Assisted Reproductive Technology (Regulation) Act, 2021

The Assisted Reproductive Technology (Regulation) Act, 2021 provides a statutory framework for regulating assisted reproductive technology(ART) services in India. It brings ART clinics and banks, gamete donors, patients, embryos and ART-born children within a common regulatory system, while seeking to ensure the safe, ethical and transparent use of reproductive technologies.

About the Assisted Reproductive Technology (Regulation) Act, 2021

The Assisted Reproductive Technology (Regulation) Act, 2021 is a central law enacted to regulate Assisted Reproductive Technology (ART) clinics and ART banks in India. 

• It was enacted on 18 December 2021 and came into force on 25 January 2022. 
• Main objective: The Act seeks to ensure the safe and ethical use of ART, prevent its misuse and protect the interests of patients, donors and children born through ART.

What is Assisted Reproductive Technology?

The Act defines Assisted Reproductive Technology as techniques that attempt to achieve pregnancy by handling sperm or oocytes outside the human body and subsequently transferring the gamete or embryo into the reproductive system of a woman. In-vitro fertilisation (IVF) is a common example, in which an egg is fertilised with sperm in a laboratory and the resulting embryo is transferred to the uterus.

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Assisted Reproductive Technology (Regulation) Act, 2021 Need

The need for the Assisted Reproductive Technology (Regulation) Act, 2021 arose from the rapid expansion of ART services and the absence of a comprehensive statutory framework to regulate clinics, donors, gametes and embryos.

• Regulatory gap: ART services lacked a dedicated law covering their complete functioning.
• Lack of uniform standards: Clinics needed common standards for infrastructure, equipment, medical personnel and procedures.
• Unregulated ART banks: Collection, storage and supply of sperm and oocytes required statutory oversight.
• Donor protection: Oocyte donors required safeguards against unsafe procedures and exploitation.
• Misuse prevention: Sex selection and unauthorised use or trade of gametes and embryos needed clear legal restrictions.
• Effective monitoring: Registration, inspections and a National Registry were needed to track and regulate ART services.

Assisted Reproductive Technology (Regulation) Act, 2021 Key Provisions 

The Assisted Reproductive Technology (Regulation) Act, 2021 regulates the entire ART ecosystem, from the registration of clinics and eligibility of patients to the use of donated gametes, protection of embryos, genetic testing and penalties for violations.

Regulatory framework

• Creates the National Assisted Reproductive Technology and Surrogacy Board as the apex body to set standards and regulate ART services across the country.
• Provides for State Boards to implement these standards and oversee ART services at the state level.
• Empowers appropriate authorities to register ART clinics and banks, conduct inspections and take action against violations.

Eligibility for ART services

• ART services are available to women above 21 and below 50 years and men above 21 and below 55 years.
• A married couple seeking ART must generally be certified as infertile, including cases where they have been unable to conceive after one year of unprotected intercourse or where a medical condition prevents conception.
• A single woman can also access ART services, subject to the conditions laid down under the law.

Registration of ART clinics and banks

• Every ART clinic and ART bank must be registered before providing services, ensuring that only facilities meeting prescribed standards can operate.
• Registration depends on requirements relating to infrastructure, equipment, qualified medical personnel, laboratory facilities and other standards.
• Registration remains valid for five years and can be renewed as prescribed, while serious violations can lead to suspension or cancellation.

National Registry

• Establishes a National Registry of Assisted Reproductive Technology and Surrogacy to maintain information about registered clinics, ART banks, services and treatment outcomes.
• The Registry helps authorities track the functioning of ART facilities and provides reliable data for monitoring, regulation and policymaking.

Donor regulation

• Gamete donors must undergo prescribed medical and genetic screening before their gametes can be used, reducing the risk of transmitting diseases to the child.
• Semen donors must be between 21 and 55 years, while oocyte donors must be between 23 and 35 years.
• An oocyte donor must be ever-married and have at least one living child who is at least three years old.
• Gametes obtained from a single donor cannot be supplied to more than one commissioning party, preventing their repeated use across different families.

Protection of oocyte donors

• Recognising the physical risks involved in oocyte retrieval, the Act provides for insurance coverage for 12 months against complications arising from the donation.
• An oocyte donor can donate only once in her lifetime.
• The number of oocytes retrieved from a donor is limited to seven.

Protection of patients

• ART procedures require written informed consent, ensuring that patients understand the treatment before proceeding.
• Patients must be informed about the procedure, chances of success, risks, side effects and costs involved.
• Clinics and banks must maintain the confidentiality of patient and donor information, except where disclosure is permitted by law.

Record keeping

• ART clinics and banks must maintain records relating to patients, donors, gametes, embryos, procedures and treatment outcomes.
• Records relating to gamete donation must be maintained for at least 10 years before being transferred to the National Registry.
• Such records allow regulators to monitor treatment practices and investigate complaints or violations.

Regulation of embryos

• The Act regulates the creation, storage and transfer of embryos during ART procedures.
• It places limits on the number of oocytes or embryos that can be transferred during a treatment cycle.
• It prohibits practices such as mixing semen from two individuals and splitting embryos for the purpose of twinning.

Genetic testing of embryos

• Pre-implantation genetic testing is permitted to identify known, pre-existing, heritable or genetic diseases. This prevents genetic testing from being used simply to select preferred characteristics in a child.
• Genetic testing may also be undertaken where necessary to diagnose, prevent or treat a sex-linked genetic disorder or disease.

Prohibition of sex selection

• The Act prohibits the use of ART procedures to determine or select the sex of a child. This prohibition works alongside the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, providing an additional legal safeguard against sex selection.
• The limited exception applies where genetic testing is medically necessary for a sex-linked disorder or disease.

Regulation of gametes and embryos

• Prohibits the sale and unauthorised transfer or use of human gametes, zygotes and embryos.
• Regulates the transfer of gametes and embryos outside India to prevent their misuse and commercial exploitation.
• These provisions seek to ensure that reproductive material is handled for legitimate medical purposes rather than treated as a commercial commodity.

Research involving gametes and embryos

• Places restrictions on the use of human gametes and embryos for research. Their transfer outside India for research purposes is prohibited.
• Permitted research must comply with the prescribed scientific, legal and ethical safeguards.

Rights of ART-born children

• A child born through ART is legally recognised as the biological child of the commissioning couple.
• The child enjoys the same legal rights and privileges as a child born naturally to the couple.
• A gamete donor does not acquire parental rights over the child merely because their genetic material was used.

Grievance redressal

• ART clinics and banks must establish a grievance redressal mechanism for patients and donors. This provides an institutional avenue for addressing complaints regarding treatment, services or other violations.
• It also strengthens accountability of ART service providers.

Inspection and enforcement

• Appropriate authorities can inspect ART clinics and banks, examine records and investigate suspected violations. They can take action against facilities that fail to comply with the Act, including suspension or cancellation of registration. This gives the regulatory framework an enforcement mechanism rather than making it dependent only on voluntary compliance.

Penalties

• Sex-selective ART can attract imprisonment of 5–10 years, or a fine of ₹10–25 lakh, or both.
• Other specified offences can attract a fine of ₹5–10 lakh for the first contravention.
• A subsequent contravention can attract 3–8 years of imprisonment and a fine of ₹10–20 lakh.

Cognisance of offences

• Courts can take cognisance of offences under the Act only on a complaint made by the National Board, State Board or an officer authorised by them.
• Offences are triable by a Metropolitan Magistrate, Judicial Magistrate First Class or a higher court, as prescribed under the Act.

Assisted Reproductive Technology (Regulation) Act, 2021 Significance 

• Ends the regulatory vacuum: Brings ART clinics and banks under a dedicated statutory framework instead of leaving the sector largely dependent on guidelines and professional standards.
• Standardises ART services: Mandatory registration and prescribed standards for infrastructure, equipment and medical personnel create a common regulatory baseline for ART facilities.
• Controls the donor system: Medical screening of donors, restrictions on oocyte donation and limits on the use of a donor’s gametes reduce the scope for unsafe or unregulated donor practices.
• Strengthens patient protection: Mandatory counselling, informed decision-making, disclosure of costs and risks, and grievance mechanisms give patients greater protection during ART treatment.
• Prevents misuse of genetic technology: By permitting genetic testing only for specified medical purposes and prohibiting sex selection, the Act draws a clear line between legitimate medical use and reproductive misuse.
• Creates traceability through the National Registry: A central database of ART clinics, banks, procedures and outcomes can help regulators monitor the sector and develop evidence-based policies. 
• Protects confidentiality: The Act places a statutory duty on clinics and banks to protect information relating to patients, commissioning couples and donors, subject to limited exceptions.
• Recognises the rights of ART-born children: It gives children born through ART the same legal status and rights as naturally conceived children, while denying parental rights to gamete donors.
• Creates enforceable accountability: Inspection powers, grievance mechanisms and penalties make violations by ART clinics and banks subject to legal consequences rather than merely professional regulation.

Assisted Reproductive Technology (Regulation) Act, 2021 Concerns

Despite creating a much-needed regulatory framework, the Act has raised concerns regarding access to ART, availability of donors, privacy, affordability and practical implementation.

• Affordability remains unaddressed: The Act regulates ART services but does not regulate their prices, leaving procedures such as IVF expensive for many couples.
• Risk of gamete shortage: Limiting an oocyte donor to one donation and restricting a donor’s gametes to one commissioning party may reduce donor availability and increase treatment costs.
• Exclusion from ART access: Eligibility restrictions may limit access for some unmarried couples, unmarried men and LGBTQ+ persons, raising concerns about equality and reproductive autonomy.
• Privacy concerns: The National Registry involves sensitive information about patients, donors, procedures and outcomes, raising concerns about reproductive data protection.
• Burden on smaller clinics: Registration and infrastructure requirements may be difficult for smaller ART centres to meet, particularly outside major cities.
• Risk of informal markets: Limited donor availability combined with restrictions on commercial transactions could encourage unregulated donor arrangements.
• Donor livelihood concerns: Restrictions on compensation for gamete donation may discourage donors or push some donation practices outside the formal regulatory system.
• Implementation gap: The effectiveness of the Act depends on the capacity of regulatory authorities to register, inspect and monitor ART clinics and banks effectively.