ART ACT 2021 - IVF | ICU | ICSI | OI/TI

ART ACT 2021

(Parliament passed the bill in December 2021. Act came into effect in June 2023)

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Main objective

  • To regulate ART clinics and banks
  • To prevent misuse
  • To ensure safe and ethical practice by clinicians and ART centers
  • To use data for research and development

Pre-requisites of patients to avail fertility treatments

  • The Female partner age should be between 21-50 years
  • The Male partner age should be between 21-55 years
  • The Couple should be married
  • To provide Aadhar cards for identification
  • A single woman can undergo IUI with donor sperm

Pre-requisites for the clinic to perform fertility services

  • Centre to be registered under the ART act
  • Registration to be displayed
  • To have qualified doctors/embryologists/support staff
  • Periodically update the national registry about the treatments/outcomes of registered couples.
  • Should have a grievance cell
  • Maintain all records of cases as prescribed by the ACT

Clinics should be registered based on the services they provide

1

Level 1 clinic

  • Evaluation of the couple
  • Ovulation induction
  • IUI

2

Level 2 clinic

  • Evaluation of the couple
  • Ovulation induction
  • IUI
  • IVF/ICSI
  • PGT/PGD
  • Donor sperm/ Donor egg programs

3

Surrogacy clinic

  • Where surrogacy is done for indicated cases
  • Has to be altruistic (not commercial)
  • The surrogate has to be insured for a period of 36 months and all her medical expenses are to be borne by the intending couple

Sourcing of donor eggs

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Sourcing of donor eggs

  • Evaluation, recruitment, and allocation to the couple are done by ART bank
  • Stimulation, egg collection and IVF are done by a registered level 2 clinic
  • Donor recruitment is to be done as per rules and regulations
  • All safety precautions like mild stimulation, donor insurance, etc to be ensured

Sourcing of sperm

  • Donor evaluation, recruitment and allocation to the couple are done by the ART bank
  • Clinic to procure samples from the ART Bank

Surrogacy ACT

  • A clinic should be registered as a separate surrogacy clinic under the Surrogacy Act
  • Couple should have a valid indication
  • Couple should not have a living child (unless challenged)
  • They should use their own gametes (both sperm and eggs)
  • Single women (widow/divorced) can plan surrogacy with self-eggs and donor sperm
  • It should be an altruistic surrogacy (no commercialization)- a relative or friend should act as a surrogate
  • Proper evaluation of the surrogate is to be done
  • All documents are to be procured and submitted as prescribed by the law
  • Clinic to fulfill the criteria prescribed by the law
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