Introduction

As it is popularly understood, Assisted Reproductive Technology (ART) includes operations such as in-vitro fertilizations (IVF), intrauterine insemination (IUI), oocyte and sperm donation, cryopreservation, and surrogacy. Since 2008, when the Indian Council of Medical Research originally prepared the bill to regulate the ART business, the government has been working on it (ICMR). The bill was introduced in the Lok Sabha in 2020, but it was referred to a standing committee by the House.

The ART bill was previously passed by the Lok Sabha on December 1st. The bill also aims to establish national standards and codes of behaviour for fertility clinics and sperm banks, as well as to prevent misuse and promote safe and ethical operations. Speaking in the Lok Sabha about the bill, Union Health Minister Mansukh Mandaviya said that numerous assisted reproductive technology facilities are operating without regulation in the country, and that there is a need to regulate them because the practice has health implications for people who undertake it. Thousands of infertile couples are now using or planning to use technology, and the sector has risen at a breakneck pace in recent years, prompting the authorities to consider regulating it.

The law proposes creating a national registry and licensing authority for all clinics and medical professionals working in the field. To make the registration procedure easier, the state government will appoint registration authority. The registration will be valid for five years, with the option to renew for another five.

Background of the Act

There exist 1,269 ART clinics in India, according to the Indian Council of Medical Research’s database (as of November 2019). When the number of ART clinics and the number of ART banks are combined together, the total number of ART clinics and ART banks rises to 1,846. The state with the most ART clinics is Maharashtra (266), followed by Tamil Nadu (164), Delhi (113), Karnataka (102), Uttar Pradesh (92), and Gujarat (80)

Significance

The country’s assisted reproductive technology services that are regulated would be of considerable importance and benefit. Infertile couples will be more assured and secure of ethical practices in ART facilities as a result.

Overview and key features of the Act

The purpose of the Act is to regulate and supervise assisted reproductive technology clinics and banks.as well as to prevent misuse, ensure To address reproductive health issues where assisted reproductive technology is required for becoming a parent or preserving gametes, embryos, or embryonic tissues for future use, and to ensure the safe and ethical practise of assisted reproductive technology services for future use.

Every assisted reproductive technology (ART) facility and bank must register with the National Registry of Banks and Clinics of India, according to the Act. State governments would nominate necessary authorities in their respective states to simplify the registration procedure, with the Registry serving as a single database for all facilities delivering ART treatments in India.

The registration must be renewed every five years, and it can be revoked or suspended if an entity violates the Act’s terms.

For the purposes of this Act, The National Board will create the National Assisted Reproductive Technology and Surrogacy Board.

The Central Government may, within ninety days of the Act’s commencement, by notification, establish for the purposes of this Act and the Surrogacy Act, a Registry to be known as the National Assisted Reproductive Technology and Surrogacy Registry.

The National Registry will be made up of such scientific, technical, administrative, and support workers, as well as the terms and conditions of their employment as defined by the Act.

The Act details the registration process for Assisted Technology Clinics and Banks, including procedures for registration grant, renewal, suspension, and cancellation. In the exercise of their powers and functions, The National Board, the National Registry, and the State Board shall have the ability to: (i) visit any facility related to assisted reproductive technology; and (ii) request any document or material.

Clinics and banks would be responsible for the following tasks:

Clinics and banks must ensure that the commissioning couple, women, and gamete donors are all qualified to undergo assisted reproductive technology treatments, subject to any constraints that may be imposed.

Clinics must get donor gametes from banks, which must ensure that the donors have been medically screened for any disorders that may be prescribed.

The commissioning couple or woman must be educated on the rights of a child born through assisted reproductive technology.

For concerns relating to clinics and banks, each clinic and bank shall have a grievance cell, and the method for making a complaint with such a grievance cell shall be as prescribed.

Clinics must provide a discharge certificate to the commissioning couple or woman detailing the assisted reproductive technology operation that was conducted on them.

Offences and Penalties

No advertisement regarding sex selective assisted reproductive technology facilities shall be issued, published, distributed, communicated, or caused to be issued, published, disseminated, or communicated by the clinic, its bank, or its agent in any means, including the internet.

Violations of the provisions are penalized by imprisonment for a duration of five years, extendable to 10 years, or a fine of not less than ten lakh rupees but not more than twenty-five lakh rupees, or both.

Any medical geneticist, gynaecologists , registered medical practitioner, or other person is prohibited from—

[A] Abandon, disown, or exploit the child or children produced through assisted reproduction technology in any way, or cause them to be abandoned, disowned, or exploited in any way.

[B] Sell human embryos or gametes, or run an agency, a racket, or a business that sells, buys, or trades human embryos or gametes in any way.

[C] Import or assist in the importation of human embryos or gametes in any way.

[D] Take advantage of the commissioning couple, woman, or gamete donor in every way possible.

[E] Human embryo implantation in a male person or animal.

[F] Make any human embryo or gamete available for scientific research.

[G] Obtain gamete donors or purchase gamete donors via any intermediates.

Clauses (a) to (g) are punishable for the first breach, a punishment of not less than five lakh rupees but not more than ten lakh rupees, and for consecutive violations, a sentence of not less than three years but not more than eight years in jail and a fine of not less than ten lakh rupees but not more than twenty lakh rupees.

Measures that the Act facilitates

The procedure’s cost should be closely monitored so that even the impoverished can benefit from it.

Individuals who engage in sex selection, the sale of human embryos or gametes, or those who are caught running agencies, rackets, or organisations that engage in such procedures in violation of the law should face serious penalties, according to the bill.

Treatments in ART can be obtained by the commissioning couple directly, with no need for a third party.

ART procedures are available to married couples, live-in partners, single women, and foreigners.

It also requires that the oocyte donor be covered through insurance.

The ART Bill establishes a National Board with powers similar to those granted by the Code of Civil Procedure to a civil court.

Medical tourism allows foreigners to visit India for ART services.

Conclusion

The Assisted Reproductive Technology, Act, 2021, which is new to Indian law, aims to lay down regulations to assist people who want to start a family and conceive a child in the safest and most legally valid methods possible.

“Having kids—the responsibility of rearing good, kind, ethical, responsible human beings—is the biggest job anyone can embark on.”

~Maria Shriver

Introduction

Nature has gifted women with the ability to give birth, and every woman enjoys the phase of motherhood. However, high rates of infertility and scientific advancements has prompted people to consider surrogacy. Assisted Reproductive Technology involves artificial or partially artificial techniques of causing conception. We could say that the parents biologically constructs the child, whereas the child socially constructs the parents. Because kinship and familial bonds are depending on children, infertility is considered as a serious issue. Surrogacy is a feasible option in this case. The word “surrogate” finds it origin from the Latin word “surrogatus,” which means“to person appointed to act in the place of another.” A surrogate mother is a person who bears a child for another woman, either from her own egg or from the fertilised egg of another woman implanted in her womb.

It was in the Law Commission of India two hundred twenty-eighth report that the subject was suo motu taken up for study and the need for active legislative intervention was recognised. On December 18, 2021, the Parliament passed the Assisted Reproductive Technology Regulation Act, which was followed by the Surrogacy Regulation Act 2021, and the approval of the Medical Termination of Pregnancy Amendment Bill 2020. These laws are ground-breaking in terms of protecting women’s reproductive rights.

Background

In the past, India was recognised as the global capital of “commercial surrogacy” and fertility tourism. For quite some time, India was regarded as the world’s most popular “surrogacy destination.” Many people are going to India because commercial surrogacy is illegal in most countries. People who are infertile, heterosexual couples, homosexuals, crippled and handicapped, and elderly couples were the main clientele of surrogacy tourism. Surrogacy tourism was a very profitable sector for Indian medical tourism and foreign exchange gains.

The lack of regulation in this area has resulted in a growth of surrogacy clinics and widespread exploitation of women who choose to become surrogates, many of whom are poor. Surrogacy clinics frequently engage in unethical activities, and surrogates are typically excluded from the decision-making process, which is restricted to the intended parent(s) and medical experts due to their illiteracy and poverty. Many people even withdrew from the arrangement at an advanced stage. Indian law prohibits a single adult male from adopting a female kid. Furthermore, due to the taboo surrounding assisted reproduction in India, surrogates are generally forced to bear the foetus in secret, under awful physical conditions, and for a very meagre amount.

Indian legislations on surrogacy

Surrogacy has become a thriving part of the Indian medical business; many couples from other countries travel for this reason due to the lack of restrictions, reduced costs, and availability of surrogate mothers. As there was lack of any codified law, the Indian Council of Medical Research Guidelines, published in 2005, regulate surrogacy. In Baby Manji Yamada v. Union of India, the Supreme Court legally recognised commercial surrogacy and emphasised the necessity for a legislation governing surrogacy in India, as the money-making scheme is being perpetuated in various parts of the country in 2008. The National Commission for the Protection of Children was tasked with this responsibility. The Law Commission of India’s 288th Report suggested barring commercial surrogacy and permitting altruistic surrogacy in 2009. Another occurrence in 2012 with a foreigner couple rejecting one of their twins born through a surrogate because one of them had Down syndrome. This issue resurfaced in 2014 when a 23-year-old woman died following an egg donation process at an IVF clinic. Advocate Jayashree Wad filed a public interest litigation (PIL) in the Supreme Court in 2015 in retaliation to these despicable acts, seeking that commercial surrogacy be prohibited.

Assisted Reproductive Technology (Regulation) Act, 2021

The Ministry of Health and Family Welfare had introduced the Surrogacy (Regulation) Bill, 2020, which now has been passed, which aims to restrict commercial surrogacy in India while legalising altruistic surrogacy. The Act aims to regulate and monitor assisted reproductive technology clinics and banks, as well as to prevent misuse, ensure safe and ethical practise of assisted reproductive technology services, and to address reproductive health issues such as infertility, disease, or social or medical concerns where assisted reproductive technology is required for becoming a parent or for freezing gametes, embryos, or embryonic tissues for future use due to infertility, disease, or social or medical concerns. For the purposes of this Act, the National Assisted Reproductive Technology and Surrogacy Board will be established under the National Board. Clinics and banks must ensure that the commissioning couple, women, and gamete donors are qualified to use assisted reproductive technology treatments, subject to any prescribed criteria. The clinic, or its bank or agent, shall not issue, publish, distribute, communicate, or cause to be issued, published, disseminated, or communicated any advertisement regarding sex selective assisted reproductive technology facilities in any medium, including the internet. Contravention of the provisions is punishable by imprisonment for a period of five years, extendable to 10 years, or a fine of not less than ten lakh rupees, but not more than twenty-five lakh rupees, or both.

Conclusion

Surrogacy involves a tangle of social, ethical, legal, and technological issues. Surrogacy is not only a legal issue that needs to be considered; society as a whole must treat it as a social problem and address it in such a way that our ethical standards are not jeopardised as we embrace evolving technology. However, the Act excludes LGBTQIA+ people and single males from its ambit. Furthermore, ART service providers must establish in-house ethics committees and provide mandatory counselling services. Also I feel that the procedure’s cost should be closely regulated so that even the poor can benefit from it. In addition, the government can establish ART facilities in chosen government hospitals to assist the poor and marginalised.

“Reproductive freedom is critical to a whole range of issues. If we can’t take charge of this most personal aspect of our lives, we can’t take care of anything. It should not be seen as a privilege or as a benefit, but a fundamental human right.”― Faye Wattleton

Assisted Reproductive Technology (ART), as the name suggests, involves state of the art medical assistance in order to conceive a child as against the natural biological procedure of achieving pregnancy. Evidently, ART whether it be In-Vitro Fertilization, embryo transfer, test tube babies, surrogacy, or in any other manner, comes as a very effective boon to infertile or single parents.

In India, the concept of ART has evolved by leaps and bounds. Specifically, the last two decades and the latter half of the 20th Century have witnessed the mushrooming of a large number of such technologies which assist reproduction. The history of ART in India dates way back to 1986 when India’s first IVF baby, Harsha Chawla was born. It was India’s first “Scientifically documented” baby, as they call it.

Raising a child and having a family forms an important part of the Indian values and ethics system. It is also apparent that India is not vary to the problem of increasing infertility. Thus, in this backdrop of exponentially high levels of infertility rate, mainly due to lifestyle aspects, India has accepted ART with open arms. Moreover, the social stigma attached to being infertile and the complicatedly protracted adoption procedure has further hiked the need of ART in India. As a result, there has been a positive increase in the number of hospitals, clinics and ART banks providing a wide range of much needed ART services. This makes it very clear as to why the ART industry is predicted to grow at an impeccably booming annual rate of 10%.

For a very long time, India did not have any concrete and standard regulations regulating the legal, moral, ethical, medical facets of ART. However, as the industry was flourishing quite rapidly, the possibilities of probable abuse and exploitation were also at its peak. The worst of them was the impeccable growth in the number of foreign tourists searching for an Indian surrogate who could rent her womb for their child. Further, these surrogates were increasingly subjected to ill treatment under unreasonably poor living conditions. The lack of education coupled with poverty pushed these women in the vicious cycle of “baby making”. Thus, to stop the industry from becoming a “money making machine” under the guise of helping people in having a child, the need for certain safeguards further concretized.

Such instances straightway leading to baby selling, questioned the very purity of the reproductive capability of women. Therefore, back then in 2002 and 2005 the Indian Council of Medical Research (ICMR) came up with certain guidelines regulating ART clinics and hospitals. However, these Guidelines, lacking any legal backing, could not be entirely relied upon.

The need for a concrete statutory legislation further crystallized after the case of Baby Manji Yamada vs Union of India. Here, an Indian surrogate had lent her womb to a Japanese couple who later on separated and the child born was not allowed to move out of the country due to certain permit issues. The Supreme Court instructed the government to issue the passport to Manji Yamada and she returned with her grandmother. Since the child was given to her grandmother, it was inferred from this judgment that commercial surrogacy was legally recognized in India. The judgment also highlighted the need for a legislation regulating surrogacy in India and consequently led to the issuance of the Assisted Reproductive Technology (Regulation) Bill, 2008. Unfortunately, the Bill could not gain effectiveness. After several amendments, the final version of the Bill was formulated in 2017. The Surrogacy (Regulation) Bill was also conceived in 2016. Since the conception of the Bills, the courts via its judgments have also introduced certain safeguards. One such precedent is Jan Balaz vs Anand Municipality, wherein the Gujarat High Court ruled that the surrogate child would be deemed to be an Indian citizen with the name of the surrogate mother on the birth certificate.

Both these Bills had been eluded from the light of the day for an unreasonably long period of time. It was only as recently as December 2021 that the Bills got the nod of the Parliament.

Having said that, evidently, it has been a historic achievement for India that unlike its predecessors, and the Bill has finally gained the status of an Act. However, it goes without saying that this does not mean that the battle has been won. In India, successful implementation of legislations has always been a grey area of concern. Thus, the purpose of the Act would be said to be achieved only upon its successful implementation and the attitude of the people towards it. There is still a long way to go and much more needs to be done for India to be a truly safe hub for medical tourism in the area of ART.