Assisted Reproductive Technology (Regulation) Act, 2021
The Assisted Reproductive Technology (Regulation) Act, 2021, also known as the ART (Regulation) Act, 2021, regulates assisted reproductive technology services, fertility clinics and ART banks in India. It establishes legal standards for reproductive procedures, gamete donation, registration of clinics and the protection of individuals undergoing fertility treatments.
Key Takeaways
Add LawBhoomi as your preferred source on Google.
- The Assisted Reproductive Technology (Regulation) Act, 2021, is Act No. 42 of 2021. It came into force on 25 January 2022 and provides a legal framework for regulating assisted reproductive technology clinics and banks in India.
- The Act regulates procedures involving sperm, oocytes and embryos handled outside the human body to assist reproduction. It covers services such as in vitro fertilisation (IVF), gamete donation and other recognised assisted reproductive procedures.
- Under Section 21, ART services may be provided to women above 21 years and below 50 years and men above 21 years and below 55 years, subject to the applicable legal conditions.
- The Act regulates sperm and oocyte donation. Sperm donors must be between 21 and 55 years of age, while oocyte donors must be between 23 and 35 years of age. A woman can donate oocytes only once in her lifetime.
- ART clinics and banks must obtain registration and follow prescribed medical, ethical and administrative standards. The Act establishes regulatory authorities and a National Registry to monitor their functioning.
- The Act protects the rights of children born through ART. Section 31 recognises their legal parentage and provides that gamete donors have no parental rights over children born using their donated gametes.
- The legislation prohibits sex selection, exploitation of donors, unlawful commercial dealings involving gametes and embryos, and other unethical practices. Violations may result in fines, imprisonment or both.
Contents
hide
What Is the Assisted Reproductive Technology (Regulation) Act, 2021?
The Assisted Reproductive Technology (Regulation) Act, 2021, is an Indian law enacted to regulate assisted reproductive technology clinics, ART banks and related reproductive services.
The Act provides a legal framework for the safe and ethical use of medical technologies that assist individuals in achieving pregnancy. It regulates the collection, storage, handling and use of human gametes and embryos during assisted reproductive procedures.
Before this legislation, assisted reproductive technology services in India were primarily guided by medical guidelines and professional standards. The increasing use of fertility treatments created a need for a comprehensive statutory framework.
The Act addresses concerns relating to the commercialisation of reproductive services, exploitation of gamete donors, inadequate medical standards, misuse of embryos and uncertainty regarding the legal status of children born through ART.
Explore LawBhoomi's free law library for students and lawyers.
The legislation received presidential assent on 18 December 2021 and came into force on 25 January 2022.
It contains 46 sections divided into six chapters and is administered by the Ministry of Health and Family Welfare.
What Is Assisted Reproductive Technology?
Assisted reproductive technology refers to medical techniques used to assist reproduction by handling sperm, oocytes or embryos outside the human body and transferring reproductive material into the reproductive system of a woman.
Section 2 of the ART (Regulation) Act, 2021, provides the statutory definition of assisted reproductive technology.
ART includes procedures in which human reproductive material is collected, processed or handled in a laboratory to facilitate pregnancy.
Common Examples of Assisted Reproductive Technology
In Vitro Fertilisation (IVF)
In vitro fertilisation is a fertility treatment in which an egg is fertilised with sperm outside the human body under laboratory conditions. The resulting embryo may then be transferred into the uterus.
Intracytoplasmic Sperm Injection (ICSI)
Explore the latest legal opportunities for law students and lawyers.
ICSI is a specialised procedure in which a single sperm is injected directly into an egg to facilitate fertilisation. It is commonly used in certain cases of male infertility.
Donor Sperm and Oocyte Procedures
Assisted reproductive procedures may involve sperm or eggs obtained from eligible donors. Such donations are subject to the restrictions and requirements prescribed under the Act.
Embryo Transfer
Embryo transfer involves placing an embryo into the uterus following fertilisation or other ART procedures. The Act regulates the handling, storage and transfer of embryos.
Not every fertility treatment automatically falls within the statutory definition of ART. The application of the Act depends on the nature of the procedure and whether it falls within the definition provided by the legislation.
Objectives of the ART (Regulation) Act, 2021
The principal objective of the ART (Regulation) Act, 2021, is to ensure that assisted reproductive technology services are provided in a safe, ethical and legally regulated manner.
The legislation has several important objectives.
Regulation of ART Clinics and Banks
The Act establishes a registration system for ART clinics and banks. These institutions must comply with the prescribed infrastructure, staffing, equipment and operational requirements.
Access subject-wise law notes for free on LawBhoomi.
Registration enables regulatory authorities to supervise fertility services and take action against institutions that violate legal requirements.
Prevention of Exploitation
The Act seeks to prevent the exploitation of individuals involved in assisted reproductive procedures, particularly women donating oocytes.
It regulates donor eligibility, informed consent, insurance coverage and the collection of reproductive material.
Protection of Reproductive Rights
The legislation establishes safeguards relating to informed consent, confidentiality and medical information.
Individuals undergoing ART procedures must receive relevant information about the treatment, possible complications, costs and chances of success.
These safeguards are connected with the broader concept of reproductive rights, which includes decisions concerning reproduction, bodily autonomy and access to reproductive healthcare.
Prevention of Unethical Practices
The Act prohibits sex selection, unlawful commercial dealings involving embryos and gametes, and other prohibited activities.
These restrictions are intended to prevent reproductive technologies from being used for exploitative or unlawful purposes.
Recognition of Children’s Rights
The legislation establishes the legal status of children born through ART and protects their rights.
It also clarifies that gamete donors do not acquire parental rights over children conceived using their donated reproductive material.
Important Definitions Under the ART (Regulation) Act, 2021
Section 2 contains definitions essential for understanding the scope and application of the legislation.
ART Clinic
An ART clinic is a premises equipped with facilities and medical personnel for carrying out assisted reproductive technology procedures.
Such clinics perform reproductive treatments and must satisfy the registration and operational requirements prescribed under the Act.
ART Bank
An ART bank is an institution responsible for collecting, screening and storing sperm or oocytes and supplying them to registered ART clinics.
ART banks play an important role in ensuring that reproductive material is obtained from eligible donors and handled according to prescribed medical standards.
Commissioning Couple
A commissioning couple refers to an infertile married couple approaching an ART clinic or bank for authorised reproductive services.
The Act contains specific provisions governing the rights and obligations of commissioning couples.
Woman
The Act also recognises a woman approaching an ART clinic or bank for authorised reproductive services.
This distinction is important because the statutory framework contemplates access to certain ART services by eligible women independently of a commissioning couple.
Gamete
A gamete is a reproductive cell involved in fertilisation. Sperm is the male gamete, while an oocyte or egg is the female gamete.
The Act regulates the collection, donation, storage and use of gametes.
Who Is Eligible for ART Treatment in India?
The ART (Regulation) Act, 2021, establishes age-related restrictions and other legal requirements concerning access to assisted reproductive technology services.
Section 21 contains important obligations relating to the services provided by ART clinics and banks.
Age Requirements
The Act specifies the following age limits:
| Category | Age Requirement |
| Woman receiving ART services | Above 21 years and below 50 years |
| Man receiving ART services | Above 21 years and below 55 years |
| Sperm donor | 21 to 55 years, both inclusive |
| Oocyte donor | 23 to 35 years |
These age requirements serve different purposes. The limits relating to recipients govern access to ART services, while the donor age requirements regulate the collection of reproductive material.
Eligibility also depends on compliance with other applicable provisions, including consent and medical requirements.
Can an Unmarried Woman Access ART Services?
The statutory framework recognises women as a separate category of persons who may approach registered ART clinics or banks.
Consequently, access to ART services is not confined exclusively to married commissioning couples.
However, the applicable statutory conditions, age limits, clinical requirements and regulatory restrictions remain relevant.
Registration of ART Clinics and Banks
Registration is one of the central requirements of the ART (Regulation) Act, 2021.
Chapter III, comprising Sections 15 to 20, establishes the framework concerning registration, renewal, cancellation, appeals and inspection.
Is Registration Compulsory?
ART clinics and banks are required to obtain registration under the Act.
The purpose of registration is to ensure that institutions offering assisted reproductive services satisfy legally prescribed standards.
Registered institutions are expected to maintain appropriate medical facilities, employ qualified professionals, follow approved procedures and preserve necessary records.
Conditions for Registration
The registration framework requires clinics and banks to satisfy standards concerning:
- Infrastructure and Equipment: ART clinics must maintain facilities and equipment appropriate to the reproductive procedures they perform. Laboratory conditions must support the safe handling of gametes and embryos.
- Qualified Medical Personnel: Clinics must employ appropriately qualified professionals, including personnel with the medical and technical expertise required for the services offered.
- Record Maintenance: Institutions must maintain prescribed records relating to treatment, reproductive material, donors and other matters required under the regulatory framework.
- Compliance with Legal Standards: Registration requires adherence to the Act, applicable rules and relevant instructions issued by competent authorities.
Failure to comply with the conditions of registration may result in regulatory action, including suspension or cancellation in accordance with the Act.
Renewal of Registration
The Assisted Reproductive Technology (Regulation) Amendment Rules, 2026, introduced specific provisions concerning renewal of registration certificates.
Under the amended framework, applications for renewal generally must be submitted at least 60 days before the expiry of registration.
The prescribed renewal fees include:
| Institution | Renewal Fee |
| Level 1 ART clinic | ₹25,000 |
| ART bank | ₹25,000 |
| Level 2 ART clinic | ₹1,00,000 |
Higher fees may apply where renewal applications are submitted late.
These provisions form part of the regulatory rules issued under the Act.
Regulatory Authorities Under the ART Act, 2021
Chapter II provides for the regulatory institutions responsible for implementing and monitoring the legislation.
The regulatory framework involves the National Board, State Boards, National Registry and appropriate authorities.
National Board
The National Assisted Reproductive Technology and Surrogacy Board performs regulatory and advisory functions concerning assisted reproductive technology.
Its responsibilities include advising the government on policy matters, reviewing developments in reproductive technology and supporting the establishment of appropriate standards.
State Boards
State-level regulatory bodies perform functions within their respective jurisdictions.
They support the implementation of statutory requirements and provide recommendations relating to assisted reproductive technology services.
National Registry
The National Registry maintains information concerning registered ART clinics and banks.
It serves as an important mechanism for collecting and organising information about institutions providing assisted reproductive services in India.
Appropriate Authorities
Appropriate authorities perform administrative and enforcement functions under the Act.
Their responsibilities include examining registration-related matters, conducting inspections, investigating violations and taking action within their statutory powers.
Rules for Sperm and Oocyte Donation in India
Section 27 regulates the sourcing and supply of gametes by ART banks.
The Act establishes separate requirements for sperm donors and oocyte donors because the medical procedures and associated risks differ.
Rules for Sperm Donation
The Act permits registered ART banks to obtain sperm from men between 21 and 55 years of age.
Donors must satisfy the applicable medical screening and consent requirements.
An ART bank cannot supply the sperm of a single donor to more than one commissioning couple.
These restrictions are intended to regulate donor participation and maintain accountability in the use of donated reproductive material.
Rules for Oocyte Donation
Oocyte donation is subject to additional restrictions because egg retrieval involves medical procedures that may carry physical risks.
The important requirements include:
- Age Restriction: An oocyte donor must be between 23 and 35 years of age. ART banks cannot obtain oocytes from women outside the prescribed age range.
- One-Time Donation: A woman may donate oocytes only once during her lifetime. This restriction seeks to prevent repeated exposure to the risks associated with oocyte retrieval.
- Maximum Retrieval: Not more than seven oocytes may be retrieved from an oocyte donor.
- Restriction on Recipients: An ART bank cannot supply the oocytes of one donor to more than one commissioning couple.
- Insurance Protection: The commissioning couple or woman must arrange prescribed insurance coverage in favour of the oocyte donor to address specified medical complications.
These safeguards recognise the medical and ethical concerns associated with the donation of human reproductive material.
Informed Consent Under the ART (Regulation) Act, 2021
Informed consent is an important requirement governing assisted reproductive procedures.
Sections 21 and 22 establish duties concerning counselling, consent and the provision of information.
What Information Must Be Provided?
ART clinics must provide relevant information about the proposed reproductive procedure.
This includes the nature of the treatment, its possible medical complications, estimated costs and chances of success.
Such information enables individuals to make informed decisions about undergoing fertility treatment.
Written Consent
The Act requires written informed consent in connection with ART procedures.
Consent must be obtained in accordance with the statutory requirements before relevant procedures are undertaken.
The requirement protects bodily autonomy and prevents reproductive material from being collected or used without lawful authorisation.
The broader legal requirement of obtaining valid medical consent is also relevant when examining whether a doctor can treat a patient without consent.
Protection of Donors
Consent requirements also apply to the collection and use of donated gametes.
Medical institutions must comply with applicable safeguards concerning donor participation, screening and reproductive procedures.
Rights of Children Born Through Assisted Reproductive Technology
Section 31 is one of the most important provisions of the ART (Regulation) Act, 2021.
It establishes the legal status of children born through assisted reproductive technology.
Who Are the Legal Parents of an ART Child?
Section 31 recognises a child born through ART as the biological child of the commissioning couple, with the rights and privileges available to a natural child from that couple.
The provision establishes legal parentage irrespective of whether donated reproductive material was used.
It is intended to prevent uncertainty regarding the child’s family status and legal rights.
Do Gamete Donors Have Parental Rights?
Gamete donors relinquish parental rights over children born using their donated sperm or oocytes.
Consequently, the donation of reproductive material does not, by itself, create parental rights or responsibilities towards the resulting child.
Rights of an ART Child
The legal recognition provided under Section 31 is significant for matters relating to family relationships, maintenance, inheritance and other rights arising from recognised parentage.
However, the determination of particular rights remains subject to applicable laws governing those matters.
Storage and Handling of Gametes and Embryos
Section 28 regulates the storage of gametes and embryos.
The Act permits storage for a maximum period of ten years, subject to the prescribed legal conditions.
Storage must take place through authorised institutions following applicable technical and regulatory standards.
What Happens After the Storage Period?
The Act provides a framework governing the handling of reproductive material after the permitted storage period.
The continued use, transfer or disposal of stored reproductive material must comply with the Act and applicable rules.
The 2023 amendment rules also introduced requirements concerning the transfer of gametes and embryos for personal use within India or outside India, including prior permission from the National Board in specified circumstances.
These restrictions seek to prevent unauthorised dealings involving reproductive material.
Prohibited Activities Under the ART (Regulation) Act, 2021
The Act prohibits various activities considered unlawful or unethical in the context of assisted reproduction.
Sex Selection
Sex selection through assisted reproductive technology is prohibited.
The Act also restricts advertisements promoting sex-selective ART services.
These provisions operate alongside the broader Indian legal framework concerning the prohibition of sex selection.
Sale of Gametes and Embryos
The legislation prohibits unlawful commercial dealings involving human gametes and embryos.
The regulatory framework distinguishes authorised ART services and regulated donor arrangements from prohibited commercial exploitation.
Exploitation of Donors
The Act prohibits exploitative practices involving individuals who donate reproductive material.
The restrictions are particularly important in relation to oocyte donors because repeated egg retrieval may involve significant medical risks.
ART clinics and banks must operate within the permitted legal framework.
Procedures conducted in violation of statutory restrictions, registration conditions or other mandatory requirements may attract regulatory or penal consequences.
Offences and Penalties Under the ART Act, 2021
Chapter V, comprising Sections 32 to 37, establishes offences and penalties.
The legislation imposes penalties for sex-selection advertisements, exploitation, prohibited dealings involving reproductive material and other statutory contraventions.
Punishment for Sex-Selection Advertisements
Section 32 deals with advertisements relating to sex-selective assisted reproductive technology services.
A violation may attract imprisonment for a term ranging from five to ten years, a fine ranging from ₹10 lakh to ₹25 lakh, or both.
Punishment for Exploitation and Prohibited Activities
Section 33 deals with specified prohibited activities, including exploitation and unlawful dealings involving reproductive material.
For a first contravention, the prescribed punishment includes a fine ranging from ₹5 lakh to ₹10 lakh.
For subsequent contraventions, the punishment may include imprisonment ranging from three to eight years and a fine ranging from ₹10 lakh to ₹20 lakh.
Other Offences
Section 34 addresses contraventions of provisions of the Act or rules for which no separate punishment has been specified.
Sections 35 to 37 contain provisions concerning cognizance, trial, the classification of offences and liability for offences involving ART clinics and banks.
The Act treats offences under it as cognizable and bailable.
Difference Between the ART Act, 2021 and the Surrogacy (Regulation) Act, 2021
The ART (Regulation) Act, 2021, and the Surrogacy (Regulation) Act, 2021 regulate different but related aspects of assisted reproduction.
Both laws form part of India’s legal framework governing reproductive technologies.
| Basis | ART (Regulation) Act, 2021 | Surrogacy (Regulation) Act, 2021 |
| Primary Purpose | Regulates assisted reproductive technology services | Regulates surrogacy arrangements and procedures |
| Main Institutions | ART clinics and banks | Surrogacy clinics and regulatory authorities |
| Main Subject | Fertility procedures involving reproductive material | Pregnancy carried by a surrogate mother |
| Gamete Donation | Contains specific donor eligibility and collection rules | Regulates surrogacy-related reproductive arrangements |
| Legal Parentage | Contains provisions concerning children born through ART | Contains provisions concerning children born through surrogacy |
| Commercial Restrictions | Prohibits specified unlawful commercial and exploitative practices | Prohibits commercial surrogacy |
How Are the Two Laws Connected?
Surrogacy arrangements may involve assisted reproductive procedures such as IVF and embryo transfer.
Consequently, a surrogacy arrangement may involve requirements under both legislations, depending on the services and procedures involved.
However, the eligibility requirements for surrogacy are distinct from those governing access to ART services generally.
Compliance with the ART Act does not automatically establish eligibility for surrogacy under the Surrogacy (Regulation) Act, 2021.
Importance of the ART (Regulation) Act, 2021
The ART (Regulation) Act, 2021, is important because it introduced a comprehensive statutory framework for fertility services in India.
Its significance can be understood through several aspects.
Legal Accountability of Fertility Clinics
The registration framework makes ART clinics and banks subject to statutory supervision.
Institutions cannot treat reproductive services as activities operating entirely outside government regulation.
Protection Against Commercial Exploitation
The Act establishes safeguards against unlawful commercial practices involving gametes and embryos.
It also restricts repeated oocyte donation and requires insurance protection for oocyte donors.
Recognition of Reproductive Autonomy
The provisions concerning informed consent and counselling recognise the importance of voluntary participation in medical procedures.
The legislation requires individuals to receive important information before undergoing assisted reproductive treatment.
These safeguards are also connected with the constitutional right to privacy, which protects personal autonomy and decisions concerning intimate aspects of individual life.
Certainty Regarding Legal Parentage
Section 31 provides statutory recognition of the parentage of children born through ART.
This helps address legal uncertainties that may arise when reproductive procedures involve donated sperm or oocytes.
Standardisation of Medical Practices
The Act promotes uniform regulatory standards for ART clinics and banks.
Requirements concerning registration, professional qualifications, facilities and record maintenance create a framework for monitoring reproductive services.
Limitations and Challenges of the ART (Regulation) Act, 2021
Although the legislation establishes important safeguards, its implementation raises several legal and practical issues.
Access to Fertility Treatment
The Act contains age restrictions and eligibility conditions.
These requirements may affect access to assisted reproductive services for certain individuals, giving rise to discussions concerning reproductive autonomy and equality.
Medical Costs and Affordability
Assisted reproductive procedures can involve substantial expenses.
Compliance requirements, laboratory infrastructure, specialist personnel and insurance obligations may also influence the overall cost of treatment.
The Act establishes a regulatory framework but does not guarantee universal access to affordable ART services.
Protection of Donors
The restrictions on oocyte donation are intended to reduce exploitation and medical risks.
However, effective protection depends on proper donor screening, informed consent, monitoring and enforcement.
Failure to maintain appropriate medical standards may also raise questions of medical negligence where a breach of the required standard of care causes injury to a patient or donor.
Implementation and Enforcement
The effectiveness of the legislation depends on the functioning of appropriate authorities, registration systems and inspection mechanisms.
Consistent enforcement is necessary to prevent unregistered operations and unethical reproductive practices.
Conclusion
The Assisted Reproductive Technology (Regulation) Act, 2021, is a significant development in India’s medical and reproductive law. It establishes statutory rules for fertility clinics, ART banks, gamete donation, reproductive procedures and the legal recognition of children born through assisted reproductive technology.
The Act attempts to balance access to fertility treatment with the need to protect individuals from medical risks, exploitation and unethical practices. Its provisions concerning informed consent, donor eligibility, registration, confidentiality and children’s rights form the foundation of the regulatory framework.
The Assisted Reproductive Technology (Regulation) Rules, 2022, and subsequent amendments further regulate the implementation of the legislation. Together with the Surrogacy (Regulation) Act, 2021, the ART Act forms an important part of India’s legal framework governing assisted reproduction.
Join LawBhoomi’s 100K+ Community
