanation was given by............................... ................ (name of registered medical practitioner).
5. I under the nature of that medical procedure and of the risks to me as explained by that practitioner.
6. I understand that I may withdraw my consent to the removal of that organ at any time before the operation takes place.
7. I state that particulars filled by me in the form are true and correct to my knowledge and nothing material has been concealed by me.
Signature of the prospective donor Date Note: To be sworn before Notary Public, who while attesting shall ensure that the ^son/persons swearing the affidavit(s) signs(s) on the Notary Register, as well.
• \ wherever applicable.
29[MPTII—7sPg3(i)] FORM KB) (Page 1 of 2) (To be completed by the prospective spousal donor) (see Rule 3) My full name is.................
and this is my photograph Photograph of the Donor (Attested by Notary Public) To be affixed and attested by Notary Public after it is affixed.
My permanent home address is ...............................................?............................................................................Tel:...................
My present home address is................................................................................................. ......
............. .................................... .................................................‘............... . Tel:.....................
Date of birth................................................................................................ (day/month/year) I authorize to remove for therapeutic purposes/consent to donate my .............. ..........(state which organ) to my husband/wife.......................................................
whose full name is....................................... .7.................... .......... ............ .............and who was bom on.............................................(day/month/year) and whose particulars are as follows:
Photograph of the Recipient (Attested by Notary Public) To be affixed and attested by Notary Public after it is affixed.
■}- • Ration/Consumer Card number and Date of issue & place:........................................
(Photocopy attached) and/or • Voter’s l-Card number, date of issue, Assembly constituency....................................
(Photocopy attached) and/or • Passport number and country of issue...........................................................................
(Photocopy attached) and/or • Driving Licence number, Date of issue, licensing authority............................................
(Photocopy attached) and/or • PAN................................................................................................................................
• Other proof of identity and address and/or 30 THE GAZETTE OF INDIA: EXTRAORDINARY [Part II—Sec. 3(i)1 FORM KB) [Paae-ZI I submit the following as evidence of being married to the recipient:-
(a) A certified copy of a marriage certificate OR
(b) An affidavit of a ‘near relative’ confirming the status of marriage to be sworn before Class-1 Magistrate/Notary Public.
(c) Family photographs
(d) Letter from member of Gram Panchayat I Tehsildar / Block Development Officer/ MLA/ MP certifying factum and status of marriage.
OR
(e) Other credible evidence I solemnly affirm and declare that:
Sections 2, 9 and 19 of The Transplantation of Human Organs Act 1994 have been explained to me and I-confirm that
1. I understand the nature of criminal offences referred to in the sections.
2. No payment of money or money’s worth as referred to in the Sections of the Act has been made to me or will be made to me or any other person.
3. I am giving the consent and authorisation to remove my.................................
(organ) of my own free will without any undue pressure, inducement, influence or allurement.
4. I have been given a full explanation of the nature of the medical procedure involved and the risks involved for me in the removal of my........................................(organ).
That explanation was given by.................................................... (name of registered medical practitioner).
5. I under the nature of that medical procedure and of the risks to me as explained by • that practitioner.
6. I understand that I may withdraw my consent to the removal of that organ at any time - V before the operation takes place.
7. I state that particulars filled by me in the form are true and correct to my knowledge and nothing material has been concealed by me Signature of the prospective donor Date Note: To be sworn before Notary Public, who while attesting shall ensure that the person/persons swearing the affidavit(s) signs(s) on the Notary Register, as well.
• V wherever applicable.
[HTHII—TsF53(i)] HTO ^>T TFSPH : aTOIMR”! 31 FORM 1(C) (Pagel of 2) (To be completed by the prospective un-related donor) (See Rule 3) My full name is •................ ........ .............. ............ ............................................................
and this is my photograph Photograph of the Donor (Attested by Notary Public) To be affixed and attested by Notary Public after it is affixed.
My permanent home address is ................... .................................................................................................Tel:........................
My present home address is.................... ...............
Date of birth.....................................................................................
• Ration/Consumer Card number and Date of issue & place:...
(Photocopy attached) and/or • Voter's l-Card number, date of issue, Assembly constituency (Photocopy attached) and/or • Passport number and country of issue................... .....
(Photocopy attached) and/or • Driving Licence number, Date of issue, licensing authority.....
(Photocopy attached) and/or • PAN.............................................................. ...............................
and/or • Other proof of identity and address........................ .................
Tel:........................
(day/month/year) Details of last three years income and vocation of donor.................................................
I hereby authorize to remove for therapeutic purposes/consent to donate my (state which organ) to a person whose full name is .......... ....................................... and who was bom on (day/month/year) and whose particulars are as follows:
Photograph of the Recipient (Attested by Notary Public) To be affixed and attested by Notary Public after it is affixed.
-s.______________________________ THE GAZETTE OF INDIA: EXTRAORDINARY [Part II—Sec. 3(i)] FORM 1fC) IPaae-21 • Ration/Consumer Card number and Date of issue & place:.........................................
(Photocopy attached) and/or • Voter’s l-Card number, date of issue, Assembly constituency............................ .
(Photocopy attached) and/or • Passport number and country of issue................................................................. ......
(Photocopy attached) and/or • Driving Licence number, Date of issue, licensing authority..............................................
(Photocopy attached) and/or • PAN................................................................................................................................
and/or • Other proof of identity and address...... .......................... ...............................................
I solemnly affirm and declare that:
Sections 2, 9 and 19 of The Transplantation of Human Organs Act 1994 have been explained to me and I confirm that
1. I understand the nature of criminal offences referred to in the Sections.
2. No payment of money or money’s worth as referred to in the Sections of the Act has been made to me or will be made to me or any other person.
3. I am giving the consent and authorisation to remove my...........................................
(organ) of my own free will without any undue pressure, inducement, influence or allurement.
4. I have been given a full explanation of the nature of the medical procedure involved and the risks involved for me in the removal of my....................... ................(organ).
That explanation was given by............................................ ....... (name of registered medical practitioner).
5. I under the nature of that medical procedure and of the risks to me as explained by that practitioner.
6. I understand that I may withdraw my consent to the removal of that organ at any time before the operation takes place.
7. I state that particulars filled by me in the form are true and correct to my knowledge and nothing material has been concealed by me.
Signature of the prospective donor Date Note: To be sworn before Notary Public, who while attesting shall ensure that the person/persons swearing the affidavit(s) signs(s) on the Notary Register, as well.
• wherever applicable.
[MPT II—-^3(i)] MP7T : WOT FORM 2 33 [See rule 4(1) (b)] (To be completed by the concerned Medical Practitioner) I, Dr......................................... ..........possessing qualification of..............
registered as medical practitioner at serial no......................... by the ..............
.................................................................... . Medical Council, certify that I have examined Shri/ Smt./ Km.....................................................S/o, D/o, W/o Shri...............................................
aged.............. who has given informed consent about donation of the organ, namely (name of the organ) ........................................... to Shri/Smt./Kin .......................................................
who is a ‘near relative’ of the donor/other than near relative of the donor, who had been approved by the Authorisation Committee/ Registered Medical Practitioner i.e. Incharge of transplant centre (as the case may be) and that the said donor is in proper state of health and is medically fit to be subjected to the procedure of organ removal.
Place:........................ ......
Date:...............................
Signature of Doctor Seal To be affixed (pasted) and attested by the doctor concerned.
The signatures and seal should partially appear on photograph and document without disfiguring the face in photograph.
Photograph of the Donor (Attested by doctor) I, Dr./Mr./Mrs.
To be affixed (pasted) and attested by the doctor concerned.
The signatures and seal should partially appear on photograph and document without disfiguring the face in photograph.
Photograph of the recipient (Attested by the doctor) FORM 3 [See Rule 4(1 )(c)] ................................ working as.......................................
at and possessing qualification of certify that Shri/ Smt./ Km. S/o, D/o, VV/o Shri/ Smt. aged the donor and Shri/ Smt. S/o, D/o, W/o Shri/Smt..................................... ........ aged .............. the proposed recipient of the organ to be donated by the said donor are related to each other as brother/sister/mother/father/son/daughter as per their statement and the fact of this relationship has been established I not established by the results of the tests for Antigenic Products of the Human Major Histocompatibility Complex. The results of the tests aie attached.
Place... Signature (To be signed by the Head of the Laboratory Date...................................
Seal 27 75 5 34 ____________________________ THE GAZETTE OF INDIA: EXTRAORDINARY____________ [Part II—Sec. 3(i)] FORM 10 (Pagel of 2) APPLICATION FOR APPROVAL FOR TRANSPLANTATION (LIVE DONOR) (To be completed by the proposed recipient and the proposed donor) [See Rule 4(1) (c)(d)(e)] To be self To be self attested across attested across the affixed the affixed photograph photograph Photograph of the Donor Photograph of the recipient (Self-attested) (Self-attested) Whereas I ....;..................................................................................... S/o, D/o, W/o, Shri/Smt............................ ............................................... aged ........... residing at ........................................................................................................................................ have been advised by my doctor .....................................i...........that I am suffering from ........................ ....................................... .................and may be benefited by transplantation of.............. .............................................into my body.
And whereas I .................................................................................... S/o, D/o, W/o, Shri/Smt................................. ............ ...................................aged ............ ......... residing at ............................................................................................ by the following reason(s):- a) by virtue of being a near relative i.e.....................................................
b) by reason of affection/attachment/other special reason as explained below :- I would therefore like to donate my (name of the organ).................................. ............. . to Shri/Smt................................................
We.............................................................. and.......... ................................................................
(Donor) (Recipient) hereby apply to Authorization Committee for permission for such transplantation to be carried out.
We solemnly affirm that the above decision has been taken without any undue pressure, inducement, influence or allurement and that all possible consequences and options of organ transplantation have been explained to us.
35[HPTii—7sprg3(j)] HRH w* : 3mTNKui FORMIOfPaae 21 Instructions for the applicants:-
1. Form 10 must be submitted along with the completed Form 1(A), or Form 1(B) or Form 1(C) as may be applicable.
2. The applicable Form i.e. Form 1(A) or Form 1(B) or Form 1(C) as the case may be, should be accompanied with all documents mentioned in the applicable form and all relevant queries set out in the applicable form must be adequately answered.
3. Completed Form 3 to be submitted along with the laboratory report.
4. The doctor’s advice recommending transplantation must be enclosed with the application.
5. In addition to above, in case the proposed transplant is between unrelated persons, appropriate evidence of vocation and income of the donor as well as the recipient for the last three years must be enclosed with this application. It is clarified that the evidence of income does not necessarily mean the proof of income tax returns, keeping in view that the applicant(s) in a given case may not be filing income tax returns.
6. The application shall be accepted for consideration by the Authorisation Committee only if it is complete in all respects and any omission of the documents or the information required in the forms mentioned above, shall render the application incomplete.
7. As per the Supreme Court’s judgement dated 31.03.2005, the approval/ No Objection Certificate from the concerned State/ Union Territory Government or Authorisation Committees is mandatory from the domicile State/ Union Territory of donor as well as recipient. It is understood that final approval for transplantation should be granted by the Authorisation Committee/ Registered Medical Practitioner i.e. Incharge of transplant centre (as the case may be) where transplantation should be done.
We have read and understood the above instructions.
Signature of the Prospective Donor Date:
Place:
Signature of Prospective Recipient Date:
Place:
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