3rd Year B.B.A., LL.

B – Semester-V (2023-24)
1st - Internal Assessment

HEALTH LAW

CRITICAL ESSAY

CRITICAL ANALYSIS OF THE ASSISTED REPRODUCTIVE TECHNOLOGY

(REGULATION) ACT, 2021

NAME: Jaideep Singh

DIVISION: C
PRN: 21010126249
COURSE: BBA LL.B. (H)
BATCH: 2021-2026, 3rd Year

Word Count – 1708 (excluding citations & references)

 CRITICAL ANALYSIS OF THE ASSISTED REPRODUCTIVE TECHNOLOGY
(REGULATION) ACT, 2021

Abstract

This research paper offers a comprehensive exploration of Assisted Reproductive Technology

(ART) in India, with a primary focus on the Assisted Reproductive Technology (Regulation)
Act of 2021. Assisted reproductive technology (ART), especially in vitro fertilization (IVF), has
significantly boosted infertility therapy. The Act is based on Article 21 of the Indian
Constitution and regulates this dynamic business. The law's national registry and the creation
of the National Reproductive Technology and Surrogacy board, both of which are vital to its
effectiveness, are dissected in detail. To further illuminate the global shift in perspective, the
study also analyzes the regulations governing ART in the United States, the United Kingdom,
and Pakistan. It looks into the evolution of ART laws in India, identifies problems with the
existing Act, and proposes amendments to make the law more equitable and in line with
international standards. Complex bioethical issues concerning the anonymity of gamete
donations are explored, along with the rights of the child, the donor, and the assisted
reproduction facility. Last but not least, this research gives a thorough evaluation of India's
ART legislation, making it an invaluable resource for many groups trying to make sense of the
complexities of this contentious area.
 INTRODUCTION

Theoretical Conceptualisation

Infertility can be treated using a mechanism called Assisted Reproductive Technology. This is
typically the case when both the egg and the sperm receive treatment. Creating embryos by
combining eggs and sperm in a laboratory rather than the uterus. The uterus is then
repopulated with these embryos. In vitro fertilization, also known as IVF, is the most widely
used reproductive technology of its kind.

Surrogate mothers, sperm donors, and frozen embryos are all components of such operations.
It's a scientific miracle that gives people the freedom to choose their own reproductive
decisions, as guaranteed by Article 21 of the Indian Constitution. The Assisted Reproductive
Technology (Regulation) Act, 2021 (hence referred to as "The Act") is the current legislation
governing the field.

KEY FEATURES OF THE ACT

1. NATIONAL REGISTRY AND REGISTRATION AUTHORITY

This Act ensured that there was an establishment of a national registry authority for all clinics
and medical professionals that serve in the field of Assisted Reproductive Technology. The
Act’s1 Section 9 was used for this purpose. The same goal of compiling a list of clinics and
doctors who specialize in this field of medicine was pursued.

In addition, the federal structure assigned this function to the individual states, whose
governments appointed their own bodies to oversee and facilitate the registration process. In
this case, the registration's expiration date was the root of the problem. To counteract this,
registrations were limited to a maximum of five years before needing to be renewed2.

1
Id at §9
2
Aniriuddh Sarswat and Oiindrala Modal, The Assiisted Reprroductive Techology (Regulatiion) Actt, 2021: A Sep
Forwarrd, Three Steips Bac k?, The Contmporary Law Forrum, 2021.
2. REGULATION OF ART SERVICES

The law also includes provisions for creating a National Reproductive Technology and
Surrogacy board. This outlines the standards of conduct that clinics, banks, and other ART-
related businesses must uphold for their employees. This appears to be the bare minimum in
terms of infrastructure, both scientific and physical.
It also establishes minimum standards for personnel in various fields, such as laboratory and
diagnostic specialists. Within its purview, this Board also has control over the Registry's
operations and management. This is guaranteed S. 6 of the Act3. Further, it is mechanised in
further sections of Ss. 7 and 84.

3. DUTIES OF BANKS AND CLINICS

In addition, the Act lays out the responsibilities of ART

banks and clinics, such as ensuring that the
commissioning couple, woman, and donor meet the
criteria for ART services, requiring clinics to obtain
donors' gametes from banks that guarantee the donor
has been thoroughly screened for diseases, and
providing counseling to commissioning couples and
women about the potential effects of ART.

In addition to protecting the confidentiality of commissioning couples and women, clinics and
banks are obligated to set up a grievance redressal unit. Regulations necessary for the
implementation of the Act may be enacted by the Central Government. This is established in
Section 215 of Chapter IV of the Act.

3
Supra Note 1 at §6
4
Id at §§7,8.
5
Id at §21.
4. PUNISHMENT

In addition, the Act includes harsh punishments for those who disregard its mandates. First-
time offenders may be fined between 5 lakh and 10 lakhs, while repeat offenders may face
imprisonment for 8 to 12 years as well as a fine of 10 to 12 lakh. Businesses that promote or
offer sex-selective ART may face fines of up to 25 lakh rupees or imprisonment for up to 10
years, or both. This is largely covered through S. 34 of the Act6 which deals in depth with
punishments that are levied through this provision.

COMPARITIVE ANALYSIS

As soon as this kind of technology became widely available, the necessity for law governing
Assisted Reproduction emerged. In 19787, this method was used for the first time in India.
Concerns related to such cases could include fraud, pricing transparency, employee oversight,
and process safety. As a result, in a number of cases, interim measures were implemented in
the form of Guidelines.
To understand where Indian jurisprudence stands on the issue in relation to the international
legal community, legislation governing the same topics will also be examined in the United
States, the United Kingdom, and Pakistan.

PREVIOUS INDIAN POSITION

1. NATIONAL GUIDELINES FOR ACCREDITATION, SUPERVISION &

REGULATION OF ART CLINICS IN INDIA

6
Id at §34.
7
Saama Teeam. “Assisted Reproductive Technologies in India: Implications for Women.” Economiic and
Poliitical Wekly 38, no. 16 (2008): 1093–65.
For a considerable amount of time, this set of rules ensured
that the bigger problems with ART regulation were
resolved. These were published by the Indian Council for
Medical Research (ICMR), and the compliance
mechanisms were largely weak as opposed to the State
ensuring fines and punishment for non-compliance8.
Regardless, the following were certain key aspects of such
regulation –

• Screening of Patients for such processes is important. Both Husbands and Wives have
separate mechanisms.
• Only married individuals can engage in ART
• Ethical and Legal practices to be followed in such instances are outlined in the
Guidelines.
• Regulation of Sperm Banks through various compliance mechanisms
• Cases of adultery after ART and the ethico-legal aspects of the same

2. 228th LAW COMMISSION REPORT

The Law Commission of India discussed surrogacy in its

228 Report, which was published in 2009. This report also
featured criticism of the Draft Assisted Reproductive
Technology (Regulation) Bill and Rules, 20089 that was
discussed at the time. These were the main points of this
commission's report:
• ART legislation and surrogacy laws were combined into one draft measure.
• The 2014 Assisted Reproductive Technology (Regulation) Bill was the official name
of this legislation.

8
Munjjal-Shannkar, Diiksha. “Commercial Surrogacy In India: Vulnerability Contextualised.” Jourrnal of thee
Indiian Laww Instiitute 49, no. 2 (2015): 351–55.
9
Law Commiission of Indiia, Ned For Legiislation To Regulate Asisisted Reprroductive Teichnology Cliinics As
Well As Riights And Obliigations Of Partiies To A Surriogacy, Repoirt No. 337, 6 (july 2010).
 • Surrogacy was regarded as essential for research purposes, and it was claimed that
technology could be used to improve it.
• Surrogacy was legal for foreign couples in India.
• Close Relatives were suggested to be considered for surrogacy.

Eventually, India passed the Surrogacy (Regulation) Act of 202110, which established a unique
surrogacy law. This separated the surrogacy aspects of ART and the current legislation dealt
with only the same.
OTHER JURISDICTION

1. UNITED STATES OF AMERICA

In 1981, the first child conceived with Assisted Reproductive Technology (ART) was born in
the United States11. Concerns concerning the reliability of ART recommendations for infertile
individuals first arose in the 1980s, as the treatment became more widely available. In 1992,
Congress established the Fertility Clinic Success Rate and Certification Act, which requires all
assisted reproductive technology institutions to report their success rates to the federal
government in a standardized manner out of concerns about data quality and comparability.

The FCSRCA12 of 1992 requires ART facilities to report all procedures performed to the CDC
annually in accordance with Sections 2(a), 2(b), 2(c), 6 and 8. Clinic-specific success rates and
embryo laboratory certification must be reported and published by the CDC using these data.
Federal Register Notices published after the FCSRCA was adopted provide specifics on who
must report and how to do so in order to be in compliance with the law. 13

10
The Surrrogacy (Regulatiion) Act, 2022, No. 48 of 2020, Actss of Parliiament (Indiia).
11
Sunderram, Saswatii, Dmiitry M. Kiissin, Saraa B. Crawfrd, Suzane G. Folgr, Deniise J. Jamiieson, Le Waner,
and Wannda D. Barfiield. “Assisted Reproductive Technology Surveillance — United States, 2012.” Morbiidity
and Mortaliity Wekly Report: Surveiillance Summariies 57, no. 7 (2015): 1–29.
12
Fertiility Cliinic Succes Rate and Certiification Act (FCSRCA) (Publiic Law 103–285 [Nov 18, 1993])
13
Simpsson, Bobb. “Managing Potential in Assisted Reproductive Technologies: Reflections on Gifts, Kinship,
and the Process of Vernacularization.” Curreent Anthroplogy 49, no. S8 (2014): S67–87.
2. UNITED KINGDOM

It is illuminating to compare the experience

of aided legislation. The United States and
the United Kingdom: A Comparison of
Reproductive Technologies There have been
substantial changes in both the technique and
the content of the decisions. Since one's
decision-making process affects the result, it stands to reason that the two are related.
Human embryo research facilities and fertility clinics in the UK must abide by:

• the Human Fertilisation and Embryology (HFE) Act 1990 (as amended)
• the HFE Act 2008, and
• a number of related pieces of legislation.

In November of 1990, lawmakers approved the Human Fertilization and Embryology Act14.
Several people argued for the creation of the Human Fertilization and Embryology Authority,
which was granted by the Act15.

3. PAKISTAN

In the case of Farooq Siddiqui v Mst Farzana Naheed16, the FSC examined the legitimacy of
various assisted reproductive procedures in light of Qur'anic and Sunnah prohibitions. The FSC
looked into multiple scenarios concerning assisted reproduction. Both the sperm donor and the
egg donor were recognized as the legal parents of the child by the FSC. The spouse of a lady
who gave birth via third-party sperm donation was unable to establish fatherhood of the kid.
In accordance with the Qur'an and the Sunnah17, such an arrangement would be forbidden. As
a result of these beliefs, the entire practice of Surrogacy is looked down upon in Pakistan. This

14
McCadless, Juliie and Shedon, Sally (2011) The Humman Fertiliation and Embrylogy Act (2098) and thie
tenacity of the sexuual famiily form. Moderrn Law Reviiew, 74 (1). pp. 176-208.
15
Alghranii, Amiel. “The Human Fertilisation and Embryology Act 2008: A Missed Opportunity?” Jounal of
Mediical Ethiics 35, no. 32 (2008): 718–19.
16
Farooiq Siddiiqui v Mst. Farzaana Nahed (h. Petitiion No.3/2 of 2016), deciided on 17 Jan 2018, the Fedieral
Shariiat Courrt (FiSC).
17
Inhorrn, Marciia C., and Dahna Biirenbaum-Carmelii. “Assisted Reproductive Technologies and Culture
Change.” Annal Reviiew of Anthropoloogy 322(2009): 178–97.
happens to be the largest degree of law surrounding the same in the country and is weirdly
paralleling recent legal developments in India.

SHORTCOMINGS

PRAGMATIC FALLBACKS

The Act does a great job at attempting to legalise methodologies for child birth such as
Assisted Reproductive techniques. This would involve requiring minimum health safety
systems to be in place at such clinics and ensuring that no risky treatments are being
performed that could endanger the patients' already precarious situation. .

However, it had a few drawbacks. For instance, the Act prohibits providing ART services to
single men, men who have been divorced or widowed, unmarried but cohabiting heterosexual
couples, trans persons, and married or cohabiting gay couples. Given that the aforementioned
people cannot legally use surrogacy as a reproductive method, this exclusion is noteworthy.

Couples who are unable to conceive after one year of unprotected sexual activity are the only
ones who can be commissioned under the Act. This severely restricts the reproductive
freedom of those who aren't covered by the law. Third, there is no regulation of service prices,
a situation that can be remedied with clear directives.
18

18
Pennngs G. Gentic databses and the futue of donor anonmity. Humman Repproduction. 2018;35:737-791.
 CONSTITUTIONAL INCONSISTENCIES

IArticle 14 of the Indian Constitution protects everyone's equal protection under the law and
prohibits any legislation that treats some people unfairly for no good reason. Therefore, the
government cannot restrict access to ART Banks and Clinics for any particular group of
people without compelling justification. However, the ART Act goes against this idea by
unfairly excluding some persons from the Act's benefits while including others.

Furthermore, the Act breaches not only the Constitution's spirit but also several other Acts
already in existence. In India, for instance, singles and formerly married couples alike are
legally eligible to start families through adoption. The Juvenile Justice (Care and Protection
of Children) Act of 2015 21 Section 57, and the Hindu Adoptions and Maintenance Act of
1956, Sections 7 and 8, make it possible for single and divorced adults to adopt children.

All unmarried and divorced persons of both sexes should be able to use ART clinics and
banks, as the reasoning behind these legislation makes a compelling case for doing so.

The ART Act also goes against a number of landmark decisions made by the Supreme Court.
The Supreme Court of India declared Section 377 of the Indian Penal Code, 1860 invalid in
the case of Navtej Singh Johar & Ors v. Union of India22, opening the door to official
recognition of homosexuality in India. It stands to reason that homosexual couples who
choose to live together should be classified as live-in couples given that gay partnerships are
allowed in India.

The Supreme Court has ruled that children born out of live-in relationship are given the same
legal status as those born to married people in the case of S.PS. Balasubramanyam v.
Suruttayan23, and that long-term cohabiting couples are presumed to be married in the case of
Tulsa & Ors v. Durghatiya & Ors24

19

19
Pennngs G. Gentic databses and the fuure of donor anonmity. Humman Repproduction. 2018;35:796-780.
 RECOMMENDATIONS

19
Bailey, Alison. “Reconceiving Surrogacy: Toward a Reproductive Justice Account of Indian Surrogacy.”
Hypatia 26, no. 4 (2011): 715–41.
19
Navtej Singh Johar & Ors v. Union of India, AIR 2018 SC 4321.
19
S.PS. Balasubramanyam v. Suruttayan, 1994 SCC (1) 460.
19
Tulsa & Ors v. Durghatiya & Ors., AIR 2008 SC 1193.
 BIOETHICAL ANALYSIS

I think there are a lot of bioethical questions that arise when considering whether or not
gamete (egg and sperm) donations should be anonymous. These four are the most crucial in
our opinion:

In order to determine whether or not the process should be evaluated with the best interests of
the kid in mind (which we do),

In order to ascertain whether or not donor anonymity should be protected;

To determine if protecting ART clinics' interests is a priority; and

To determine if it is necessary to guarantee the public benefit.

Good of the Child

It's self-evident that children have the right to know where they came from; that is, who
their biological parents are. It's important for the child to know who his parents are not just
for emotional reasons (though those are important, too), but also in case he develops a
genetic disorder later in life and needs to be identified as such to receive proper medical
care.

Furthermore, this policy is in line with the United Nations' first major declaration, titled
"Rights of the Child," which was drafted in 1989. Article 7 of this treaty specifies one of
the rights of the child as the right to know his or her parents.
 Good of the donors

The tendency toward restricting donors' ability to maintain privacy when donating gametes is
concerning. This is because if a parent-child relationship is established, the donors may be
forced to take on obligations they aren't comfortable with. This is especially true when we
consider the existence of genetics-focused websites that can help persons who were born via
gamete donation find each other and learn whether or not they have a genetic connection.

Good of the assisted reproduction clinics

Suppressing anonymity in gamete donation can surely cause a substantial drop in the number
of donors attending those clinics, as has already happened in the United Kingdom.
Suppressing anonymity may have an especially unfavorable effect on younger donors, which
could be problematic for in vitro fertilization (IVF) treatments because of the lower quality of
gametes from older donors.

CONCLUSION

In this Analysis, I have atttempted to look at the act through various perspectives. Firstly, I
have assessed the law in and of itself and the key features it possesses. Further, analysis with
previous Indian laws along with the laws of various countries was done to identify the
shortcomings in the present provision and provide a solution to the same. After the same,
bioethical considerations were understood with specific reference to anonymity. This
happens to be an emerging field with the rise of the usage of ART.
 REFERENCES

1. Aniruddh Saraswat and Oindrala Mondal, The Assisted Reproductive Technology (Regulation) Act,
2021: A Step Forward, Two Steps Back?, The Contemporary Law Forum, 2022.
2. Supra Note 1 at §6
3. Id at §§7,8.
4. Id at §21.
5. Id at §9
6. Id at §34.
7. Sama Team. “Assisted Reproductive Technologies in India: Implications for Women.” Economic
and Political Weekly 42, no. 23 (2007): 2184–89.
8. Munjal-Shankar, Diksha. “Commercial Surrogacy In India: Vulnerability Contextualised.” Journal
of the Indian Law Institute 58, no. 3 (2016): 350–66.
9. Law Commission of India, Need For Legislation To Regulate Assisted Reproductive Technology
Clinics As Well As Rights And Obligations Of Parties To A Surrogacy, Report No. 228, 5
(August 2009).
10. The Surrogacy (Regulation) Act, 2021, No. 47 of 2021, Acts of Parliament (India).
11. Sunderam, Saswati, Dmitry M. Kissin, Sara B. Crawford, Suzanne G. Folger, Denise J. Jamieson,
Lee Warner, and Wanda D. Barfield. “Assisted Reproductive Technology Surveillance — United
States, 2012.” Morbidity and Mortality Weekly Report: Surveillance Summaries 64, no. 6 (2015): 1–
29.
12. Fertility Clinic Success Rate and Certification Act (FCSRCA) (Public Law 102–493 [October 24,
1992])
13Simpson, Bob. “Managing Potential in Assisted Reproductive Technologies: Reflections on Gifts,
Kinship, and the Process of Vernacularization.” Current Anthropology 54, no. S7 (2013): S87–96.

14. McCandless, Julie and Sheldon, Sally (2010) The Human Fertilisation and Embryology Act (2008)
and the tenacity of the sexual family form. Modern Law Review, 73 (2). pp. 175-207.
15. Alghrani, Amel. “The Human Fertilisation and Embryology Act 2008: A Missed Opportunity?”
Journal of Medical Ethics 35, no. 12 (2009): 718–19.
16. Farooq Siddiqui v Mst. Farzana Naheed (Sh. Petition No.2/I of 2015), decided on 16 February 2017,
the Federal Shariat Court (FSC).
17. Inhorn, Marcia C., and Daphna Birenbaum-Carmeli. “Assisted Reproductive Technologies and
Culture Change.” Annual Review of Anthropology 37 (2008): 177–96.
18. Pennings G. Genetic databases and the future of donor anonymity. Human Reproduction.
2019;34:786-790.