ART Bank Law

The full form of ART is Assisted Reproductive Technology. ART Banks helps individuals and couples to preserve their reproductive potential through safe and advanced methods. However, there are some new rules and regulations according to the ART bank law 2021.

What does an ART Bank do?

ART Bank is an organization who are responsible for collecting, storing, and supplying gametes to the assisted reproductive technology clinics or their patients. However, the new gazette published on 25 January, 2022 has put restrictions on the role of ART Bank.

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Regulations of New ART Bank Law

  • It instructs that all ART banks must be registered with the NRAB (National Registry of ART Banks). They should obtain a license from the NAA (National ART Authority) before proceeding with operations.
  • Every bank conducting ART, exclusively or partly, shall apply for registration within a period of 60 days from the date of establishment of the National Registry. 
  • As per the Ministry of Health and Family Welfare (MoHFM), ART banks will be responsible for collecting, screening, and registering the donor whether it’s an egg or sperm donor. They should maintain proper records for every donor. If there’s any changes or alterations then they should inform the National Registry.
  • ART banks should follow the quality standards strictly. They must meet the standards and quality set by the NAA and ICMR (Indian Council of Medical Research).
  • They must have sufficient facilities and infrastructure, trained professionals, and equipment to ensure the best quality and safety of their services.
  • The ART Bank Law also prohibits specific practices such as sex selection, commercial surrogacy, and the use of donor sperm or eggs without the permission of the donor.
  • Additionally, it restricts the number of embryos transferred during IVF procedures.

Roles and Responsibilities of an ART Bank

The duties that are defined in the ART Bank Law 2021 are as follows:

  • The ART Bank shall be solely responsible for the collection, screening, and registration of egg and semen donors as well as sperm freezing.
  • Shall ensure gamete donor eligibility for donation. The eligibility criteria are mentioned below:

Age Limit

Semen Donor

Between 21 to 55 years of age.

Egg Donor

Between 23-35 years of age.

Donors should be tested negative for the diseases mentioned below:

HBV
(Hepatitis B Virus)
HCV
(Hepatitis C Virus)
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HIV (Human Immunodeficiency Virus)- Type 1 and 2
Treponema Pallidum image
Treponema Pallidum (Syphilis) through VDRL
  • The ART Bank shall not supply the oocyte or sperm of a single donor to more than a single couple.
  • An egg donor shall donate only once in her life. Not more than seven oocytes shall be retrieved from the donor.
  • All unused oocytes shall be kept and preserved by ART Bank for use on the same recipient.
  • A bank shall get all the necessary details in respect of an oocyte or sperm donor, including the following:
  • Name
  • Aadhaar Number
  • Residential Address
  • They shall not disclose the information about treatment to anybody except to the database to be maintained by the National Registry or by an order of a court of qualified jurisdiction.
  • Every ART Bank shall maintain a grievance cell for making any complaint.
  • They shall cryopreserve any human gametes with proper instructions and permission in written form from all the parties involved in the ART Bank services.
  • They shall ensure that all the above said records are kept safe for at least a period of 10 years and till the expiration. The Bank shall transfer the records to the Central database of the National Registry.
  • Consents must be collected and signed by the ART banks to start the process and collect embryos and sperm.
  • ART Bank must provide all details periodically to National Registry related to:
  • The procedure being undertaken.
  • The enrollment of gamete donors.
  • Result of the procedures and complications if there’s any.

The information should be submitted to the National Registry within one month of enrolling Gamete Donor.

New Regulation for Egg Donors

The ministry has made it mandatory for the ART Banks to ensure that the couple purchase a general health insurance coverage for the donor for a period of at least 1 year. The amount shall be enough to cover all the medical expenses. Additionally, the couple needs to sign an affidavit, take a vow before a Judicial Magistrate or a Metropolitan Magistrate offering a guarantee.