Assisted Reproductive Technology Regulation Framework

Context

• The Ministry of Health and Family Welfare amended the Assisted Reproductive Technology regulatory framework in 2023 under the Assisted Reproductive Technology (Regulation) Act, 2021.
• The amendments supplemented the existing framework governing ART clinics, banks, gamete and embryo transfer, and medical professionals.

What is Assisted Reproductive Technology?

• Assisted Reproductive Technology (ART) refers to techniques used to achieve pregnancy by handling sperm or oocytes outside the human body and transferring a gamete or embryo into the reproductive system of a woman.
• Common ART procedures include in-vitro fertilisation (IVF), intracytoplasmic sperm injection (ICSI), gamete donation and embryo transfer.
• ART is distinct from surrogacy: ART concerns assisted conception, whereas surrogacy involves another woman carrying the pregnancy.

Regulation of ART Clinics and Banks

• Every ART clinic and bank must be registered under the National Registry.
• Registration is generally valid for five years and may be renewed.
• Registration may be suspended or cancelled for violation of the Act, Rules or prescribed standards.
• The National and State Assisted Reproductive Technology and Surrogacy Boards provide policy guidance, monitoring and regulatory oversight.

Donor, Consent and Child Protection

• ART banks may obtain semen from men aged 21–55 years and oocytes from women aged 23–35 years.
• An oocyte donor must be an ever-married woman with at least one living child aged three years or more and may donate only once in her lifetime.
• ART procedures require written informed consent of the persons concerned.
• The commissioning couple or woman must provide 12-month insurance coverage for the oocyte donor against complications arising from oocyte retrieval.
• A child born through ART is legally treated as the biological child of the commissioning couple, while the donor has no parental rights over the child.

What Did the 2023 Amendments Change?

• The February 2023 amendment introduced a prescribed permission process for the transfer of one’s own gametes and embryos for personal use within or outside India.
• Such transfer requires prior permission of the National Board and compliance with the prescribed forms and procedure.
• The July 2023 amendment revised the qualification and experience requirements for an andrologist, including specified hands-on experience in surgical sperm-retrieval procedures.
• These amendments supplemented, rather than replaced, the broader regulatory framework created by the 2021 Act and 2022 Rules.

Key Concerns

• Restricted donor pool: Narrow eligibility conditions may reduce the availability of suitable oocyte donors.
• Higher treatment costs: Insurance requirements, regulatory compliance and limited donor availability may increase ART expenses.
• Access concern: As a policy concern, strict eligibility and procedural requirements may make treatment more difficult for some intending parents.
• Regulation versus autonomy: The framework must balance donor protection, child welfare and reproductive choice.

FAQs

Q1. What is ART?
ART refers to techniques used to achieve pregnancy by handling sperm or oocytes outside the human body and transferring a gamete or embryo into a woman’s reproductive system.

Q2. Which law regulates ART in India?
The Assisted Reproductive Technology (Regulation) Act, 2021.

Q3. What are the permitted donor age groups?
Men 21–55 years and women 23–35 years.

Q4. What did the February 2023 amendment address?
It introduced a permission process for the transfer of one’s own gametes and embryos for personal use within or outside India.

Q5. What is the legal status of a child born through ART?
The child is treated as the biological child of the commissioning couple, while the donor has no parental rights.