Surrogacy (Regulation) Rules, 2022
[21
June 2022]
G.S.R. 460(E).-In exercise of the powers
conferred by section 50 of the Surrogacy (Regulation) Act, 2021 (47 of 2021),
the Central Government hereby makes the following rules, namely: -
Rule - 1.Short title and commencement
(1)
These rules may be
called the Surrogacy (Regulation) Rules, 2022.
(2) They
shall come into force on the date of their publication in the Official Gazette.
Rule - 2.Definitions
In these rules,
unless the context otherwise requires; -
(a)
Act means the
Surrogacy (Regulation) Act, 2021 (47 of 2021);
(b)
form means a form
appended to these rules;
(c)
section means a
section of the Act;
(d) words
and expressions used herein and not defined but defined in the Act shall have
the meanings respectively assigned to them in the Act.
Rule - 3.The requirement, and qualification for persons employed, at a registered surrogacy clinic
(1)
The minimum
requirement of staff and their qualification for surrogacy clinic shall be as specified
in Schedule I, Part 1.
(2) The
minimum requirement of equipment for surrogacy clinic shall conform to the
requirement as specified in Schedule I, Part 2.
Rule - 4.
The manner of application
for obtaining a certificate of recommendation by the Board shall be as
specified in Form 1.
Rule - 5.Insurance coverage
(1)
The intending
woman or couple shall purchase a general health insurance coverage in favour of
surrogate mother for a period of thirty six months from an insurance company or
an agent recognized by the Insurance Regulatory and Development Authority
established under the provisions of the Insurance Regulatory and Development
Authority Act, (41 of 1999) for an amount which is sufficient enough to cover
all expenses for all complications arising out of pregnancy and also covering
post- partum delivery complications.
(2) The
intending couple/woman shall sign an affidavit to be sworn before a
Metropolitan Magistrate or a Judicial Magistrate of the first-class giving
guarantee as per clause (q) of sub section (1) of section 2 of the Surrogacy
(Regulation) Act, (47 of 2021).
Rule - 6.Number of attempts of surrogacy procedure
The number of
attempts of any surrogacy procedure on the surrogate mother shall not be more
than three times.
Rule - 7.Consent of a surrogate mother
The consent of a
surrogate mother shall be as specified in Form 2.
Rule - 8.Number of embryos to be implanted in the uterus of the surrogate mother
The gynaecologist
shall transfer one embryo in the uterus of a surrogate mother during a
treatment cycle:
Provided that only
in special circumstances up to three embryos may be transferred.
Rule - 9.Conditions under which the surrogate mother may be allowed for abortion
The surrogate
mother may be allowed for abortion during the process of surrogacy in
accordance with the Medical Termination of Pregnancy Act, 1971 (34 of 1971).
Rule - 10.Form and manner for registration and fee for a surrogacy clinic
(1)
An application for
registration for a surrogacy clinic shall be made by the surrogacy clinic which
is carrying out procedures related to the Surrogacy, as provided in the Act to
the appropriate authority in Form 3.
(2) Every
application for registration shall be accompanied by an application fee of
rupees two lakhs for surrogacy clinic and the application fee once paid shall
not be refunded:
Provided that, if
an application for registration of any surrogacy clinic is rejected by the
appropriate authority, no fee shall be required to be paid on re-submission of
the application by the applicant for the same clinic:
Provided further
that such establishment in the government run institutes need not pay for
application.
Rule - 11.Period, manner and form for certificate of registration
(1)
The appropriate
authority shall, after making such enquiry and after satisfying itself that the
applicant has complied with all the requirements, shall grant a certificate of
registration in Form 4 to the applicant.
(2) A
copy of the certificate of registration shall be displayed by the registered
surrogacy clinic at a conspicuous place at its place of business.
Rule - 12.Appeal
(1)
The surrogacy
clinic, or the intending woman, or couple may, within a period of thirty days
from the date of receipt of the communication relating to order of rejection of
application, suspension or cancellation of registration by the appropriate
authority under section 13 and communication relating to rejection of the
certificates under section 14, prefer an appeal against such order.
(2) The
form of appeal shall be as specified in Form 5.
Rule - 13.Manner in which the seizure of documents, records, objects, etc., shall be made and seizure list shall be prepared and delivered
(1)
Every surrogacy
clinic shall allow the National Board or National Registry or State Board or
Appropriate Authority or to any other person authorised in this behalf to
inspect the place, equipment and records.
(2)
An inspection of
an already registered clinic may be done without any notice, during the working
hours of the clinic.
(3) The
authorities referred to in subsection (1) shall ensure that the entry and
search procedure do not place at risk the gametes or embryos stored in the
facility.
Rule - 14.Medical indications necessitating gestational surrogacy
A woman may opt
for surrogacy if; -
(a)
she has no uterus
or missing uterus or abnormal uterus (like hypoplastic uterus or intrauterine
adhesions or thin endometrium or small uni-cornuate uterus, T-shaped uterus) or
if the uterus is surgically removed due to any medical conditions such as
gynaecological cancer;
(b)
intended parent or
woman who has repeatedly failed to conceive after multiple In vitro
fertilization or Intracytoplasmic sperm injection attempts. (Recurrent
implantation failure);
(c)
multiple pregnancy
losses resulting from an unexplained medical reason. unexplained graft
rejection due to exaggerated immune response;
(d) any
illness that makes it impossible for woman to carry a pregnancy to viability or
pregnancy that is life threatening.
SCHEDULE 1
Part 1
[See rules 3 (1)]
(1)
Staff of surrogacy
clinics.- Surrogacy clinics shall have at least one gynaecologist, one
anesthetist, one embryologist and one counselor. The clinic may employ
additional staff by the Assisted Reproductive Technology Level 2 clinics;
normally Director, Andrologist and shall appoint such staff as may be necessary
to assist the clinic into day-to-day work.
(2)
Qualification for
doctors and other staff in surrogacy clinics.- The qualification of staff in
surrogacy clinics shall be as under:
(a) Gyanecologist:
The gyanecologist shall be a medical post-graduate in gyanecology and
obstetrics and should have record of performing 50 ovum pickup procedures and
at least three years of working experience in an ART clinic under supervision
of a trained ART specialist (In the case of gynecologists practicing ART or IVF
and are working in ART clinics before the commencement of this Act a post
graduate degree in gynecology and obstetrics with at least three years
experience and record of 50 ovum pickup procedures shall be acceptable); or
A
medical post-graduate in gynaecology and obstetrics with super specialist
Doctorate of Medicine/Fellowship in reproductive medicine with experience not
less than three years of working in an Assisted Reproductive Technology clinic.
(b) Andrologist
shall be a Master of Chirurgiae or Diplomate of National Board in urology with
special training in diagnosing and treating male infertility.
(c) Embryologist:
(i) Postgraduate
in clinical embryology (graduated with the full-time program with a minimum of
four semesters) from a recognised university or institute with additional three
years of human ART laboratory experience in handling human gametes and embryos;
(ii) Ph.D.
holder (full-time, Ph.D. project should be related to Clinical
Embryology/assisted reproductive technology/fertility) from a recognised
university or institute or with an additional one year of human ART laboratory
experience in handling human gametes and embryos;
(iii) Medical
graduate (MBBS) or Veterinary graduate (BVSc) with a postgraduate degree in
Clinical Embryology (full-time program) from a recognised university or
institute with additional two years of ART laboratory experience in handling
human gametes and embryos;
(iv) Postgraduate
in life sciences/Biotechnology with at least one year of on-site, full-time
clinical embryology certified training in addition to four years experience in
handling human gametes and embryos in a registered ART level 2 clinics.
As
a one-time measure all embryologists working in Assisted Reproductive
Technology or In vitro fertilization clinics before the commencement of the
Act, with the following below mentioned qualifications and experience may be
allowed to continue as embryologists.
However,
after the commencement of this Act, all clinics will hire Embryologists only
with any of the above-mentioned four qualifications and experience criteria.
Graduate
in Life Sciences /biotechnology/ reproductive biology/ veterinary science with
at least five years experience of working in a registered Assisted Reproductive
Technology / In vitro fertilization clinic, who have performed at least 500 IVF
lab procedures (including Intracytoplasmic sperm injection I and at least 100
cycles of cryopreservation of embryos).
(d) Counselor:
A person who is a graduate in psychology or clinical psychology or nursing or
life sciences from a recognised university or institute.
(e) Anesthetist:
Anesthetist shall be a medical postgraduate in Anesthesia from a recognised
university or institute.
(f) Director:
The director should have a post-graduate degree in medical /life
sciences/Management Sciences from a recognised university or institute.
SCHEDULE 1
Part 2
[see rule 3(2)]
1.
Equipments: -
Microscope:
(a) Incubator
(minimum 02 in number);
(b) Laminar
Airflow;
(c) Sperm
counting Chambers;
(d) Centrifuge;
(e) Refrigerator;
(f) Equipment
for cryopreservation;
(g) Ovum
aspiration pump;
(h) Ultrasonography
machine with transvaginal probe and needle guard;
(i) Test
tube warmer;
(j) Anesthesia
resuscitation trolley.
FORM 1
[See rule 4]
Application Form for Couple of Indian
Origin/Intending woman for availing Surrogacy addressed to Board
I/
We (Details as given below) request for a certificate of recommendation for
availing Surrogacy Services
1.
Basic Information
1.1
Details of Intended Father:
1.
Name:
2.
Surname:
3.
Date of Birth:
4.
Blood Group:
5.
Age in years:
6.
Sex: Male/ Female
7.
Nationality:
8.
Occupation:
9.
Marital Status: Married/ Divorced /Widow.
10.
Address: (Please give details of Address in India if available and the present
foreign country of residence)
(i)
Present:
(ii)
Permanent
11.
Telephone/Mob. No. (Details of number in India and the country of residence)
12.
Email:
13.
Social Security Number or Equivalent
14.
Passport Number
1.2
Details of the Intended Mother:
1.
Name:
2.
Surname
3.
Date of Birth:
4.
Blood Group:
5.
Age in years
6.
Sex: Male Female
7.
Nationality:
8.
Occupation:
9.
Marital Status: Married/ Divorced /Widow.
10.
Address: (Please give details of Address in India if available and the present
foreign country of residence)
(i)
Present:
(ii)
Permanent
11.
Telephone/Mob. No. (Details of number in India and the country of residence)
12.
Email:
13.
Social Security Number or Equivalent
14.
Passport Number
1.3
Briefly describe the reason for availing surrogacy
Declaration
I
hereby declare that the above statements are true to the best of my knowledge
and belief.
Date:
................Signature of the Intended father
Place:
................
Signature
of the Intended Mother
Self
attested Documents required for applying
1.
Proof of marriage
/ Marriage Certificate (If applicable)
2.
Proof of age/
Birth certificate/10th certificate/ or any equivalent.
( Note: Certificate of essentiality is to be obtained from appropriate
authority and Certificate of Medical Indication is to be obtained from the
District Medical Board)
FORM 2
[See rule 7]
Consent of the Surrogate Mother and Agreement for
Surrogacy
I,
____________________________________ (the woman), aged _______ Years (address)
________________________________________ (Aadhar Number), having _______
(Number of children) child/children __________ (age in years) of my own have
agreed to act as a surrogate mother for Intending couple/intending woman Name
_________________ Husband Name _______________ Wife/ ________________ Intending
woman Age _______ Husband Age _____ Wife/Intending woman __________________ had
a full discussion with Dr. _____________________________ of the Surrogacy
clinic on _______________________ in regard to the matter of my acting as a
surrogate mother for the child/children of the above couple.
1.
That I understand
that the methods of treatment may include:
(a) stimulation
of the genetic mother for follicular recruitment;
(b) the
recovery of one or more oocytes from the genetic mother by ultrasound-guided
oocyte recovery or by laparoscopy;
(c) the
fertilization of the oocytes from the genetic mother with the sperm of her
husband;
(d) the
fertilization of a donor oocyte by the sperm of the husband;
(e) the
maintenance and storage by cryopreservation of the embryo resulting from such
fertilization until, in the view of the medical and scientific staff, it is
ready for transfer;
(f) implantation
of the embryo obtained through any of the above possibilities into my uterus,
after the necessary treatment if any.
2.
That I have been
assured that the genetic mother and the genetic father have been screened for
HIV and hepatitis B and C and other sexually transmitted diseases before oocyte
recovery and found to be seronegative for all these diseases. I have, however,
been also informed that there is a small risk of the mother or the father
becoming seropositive for Human immunodeficiency (HIV) during the window period.
3.
That I consent to
the above procedures and the administration of such drugs that may be necessary
to assist in preparing my uterus for embryo transfer, and for support in the
luteal phase.
4.
That I understand
and accept that there is no certainty that a pregnancy may result from these
procedures.
5.
That I understand
and accept that the medical and scientific staff may give no assurance that any
pregnancy will result in the delivery of a normal and living child or children.
6.
That I am
unrelated or related (relation) _____________________________ to the couple
(the would-be genetic parents).
7.
That I have worked
out medical and other expenses and conditions of the surrogacy with the couple
in writing and an appropriately authenticated copy of the agreement has been
filed with the clinic, which the clinic shall keep confidential. A General
health insurance coverage in favor of the surrogate mother from an insurance
company or an agent recognized by the Insurance Regulatory and Development
Authority established under the Insurance Regulatory and Development Authority
Act, 1999 (41 of 1999) has been purchased by the intending couple/woman.
8.
That I agree to
relinquish all my rights over the child and hand over the child/children to
__________________________, or _____________ and _____________________ in case
of a intending couple, or to ______________________________ in case of their
separation during my pregnancy, or to the survivor in case of the death of one
of them during pregnancy, or to ------------- -------------------------- in
case of death of both of them, or to
----------------------------------------------- ---- in case of guarantor
intending couple/ woman, as soon as I am permitted to do so by the hospital or
clinic or nursing home where the child or children are delivered.
9.
That I have been
provided with the written consent of all of those name(s) mentioned above.
10.
That I undertake
to inform the surrogacy clinic, ______________________, of the result of the
pregnancy.
11.
That I take no
responsibility that the child or children delivered by me will be normal in all
respects. I understand that the biological parent(s) of the child/ children has
/ have a legal obligation to accept the child or children that I deliver and
that the child or children would have all the inheritance rights of a child or
children of the biological parent(s) as per the prevailing law.
12.
That I shall not
be asked to go through sex determination tests for the child/ children during
the pregnancy and that I have the full right to refuse such tests.
13.
That I understand
that I would have the right to terminate the pregnancy in case of any
complication as advised by the doctors, under the provisions of the Medical
Termination of Pregnancy Act, 1971 (34 of 1971).
14.
That I certify
that I have not born any child through surrogacy before.
15.
That I have been
tested for HIV, hepatitis B and C and shown to be seronegative for these
viruses just before embryo transfer.
16.
That I shall not
have intercourse of any kind once the cycle preparation is initiated.
17.
That I certify
that (a) I have not had any drug intravenously administered into me through a
shared syringe; and (b) I have not undergone blood transfusion in the last six
months.
18.
That I also
declare that I shall not use drugs intravenously, or undergo blood transfusion
excepting of blood obtained through a certified blood bank on medical advice.
19.
That I undertake
not to disclose the identity of the party seeking the surrogacy.
20.
That In the case
of the death or unavailability of the party seeking my help as the surrogate
mother, I shall deliver the child/children to ______________________ or
___________________________ in this order; I shall be provided, before the
embryo transfer into me, a written agreement of the above persons that they
shall be legally bound to accept the child or children in the case of the
above-mentioned eventuality. (If applicable)
(Strike off if not applicable.)
Endorsement
by the Surrogacy Clinic
I/we
have personally explained to _____________________ and ______________ the details
and implications of his / her / their signing this consent / approval form, and
made sure to the extent humanly possible that he / she / they understand these
details and implications.
Signed:
(Surrogate
Mother)
Signature
of Intending couple/Woman
Name,
address and signature of the Witness from the Surrogacy clinic
Name
and signature of the Doctor
Name
and address of the Surrogacy Clinic
Dated:
FORM 3
[See rule 10]
APPLICATION FORM REGISTRATION OF A SURROGACY CLINIC
Name
of the Surrogacy clinic:
Address
of the Surrogacy clinic:
State:
_________________ City: ___________________ Pin Code:
Telephone
No. (with STD Code) (Surrogacy clinic only):
Mobile No. of Surrogacy clinic
E-mail
(Surrogacy clinic):
Website,
if any
1.
Status of your Surrogacy clinic:
1.
Government 2. Private Any other, please specify................................
2.
Date of establishment of your Surrogacy clinic:
3.
Whether your Surrogacy clinic is registered under following Acts/Authorities
(Please provide details) Yes / No
1.
The Medical Termination of Pregnancy (MTP) Act, 1971 (44 of 1971)
2.
The Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex
Selection) Act, 1994 (57 of 1994)
4.
Whether your Surrogacy clinic has Director
(1.
Yes 2. No)
a)
Name
b)
Qualification
c)
Registration No. if applicable
5.
Details of staff
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Post
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Name
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Qualification
|
Registration No. if applicable
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Gynaecologist
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Anesthetist
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Clinical Embryologist
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Andrologist
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Counsellor
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6. List of equipments
7. Indicate which of the following procedures are being carried out at your
Surrogacy clinic
1.
Yes 2. No
(a)
Intra-uterine
Insemination using Husband Semen (IUI-H)
(b)
Intra-uterine
Insemination using Donor Semen (IUI-D)
(c)
In vitro
Fertilization-Embryo Transfer (IVF-ET)
(d)
Intra-cytoplasmic
Sperm Injection (ICSI)
(e)
Processing of
semen
(f)
Storage of gametes
(sperm and oocyte) and or embryos of patient
(g)
Pre-implantation
Genetic Testing
(h)
Any other
procedure, please specify.....................................
8.
Any additional Information
DECLARATION
I
hereby declare that the entries in this form and the additional particulars (if
any), furnished herewith are true to the best of my knowledge and belief.
Date:
_____________
FORM 4
[See rule 11]
CERTIFICATE OF REGISTRATION
Surrogacy Clinic
(To be issued in duplicate)
Certificate
No.:
1.
In exercise of the powers conferred under section 12 (1) of the Surrogacy
(Regulation) Act, 2021 (47 of 2021), the Appropriate Authority .....................................
hereby grants registration to the Surrogacy Clinic named below for purposes of
carrying out surrogacy or surrogacy procedures as per the aforesaid Act, for a
period of ..................................... years ending on .....................................
(a)
Name and address of the Surrogacy clinic:
(b)
Type of institution (Government / Private)
2.
This registration is granted subject to the aforesaid Act and Rules there under
and any contravention thereof shall result in suspension or cancellation of
this certificate of registration before the expiry of the said period of three
years.
3.
Registration No. allotted
4.
For renewed Certificate of Registration only: Period of validity of earlier
Certificate of Registration from ..................................... To
.....................................
Signature, Name and Designation of
the Appropriate Authority
Date:
.....................................
Place:
.....................................
SEAL
Display
one copy of this certificate at a conspicuous place at the place of business
*Strike
out whichever is not applicable or necessary
FORM 5
[See rule 12]
Appeal
No./20......................Made against ...................... to the State
Government /Central Government In the matter of:
Name
and Address of Appellant
Versus
Name
and Address of the Authority Whose Order is Challenged Respondent Most
respectfully showeth:
The
above-mentioned appellant appeals against the order passed by
the...................... concerned Appropriate Authority at
...................... (Name of place and address) against the appellant in
(details of the case if any)
dated...................... and sets forth the following grounds of objection
of the order appealed: -
1.
Particulars of the order including number of orders, if any, against which the
appeal is Preferred.
2.
Brief facts of the case.
3.
Findings of the Appropriate Authority challenged.
4.
Grounds of appeal.
5.
Copy of the order enclosed along with all the documents relied upon by the
Appellant.
6.
Any other information/documents in support of appeal
Prayer:
That
the appellant, therefore prays for the reasons stated above the order under the
appeal be set aside and quashed and order deemed just and proper may kindly be
passed in favor of the appellant.
Signature
of the Appellant
Place:
......................
Date:
......................
Verification
I,
...................... do hereby verify that the contents of para
...................... to ...................... are true and correct to the
best of my knowledge and belief and no part is false and nothing material has
been concealed therein.
Signature
of the Appellant
List
of Documents
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Particulars
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