SURROGACY (REGULATION) ACT, 2021
1. Short title and commencement 1
2. De nitions 1 CHAPTER II REGULATION OF SURROGACY CLINICS
3. Prohibition and regulation of surrogacy clinics 6 CHAPTER III REGULATION OF SURROGACY AND SURROGACY PROCEDURES
4. Regulation of surrogacy and surrogacy procedures 8
5. Prohibition of conducting surrogacy 11
6. Written informed consent of surrogate mother 11
7. Prohibition to abandon child born through surrogacy 12
8. Rights of surrogate child 12
9. Number of oocytes or human embryos to be implanted 13
10. Prohibition of abortion 13
CHAPTER IV
11.
15. Establishment of National Assisted Reproductive Technology and Surrogacy Registry
16. Application of provisions of Assisted Reproductive Technology Act with respect to National Registry 15
CHAPTER V
NATIONAL ASSISTED REPRODUCTIVE TECHNOLOGY AND SURROGACY BOARD AND STATE ASSISTED REPRODUCTIVE TECHNOLOGY AND SURROGACY BOARDS
17.
18.
22.
23.
24.
26.
31.
32.
33. Authentication of orders and other instruments of State Board
34. Eligibility of member for re-appointment
CHAPTER VI
35. Appointment of appropriate authority
36. Functions of appropriate authority
37. Powers of appropriate authorities
CHAPTER VII
38. Prohibition of commercial surrogacy, exploitation of surrogate mothers and children born through surrogacy
39. Punishment for contravention of provisions of Act
40. Punishment for not following altruistic surrogacy
41. Penalty for contravention of provisions of Act or rules for which no speci c punishment is provided
42. Presumption in the case of surrogacy
43. Offence to be cognizable, non-bailable and non-compoundable
44. Cognizance of offences
45. Certain provisions of Code of Criminal Procedure, 1973 not to apply
ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION) ACT, 2021
1. Short title and commencement
2. De nitions
AUTHORITIES TO REGULATE ASSISTED
3. National Assisted Reproductive Technology and Surrogacy Board
4. Application of provisions of Surrogacy Act with respect to National Board
5. Powers and functions of National Board
6. State Assisted Reproductive Technology and Surrogacy Board
7. Application of provisions of Surrogacy Act with respect to State Board
8. Powers and functions of State Board
9. Establishment of National Registry of clinics and banks
10. Composition of National Registry
11. Functions of National Registry
12. Appointment of appropriate authority
13. Functions of appropriate authority
14. Powers of appropriate authority
PROCEDURES
15. Registration of
16.
17.
CHAPTER IV
DUTIES OF ASSISTED REPRODUCTIVE TECHNOLOGY CLINIC AND ASSISTED REPRODUCTIVE TECHNOLOGY BANK
21. General duties of assisted reproductive technology clinics and banks 53
22. Written informed consent 56
23. Duties of assisted reproductive technology clinics and banks to keep accurate records 57
24. Duties of assisted reproductive technology clinics using human gametes and embryos 58
25. Pre-implantation Genetic Diagnosis
26. Sex selection
27. Sourcing of gametes by assisted reproductive technology banks
28. Storage and handling of human gametes and embryos
29. Restriction on sale, etc., of human gametes, zygotes and embryos 64
30. Research on human gametes and embryos 64
31. Rights of child born through assisted reproductive technology 64
CHAPTER V
AND PENALTIES
32. Sex selective assisted reproductive technology
33. Offences and penalties
34. Punishment for contravention of provisions of Act or rules for which no speci c punishment is provided
35. Cognizance of offences
36. Offences to be cognizable and bailable
37. Offences by clinics or banks
CHAPTER VI
MISCELLANEOUS
38. Power of Central Government to issue directions to National Board National Registry and appropriate authority
39. Power of State Government to issue directions to State Board, etc.
40. Power to search and seize records, etc.
41. Protection of action taken in good faith
42. Power to make rules
43. Power to make regulations
44. Laying of rules, regulations and noti cations
45. Application of other laws not barred
46. Power to remove dif culties
ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION) RULES, 2022
1. Short title and commencement 77
2. De nitions 77
3. Assisted Reproductive Technology (ART) clinics and banks 77
4. Staff requirement and quali cations in ART clinics and banks 78
5. List of minimum equipments 78
6. Format for granting of licenses to clinics or banks 78
7. Form and manner of an application for registration and fee payable thereof under sub-section (2) of section 15 78
8. Certi cate of registration 78
9. Manner of appeal 79
10. The medical examination of donor
11. Grievance redressal
12. Insurance coverage/Guarantee for oocyte donor 79
13. Other duties of clinics 79
14. Examination of gamete donors by ART banks 80
15. Manner of obtaining information in respect of a sperm or oocyte donor by a bank 80
16. Manner of obtaining the consent of the commissioning couple or individual for perishing or donating the gametes of a donor or embryo 80
17. Research on human gametes or embryo within India 80
18. Search and seizure of records 81
19. Transfer of gametes and embryos for personal use within or outside India 81
SCHEDULE 81
FORM 1: Registration Form for Art Clinic
FORM 2: Registration Form for Art Bank 85
FORM 3: Certi cate of registration
FORM 4:
FORM 5: Format for making complaint to Grievance Cell
FORM 6: Consent form to be signed by the couple or woman
FORM 7: Consent for IUI with Husband’s Semen/Sperm
FORM 8: Consent for intrauterine insemination with Donor Semen 91
FORM 9: Consent for freezing of embryos 92
FORM 10: Consent for Freezing of Gametes/Sperm/Oocytes 93
FORM 11: Assent for freezing of gametes Sperm/Oocytes and parental consent 95
FORM 12: Consent for Oocyte Retrieval
FORM 13: Consent form for the Donor of Oocytes
FORM 14: Record of use of donor gametes
FORM 14A: 99
FORM 14B: Oocyte-Embryo Record
FORM 15: Consent form for the donor of sperm 101
FORM 16: Application form for transfer of gametes (Sperms and Oocyte or Embryos ) within and outside India 102
FORM 17: Af davit for transfer of embryos outside India 103
FORM 18: Af davit for transfer of gametes (Sperm/Oocyte) outside India 104
FORM 19: Af davit for transfer of embryos within India
FORM 20: Af davit for transfer of gametes (Sperms/Oocytes) within India
FORM 21: Af davit from the clinic holding the frozen embryos
FORM 22: Af davit from clinic holding gametes (Sperms/Oocytes) 107
FORM 23: Af davit from clinic receiving the frozen embryos
FORM 24: Af davit from clinic receiving the frozen gametes
NATIONAL ASSISTED
REPRODUCTIVE TECHNOLOGY AND SURROGACY BOARD (APPOINTMENT OF EXPERT MEMBERS BY NOMINATING) RULES, 2022
1. Short title and commencement
2. Manner of appointment of Expert Members under clause (f) of sub-section (2) of section 17
3. Quali cation and experience for Expert Members 110
4. Age limit 111
5. Re-appointment of Members 111
STATE ASSISTED REPRODUCTIVE TECHNOLOGY AND SURROGACY BOARD (APPOINTMENT OF EXPERT MEMBERS) RULES, 2022
1. Short title and commencement 112
2. Manner of appointment of Expert Members under clause (f) of section 27 of the Surrogacy (Regulation) Act, 2021 in States and Union Territories 112
3. Quali cation and experience for Expert Members 112
4. Age limit 113
5. Re-appointment of Members 113
SURROGACY (REGULATION) RULES, 2022
1. Short title and commencement 114
2. De nitions 114
3. The requirement, and quali cation for persons employed, at a registered surrogacy clinic 114
4. 114
5. Insurance coverage 115
6. Number of attempts of surrogacy procedure 115
7. Consent of a surrogate mother 115
8. Number of embryos to be implanted in the uterus of the surrogate mother 115
9. Conditions under which the surrogate mother may be allowed for abortion 115
10. Form and manner for registration and fee for a surrogacy clinic 115
11. Period, manner and form for certi cate of registration 116
12. Appeal 116
13. Manner in which the seizure of documents, records, objects, etc., shall be made and seizure list shall be prepared and delivered 116
14. Medical indications necessitating gestational surrogacy 116 SCHEDULE 1 118
FORM 1: Application Form for Couple of Indian Origin/Intending woman for availing Surrogacy addressed to Board 118
FORM 2: Consent of the Surrogate Mother and Agreement for Surrogacy 119
FORM 3: Application Form - Registration of a Surrogacy Clinic 122
FORM 4: Certi cate of Registration 123
FORM 5: 124
ASSISTED REPRODUCTIVE TECHNOLOGY REGULATIONS, 2023
1. Short title and commencement 125
2. The manner of retrieving the oocytes under clause (a) of section 24 125
3. The manner of placing the embryos in the uterus of a woman under clause (b) of section 24 125
SURROGACY REGULATIONS, 2023
1. Short title and commencement 126
2. The ful lment of other condition under which eligibility certi cate to be issued by the appropriate authority under sub-clause (c) of clause (iii) of section 4 126
3. The time and place of the meeting of the National Board and the procedure to be followed for the transaction of business at such meeting and the number of Members which shall form the quorum under sub-section (1) of section 19 126
4. The manner in which a person may be temporarily associated with the National Board under sub-section (1) of section 22 127
5. The time and place of the meetings of the State Board and the procedure to be followed for the transaction of business at such meetings and the number of Members which shall form the quorum under sub-section (1) of section 29 127
6. The manner in which a person may be temporarily associated with the State Board under sub-section (1) of section 32 127
SURROGACY (REGULATION) REMOVAL OF DIFFICULTIES ORDER, 2022
Surrogacy (Regulation) Removal of Dif culties Order, 2022 128
ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION) AND SURROGACY (REGULATION) (REMOVAL OF DIFFICULTIES) ORDER, 2022
Assisted Reproductive Technology (Regulation) and Surrogacy (Regulation) (Removal of Dif culties) Order, 2022
Surrogacy (Regulation) Act, 2021
[47 OF 2021]1
An Act to constitute National Assisted Reproductive Technology and Surrogacy Board, State Assisted Reproductive Technology and Surrogacy Boards and appointment of appropriate authorities for regulation of the practice and process of surrogacy and for matters connected therewith or incidental thereto.
BE it enacted by Parliament in the Seventy-second Year of the Republic of India as follows:—
CHAPTER I
PRELIMINARY
Short title and commencement.
1. (1) This Act may be called the Surrogacy (Regulation) Act, 2021.
(2) It shall come into force on such date as the Central Government may, by notication2 in the Of cial Gazette, appoint.
COMMENTS
SECTION NOTES
1.1 Short title
The Act is formally titled as “The Surrogacy (Regulation) Act, 2021.”
This title establishes the primary identification of the law for legal referencing and citation.
1.2 Commencement of the Act
The provision allows the Government to bring the Act into force in a phased manner or on a specific date [w.e.f. 25-1-2022] as deemed fit.
De nitions.
2. (1) In this Act, unless the context otherwise requires,— (a) “abandoned child” means a child born out of surrogacy procedure who has been deserted by his intending parents or guardians and declared as abandoned by the appropriate authority after due enquiry;
1. Dated 25-12-2021.
2. NOTIFICATION S.O. 292(E), DATED 20-1-2022—In exercise of the powers conferred by sub-section (2) of section 1 of the Surrogacy (Regulation) Act, 2021 (47 of 2021), the Central Government hereby appoints the 25th day of January, 2022 as the date on which the provisions of the said Act shall come into force.
(
(b) “altruistic surrogacy” means the surrogacy in which no charges, expenses, fees, remuneration or monetary incentive of whatever nature, except the medical expenses and such other prescribed expenses incurred on surrogate mother and the insurance coverage for the surrogate mother, are given to the surrogate mother or her dependents or her representative;
(
(c) “appropriate authority” means the appropriate authority appointed under section 35;
(
(
(
d) “Assisted Reproductive Technology Act” means the Assisted Reproductive Technology (Regulation) Act, 2021;
e) “Board” means the National Assisted Reproductive Technology and Surrogacy Board constituted under section 17;
f) “clinical establishment” shall have the same meaning as assigned to it in the Clinical Establishments (Registration and Regulation) Act, 2010 (23 of 2010);
g) “commercial surrogacy” means commercialisation of surrogacy services or procedures or its component services or component procedures including selling or buying of human embryo or trading in the sale or purchase of human embryo or gametes or selling or buying or trading the services of surrogate motherhood by way of giving payment, reward, benefit, fees, remuneration or monetary incentive in cash or kind, to the surrogate mother or her dependents or her representative, except the medical expenses and such other prescribed expenses incurred on the surrogate mother and the insurance coverage for the surrogate mother;
h) “couple” means the legally married Indian man and woman above the age of 21 years and 18 years respectively;
(i) “egg” includes the female gamete;
(j) “embryo” means a developing or developed organism after fertilisation till the end of fifty-six days;
(k) “embryologist” means a person who possesses any post-graduate medical qualification or doctoral degree in the field of embryology or clinical embryology from a recognised university with not less than two years of clinical experience;
(l) “fertilisation” means the penetration of the ovum by the spermatozoan and fusion of genetic materials resulting in the development of a zygote;
(m) “foetus” means a human organism during the period of its development beginning on the fifty-seventh day following fertilisation or creation (excluding any time in which its development has been suspended) and ending at the birth;
(n) “gamete” means sperm and oocyte;
(o) “gynaecologist” shall have the same meaning as assigned to it in the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (57 of 1994);
(p) “implantation” means the attachment and subsequent penetration by the zona-free blastocyst, which starts five to seven days following fertilisation; S.
3 SURROGACY (REGULATION) ACT, 2021 S. 2
(q) “insurance” means an arrangement by which a company, individual or intending couple undertake to provide a guarantee of compensation for medical expenses, health issues, specified loss, damage, illness or death of surrogate mother and such other prescribed expenses incurred on such surrogate mother during the process of surrogacy;
(r) “intending couple” means a couple who have a medical indication necessitating gestational surrogacy and who intend to become parents through surrogacy;
(s) “intending woman” means an Indian woman who is a widow or divorcee between the age of 35 to 45 years and who intends to avail the surrogacy;
(t) “Member” means a Member of the National Assisted Reproductive Technology and Surrogacy Board or a State Assisted Reproductive Technology and Surrogacy Board, as the case may be;
(u) “notification” means a notification published in the Official Gazette;
(v) “oocyte” means naturally ovulating oocyte in the female genetic tract;
(w) “Paediatrician” means a person who possesses a post-graduate qualification in paediatrics as recognised under the Indian Medical Council Act, 1956 (102 of 1956);
(x) “prescribed” means prescribed by rules made under this Act;
(y) “registered medical practitioner” means a medical practitioner who possesses any recognised medical qualification as defined in clause (h) of section 2 of the Indian Medical Council Act, 1956 and whose name has been entered in a State Medical Register;
(z) “regulation” means regulations made by the Board under this Act;
(za) “sex selection” shall have the same meaning as assigned to it in clause (o) of section 2 of the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (57 of 1994);
(zb) “State Board” means the State Assisted Reproductive Technology and Surrogacy Board constituted under section 26;
(zc) “State Government” in relation to Union territory with Legislature, means the Administrator of the Union territory appointed by the President under article 239 of the Constitution;
(zd) “surrogacy” means a practice whereby one woman bears and gives birth to a child for an intending couple with the intention of handing over such child to the intending couple after the birth;
(ze) “surrogacy clinic” means surrogacy clinic, centre or laboratory, conducting assisted reproductive technology services, in vitro fertilisation services, genetic counselling centre, genetic laboratory, Assisted Reproductive Technology Banks conducting surrogacy procedure or any clinical establishment, by whatsoever name called, conducting surrogacy procedures in any form;
(zf) “surrogacy procedures” means all gynaecological, obstetrical or medical procedures, techniques, tests, practices or services involving handling of human gametes and human embryo in surrogacy;
(zg) “surrogate mother” means a woman who agrees to bear a child (who is genetically related to the intending couple or intending woman) through surrogacy from the implantation of embryo in her womb and fulfils the conditions as provided in sub-clause (b) of clause (iii) of section 4; (zh) “zygote” means the fertilised oocyte prior to the first cell division.
(2) Words and expressions used herein and not de ned in this Act but de ned in the Assisted Reproductive Technology Act shall have the meanings respectively assigned to them in that Act.
COMMENTS
SECTION NOTES
2.1 “Abandoned Child” [Section 2(a)]
Refers to a child born through surrogacy who is deserted by the intending parents or guardians. The child must be formally declared abandoned by the appropriate authority after a due enquiry.
2.2 “Altruistic Surrogacy” [Section 2(b)]
A type of surrogacy where the surrogate mother does not receive payment or monetary compensation, except for:
Medical expenses and other prescribed expenses.
2.3 “Commercial Surrogacy” [Section 2(g)]
This term refers to the commercialization of surrogacy, including the sale or purchase of embryos, gametes, or surrogate services.
Under commercial surrogacy, the surrogate mother receives financial compensation beyond medical expenses, which distinguishes it from altruistic surrogacy.
2.4 “Couple” [Section 2(h)]
Refers to a legally married Indian couple, with both individuals meeting the age criteria:
The man must be 21 years or older and
The woman must be 18 years or older.
2.5 “Embryo” [Section 2(j)]
Defined as a developing organism from fertilization until the end of 56 days, representing the early stages of human life.
2.6 “Embryologist” [Section 2(k)]
A professional with post-graduate or doctoral qualifications in embryology and at least two years of clinical experience in the field.
2.7 “Fertilisation” [Section 2(l)]
The process where the sperm and egg unite, forming a zygote, which is the first stage of embryonic development.
2.8 “Foetus” [Section 2(m)]
The term for a human organism in the developmental stage from 57 days after fertilization until birth, excluding any period during which its development is suspended. S. 2
2.9 “Implantation” [Section 2(p)]
The process where a fertilized embryo attaches to the uterine wall, beginning 5 to 7 days after fertilization.
2.10 “Insurance”
Refers to a compensation arrangement that covers: The medical expenses, health issues, and other prescribed expenses. Related to the surrogate mother during the surrogacy process.
2.11 “Intending Couple” [Section 2(r)]
Refers to a legally married couple who, due to medical reasons, require gestational surrogacy to become parents.
2.12 “Intending Woman” [Section 2(s)]
A widowed or divorced Indian woman between 35-45 years of age who intends to use surrogacy to have a child.
2.13 “Paediatrician” [Section 2(w)]
A doctor who specializes in child health and holds a post-graduate qualification in paediatrics.
2.14 “Registered Medical Practitioner” [Section 2(y)]
A medical professional whose name is officially registered with a State Medical Register.
2.15 “Sex Selection” [Section 2(za)]
As defined in section 2(o) of the Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, It refers to any action intended to select the sex of a child, which is prohibited by law.
2.16 “State Government” [Section 2(zc)]
In the context of a Union Territory with a legislature, this refers to the Administrator appointed by the President.
2.17 “Surrogacy” [Section 2(zd)]
The practice of a woman bearing and giving birth to a child for an intending couple with the intent to hand over the child after birth.
2.18 “Surrogacy Clinic” [Section 2(ze)]
A clinic, center, or laboratory conducting assisted reproductive technology services related to surrogacy.
This includes clinics that provide In Vitro Fertilization (IVF) services, genetic counseling, and other surrogacy-related medical procedures.
2.19 “Surrogacy Procedures” [Section 2(zf)]
Encompasses all the medical procedures and services associated with surrogacy, including the handling of human gametes and embryos.
2.20 “Surrogate Mother” [Section 2(zg)]
A woman who agrees to carry and give birth to a child through surrogacy, genetically related to the intending couple or woman, and meets the conditions set out in section 4.
2.21 “Zygote” [Section 2(zh)]
Refers to the fertilized egg (oocyte) prior to the first cell division.
The zygote is the first stage in the development of an embryo. 5 SURROGACY (REGULATION) ACT, 2021 S. 2
