Introduction
The Assisted Reproductive Technology (Regulation) Act, 2021, marks a pivotal development in India’s healthcare and legal landscape. As assisted reproductive technologies (ART) like IVF, ICSI, and gamete donation have gained prominence, the need for structured and ethical regulation has become imperative. The ART Act seeks to protect the interests of all stakeholders, particularly intending parents, donors, surrogate mothers, and children born through ART. For hospitals and ART clinics, compliance with this law is not just a legal requirement but a moral and professional responsibility. This blog provides an in-depth exploration of the compliance framework mandated under the ART Law for hospitals and institutions in India.
Mandatory Registration of Assisted Reproductive Technology Clinics and Banks
A cornerstone of compliance under the Assisted Reproductive Technology (Regulation) Act, 2021 is the mandatory registration of all ART clinics and ART banks. This ensures that entities offering assisted reproductive services operate within a standardized, ethical, and medically sound framework.
Section 14 of the Act explicitly states that no ART clinic or ART bank shall commence or continue operations without obtaining registration from the appropriate authority. Registration must be obtained through the National Assisted Reproductive Technology and Surrogacy Board (NARTSB), as well as the respective State Boards, depending on the location of the clinic or bank.
To obtain registration, facilities are required to submit detailed documentation on:
- The range of ART services offered;
- Availability of qualified medical and paramedical staff;
- Infrastructure and laboratory facilities;
- Compliance with ethical and medical standards prescribed by the Act and related rules.
Once granted, registration is not indefinite. It must be renewed periodically and the certificate must be displayed prominently at the premises. This transparency allows for public awareness and regulatory oversight.
Non-compliance with the registration requirements is treated as a serious offence. Violators may face penalties including:
- Monetary fines;
- Suspension or cancellation of license;
- In severe cases, imprisonment as prescribed under the Act.
The mandatory registration mechanism is designed not only to curb unethical practices and fly-by-night operators but also to protect the rights of donors, surrogates, and intending parents by ensuring accountability and standardization across the ART sector in India.
Staff Qualification and Credential Verification in ART Facilities
Hospitals and institutions offering Assisted Reproductive Technology (ART) services are legally mandated to maintain high standards of medical professionalism and ethical integrity. A critical component of this compliance involves ensuring that all personnel engaged in ART procedures meet stringent qualification and verification criteria.
Firstly, every medical professional involved in ART—including gynaecologists, anesthetists, and reproductive endocrinologists—must be registered with the Medical Council of India (MCI) or the relevant State Medical Council. This ensures that practitioners adhere to nationally recognized standards of medical education and ethical conduct.
In addition, only trained and qualified professionals should be employed for ART services. This includes certified embryologists, lab technicians, counsellors, and nursing staff who are equipped to handle complex reproductive procedures such as in vitro fertilization (IVF), gamete preservation, and embryo transfer.
The law also mandates comprehensive background checks and verification of all professional credentials before employment. Institutions are expected to retain documentary proof of staff qualifications and make these available during inspections or audits by regulatory authorities.
These measures are crucial not only for patient safety and procedural success but also for fostering public trust in ART services. Failure to comply may lead to penalties, including suspension of registration and legal action under the ART Act.
Record-Keeping and Data Reporting Obligations under the ART Act
Under the Assisted Reproductive Technology (Regulation) Act, maintaining meticulous documentation is a core compliance requirement for ART clinics and banks. All facilities are legally obligated to preserve comprehensive medical and procedural records for a minimum of 10 years. Following this period, these records must be transferred to the national database managed by the National Registry, ensuring long-term traceability and regulatory oversight.
ART clinics must retain complete medical histories of donors, intending couples, and surrogate mothers (if applicable). This includes diagnostic reports, fertility assessments, medication logs, and treatment outcomes. Informed consent forms, procedural protocols, and complication reports are also required to be recorded and archived meticulously.
Additionally, all registered clinics and banks are expected to submit quarterly data reports to the designated authority, as per the format prescribed by the National Assisted Reproductive Technology and Surrogacy Board (NARTSB). These reports contribute to the national surveillance and policy formulation on reproductive technologies.
Failure to adhere to record-keeping or reporting mandates can result in serious legal consequences, including fines, suspension of registration, or criminal prosecution. These provisions aim to uphold transparency, protect patient rights, and facilitate uniform standards in ART practice across India.
Confidentiality Obligations under the ART Act
Confidentiality is a cornerstone of patient trust and ethical medical practice, and the Assisted Reproductive Technology (Regulation) Act, 2021 lays down clear obligations in this regard. As per Section 29 of the Act, all ART clinics and banks are mandated to maintain strict confidentiality of patient and donor information. Any personal or medical data, including identity details, medical history, and treatment outcomes, must be securely stored and not disclosed without explicit written consent from the concerned individual.
Section 30 of the Act further prohibits the sharing of such sensitive data with third parties, including insurers, researchers, or other institutions, unless legally mandated or consented to in writing by the patient or donor. Violation of these provisions may lead to penalties including fines and imprisonment, as outlined in the penalty sections of the Act.
Additionally, ART clinics and hospitals must establish secure digital and physical systems for the storage and retrieval of records to prevent unauthorized access or leaks. A breach of confidentiality not only constitutes an offence under the ART Act but also infringes upon the fundamental right to privacy under Article 21 of the Indian Constitution, as upheld by the Supreme Court in K.S. Puttaswamy v. Union of India (2017).
Prohibited Practices under the ART Act
The Assisted Reproductive Technology (Regulation) Act, 2021 incorporates strict prohibitions to safeguard ethical standards and prevent exploitation in fertility treatment. Under Section 31, sex-selective ART procedures are explicitly banned, in line with the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994 (PCPNDT Act). Clinics found engaging in sex determination or selection face severe criminal liability.
Section 7 of the ART Act prohibits the use of donor gametes without the written informed consent of the donor and the intending couple. The use of anonymous gametes without consent constitutes a serious breach of both legal and ethical norms.
Furthermore, the commercialisation of gamete donation or surrogacy is strictly forbidden. Section 21 prohibits any form of monetary compensation to donors beyond prescribed expenses, while Section 41 imposes punishment for advertising, offering, or promoting commercial ART services.
Additionally, Section 38 makes it illegal for clinics to mislead the public through advertisements, including claims of guaranteed success or false statistics.
Violations of these provisions attract stringent penalties under Section 42, including imprisonment of up to 10 years and fines up to ₹25 lakh, reinforcing the law’s commitment to ethical and non-exploitative reproductive healthcare in India.
Quality and Safety Standards for ART Clinics under the ART Act
Under the Assisted Reproductive Technology (Regulation) Act, 2021, hospitals and institutions offering ART services are legally required to maintain high standards of quality, hygiene, and safety to ensure patient welfare and procedural integrity. Section 20 mandates that all ART procedures be conducted in sterile, clinically controlled environments, minimizing the risk of infection and procedural failure.
To comply with these obligations, equipment used in ART laboratories must be regularly maintained, calibrated, and recorded. This ensures accuracy in gamete handling, fertilization, and embryo transfer. ART laboratories are further expected to follow ISO-certified protocols, as well as bioethical guidelines laid down by the National Advisory Board under the Act, as referenced in Section 33.
Additionally, the Act emphasizes the importance of internal quality control and periodic audits. Institutions must conduct regular audits and self-assessments to monitor adherence to operational and safety norms. These audits help identify gaps, promote accountability, and enhance service delivery.
Non-compliance with these safety and quality standards can lead to penalties under Section 42, including suspension or cancellation of registration, fines, or even criminal prosecution. Thus, strict adherence is not only a legal obligation but a professional and ethical necessity in ART practice.
Donor Screening and Ethical Protocols in ART Banks
Under the Assisted Reproductive Technology (Regulation) Act, 2021, ART banks are obligated to follow strict guidelines for screening and managing gamete donors to uphold ethical standards and safeguard the health and rights of all parties involved. According to Section 13 of the Act, every ART bank must ensure that comprehensive medical and psychological evaluations are conducted before accepting any gamete donor.
Donors must be screened for genetic disorders, infectious diseases, and psychological stability to minimize risks to recipients and potential offspring. As per Section 15, all donors are required to sign informed consent forms, which clearly state the medical risks, confidentiality clauses, and legal relinquishment of parental rights.
Further, in accordance with Schedule I of the Rules, the use of gametes from a single donor is restricted to a maximum of 75 recipients nationwide. This measure is aimed at preventing inadvertent consanguinity and genetic complications within the population.
Additionally, ART banks must maintain transparent documentation of donor identities, screening procedures, consent forms, and usage records. Failure to follow these ethical and procedural standards can result in penalties under Section 42, including fines, suspension of registration, or imprisonment. These safeguards are central to ensuring safe and responsible reproductive care.
Regulatory Oversight and Enforcement Powers under the ART Act
The Assisted Reproductive Technology (Regulation) Act, 2021 establishes a robust regulatory framework through the creation of the National Assisted Reproductive Technology and Surrogacy Board (NARTSB) and State Boards, empowered to ensure strict compliance by ART clinics and banks.
Under Section 20 of the Act, these boards are authorised to conduct inspections of any ART clinic or bank at any time, with or without prior notice. The purpose of these inspections is to verify adherence to registration conditions, ethical practices, record maintenance, infrastructure standards, and safety protocols. Clinics and banks are legally required to cooperate, provide necessary records, and facilitate the inspection process.
If non-compliance is detected, Section 21 empowers the appropriate authority to suspend or cancel the registration of the violating facility. In cases of severe or repeated violations—such as use of unauthorised donor gametes, breach of confidentiality, or unethical practices—the Board may recommend criminal prosecution, as per Section 42, leading to penalties including fines and imprisonment of up to 10 years.
Hospitals and institutions offering ART services must therefore view compliance not merely as a formality but as a legal and ethical obligation, central to safeguarding reproductive rights and maintaining public trust in assisted reproductive care.
Penalties for Non-Compliance under the ART Act, 2021
The Assisted Reproductive Technology (Regulation) Act, 2021 imposes strict penalties to deter unethical and unlawful practices in ART clinics and banks. These penalties are clearly outlined to hold institutions and professionals accountable for violations.
Under Section 26, operating an unregistered ART clinic or bank is a grave offence, punishable with imprisonment of up to 10 years and a fine of up to ₹25 lakh. This makes registration the foundational compliance requirement under the Act.
Section 28 criminalises the performance of ART procedures without obtaining proper informed consent, prescribing 3 to 5 years of imprisonment and a fine of ₹5–10 lakh. This underscores the critical importance of documented, informed consent from all parties involved.
Further, Section 27 prohibits the commercial exploitation of donors, particularly women, and violations here can result in 5 to 10 years of imprisonment and fines up to ₹10 lakh. This provision aims to curb coercive or profit-driven donor practices.
Additionally, Section 33 penalises misleading or false advertisements of ART services with fines up to ₹10 lakh, safeguarding patients from deceptive marketing.
Legal and compliance officers in hospitals must be well-versed with these statutory provisions to mitigate risks, ensure ethical practice, and uphold patient rights under the ART framework.
Insurance and Compensation Requirements under the ART Act, 2021
The Assisted Reproductive Technology (Regulation) Act, 2021 lays strong emphasis on the protection and welfare of surrogate mothers and donors, particularly through provisions related to insurance and compensation.
As per Section 6(8) of the Surrogacy (Regulation) Act, 2021—read with relevant clauses under the ART Act—ART clinics are mandated to provide medical insurance coverage for surrogate mothers for a minimum period of 36 months, covering all medical expenses and any unforeseen complications arising from the procedure. Although primarily under the Surrogacy Act, these obligations are enforced jointly with the ART Act to ensure cohesive regulation of ART procedures involving surrogacy.
Additionally, Section 21 of the ART Act requires clinics and banks to ensure that all compensation or reimbursements to gamete donors and surrogate mothers are clearly documented through legal agreements. These agreements must be signed by all parties involved and submitted to the appropriate authority as part of the registration and monitoring process.
Moreover, in instances of medical negligence, clinics may be held liable for financial redress, including damages or compensation to the affected party. Failure to adhere to these provisions can result in penalties under Sections 26–30, which include imprisonment and heavy fines.
These safeguards aim to uphold dignity, ensure informed participation, and prevent exploitation.
Continuous Training and Skill Development under the ART Act, 2021
To uphold the highest standards in assisted reproductive care, the Assisted Reproductive Technology (Regulation) Act, 2021 emphasizes the importance of continuous training and professional development for all personnel involved in ART procedures.
Under Section 19(3) of the ART Act, every registered clinic is required to employ only qualified and adequately trained professionals, including embryologists, gynecologists, and laboratory technicians. However, the Act goes beyond initial qualifications by encouraging ongoing capacity building to ensure staff remain up to date with emerging technologies, evolving protocols, and ethical norms.
The National and State ART and Surrogacy Boards, empowered under Section 17 and Section 18, are tasked with formulating training modules, conducting workshops, and organizing Continuing Medical Education (CME) programs for medical professionals and clinic staff. These training sessions are meant to cover both technical advancements in ART procedures (like cryopreservation or ICSI) and non-technical aspects, such as patient counselling, ethical guidelines, and data protection laws.
Hospitals and ART institutions are expected to maintain records of participation in such programs and submit updates during regulatory inspections. Regular training not only strengthens compliance but also enhances the quality and safety of services offered—reinforcing the Act’s core goal of ethical, patient-centered reproductive care.
Building a Legally Sound ART Ecosystem
The ART (Regulation) Act, 2021, has ushered in a new era of accountability and transparency in assisted reproductive services in India. For hospitals and institutions, the compliance mandates under the ART Law are comprehensive, covering everything from registration to patient rights, from ethical standards to legal liabilities.
While these requirements may appear stringent, they are crucial for building public trust and ensuring that ART services remain safe, ethical, and accessible. As India continues to evolve as a hub for medical innovation, adherence to ART regulations will be key to sustainable and equitable growth in the fertility industry. Hospitals and clinics must view compliance not as a burden but as a framework for delivering world-class reproductive healthcare.
By aligning with the ART Law, institutions can contribute meaningfully to India’s reproductive rights journey, protecting patients, empowering professionals, and fostering a culture of ethical care.
