# The ART Act 2021 Explained for IVF Clinic Owners > Source: https://www.vitrifysoftware.com/art-act-2021-explained-for-ivf-clinics/ IVF Software Compliance The Assisted Reproductive Technology (Regulation) Act 2021 is in force and governs every ART clinic and bank in India. For an owner it comes down to a short list: register and renew every 5 years, meet the clinic duties, take written consent, respect the cycle limits, keep records for at least 10 years and report to the National Registry. If the clinic contravenes the Act, its executive head is liable unless due diligence is proved. ![The ART Act 2021 Explained for IVF Clinic Owners] ## Table of Contents Introduction What the Act Is and Who It Covers Registration and the Five-Year Certificate The Clinic's Day-to-Day Duties Consent Comes Before Everything The Three-Embryo and Single-Donor Limits Records and Registry Reporting Penalties and Who Is Liable How Software Helps an Owner Stay Compliant FAQs Conclusion ## Introduction An owner does not need to read every clause to run a clinic that stays on the right side of the law. What an owner does need is a clear picture of what the Act asks, who it asks it of and where the proof comes from. This post is that picture, in plain language and in the order a clinic meets each duty. It is an overview rather than a clause-by-clause guide. For the full duty-by-duty treatment, read our guide to [ART Act 2021 compliance](https://www.vitrifysoftware.com/art-2021-compliance/). ## What the Act Is and Who It Covers The ART (Regulation) Act 2021 is in force. It sets out how ART clinics and banks register, what records they keep and what they report. It applies to every ART clinic and every ART bank in India, whatever its size. The obligations sit with the clinic and with its executive head. That matters for an owner, because the Act ties liability to the person in charge, not only to the organisation. The rest of the Act is easier to follow once you see that almost every duty is proved with a record. ## Registration and the Five-Year Certificate Every ART clinic and every ART bank must register through the appropriate authority with the National Registry (s.15-16). The State Board inspects a clinic before registration is granted. The certificate of registration is valid for 5 years and has to be displayed prominently. 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, and they need to stay in order for every renewal after it. ## The Clinic's Day-to-Day Duties Section 21 lists the duties a registered clinic carries every day. In plain terms, a clinic has to: Check the eligibility of the people it treats. Counsel them on the chances of success, the risks, the cost and the side effects of treatment. Keep their information confidential (s.21(e)). Run a mandatory grievance cell (s.21(f)). Treat within the age limits: women above 21 and below 50, and men above 21 and below 55 (s.21(g)). Report enrolment, procedures and outcomes or complications to the National Registry at regular intervals (s.21(j)). None of these is unusual for a well-run clinic. The difference the Act makes is that each one may have to be shown, so the counselling, the grievance log and the reports all need to leave a record. ## Consent Comes Before Everything 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 one general form does not cover them. Consent can be withdrawn at any time before transfer to the uterus. A clinic therefore needs to know whether consent still stands before each step, not only at the start. The Act also requires insurance for the oocyte donor for 12 months. ## The Three-Embryo and Single-Donor 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 the same cycle, semen may not be mixed and embryo splitting is prohibited. Separately, gametes and embryos may not be stored for more than 10 years (s.28(2)). For an owner, the useful way to read the Act is duty by duty, with the record that shows each one: Duty Where in the Act The record that shows it Registration and renewal s.15-17 The certificate, displayed and renewed every 5 years Eligibility and counselling s.21 Notes of the eligibility check and counselling Written consent s.22 Signed consent from all parties, with specific consents Cycle limits s.24 The cycle record of what was placed and from which donor Detailed records s.23 Records of donor oocytes, sperm and embryos, kept 10 years Registry reporting s.21(j) Reports of enrolment, procedures and outcomes ## Records and Registry Reporting Section 23 requires a clinic to maintain detailed records of donor oocytes, sperm and embryos. Records are kept for at least 10 years and then transferred to the central database, and they must be available for inspection. Once the National Registry is live, this information is submitted online within one month. Add the periodic reporting under s.21(j) and the picture is clear: reporting is only as good as the records behind it. A clinic that keeps complete records as it works can report from them. A clinic that does not ends up rebuilding them under a deadline. ## Penalties and Who Is Liable 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 an Owner Stay Compliant Software does not make a clinic compliant. The duties stay with the clinic and its executive head. What software does is keep the evidence complete as the work happens, so it is there when an inspector, the Registry or the owner asks for it. Vitrify supports: Structured record keeping with long retention, behind the [EHR and EMR](https://www.vitrifysoftware.com/ehr-emr/). 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. Cycle-rule checks, with electronic witnessing and gamete and embryo traceability. Grievance and complaint logging. Secure data, including donor records in the [ART bank software](https://www.vitrifysoftware.com/art-bank-software/). If your clinic is also working towards accreditation, read our guide to [NABH compliant IVF software](https://www.vitrifysoftware.com/nabh-ivf-software/). To weigh up vendors, see our guide to the [best IVF software in India](https://www.vitrifysoftware.com/best-ivf-software-india/), and for costs, see [IVF software pricing](https://www.vitrifysoftware.com/pricing/). ## FAQs ### Q1. Is the ART Act 2021 in force? Yes. The ART (Regulation) Act 2021 is in force and governs every ART clinic and bank in India. Each one must register through the appropriate authority with the National Registry. ### Q2. How long is an ART clinic registration valid? The certificate of registration is valid for 5 years and must be displayed prominently. Renewal is also for 5 years (s.17), and the State Board inspects before registration is granted. ### Q3. What age limits does the Act set? Women above 21 and below 50, and men above 21 and below 55 (s.21(g)). ### Q4. Who is liable if a clinic breaks the Act? The executive head of the clinic or bank, unless due diligence is proved (s.37). A first contravention can bring a fine of 5 to 10 lakh rupees, and a later one imprisonment of 3 to 8 years and a fine of 10 to 20 lakh rupees (s.33(2)). ### Q5. Can software make a clinic compliant? No. The duties stay with the clinic and its executive head. Software keeps the records behind each duty complete and easy to retrieve, which is the evidence an inspection or the Registry asks for. ## Conclusion The ART Act 2021 asks a lot of a clinic, but it asks for it in a consistent way: do the right thing, then be able to show it. Registration, consent, the cycle limits, records and reporting all come back to evidence the clinic keeps. Start from [Vitrify IVF software](https://www.vitrifysoftware.com/), browse the [IVF software modules](https://www.vitrifysoftware.com/products/) or find [IVF software for your clinic type](https://www.vitrifysoftware.com/solutions/). To see clinics on the national ART registry in India, browse the [IVF clinic directory](https://www.vitrifysoftware.com/find/), Vitrify Explore. Book a demo to see how Vitrify keeps the records behind every duty in one place. ## Related reading - [National ART Registry Reporting Checklist for IVF Clinics](https://www.vitrifysoftware.com/national-art-registry-reporting-for-ivf-clinics/) - [NABH Accreditation for Fertility Clinics and the 2025 Draft](https://www.vitrifysoftware.com/nabh-accreditation-for-fertility-clinics/) - [ART Clinic Record Keeping and Consent Rules in India](https://www.vitrifysoftware.com/art-clinic-record-keeping-and-consent-india/) [Explore the Data Migration and Compliance hub](https://www.vitrifysoftware.com/data-migration-and-compliance/) [← Back to Blog](https://www.vitrifysoftware.com/blog/)