What to know about India’s ART Regulation and Surrogacy Regulation Acts

In December 2021, the Indian Parliament passed two laws that significantly alter the country’s fertility landscape. Historically, India has not regulated practices and rules around access, eligibility, and clinics for assisted reproductive technology (ART) and gestational carrier (GC) journeys (commonly known as surrogacy). 

The laws passed are called the Assisted Reproductive Technology (Regulation) Act, 2021, which regulates who is eligible for ART treatment, establishes a registry for ART clinics, and regulates ART treatments, including the use of donor gametes; and the Surrogacy (Regulation) Act, 2021, which regulates GC journeys. Both laws went into effect on January 25, 2022.

In addition, the Indian government is assembling national and state-level ART and surrogacy Boards to oversee the administration of these laws and has recently released rules governing both the ART Act and the Surrogacy Act. These rules provide some details of how the laws will be implemented.

How the new laws impact GC (surrogacy) journeys in India

• Commercial GC journeys are no longer legally allowed; the law provides for a 10-month transitional period until November 2022 to protect the well-being of existing GCs. 
• Clinics providing GC services will need to apply to the National ART and Surrogacy Registry in order to legally operate.
• All GC clinics that are approved by the Registry will receive a registration certificate that must be displayed in the clinic.
• GC clinics will be subject to regulation and oversight by the National ART and Surrogacy Board.
• The Surrogacy (Regulation) Act establishes eligibility criteria to access GC services, including age, marital status, nationality, and others. Intending parent(s) that meet these requirements can pursue altruistic GC journeys with registered surrogacy clinics.

How the new laws impact ART journeys in India

• ART clinics, OB/GYN centers providing IUI, and donor banks will need to apply to the National ART and Surrogacy Registry in order to legally operate. 
• There are two classifications for clinics: Level 1 (intrauterine insemination, or IUI, only) and Level 2 (in vitro fertilization, or IVF, and research).
• The rules dictate clinics’ and banks’ staff (doctors, embryologists, medical directors, etc.) qualifications and training, facilities requirements, and documentation including new insurance requirements for donor material. Clinics and banks must cease providing ART services (including IUI) if they have not submitted their application to the Registry within 60 days of the establishment of the Registry.
• All ART clinics and banks that are approved by the Registry will receive a registration certificate that must be displayed in the clinic/bank.
• The Act establishes age and marital status criteria to access ART. Intending parent(s) that meet these requirements can pursue assisted reproduction journeys, including donor-assisted reproduction, with registered clinics and banks.

Carrot is closely monitoring the implementation and impacts of the ART and Surrogacy Acts. If there are any official changes or clarifications, we will continue to proactively reach out to registered members in India and update our blog. We encourage members to speak with their clinics to understand if and how these new regulations will apply to their unique journeys. If you are a Carrot member and have any questions about the impact of these regulations on your journey, please reach out to us anytime.