The Assisted Reproductive Technology (Regulation) Act, 2021
Administered Ministry: Ministry of Health and Family Welfare / Department of Health Research
Act details
| Short title | The Assisted Reproductive Technology (Regulation) Act, 2021 |
|---|---|
| Long title | An Act for the regulation and supervision of the assisted reproductive technology clinics and the assisted reproductive technology banks, prevention of misuse, safe and ethical practice of assisted reproductive technology services for addressing the issues of reproductive health where assisted reproductive technlogy is required for becoming a parent or for freezing gametes, embryos, embryonic tissues for further use due to infertility, disease or social or medical concerns and for regulation and supervision of research and development and for matters connected therewith or incidental thereto. |
| Act number | 42 of 2021 |
| Act year | 2021 |
| Enactment date | 18 Dec 2021 |
| Ministry | Ministry of Health and Family Welfare / Department of Health Research |
| Department | Department of Health Research |
| Jurisdiction | Central (Parliament of India) |
| Sections | 46 |
| Status | Not repealed |
| Last checked on India Code | 28 Oct 2026 |
| Source | India Code, Government of India |
Summary
Summary of The Assisted Reproductive Technology (Regulation) Act, 2021
Overview
• Key Focus: Comprehensive Regulation of Assisted Reproductive Technology (ART) Services
Core Objectives & Governance
1. Regulatory Oversight: Ensuring ethical practices in ART clinics and banks through:
• National Registry: Central database for ART facilities, aiding policymaking and research.
• National Assisted Reproductive Technology and Surrogacy Board
• State Boards
• Appropriate Authorities (Composition includes governmental, legal, and medical representatives)
2. Protection & Rights:
• Children Born via ART: Full legal rights.
• Donors & Commissioning Parties: Protected privacy and defined rights/responsibilities.
Penalties & Prohibitions
• Banned Practices:
• Sex Selection
• Commercialization of Gametes/Embryos
• Exploitation of Donors/Children
• Penalties:
• Imprisonment: Up to 10 Years for Serious Offences
• Fines: Minimum ₹10 Lakh to ₹25 Lakh
Operational & Administrative Framework
• Meetings & Procedures: Defined for National and State Boards
• Temporary Associations: Allowed for expertise input
• Quorum & Decision Making: Structured for effective governance
Legislative history
Legislative History:
The Assisted Reproductive Technology (Regulation) Act, 2021
Sources: India Code, Ministry of Health and Family Welfare Official Records
Short Title - The Assisted Reproductive Technology (Regulation) Act, 2021
Act Number / Year - Act No. 42 of 2021
Act ID (India Code) - 202142
Presidential Assent / Enactment Date - December 18, 2021
Official Gazette Publication - December 2021
Enforcement Date - January 25, 2022
Nodal Ministry - Ministry of Health and Family Welfare
Nodal Department - Department of Health Research
Precedent & Statutory Rationale
1. Regulation of the Booming ART Sector:
o Prior to 2021, India's rapidly growing assisted reproductive technology (ART) sector operated largely without comprehensive statutory oversight, leading to concerns regarding commercialization, lack of standard medical protocols, exploitation of donors and surrogates, and ethical issues surrounding gamete and embryo storage.
o The legislation was introduced to bridge this regulatory vacuum, ensuring safe, ethical, and accountable practices across ART clinics and banks nationwide.
2. Establishment of Oversight and Quality Standards:
o The Act provides for the strict regulation and supervision of ART clinics and banks, mandates proper screening and testing of donors for diseases, and lays down standardized guidelines for the storage and handling of gametes and embryos.
o It establishes the National Assisted Reproductive Technology and Surrogacy Board along with State Boards to enforce compliance, register clinics, and penalize unethical practices or commercial exploitation.
Parliamentary Trajectory & Enactment
• Formulation: Drafted and piloted by the Ministry of Health and Family Welfare (Department of Health Research) to institute a robust legal framework protecting the rights and health of parents, children, and donors involved in assisted reproduction.
• Parliamentary Passage: Tabled, debated, and passed by both Houses of Parliament, receiving Presidential Assent on December 18, 2021.
• Enforcement: Enforced on January 25, 2022.