Judicial Review Of Assisted Reproductive Technology (Regulation) Act, 2021

I. Introduction

Technology in the medical field has evolved over the years and gradually gave birth to alternate reproductive options, by introducing the Assisted Reproductive Technology (Regulation) Act, of 2021 (ART Act). The ART Act marks a significant legislative intervention in India's healthcare landscape. The Act encompasses framework to govern reproductive procedures, ensuring transparency, accountability, liability, and ethical practices in ART clinics/banks. By safeguarding the interests of donors, commissioning parents, and children born through ART, it addresses enduring concerns of exploitation, commercialisation, and regulatory vacuum in the reproductive health sector. This paper attempts to critically analyse the ART Act, by examining its interplay with the Surrogacy (Regulation) Act, of 2021 (Surrogacy Act), and highlights emerging judicial trends shaping the interpretation of these laws, particularly concerning and reproductive rights.

II. Legislative Background of the ART Act

Both the ART Act and the Surrogacy Act were introduced simultaneously to provide dual framework for regulating advanced reproductive technologies in India. While the Surrogacy Act governs altruistic surrogacy arrangements, the ART Act primarily regulates assisted reproductive technology clinics / banks, and the use of gametes and embryos. It lists down the registration process, allots responsibilities, and imposes penalties for any violations. The dual legislation was intended to work symbiotically, with assisted reproductive technology serving as the preliminary stage in several surrogacy arrangements. The ART Act gives assistance through certain special medical techniques which helps commissioning couple to conceive.

III. Legislative Reform: Understanding Insights from the 129^th Parliamentary Standing Committee Report

The ART Bill, introduced in [·], proposed that commissioning couple should be married for minimum five years to avail treatment under the ART Act. This provision was unjust and eventually after recommendations made in the 129^th Report of the Parliamentary Standing Committee on Health and Family Welfare, this provision was removed from the final legislation, thereby providing access and aligning the law with evolving social requirements.

IV. Requirements under the ART Act

Under the ART Act, treatment is permitted for the following categories of persons:

• Married heterosexual couples;
• Persons in live-in relationships;
• Single women; and
• Foreign nationals (subject to regulations).

However, the ART Act explicitly excludes:

• Same-sex couples;
• Unmarried men;
• Single fathers; and
• Persons who are not medically diagnosed with infertility.

V. Exclusion of Same-Sex Couples: Post - Legal Dissonance in the case of Navtej Johar¹

Although the Supreme Court of India acknowledges sexual orientation as part of the right to dignity and privacy, the ART Act does not provide access to same-sex couples. This exclusion forms a bridge that weakens the progressive spirit of the Constitution of India and has attracted widespread criticism considering it to be violative of Article 14 and Article 21 of the Constitution of India.

• Right to Bodily Autonomy under Article 21

• "The right to privacy entails the right to make decisions about one's body and intimate conduct."
• "The choice of whom to partner, the ability to find fulfilment in sexual intimacies... are intrinsic to the constitutional protection of sexual orientation."
• This reinforced bodily justice by protecting the individual's freedom over their body and sexual identity.

This classification has raised significant questions and debates regarding equality, privacy and the right to reproductive autonomy.

VI. Judicial Reforms

In the case of Arun Muthuvel v. Union of India², the Supreme Court granted interim relief to a woman with MRKH Syndrome by permitting use of donor eggs for surrogacy despite an amendment to Surrogacy Act in 2023 which mandated genetic links to both intending parents. The Supreme Court held that the 2023 Amendment contradicted the parent Surrogacy Act and should not apply retrospectively. The 2023 Amendment should be read in a way that a genetic link with at least one intending parent should suffice.

This ruling emphasizes the necessity for harmony between the ART Act and the Surrogacy Act. It affirms that the right to avail of assisted reproductive technology procedures should not be curtailed due to restrictive genetic link requirements, particularly for individuals with congenital or acquired infertility conditions. The judgment reaffirms the primacy of reproductive rights within India's constitutional framework and calls for a purposive and rights-based reading of interrelated reproductive statutes.

While the above case is pending final adjudication, the Supreme Court framed several issues to be decided in this case.

• Validity of Earlier Ban on Donor Gametes – The 2023 Amendment barred use of donor gametes, even for medically infertile couples.
• Interpretation of Surrogacy (2024 Amendment) – The 2024 Amendment allows donor gametes if one gamete is from the intending couple and certified by a medical board.
• Role of District Medical Board – Approval from the District Medical Board is required to establish medical necessity for donor gametes.

• Discrimination Against Single Women

• Effect on Pending Petitions – Since the 2024 Amendment replaced the 2023 Amendment, many challenges to the old rule have become infructuous.
• Challenge to Surrogacy Act & ART Act – Petitioners continue to challenge other provisions of the Surrogacy Act and ART Act for being unconstitutional.

• Right to Reproductive Autonomy – The core issue is whether the laws respect an individual's right to make reproductive choices freely.

The final verdict in the above case is expected to be landmark and could be transformative moment for India's surrogacy and assisted reproductive technology legal framework. If the court upholds the right to use donor gametes in medically justified cases, it will reinforce the future direction of reproductive laws towards greater inclusion, flexibility, and protection of individual rights.

Following this judgment, the Assisted Reproductive Technology (Regulation) Act, 2021 is likely to see vital reforms, such as:

• Adoption of a rights-based and medically informed approach to infertility treatment,
• Establishment of standardised and time-bound procedures for medical certification,
• Extension of equal reproductive choices to single women, and
• Alignment of assisted reproductive technology regulations with constitutional principles of dignity, privacy, and autonomy.

In essence, the Supreme Court's reasoning will likely shape a legal environment where reproductive technologies are regulated with empathy, medical rationale, and constitutional safeguards, paving the way for more humane and equitable policies.

VII. Disputes Arising out of Section 21(g) of the ART Act: Age Restrictions

Section 21(g) of the ART Act prescribes age limits for accessing assisted reproductive technology services as 21 to 50 years for women and 21 to 55 years for men. However, as a matter of practice, the assisted reproductive technology clinics/banks in several cases have refused treatment to commissioning couples when either of spouse falls outside this age bracket, even when one partner remains eligible. Few of such cases were challenged in court.

VIII. Notable Judicial Interpretations of the ART Act in relation to Section 21(g) of the ART Act

1. Sudarshan Mandal v. Union of India³

The Calcutta High Court clarified that the ART Act cannot be biased only towards married woman and place discrimination on unmarried women. It upheld a woman's right to use third-party sperm where her spouse was ineligible due to age, recognising individual reproductive autonomy.

2. Sanchita Ghosh v. Union of India⁴

In this case the Calcutta High Court held that assisted reproductive technology clinics are required to provide treatment if either spouse is within the statutory age limit for assisted reproduction. It harmoniously interpreted Section 21(g) of the ART Act to prevent unreasonable denial of treatment and validate the couple's right to parenthood.

3. Shyamoli Saha v. Union of India⁵

The [Calcutta] High Court permitted a woman to access assisted reproductive technology services despite her husband not fulfilling the criteria under Section 21(g)(ii) of the ART Act. The ruling highlighted that reproductive rights are individual and cannot be revoked due to the partner's disqualification when the partner has no genetic involvement in the assisted reproductive technology procedure.

4. Smt. Gomathi Ramesh vs Union of India⁶

A couple approached the court seeking approval to undergo surrogacy under the Surrogacy Act, after the husband was barred due to the age limit set under the ART Act. Although they initially challenged the age restriction, they later withdrew that challenge.

They sought to use donor eggs due to the husband's ineligibility and relied upon case of Sudarsan Mandal, which allowed treatment under ART Act in similar circumstances. The Karnataka High Court, considering the facts and precedent, allowed the couple to proceed with treatment, provided they comply with the applicable provisions of the ART Act.

IX. Conclusion

While the ART Act provides the foundation of assisted reproduction, its restrictive requirements and rigid statutory provisions makes it difficult for people to avail the treatment. Therefore, it continues to raise constitutional and ethical concerns. However, Indian courts have interpreted the reproductive rights through purposive and rights-based interpretations which increased the possibility to avail the treatment. Key judicial pronouncements reflect a trend toward inclusivity, autonomy, and non-discrimination, legislative amendments which gave pathway for the ART Act were non-biased and non-discriminatory and implemented the act in alignment with constitutional guarantees and global human rights standards. Until then, the judiciary trends ensure that the spirit of reproductive rights prevails over procedural obligations.

Footnotes

1. (2018) 10 SCC 1

2. Writ Petition (Civil) No. 756 of 2022

3. 2024 SCC Online Cal 4031

4. W.P.A 12154 of 2023 in the High Court of Calcutta

5. 2024 SCC Online Cal 10379

6. Writ Petition No. 8756 of 2024 (GM-RES) | In the High Court of Karnataka at Bengaluru

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