current art law

20Feb, 2024

Current ART Law

ART Level 1 Clinic

fertility clinic

Level 1 clinics can carry out only IUI as part of the infertility treatment.

Registration fees - 50,000 rupees for five years

Minimum staff requirement

  1. Gynaecologist (Medical post-graduate in OBGYN)

Equipment and Infrastructure

The following are the minimum requirements to get registered as an ART Level 1 clinic,

  1. Microscope
  2. Centrifuge
  3. Refrigerator

What can Level 1 ART clinic do?

  1. OPD consultation
  2. Folliculometry by USG
  3. Semen Preparation (including donor semen)
  4. Perform IUI

What Level 1 ART clinic cannot do?

  1. Cannot perform donor gamete cryopreservation
  2. Any ART bank-related work
  3. IVF
  4. ICSI
  5. ET
  6. PGT
  7. Surrogacy
  8. Research

ART Level 2 Clinic

ART Level 2 fertility clinic

Registered Level 2 can undertake procedures and techniques that attempt to obtain a pregnancy such as surgical retrieval of gametes, embryo transfer, storage of gametes, etc.

Registration fees - 2,00,000 INR for 5 years

Minimum staff requirement

  • One gynecologist
    • MD/MS/DNB/PG Diploma in OBGYN + minimum 50 oocyte pickup + 3 years of experience in infertility
    • Medical postgraduate in OBGYN with superspecialist Doctorate of Medicine/Fellowship in reproductive medicine + 3 years of experience in infertility
  • One Anaesthetist
    • Medical post-graduate in Anesthesia
  • One embryologist
    • Postgraduate in clinical embryology (full-time program with minimum four semesters) + 3 years of human ART laboratory experience in handling human gametes and embryos
    • Ph.D. (Full-time- thesis related to clinical embryology or ART or fertility) + one year of human ART laboratory experience in handling human gametes and embryos
    • Medical graduate (MBBS) or veterinary graduate (BVSc) + full time postgraduate degree in clinical embryology + human ART laboratory experience of at least two years
    • Postgraduate in Biotechnology/life sciences with a minimum of one year of onsite full-time clinical embryology certified training + four years of experience in handling human gametes and embryos in a registered ART level 2 clinic
  • One counsellor
    • Graduate in Psychology/ clinical psychology/ Nursing/ Life sciences

Additional Staff (may be employed but not mandatory)

  • Director
    • Postgraduate degree in medical sciences/life sciences/ management
  • Andrologist
    • MCh/DNB in urology
    • MS general surgery
    • MCh/FNB/DM in reproductive medicine

Minimum 2 years of experience + hands-on experience of a minimum of 15 surgical sperm retrieval (PESA/TESA/TESE/MESA/MICROTESE procedures)

Equipment and Infrastructure

The following are the minimum requirements to get registered as a Level 1 ART clinic,

  1. Microscope
  2. Incubator (minimum of 2)
  3. Laminar Airflow
  4. Sperm counting chambers
  5. Centrifuge
  6. Refrigerator
  7. Equipment for cryopreservation
  8. Ovum aspiration pump
  9. USG machine with TVS probe and needle guard
  10. Test tube warmer
  11. Anesthesia resuscitation trolley

What can the ART Level 2 clinic do?

  1. OPD consultation
  2. Folliculometry by USG
  3. IUI
  4. IVF
  5. ICSI
  6. PGT
  7. Any surgical sperm extraction procedure – TESA/PESA/TESE/MICRO TESE and research
  8. Donor IUI/IVF
  9. Donor sperm procured from the ART bank can be stored in the level 2 clinic if not used immediately
  10. Donor oocytes can be procured from the ART bank
  11. Perform donor oocyte retrieval (shall retrieve all formed follicles but utilize only 7 oocytes)
  12. Donor oocyte can be used with the husband’s sperm of a prespecified intending couple
  13. Donor oocyte can be fertilized with donor sperm if clinically intended (if aspermia/azoospermia/poor sperm quality in the prespecified intending couple)
  14. 7 donor oocytes may be frozen for future use for the intending couple only
  15. Single mother IVF/ICSI with donor sperm if she is clinically indicated to avail of IVF

What ART Level 2 clinic cannot do?

  1. Cannot perform donor sperm cryopreservation
  2. Cannot offer surrogacy-related services (if there is surrogacy registration along with ART level 2 registration)

The following Consent forms are to be maintained in the ART level 2 clinic

informed consent
  1. consent form for the couple/ woman (Form-6)
  2. consent for IUI with husband’s semen or sperm (Form-7)
  3. consent for IUI/IVF/ICSI with donor semen (Form-8)
  4. consent for freezing of embryos (Form-9)
  5. consent for freezing gametes (Form-10)
  6. assent for freezing of gametes sperm or oocytes and parental consent (Form11)
  7. consent for oocyte retrieval (Form-12)
  8. consent from the oocyte donor (Form-13)

ART Bank

ART banks facilitate the storage and distribution of human sperm/ oocytes/embryos for future use in ART.

Registration Fees for ART bank is 50,000 INR for 5 years

Minimum Staff requirements

  1. Registered Medical Practitioner (Trained in the handling, preparation, and storage of semen samples)

Equipment and Infrastructures

  1. Centrifuge
  2. Incubator
  3. Microscope
  4. Laminar Airflow

What can ART Bank do?

oocyte banking
  1. Male and Female Donor Registration
  2. Semen analysis of Donor
  3. Blood test of Donor
  4. Cryopreservation of Donor sperm
  5. Donor oocyte freezing facility (optional)
  6. Maintain all donor-related confidential documents in a locker and only authorized people have access to those documents

What ART bank cannot do?

  1. Ovarian stimulation
  2. Perform any ART procedures such as gamete retrieval
  3. ART treatments such as IUI/ICSI/IVF/ET/surrogacy to any patient

The ART banks should maintain

  1. Record of use of donor gametes as specified in Forms 14, 14 A and 14B
  2. consent form for the donor of sperm as specified in Form 15

Surrogacy Clinic

The surrogacy clinic will guide a commissioning couple/ woman by providing them with range of services required in the process including matching intended parents with surrogates, medical screening and evaluation, legal guidance, support throughout the surrogacy journey.


Registration fee of 2,00,000 INR for 3 years

Staff requirements

Staff requirements and their qualification are all similar to ART Level 2 Clinic

Equipment and Infrastructures

They are all similar to ART Level 2 Clinic

What can the Surrogacy clinic do?

They can perform all surrogacy-related procedures such as

  1. 1. Intrauterine insemination using husband Semen (IUI-H)
  2. Intra-uterine insemination using Donor Semen (IUI-D)
  3. In vitro fertilization with Embryo Transfer (IVF- ET)
  4. Intra-cytoplasmic Sperm Injection (ICSI)
  5. Processing of semen
  6. Storage of gametes (sperm and oocyte) and or embryos of patients
  7. Pre-implantation genetic testing

Record maintenance in the surrogacy clinic

record keeping

The surrogacy clinic should maintain all forms, consent letters, reports, records, charts, agreements, and every document mandated by the Surrogacy Act, of 2022. These documents should be preserved for 25 years. These records should be provided during inspection of the appropriate authority if requested. In case of any criminal proceedings or other proceedings involving the surrogacy clinic, the documents should be maintained until the end of the proceedings.

The above information is subject to changes. To know about recent amendments to the ART Regulation Act and Surrogacy Regulation Act, click this link

Raise your awareness about the legal aspects of assisted reproduction and requirements to set up ART clinics by enrolling in our Fellowship in reproductive medicine at Medline academics. Become knowledgeable to navigate the complex legal facets of ART and surrogacy through curriculum.

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