The Assisted Reproductive Technology (Regulation) Act, 2021

The Assisted Reproductive Technology (Regulation) Act, 2021, regulates ART clinics and banks in India, ensuring safe and ethical practices while addressing reproductive health issues.

Ministry of Health and Family Welfare

The Assisted Reproductive Technology (Regulation) Act, 2021, aims to regulate and supervise assisted reproductive technology clinics and banks, prevent misuse, and ensure the safe and ethical practice of ART services in India.

1: Act Background and Ministry Under Which This Act Is:

The Assisted Reproductive Technology (Regulation) Act, 2021, was enacted to regulate and supervise assisted reproductive technology (ART) clinics and banks, prevent their misuse, and ensure the safe and ethical practice of ART services. This act addresses the issues of reproductive health where ART is required for becoming a parent or for freezing gametes and embryos. The act falls under the administrative purview of the Ministry of Health and Family Welfare, which is responsible for overseeing the implementation and enforcement of regulations related to assisted reproductive technology. The ministry plays a vital role in ensuring ethical and safe reproductive healthcare practices.

2: Enactment Date, Number of Chapters, Number of Sections:

The Assisted Reproductive Technology (Regulation) Act, 2021, was enacted on 18th December, 2021, and is known as Act No. 42 of 2021. The act is structured into six chapters. It comprises 46 sections, covering various aspects such as definitions, regulatory bodies, duties of clinics and banks, procedures for registration, offenses and penalties, and miscellaneous provisions. The act aims to create a comprehensive regulatory framework for ART services. The act has been amended over time to reflect changing requirements.

3: Act Governed By:

The Assisted Reproductive Technology Act is governed by the Central Government, which has the power to make rules and regulations under the Act. The act establishes the National Assisted Reproductive Technology and Surrogacy Board and State Assisted Reproductive Technology and Surrogacy Boards to oversee the implementation of the act. The act is governed by the provisions outlined within it, as well as rules and regulations framed by the Central government. It is therefore a combination of central and state oversight.

4: On Whom It Is Applicable:

The provisions of the Assisted Reproductive Technology Act are applicable to all individuals and entities involved in the provision of assisted reproductive technology services in India. This includes ART clinics, ART banks, commissioning couples, women seeking ART procedures, gamete donors, and all professionals involved in the assisted reproductive technology field. The act ensures that all such individuals and entities adhere to the standards and regulations outlined. The general public are indirect beneficiaries of the Act’s provisions.

5: Penalties/Punishments:

The act prescribes various penalties for non-compliance and offenses, including:

  • Sex Selective ART: Offering sex-selective ART services can lead to imprisonment and fines.

  • Illegal Trade in Gametes/Embryos: Selling human embryos or gametes, or operating related agencies, attracts imprisonment and fines.

  • Non-Compliance: Contravention of the act’s provisions can lead to imprisonment and fines. The act emphasizes ethical practices and preventing illegal activities.

6: Important Pointers:

  • National Board: The act establishes the National Assisted Reproductive Technology and Surrogacy Board to oversee ART services.

  • State Boards: It provides for the formation of State Assisted Reproductive Technology and Surrogacy Boards to oversee implementation at the state level.

  • National Registry: It establishes a National Registry of clinics and banks to maintain a database.

  • Regulation of Clinics and Banks: It regulates the functioning of ART clinics and banks, setting standards for facilities and services.

  • Informed Consent: It mandates written informed consent from all parties seeking ART services.

  • Prohibition of Sex Selection: It prohibits sex selection through assisted reproductive technology.

  • Restrictions on Gamete Use: It places restrictions on the use, storage, and sale of human gametes and embryos.

  • Rule-Making Power: It empowers the Central Government to make rules and the National Board to make regulations for carrying out the purposes of the act. The act provides a comprehensive framework for ART regulation.

7: Act Copy:

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