The ART Act 2021 asks a clinic to keep detailed records of donor oocytes, sperm and embryos for at least 10 years, then transfer them to the central database, with records available for inspection throughout. No treatment can start without written informed consent from all parties, and consent can be withdrawn at any time before transfer to the uterus. Both duties are met with records the clinic keeps as it works.
Record-keeping and consent are the two duties in the ART Act 2021 that touch every patient, every donor and every cycle. They are also the two an inspection leans on, because almost every other duty is proved through them.
This post goes deeper on both than an overview can. For the full set of duties, read our guide to ART Act 2021 compliance.
Section 23 requires a clinic to maintain detailed records of donor oocytes, sperm and embryos. Around that core, the other duties in the Act each leave their own record:
Detailed records of donor oocytes, sperm and embryos (s.23).
Written informed consent from all parties, including the specific consents for cryopreservation and for creating embryos (s.22).
The reports of enrolment, procedures and outcomes or complications made to the National Registry (s.21(j)).
The grievances raised with the clinic's mandatory grievance cell (s.21(f)).
Records are kept for at least 10 years and then transferred to the central database, and they must be available for inspection (s.23). Once the National Registry is live, this information is also submitted online within one month.
Ten years is long enough for staff to change, systems to be replaced and paper to fade. A record that has to survive that long needs a clear structure, a clear owner and a way to find it again quickly.
The transfer the Act spells out is the one to the central database after the retention period. A clinic that is closing, merging or changing hands should confirm with the appropriate authority how its records are to be handed over, and keep them complete and available for inspection until that is done.
A handover is far easier when records are already structured and held in one place. Scattered files are hard to transfer and harder to prove complete.
A different ten years applies to the samples themselves. Gametes and embryos may not be stored for more than 10 years (s.28(2)). It is easy to confuse the two, so it helps to set them side by side:
| Rule | Where in the Act | What it sets |
|---|---|---|
| Record retention | s.23 | At least 10 years, then transfer to the central database |
| Storage of gametes and embryos | s.28(2) | No more than 10 years |
| Registry submission | s.23 | Online within one month, once the Registry is live |
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, so a clinic needs to know which consents a given step depends on, not only that a form was signed.
The Act also requires insurance for the oocyte donor for 12 months, which belongs in the same file as the donor's consent.
Consent can be withdrawn at any time before transfer to the uterus. That turns consent from a one-time document into a status the clinic has to check before each step.
The practical risk is a withdrawal recorded in one place and missed in another. The fix is to record a withdrawal against the same record the laboratory works from, so the current position is visible to the people about to act on it.
A clinic keeps the information of the people it treats confidential (s.21(e)) and runs a mandatory grievance cell (s.21(f)). Detailed records are only safe to keep for 10 years if access to them is controlled for all of that time.
Vitrify supports structured record keeping with long retention, so records hold together for the full period, and the EHR and EMR keeps the clinical record in one place. Records that still sit on paper or in spreadsheets are the hardest to keep retrievable for ten years, which is where data migration comes in.
Digital informed-consent capture with withdrawal tracking shows staff the current position before a transfer. Role-based access control and an audit trail limit who can open a record and show who did, and grievances and complaints can be logged and followed through in the same system.
For accreditation, read our guide to NABH compliant IVF software. To compare systems, see our guide to the best IVF software in India and our IVF software pricing.
At least 10 years. Under s.23, records of donor oocytes, sperm and embryos are kept for at least 10 years and then transferred to the central database.
No. Records are kept for at least 10 years (s.23), while gametes and embryos may not be stored for more than 10 years (s.28(2)).
Written informed consent from all parties before any treatment (s.22). Cryopreservation and the creation of embryos each need their own specific written consent.
Yes. Consent can be withdrawn at any time before transfer to the uterus, so a clinic needs to check that consent still stands before each step.
Records are kept for at least 10 years and then transferred to the central database. A clinic that is closing or changing hands should confirm the handover with the appropriate authority and keep its records complete and available for inspection until then.
Good record-keeping and good consent practice are the same discipline: write it down when it happens, keep it whole and make the current position easy to see. Keep detailed records for at least 10 years, take written consent from all parties and treat a withdrawal before transfer as final. Start from Vitrify IVF software, browse the IVF software modules or find IVF software for your clinic type. To see clinics on the national ART registry in India, browse the IVF clinic directory, Vitrify Explore. Book a demo to see how Vitrify keeps records and consent together.
