ART Clinics

The ART clinics operating in India are divided into two categories for registration and maintenance purposes. These are Level 1 and Level 2 ART clinics. Level 1 ART clinics only carry out one procedure, which is Intrauterine Insemination (IUI) for the treatment of infertility.

On the other hand, Level 2 ART clinics perform procedures and techniques aimed at obtaining a pregnancy, which is not possible through natural means. These clinics can follow one or more of the procedures mentioned below:

1. Surgical retrieval of gametes
2. Handling of oocytes outside the human body
3. Use of sperm for fertilization of oocytes
4. Transfer of embryos into the reproductive system of a woman
5. Carry out storage of gametes or embryos or perform any kind of procedure or technique involving gametes or embryos.

It is important to note that Level 2 ART clinics are also permitted to carry out research-related activities.

(Note: Level 2 ART clinics are permitted to carry out research-related activities)

ART Banks

The rules governing ART also specify certain obligations for ART banks. These banks must have the necessary facilities to carry out specific activities, which are outlined below:

1. Screening, collection, and registration of semen donors.
2. Cryopreservation of sperm.
3. Screening and registration of oocyte donors.
4. Operating as semen banks or oocyte banks, or both.
5. Maintaining records of all donors and updating the National Registry regularly.

STAFF REQUIREMENTS

In addition, all ART clinics and banks must meet certain staffing requirements and have qualified personnel in order to be eligible for registration. These requirements include:

Level 1 ART Clinic:

This requirement mandates that at least one gynecologist must be present at all ART Clinics and Banks seeking registration.

Qualification:

The gynecologist must hold a post-graduate medical degree in gynecology and obstetrics.

Level 2 ART Clinic:

details of the minimum staff requirements for Level 2 ART clinics, along with their required qualifications:

1. Gynecologist: The gynecologist must be a medical post-graduate in gynecology and obstetrics and should have a record of performing 50 ovum pickup procedures under the supervision of a trained ART specialist with at least three years of working experience in an ART clinic under supervision. In the case of gynecologists practicing ART or IVF and working in ART clinics before the commencement of the ART Act of 2021, a postgraduate degree in gynecology and obstetrics with at least three years of experience and a record of 50 ovum pickup procedures can be acceptable.
2. Andrologist: The andrologist in a clinic or a bank will be an Mch or DNB in Urology with special training in Diagnosing and Treating Male infertility.
3. Embryologist: The embryologist must have one of the following qualifications:

• Post-graduate in clinical embryology (graduated with the full-time program with a minimum of four semesters) from a recognized University with additional three years of human ART laboratory experience in handling human gametes and embryos.
• Ph.D. holder, (full-time Ph.D. project must be related to Clinical Embryology or assisted reproductive technology or fertility) from a recognized university with an additional year of human ART laboratory experience in handling human gametes and embryos.
• Medical graduate (MBBS) or Veterinary graduate (BVSc) with a post-graduate degree in Clinical Embryology (full-time program) from a recognized University with additional two years of ART laboratory experience in handling human gametes and embryos.
• Post-graduate in life sciences or Biotechnology with a minimum of one year of on-site, full-time clinical embryology certified training in addition to four years experience in handling human gametes and embryos in a registered ART level 2 clinic.

Note: All embryologists working in ART or IVF clinics before 7th July 2022 can be allowed to continue as embryologists. However, after the commencement of these rules, all clinics will hire embryologists with any of the above-mentioned qualifications and experience as a criterion.

4. Counselor: A graduate in Psychology or Clinical Psychology or Nursing or Life Sciences.
5. Anesthetist: A medical post-graduate in Anesthesia.

GRIEVANCE REDRESSAL

• All ART clinics and banks must establish and maintain a grievance cell.
• The purpose of the grievance cell is to address complaints made by the commissioning couple, donor, or surrogate mother (or any representative).
• The grievance cell is a requirement for registration.
• A complaint can be made to the grievance cell using the format provided in ‘Form 5’ of the 2022 ART Rules.

APPLICATION FOR REGISTRATION

Once an ART clinic or bank fulfills the eligibility criteria, it can apply for registration before the appropriate authority by following the prescribed process. The application process and required forms are specified in the ART Rules of 2022.

For instance, an ART Clinic can apply for registration using ‘Form 1’ while an ART Bank can use ‘Form 2’. Interested parties can access the ART Rules of 2022 by visiting the website artsurrogacy.gov.in. Click on ‘Notifications’ and then navigate to ‘Rules’ to find the ‘ART Rules 2022 notification dated 09/06/2022’ and access the rules.

FORMS

1. Form 1 in the 2022 ART Rules offers an application form for registering an ART clinic, both Level 1 and Level 2.
2. Form 2 in the 2022 ART Rules offers an application form for registering an ART bank.
3. Form 3 in the 2022 ART Rules provides for the issuance of a certificate of registration by the appropriate authority to the ART bank or clinic.
4. Form 4 in the 2022 ART Rules provides an application through which an ART clinic or bank can appeal to the State or Central government if dissatisfied with the decision of the appropriate authority for granting registration.
5. Form 5 in the 2022 ART Rules provides a format for complaints to be made in the grievance cell of the ART clinic or bank by the commissioning couple, surrogate mother, or donor.

Role of Appropriate Authority

• ART clinics and banks must be registered with the National Registry to operate.
• According to Section 16(1) of the ART Act, the Appropriate Authority must attend to an application for registration within 30 days of receipt.
• If the application does not conform to the ART Act or its rules, the Authority can reject it but must provide an opportunity for the clinic or bank to fix any defects and have a hearing before doing so.
• If registration is neither granted nor rejected within 30 days, the Authority must provide reasons for the delay within 7 days.
• The Authority must inform the State Board of the registration within one month of it being granted.

Inspection by State Boards and the National Board

• Approval for registration of ART services cannot be granted without an inspection of the applicant’s premises by the State Board.
• The State Boards, National Board, and National Registry have been granted the power to inspect any premises offering ART services and request relevant documents and materials.
• The inspection process is mandatory before granting approval for registration.

Appeal against order of Appropriate Authority

The ART clinic or bank has the right to appeal under Section 19 if their application for registration has been rejected, suspended, or canceled by the Appropriate Authority and they believe their claim is legitimate.

If the order under appeal is of the Appropriate Authority of a State, the ART clinic or bank can appeal before the State Government. If the order under appeal is against the Appropriate Authority of a Union Territory, then the appeal must be made before the Central Government.

The appeal must be made within a period of 30 days from the date of order of the Appropriate Authority.

Writ Petition

If an ART Clinic or Bank is dissatisfied with the order of either the State or Central Government, it may file a writ petition before the jurisdictional High Court against such order.

CONCLUSION

In conclusion, all ART Clinics and Banks operating in India must be registered with the National Registry established under the ART Act, 2021. ART Rules of 2022 have been enacted by the MoHFW to outline the registration requirements, which include certain staff, qualifications, and equipment requirements. Additionally, all ART Clinics and Banks must establish and maintain a Grievance Cell to address the complaints made by the parties involved in an ART procedure.

Moreover, the Appropriate Authority and the State Board must physically inspect the premises of the ART Clinic or Bank before granting registration. If the Appropriate Authority rejects the registration application, and the ART Clinic or Bank believes that it fulfills all requirements under the ART Rules, it can approach the State Government (if the authority is of a state) or the Central Government (if the authority is of a Union Territory). In case of further grievance, the ART Clinic or Bank can approach the High Court with competent jurisdiction under a writ petition.

It is important to note that such appeals would not be valid if the Appropriate Authority or the State Board/National Board finds any deficiencies in the requirements mentioned under the Rules or during the physical inspection of the premises.