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