The Assisted Reproductive Technology (Regulation) Act 2021 is in force, and every ART clinic and bank in India works under it. The main duties are to register with the National Registry, keep detailed records for at least 10 years, report to the Registry, take written informed consent from all parties and respect the per-cycle limits on embryos and donors. Vitrify helps clinics keep the records behind each of these duties in one system.
THE LAW
The Act sets out how ART clinics and banks register, what records they keep and what they report. Registration runs through the appropriate authority with the National Registry, and the State Board inspects a clinic before it is registered (s.15-16). A registered clinic then carries a set of duties under s.21. It checks the eligibility of the people it treats and counsels them on the chances of success, the risks, the cost and the side effects of treatment. It keeps their information confidential (s.21(e)), runs a mandatory grievance cell (s.21(f)) and reports enrolment, procedures and outcomes or complications to the National Registry at regular intervals (s.21(j)). The Act also sets age limits: women above 21 and below 50, and men above 21 and below 55 (s.21(g)).
Consent, records and the treatment cycle are regulated just as closely. No treatment can begin without written informed consent from all parties (s.22). Detailed records of donor oocytes, sperm and embryos are kept for at least 10 years (s.23). No more than three oocytes or embryos may be placed in a cycle, and gametes or embryos from more than one donor cannot be used in the same cycle (s.24). Gametes and embryos may not be stored for more than 10 years (s.28(2)).
Nearly every one of these duties is answered by a record. An inspector or the Registry can ask a clinic to show what was done, when, by whom and with whose consent, and that answer has to come from the clinic's own documentation. This page takes each duty in turn and shows how clinic software helps a team keep that evidence complete and easy to retrieve. The obligations sit with the clinic and its executive head: software supports compliance, it does not take over the clinic's responsibility.
REGISTRATION
Every ART clinic and every ART bank must register through the appropriate authority with the National Registry (s.15-16). The State Board carries out an inspection before registration is granted. The certificate of registration is valid for 5 years and has to be displayed prominently, and renewal is also for 5 years (s.17).
Because the inspection comes before the certificate, the records a clinic is judged on need to be in order from the first day. Vitrify keeps patient, consent and laboratory records in a structured form from the start, so the same evidence serves the first inspection and every renewal after it.
RECORDS AND REPORTING
Section 23 requires a clinic to maintain detailed records of donor oocytes, sperm and embryos. Once the National Registry is live, this information is submitted online within one month. Records are kept for at least 10 years and then transferred to the central database, and they must be available for inspection. Section 21(j) adds periodic reporting of enrolment, procedures and outcomes or complications to the National Registry.
Vitrify supports structured record keeping with long retention, together with export and reporting for the National ART and Surrogacy Registry. A submission inside the one-month window is then drawn from records the team already keeps, rather than rebuilt by hand.
CONSENT AND CONFIDENTIALITY
No treatment may be given without written informed consent from all parties (s.22). Cryopreservation and the creation of embryos each need their own specific written consent. Consent can be withdrawn at any time before transfer to the uterus, so a clinic needs to know whether consent still stands before each step. The Act also requires insurance for the oocyte donor for 12 months. Confidentiality is a clinic duty in its own right (s.21(e)), and so is a grievance cell (s.21(f)).
Vitrify captures informed consent digitally and tracks a withdrawal against the record, so staff can see the current position before a transfer. Role-based access control and an audit trail limit who can open a record and show who did. Grievances and complaints can be logged and followed through in the same system.
CYCLE LIMITS
Section 24 sets firm limits on every treatment cycle. No more than three oocytes or embryos may be placed per cycle. Gametes or embryos from more than one donor cannot be used in a cycle, semen may not be mixed, and embryo splitting is prohibited.
Cycle-rule checks in Vitrify help a team catch a plan that would break one of these limits. Electronic witnessing and unique identifiers keep each gamete and embryo traceable to its source, which is how a clinic shows that a cycle used a single donor.
PENALTIES
A first contravention can bring a fine of 5 to 10 lakh rupees. A later contravention can bring imprisonment of 3 to 8 years and a fine of 10 to 20 lakh rupees (s.33(2)). Where a clinic or bank contravenes the Act, its executive head is liable unless due diligence is proved (s.37).
Due diligence is shown with records. An audit trail of consent, access and laboratory steps is the kind of evidence an executive head can point to.
HOW SOFTWARE HELPS
Each duty in the Act lines up with a capability a clinic can look for in its software. These are the ones Vitrify provides.
Structured record keeping, so the evidence is in order before the State Board inspects and at each renewal.
Structured records with long retention, available when an inspection asks for them.
Export and reporting for the National ART and Surrogacy Registry.
Digital informed-consent capture with withdrawal tracking.
Role-based access control and an audit trail.
Grievance and complaint logging.
Cycle-rule checks, with electronic witnessing and gamete and embryo traceability through unique identifiers.
Secure data with planned downtime handling.
See how this works in the EHR and EMR, lab management, cryo storage and ART bank software. For the accreditation side, read our guide to NABH compliant IVF software.
FAQ
Short answers on the duties the Act places on ART clinics and banks in India.
KEEP EXPLORING
Start from the Vitrify home page, browse every module on the products hub, find the setup that fits your clinic on the solutions hub or compare plans on pricing. Related reading: NABH Compliant IVF Software, the IVF clinic software guides and IVF software in India.
