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Fertility Services Regulation Needs Re and New Thinking

Fertility Services Regulation Needs Re and New Thinking - A brief study on Assisted Reproductive Technology and its legal regulations in India

“As the family goes, so goes the nation and so goes the whole world in which we live.” -John Paul II

The above statement can be considered as a universal fact. In other words, one can say that every single family in every nation contributes collectively to make this world go on and on. The human race has evolved in many different ways spanning a time period of thousands of years but the urge to procreate has not changed. Humans are probably only species to maintain lifelong contact with their children and no matter what they don’t let go of that emotion. So it is natural that when men start his family the urge to have children is natural.

The desire to procreate is a very fundamental attribute of the human race.It will not be possible to say of those families who cannot chip in or a couple who cannot become parents. In medical terminology, the incapacity to have own child is known as Infertility. Infertility, though not life threatening, causes intense mental agony and trauma that can only be best described by infertile couples themselves.[2]Sadly, many are denied the joy of parenthood due to several reasons like biological, medical or otherwise.

For families facing infertility, decisions about family building become complex. In previous days people were forced to undergo for adoption, but infertility has traditionally been an area of medicine and because of advancement in science physicians got a chance to help their patients, in them, one of the way to have biologically related child by infertile couple through medical intervention is ‘Assisted Reproductive Technology’ (ART). In present society this technology is famous as ‘test tube baby technology’.[3]

One of the most important advantages in ART is, through ART people may have genetic relation with their child. In case of adoption children may or may not be genetically related to the adoptive parents.

Definition of ART:
Assisted Reproductive technology (ART) has been defined under the ART (regulation) Bill (in India) as “assisted reproductive technology”, with its grammatical variations and cognate expressions, means all techniques that attempt to obtain a pregnancy by handling or manipulating the sperm or the oocyte outside the human body and transferring the gamete or the embryo into the reproductive tract of a woman.[4]

Origin of ART:
Although it is generally perceived that assisted reproductive technology (ART) is a recent development, the practice of artificial insemination became common in the mid twentieth century. The first known example of artificial insemination dated as far back as 1785 and was conducted by a Scottish surgeon, John Hunter.[5]But ART was popularized in the year 1978.On 25thJuly 1978, world’s first human test tube baby Louise Joy Brown was born at Oldham General Hospital in England. Architects were Robert Edward and Patrick Steptoe. Officially it was the beginning of ART in the world. By the birth of Louise Brown, the world celebrated the start of a new era of assisted human reproductive technology. Edwards was awarded the Nobel Prize in Medicine in 2010 for his efforts.[6]

Origin of ART in India:
The world’s second and India’s first IVF baby Kanupriya Agarwalalias Durga, was born in Calcutta on 3rdOctober 1978, about two months after the world’s first IVF baby, Louise Brown. This was achieved by the Great scientist and Creator of the India’s first (in fact unofficial) test-tube baby, Dr. Subhash Mukhopadhyay. In this research Mukhopadhyay was assisted by Sunit Mukherji and S.K. Bhattacharya.[7]

Eight years after the birth of 'Durga', India's second Test-tube baby (officially first) Harsha Chawda was born at the state run hospital K.E.M. Hospital in Mumbai on 6thAugust 1986.Some records say that Harsha is the 'first' Test-tube baby because of the controversy involving around Durga’s birth.[8]Baby Harsha created by Dr T.C. Anand Kumar, a reproductive biologist, with his team. He is known for having created India’s first test-tube baby (officially). However after baby Harsh’s birth, the field of assisted reproduction has been developed rapidly in our India with newer techniques, modifications of existing ones and new approaches. In fact ART is a field that is dynamic and ever changing.[9]

There are many different types of Assisted Reproductive Technologies (ART's) available today; they are IVF, GIFT, ZIFT,ICSI, Donor eggs or sperm and more importantlySurrogacy.[10]Surrogacy is not a technique, but an arrangement;[11]it is also included under the umbrella term of ART.[12]ART technology is commonly known as ‘test tube baby technology’.[13]For the most part, ARTs do not treat the biological problems that give rise to infertility but circumvent them—most ARTs offer ways to create children despite underlying fertility problems. More importantly, ARTs sometimes require the use of reproductive resources—sperm, eggs, or wombs—from third parties who are not expected to play a role in raising the resulting children.

Regulation of ART:
No doubt assisted reproduction is a great scientific achievement and has been giving hope to millions of couples suffering from infertility but one has to agree that each and every issue has its own merits and demerits which are inevitable. So in the case of ART also there are number of problematic issues which have been raising numerous controversies regarding ethical, legal, social, health etc questions, that society must address in which the lion share is occupied by legal as well as ethical issues. Over time, in response to these issues some governments in industrialized countries moved towards regulating ART services. Stricter legislations to limit patients’ access to treatment in various ways like ban or limited certain procedures (such as prohibition of multiple embryos implantation etc), excluded some patients from treatment (older women, lesbians and gay men, single women or men), restrictions on eggs, sperm donation and on surrogacy arrangements etc.[14]

Internationally there are two main different approaches to the regulation of ART. Some countries such as the UK, Germany and most of Scandinavia have passed laws covering most of the aspects of ART. Many other countries such as the USA have fewer laws in this area, and the regulation of fertility treatments is overseen by professional bodies. There is much debate in the field of assisted reproduction as to where the balance should lie between professional standard setting and legislation.[15]Unfortunately, even India also not provided statutory regulations up to now.

In India since 2002, ART has been recognized as infertility treatment under the Government of India Ministry of Tourism Policy.[16]In the year 2005 for the first time Indian Council of Medical Research (ICMR) and National Academy of Medical Sciences (NAMS) by the order of the Ministry of Health and Family Welfare, Government of India, have come out with National Guidelines for accreditation, supervision and regulation of ART clinics in India, which are non-statutory provisions.[17]After this, in the year 2009, 18th Law commission also submitted its 228threport on ‘Need for legislation to regulate assisted reproductive technology clinics as well as rights and obligations of parties to a surrogacy.

In the year 2012 government of India limited surrogacy to some kind of foreigners[18].Very recently in hurried move government released information to the press that it looks for disallowing commercial surrogacy for foreign nationals. Also, ICMR sent out the notification to all ART Clinics on27thOctober 2015requesting them not to “entertain” foreign nationals for surrogacy arrangements in India.[19]This step taken by the government in response to a Public interest litigation petition[20]filed by Jayashree Wad, an advocate on record in Supreme Court impleading herself in the Jan Balaz Case[21](German Couple’s Case) and requested the court to ban commercial surrogacy. More over a group of Indian cabinet Ministers on 25thAugust, 2016 approved a new surrogacy bill 2016 and gave its green signal to the bill to introduce in Parliament,[22]which aim to prohibit total commercial surrogacy even for Indians. Present Minister for External Affairs Sushma Swaraj said that “this new bill aimedto ban commercial surrogacy. More over only Indian nationals will be allowed for altruistic surrogacy. Foreign nationals or even NRI or OIC will not be allowed. And only married couples will allow opting of surrogacy that means Gay, single, live-in couples are not allowed”.[23]

In fact all these are non statutory provisions, though Indian legislature drafted ART regulation bill in the year 2008, 2010, 2013 thereafter, very recently in the year 2014. The struggle for enacting proper law did not come true even today. The ART Bill 2014 circulated or placed in the public domain for discussion, comment or opinion.[24]

Moreover, recently the Health Ministry proposed the draft Surrogacy Bill, 2016 aims at regulating commissioning of surrogacy in the country in a proper manner,[25]with lots of restrictions on receiving surrogacy. Like aboveIndian government, came out with a draft bill on Assisted Reproductive Technology (Regulation) Bill and Rules 2008, which later replaced by 2010, 2013 and 2014 bills. But up to now (2018) the struggle for statutory regulation regarding ART was not fulfill in India.

Judicial contribution:
ART services development in India has been creating numerous ethical, economical, social and legal controversies. Here more importantly offering ART by Indian people and clinics to foreigners pawed the way for commidification of motherhood and miss use of technology for exploitation of poor women. In this circumstance Hon’ble Supreme Court and Hon’ble High courts had interpreted the ART regulations, ancillary issues relation to it and its goals in an appreciable manner through innovative interpretations in many cases from 2008Baby Manji Yamada case[26]to very recently Jayashree Wad PIL[27]Case.

Form the above discussion one can understand that whenever the choice occurred to the judiciary to pronounce judgment regarding the ART regulation and incidentally had relation to ART services like surrogacy it had done its best to protect the goals of the ART regulation and interest of the country.

The Supreme Court has not only made the fundamental rights and directive principles real and effective, but has also expanded the scope of several fundamental rights by its pronouncements and has evolved new human rights jurisprudence in India by adding reproductive rights. It has undergone a radical change in the last few years and it is now increasingly being identified by justices as well as by people as “the last resort for the purpose of the bewildered”.

It is the fact that the implementation of the ART regulations in strict manner by the administrative is not happening in reality even after the Apex Court of India had issued several guild lines. Finally, one has to agree that without a full pledged legislation to deal with ART services it is very difficult to courts to tackle issues has been rising by ART.

Ethical Concern in ART:
It is fact that ethics may vary from place to place time to time and country to country more importantly from situation to situation, for clear understanding of ART services one has to understand several issues such as the structure of the assisted reproductive family, the welfare of the child, genetic material donation (donation of sperm or egg or embryo), age criteria (age of the intending parents/commissioning parents), pre-implantaion genetic diagnosis/ selective embryo reduction (to have desired baby, including sex selection), confidentiality, right to know information by child born through ART, more importantly contract of commercial surrogacy, legitimacy of the child born through ART (mainly by third party donation or help) etc. ethical issues has been giving rise several conflicts between all these issues.

There are number of disadvantages in ART services that to in cross bordered ART services. It is fact that ART services are evils which, interfere with natural capacity, but it is a necessary evil in this present era. According to utilitarian theory it is the responsibility of the state to make a law which provides ‘greatest happiness to the greatest number’ in case of ART regulation. So, there is an urgent need to address this ART issue through law, which must and should maintain balance between etc.

So, there is an urgent need to embark on a massive nationwide sensitization and advocacy campaign for proper law with specific focus on the importance of the ART services to reinforce the view stated by law commission of India, in its 228threport as ART services are an asset and not a burden. ART has been giving hope to the numerous infertile couples that to theses ART services for foreigners providing finance as well as global market to India, Which is the concept of reproductive tourism within India. Though there are little bit problems they can be minimized with proper law. Prohibiting surrogacy to foreigners, commercial surrogacy to Indians without statutory law may lead to number of problems, so basing on this reasons there is an urgent need for addressing this contemporary issue.

After the birth of world’s first test tub baby[28]this ART has been updating in accordance with advancement of days. ART isa field that is dynamic and ever changing, such as pre-implantation genetics, cloning etc. New technologies have been changing the capabilities of ART. Based on the need of the particular individual numerous methods available in ART, such as IVF, GIFT, ZIFT, ICSI, Donor eggs or sperm and more importantlySurrogacy.

These technologies lead to numerous appreciations at the same time criticism also. More over different nations approach for this ART is also different based on the history and cultural background of the nation.
Now a day’s people approaching ART clinics to have their biological child, to escape from stigma, social suffering, mental agony and because of several reasons regarding childlessness. For having ART treatment people are also travelling to other countries, without boundary barriers, which caused for reproductive tourism or cross border reproductive care. Many are calling it simply as ‘reproductive tourism’ or ‘reproductive exile’ instead of calling it as ‘cross border reproductive care’, but these words are not reflecting patients’ real mental agony and necessity, in particular their emotion to avoid there social stigma as infertile. More over these terms made them as offenders. As said by law commission in its 228threport infertility is a cause for several problems for couple like in India.[29]Just prohibiting these services on vague moral grounds without a proper assessment of social ends and purposes would be irrational.[30]

Since ages it is evident that people who are not satisfied with unreasonable customs, vague morals and unjust laws of the society, and who find great satisfaction beyond all these, they like to refuse to these unreasonable norms of society at any cost. In case of ART services one can witness it. So in this era there is a need for reasonable regulations at international as well as in nations.

The right to have ART services to establish one’s own family recognized as one of the important human right in international legal regime. But there are no uniform approaches and regulations regarding ART in all nations. Different nations have different approaches on these services, some countries providing ART services without any restrictions, but providing with some restrictions and some have rigid regulations on ART and some not. It is also fact in case of India, but the struggle for making law regarding ART regulation was not become real even today in India.

Because of age old traditions and culture India also interpreting this ART services in a negative way by putting too much unreasonable restrictions. ART has been raising a wide range of issues like social, medical, legal and ethical, more so in case of surrogacy, as it involves humans (as third party) to participate in this process for the benefit of others either for some monetary benefit or for pleasure. Some feminists say, in surrogacy, wealthy people are exploiting poor people and they mad women womb as money bag, so it should ban. Scholars opine that not only surrogacy, but also all ART services and reproductive travel, exemplifies the commodification of the body.

Many people demanding that too much commercialization in ART should stop, because, some people as well as some countries providing these services only to monetary benefit and they are viewing it as one of the money yielding business. Based on this commercial surrogacy is banned in many countries and in some it is permitted with certain restrictions. In India, there is no specific law relating to surrogacy or ART services except non-statutory guidelines by ICMR in the year 2005.

In India ICMR came up with ‘Guidelines for Accreditation, Supervision and Regulation of ART clinics in India 2005’, noticing the mushrooming of infertility and ART clinics in the country after India’s second (officially first) test tube baby Harsha created by Dr T.C. Anand Kumar, a reproductive biologist, with his team.[31]The guidelines received critical assessment from different quarters, especially women’s groups and social activists. Subsequently, because of law commission recommendations in its 228threport, Indian government drafted ‘the assisted reproductive technology’ bill 2008, later 2010 and 2014 which is pending to become an Act.
Under ICMR guidelines as well as, all these ART regulation bills it is mandatory to register the ART clinics and banks in order to regulate them in proper manner. It is also aimed to prevent the transmission of communicable diseases from donors to children, prohibition of sex selection, to maintain confidentiality regarding identity of the donors, most importantly to provide ethical and legal codes for ART seekers as well as to the providers. It also includes surrogacy arrangements.

Even after this new ART bill 2014, there are strong voices against commercial surrogacy mainly surrogacy services by Indians to foreigners as well as by Indians for monetary benefits. So, in the year 2015 the Indian government Prohibited surrogacy arrangements to foreigners.[32]Later the Government has recently proposed a novel legislative proposal on Surrogacy in the year 2016.The draft Surrogacy Bill, 2016 aims at regulating commissioning of surrogacy in the country in a proper manner, more over this bill prohibiting commercial surrogacy, it allows only altruistic surrogacy. It was approved by group of cabinet Ministers and cabinet gave its green signal to the bill to be introduced in Parliament.[33]In fact by this new Surrogacy Bill 2016 Indian government solely addressing, dealing with the issues related to “surrogacy” in exclusion of other ART Techniques by which it narrowed the surrogacy bill scope. By this one can presume that ART bill 2014 may be replaced by new bill in accordance with surrogacy bill 2016.

It is true that in all issues there will be good as well as bad; it is the duty of the people and government in a civilized society to avoid conflicts through proper regulation for peaceful enjoyment of life. Though ART services are evils, are interfering with natural process of getting child, because of numerous reasons it become a necessary evil. This evil can be controlled by states with due care. Finally one can say that though there are number of disadvantages in ART services that to in cross bordered ART services. It can be made it as, more useful and less harmful through proper laws by state.

After a critical reading the author of this research report saying that, first, people should come out from all myths regarding the ART and they must accept this new and innovative medical science technology. It is duty of the society to respect the feeling of childless couples; based on vague moral, religious and ethical grounds it is not good to comment or to restrict ART. It neither healthy to society nor to the country.

Each one in this society has a role to play, to understand the importance of the ART - as parents, siblings, family members and friends. And as a professionals, either teachers, doctors, lawyers, judges, administrators, law enforcement persons, elected representatives, journalists, writers, artists...... etc. whatever the status of an individual, everyone has to communicate other by arts, crafts, writings, speeches... etc. and whatever the medium, the messages like seeking ART neither a sin nor illegal but it should only obtain by needy. Keeping in the mind that children are the precious than anything, researcher (author) requesting Indian legislators to provide regulation of ART and cross boarder reproductive care, with reasonable restrictions, not on vague moral and ethical principles and it should implement with dedicative manner. Moreover, whatever the law commends or prohibits it will only be successful when people accept them. So, researcher (author) also requesting the society to accept ART as a savior and God given gift to infertile couple. Yes, it is well established fact that those societies which follow reasonable moral and ethical norms will blessed with peace and prosperity but a growth of the society should not stopped because of vague moral and ethical principles. At the same time individual and society must and should remember that there will be a better tomorrow, if technology utilized with reasoned mind and consciousness.

“Science is a beautiful gift to humanity; we should not distort it” – A.P.J. Abdul Kalam[34]

*Assistant Professor, Smt. V.D. Siddartha Law College, Kanuru, Vijayawada, Krishna District, Andhra Pradesh, India. Pin code: 52007. Phon No. 9491448532, E-mail: [email protected].
[1]Pope Saint John Paul IIwaspopefrom 1978 to 2005. He is widely known to Catholics asSaint John Paul the Great, especially in the names of institutions.
Available at:,
(Visited on 2015 March 20).
[2]“National Guidelines for Accreditation, Supervision & Regulation ofART Clinics in India, 2005”Chapter 1 - Introduction, Brief history of ART and Requirement of ART Clinicsfirst paragraph first lines. (farmed byIndian Council of Medical Research (ICMR) andNational Academy of Medical Sciences (NAMS)).
Available at:http://www.
[3]“Surrogacy in India and its legal and ethical implications”, by Shaista Amin, Research Scholar, Dept. of Law, University of Kashmir, Srinagar, India and Asma Rehman, Lecturer, Kashmir Law College, Nowshera, Srinagar, India. Published in Journal of International academic research for multidisciplinary, Impact Factor 1.393, ISSN: 2320-5083, Volume 2, Issue 4, May 2014.
Available at:
[4]The Assisted Reproductive Technologies (Regulation) Bill, 2014, Sec. 2(c)
Available at : %20(Regulation)%20Bill,%202014.pdf
[5]Wilder, B. (2002), Assisted Reproductive Technology: Trends and Suggestions for the Developing Law. Journal of the American Academy of Matrimonial Lawyers, 18, 177-209.
Available at:
[6]Available at:
[7]Available at: on 2014 August 8).
[8]Anindita Ghose’s tweet share on“the forgotten hero of IVF”(onThu, Oct 14 2010. 10:33 PM).
Available at:
[9]“The Ethical, Legal, and Social Issues Impacted by Modern Assisted Reproductive Technologies” by Paul R. Brezina and Yulian Zhao, Hindawi Publishing Corporation, Obstetrics and Gynecology International, Volume 2012, Article ID 686253, doi:10.1155/2012/686253.
Available at:
[10]The Assisted Reproductive Technologies (Regulation) Bill, 2014 sec. 2(zq) defines surrogacy as “surrogacy” means an arrangement in which a woman agrees to a pregnancy, achieved through assisted reproductive technology, in which neither of the gametes belong to her or her husband, with the intention to carry it and hand over the child to the commissioning couple for whom she is acting as a surrogate; Sec. 2(zr) says about “surrogate mother” and Sec. 2(zs) says about “surrogacy agreement” means.
Available at : 20(Regulation)%20Bill,%202014.pdf
[11]There are two main types in surrogacy they are traditional or straight and host or gestational.
Traditional orStraightSurrogacy:The surrogate mother is impregnated with semen from the intended father or sperm donor and uses her own eggs. This means that the surrogate mother is genetically related to the child. The insemination procedure can be conducted at home, using an insemination kit, or can be performed by a fertility clinic.
Hostor Gestational Surrogacy:The more popular and effective method, this procedure involves in vitro fertilization (IVF) with the eggs of the intended mother or those of an egg donor. Here the surrogate mother is not genetically related to the child. This method is more complicated medically; it tends to be more expensive than traditional surrogacy.
[12]Available at :
[13]“Surrogacy in India and its Legal and Ethical implications”, by Shaista Amin, Research Scholar, Dept. of Law, University of Kashmir, Srinagar, India and Asma Rehman, Lecturer, Kashmir Law College, Nowshera, Srinagar, India. published in journal of international academic research for multidisciplinary, Impact Factor 1.393, ISSN: 2320-5083, Volume 2, Issue 4, May 2014.
Available at: on 2015 March 20).
[14]Storrow, Richard F. 2006. “Quests for Conception: Fertility Tourists, Globalization and Feminist Legal Theory.” Hastings Law Journal, pp 57: 302-303.
Available at : Footnotes 5)
(visited on 2014 May 3)
[15]Kevin Coward and Dagan Wells, Textbook of Clinical Embryology, edited and Published by Cambridge University Press. © Cambridge University Press 2013.
Available at: (visited on 2014 August 8).
[16]Available at: on 2015 October 12).
[17]Available at:
[18]According to The Ministry of Home Affairs (MHA) guidelines of July 9, 2012, surrogacy services prohibited to foreign single parent, gay couple.
[19]Notice Number : 5/10/8/2008-RHN, Dated : 27/10/2015.
Available at : And
[20]Jayashree Wad v. Union of India , Writ Petition civil no. 95 of 2015 yr
Available at:
[21]Jan Balaz v. Anand Municipality and 6 Orson 17 June, 2008 (AIR 2010 Guj 21)
Available at:
[22]Available at:
[23]Available at :
[24]This draft bill available at Draft%20Assisted%20Reproductive% 20Technology%20(Regulation)%20Bill,%202014.pdf
[25]In fact surrogacy is one of the arrangements in ART for having biological child through third party. ART means not whole and sole, but because of this concept of surrogacy, ART got public awareness.
[26]Baby Manji Yamada v. Union of India & Others. [2008]13 SCC 518 or (2008)INSC 1656
[27]Jayashree Wad v. Union of India, Writ Petition civil no. 95 of 2015 yr
Available at: ground-latest-developments.pdf
[28]On 25 July 1978, world’s first human test tube baby Louise Joy Brown was born atOldham General Hospitalin England. Architects were Robert Edward and Patrick Steptoe.
Available at :
[29]Para 1.2 The growth in the ART methods is recognition of the fact that infertility as a medical condition is a huge impediment in the overall wellbeing of couples and cannot be overlooked especially in a patriarchal society like India. A woman is respected as a wife only if she is mother of a child, so that her husband's masculinity and sexual potency is proved and the lineage continues. Some authors put it as follows: The parents construct the child biologically, while the child constructs the parents socially. The problem however arises when the parents are unable to construct the child through the conventional biological means. Infertility is seen as a major problem as kinship and family ties are dependent on progeny. Herein surrogacy comes as a supreme saviour. Page 9.
Available at :
[30]See Law commission of India 228threport, cover letter Para 4 The legal issues related with surrogacy are very complex and need to be addressed by a comprehensive legislation. Surrogacy involves conflict of various interests and has inscrutable impact on the primary unit 6 of society viz. family. Non-intervention of law in this knotty issue will not be proper at a time when law is to act as ardent defender of human liberty and an instrument of distribution of positive entitlements. At the same time, prohibition on vague moral grounds without a proper assessment of social ends and purposes which surrogacy can serve would be irrational. Active legislative intervention is required to facilitate correct uses of the new technology i.e. ART and relinquish the cocooned approach to legalization of surrogacy adopted hitherto. The need of the hour is to adopt a pragmatic approach by legalizing altruistic surrogacy arrangements and prohibit commercial ones.
Available at :
[31]Available at :
[32]Notice number: 5/10/8/2008-RHN, dated: 27/10/2015. This notice send by Dr. R.S. Sharma, Head, Scientist-G & Sr.DDG of Indian council of medical research, department of health research (Ministry of health and family welfare) to all ART clinics and banks the exact words are “Dear Drs., I am directed to inform you that as per the stand of department of health research, ministry of health and family welfare, govt. of India, the surrogacy will be limited to Indian married couples only and not to the foreigners. Therefore, your are requested not to entertain any foreigners for availing surrogacy services in India. This issues with the approval of the Director General, ICMR”.
Available at : 20ART%20clinics.pdf
[34]Available online at:

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