{"id":121975,"date":"2026-09-03T15:19:19","date_gmt":"2026-09-03T09:49:19","guid":{"rendered":"https:\/\/vajiramandravi.com\/current-affairs\/?p=121975"},"modified":"2026-09-03T15:19:19","modified_gmt":"2026-09-03T09:49:19","slug":"assisted-reproductive-technology-regulation-act-2021","status":"publish","type":"post","link":"https:\/\/vajiramandravi.com\/current-affairs\/assisted-reproductive-technology-regulation-act-2021\/","title":{"rendered":"Assisted Reproductive Technology (Regulation) Act, 2021"},"content":{"rendered":"

The <\/span>Assisted Reproductive Technology (Regulation) Act, 2021 <\/b>provides a s<\/span>tatutory framework for regulating assisted reproductive technology(ART) services in India<\/b>. 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.<\/span><\/p>\n

About the Assisted Reproductive Technology (Regulation) Act, 2021<\/b><\/h2>\n

The <\/span>Assisted Reproductive Technology (Regulation) Act, 2021<\/b> is a central law enacted to regulate Assisted Reproductive Technology (ART) clinics and ART banks in India.\u00a0<\/span><\/p>\n

    \n
  • It was enacted on 18 December 2021 and came into force on 25 January 2022.\u00a0<\/span><\/li>\n
  • Main objective<\/b>: 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.<\/span><\/li>\n<\/ul>\n

    What is Assisted Reproductive Technology?<\/b><\/h2>\n

    The Act defines Assisted Reproductive Technology as <\/span>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<\/b>. <\/span>In-vitro fertilisation (IVF)<\/span><\/i> is a common example, in which an egg is fertilised with sperm in a laboratory and the resulting embryo is transferred to the uterus.<\/span><\/p>\n

    Assisted Reproductive Technology (Regulation) Act, 2021 Need<\/b><\/h2>\n

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

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

      Assisted Reproductive Technology (Regulation) Act, 2021 Key Provisions\u00a0<\/b><\/h2>\n

      The <\/span>Assisted Reproductive Technology (Regulation) Act, 2021<\/b> 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.<\/span><\/p>\n

      Regulatory framework<\/b><\/p>\n

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

        Eligibility for ART services<\/b><\/p>\n

          \n
        • ART services are available to women above 21 and below 50 years and men above 21 and below 55 years.<\/span><\/li>\n
        • 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.<\/span><\/li>\n
        • A single woman can also access ART services, subject to the conditions laid down under the law.<\/span><\/li>\n<\/ul>\n

          Registration of ART clinics and banks<\/b><\/p>\n

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

            National Registry<\/b><\/p>\n

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

              Donor regulation<\/b><\/p>\n

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

                Protection of oocyte donors<\/b><\/p>\n

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

                  Protection of patients<\/b><\/p>\n

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

                    Record keeping<\/b><\/p>\n

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

                      Regulation of embryos<\/b><\/p>\n

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

                        Genetic testing of embryos<\/b><\/p>\n

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

                          Prohibition of sex selection<\/b><\/p>\n

                            \n
                          • The Act prohibits the use of ART procedures to determine or select the sex of a child. <\/span>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.<\/span><\/li>\n
                          • The limited exception applies where genetic testing is medically necessary for a sex-linked disorder or disease.<\/span><\/li>\n<\/ul>\n

                            Regulation of gametes and embryos<\/b><\/p>\n

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

                              Research involving gametes and embryos<\/b><\/p>\n

                                \n
                              • Places restrictions on the use of human gametes and embryos for research. <\/span>Their transfer outside India for research purposes is prohibited.<\/span><\/li>\n
                              • Permitted research must comply with the prescribed scientific, legal and ethical safeguards.<\/span><\/li>\n<\/ul>\n

                                Rights of ART-born children<\/b><\/p>\n

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

                                  Grievance redressal<\/b><\/p>\n

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

                                    Inspection and enforcement<\/b><\/p>\n

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

                                      Penalties<\/b><\/p>\n

                                        \n
                                      • Sex-selective ART can attract imprisonment of 5\u201310 years, or a fine of \u20b910\u201325 lakh, or both.<\/span><\/li>\n
                                      • Other specified offences can attract a fine of \u20b95\u201310 lakh for the first contravention.<\/span><\/li>\n
                                      • A subsequent contravention can attract 3\u20138 years of imprisonment and a fine of \u20b910\u201320 lakh.<\/span><\/li>\n<\/ul>\n

                                        Cognisance of offences<\/b><\/p>\n

                                          \n
                                        • 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.<\/span><\/li>\n
                                        • Offences are triable by a Metropolitan Magistrate, Judicial Magistrate First Class or a higher court, as prescribed under the Act.<\/span><\/li>\n<\/ul>\n

                                          Assisted Reproductive Technology (Regulation) Act, 2021 Significance\u00a0<\/b><\/h2>\n
                                            \n
                                          • Ends the regulatory vacuum<\/b>: Brings ART clinics and banks under a dedicated statutory framework instead of leaving the sector largely dependent on guidelines and professional standards.<\/span><\/li>\n
                                          • Standardises ART services<\/b>: Mandatory registration and prescribed standards for infrastructure, equipment and medical personnel create a common regulatory baseline for ART facilities.<\/span><\/li>\n
                                          • Controls the donor system<\/b>: 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.<\/span><\/li>\n
                                          • Strengthens patient protection<\/b>: Mandatory counselling, informed decision-making, disclosure of costs and risks, and grievance mechanisms give patients greater protection during ART treatment.<\/span><\/li>\n
                                          • Prevents misuse of genetic technology<\/b>: 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.<\/span><\/li>\n
                                          • Creates traceability through the National Registry<\/b>: A central database of ART clinics, banks, procedures and outcomes can help regulators monitor the sector and develop evidence-based policies.\u00a0<\/span><\/li>\n
                                          • Protects confidentiality<\/b>: The Act places a statutory duty on clinics and banks to protect information relating to patients, commissioning couples and donors, subject to limited exceptions.<\/span><\/li>\n
                                          • Recognises the rights of ART-born children<\/b>: It gives children born through ART the same legal status and rights as naturally conceived children, while denying parental rights to gamete donors.<\/span><\/li>\n
                                          • Creates enforceable accountability<\/b>: Inspection powers, grievance mechanisms and penalties make violations by ART clinics and banks subject to legal consequences rather than merely professional regulation.<\/span><\/li>\n<\/ul>\n

                                            Assisted Reproductive Technology (Regulation) Act, 2021 Concerns<\/b><\/h2>\n

                                            Despite creating a much-needed regulatory framework, the Act has raised concerns regarding access to ART, availability of donors, privacy, affordability and practical implementation.<\/span><\/p>\n

                                              \n
                                            • Affordability remains unaddressed<\/b>: The Act regulates ART services but does not regulate their prices, leaving procedures such as IVF expensive for many couples.<\/span><\/li>\n
                                            • Risk of gamete shortage<\/b>: Limiting an oocyte donor to one donation and restricting a donor\u2019s gametes to one commissioning party may reduce donor availability and increase treatment costs.<\/span><\/li>\n
                                            • Exclusion from ART access<\/b>: Eligibility restrictions may limit access for some unmarried couples, unmarried men and LGBTQ+ persons, raising concerns about equality and reproductive autonomy.<\/span><\/li>\n
                                            • Privacy concerns<\/b>: The National Registry involves sensitive information about patients, donors, procedures and outcomes, raising concerns about reproductive data protection.<\/span><\/li>\n
                                            • Burden on smaller clinics<\/b>: Registration and infrastructure requirements may be difficult for smaller ART centres to meet, particularly outside major cities.<\/span><\/li>\n
                                            • Risk of informal markets<\/b>: Limited donor availability combined with restrictions on commercial transactions could encourage unregulated donor arrangements.<\/span><\/li>\n
                                            • Donor livelihood concerns<\/b>: Restrictions on compensation for gamete donation may discourage donors or push some donation practices outside the formal regulatory system.<\/span><\/li>\n
                                            • Implementation gap<\/b>: The effectiveness of the Act depends on the capacity of regulatory authorities to register, inspect and monitor ART clinics and banks effectively.<\/span><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

                                              Know the Assisted Reproductive Technology Regulation Act, 2021, including its objectives, key provisions, donor rules, penalties, significance and concerns.<\/p>\n","protected":false},"author":30,"featured_media":121987,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[786],"tags":[],"class_list":["post-121975","post","type-post","status-publish","format-standard","has-post-thumbnail","category-general-studies","no-featured-image-padding"],"acf":[],"_links":{"self":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/121975","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/users\/30"}],"replies":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/comments?post=121975"}],"version-history":[{"count":3,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/121975\/revisions"}],"predecessor-version":[{"id":122654,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/121975\/revisions\/122654"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/media\/121987"}],"wp:attachment":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/media?parent=121975"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/categories?post=121975"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/tags?post=121975"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}