Donor Requirements and Legal Standards for ART Banks Under India’s ART Act, 2021
India’s Assisted Reproductive Technology (Regulation) Act, 2021 establishes a regulated framework for fertility clinics and ART banks, with defined rules for donor screening, gamete handling, recordkeeping, and oversight. ART banks have a distinct compliance role because they manage collection, testing, storage, and supply of gametes within defined legal limits.
This article explains how ART banks function within the regulatory system, what eligibility and screening standards apply to donors, how registration and inspections work, and what confidentiality and documentation duties institutions must follow.
Scope of Regulation and the Role of ART Banks
The ART Act 2021 creates a structured compliance environment intended to reduce unsafe practices and standardize operating procedures. Within this system, ART banks are not simply storage facilities. They are expected to maintain traceability for each donation event, ensure all required tests and consents are completed before use, and keep records in a manner suitable for inspection.
ART banks typically handle intake and screening workflows, coordinate collection processes, manage cryopreservation, and supply gametes to authorized ART clinics according to legally permitted pathways. This role requires clear internal SOPs for labeling, chain-of-custody controls, equipment maintenance, and incident reporting. Banks must also support registry-linked reporting where required, which makes accurate documentation a core operational function.
Because the legal framework includes both medical and administrative requirements, compliance is not limited to laboratory quality. It also includes staff accountability, documentation integrity, and consistent application of eligibility rules.
Donor Eligibility Rules and Supply Restrictions
Eligibility rules are set to protect recipient safety, reduce legal ambiguity, and ensure standardized ethical boundaries. A key compliance requirement is donor eligibility, including age thresholds and restrictions on how a donor’s gametes may be supplied.
For example, the Act specifies an age bracket for male donors and limits how donation may be used across commissioning parties. Banks must ensure that the donor’s identity and donation history are tracked in a way that prevents supply beyond permitted limits. This requires strong internal systems—manual or digital—capable of verifying whether a donor’s material has already been assigned or supplied in a way that would breach restrictions.
Eligibility checks also typically involve verifying identity documentation, ensuring the donor meets baseline medical suitability criteria, and confirming that required consents are signed in the prescribed manner. Where institutions rely on external referrals, banks still remain responsible for ensuring the internal compliance checklist is complete before collection or storage is finalized.
Mandatory Testing and Screening Protocols
Before collection and release, donor screening is central to the regulatory framework. Banks must ensure medical screening is completed for communicable diseases and that results are documented, validated, and stored securely. Screening protocols commonly include testing for major transmissible infections and other evaluations required by applicable rules and clinical standards.
In addition to infectious disease screening, banks may be required to conduct or document genetic screening and medical history checks aimed at reducing inheritable risk factors. The exact test panel and documentation requirements can vary depending on notified rules, operational guidance, and inspection expectations, but the compliance principle remains stable: no collection or supply should proceed without documented screening completion.
Operationally, this demands a clear sample-management workflow, including unique identifiers, controlled access to reports, and safe retention of test outcomes. Banks should also maintain quality controls to reduce errors such as sample mix-ups, incomplete documentation, or use of expired test results.
Comparison of Regulated ART Entities
The legal framework distinguishes between categories of ART entities by scope of practice. The table below summarizes functional differences often used in compliance planning.
| Entity Type | Primary Scope | Donor Material Storage | Typical Staffing Focus | Oversight Linkage |
|---|---|---|---|---|
| ART Clinic (Level 1) | Limited ART procedures (e.g., IUI) | Generally restricted or procedure-limited | Clinical team | Registry-linked oversight |
| ART Clinic (Level 2) | Advanced ART procedures (e.g., IVF/ICSI) | Procedure-linked storage may occur | Clinical + lab team | Registry-linked oversight |
| ART Bank | Screening, storage, and supply | Long-term cryopreservation and traceability | Medical director + technicians | Registry-linked oversight |
This separation matters because banks are evaluated primarily on screening integrity, storage controls, documentation, and supply compliance, while clinics are evaluated primarily on treatment delivery and clinical outcomes within regulatory limits.
Registration, Inspections, and Operational Controls
A core compliance pillar is ART bank registration with the appropriate authority and adherence to inspection requirements. Registration is not only an administrative step; it is tied to operational standards that can be evaluated through audits, site visits, and record reviews.
Typical inspection focus areas include: facility hygiene and safety controls, equipment calibration and maintenance logs, sample labeling standards, access controls for cryostorage, staff qualification records, and completeness of documentation for donor intake and screening. Banks are usually expected to display registration credentials as required, maintain traceable records for each stored sample, and ensure that records can be produced quickly for regulatory review.
Operational controls also include incident management protocols. If storage equipment fails or temperature excursions occur, the bank should have documented escalation steps, corrective actions, and reporting processes consistent with regulatory expectations.
Confidentiality, Consent, and Recordkeeping Requirements
Legal compliance extends beyond storage and testing into privacy and legal status. Banks must follow confidentiality requirements by protecting donor identity data and restricting disclosures. While banks may maintain detailed donor records, access should be limited to authorized personnel and governed by written policies.
Consent documentation is equally critical. Donors must provide informed consent in the required format, and records must reflect that the donor understood the implications, including the legal status of donation and limitations on use. Banks should also maintain records of sample movement, storage duration, disposal protocols, and supply events, ensuring that every step is traceable.
Because compliance disputes often arise from documentation gaps rather than medical practice alone, record accuracy, retention discipline, and secure storage of sensitive information are operational priorities.
Conclusion
ART banks operate within a compliance-focused regulatory environment where donor screening, eligibility checks, lawful supply limits, confidentiality safeguards, and inspection-ready documentation are essential. The ART Act, 2021 formalizes these responsibilities to improve safety, reduce ethical ambiguity, and ensure accountable handling of gametes across the ART ecosystem. Institutions and stakeholders benefit when processes are transparent, records are complete, and legal standards are applied consistently throughout donor intake, storage, and supply workflows.