Short answer. This is a checklist we use for donor egg cases: 9 documents from the ART Bank and 5 from the ART clinic. Several are required by the ART Act, 2021 and the ART Rules, 2022. Others are our own good practice. Treat the list as a working checklist, not a hard and fixed rule. The Act and Rules decide what is mandatory.
Why a document file matters
An ART Bank screens and registers the donor (Rules r.3(2)(ii)). It must also keep the records of all its donors and update the National Registry (Rules r.3(2)(iv); Act s.27(6)). The clinic stimulates and retrieves, and keeps its own consent records (Rules r.13(1)). When both keep matching papers, any inspection or query can be answered quickly (Rules r.18).
From the ART Bank
- Donor ID. Each donor gets an ID. The Rules require a separate register that links this ID to her name and address, kept locked and open to a few sworn persons (note at the end of Forms 14, 14A and 14B).
- Donor application. Our own record of how she applied. The Rules do not name it.
- Aadhaar, verified. The bank must obtain the donor’s name, Aadhaar number and address (Act s.27(6)).
- Blood investigations. The donor is tested for HIV 1 and 2, Hepatitis B, Hepatitis C and syphilis by VDRL (Act s.21(b); Rules r.10 and r.14). The doctors may add other tests, as our own practice.
- Insurance cover. The commissioning couple or woman buys 12 months of cover for the donor from an IRDA recognised insurer (Act s.22(1)(b); Rules r.12(i)).
- The intending couple’s affidavit and the donor’s confidentiality undertaking. The intending couple gives an affidavit before a Metropolitan or Judicial Magistrate (Rules r.12(ii)). The donor gives a written undertaking of confidentiality (Act s.27(6)).
- Form 14A and the acknowledgement copy. The Rules make Forms 14, 14A and 14B the bank’s record of use of donor gametes (Rules r.13(2)(i)). Form 14B is listed below with the clinic’s embryology record.
- Independent counselling. Form 13 records that the donor was counselled by an independent counsellor. Our psychologist counselling record goes in the file.
- Donor register. The register of donor names and addresses that matches each donor ID, kept by the bank (note at the end of Forms 14, 14A and 14B; Rules r.3(2)(iv)).
From the ART clinic
- Acknowledgement copy for supply of the donor. Our own receipt that the clinic received the donor from the bank. The Rules do not name it.
- Form 13 consent copy. The oocyte donor consents in Form 13. The clinic fills it, and the bank keeps a copy when it recruited and screened the donor (Act s.22(1)(a); Rules r.13(1)(f)(viii), Form 13 note).
- Form 14B, the oocyte and embryo record. The clinic completes the embryology record of the cycle. It has an Aadhaar number field and forms part of the bank’s record of use of donor gametes (Rules r.13(2)(i), Form 14B).
- Consent for the retrieval procedure. The Rules list a consent for oocyte retrieval (Rules r.13(1)(f)(vii), Form 12). The donor’s own consent is Form 13 (item 11). Retrieval takes place at a registered ART clinic (Rules r.3(1)(ii)).
- Discharge summary. The clinic’s record of the retrieval and the donor’s discharge. This is clinical good practice.
Keep it safe and confidential
Details of the couple, the woman and the donor are confidential (Act s.21(e)). Keep the donor register locked, share it with as few people as possible, and share donor details only where the Act allows.
A bank and a clinic register separately, even on the same premises (Government of India, Ministry of Health and Family Welfare (Department of Health Research), File No. I.11019/37/2023-HR dated 9 Mar 2023, Q2). Each keeps its own set.
Zoi Fertility is the registered ART Bank behind the Egg Donor India programme (URN MH/AB/2022/10691/Mumbai/83).
Contact the ART Bank · For clinics · Read the full law guide
Questions
What documents does an ART Bank keep for an egg donor?
The donor ID, application, verified Aadhaar, blood test reports, insurance cover, the couple’s affidavit and the donor’s undertaking, Form 14A with the acknowledgement copy, the counselling record and the donor register (Act s.22, s.27(6); Rules r.10, r.12, r.13(2)(i)).
What does the ART clinic keep?
The supply acknowledgement, the Form 13 consent copy, Form 14B, the retrieval consent and the discharge summary (Rules r.13).
Is this list a legal requirement?
Part of it. The Act and Rules require the Aadhaar record, tests, insurance, consents and Forms 13, 14, 14A and 14B. The rest is our own good practice, so use it as a checklist.
Who keeps the donor’s identity record?
The ART Bank, in a locked register open to a few sworn persons (note at the end of Forms 14, 14A and 14B; Act s.21(e)).
References
- Assisted Reproductive Technology (Regulation) Act, 2021 (Act No. 42 of 2021): section 21(b) and (e); section 22(1); section 27(6).
- Assisted Reproductive Technology (Regulation) Rules, 2022 (G.S.R. 419(E)): rules 3(1)(ii), 3(2)(ii) and (iv), 10, 12, 13, 14 and 18; Forms 12, 13, 14, 14A and 14B.
- Government of India, Ministry of Health and Family Welfare (Department of Health Research): File No. I.11019/37/2023-HR dated 9 Mar 2023.
This page explains the law as published. It is not legal advice.
