Reproductive Technology Regulation in India

India regulates assisted reproductive technology (ART) through a comprehensive legislative and regulatory framework designed to ensure ethical practices, prevent misuse, and protect the rights of all parties involved in fertility treatments.

The Primary Legislative Framework

The Assisted Reproductive Technology (Regulation) Act, 2021 is the primary legislation for reproductive technology regulation in India. This Act was passed by Parliament on December 20, 2021, and signed into law on December 18, 2021. It establishes a structured regulatory system with the central objective of regulating and supervising ART clinics and banks, preventing misuse, and ensuring safe and ethical practices for reproductive health.​

Complementing this is the ART (Regulation) Rules, 2022, which provides detailed implementation guidelines and operational procedures for the Act.​

Regulatory Structure and Governance

The regulation is implemented through a two-tier governance system. The National ART and Surrogacy Board handles policy formulation and nationwide oversight, while State ART and Surrogacy Boards coordinate enforcement at the state level. These boards work with Appropriate Authorities designated in each state and union territory to oversee registration, compliance, and enforcement.​

A National Registry of Banks and Clinics serves as a centralized database maintaining records of all registered ART clinics and banks across the country. This registry is accessible online through the National ART & Surrogacy Portal and acts as the central authority for clinic and bank registration information.​

Clinic Classification and Registration Requirements

The Act establishes a two-level clinic classification system.​

• Level 1 ART Clinics can perform basic infertility procedures such as intrauterine insemination (IUI).​
• Level 2 ART Clinics are equipped to handle complex procedures, including in vitro fertilization (IVF) and embryo transfer.​
  

All ART clinics and banks must obtain mandatory registration with the National Registry to operate legally. Registration is valid for five years and can be renewed for an additional five years. Registration must be prominently displayed at the clinic or bank premises.​

The registration process requires submission of applications through the Appropriate Authority in each jurisdiction, with applicants needing to meet specific staffing, infrastructure, equipment, and facility requirements. The Appropriate Authority must process applications within 30 days of receipt, and registration cannot be granted without a physical inspection of the premises by the State Board.​

Eligibility Criteria for ART Services

Access to ART services is restricted to specific categories of individuals.​

• Married couples where the woman is between 21 and 50 years of age and the man is between 21 and 55 years of age are eligible.

Additionally, married couples must demonstrate infertility, defined as the inability to conceive after one year of unprotected coitus or the presence of a proven medical condition preventing conception.​

• Ever-married single Indian women (widows or divorced women) aged 21-50 years are also eligible to access ART services.​

The Act notably excludes unmarried men, single fathers, widowers, unmarried cohabiting couples, transgender individuals, and homosexual couples from accessing ART services, a provision that has drawn criticism regarding constitutional equality principles.​

Mandated Procedures and Requirements

• All ART clinics and banks must obtain written informed consent from commissioning parties and donors before conducting any procedures.​
• Mandatory genetic disease screening before embryo implantation is required. Sex-selective ART procedures are explicitly prohibited, and clinics cannot offer sex determination services.​
• Commissioning couples must provide insurance coverage for egg donors to protect against any loss, damage, or death related to the donation process.​
• All ART clinics and banks must establish and maintain a Grievance Redressal Cell to address complaints from commissioning couples, surrogates, and donors. Additionally, clinics must provide mandatory counselling to couples and individuals considering ART to ensure informed decision making.​

Restrictions on Gamete Donation

• India operates under an altruistic donation model, meaning sperm donation is restricted to altruistic arrangements only with no commercial compensation for donors.​
• Women can donate oocytes (eggs) only once in their lifetime, with a maximum of 7 oocytes retrievable per donation. ART banks are prohibited from supplying reproductive cells from a single donor to more than one commissioning couple.​

Research Regulation

The Act includes provisions governing research involving human gametes, embryos, and gonadal tissues, ensuring that research is conducted ethically and in compliance with established guidelines.​

Penalties and Enforcement

The regulatory framework includes stringent enforcement mechanisms with significant penalties for violations.​

For first-time violations of general provisions, offenders face fines ranging from ₹5 to ₹10 lakhs (approximately USD 6,000–12,000). Subsequent violations are punishable with imprisonment of 3 to 8 years plus fines ranging from ₹10 to ₹20 lakhs (USD 12,000–24,000).​

For sex-selective ART violations, penalties are notably stricter, with imprisonment of 5 to 10 years, fines ranging from ₹10 to ₹25 lakhs (USD 12,000–30,000), or both.​

Repeated offenses involving clinic or bank ownership can result in imprisonment of 8 to 12 years plus fines of ₹8 to ₹12 lakhs (USD 9,600–14,400).​

Rights of Children Born Through ART

Children born through ART are legally deemed to be biological children of the commissioning couple and are entitled to all rights and privileges available to natural children. Importantly, gamete donors have no parental rights over children born through the use of their genetic material.​

Data Management and Privacy Considerations

ART clinics and banks must share specific information with the National Registry, including details about enrolled commissioning parties and donors, procedures undertaken, and procedural outcomes. However, this data collection requirement has raised concerns regarding the right to privacy, particularly regarding the mandatory collection of Aadhaar details from donors.​

Identified Gaps and Limitations

Despite being a comprehensive regulatory framework, the Act has several acknowledged limitations. The eligibility restrictions exclude significant populations from accessing ART services despite legal permission for adoption by unmarried individuals and single fathers under other Indian laws. Additionally, the Act does not include provisions regulating service costs, leaving pricing largely uncontrolled.