[24th
February 2023] In exercise of the powers
conferred by clause (z) of sub-section (2) of section 42 of the Assisted
Reproductive Technology (Regulation) Act, 2021 (42 of 2021), the Central
Government hereby makes the following rules further to amend the Assisted
Reproductive Technology (Regulation) Rules, 2022, namely: - (1)
These rules may be called the Assisted
Reproductive Technology (Regulations) Amendment Rules, 2023. (2)
They shall come into force from the date of
their publication in the Official Gazette. (a)
after rule 18, the following rule shall be
inserted, namely: - "19.
Transfer of gametes and embryos for
personal use within or outside India. - Whoever intends to transfer
own gametes and embryos for personal use within or outside India under section
29 of the Act, shall apply or furnish declaration in Forms 16 to 24, as may be
applicable and obtain the prior permission of the National Board." (b)
Schedule 1 shall be renumbered as Schedule
thereof and in the Schedule as so renumbered, after Form 15, the following
forms shall be inserted, namely: - [see
rule 19 (i)] Application
form for transfer of gametes (Sperms and oocyte or embryos ) within and outside
India (1)
Name of applicant:
.............................................................................. (2)
Marital Status :..........................(married/single/divorced) (3)
Name of the Spouse (if
applicable).................................................... (4)
Address:
........................................................................................................ (5)
Contact
no........................................................................................................ (6)
Email
id........................................................................................................ (7)
Aadhar no..........................Spouse.
.......................... (if applicable) (8)
Passport no. ..........................
Spouse. .......................... (if applicable) (9)
PAN no.......................... Spouse.
.......................... (if applicable) (10)
Date of Birth of applicant
/spouse..........................(DD/MM/YY) (11)
Transfer of
..........................(Embryos/ Sperms/ Oocytes) (12)
Transfer: .......................... (within
/outside India) (13)
From (name of the doctor / address of clinic/
contact/ email address): .................................................................................................................................. .................................................................................................................................. (14)
To (name of the doctor/ address of clinic/
contact/ email address): .................................................................................................................................. .................................................................................................................................. (15)
Quantity ..........................vials
(sperm)/ No. of oocytes/embryos) (15
A) Purpose of transfer (whether Invitro Fertilization or Surrogacy)
.......................... (16)
Affidavit executed: yes / no (17)
Affidavit from clinic holding
gametes/embryos: yes/ no (18)
Affidavit from clinic receiving
gametes/embryos: yes/ no (19)
List of supporting documents: (20)
Copy of Aadhar (Yes/No) (21)
Copy of Passport (Yes/No) (If transfer
outside India) (22)
Copy of Social Security Number (If Person of
Indian Origin/ Foreigner) (23)
Date of applying Declaration I/ we hereby declare that
these gametes (sperm/ oocyte)/embryos are our own and are being transferred for
personal use only. Signature of Applicant
Signature of Spouse (if applicable) Note: Strike off what is not
applicable Form
17 [See
rule 19 (ii)] Affidavit
for transfer of embryos outside India I/we..........................
and.......................... Resident of
.................................................... Aadhar
No.......................... and .......................... (if applicable)
/Passport no.......................... (Husband)..........................
(Wife)/or .......................... (Name of individual). I/We have
cryopreserved my/ our embryos since ………….. (date) at
....................................................name and address of the
clinic) and we wish to transfer my/ our .......................... ( number of
embryos) outside Indiato .......................... ..........................
(name and address of the Foreign ART clinic) for the purpose of ( Whether
Invitro Fertilization or Surrogacy) .......................... ........................................................................................................ These embryos have been
created using sperms of .......................... and oocyte of
.......................... and no sex selection has been performed on these
embryos. The transfer of embryos
requested above is not in contravention to any of the provisions of the
Assisted Reproductive Technology (Regulation) Act, 2021 (42 of 2021). Also the
present regulatory provisions of the country where I/Weintend to transfer the
embryos permits the transfer of these embryos. I/We understand that selling
human embryos or gametes, run an agency, a racket or an organisation for
selling, purchasing or trading in human embryos or gametes shall be a
punishable offence. DECLARATION I/ we hereby declare that
the entries in this affidavit and the additional particulars, if any, furnished
herewith are true to the best of my knowledge and belief. Date: _____________ Place:____________ Name and Signature of couple / Individual Paste duly attested Photo Note: Strike off which is
not applicable *Note: The Affidavit shall
be executed on Non-Judicial Stamp paper duly sworn before Metropolitan
Magistrate or a Judicial Magistrate of First Class or an Executive Magistrate
or a Notary Public. In case the applicant is outside India then the Affidavit
shall be executed through an authorized Attorney in India. Form
18 [See
rule 19 (iii)] Affidavit
for transfer of gametes (sperm/oocyte) outside India I/we....................................................
and.................................................... Resident of
........................................................................................................Aadhar
No.......................... and ..........................
(if applicable) /Passport no..........................
(Husband).......................... (Wife)/or ..........................
(Individual). I/We have cryopreserved my/ our ..........................
(sperm/oocyte) since .......................... (date) at ..........................(name
and address of the clinic) and we wish to transfer my/ our
.......................... (number/vial) of gametes(sperm/oocyte) to
.......................... (Name and address of the
Foreign ART clinic) for the purpose of (Whether Invitro Fertilization or
Surrogacy)
........................................................................................................ I /We also certify that that
no separation of X and Y chromosomes has been done on the gamete (sperm/
oocyte) The transfer of gametes
requested above is not in contravention to any of the provisions of the
Assisted Reproductive Technology (Regulation) Act, 2021 (42 of 2021). I/We understand that selling
human embryos or gametes, run an agency, a racket or an organisation for selling,
purchasing or trading in human embryos or gametes shall be a punishable
offence. DECLARATION I/ we hereby declare that
the entries in this affidavit and the additional particulars, if any, furnished
herewith are true to the best of my knowledge and belief. Date: _____________ Place: ____________ Name and Signature of
Husband & wife / Individual Paste duly attested Photo Note: Strike off which is
not applicable *Note: The Affidavit shall
be executed on Non-Judicial Stamp paper duly sworn before Metropolitan
Magistrate or a Judicial Magistrate of First Class or an Executive Magistrate
or a Notary Public. In case the applicant is outside India then the Affidavit
shall be executed through an authorized Attorney in India. Form
19 [See
rule 19 (iv)] Affidavit
for transfer of embryos within India I/we....................................................
and.................................................... Resident of
........................................................................................................ ........................................................................................................ ..........................Aadhar
No.......................... and .......................... (if applicable)
/Passport no.......................... (Husband) ..........................
(Wife)/or .......................... (Individual). I/We have cryopreserved my/
our embryos since .......................... (date) at
.......................... .......................... (name and address of the
clinic) and we wish to transfer my/ our .......................... ( number of
embryos) to.................................................... (name and
address of the clinic) for the purpose of (Whether Invitro Fertilization or
Surrogacy) .............................................................................. .............................................................................. ..........................These
embryos have been created using sperms of ....................................................and
oocyte of ....................................................and
no sex selection has been performed on these embryos.
The present regulatory provisions of the country where I/We intend to transfer
the embryos permits the transfer of these embryos. The transfer of embryos
requested above is not in contravention to any of the provisions of the
Assisted Reproductive Technology (Regulation) Act, 2021 (42 of 2021). I/We understand that selling
human embryos or gametes, run an agency, a racket or an organisation for
selling, purchasing or trading in human embryos or gametes shall be a
punishable offence. DECLARATION I/ we hereby declare that
the entries in this affidavit and the additional particulars, if any, furnished
herewith are true to the best of my knowledge and belief. Date: _____________ Place:____________ Name and Signature of couple / Individual Paste duly attested Photo Note: Strike off which is
not applicable *Note: The Affidavit shall
be executed on Non-Judicial Stamp paper duly sworn before Metropolitan
Magistrate or a Judicial Magistrate of First Class or an Executive Magistrate
or a Notary Public. In case the applicant is outside India then the Affidavit
shall be executed through an authorized Attorney in India. Form
20 [See
rule 19 (v)] Affidavit
for transfer of gametes (sperms/oocytes) within India I/we....................................................and..........................Resident
of .......................... .................................................................................................................................. ..........................Aadhar
No.......................... and .......................... (if applicable)
/Passport no.......................... (Husband) ..........................
(Wife)/or .......................... (Individual). I/We have cryopreserved my/
our .......................... (sperms/oocytes) since
.......................... (date) at ....................................................
(name and address of the clinic) and we wish to transfer my/ our
.......................... (number/vial) of gametes(sperm/oocyte)) to
............................................................................................................................................................ ............................................................................................................................................................ (name and address of the
clinic) for the purpose of (Whether Invitro Fertilization or Surrogacy) .................................................... .................................................... .................................................... I /We also certify that that
no separation of X and Y chromosomes has been done on the gamete
(sperm/oocyte). The transfer of gametes
requested above is not in contravention to any of the provisions of the
Assisted Reproductive Technology (Regulation) Act, 2021 (42 of 2021). I/We understand that selling
human embryos or gametes, run an agency, a racket or an organisation for
selling, purchasing or trading in human embryos or gametes shall be a
punishable offence. DECLARATION I/ we hereby declare that
the entries in this affidavit and the additional particulars, if any, furnished
herewith are true to the best of my knowledge and belief. Date: _____________ Place:____________ Name and Signature of couple / Individual Paste duly attested Photo Note: Strike off which is
not applicable *Note: The Affidavit shall
be executed on Non-Judicial Stamp paper duly sworn before Metropolitan
Magistrate or a Judicial Magistrate of First Class or an Executive Magistrate
or a Notary Public. In case the applicant is outside India then the Affidavit
shall be executed through an authorized Attorney in India. Form
21 [See
rule 19 (vi)] Affidavit
from the clinic holding the frozen embryos This is to certify that our
clinic (Name/ Address and Registration Number of the Assisted Reproductive Technology
Clinic) has created.......................... (number of embryos) of Mr.
.......................... (Aadhaar Number /Passport number/ Social Security
Number) and Mrs.......................... (Aadhaar Number /Passport number/
Social Security Number) for the purpose.......................... (Whether
Invitro Fertilization or Surrogacy). Total number of embryos
created and date of creation: Total number of embryos
used: Number of remaining embryos: The embryos have not been
subjected to sex selection: Signature and Stamp of the
Assisted Reproductive Technology Clinic Date: *Note: The Affidavits shall
be executed on Non-Judicial Stamp paper duly sworn before Metropolitan
Magistrate or a Judicial Magistrate of First Class or an Executive Magistrate
or a Notary Public. In case of transfer of gametes or embryos outside India the
affidavit shall be executed through a court abroad of level equivalent to
Metropolitan Magistrate or a Judicial Magistrate of First Class or an Executive
Magistrate or a Notary Public. Form
22 [See
rule 19 (vii)] Affidavit
from clinic holding gametes (Sperms /oocytes) This is to certify that our
clinic (Name/ Address and Registration Number of the Assisted Reproductive
Technology Clinic) has stored the frozen semen sample of Mr.
.......................... (Aadhaar Number /Passport number/ Social Security
Number). We are ready to transfer all these vials of semen sample of Mr
.......................... (Name/Address/Contact Number) for the purpose of
.......................... (Whether Invitro Fertilization or Surrogacy) The frozen semen sample of
Mr. .......................... have not been subjected to any procedure
resulting in separation of X or Y fractions. Total semen vials frozen and
date of freezing: Total semen vials used: Number of remaining
vials.......................... Signature and Stamp of the
Assisted Reproductive Technology Clinic Date: OR This is to certify that our
clinic (Name/ Address and Registration Number of the Assisted Reproductive
Technology Clinic) has (number..........................) of oocytes from Ms.
.......................... (Aadhaar Number /Passport number/ Social Security
Number) frozen in our clinic. We are ready to transfer all these occytes of
Ms.......................... (Name/Address/Contact Number)for the purpose of
.......................... (Whether Invitro
Fertilization or Surrogacy) Total Number of oocytes
retrieved and date of retrieval and freezing: Number of oocytes used for
creation of embryos: Number of remaining oocytes: Signature and Stamp of the
Assisted Reproductive Technology Clinic Date: *Note : The Affidavits shall
be executed on Non-Judicial Stamp paper duly sworn before Metropolitan
Magistrate or a Judicial Magistrate of First Class or an Executive Magistrate
or a Notary Public. In case of transfer of gametes or embryos outside India the
Affidavit shall be executed through a court abroad of level equivalent to
Metropolitan Magistrate or a Judicial Magistrate of First Class or an Executive
Magistrate or a Notary Public. [See
rule 19 (viii)] Affidavit
from clinic receiving the frozen embryos This is to certify that our
clinic (Name/ Address and Registration Number of the Assisted Reproductive
Technology Clinic) is willing to receive .......................... (Number)
ofthe frozen embryos of Mr. .......................... (Aadhaar Number
/Passport number/ Social Security Number) and Mrs. ..........................
(Name, Aadhaar number/ Passport number/ Social Security Number) to be used for
the purpose .......................... (Whether Invitro Fertilization or
Surrogacy). Signature and stamp of the
Assisted Reproductive Technology Clinic Date: *Note: The Affidavits shall
be executed on Non-Judicial Stamp paper duly sworn before Metropolitan
Magistrate or a Judicial Magistrate of First Class or an Executive Magistrate
or a Notary Public. In case of transfer of gametes or embryos outside India the
Affidavit shall be executed through a court abroad of level equivalent to
Metropolitan Magistrate or a Judicial Magistrate of First Class or an Executive
Magistrate or a Notary Public. Form
24 [See
rule 19 (ix)] Affidavit
from clinic receiving the frozen gametes This is to certify that our
clinic (Name/ Address and Registration Number of the Assisted Reproductive
Technology Clinic) is willing to receive .......................... number of
vials of the frozen semen sample of Mr. .......................... (Aadhaar
Number /Passport number/ Social Security Number). The frozen semen sample will
not been subjected to any procedure resulting in separation of X or Y
fractions. The semen will be used for the treatment of
Ms.......................... and/ or Mr........................... Signature and Stamp of the
Assisted Reproductive Technology Clinic Date: OR This is to certify that our
clinic (Name/ Address and Registration Number of the Assisted Reproductive Technology
Clinic) is willing to receive.......................... number of frozen
oocytes of Ms. .......................... (Aadhaar Number /Passport number/
Social Security Number).The oocytes will be used for the treatment of
Ms.......................... and/ or Mr.......................... Signature and Stamp of the
Assisted Reproductive Technology Clinic Date: *Note: The clinics holding
the gametes or embryos and receiving the gametes or embryos, both shall execute
Affidavits on Non-Judicial Stamp paper duly sworn before Metropolitan
Magistrate or a Judicial Magistrate of First Class or an Executive Magistrate
or a Notary Public. In case of transfer of gametes or embryos outside India,
the Affidavit shall be executed through a court abroad of level equivalent to
Metropolitan Magistrate or a Judicial Magistrate of First Class or an Executive
Magistrate or a Notary Public."Assisted
Reproductive Technology (Regulations) Amendment Rules, 2023
In the Assisted Reproductive Technology (Regulation) Rules, 2022, -
"Form 16
Form 23