How to Register ART Clinics and Banks in NCT of Delhi

INTRODUCTION

All ART Clinics and Banks operating in the NCT of Delhi must be duly registered with the state ‘appropriate authority,’ as required under Section 15(1) of the ‘Assisted Reproductive Technology Act, 2021 (hereinafter, referred to as the ‘ART Act’).

Under Section 15(2) of the ART Act, the application for registration of an ART clinic or bank is to be submitted to the National Registry through the Appropriate Authority designated for the NCT of Delhi. As per the current status, the Govt. of Delhi has not established a separate ‘appropriate authority’ as required under Section 12(2) of the ART Act. However, the Govt. has designated that all applications for registration of ART banks and clinics in the NCT of Delhi are to be made before the ‘Directorate of Family Welfare, Civil Lines, New Delhi 110054 (hereinafter, referred to as the ‘Authority’).’

The Authority will only grant registration after a proper inspection of the premises of the respective ART clinic or bank. Any registration, once granted, is essentially 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.

QUALIFICATION FOR REGISTRATION

To qualify for registration, every ART Clinic or Bank must fulfill all the requirements mentioned in the ‘Assisted Reproductive Technology Rules, 2022 (hereinafter, referred to as the ‘ART Rules’). The same are enumerated below in successive paragraphs.

ART CLINICS

For the purpose of registration, the ART clinics operating in Delhi have been divided into two categories. These are the ‘Level 1’ and ‘Level 2’ ART clinics.

Registration fee for Level 1 ART Clinics is INR 50,000/– and for Level 2 Clinics is INR 2,00,000/-.

Further characteristics of these clinics are mentioned below:

• Level 1 ART Clinics

(For treatment of Infertility)

These are the clinics where only one procedure i.e., the ‘Intrauterine Insemination’ (IUI) process is carried out. This procedure is carried out for the treatment of infertility.

(Min. Staff Requirement)

A minimum of 1 gynecologist is required.

(Min. Qualification of Staff)

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

(Min. Equipment Required)

Microscope; Centrifuge; Refrigerator.

• Level 2 ART Clinics

(For obtaining pregnancy through ART)

Level 2 clinics are where the 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)

(Min. Staff Requirement)

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

(Min. Qualification of Staff)

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 are 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).

• 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.

• Embryologist: 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.

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 qualifications 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).

• Counselor: A graduate in Psychology or Clinical Psychology or Nursing or Life Sciences.
• Anesthetist: A medical post-graduate in Anaesthesia.

(Min. Equipment Required)

• 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
• Anaesthesia resuscitation trolley.

ART BANKS

The ART Rules have incorporated certain responsibilities that every ART Bank operating in the NCT of Delhi must fulfill. In this light, every ART bank is:

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

The fee for the registration of an ART bank is INR 50,000/-.

(Min Staff Requirement)

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

(Min. Equipment Required)

Centrifuge machine; Incubator; Microscope; Laminar Air Flow.

REGISTRATION PROCESS

After being satisfied that the ART Clinic or bank qualifies for the requirements specified in the ART Rules, one may move an application for registration The process for registration can be undertaken online at the following website: –

NARTSR | Dashboard (artsurrogacy.gov.in)

Firstly, an account must be created on the above-mentioned National web portal by signing up.

Secondly, after successful signup, a link would be sent by the National ART and Surrogacy Registry to the email address provided by the user.

Thirdly, open the link and enter the registered email id and password as ‘User Id’ and ‘Password’.

Fourthly, select the Form for your ART clinic/bank and fill out the details regarding the same and submit the form.  

Lastly, after submission, the PDF printout of the filled-in application form duly signed by the authorized signatory/ competent authority (with name & contact details) on behalf of the clinic/bank should be submitted electronically or by registered post or in person to the SOP, Directorate of Family Welfare of NCT of Delhi (address provided above) through the office of Health Secretary of Govt of Delhi.

DOCUMENTS TO BE SUBMITTED

• Print out of Application Form as submitted on the National Registry portal under ART & Surrogacy Act (2 copies).
• Demand Draft in the favor of “U. T. Appropriate Authority ART & Surrogacy, GNCT of Delhi.”
• Degree, qualification & DMC registration of Director, Gynaecologist, Embryologist, Andrologist (minimum three year of experience for level -2 clinic), Anaesthetist, Counsellor, Radiologist, Sonologist (as per ART & Surrogacy Act, 2021 and PC& PNDT Act) with phone number and e-mail ID and Documents pertaining to permanent /Local address of the applicant. (Photo ID Proof) along with Two recent Passport Size Photographs of the Director/applicant, & 1 photograph of Radiologist, Gynaecologist, Embryologist, Andrologist, Anaesthetist, Counsellor, Radiologist, and Sonologist self-attested.
• Other staff details and documents attached (Staff Nurse, Lab Technician/Imaging Technician/OT Technicians, etc.)
• Invoice and list of Equipment (Machine Number, Model No, etc. (as prescribed in ART & surrogacy as per the type of centers)
• Copy of PNDT & MTP registration certificate of the center.
• Grievance cell details in Center Letter Head.
• Address proof Documents pertaining to the address of the center. Certified copies from the Competent Authority regarding Property papers/Lease agreements with a minimum validity of five years as per the Indian Registration Act 1908 are to be submitted.

• Following details on Centres letterhead: –

• Type of ownership of Organisation (individual ownership/partnership/company/co-operative/any other to be specified). In case the type of organization is other than individual ownership, furnish a copy of articles of association and names and addresses of other persons responsible for the management, Registration Certificate Trademarks Act, 1999, certificate of Incorporation Affidavit regarding board regulation etc. as enclosure duly certified by the competent authority.
• Type of Institution (Govt. Hospital/Municipal Hospital/Public Hospital/Private Hospital/Private Nursing Home/Private Clinic/Private Laboratory/any other to be stated.)

• Bank details of the Organization (A/c no., Bank Details with a copy of PAN Card, Name & address of the Bank with a 6-month bank statement)
• Affidavits from Director/applicant, Gynaecologist, Embryologist, Andrologist, Counsellor, Radiologist, Registered Medical   Practitioner/ Sonologist on Rs. 10/- stamp paper, Registered Notary/ Oath Commissioner attested.

• Affidavit by the hospital owner on Rs.10/-stamp paper, Registered Notary/ Oath commissioner attested certifying that the center conforms the provision of compendium of norms for designing of hospitals and medical institutions (issued by CPWD, Ministry of Housing and Urban Affairs, Govt. of India. Fire NOC form Department of Fire Services, GNCTD if applicable) & built as per the instructions on Rs.10/-stamp paper, Registered Notary / Oath commissioner attested.

• Affidavit by the owner certifying that the ART / Surrogacy clinic, ART bank conforms to the provisions of Master Plan for Delhi as per clause 15.7 of MPD 2021 & built as per the instructions of MPD Plan 2021 on Rs. 10/-stamp Paper, Registered Notary/ Oath Commissioner attested.
• Affidavit by the owner and radiologist that no court case is pending against his/her in any court related to PC & PNDT Act, 1994. PNDT rule as per Rule 18 (code of conduct to be observed by persons working at GC, GCC, GL & 18A (4) [II].
• As per the aforementioned point, 9 private limited companies certified copies of the Memorandum of Association.
• Map of the center showing the location of the ultrasound room/ART-IVF OPD/Procedure Room/OT/Lab/Sample Collection Room/Waiting Area/ Entry- Exit etc.

NOTE- ALL DOCUMENTS & PHOTOGRAPHS SHOULD BE SELF-ATTESTED COMPUTER TYPED AND TO BE PLACED IN SERIAL ORDER IN A FILE WITH PAGING FOR ACKNOWLEDGEMENT.

SAMPLE FORMATS AND AFFIDAVITS

1. Sample format for submitting a list of equipment to be found by clicking here.
2. Sample format for employees or doctors to be found by clicking here.
3. Sample affidavit for Board Resolution in case of private company/partnership to be found by clicking here.
4. Sample affidavit in case of Individual Ownership to be found by clicking here.
5. Sample format for Index list of the Doctor/Embryologist/Medical Geneticist etc to be found by clicking here.