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Can an IVF Clinic Operate Without ART Registration in India? Legal Risks Explained

Planning to start an IVF clinic in India or already operating one? ART registration is not a formality that can simply be completed later. The Assisted Reproductive Technology (Regulation) Act, 2021 introduced a specific regulatory framework for Assisted Reproductive Technology (ART) clinics and ART banks in India. Under this framework, clinics undertaking ART procedures are required to obtain registration and comply with prescribed standards relating to infrastructure, equipment, specialised manpower, records, consent and other operational requirements. This raises an important practical question for fertility centres:

Can an IVF clinic operate without ART registration in India?

The short answer is no, where the clinic is undertaking activities covered by the ART regulatory framework. Section 15 of the ART Act expressly provides that a person cannot establish an ART clinic or undertake ART procedures unless the clinic is duly registered under the Act.

For an IVF clinic, therefore, registration should be treated as part of the legal foundation of the practice, not as paperwork to be completed after the clinic has already started providing ART services. This article explains what the law requires, what risks an unregistered IVF clinic may face, whether other healthcare registrations are enough, and what clinics should consider if they discover a registration or renewal gap.

What Is ART Registration for an IVF Clinic?

Assisted Reproductive Technology covers medical and laboratory procedures used to assist reproduction. The National ART & Surrogacy Portal describes IVF as a sequence of procedures involving extracorporeal fertilisation of gametes, including conventional in-vitro insemination and ICSI. The ART Act, 2021 was introduced to regulate and supervise ART clinics and ART banks, promote safe and ethical ART practices, prevent misuse, and establish a regulatory structure for these services.

ART registration is therefore the statutory registration of an eligible ART clinic or bank with the appropriate authority under the framework established by the Act and Rules. It is important to understand that ART registration is establishment-level regulatory approval. It is different from the professional registration of an individual doctor. A gynaecologist may be appropriately registered to practise medicine, for example, but that does not by itself mean that the IVF clinic where ART procedures are undertaken is registered under the ART Act. That distinction is often overlooked when healthcare facilities review their compliance position.

Can an IVF Clinic Operate Without ART Registration?

No,  if it is undertaking ART activities covered by the Act. Section 15(1) of the Assisted Reproductive Technology (Regulation) Act, 2021 states that no person may establish an ART clinic or bank for undertaking ART or render ART procedures in any form unless the clinic or bank is duly registered under the Act. This is significant because the requirement is not framed as an optional certification or quality accreditation. It is a statutory registration requirement. The Act further provides that registration applications are made to the National Registry through the appropriate authority and that a clinic cannot be registered unless the appropriate authority is satisfied about prescribed facilities, equipment, specialised manpower, physical infrastructure and diagnostic facilities. 

In other words, registration is linked to the clinic's ability to demonstrate that it can lawfully and safely provide the relevant ART services. For a clinic planning to provide IVF, ICSI, embryo-related procedures or other regulated ART services, the registration position should therefore be resolved before commencing the relevant operations, rather than treated as a post-launch administrative exercise.

Does Every IVF Facility Have the Same Registration Requirements?

Not necessarily. The ART Rules distinguish between different categories of ART clinics, including Level 1 and Level 2 ART clinics, with different permitted activities, staffing and infrastructure requirements. This distinction matters because a clinic should not assume that obtaining one type of registration automatically authorises every ART procedure. The nature and scope of services being provided should be assessed against the applicable ART framework.

For example, Level 1 and Level 2 clinics have different regulatory requirements under the Rules. A facility planning to perform more complex ART procedures therefore needs to assess whether its proposed services, personnel, laboratory infrastructure and equipment correspond to the appropriate category. This is one reason why an ART registration assessment should happen during the clinic planning and setup stage, rather than after the facility is already operational.

Is Hospital or Clinical Establishment Registration Enough?

This is one of the most common misconceptions. A fertility centre may have other registrations, permissions or approvals applicable to its healthcare establishment. Depending on the state and the nature of the facility, these may relate to clinical establishments, biomedical waste, fire safety, pharmacy, laboratory operations, professional registrations or other areas. However, those permissions should not automatically be treated as a substitute for ART registration. The ART Act creates a separate regulatory framework specifically for ART clinics and ART banks. Therefore, the right question is not: Does our hospital have registration?

It is:

“Does our facility have the registrations and approvals required for the specific healthcare and ART activities it is undertaking?”

This distinction becomes particularly important for hospitals that have added an IVF or fertility unit to an existing medical facility. The hospital's existing compliance status should be reviewed alongside the ART-specific requirements rather than assumed to cover them.

What Happens If an IVF Clinic Operates Without ART Registration?

The consequences can extend beyond a simple administrative delay. An unregistered clinic may face regulatory scrutiny because the underlying activity itself is subject to statutory registration. The ART Act gives appropriate authorities powers relating to enforcement, including powers to summon persons possessing relevant information, require production of documents or material objects, and search premises suspected of violating the Act or Rules. The Act also establishes a framework for suspension and cancellation of registration where a registered clinic breaches the Act, Rules or Regulations. For an unregistered facility, the concern is even more fundamental: the clinic may be carrying out regulated ART activity without having first obtained the statutory registration required to do so.

The practical consequences can include:

Regulatory intervention
The clinic may come under the scrutiny of the relevant authority if its operations, registration status or compliance are questioned.

Operational disruption
If the regulatory position is not in order, the clinic may have to address the deficiency before it can continue or expand the relevant ART activities.

Documentation concerns
An inspection or regulatory review may require the clinic to demonstrate compliance with applicable staffing, infrastructure, equipment, consent, records and other requirements.

Patient-related risk
ART treatment involves highly sensitive medical decisions and records. A regulatory problem at the clinic level can therefore become particularly serious where it affects ongoing patient treatment, stored reproductive material, documentation or communication with patients.

Reputational impact
For fertility centres, trust is particularly important. Patients generally expect the facility handling their reproductive treatment and associated medical information to operate within the applicable regulatory framework.A registration gap can therefore become a business risk as well as a legal one.

Are There Specific Penalties Under the ART Act?

The ART Act contains a dedicated chapter dealing with offences and penalties. Importantly, the Act does not mean that every regulatory issue automatically carries the same criminal consequence. The applicable provision depends on the nature of the contravention.For example, Section 33 provides penalties for specified prohibited conduct, including exploitation of commissioning couples, women or gamete donors, certain prohibited transactions involving embryos or gametes, and other listed conduct. For a first contravention, the Act provides for a fine of not less than ₹5 lakh, which may extend to ₹10 lakh; subsequent contraventions can attract imprisonment and a higher fine.

Section 34 further provides punishment for contraventions of the Act or Rules where no specific punishment has otherwise been provided, by applying the punishment framework referred to in Section 33(2). This is why clinics should be careful about making broad claims such as “an unregistered IVF clinic will automatically face X penalty.”The legal consequence depends on the specific facts, the provision breached, and the regulatory action taken. A proper compliance assessment is therefore preferable to relying on general assumptions about penalties.

Can a Clinic Apply for Registration After Starting Operations?

This is where timing becomes important. The ART Act establishes registration as a prerequisite to establishing or operating an ART clinic for undertaking ART procedures. Therefore, the safer compliance approach is to complete the registration assessment and required process before commencing regulated ART operations.For an existing clinic that discovers a gap, however, the response should be structured rather than reactionary.

The clinic should first establish:

• what ART procedures it is currently providing;
• what category of ART clinic applies;
• whether an application has previously been submitted;
• whether registration was granted, rejected, suspended or allowed to lapse;
• whether the current registration certificate covers the present facility and operations;
• whether staffing and infrastructure remain compliant;
• whether patient and donor records are properly maintained; and
• whether any renewal or regulatory submissions are pending.

The appropriate corrective strategy can then be determined based on the actual regulatory position.

What Does an IVF Clinic Need for ART Registration?

ART registration is not simply an online form. The Act links registration to the clinic's ability to maintain prescribed facilities, equipment, specialised manpower, physical infrastructure and diagnostic facilities. The National ART & Surrogacy Registry currently provides an online registration process for ART clinics, ART banks and surrogacy clinics. The Registry instructs applicants to create an account, complete the relevant application and submit the signed application along with the prescribed fee to the appropriate authority within the stated timeline. Before applying, an IVF clinic should therefore review its compliance readiness.

This may include:

Facility and infrastructure: Whether the physical setup corresponds to the category and procedures proposed.

Medical and technical personnel: Whether required personnel are available and their qualifications and supporting records are in order.

Equipment: Whether the required equipment is available, functional and appropriately documented.

Clinical documentation: Whether consent forms, patient records, treatment documentation and related records are properly maintained.

Donor-related compliance: Where donor gametes are involved, whether applicable testing, documentation, insurance and record requirements are being followed.

Regulatory documentation: Whether the information submitted to the Registry accurately reflects the clinic's actual operations.
This is why registration preparation is best treated as a compliance exercise, not merely an application exercise.

How Long Is ART Registration Valid?

Under Section 16 of the ART Act, registration granted to an ART clinic or ART bank is valid for five years. The registration certificate is required to be displayed prominently at the clinic or bank. The Act also provides for renewal for a further period of five years, subject to the applicable conditions and prescribed fee. For clinics, this means that obtaining the original certificate is not the end of regulatory responsibility. The expiry date should be treated as an important compliance milestone.

What Changed for ART Registration Renewal in 2026?

This is particularly important for existing IVF clinics. The Assisted Reproductive Technology (Regulation) Amendment Rules, 2026, notified in June 2026, introduced a specific renewal mechanism through new Rule 8A. The amendment requires ART clinics and ART banks to apply for renewal through the National Registry portal 60 days before the expiry of their registration certificate.

The prescribed renewal fees are:

If the renewal application is not made within the prescribed 60-day period before expiry, the initial registration fee rates apply instead: ₹50,000 for a Level 1 ART clinic, ₹2,00,000 for a Level 2 ART clinic and ₹50,000 for an ART bank. Government-run institutes are exempt from renewal fees under the amended framework.

The amended framework also requires the signed PDF of the online application to be submitted to the relevant Appropriate Authority, and the authority is required to process the renewal within 60 days, subject to inspection and compliance. If renewal is rejected, reasons must be recorded, and the applicant must be allowed to be heard. The renewed certificate remains valid for a further five years from the expiry date of the previous certificate.  For existing IVF clinics, the practical takeaway is simple: Do not wait until the registration certificate is about to expire before reviewing compliance.

What If an IVF Clinic's Registration Has Expired?

An expired certificate should not simply be treated as a paperwork issue. The clinic should immediately establish whether:

1. the registration has actually expired;
2. a renewal application has already been submitted;
3. the application was submitted within the prescribed timeline;
4. the required fee and signed documentation were submitted;
5. the authority has raised any compliance or inspection issue; and
6. the clinic has continued providing ART services during the period in question.

These facts can materially affect the appropriate legal response. The 2026 Rules provide a structured renewal mechanism, but clinics should not assume that an expired registration automatically continues simply because a renewal process is contemplated. Where there is uncertainty, obtaining a clinic-specific regulatory assessment is considerably safer than relying on informal interpretations.

What About IVF Clinics That Were Already Operating Before the ART Framework?

Some established fertility centres have been operating for years and may have accumulated registrations under different legal and regulatory frameworks. That history is relevant, but it does not mean that a clinic can ignore the current ART regulatory framework. The ART Act specifically regulates the establishment and operation of ART clinics and banks and provides for registration, inspection, standards and continuing regulatory oversight. An older clinic should therefore review its present position against the current requirements rather than assuming that its historical approvals are sufficient.

This is particularly important if the clinic has:

• expanded its IVF laboratory;
• introduced new ART procedures;
• changed its ownership or organisational structure;
• changed premises;
• expanded its donor programme;
• changed key medical or technical personnel; or
• allowed its registration to approach or pass expiry.

ART Registration Is Only the Beginning of IVF Clinic Compliance

One of the biggest mistakes a fertility centre can make is to treat registration as the finish line. It is better understood as the beginning of an ongoing compliance responsibility. The ART Act contains provisions concerning the general duties of ART clinics and banks, written informed consent, maintenance of accurate records, use of human gametes and embryos, preimplantation genetic diagnosis and other regulated areas.

For example, Section 22 addresses written informed consent, while Section 23 deals with the duty to maintain accurate records. A clinic therefore needs systems that continue working after registration is granted. That includes keeping staff documentation current, maintaining appropriate records, documenting consent properly, preserving donor-related information, managing patient information responsibly and preparing for inspections. This is where regulatory compliance becomes an operational function rather than a one-time legal task.

What Should an IVF Clinic Do If It Is Currently Unregistered?

If a clinic believes it may be operating without the required ART registration, it should avoid making assumptions about the solution. A sensible first step is a regulatory gap assessment. The review should establish the clinic's current position against the ART framework, including:

1. Registration status: Confirm whether the clinic has ever applied for ART registration and identify the status of any application or certificate.

2. Scope of services: Map the actual procedures currently being offered against the applicable ART categories and requirements.

3. Infrastructure and equipment: Review whether the facility meets the applicable requirements for the services being provided.

4. Personnel: Verify qualifications, appointments and supporting documentation for the relevant medical and technical staff.

5. Patient documentation: Review informed-consent documentation, treatment records and other required clinical records.

6. Donor and reproductive material records: Where applicable, review donor documentation, testing, insurance, storage and record management.

7. Data privacy: IVF clinics handle highly sensitive health and reproductive information. Patient information should therefore also be reviewed from a data-protection and governance perspective.

8. Renewal and regulatory filings: Existing registered clinics should verify certificate validity, renewal deadlines and submissions rather than waiting for an authority to identify a lapse. The objective is not simply to obtain a certificate. The objective is to ensure that the clinic's actual operations align with the regulatory framework under which it is seeking registration.

Common Misconceptions About ART Registration

Our doctor is registered, so our IVF centre is registered. Not necessarily. Professional registration of a doctor and registration of an ART clinic are separate regulatory matters. We already have hospital registration: That may satisfy some other legal requirement, but it should not automatically be treated as a substitute for ART registration. We can start IVF services and apply for registration later: The ART Act specifically requires registration before establishing or operating an ART clinic for undertaking ART procedures.  Once we receive ART registration, we don't have to worry about compliance again: Registration is not the end of the clinic's obligations. Consent, records, staffing, infrastructure, reporting and other requirements continue to matter. Renewal is just a formality: The 2026 amendment makes renewal a structured process involving advance filing, prescribed fees and regulatory review.

Why ART Compliance Matters Beyond Avoiding Penalties

Legal compliance in fertility care is ultimately about more than avoiding regulatory action. IVF treatment involves decisions and information that are deeply personal. Clinics may handle reproductive histories, treatment records, donor information, genetic information, embryos and other highly sensitive data and material. A sound regulatory framework helps create accountability around how these services are provided. For a clinic owner, compliance can also bring practical business benefits:

It creates operational clarity. Staff know what documentation and procedures are required.

It reduces avoidable regulatory exposure. Potential gaps can be identified before they become enforcement issues.

It strengthens patient confidence. Patients are more likely to trust a facility that demonstrates organised and transparent compliance.

It supports sustainable growth. A clinic expanding its services is better positioned when its regulatory foundation is already in place. For these reasons, ART compliance should be viewed as part of good healthcare governance, not simply a regulatory burden.

Final Takeaway

Can an IVF clinic operate without ART registration in India?  If the clinic undertakes ART activities covered by the ART Act, the answer is no. Section 15 establishes registration as a prerequisite for establishing or operating an ART clinic for undertaking ART procedures. But registration is only one part of the compliance picture.

An IVF clinic also needs to consider its ART category, infrastructure, equipment, qualified personnel, patient consent, records, donor-related requirements, ongoing regulatory duties and renewal obligations. The 2026 amendments make it even more important for existing clinics to track their registration validity and renewal timelines actively. For a new fertility centre, the best time to address ART compliance is before operations begin. 

For an existing clinic, the right time is before a regulatory gap becomes a problem. At Lexcuriam, we advise healthcare and fertility-sector organisations on ART registration, healthcare regulatory compliance, legal documentation, contracts and data privacy, helping clinics build compliance into their operations rather than addressing it only after a notice, inspection or dispute. Need to assess your IVF clinic's ART registration or compliance position? Consult a healthcare regulatory lawyer before proceeding with regulated ART operations.