Rule, 2023

Text

Reproduced from the document India Code holds for this instrument. The Gazette prints Hindi and English side by side and this is the English; the Department's own PDF remains the authority.

EXTRAORDINARY

PUBLISHED BY AUTHORITY

No. 104] NEW DELHI, FRIDAY, FEBRUARY 24, 2023/PHALGUNA 5, 1944

1. आवेिक का नाम: ................................................................................................

4. पता: ................................................................................................................

5. संपका नं. ...........................................................................................................

6. ईमेल आईडी ...................................................................................................... ................................................................................................ ……………………………… (जललजनक ह।ै ................................................................…………………………………………………… (जललजनक

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health Research)

NOTIFICATION

New Delhi, the 24th February, 2023

G.S.R 126(E).—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. (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.

2. In the Assisted Reproductive Technology (Regulation) Rules, 2022, -

(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: - “Form 16 [see rule 19 (i)] Application form for transfer of gametes (Sperms and oocyte or embryos ) within and outside India

1. Name of applicant: ……………………………………………………………………………………

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 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: _____________ 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 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: _____________ 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 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: _____________ 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 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.

Form 23 [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 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.” GEETA NARAYAN, Jt. Secy.

Note : The Assisted Reproductive Technology (Regulation) Rules, 2022 was published in the Gazette of India, Extraordinary, Part II, Section 3, Subsection (i) vide notification number

G.S.R.419 (E), dated the 7 th June, 2022 and subsequently amended vide notification number

G.S.R.771 (E), dated the 10 th October, 2022 and Published by the Controller of Publications, Delhi-110054.

MANOJ KUMAR VERMA

Provisions this rule answers to

Read out of the instrument itself: an enabling provision is one it says it was made under, which is the power it rests on. The rest it names without resting on.

Other instruments under the same Act

All of the The Assisted Reproductive Technology (Regulation) Act, 2021