A Comprehensive Guide to Donor Requirements and Legal Standards for ART Banks in India
The implementation of the Assisted Reproductive Technology (Regulation) Act, 2021 marked a significant regulatory development in Indiaās reproductive healthcare framework. The Act establishes structured oversight for clinics and ART banks involved in the collection, screening, storage, and use of gametes. By introducing standardized legal and medical protocols, the law aims to ensure ethical practices, patient safety, and institutional accountability.
This guide explains donor eligibility conditions, screening requirements, registration norms, confidentiality rules, and compliance obligations applicable to ART banks in India.
Regulatory Framework Under the ART Act, 2021
The ART Act, 2021 provides a centralized regulatory structure governing fertility clinics and ART banks. All entities engaged in assisted reproductive procedures must comply with licensing, reporting, and operational standards set by the National Assisted Reproductive Technology and Surrogacy Registry.
ART banks are specifically authorized to handle screening, storage, and distribution of gametes. Their operations are monitored through mandatory registration and periodic inspection. This regulatory approach ensures that procedures related to donation and storage follow recognized medical standards and legal safeguards.
Non-compliance with statutory requirements may result in penalties, including suspension of registration and other legal consequences under applicable provisions.
Donor Eligibility Criteria
Donor eligibility is defined to protect the biological, medical, and legal interests of all parties involved. Under current regulations, a male donor must fall within the prescribed age range of 21 to 55 years. The age criteria are intended to ensure physical maturity and acceptable health parameters.
A key regulatory provision restricts donation to a single commissioning couple or woman. This āsingle-recipientā rule is designed to prevent legal ambiguity and reduce the risk of future disputes.
Additional eligibility conditions include medical fitness, absence of disqualifying health conditions, and completion of required screening procedures. ART banks must verify these requirements before accepting any donation.
Mandatory Medical and Genetic Screening
Comprehensive health screening is compulsory prior to gamete collection. The regulations require testing for communicable diseases, including:
- HIV (Types 1 and 2)
- Hepatitis B
- Hepatitis C
- Syphilis
These screenings are conducted to safeguard recipient health and minimize transmission risks.
In addition to infectious disease testing, ART banks must conduct genetic screening to identify potential hereditary conditions. Documentation of all medical evaluations is mandatory and must be preserved as part of institutional records.
No donation may proceed without completion and verification of these medical assessments.
Comparative Standards for ART Entities
The ART Act distinguishes between different categories of reproductive service providers. The following table outlines structural differences:
| Feature | ART Level 1 Clinic | ART Level 2 Clinic | ART Bank |
|---|---|---|---|
| Primary Function | Intrauterine Insemination (IUI) | IVF, ICSI, and Research | Screening and Storage of Gametes |
| Donor Storage | Not Permitted | Short-term / Procedural | Long-term Cryopreservation |
| Registration Fee | ā¹50,000 | ā¹2,00,000 | ā¹50,000 |
| Staffing | Gynecologist | Gynecologist & Embryologist | Medical Director & Technicians |
| Oversight | National Registry | National Registry | National Registry |
Each category operates within defined functional boundaries, with ART banks exclusively responsible for long-term cryopreservation and donor screening.
Registration and Operational Compliance
Registration with the National ART and Surrogacy Registry is mandatory for all ART banks. Registration remains valid for five years and is subject to renewal following inspection and regulatory review by state authorities.
Banks must prominently display registration certificates within their premises. They are also required to maintain standardized record-keeping systems, update the National Registry regarding donation activity, and ensure traceability of stored biological materials.
Failure to comply with registration norms or reporting obligations may attract statutory penalties under the Act.
Confidentiality and Legal Parentage
Confidentiality is a core legal principle under the ART framework. ART banks are required to maintain detailed donor records, including identity documentation and medical history. However, this information is strictly confidential.
The identity of the donor is not disclosed to the commissioning couple or the child. Similarly, recipientsā identities remain confidential from the donor.
The law also clarifies parental rights: the commissioning couple is legally recognized as the parents of the child born through ART procedures. The donor does not retain parental rights or responsibilities.
Documentation and Informed Consent
Written informed consent is mandatory prior to any donation. The consent document must clearly explain:
- The medical procedures involved
- Potential health risks
- Legal implications of donation
- Status of parental rights
ART banks must ensure that consent is obtained in the prescribed format and properly recorded. Additionally, updates regarding donations and outcomes must be submitted to the National Registry as required by law.
Thorough documentation supports transparency, legal clarity, and ethical practice within the ART ecosystem.
Conclusion
The ART Act, 2021 establishes a structured legal and medical framework governing gamete donation and ART bank operations in India. Defined eligibility criteria, mandatory health screening, strict confidentiality provisions, and formal registration requirements form the foundation of compliance.
For both donors and institutions, adherence to these standards ensures ethical conduct, medical safety, and legal clarity. Understanding regulatory requirements is essential for participation in Indiaās assisted reproductive technology system in a lawful and responsible manner.