CLONING: BIOETHICAL AND LEGAL OVERVIEW

ABSTRACT

The mushrooming of technology, the development of Dolly the sheep and the derivation and iso-
lation of embryonic stem cells from the human embryos in the late twentieth century have al-
ready opened new avenues of a unique biomedical world, however, the same is laden with conse-
quences. In contemporary times, cloning has remarkably developed all over the world. However,
the requisite legal framework is yet to be constructed such that it aids and safeguards the devel-
opments relating to cloning. This mushrooming legal gap could result in abuse of scientific re-
search in order to derive illegal benefits out of this biomedical tool. Thus, to prevent such conse-
quences and safeguard this science, attempts are needed to embark on constituting an apt legal
and ethical system and a sanctioned comprehensive law. This article shines light on various types
of cloning, the legality surrounding human cloning, the merits and demerits of this science, the
ethical, moral and religious considerations around human cloning and the legislations and poli-
cies of various countries and International Organisations about this subject.

METHOD, MEANING AND SCIENCE

Cloning, in common parlance, is construed as a process to create a genetically identical copy of a

biological unit from which it was derived.1 The biological unit cloned can range from DNA se-
quences, molecules, cells, tissues to complete organisms. It is especially done with the applica-
tion of bio-technological methods.2 Thus, the term cloning can refer to multifarious processes
and is ambiguous and cryptic. Cloning is of three variants, namely, molecular, cellular and nu-
clear transplantation.3 The cells that are cloned by molecular cloning and cellular cloning, al-
though of great economic and medical value to humankind cannot be developed into embryos.4

1 Ajai Kumar, Human Cloning: A Socio - Legal and Ethical Appraisal, 52 JILI 92, 92 (2010).
2 National guidelines for Stem Cell research, 2017 (India).
3 Shannon H. Smith, Ignorance Is Not Bliss: Why a Ban on Human Cloning is Unacceptable, 9(2) HM:JLM 311,
323 (1999).
4 5 HENRY T. GREELY, THE END OF SEX & THE FUTURE OF HUMAN REPRODUCTION 29 (Harvard
University Press, 2016); Id at 333.
Thus, they are not relevant in the context of this article as it restrict itself to human cloning. On
the other hand, nuclear transplantation cloning can result in the formation of an embryo. It in-
volves the fusion of nucleus of a somatic cell into the ovum. Human cloning can be performed
by two different, commonly practiced methodologies i.e. Somatic Cell Nuclear Transfer tech-
nique and Blastomere Separation technique.5

SOMATIC CELL NUCLEAR TRANSFER

Somatic Cell Nuclear Transfer or SCNT was first applied on Dolly the sheep. 6 According to this
technique, the cloning is conducted by extracting the haploid nucleus from an unfertilised ovum
and substituting such nucleus with the diploid nucleus taken from a donor somatic cell. The cell
so formed is referred to as a ‘reconstructed egg.’ The reconstructed egg cell’s nucleus induces
certain electric current that fuse the nucleus and the ovum and eventually, the reconstructed egg
cell develops into an embryo.7 Since the nuclear material contain chromosomes which deter-
mines the inherent characteristics and traits of the offspring, the developed clone shall resemble
the donor of the nucleus.

BLASTOMERE SEPARATION TECHNIQUE

The technique of Blastomere Separation requires the splitting of an embryo in early stages of de-
velopment thereby letting each of the split Blastomere cells to grow into a separate and individ-
ual organism.8 This technique, in contrast to SCNT is only applicable for the cloning of fertilised
eggs rather than adult stem cells.

TYPES OF CLONING

5 Carmel Shalev, Human Cloning and Human Rights: A Commentary, 6 HHRJ 60, 61 (2002).
6 POLKINGHORNE J, HUMAN CLONING: RELIGIOUS RESPONSES 35 (Louisville: Westminster John Know
Press, 1997).
7 Carmel Shalev, supra note 5, at 89.
8 GENETICS AND SOCIETY, https://www.geneticsandsociety.org/internal-content/reproductive-cloning-argu-
ments-pro-and-con (last visited Jan. 24, 2021).
Cloning by nuclear transplantation method is done for two purposes, reproductive and therapeu-
tic. Reproductive cloning is construed as the process of cloning wherein the embryo is reared af-
ter SCNT and is eventually embedded in the uterus of either the ovum donor or another surrogate
recipient. This embryo thereby gradually develops into a foetus and ultimately into a complete
organism. The developed organism is absolutely identical to the donor of the somatic cell in ge-
netic terms.9 The intention of such cloning is the generation of a living organism being endowed
with the same DNA as an already existing organism. All mammal clones such as Dolly the
sheep, Millie the pig, Dewey the deer, Prometea the horse etc. have been developed through re-
productive cloning.10

The initial process of therapeutic cloning is similar to the procedure of reproductive cloning.
However, As soon as the blastocyst stage is reached (approximately 14 days from conception),
the embryonic stem cells are derived and harvested to develop into tissues or organs used for var-
ious medical treatments and therapies.11 However, post the removal of stem cells from the SCNT
developed embryonic cells, the embryo cannot develop further and causes the death of the em-
bryo. The intent of this form of cloning is to create human embryos, merely to acquire stem cells
for medical applications.12

ETHICAL CONSIDERATIONS IN CLONING

In most cases of medical advancement, inceptive fears give way to wary acceptance, however
with every new advancement the underlying suspiciousness is reawakened. For example, the
process of artificial insemination by donors, was regarded to be a form of adultery when it was
introduced in the late 1940s. However, today it is an accepted treatment of infertility. Similarly,
in 1978 when Louis Brown was born via in vitro fertilisation it provided a new but controversial
method to parenthood. There is a continuing debate about safety, legality and ethical acceptabil-
ity of such technological advancements13. It's evident that morality and law can only slow the

9 National, supra note 2, at 49.

10 Carmel, supra note 5, at 67.
11 Id. at 3.
12 Dr John I Fleming, Cloning: Sometimes ‘Nice’ sometimes ‘Nasty’ ?, 11(2) BRNOP 1, 2 (1999), http:/
Resources/OnlineArticles.pdf.
march of science and not stop it. Varying ethical issues arise out of human cloning. These ethical
and moral considerations related can be divided on the basis of the type of cloning.

ETHICAL CONSIDERATIONS IN THERAPEUTIC CLONING

A discussed above the therapeutic cloning requires creation of an embryo only to extract stem
cells from it which are then grown into an organ or body part. The initial embryo is destroyed
due to this extraction. Even in in vitro fertilisation, some of the embryos which are created are
not used and end by being destroyed14, but what causes the ethical issue in therapeutic cloning
and not in vitro fertilisation is the aim behind the creation of these embryos. In IVF technology,
creation of embryos is to bring life into the world whereas, the ultimate aim for creation of the
embryos in therapeutic cloning is to destroy the embryo once it is used. This is said to be akin to
using humanity as a mere means 15 for harvesting organs which is regarded to be highly unethical
and disrespects the humanity and dignity of human life.

In India the Stem Cell guidelines don’t allow for keeping an embryo after 14 days of fertilisa-
tion.16 Moreover, the Medical Termination of Pregnancy, Act, 1971 allows abortions upto 12
weeks on the mother’s consent and till 24 weeks if there is a risk to the health of the mother.17
Similarly, abortion is allowed in UK upto 24 weeks for socio-economic reasons and beyond that
for medical reasons.18 All major European nations, barring Poland allow for abortion at least upto
12 weeks for pregnancy for broad socioeconomic reasons.19 Even n the USA most states have le-
galised abortion in the first and the second trimester after the land mark judgement of Roe v
Wade.20 Moreover, certain religions like Isalm and Jewish faith provide that humanity begins af-

13 Seth Cyprianus, The Implication of Kant’s Ethical Theory in the morality of Human Cloning, ACADEMIA,
( Jan. 22, 2020, 10:10 AM), https://www.academia.edu The_Implication_of_Kant s_Ethical_Theory_in_The_moral-
ity_ of_ Human_Cloning.
14 Ayushi Sinha, Human Cloning in India: What are the legal implications ?, IRALR ( Jan. 23, 2020, 10:50
AM),https://www.iralr.in/post/human-cloning-in-india-what-are-the-legal-implications.
15 Seth, supra note 13, at 13.
16  Paridhi Goel, Laws related to donation of eggs and sperm in India, IPLEADERS, ( Jan. 24, 2020, 10:50 AM),
https://blog.ipleaders.in/laws-related-donation-eggs-sperm-india/.
17 Medical Termination of Pregnancy, Act, 1971, § 3, No. 34, Acts of Parliament, 1971 (India).
18 Human Fertilisation and Embryology Act, 2008 c 22, 2008, (UK).
19 Adèle Langlois, The global governance of human cloning: the case of UNESCO, NATURE, ( Jan. 24, 2020,
10:50 AM), https://www.nature.com/articles/palcomms201719.
20 Roe v. Wade, 410 US 113 (1973).
ter four months and forty days respectively.21 Thus, it is evident that myriad schools of thought
and legislations point at the same conclusion, that that in the first two weeks, the embryo is
merely a cluster of cells and not a human being. Thus it is contended that such embryo can be
used for medical therapies and research.

The destruction of this early state embryo is a small price to pay when put against the myriad
benefits of therapeutic cloning. Therapeutic cloning shall resolve the issue of rejection of trans-
planted organs by the patients’ immune system, as cells of the organ made by therapeutic cloning
would be genetically identical to the patient's cells. It also has compelling capacity in the treat-
ment of various serious ailments including diabetes, Parkinson’s disease, cystic fibrosis, spinal
cord damage, Alzheimer’s disease etc.22 However, it is to be noted that since this technology is in
its incipient stages it requires multiple attempts to create a viable cloned embryo. 23Thus it may
put women at risk as providers of ova for such projects. Such scientific experiments will put a
woman’s health and body at risk even if consent is provided by them. Thus it is extremely impor-
tant that these procedures are carefully regulated and examined.

ETHICAL CONSIDERATIONS IN REPRODUCTIVE CLONING

As provided above the creation of an embryo through SCNT and then implanting it into a human
or primate uterus is called reproductive cloning. The supporters of reproductive cloning aver that
it will act like another form of reproduction in which infertile couples or single parents can have
children. It is a new step towards reproductive freedom where “it is the right of the individual,
married or single, to be free from unwanted governmental intrusion into matters so affecting a
person as a decision whether to bear or beget a child.” However, it is pertinent to note that the re-
productive rights are negative rights which protect reproductive freedoms, they do not provide a
positive right to beget a child.24

21 SL Nabavizadeh, et.al., Cloning: A Review on Bioethics, Legal, Jurisprudence and Regenerative Issues in Iran,
5(3) WJPS 1, 56 (2016), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5109382/.
22 Seth, supra note 13, at 10.
23 Rinie Steinmann, ‘The core meaning of human dignity’ 19 PELJ 8, 24 (2016).
24 Rohan Banerjee et al., Human Cloning- Legal and policy concerns, 2 CASIHR JHRP 25, 46 (2018).
The main ethical consideration that arises in this kind of cloning concerns the human dignity. At
the heart of this argument is that such cloning would diminish the sense of uniqueness of an indi-
vidual as a his genome shall be copied and since dignity is closely connected to uniqueness, a
person’s fundamental right to dignity shall be violated.25 In essence creation of a generic copy of
a pre-existing human, shall violate inalienable fundamental rights of the pre-existing human. It
would also lead to devaluation of clones in comparison with non-clones as they’re mere copies
of the original human. Devaluation of human closes shall be akin to devaluing humans as clones
are also essentially humans and are to be provided with equal human dignity. Thus by permitted
reproduction closing, there shall be violation to the fundamental right to dignity of both the origi-
nal as well as the clone.

Creation of such cloned individuals can also lead to practices of human trafficking and data pri-
vacy issues. It can lead to commodification of the cloned humans where they will be merely used
as body doubles or medical supplies for their pre-existing human counterparts. The process can
also easily be manipulated by applications of genetic engineering to produce humans with spe-
cific capabilities or ‘designer babies’. It shall potentially of turn the child into a commodity and
the woman bearing the child into a clone rearing machine. Lastly, the process is inherently un-
safe and has not been tested on humans thus, the possibility of mutation and biological damage 26
cannot be ruled off the books.

CURRENT ETHICAL STANCE IN HUMAN CLONING

There are two possible ethical stances that can be taken in regard to therapeutic cloning i.e.
whether to protect incipient human life or to save human life by curing a potentially fatal ail-
ment. Further disagreements arise regarding the level of protection and respect required at differ-
ent stages of embryonic development 27. The most accepted position on this topic is the ‘Propor-
tional Status Position’28; wherein the moral status of the embryo increases with its growth and it
can only be equated with a human being after a certain stage of development has been attained.

25 Id. at 44.
26 Kaan Sheung-Hung Terry, At the Beginning of Life, 22 SACLJ 883, 885 (2010).
27 SL Nabavizadeh, supra note 21, at 44.
28 Id. at 42.
Thus, any research conducted on the embryo before it reaches such a stage is permitted. Most na-
tions allow human embryonic stem cell research before the blastocyst stage as around this thresh-
old, the primitive streak appears, signalling the onset of cell differentiation and development of
organ systems, including the nervous system, meaning thereby, an embryo after the formation of
the primitive streak can feel pain.29 Reproductive cloning is banned all over the world due to its
infringement of human dignity and inherently unsafe process.

RELIGIOUS OVERTONES IN HUMAN CLONING

The argument against cloning acquires religious overtones when it is argued that producing
cloned human embryos amounts to “playing God”, usurping God’s role in the universe and vio-
lating the basic principles of life and God’s “plan for the world” 30. Several major religions have
made submissions on the issue of cloning and the moral status of embryos.

The Catholic Church has objected to the destruction of the embryo for research as it believes that
life begins at conception and from the moment of conception, a human embryo should be ac-
corded the complete moral rights of a human being.31 Therefore, the destruction of the embryo
during therapeutic cloning is a gravely immoral act. 32 However, the Catholic and Protestant
Christian scholars ave expressly stated that they are not against human embryonic research and
that stem cells should be derived from competent consenting adults or from umbilical cord
blood.33 The church has vehemently opposed reproductive cloning has it opposes god’s design
for human reproduction. Taoist view is also similar to the christian view on human cloning. Bud-
dhist scholars support stem cell research that will potentially benefit mankind, but are against hu-
man cloning.34

29 Kaan, supra note 24, at 884.

30 Rohan, supra note 24, at 29.
31 M. Asif Ismail, Closing in on human cloning, PUBLIC INTEGRITY ( Jan. 24, 2020, 10:50 AM), http://
www.publicintegrity.org/2004/04/19/6428/closing-human-cloning.
32 Rohan, supra note 24, at 30.
33 ROVANE C., GENETICS AND PERSONAL IDENTITY 245 (Blackwell Publisher, 2002).
34 Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning, 2002
(Singapore).
Islam does not place any judgement on an embryo as according to the faith an embryo is only
considered as a human life after it is 4 months old as the soul enters it around this time. 35 How-
ever, Islam opposes reproductive cloning as, it considers artificial production of offspring’s
through reproductive cloning amounts to playing god.36 Jewish faith also supports this stand as
according to them prior to forty days gestation, the foetus lacks ‘humanity’.37Previously, St
Thomas Aquinas of the Roman Catholic Church also favoured a later ensoulment38.

All religious scholars agree that in the more advanced stages of development, greater protection
and rights should be attributed to the embryo. 39 They also vehemently oppose reproductive
cloning as they hold it to be against god’s plan for humanity.40

CLONING LEGISLATIONS AROUND THE GLOBE

Various countries and international organisations have created their own Legal lacunae on
cloning. Some of the most pertinent legal regulations regarding cloning throughout the world are
discussed subsequently.

UNITED STATES OF AMERICA

The American cloning policies are a patchwork of hastily drafted state legislations and un-en-
acted federal laws. Following its creation of Dolly the Sheep, in 1997, US President announced
an executive ban on federal funding for “human cloning”.41 Subsequently the National Bioethics
Advisory Commission banned cloning for a period of ten years.42 After the expiry of this morato-
rium, there are no federal laws on cloning in USA, however, certain aspects of cloning have been
discussed in different federal laws and state legislations. These aspects include, whether different

35 Rinie, supra note 23, at 26.

36 Malby S, Human dignity and human reproductive cloning, 6 HHR 103, 130 (2002).
37 Id. at 127.
38 Haldane J. & Lee P. Aquinas, Human Ensoulment, Abortion and the Value of Life, 78 SAPJ 255, 257 (2003).
39 POLKINGHORNE, supra note 6, at 41.
40 Wright TG; Second Thoughts: How Human Cloning Can Promote Human Dignity, 35 VULR 1,33 (2000).
41 2 WILLIAM J. CLINTON, PUBLIC PAPERS OF THE PRESIDENTS OF THE UNITED STATES 34 (Gov-
ernment Printing Office, 1994).
42 Human Cloning Prohibition Act, HR 1644, 2001 (USA).
types of cloning should be governed differently; funding of cloning-related research; and, the
regulation of egg procurement.43 

The US ratified the United Nations Declaration on Human Cloning, 200544 thereby banning all
human cloning research. However the country does not go by the technical definition of repro-
ductive cloning and merely bans any activities on Human cloning 45 or “cloning-to-produce-chil-
dren.” This non-distinction is seen in the National Institute of Health’s directive which does not
restrict funding or research on reproductive cloning involving non-human primates. The prohibi-
tion on funding works as an indirect ban on Human cloning, resolving the debate for the time be-
ing. Moreover, the US Patents and Trademark Office is forbidden from issuing patents “directed
to or encompassing” human organisms (including embryos) to deter incentive to conduct such
research.46 The Public Health and Welfare47 act prohibits the buying and selling of human organs
and also provides for payment of consideration to gamete providers be it for IVF clinics or other-
wise. The state policies in the USA regarding funding of cloning related research are inconsis-
tent, they go from generous funding for cloning-for-biomedical-research to criminal prohibitions
against it to no official policy whatsoever. More than half of the states have no laws addressing
cloning.48On the federal level the constitutional questions of “right of scientific inquiry" and “re-
productive rights” is still being debated in the US Congress.49

The lack of a comprehensive national policy explaining the difference between therapeutic and
reproductive cloning and regulating such research puts USA behind the curve compared with
many other countries. The nation may need to develop comprehensive guidelines and regulations
on the subject to better protect the rights of its citizens while catering to the needs of the techno -
logical development in this field.

43 Sharon N. Covington & William E. Gibbons, What is happening to the price of eggs?, 5 Fertil. 1001, 1004
(2007).
44 United Nations Declaration on Human Cloning, 2005.
45 The Witherspoon Council, The Threat of Human Cloning, THE NEW ATLANTIS ( Jan. 24, 2020, 10:50 AM),
https://www.thenewatlantis.com/publications/part-four-cloning-policy-in-the-united-states#_ftn57.
46 The Leahy-Smith America Invents Act, 35 USC 1, 2011 (US).
47 The Public Health and Welfare, 42 U.S.C, 1944 (US).
48 The Witherspoon Council, supra note 45.
49 Id.
EUROPE

The Charter of Fundamental Rights of the European Union prohibits reproductive cloning of hu-
man beings, 2012, this is covered under the right to integrity of a person. The charter provides
that the biological research into this field is violative of the basic human dignity of a human be-
ing.

The European Convention on Human Rights and Biomedicine50 promoted by the Council of Eu-
rope prohibits any intervention seeking to create a human identical to another human whether
living or dead. This convention was made after the creation of Dolly the Sheep. This hastily
made convention was made as an attempt to curb research related to human cloning due to its
ethical considerations regarding human dignity. The prohibition appears to cover therapeutic as
well as reproductive cloning  as the it prohibition on cloning of human beings under this conven-
tion covers all nuclear transfer methods seeking to create identical human beings. 51 This conven-
tion is outdated and fails to distinguish between different types of cloning. Moreover, major
countries like UK and Germany did not sign this convention and made national legislations re-
garding human cloning.52

UNITED KINGDOM

As provided above, UK is not a part of the European Convention on Human Rights and Biomed -
icine. Th county passed the Human Reproductive Cloning Act in 2001 to ban all forms of human
reproductive along in the country.53 This act was repealed by the Human Fertilisation and Em-
bryology Act 2008 or HEFA.54 The 2008 act also amended the Human Fertilisation and Embry-
ology Act, 199055 and the Surrogacy Arrangements Act, 1985.56

50 Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application
of Biology and Medicine (1997) ETS 164/4.
51 Id, at article 7.
52 C Mik, Human cloning in the activities of the European Union, 5 (1 Suppl 1) Med Wieku Rozwoj, 195, 210
(2001).
53 Human Reproductive Cloning Act, 2001 c 23, 2001, (UK).
54 Human, supra note 18.
55 Human Fertilisation and Embryology Act, 1990 c 37, 1990 (UK).
56 Surrogacy Arrangements Act 1985, c. 49, 1985 (UK).
Section 3 and 4 of the HEFA 57 stipulates that it is a crime to place a human, admixed or a non
human embryo in a woman unless it was created by the fertilisation of an egg from the ovaries of
a woman by sperm from the testes of a man. Thus, the act specifically criminalises reproductive
cloning. The Act goes on to regulate the process of therapeutic cloning and related research. It
provides for a licensing procedure related to activities in connection with the derivation from em-
bryos of stem cells that are intended for human application. The Act establishes The Human Fer-
tilisation and Embryology Authority which shall grant such licence in storage, research and treat-
ment.58

This is a holistic legislation providing adequate differentiation between the types of cloning. The
licensing procedure ensures that only bonafide research on cloning is funded and allowed in the
country. This helps the nation curb research relating to illegal reproductive cloning while allow-
ing the advancement of science.

MIDDLE EAST

Cloning inside the Eastern Mediterranean Region is powerfully connected to the religious be-
liefs, moral standards and ethical norms subsiding in the area. Most nations in the region have
failed to make substantive legislation on the subject. 59 However, a general reoccurring theme in
the region is that cloning in itself does not contradict the Islamic faith 60 as the ability to make
clones is ordained to humankind by God itself making God the actual creator 61. Thus, cloning of
plants and animals for curing human diseases and improving productivity is not prohibited under
Islamic law. Throughout the Muslim world, and in all the religious fatwa resolutions and recom-
mendations against cloning, a clear message emanates: that the well-being of individual beings is
sacred. Thus, Islam encourages research and investigation.

57 Human, supra note 18 at § 3, 4.

58 Human, supra note 18 at § 16.
59 Cynthia Fox, Where Does Your Country Currently Stand on Therapeutic Cloning? IEEE -EMBS , 2,2 (2004).
60 Mufti Taqi Usmani, Cloning: Islamic Fiqh Academy: deliberations of the 97 meeting, ALBALAGH (Mar. 27,
2020, 9:29 PM) , https://www.albalagh.net/qa/ifa.shtml.
61 Sacchadena AA, Cloning in the Quran and tradition and Islamic perspectives on human cloning, PEOPLE. VIR-
GINIA (Mar. 27, 2020, 10:30 PM), www.people.virginia.edul-article4.htrn.
Research on human gametes and fertilisation is prohibited unless done within the ambit of the
Shariah. Human organs can also be used for medical purposes in scientific research after acquir-
ing official authorisation. Carrying out experiments that may benefit human embryos, or to gain
new knowledge about embryo is permitted as Islam prefers a later ensoulment. However, hu-
mans cannot be used for these experiments, even death row inmates cannot be used as guinea
pigs for medical research, thus indirectly there is a ban on reproductive cloning. 62 Some countries
like Saudi Arabia go a step further and directly ban research in human cloning while making it a
penal offence.63

INTERNATIONAL ORGANISATIONS

The international perspective on cloning humans is extremely grim, despite the enormous poten-
tial of this biomedical tool. The Universal Declaration on Human Genome and Human Rights
was drafted and applied by the UNESCO in 1997. This declaration clearly prohibits the realms of
cloning of homo sapiens and any such practices on account of transgressing the rights of human
dignity, thereby banning both reproductive and therapeutic cloning. In 2001, the UN General As-
sembly held debates regarding the International Convention Against Reproductive Cloning of
Humans.64 Certain member States including the Holy City, Italy, Costa Rica, France, Germany,
Spain etc. resolved to extend a ban to all forms of cloning. Since, the UN even after extensive
discussions could not come up to a conclusive agreement, it implemented non-binding declara-
tions on Human Cloning65 wherein it cast a blanket ban on all types of cloning that was contrary
to human dignity.66

Other premier International Organisations, like World Health Organisation (WHO) and the
World Medical Association (WMA) have also sought for a total global ban on the practices of re-

62 ARAB NEWS, https://www.arabnews.com/saudi-arabia/news/731846 (Jan. 21, 2022, 9:29 PM).

63 Id.
64 Adèle, supra note 19.
65 Universal Declaration on Bioethics and Human Rights, 2005; International Declaration on Human Genetic Data,
2003
66 Ajai, supra note 1, at 94.
productive cloning67. The WHO also prepared guidelines on Medical Genetics and Biotechnol-
ogy: Implications for Public Health. This document had called for a blanket ban on any form of
inheritable genetic modification.

INDIA

India had voted against the adoption of the UN declaration on the Human Genome and Human
Rights as it prohibited therapeutic cloning. India does not have specific law regarding regulation
of cloning but the Indian Council of Medical Research has laid down certain guidelines.68 These
guidelines discuss about the status of both therapeutic cloning and reproductive cloning.

The Guidelines for Stem Cell Research, 2017 were made to define and regulate cloning. The
guidelines categorise cloning by SCNT into reproductive cloning and therapeutic cloning. They
prohibit in vitro culture of intact human embryos, beyond 14 days of fertilisation or formation of
primitive streak into uterus in humans or primates 69. Thus, prohibiting reproductive cloning un-
conditionally70.

The National Ethical Guidelines for Biomedical and Health Research involving human partici-
pants was brought in the year 2017.71 The guidelines classify research into permissible, re-
stricted and prohibited while protecting donors from exploitation and commodification. Thera-
peutic cloning is in the restricted category.72 It is permissible in cases of life threatening genetic
disease, when it is the only therapeutic option. However, such cases require approvals of the au-
thority set under the guidelines and long term surveillance measures. Reproductive cloning is put
in the restricted category under these guidelines.73

67 Rukhmini Bobde, Clone or Not to Clone, 4 PL WebJour 1, 5 (2003).

68 National, supra note 2, at 48.
69 Id.
70 National, supra note 2, at 25.
71 National Ethical Guidelines for Biomedical and Health Research involving Human Participant, 2017 (India).
72 Id., at 65.
73 National, supra note 71, at 80.
These guidelines are non binding in nature by themselves but, are enforceable through the New
Drugs and Clinical Trial Rules, 201974 stemming from the Drugs and Cosmetics Act, 1940.75
Since stem cells fall in the definition of “drug” under this act and therapeutic cloning is a re-
stricted field of research, the Central Government can halt such research under the garb of public
interest.76 A contravention of such a halt is an offence punishable upto 3 years of imprisonment
and a fine upto five thousand rupees.77 However, under this act there is no punishment for con-
duction prohibited research if they do not lead to formation of a “drug”. Thus, reproductive
cloning research, though prohibited is not punishable. Moreover, Reproductive cloning has also
been banned under the Assisted Reproductive Technology (Regulation) Bill 200878.

CONCLUSION

In conclusion, human cloning is a pandoras box that is waiting to be explored. While the advo-
cates of this bioethical tool state that cloning is an immense potential that is waiting to be har-
nessed, the critics state that it is a blatant violation of human dignity and is against the order of
nature. Both of these views are connect to a certain extent. However, one thing is for certain, this
technology is unable to flourish due to the improper and haphazard regulations all around the
globe. There is a lack of a comprehensive global framework regarding research and application
of human cloning. A conclusive binding international document providing adequate definitions
of the types of cloning and the extent to which they are permitted is the need of the hour. The in -
strument should also cover important issues like the extent to which embryos can be developed
and used for research. The objections of the religious communities should be balanced against
the advancement of science. Moreover, as evidenced by human history, legal and moral embar-
goes can only slow the process of science not stop, thus the instrument should to sufficiently
broad and forward looking so as to include future advancements of science, including a situation
where reproductive cloning might be considered as safe and as a valid artificial reproductive
technique, similar to IVF or surrogacy.

74 New Drugs and Clinical Trial Rules, 2019, Published by Authority, 2019 (India).
75 Drugs and Cosmetics Act, 1940, No. 23, Acts of Parliament, 1940 (India).
76 Drugs and Cosmetics Act, 1940, § 26A, No. 23, Acts of Parliament, 1940 (India).
77 Drugs and Cosmetics Act, 1940, § 27A, No. 23, Acts of Parliament, 1940 (India).
78 Assisted reproductive technology (Regulation) Bill, 2008, § 31, 2008 ( India).
In the Indian context, although there are guidelines to define and categorise cloning, there is a
lack of substantive legislation available on the subject. The first step towards a better regulation
of the field shall be to pass the Assisted Reproductive Technology (Regulation) Bill 2008. Sec-
ondly, a national framework to regulate, fund and apply research related to human cloning
should be developed. India can look to the UK model for inspiration on the licensing of such ac-
tivities. Funding of such research should also be regulated while protecting the interests of the
participants and donors of the ova used in such research. Till the techniques of reproductive
cloning are made foolproof and safe for human application, it might be a good idea to prohibit
the patentability of such techniques.