Surrogacy and ART Regulations in India: Legal Framework Under Surrogacy Act 2021 and ART Act 2021

Executive Summary

The Surrogacy (Regulation) Act, 2021 and the Assisted Reproductive Technology (Regulation) Act, 2021 provide comprehensive legal frameworks governing surrogacy and assisted reproduction in India. These landmark legislations ban commercial surrogacy, establish eligibility criteria for intending couples and surrogates, mandate registration of ART clinics, and impose stringent penalties for violations.

Key Statistics & Regulatory Landscape

• Infertility Rate: 10-15% of Indian couples face infertility
• ART Clinics: Over 2,500 registered ART clinics and banks across India
• Annual ART Cycles: Approximately 2.5 lakh ART cycles performed annually
• Surrogacy Cases: Estimated 2,000-3,000 surrogacy arrangements annually (pre-2021 Act)
• Commercial Surrogacy Ban: Effective from January 2022
• Success Rate: 30-35% live birth rate per ART cycle

Regulatory Authorities: National Assisted Reproductive Technology and Surrogacy Board, State ART and Surrogacy Boards, National Registry of ART Clinics and Banks.

1. Surrogacy (Regulation) Act, 2021: Overview

1.1 Objectives and Legislative Intent

Primary Objectives:

1. Prohibit Commercial Surrogacy: Ban payment to surrogate mothers beyond medical expenses and insurance
2. Regulate Altruistic Surrogacy: Permit surrogacy only for altruistic purposes with close relatives
3. Protect Surrogate Rights: Ensure surrogate's informed consent, medical screening, and insurance coverage
4. Prevent Exploitation: Prevent exploitation of vulnerable women (poor, illiterate) as commercial surrogates
5. Establish Regulatory Framework: Create national and state boards to regulate surrogacy arrangements

1.2 Key Definitions

1.3 Commercial Surrogacy Ban: Scope and Penalties

Section 4 - Prohibition of Commercial Surrogacy:

No person, organization, ART clinic, or surrogacy clinic shall:

• Undertake or advertise commercial surrogacy
• Exploit surrogate mother or intending couple
• Abandon, exploit, or disown child born through surrogacy

Penalties (Section 36-45):

Cognizable and Non-Bailable: Offenses under Surrogacy Act are cognizable (police can arrest without warrant) and non-bailable.

2. Eligibility Criteria for Surrogacy

2.1 Eligibility of Intending Couple

Section 4(iii)(b) - Who Can Commission Surrogacy:

Intending couple must meet ALL of the following criteria:

Infertility Certification: District Medical Board (comprising gynecologist, pediatrician, and physician) must certify that couple has proven infertility after exhausting other infertility treatments.

2.2 Eligibility of Surrogate Mother

Section 4(iii)(a) - Who Can Be a Surrogate:

Surrogate mother must meet ALL of the following criteria:

"Close Relative" Definition: While Act uses term "close relative," Rules do NOT define it. Courts and authorities interpret as: Mother, sister, sister-in-law, aunt, cousin (first degree or second degree).

Critical Gap: Absence of clear definition has created implementation challenges; many states issuing guidelines restricting to immediate family only.

2.3 Registration and Approval Process

Step-by-Step Procedure for Surrogacy Arrangement:

Documents Required:

For Intending Couple:

• Marriage certificate (min. 5 years of marriage)
• Age proof (Aadhaar, passport)
• Infertility certificate from District Medical Board
• Certificate proving no surviving biological/adopted child (or medical certificate for disabled child)
• Insurance policy for surrogate (36 months coverage)

For Surrogate Mother:

• Age proof
• Proof of close relationship with intending couple (birth certificate, family records)
• Medical fitness certificate
• Consent of surrogate's husband
• Certificate that surrogate has not been surrogate previously

3. Assisted Reproductive Technology (Regulation) Act, 2021

3.1 ART Act: Scope and Objectives

Objectives:

1. Regulate ART clinics and prevent misuse of ART services
2. Ensure safe, ethical, and standardized ART practices
3. Protect rights of parties to ART (intending couple, donor, child born through ART)
4. Establish National and State ART and Surrogacy Boards
5. Create National Registry of ART clinics, banks, and donors

Scope: Covers all ART services including:

• In-Vitro Fertilization (IVF)
• Intra-Cytoplasmic Sperm Injection (ICSI)
• Gamete donation (sperm, egg)
• Embryo donation
• Gestational surrogacy
• Intrauterine insemination (IUI)
• Embryo/gamete cryopreservation

3.2 Registration of ART Clinics and Banks

Mandatory Registration (Section 10):

Every ART clinic and ART bank must register with National Registry (maintained by National Board).

Application Process:

Minimum Standards for ART Clinics:

Infrastructure:

• Counseling room
• Procedure room (IVF laboratory with laminar flow, incubators)
• Operation theater (for oocyte retrieval, embryo transfer)
• Andrology laboratory (for semen analysis and processing)
• Cryopreservation facility (liquid nitrogen storage for embryos/gametes)

Staffing:

• Registered Medical Practitioner (MBBS) with DGO/DNB/MD (OB-GYN) or Urology/Andrology
• Embryologist (MSc/PhD in Embryology/Life Sciences with ART training)
• Counselor (Psychology/Social Work degree)
• Laboratory Technician
• Nurse (GNM/BSc Nursing)

Equipment:

• Ultrasound machine
• IVF workstation with HEPA filter
• CO2 incubator for embryo culture
• Micromanipulator for ICSI
• Liquid nitrogen storage tanks
• Sperm analyzer

3.3 Donor Gametes: Regulation and Anonymity

Gamete Donation Provisions:

Eligibility of Gamete Donor:

Anonymity and Confidentiality (Section 23):

• Donor Identity: Completely anonymous to intending couple and child
• Intending Couple Identity: Anonymous to donor
• Records Maintained: ART clinic maintains donor records for 10 years (accessible only to National Registry)

Exception: If child born through donor gametes develops genetic disease, donor's medical history can be accessed (but NOT identity).

Prohibition on Disclosure: ART clinic or bank that discloses donor/recipient identity faces penalty (imprisonment up to 3 years + fine up to ₹5 lakh).

3.4 Rights of Child Born Through ART

Section 22 - Rights of Child:

1. Right to Know Donor Conception (at age 18): Child has right to know they were born through donor gametes (clinic must inform parents to disclose to child)
2. Right to Medical History: Child can access donor's medical history (but NOT identity) if needed for treatment
3. Right to Citizenship: Child deemed to be biological child of intending couple; entitled to all inheritance and succession rights
4. Right to Maintenance: Intending couple legally obligated to provide for child, even if marriage dissolves

No Right to Know Donor Identity: To protect donor privacy and prevent future claims, child does NOT have right to know donor's identity.

4. Prohibited Practices Under ART Act

4.1 Sex Selection Ban

Section 19 - Prohibition of Sex Selection:

No person, ART clinic, or genetic counseling center shall:

• Conduct or facilitate pre-conception or pre-implantation sex selection
• Select embryos based on sex (except to prevent sex-linked genetic disease)
• Separate sperm for sex selection purposes

Penalty: Imprisonment up to 5 years + fine up to ₹10 lakh + cancellation of clinic registration.

Exception: Sex selection permitted ONLY to prevent sex-linked genetic disorders (e.g., Hemophilia, Duchenne Muscular Dystrophy) - requires approval from State Board.

4.2 Other Prohibited Practices

5. National and State ART and Surrogacy Boards

5.1 National Assisted Reproductive Technology and Surrogacy Board

Constitution (Section 3 of ART Act, Section 3 of Surrogacy Act):

Composition:

Functions:

1. Frame guidelines and codes of conduct for ART clinics, surrogacy clinics, and ART banks
2. Maintain National Registry of ART clinics, banks, surrogates, and donors
3. Supervise State Boards
4. Recommend to government on policy matters related to ART and surrogacy
5. Grant/reject registration of ART clinics and banks
6. Hear appeals against State Board orders

5.2 State Assisted Reproductive Technology and Surrogacy Board

Constitution: Each state/UT must constitute State Board.

Composition: Similar to National Board (state-level officials and experts).

Functions:

1. Register surrogacy clinics and ART clinics in the state
2. Investigate complaints against clinics
3. Conduct inspections and enforce compliance
4. Recommend suspension/cancellation of registration for violations
5. Maintain state-level database of surrogacy arrangements and ART procedures

5.3 National Registry of ART Clinics and Surrogacy Clinics

Purpose:

• Centralized database of all registered clinics, banks, surrogates, and donors
• Track surrogacy arrangements and ART cycles
• Prevent misuse (e.g., multiple surrogacies by same woman, sex selection)

Data Maintained:

• ART clinic/bank details (name, location, registration status)
• Surrogate details (anonymized; number of surrogacies)
• Donor details (anonymized; number of donations)
• Intending couple details (for surrogacy)
• ART procedure outcomes (success rate, live births, complications)

Access: Registry accessible to National/State Boards, registered clinics (for verification), and law enforcement (for investigation of offenses).

6. Comparative Analysis: Pre-2021 vs. Post-2021 Regime

6.1 Surrogacy Landscape: Before and After

Impact of Ban:

• Commercial surrogacy industry (estimated ₹2,000-3,000 crore annually) shut down
• Foreign "reproductive tourism" ended
• Surrogacy became accessible only to limited group (married, infertile, Indian couples with close relative willing to be surrogate)
• Concerns raised by LGBTQ+ community, singles, and NRI couples excluded from surrogacy

6.2 ART Regulation: Before and After

7. Challenges and Criticisms

7.1 Exclusionary Eligibility Criteria

Criticisms:

1. Discrimination Against Singles and LGBTQ+: Act restricts surrogacy to married heterosexual couples, excluding single parents and LGBTQ+ individuals seeking parenthood.

2. NRI and Foreigner Exclusion: Indian nationals living abroad (NRIs) and foreign nationals cannot commission surrogacy in India, even for medical necessity.

3. "Close Relative" Ambiguity: Absence of clear definition of "close relative" has led to inconsistent implementation; many potential surrogates unable to find eligible family member.

4. Overly Restrictive: Criteria (no surviving child, first surrogacy only, close relative) make surrogacy inaccessible to many infertile couples.

Judicial Challenges: Several writ petitions filed in High Courts challenging constitutionality of exclusionary provisions; cases pending.

7.2 Implementation Gaps

Operational Challenges:

• State Board Delays: Several states have not constituted State Boards, delaying registration process
• National Registry Not Fully Operational: As of 2024, National Registry still under development; full-scale implementation pending
• Lack of Clarity on Procedures: Detailed procedures for obtaining certificates from District Medical Board and State Surrogacy Board not uniformly implemented

Industry Impact:

• Many ART clinics have stopped offering surrogacy services due to stringent compliance requirements and limited eligible couples
• Underground commercial surrogacy networks may emerge (enforcement challenge)

8. Compliance Checklist for ART Clinics and Surrogacy Clinics

8.1 Pre-Operational Compliance

• Obtain registration from State ART/Surrogacy Board (Form 1 application)
• Ensure infrastructure meets minimum standards (counseling room, IVF lab, OT, cryopreservation)
• Hire qualified staff (gynecologist, embryologist, counselor, nurse)
• Procure essential equipment (incubators, micromanipulators, liquid nitrogen tanks)
• Establish Standard Operating Procedures (SOPs) for all ART procedures

8.2 Operational Compliance

For Each Surrogacy Case:

• Verify intending couple's eligibility (age, nationality, marriage, infertility certificate, no surviving child)
• Verify surrogate's eligibility (age, marital status, own child, close relative, first surrogacy, medical fitness)
• Obtain "Essentiality Certificate" and "Eligibility Certificate" from State Surrogacy Board
• Draft surrogacy agreement (no payment clause; surrogate's informed consent; insurance coverage)
• Provide comprehensive insurance to surrogate (36 months coverage for pregnancy-related risks)
• Maintain confidentiality of all parties

For Each ART Procedure:

• Obtain informed consent from intending couple/couple/individual
• Conduct medical screening of gamete donor (if using donor gametes)
• Maintain anonymity of donor and recipient
• Register donor in National Registry (anonymized)
• Provide counseling to intending couple (success rates, risks, alternatives)
• Document entire ART procedure (embryo creation, transfer, cryopreservation)
• Report outcome to National Registry (pregnancy, live birth, complications)

Prohibited Acts to Avoid:

• No sex selection (except for sex-linked genetic disease with Board approval)
• No commercial surrogacy (no payment to surrogate beyond medical expenses)
• No disclosure of donor/recipient identity
• No sale or commercial dealing in embryos/gametes
• No offering ART services without valid registration

8.3 Record Maintenance and Reporting

Records to Maintain (for minimum 10 years):

• Intending couple's details (age proof, infertility certificate, marriage certificate)
• Surrogate's details (eligibility documents, medical fitness certificate, consent)
• Surrogacy agreement
• Donor details (anonymized; medical screening reports)
• ART procedure details (embryo creation date, transfer date, outcome)
• Cryopreservation records (embryo/gamete storage details, consent for storage duration)
• Adverse events and complications

Reporting to State/National Board:

• Monthly return of all surrogacy arrangements initiated
• Quarterly return of all ART cycles performed
• Annual audit report (financial and clinical audit)
• Immediate reporting of serious adverse events (maternal death, severe complications)

9. Future Outlook and Recommendations

9.1 Proposed Amendments and Reforms

Pending Proposals:

1. Expand Eligibility: Include singles, LGBTQ+ individuals, NRIs (with safeguards)
2. Clarify "Close Relative": Define clearly in Rules to avoid implementation confusion
3. Streamline Approval Process: Reduce bureaucracy; timeline-bound approvals
4. Regulate Cross-Border Surrogacy: For Indian couples seeking surrogacy abroad (medical tourism to countries like Ukraine, Georgia)

9.2 Recommendations for Stakeholders

For Government:

• Fast-track constitution of State Boards in all states
• Operationalize National Registry fully with online access
• Conduct public awareness campaigns on ART and surrogacy laws
• Provide financial assistance to infertile couples (subsidized ART treatment)

For ART Clinics:

• Ensure full compliance with registration and operational standards
• Invest in staff training on ethical ART practices
• Adopt best practices (ICMR guidelines, international ART protocols)
• Maintain transparent communication with patients

For Intending Couples:

• Understand eligibility criteria before approaching surrogacy
• Verify clinic's registration status before availing services
• Seek legal advice on surrogacy agreement and parental rights
• Explore adoption as alternative (less restrictive than surrogacy)

Conclusion

The Surrogacy Act, 2021 and ART Act, 2021 represent India's first comprehensive statutory framework for assisted reproduction, balancing the need to assist infertile couples with protection against exploitation and unethical practices. Key achievements:

1. Commercial Surrogacy Ban: Ends exploitation of vulnerable women as commercial surrogates
2. Altruistic Surrogacy Framework: Ensures surrogacy is for genuine medical necessity, not convenience
3. ART Regulation: Standardizes ART practices, ensuring safety and ethical compliance
4. Child Rights: Establishes clear legal status and rights of children born through ART/surrogacy
5. Penalties: Deters illegal practices with stringent punishment

Challenges Remain:

• Exclusionary eligibility criteria limit access
• Implementation gaps due to delayed State Board constitutions
• Need for clearer procedural guidelines

Way Forward:

• Inclusive amendments to accommodate diverse family structures
• Efficient operationalization of National Registry
• Continuous review and reform based on implementation experience

References & Resources

Statutes and Rules:

• The Surrogacy (Regulation) Act, 2021
• The Assisted Reproductive Technology (Regulation) Act, 2021
• Surrogacy (Regulation) Rules, 2022
• ART (Regulation) Rules, 2022

Official Resources:

• Ministry of Health & Family Welfare: https://mohfw.gov.in
• Indian Council of Medical Research (ICMR): https://www.icmr.gov.in
• National ART & Surrogacy Registry: (under development)