Sec 16
Registration
Every ART clinic and bank must register with the National ART & Surrogacy Registry; registration is valid for 5 years
Compliance Hub · ART Act
ART Act 2021 guide for IVF clinics
A plain-language summary of what the Assisted Reproductive Technology (Regulation) Act 2021 requires of clinics, with the section and source for every point.
Educational information, not legal advice. Last reviewed: .
- Registration validity
- 5 years
- Minimum record keeping
- 10 years
- Max oocytes or embryos per transfer
- 3
- Fine for a first contravention
- ₹5–10 lakh
01
Running the clinic
Registration, records, confidentiality and a way to raise complaints.
Sec 21
Records
Detailed records kept for at least 10 years; share information with the National Registry
Sec 21
Confidentiality
Information on couple, woman and donor kept confidential
Sec 21
Grievance
Maintain a grievance cell
02
Patients and consent
Who can be treated, and what they must be told and agree to.
Sec 21
Eligibility
Screen commissioning couple, woman and gamete donors for eligibility
Sec 21
Age limits
Woman above 21 and below 50; man above 21 and below 55
Sec 21
Counselling
Professional counselling on all implications and chances
Sec 22
Consent
Written informed consent of all parties; 12-month insurance for oocyte donors; cryopreservation needs written instructions for death or incapacity; either partner can withdraw consent before transfer
03
Treatment and the lab
Limits on transfers, donors and genetic testing.
Sec 21
Embryo transfer
Not more than three oocytes or embryos placed in the uterus in a treatment cycle
Sec 27
Oocyte donors
Aged 23–35; donate only once in life; not more than seven oocytes retrieved
Sec 25
Genetic testing
PGT only to screen for known, pre-existing, heritable or genetic diseases
Sec 26
Sex selection
Must not offer a child of pre-determined sex
04
Advertising
What a clinic may never promote, online or offline.
Sec 32
Advertising
No advertisement of sex-selective ART in any manner, including the internet (5–10 years' imprisonment or ₹10–25 lakh fine)
Penalties
Sec 33First contravention: ₹5–10 lakh fine. Later: 3–8 years' imprisonment and ₹10–20 lakh fine
FAQ
Common questions
Each answer is the requirement as stated in the guide above.
What does the ART Act say about registration?
Every ART clinic and bank must register with the National ART & Surrogacy Registry; registration is valid for 5 years (Sec 16).
What does the ART Act say about eligibility?
Screen commissioning couple, woman and gamete donors for eligibility (Sec 21).
What does the ART Act say about age limits?
Woman above 21 and below 50; man above 21 and below 55 (Sec 21).
What does the ART Act say about embryo transfer?
Not more than three oocytes or embryos placed in the uterus in a treatment cycle (Sec 21).
What does the ART Act say about counselling?
Professional counselling on all implications and chances (Sec 21).
What does the ART Act say about consent?
Written informed consent of all parties; 12-month insurance for oocyte donors; cryopreservation needs written instructions for death or incapacity; either partner can withdraw consent before transfer (Sec 22).
What does the ART Act say about oocyte donors?
Aged 23–35; donate only once in life; not more than seven oocytes retrieved (Sec 27).
What does the ART Act say about genetic testing?
PGT only to screen for known, pre-existing, heritable or genetic diseases (Sec 25).
What does the ART Act say about sex selection?
Must not offer a child of pre-determined sex (Sec 26).
What does the ART Act say about advertising?
No advertisement of sex-selective ART in any manner, including the internet (5–10 years' imprisonment or ₹10–25 lakh fine) (Sec 32).
What does the ART Act say about records?
Detailed records kept for at least 10 years; share information with the National Registry (Sec 21).
What does the ART Act say about confidentiality?
Information on couple, woman and donor kept confidential (Sec 21).
What does the ART Act say about grievance?
Maintain a grievance cell (Sec 21).
What does the ART Act say about penalties?
First contravention: ₹5–10 lakh fine. Later: 3–8 years' imprisonment and ₹10–20 lakh fine (Sec 33).
Your next step
Need help closing the gaps?
Talk to the Garbha.ai team about how your clinic handles records, consent and data.
Educational information, not legal advice. Last reviewed: .
Compliance Hub