ART - Rules and Regulations
Frequently Asked Questions on ART (Regulation) Act, 2021
A) Eligibility Criteria for availing ART services in India
The age criteria for woman and man to avail IVF treatment in India is between 21 to 50 years and 21 to 55 years respectively. (Section 21 (g) of ART Act.2021)
No. There is no provision to relax the age criteria for the commissioning couple under the ART Act, 2021 .
Yes. Any woman who is above the age of 21 years and below the age of 50 years can avail ART services.
Yes. Foreigners can aval IVF treatment in India subject to the fulfilment of the eligibility criteria prescribed under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Rules made there under.
No, single man cannot avail IVF treatment in India.
Any man between the age of 21-55 years can donate sperm and any woman between the age of 23-35 years can donate eggs in (oocytes). (Section 27(2) (a) & 2 (b)of ART Act, 2021)
Yes. There is no bar under the ART Act for a couple or a woman to undergo ART or IVF treatment for a second child.
A commissioning couple is an infertile married couple who approaches an ART clinic or bank for ART services.
(B) Gamete donation & donor regulations
Gamete donor means a person who provides sperm or oocyte(eggs) with the objective of enabling an infertile couple or woman to have a child. (Section 2 (1) (h) of ART Act, 2021)
No. Sperm donor cannot donate sperm to more than one commissioning couple. (Section 27 (3) of ART Act, 2021
No. Oocytes of a donor cannot be shared with more than one commissioning couple (Section 27 (3) of ART Act, 2021)
A woman can donate eggs (oocytes) only once in her lifetime subject to fulfilment of the eligibility criteria prescribed under the Assisted Reproductive Technology (Regulation) Act, 2021 and the rules made there under. (Section 27 (4) of ART Act, 2021)
For retrieving oocytes from the donor, clinics shall make efforts to retrieve not more than seven oocytes during one cycle. However, the clinics shall retrieve all formed follicles. (Para 2 of ART Regulations 2023 dated 5th April 2023)
The sale and purchase of gametes /embryos is a punishable offence as mentioned in Section 33 (1) (b) of the Assisted Reproductive Technology (Regulation) Act, 2021.
A known person /friend or relative of the couple can donate eggs but only after the screening and registration of the egg donor by a registered ART bank. The egg donor shall donate oocytes only once in her life subject to fulfilment of all the eligibility criteria prescribed under the Assisted Reproductive Technology (Regulation) Act, 2021 and Rules made thereunder.
Yes, the couple can bring their own egg donor and the donor should satisfy the prescribed criteria under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Rules made thereunder.
No. All unused eggs shall be preserved by the banks for use on the same recipient.
No. The surgical retrieval of gametes (which includes ovum pickup) shall be done by the registered Level 2 ART Clinic.
Yes. Any woman above the age of twenty-one years and below the age of fifty years may undergo IVF or IUI treatments with donor sperm subject to the fulfillment of the other eligibility criteria prescribed under the Assisted Reproductive Technology (Regulation) Act, 2021 and the rules made thereunder.
Yes. Donor gametes must be obtained from registered ART banks and the donors must be medically tested for specified diseases. The gametes of a donor shall be used for one commissioning couple subject to fulfillment of other criteria prescribed under section 27 of the ART Act and rules made thereunder.
The sperm or oocyte donor shall be tested for the following communicable diseases, namely:- (a) Human immunodeficiency virus (HIV), types 1 and 2: (b) Hepatitis B virus (HBV); (c) Hepatitis C virus (HCV); (d) Treponema pallidum (syphilis) through VDRL.(Rule 10 of ART Rules, 2022)
(C) Insurance coverage
The ART Act provides for insurance coverage for a period of 12 months to be purchased by the commissioning couple or woman in favour of the oocyte donor from an insurance company or an agent recognized by the IRDAI for an amount, which is sufficient enough to cover all expenses for all complications arising due to oocyte retrieval. Section 22 (1) (b) ART Act.
No. There is no provision of insurance coverage for sperm donor.
(D) Transfer of embryos and gametes
Yes. Frozen oocytes/sperms/embryos can be transferred from one ART clinic to another clinic within or outside India with the permission of the National Board in accordance with section 29 of the ART (Regulation) Act,2021 and Rules made there under.
The requisite documents for applying for permission for transfer of embryos/gametes are given as under:
- Application form (Form 16)
2 Affidavit from the applicant for transfer of frozen embryos/gametes (Form 17-20).
- Affidavit of the clinic holding the frozen embryos/gametes (Form 21-22).
4 Affidavit of the clinic receiving the frozen embryos/gametes (Form 23-24).
The detailed forms regarding transfer of embryos/ gametes are prescribed under Rule 19 of the ART (Regulation) Rules, 2023 notified on 24.02.2023 which are available on the following link
https://artsurrogacy.gov.in/public/fornt/assets/images/permission_for_transfer%20of_embryos_gametes/assisted-Reproductive-Technology-Amendment-Rules-2023.pdf.
No. As per the Assisted Reproductive Technology (Regulation) Act,2021 and the Surrogacy (Regulation) Act,2021 the import of human embryos/gametes is strictly prohibited. It is a punishable offence and can result in imprisonment and fines as specified under the Act. (Section 33 (1) (c) of ART Act , 2021 and 38 (1) (f) of Surrogacy Act,2021)
No. There is no requirement of engaging a lawyer to apply for permission for transfer of embryos/gametes from one clinic to another clinic.
No. There is no fee for applying/ processing of the application for transfer of embryos/gametes within or outside India.
(E) Ethical Practices & Safeguards
No. Written informed consent from all parties seeking ART is mandatory before performing any procedures.
Any act to determine or increase the probability of the sex of the child to be born through ART is prohibited.
No. A clinic shall never mix semen from two individuals for the procedures specified under ART Act. Mixing of semen sample of two individuals is a punishable offence.
No. A married woman cannot undergo IVF or IUI treatment without the consent of her husband. The written informed consent from all parties seeking ART is mandatory before performing any procedures.
(F) Rights and Welfare
Yes. A child born through ART/Surrogacy has same rights as that of a biological child and is entitled to all the rights and privileges available to a natural child.
No. Donors must relinquish all parental rights over the child born from their gametes.
Yes. Either party can withdraw consent at any time before the transfer of embryos or gametes to the woman’s uterus.
Yes. There is no prohibition under the ART Act, 2021 for use of frozen embryos second time for the purpose of own IVF treatment.
(G) Duties ART Clinics have regarding patient counselling
Clinics must provide professional counselling about the implications and chances of success of ART procedures, including risks and costs.
There is no bar under the Assisted Reproductive Technology (Regulation) Act, 2021 for such counselling. However, the ART procedures can only be performed on woman of age ranging from 21 years to 50 years.
(H) Level 1 & level 2 clinics
There are two levels of ART clinic:
(i) Level 1 ART Clinics, where only intrauterine insemination (IUI) procedure is carried out as part of treatment;
(ii) Level 2 ART clinics, where the procedures that attempt to obtain a pregnancy are carried out by any or all of the following, namely:-
(a) surgical retrieval of gametes
(b) handling the oocyte outside the human body
(c) use sperms for fertilization of oocytes
(d) transfer of the embryo into the reproductive system of a woman
(e) carryout storage of gametes or embryos or perform any kind of procedure or technique involving gametes or embryos
No. The oocyte retrieval must be done at a registered Level 2 ART clinic only.
Yes. However separate registration is required for the ART Bank, even if it is co-located within an ART Level 1 or Level 2 facility. The Clinic and bank must also fulfil the requirements of staff, equipment’s and other procedural requirements prescribed under the ART act and ART Rules.
Yes. The voluntary egg donors can undergo procedure for egg retrieval at registered Level 2 ART clinic. However, the registration and screening of egg donors shall only be done by a registered ART bank. The donor should satisfy the prescribed criteria under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Rules made thereunder.