The Assisted Reproductive Technology (Regulation) Act, 2021
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.
Administered by. Ministry of Health and Family Welfare, Department of Health Research · Other Acts of 2021
Preamble
THE ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION) ACT, 2021
ACT NO. 42 OF 2021
[18th December, 2021.] 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 technology 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.
BE it enacted by Parliament in the Seventy-second Year of the Republic of India as follows:--
What this Act covers
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
Sections
Type to filter. 46 sections.
- 1Short title, extent and commencement
- 2Definitions
- 3National Assisted Reproductive Technology and Surrogacy Board
- 4Application of provisions of Surrogacy Act with respect to National Board
- 5Powers and functions of National Board
- 6State Assisted Reproductive Technology and Surrogacy Board
- 7Application of provisions of Surrogacy Act with respect to State Board
- 8Powers and functions of State Board
- 9Establishment of National Registry of clinics and banks
- 10Composition of National Registry
- 11Functions of National Registry
- 12Appointment of appropriate authority
- 13Functions of appropriate authority
- 14Powers of appropriate authority
- 15Registration of assisted reproductive technology clinic or assisted reproductive technology bank
- 16Grant of registration
- 17Renewal of registration
- 18Suspension or cancellation of registration
- 19Appeal
- 20Power to inspect premises, etc
- 21General duties of assisted reproductive technology clinics and banks
- 22Written informed consent
- 23Duties of assisted reproductive technology clinics and banks to keep accurate records
- 24Duties of assisted reproductive technology clinics using human gametes and embryos
- 25Preimplantation Genetic Diagnosis
- 26Sex selection
- 27Sourcing of gametes by assisted reproductive technology banks
- 28Storage and handling of human gametes and embryos
- 29Restriction on sale, etc., of human gametes, zygotes and embryos
- 30Research on human gametes and embryos
- 31Rights of child born through assisted reproductive technology
- 32Sex selective assisted reproductive technology
- 33Offences and penalties
- 34Punishment for contravention of provisions of Act or rules for which no specific punishment is provided
- 35Cognizance of offences
- 36Offences to be cognizable and bailable
- 37Offences by clinics or banks
- 38Power of Central Government to issue directions to National Board, National Registry and appropriate authority
- 39Power of State Government to issue directions to State Board, etc
- 40Power to search and seize records, etc
- 41Protection of action taken in good faith
- 42Power to make rules
- 43Power to make regulations
- 44Laying of rules, regulations and notifications
- 45Application of other laws not barred
- 46Power to remove difficulties
Legislative history
Legislative History: The Assisted Reproductive Technology (Regulation) Act, 2021 Sources: India Code (indiacode.nic.in), 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.
Rules made under this Act
4 sets of Rules. India Code publishes Rules as a record and a document rather than as text, so these are indexed here and not reproduced. All Rules.
- ART Amendment Rules, 20232023
- The ART Regulation 20232023
- ART (Regulation) amendment Rules, 20222022
- ART Rules 20222022
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Source and method. Compiled from the enactments of Parliament and of the State legislatures as published on India Code, and republished together with commentary and other original matter under section 52(1)(q)(ii) of the Copyright Act, 1957. Structured, cross-referenced and maintained by eCourtsIndia. Every one of the 46 sections of this Act has its own page. This page is not a substitute for legal advice.