(Assisted Reproductive Technology Bank)

An ART Bank is a licensed organization responsible for collecting, storing, and supplying donor gametes (sperm or eggs) to fertility clinics or individuals undergoing assisted reproductive treatments.

As per the latest government regulations (Gazette notification, June 7, 2022), ART Banks are now strictly limited to handling donated gametes only, not gametes from patients themselves—this narrows the scope originally outlined in the ART Law of 2021.

Key Regulations for ART Banks (Under ART Act 2021)

The ART Act 2021, regulated by the Ministry of Health and Family Welfare, ensures that ART Banks operate ethically and transparently. Here’s what they must do:

1. Get Licensed: All ART Banks must be registered with the National Registry of ART Banks (NRAB) and licensed by the National ART Authority (NAA).

2. Screen & Register Donors: ART Banks handle both egg and sperm donors—ensuring they meet eligibility criteria, undergo medical screening, and are officially registered.

3. Maintain Records: Detailed donor records must be maintained for at least 10 years, and then transferred to the central National Registry database.

4. Adhere to Quality Standards: Banks must follow stringent quality norms set by ICMR and NAA, including proper infrastructure, trained staff, and secure storage.

5. Prohibit Unethical Practices:

• No commercial surrogacy
• No sex selection
• No use of donor gametes without full legal consent

According to ART Law 2021, female donors (egg donors) must:

• Be between 23–35 years of age
• Test negative for HIV, Hepatitis B (HbSAg), Syphilis (VDRL), and Hepatitis C (HCV)
• Donate only once—strictly one-time donation to avoid exploitation

Additional Legal Safeguards for Egg Donors

Health Insurance for Donors: The couple receiving the donated eggs must buy a 1-year health insurance policy for the donor. This covers any possible medical complications during or after egg retrieval.

• The policy must be from an IRDA-approved company
• A legal affidavit must be signed before a Judicial Magistrate, confirming this arrangement

Consent Protocols:

• Donors and recipients must sign government-approved consent forms before any procedure
• ART Banks cannot proceed without these signed documents

Core Responsibilities of an ART Bank

• Screen and Register egg/sperm donors
• Cryopreserve donated gametes securely with written consent
• Ensure no donor’s gametes are used for more than one couple
• Maintain confidentiality of all donor and recipient information
• Report all donor enrollments and procedures to the National Registry within 1 month
• Maintain an internal grievance redressal system
• Dispose or donate unused gametes for research (with consent) after 10 years