Registration of ART Clinics and Banks: Complete Procedure, Appeal and Writ Petition.

INTRODUCTION

All ART clinics and banks operating in India must be duly registered under the ART Act of 2021. Under Section 15(2), the application for registration of an ART clinic or bank is to be filed to the National Registry through the Appropriate Authority designated in the city. The process for registration can be undertaken online at the following website: –

NARTSR | Dashboard (artsurrogacy.gov.in)

Any registration will only be granted after an inspection of the premises of the ART clinics or banks by the State Board. A registration, once granted is valid for a period of 5 years and the registration certificate is required to be displayed at a conspicuous place at the clinic or the bank.

The ‘Ministry of Health and Family Welfare’ (MoHFW) on 7^th June had passed the ‘Assisted Reproduction Technology (Regulation) Rules of 2022.’ These Rules incorporate pertinent information regarding the classification of ART Clinics, the registration process of an ART Clinics or Bank etc. Based on the said rules, this blog attempts to provide a detailed procedure for the registration of ART clinics and banks.  

ART Clinics

For the purpose of registration and maintenance, the ART clinics operating in India have been divided into two categories. These are the ‘Level 1’ and ‘Level 2’ ART clinics. Further characteristics of these clinics are mentioned below:

1. Level 1 ART Clinics: These are the clinics where only one procedure i.e., the Intrauterine Insemination (IUI) is carried out. This procedure is carried out for the treatment of infertility.

2. Level 2 ART Clinics: These are the clinics where procedures and techniques that attempt to obtain a pregnancy (when the same is not possible through natural means) are carried out. Level 2 clinics can follow one or more of the following procedures:

• Surgical retrieval of gametes
• Handling of oocytes outside the human body
• Use sperms for fertilization of oocytes
• Transfer of embryos into the reproductive system of a woman
• Carryout storage of gametes or embryos or perform any kind of procedure or technique involving gametes or embryos

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

ART Banks

The rules have provided for certain responsibilities with regards to the ART banks. All ART banks must have facilities for carrying out the below mentioned activities. In this light, the ART banks are:

• responsible for screening, collection, and registration of the semen donor
• responsible for cryopreservation of sperms.
• responsible for performing screening and registration of oocyte donor.
• responsible for operating as semen banks or oocyte banks or both.
• responsible for maintaining records of all the donors and to regularly update the National Registry

STAFF REQUIREMENTS

Further, all ART Clinics and Banks must satisfy the staff requirements (who also have adequate qualifications) to be able to qualify for registration. The same has been mentioned below:

Level 1 ART Clinic:

Minimum 1 gynecologist is required.

Qualification:

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

Level 2 ART Clinic:

Level 2 ART clinics must have a minimum of:

• 1 gynecologist
• 1 anesthetist
• 1 embryologist
• 1 counselor (professional counselling)

Qualification:

1. Gynecologist: The gynecologist must be a medical post-graduate in gynecology and obstetrics and should have record of performing 50 ovum pickup procedures under 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 are working in ART clinics before the commencement of the ART Act of 2021, a post graduate degree in gynecology and obstetrics with at least three years’ experience and record of 50 ovum pickup procedures can be acceptable).

• Andrologist: The andrologist in a clinic or a bank will be a Mch or DNB in Urology with special training in Diagnosing and Treating Male infertility.

• Embryologist: Post-graduate in clinical embryology (graduated with full time program with minimum four semesters) from a recognized University with additional three years of human ART laboratory experiences in handling human gametes and embryos.

OR

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 one year of human ART laboratory experience in handling human gametes and embryos.

OR

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.

OR

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 7^th 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 qualification and experience as a criterion: –

Graduate in Life Sciences or Biotechnology or Reproductive Biology/ Veterinary Science with at least five years’ experience of working in a registered ART or IVF clinic, who have performed at least 500 IVF lab procedures (including Intra Cytoplasmic Sperm Injection and at least 100 cycles of cryopreservation of embryos).

• Counsellor: A graduate in Psychology or Clinical Psychology or Nursing or Life Sciences.

• Anesthetist: A medical post-graduate in Anesthesia.

ART Banks

A minimum of one Registered Medical Practitioner trained in the handling, preparation, and storage of Semen samples is needed.

EQUIPMENT REQUIRED

1. Level 1 ART Clinic: (Minimum equipment required for registration):

• Microscope
• Centrifuge
• Refrigerator

1. Level 2 ART Clinic: (Minimum equipment required for registration):

• Microscope
• Incubator (minimum 2 in number)
• Laminar Airflow
• Sperm Counting Chambers
• Centrifuge
• Refrigerator
• Equipment for Crypto preservation
• Ovum Aspiration pump
• USG machine with transvaginal probe and needle guard
• Test tube warmer
• Anesthesia resuscitation trolley.

1. ART Banks: (Minimum equipment required for registration):

• Centrifuge Machine
• Incubator
• Microscope
• Laminar Air Flow

GRIEVANCE REDRESSAL

Further, it is mandated under the Rules that all ART clinics and banks are must establish and maintain a grievance cell for addressing the complaints made by the commissioning couple, donor, or the surrogate mother (or any representative) to be eligible for registration.

A complaint to the grievance redressal cell can be made in the format provided in ‘Form 5’ of the 2022 ART Rules.

APPLICATION FOR REGISTRATION

After fulfilling the criterion mentioned above, an ART clinic or bank, if it deems fit can make an application in the prescribed manner before the appropriate authority for the grant of registration. The manner in which the application has to be made is provided in the various ‘Forms’ given in the ART Rules of 2022.

Similarly, the application for registration of an ART Clinic can be made in the format provided in ‘Form 1’ of the Rules. Further, for registration of an ART Bank, an application can be made via ‘Form 2’ of the Rules.

To access the ART Rules of 2022, please visit the website artsurrogacy.gov.in.

Further, go to ‘Notifications’ and then click on ‘Rules.’ Thereafter, click on ‘ART Rules 2022 notification dated 09/06/2022’ to get access to the 2022 ART rules.

FORMS

• Form 1 of the 2022 ART Rules provide for an application form for registration of an ART clinic. (Both Level 1 and Level 2 clinics)

• Form 2 of the 2022 ART Rules provide for an application form for registration of an ART bank.

• Form 3 of the 2022 ART Rules provide for a certificate to be issued by the appropriate authority granting registration to the ART bank or clinic. (Certificate of Registration).

• Form 4 of the 2022 ART Rules provide for an application through which an appeal can be preferred by the ART clinic or bank before the State of Central government, in case of dissatisfaction with the decision of appropriate authority for grant of registration.

• Form 5 of the 2022 ART Rules provides for a format in which a complaint can be preferred in the Grievance cell of the ART clinic or bank by the commissioning couple, surrogate mother, or the donor.  

Role of Appropriate Authority

It is established that any ART Clinic or Bank cannot be established and cannot operate unless it is duly registered with the National Registry.

As per Section 16(1) of the ART Act, the Appropriate Authority on receipt of an application for registration must attend the same within 30 days.

The Authority can reject the application if the same does not conform to the provisions of the ART Act, or the Rules made thereunder. However, before rejecting the application, the Authority has to give full opportunity to ‘remove any defect’ in the application and also provide an opportunity for a hearing to the ART Clinic or Bank in the matter.

It is also provided that if registration is neither granted nor rejected within 30 days, then the Appropriate Authority can, within 7 days, cite reasons for failure to process the application for registration.

The Authority must, within a period of one month of registration being granted under this section, intimate such registration to the State Board.

Inspection by State Boards and the National Board

No registration can be granted unless the State Board has inspected the premises of the applicant. The State Boards have the power to inspect any premises conducting ART services and call for any documents or materials pertaining to the same.

Such powers of inspection have also been granted to the National Board and the National Registry.

The inspection process is a must before granting of approval to any application for registration.

Appeal against order of Appropriate Authority

Further, if in case the application for registration has been rejected, suspended, or canceled by the Appropriate Authority, and the ART Clinic or Bank is of the opinion that their claim is legitimate, then the ART clinic or bank has a right to appeal under Section 19 before the State Government, if the order under appeal is of the Appropriate Authority of a State.

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

Writ Petition

If the ART Clinic or Bank is not satisfied with the order of the State Government or the Central Government, then it shall have the right to file a writ petition before the jurisdictional High Court against the order of the State or Central Government.

CONCLUSION

To conclude, all ART Clinics and Banks operating in India must be registered with the National Registry established under the ART Act, 2021. The MoHFW has also enacted ART Rules of 2022 whereby the details regarding registration have been mentioned. The requirements include certain staff requirements, qualification requirements, and equipment requirements. Further, the Rules also mandate all ART Clinics and Banks to establish and maintain a Grievance Cell to address the complaints made by the parties involved in an ART procedure (commissioning parents, surrogate mother and the donor).

Further, the Appropriate Authority and the State Board must conduct physical inspection of the premises of the ART Clinic or Bank before granting registration.

If the Appropriate Authority rejects the registration application of the ART Clinic or Bank and the Clinic or Bank is of the opinion that they fulfil all requirements mentioned under the ART Rules, the said Clinic or Bank can approach the State Government (if the authority is of a state) or the Central Government (if the authority is of a Union Territory). Furthermore, upon being further aggrieved by the decision of the Central or State Government, the Clinic or Bank can approach the High Court with competent jurisdiction under a writ petition advancing their concerns.

It is pertinent to note that such appeals would not be valid in case there is some deficiency found by the Appropriate Authority or the State Board/National Board in either the requirements mentioned under the Rules, or upon the physical inspection of the premises.