Today a fertility clinic in India that seeks NABH accreditation does so under the general NABH hospital accreditation standards. NABH has also released a draft accreditation standard written for ART clinics, first edition 2025, which is still a draft and can change. Its requirements on records, access control, traceability and Registry reporting show clearly where assessment is heading.
Accreditation questions from fertility clinics usually start in the same place: is there an NABH standard for IVF, and does it apply yet? The honest answer has two parts, and mixing them up leads clinics either to ignore the direction of travel or to treat a draft as settled rules.
This post separates what applies today from what the draft proposes, then takes the draft's requirements one at a time. For the legal duties that sit alongside accreditation, read our guide to ART Act 2021 compliance.
A fertility clinic that seeks NABH accreditation today does so under the general NABH hospital accreditation standards. There is not yet a finished accreditation scheme for ART clinics.
What exists is a draft. NABH has released a draft ART clinic accreditation standard, first edition 2025. Until it is final, its wording can still change, so a clinic should read it as a clear signal of direction rather than as rules already in force. Among its chapters, the draft covers the Information Management System (IMS) and Care of Patients (COP), and those two hold the requirements that clinic records touch most directly.
| Draft requirement (2025 draft, first edition) | Reference |
|---|---|
| Unique record identifier; entries chronological, dated, timed and attributable | IMS.1 |
| Retention in line with national and state law | IMS.1e |
| Authentication, access control and automatic log-off | IMS.4a |
| A tested programme for planned and unplanned downtime | IMS.2c |
| At least two unique identifiers for patients, donors, recipients, gametes and embryos | COP.1d |
| Multi-layered documentation, traceability and confidentiality of samples | COP.8c |
| Regular reporting of gamete and embryo data to the Registry | COP.8f |
Under IMS.1 of the draft, every medical record carries a unique identifier, and each entry is chronological, dated, timed and attributable to the person who made it. Records are retained as national and state law requires (IMS.1e).
For ART clinics in India, that law includes the ART (Regulation) Act 2021, which requires records to be kept for at least 10 years (s.23). A record that holds together for that long needs every entry to carry its time and its author from the start.
IMS.4a of the draft asks for authentication, access control and automatic log-off, with clinical records limited to care providers. IMS.2c asks for a tested programme for planned and unplanned downtime.
Confidentiality is also a legal duty under the ART Act 2021 (s.21(e)), so access control serves both the draft standard and the law. The practical test is simple: can the clinic show who opened a record, and that only people providing care could?
COP.1d of the draft asks a clinic to identify patients, donors, recipients, gametes and embryos with at least two unique identifiers. COP.8c asks for multi-layered documentation, traceability and confidentiality for gamete and embryo samples.
Two identifiers on every sample is what lets a clinic follow it from its source through every laboratory step, and show that it did. It is the same evidence that shows a cycle used a single donor under the Act's cycle limits.
COP.8f of the draft asks for regular reporting of gamete and embryo data to the National ART and Surrogacy Registry. This sits alongside the reporting duties in the ART (Regulation) Act 2021, so a clinic that already reports well under the Act is most of the way there.
Accreditation is awarded to the clinic, not to its software. What software does is produce the evidence an assessment asks for as the work happens. Vitrify supports structured record keeping with long retention and an audit trail, role-based access control, secure data with planned downtime handling, electronic witnessing and gamete and embryo traceability with unique identifiers, and export and reporting for the National ART and Surrogacy Registry.
In practice that evidence lives in the lab management record for every embryology step and in cryo storage for every stored sample. For the full requirement-by-requirement map, 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.
There is a draft. NABH has released a draft ART clinic accreditation standard, first edition 2025. It is not final, and general NABH hospital accreditation is what applies to fertility clinics today.
There is little to gain by waiting. The draft asks for attributable records, access control and two-identifier traceability, and a clinic that keeps those records now is keeping what the requirements describe, whichever way the final standard settles.
At least two unique identifiers for patients, donors, recipients, gametes and embryos (COP.1d).
No. Accreditation is awarded to the clinic, not to its software. Software produces the evidence an assessment asks for.
It asks for a tested programme for planned and unplanned downtime (IMS.2c).
NABH for fertility clinics is in transition. General hospital accreditation applies today, and the 2025 draft ART standard shows where assessment is going: attributable records, controlled access, two-identifier traceability and regular Registry reporting. 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 the records an assessment looks for.
