ASSIGNMENT ON

ASSISTED REPRODUCTIVE TECHNOLOGY IN

INDIA

Subject: Technology and Law

Submitted to:

Ms. Upma Shree

Assistant Professor

Submitted by:

SHREYA SAXENA -20817703815

SNEH -21817703815
SRISHTI DHOUNDIYAL -22017703815

VII – D, BA LL.B. (H)

Batch: 2015-2020

VIVEKANANDA INSTITUTE OF PROFESSIONAL STUDIES,

GGSIP UNIVERSITY, NEW DELHI
 THE ASSISTED REPRODUCTIVE TECHNOLOGY (REGULATION) BILL, 2017

Drafted to establish the National Board, the State Boards and the National Registry for the
Regulation and Supervision of assisted reproductive technology clinics and the assisted
reproductive technology banks, for prevention of misuse and for safe and ethical practice of
assisted reproductive technology services and for matters connected therewith or incidental
thereto1. As per the bill, assisted reproductive technique has been defined as “assisted
reproductive technology”2 with its grammatical variations and cognate expressions, means all
techniques that attempt to obtain a pregnancy by handling the sperm or the oocyte outside the
human body and transferring the gamete or the embryo into the reproductive tract of a
woman.
In cases where Reproduction through natural means is not possible, or involves risk upon the
life of the mother or the child, the assisted reproductive techniques can be of great advantage.
Few are discussed in detail below:

I. GAMETE INTRA FALLOPIAN TRANSFER (GIFT)

GIFT was introduced as a more ‘natural’ version of IVF. Instead of fertilisation

occurring in a culture dish in a laboratory, the woman’s eggs are retrieved from
her ovaries and inserted between two layers of sperm in fine tubing. This tubing is
then fed into one of the woman’s fallopian tubes, where the egg and sperm are left
to fertilise naturally. GIFT is no longer commonly used. However, it is sometimes
used as an option for couples who don’t want to use IVF for religious reasons,
providing that the woman’s fallopian tubes are functioning.

Procedure applied in the Gamete Intrafallopian Transfer3:

1 Department of Health research, Ministry of health and family welfare, Government of India
2 Section 2(c) of The
3 Gamete Intrafallopian transfer, ScienceDirect, https://www.sciencedirect.com/topics/medicine-and-
dentistry/gamete-intrafallopian-transfer
 (i) Gamete intrafallopian transfer (GIFT) is a three-step procedure that
involves removing the eggs, combining them with sperm, and immediately
placing them in the fallopian tubes, where the egg is fertilized.
(ii) The woman is given follicle-stimulating drugs to increase her chances of
producing multiple eggs. The eggs are collected via aspiration and mixed
with sperm.
(iii) Using laparoscopy, the combined egg and sperm mixture is placed in the
fallopian tubes.
(iv) GIFT is an option only if the woman has a healthy uterus and fallopian
tubes.

a. Difference between IVF and GIF,

Gamete intrafallopian transfer is not technically in vitro fertilisation because with
GIFT, fertilisation takes place inside the body, not on a petri dish. Some Catholic
moral theologians are nevertheless concerned with it because they "consider this
to be a replacement of the marital act, and therefore immoral."4

In a variation of this method, ova are removed and fertilized with the male
partner’s sperm in vitro. Then, zygotes (single diploid cells) are inserted into the
oviduct and allowed to travel down the oviduct before implantation. This is called
zygote intrafallopian transfer (ZIFT). Success rates for ZIFT and GIFT are about
the same as for IVF.
A woman must have at least one normal fallopian tube in order for GIFT to be
suitable. It is used in instances where the fertility problem relates to sperm
dysfunction, and where the couple has idiopathic (unknown cause) infertility.
Some patients may prefer the procedure to IVF for ethical reasons, since the
fertilization takes place inside the body. This is a semi invasive procedure and
requires laparoscopy.

II. IN VITRO FERTILIZATION (IVF)

4GAMETE INTRAFALLOPIAN TRANSFER (GIFT), Loras College Catholic Healthcare Ethics

In vitro fertilization (IVF) is a type of assistive reproductive technology (ART). It
involves retrieving eggs from a woman’s ovaries and fertilizing them with sperm.
This fertilized egg is known as an embryo. The embryo can then be frozen for
storage or transferred to a woman’s uterus.

Depending on the situation, IVF can use:

 Woman’s eggs and partner’s sperm

 eggs and donor sperm
 donor eggs and partner’s sperm
 donor eggs and donor sperm
 donated embryos

Process in IVF

(i) The first step in IVF is taking fertility medications for several months to
help the ovaries produce several eggs that are mature and ready for
fertilization. This is called ovulation induction.
(ii) Once ovaries have produced enough mature eggs, doctor removes the
eggs from body (this is called egg retrieval). Egg retrieval is a minor
surgical procedure that’s done at a fertility clinic.
(iii) The doctor puts a thin, hollow tube through vagina and into the ovary and
follicles that hold eggs. The needle is connected to a suction device that
gently pulls the eggs out of each follicle.
(iv) In a lab, eggs are mixed with sperm cells from partner or a donor — this is
called insemination. The eggs and sperm are stored together in a special
container, and fertilization happens. For sperm that have lower motility
(don’t swim as well), they may be injected directly into the eggs to
promote fertilization. As the cells in the fertilized eggs divide and become
embryos, people who work at the lab monitor the progress.
About 3-5 days after the egg retrieval, 1 or more embryos are put into
uterus (this is called embryo transfer). The doctor slides a thin tube
through your cervix into your uterus, and inserts the embryo directly into
uterus through the tube.
Pregnancy happens if any of the embryos attach to the lining of your uterus.

Application of IVF in India

The penetration of the IVF market in India is quite low at present with only 2,800
cycles/million infertile women in the reproductive age group (20–44 years) as compared to
China which has 6,500 cycles.5 The key challenges are lack of awareness, affordability and
accessibility. India in 2018 becomes the destination for Fertility Tourism because of most
affordable IVF treatment cost. IVF treatment cost in India varies from $2000 to $4000
(roughly between 150000/- INR to 250000/- INR including all aspects of IVF treatment with
medicines which is almost 5 times lower than IVF Cost in Western part of the world.

III. OVULATION INDUCTION

Ovulation induction uses hormonal therapy to stimulate egg development and release, or
ovulation. Historically, these drugs were designed to induce ovulation in women who did not
ovulate on their own — typically women with irregular menstrual cycles. The goal was to
produce a single, healthy egg.

The second use of ovulation induction was to increase the number of eggs reaching maturity
in a single cycle, to increase chances for conception. The initial agents for this treatment used
first for in vitro fertilization (IVF) and only later for simpler treatments were injectable
medications. These agents carry an increased risk of multiple gestation, ovarian hyper
stimulation, and increased cost and time commitment.

More recently, in the mid-90s, evidence developed to suggest there may be an advantage to
treating even ovulatory women with fertility medications. These women with "unexplained
infertility" may have subtle defects in ovulation, and medications may induce two to three
eggs to mature, versus only one. This treatment therefore improves the quality and quantity of
the ovulation, thus enhancing pregnancy rates.

In ovulatory women, ovulation induction is always combined with intrauterine insemination.

Ovulation induction should progress only after a complete and thorough evaluation. All

5IVF: Fertile Ground, Paramita Chatterjee 08 August 2016 , http://www.businessworld.in/article/IVF-Fertile-

Ground/08-08-2016-104172/
underlying hormonal disorders, such as thyroid dysfunction, should be treated before
resorting to ovulation induction with fertility drugs.6

The following common fertility drugs are used for ovulation induction.

 Clomiphene Citrate (Seraphene and Clomid)

Clomiphene citrate is an oral medication that induces ovulation by blocking estrogen

receptors. This artificial anti-estrogen effect makes your body believe that estrogen levels are
low, which stimulates the production of more follicle stimulating hormone (FSH).
Clomiphene citrate acts as a fertility agent in women by inducing superovulation — the
release of multiple eggs in a given menstrual cycle.

 Human Menopausal Gonadotropin (Pergonal, Humegon and Repronex)

Human menopausal gonadotropin (hMG) is a medication that is composed of follicle

stimulating hormone (FSH) and leutinizing hormone (LH). It is used to stimulate egg
development in women who do not ovulate spontaneously or who ovulate extremely
irregularly, or to increase the number of eggs developed in a single cycle in women who
already ovulate.

 Follicle Stimulating Hormone (Follistim/Gonal-F, Bravelle)

FSH medications are used to stimulate the recruitment and development of multiple eggs in
women during an ovulation induction cycle. FSH products may be used alone or in
combination with human menopausal gonadotropin (hMG) to induce superovulation.

 Human Chorionic Gonadotropin (Profasi, Pregnyl, Ovidrel)

Human chorionic gonadotropin (hCG) is a natural hormone that helps with the final
maturation of the eggs and triggers the ovaries to release the mature eggs (ovulation). It also

6https://www.ucsfhealth.org/education/ovulation_induction/
stimulates the corpus luteum to secrete progesterone to prepare the lining of the uterus for
implantation of the fertilized egg. Ovulation usually occurs about 36 hours after the hCG is
given.

The drug is self-administered as an injection

 Leuprolide (Lupron) and Synthetic Gonadotropin (FSH/LH) Inhibitor

Lupron suppresses the brain's secretion of leutinizing hormone (LH) and follicle stimulating
hormone (FSH). Therefore, it is used in preparation for cycles of treatment with ovulation
induction drugs, such as exogenous hMG-LH/FSH and/or FSH. It improves the recruitment
of follicles by preventing the recruitment of a dominant follicle for the next menstrual cycle.
Lupron enables the ovaries to respond with the recruitment of multiple follicles since in most
cases it's possible to override the selection of a single dominant follicle. It also prevents
premature ovulation by preventing LH release.

IV. ARTIFICIAL INSEMINATION

Artificial insemination is a fertility treatment method used to deliver sperm directly to the
cervix or uterus in the hopes of getting pregnant. Sometimes, these sperm are washed or
“prepared” to increase the likelihood a woman will get pregnant. Two chief approaches to
artificial insemination exist: intrauterine insemination (IUI) and intra-cervical insemination
(ICI). Some women may also take medications to stimulate ovarian follicle growth and
increase conception chance.

Conceiving requires a man’s sperm to travel up the vagina, through the cervix, into the
uterus, and into a fallopian tube where an egg is fertilized. However, sometimes a man’s
sperm isn’t mobile enough to make this trip. Other times, a woman’s cervix may not be
favorable to allow sperm to travel into the uterus. In these instances and other situations,
artificial insemination may help a woman conceive.

A doctor may recommend a couple pursue artificial insemination:

 after six months of having unprotected sex if a woman is older than age 35

 after a year of having unprotected sex if a woman is younger than age 35

 1. ICI

ICI is a type of artificial insemination that involves inserting sperm into the cervix. This is the
passageway just outside the uterus. This approach can be used in a doctor’s office or at home.

2. IUI

IUI is a procedure that involves inserting sperm past the cervix and directly into the uterus.
The steps for this process are similar to that of ICI, but are usually performed at a doctor’s
office and with specially prepared sperm.

V. DONOR CONCEPTION

The act of creating a baby using donated sperm, eggs or embryos

There are several ways that donor sperm, eggs or embryos can be used in ART treatments.

1. Donor sperm (donor insemination)

Donor insemination (DI) may be used when:

 a male partner does not produce sperm,

 a male partner does not produce normal sperm, or

there is a high risk of a man passing on a genetic disease or abnormality to a child.

Donor insemination may also be used by single women and women in same-sex
relationships. The process of donor insemination is the same as artificial insemination.

2. Donor eggs

Treatment with donor eggs is possible if:

 a woman cannot produce eggs or her eggs are of low quality. This may occur due to
age or premature ovarian failure (where the woman no longer produces mature eggs
for ovulation).
 a woman has experienced several miscarriages, or

There is a high risk of the woman passing on a genetic disease or abnormality to a child.
 In these cases, the egg donor undergoes hormone stimulation to produce multiple eggs.
When the eggs are mature they are retrieved and sperm from the recipient's partner or a
donor is added to the eggs. Two to five days later, when embryos are formed, an embryo
is inserted into the recipient woman’s uterus. The recipient woman may take hormones in
preparation for the embryo transfer, and for approximately 10 weeks after the embryos
have been transferred.

3. Donor embryos

Donor embryos can be used if a person or couple requires donor sperm and donor eggs to
achieve a pregnancy. Although rare, some people choose to donate frozen embryos that
they no longer need (after IVF procedures, for example) for use by others undergoing
IVF. When the recipient woman is ready, embryos are thawed and transferred to her
uterus.7

VI. SURROGACY

What is Surrogacy

When a couple wants a baby but is unable to have a child because either or both partners are
medically unfit to conceive, another woman is artificially inseminated with the sperm of the
father. She then carries the child full term and delivers it for the couple. In such a case, the
surrogate mother is the biological mother of the child. In instances when the father’s sperm
cannot be used, a donor sperm can also be used. This is traditional surrogacy.
There is also gestational surrogacy, wherein eggs from the mother are fertilised with the
father’s/donor’s sperm and then the embryo is placed into the uterus of the surrogate, who
carries the child to term and delivers it. In this case, the biological mother is still the woman
whose eggs are used, while the surrogate is called the birth mother.

Surrogacy in India

Surrogacy in India is estimated to be a $2.3 billion industry which is steadily cultivating.

India is changing into a hub of surrogacy-related fertility tourism, where childless couples
from various countries come to India with the hope of starting their own family.
7https://www.varta.org.au/information-support/assisted-reproductive-treatment/types-assisted-reproductive-
treatment
 While a few surrogates do not receive any financial reward for the pregnancy( altruistic
surrogacy) , most surrogate mothers do receive money to carry the child in their wombs. This
is known as commercial surrogacy.

Baby Manjhi case

Commercial Surrogacy had been legalised in India in 2002 but since then there has been no
sound legislation to fall upon in case of disputes regarding the same. Till now such disputes
have been guided by Assisted Reproductive Technique (ART) guidelines by the Indian
Council of Medical Research and the surrogacy contracts by the parties. This legislative void
was brought to the fore in the Baby Manjhi 8 case in 2008 when a Japanese couple contracted
an Indian woman to work as a surrogate. Before the woman could deliver the child, the
couple got divorced. Thus the child was born legally parentless as well as without citizenship.
Though the child was finally handed over to her grandmother, it opened questions about a
practice that had continued unabated for a number of years.

Overview of the Surrogacy Regulation Bill 2016

Although attempts were made to bring a law to address issues pertaining to such matters the
bill was subjected to subsequent revisions and never saw the light of day. Drafted in 2007 by
the then Congress government, the proposed bill underwent enormous discussions till 2015
and is now called the Surrogacy Regulation Bill according to a recent 2016 amendment made
to it.

The bill allows altruistic ethical surrogacy to intending infertile couple between the age of
23- 50 years for females and 26-55 years for males respectively.
The intending couples should be legally married for at least five years and should be Indian
citizens. This means that the bill restricts overseas Indians, foreigners, unmarried couples,
homosexuals and live-in couples from entering a surrogacy agreement.
The intending couples shall not have any surviving child either biologically or through
adoption except when they have a child who is physically or mentally challenged or suffers
from life threatening disorder with no permanent cure. The intending couple cannot abandon

8 Baby Manjhi Yamada V. Union Of India & Anr. [2008] INSC 1656 (29 September 2008)
the child born out of surrogacy under any circumstances. This also includes conditions
wherein the child may be born either mentally or physically ill or may be born terminally ill.
Also in cases where more than one child is born (twins, triplets etc.) the intending parents are
bound to accept all the children born out of such an agreement.
The child born though surrogacy will have the same rights as are available to a biological
child. The surrogate mother should be a close relative of the intending couple and should be
between the age of 25-35 years. The surrogate mother has to be a married woman who has
herself borne a child and is neither a non-resident Indian(NRI) nor a foreigner. She can act as
a surrogate mother only once.

Issues regarding Surrogacy Regulation Bill 2016

Though the surrogacy bill was proposed by Government in good faith and in order to protect
impoverished women from exploitation in the commercial surrogacy industry, the bill if
passed shall have the opposite effect. There is a possibility that the daughter's-in-law might
be coerced to act as surrogate for other family members like the brother-in-law or the sister-
in-law.
Contrary to the Government's opinion, the surrogate mothers themselves have opposed the
bill which is indeed draconian in nature. The reasons for this are obvious, while on one hand
this bill snatches away the economic opportunities of the surrogate mother, giving no
compensation in return and depriving surrogate mothers from their Right to Livelihood, on
the other hand it takes away the hope of single individuals, homosexuals, live-in couples, or
even those married Indian couples who cannot find a surrogate from within their relatives to
ever know the joy of parenthood through surrogacy.The bill violates fundamental human
rights. It is in breach of Articles 7 and 16 of the United Nations-backed Universal Declaration
of Human Rights, which call for equality before the law and the right of men and women of
full age to found a family. [3]
As the bill also restricts surrogacy as an option for NRIs and homosexuals, it is violative
of citizen's fundamental rights as laid down in Article 14 and Article 21 of the Indian
Constitution. It infringes upon the Right to Reproductive Autonomy, which includes the
Right to Procreation and Parenthood. The mode of parenthood is the prerogative of the
parent/s and is not for the state to decide
Similarly this bill is also questionable on the ground that since the law allows adoption by a
single parent, then they should be eligible to opt for surrogacy too.
 VII. PREIMPLANTATION GENETIC DIAGNOSIS

Preimplantation genetic diagnosis (PGD) is a procedure used prior to implantation to help

identify genetic defects within embryos. This serves to prevent certain genetic diseases or
disorders from being passed on to the child. The embryos used in PGD are usually created
during the process of in vitro fertilization (IVF).

Procedure:

Preimplantation genetic diagnosis begins with the normal process of in vitro fertilization that
includes egg retrieval and fertilization in a laboratory. Over the next three to five days, the
embryos will divide into multiple cells.

1. First, a couple/few cells are microsurgically removed from the embryos, which are
about 5 days developed. After this cell collection, the embryos are safely frozen.
2. The DNA of the cells is then evaluated to determine if the inheritance of a
problematic gene is present in each embryo. This process takes at least one full week.
3. Once PGD has identified embryos free of genetic problems, the embryo(s) will be
placed in the uterus (usually by an IVF procedure), and the wait for implantation and
a positive pregnancy test begins.
4. Any additional embryos that are free of genetic problems are kept frozen for possible
later use while embryos with the problematic gene(s) are destroyed. This testing
process may take weeks.

Who can benefit from PGD:

The following is a list of the type of individuals who are possible candidates for PGD:

 Carriers of sex-linked genetic disorders

 Carriers of single gene disorders
 Those with chromosomal disorders
 Women age 35 and over
 Women experiencing recurrent pregnancy loss
 Women with more than one failed fertility treatment
Benefits of PGD:

 PGD can test for more than 100 different genetic conditions.
 The procedure is performed before implantation thus allowing the couple to decide if
they wish to continue with the pregnancy.
 The procedure enables couples to pursue biological children who might not have done
so otherwise.

Concerns or Disadvantages associated with the use of PGD:

 Moral Issues: Many people believe that because life begins at conception, the
destruction of an embryo is the destruction of a person.
 Uncertainity: While PGD helps reduce the chances of conceiving a child with a
genetic disorder, it cannot completely eliminate this risk. In some cases,
further testing is needed during pregnancy to ascertain if a genetic factor is still
possible.
 Although genetically present, some diseases only generate symptoms when carriers
reach middle age. The probability of disorder development should be a topic of
discussion with the healthcare provider.

VIII. INTRA CYTOPLASMIC SPERM INJECTION

Intra Cytoplasmic Sperm Injection

Intracytoplasmic sperm injection is an in vitro fertilization (IVF) procedure in which a

single sperm cell is injected directly into the cytoplasm of an egg. This technique is used in
order to prepare the gametes for the obtention of embryos that may be transferred to a
maternal uterus. With this method acrosome reaction (penetration of the egg membrane) is
skipped.This procedure is most commonly used to overcome male infertility problems,
although it may also be used where eggs cannot easily be penetrated by sperm.
How Is ICSI Performed?

There are basically five simple steps to ICSI which include the following:

1. The mature egg is held with a specialized pipette.

2. A very delicate, sharp, and hollow needle is used to immobilize and pick up a single
sperm.

3. The needle is then carefully inserted through the shell of the egg and into the
cytoplasm of the egg.

4. The sperm is injected into the cytoplasm, and the needle is carefully removed.

5. The eggs are checked the following day for evidence of normal fertilization.

Once the steps of ICSI are complete and fertilization is successful, the embryo
transfer procedure is used to physically place the embryo in the woman’s uterus.

Advantages of ICSI
First and foremost, ICSI is a procedure which effectively eliminates male infertility by
introducing sperm cells directly into an egg. While this is no guarantee of a successful
fertilisation, it does improve the odds astronomically, which it does by removing the key
elements that often lead to male infertility. These are sperm count, motility, and morphology
(the shape and structure of the cell), all of which are vital to successful sperm action during
natural conception as they are needed to get the sperm to the egg and allow it to gain access
to the egg for fertilisation. As the main causes of male infertility are a low sperm count, poor
motility, and poor sperm shape, you can see how ICSI is the perfect solution.

ICSI’s benefits extend beyond just acting as a treatment for male infertility, but also for
anyone who is paralysed or have had in irreversible vasectomy. More importantly
however, ICSI is an option for couples who have tried and failed at a standard IVF treatment.
ICSI can be extremely useful where few eggs are available and so each one must have the
best chance of fertilisation.

Disadvantages of ICSI
ICSI’s method of directly introducing sperm into an egg defeats the natural process of only
a select few sperm making it to and fertilising an egg. This can be a disadvantage because
this selection process is nature’s way of making sure that the best sperm with the best
genetic material are the ones with the best chance at fertilising an egg. Removing that
selection process can lead to an increase risk of developmental and health issues for ICSI
children, as well as a higher risk of miscarriage because of the poorer genetic material
involved.

As ICSI has only been in use for less than two decades, some concerns are hard to dismiss at
present. One of these is the worry that children conceived through ICSI are infertile or
sub-fertile as a consequence of the procedure, but again because the technique hasn’t been in
use for that long, there is no concrete evidence to back such a claim.

CONCLUSION

While Technology is evolving day to day to make human lives better, it seems that the Legal
Juriprudence regarding the same is not developing at the same pace. While some of the above
discussed procedures are simple, and do not have any legal consequences, there are other
issues which are more complex in nature, and involve legal and ethical considerations, for
example: surrogacy.

There are grave lacunas present in the Bill, which is itself insufficient. The scope of the Bill
is wide but at the same time, it lacks clarity. The present times call for a legislation which is
detailed and takes into consideration any issues: legal or ethical which have arisen so far, or
may arise in the future.