What is Assisted Reproductive Technology (Regulation) Bill, 2020

The Union Cabinet adopted the Assisted Reproductive Technology Regulation Bill, 2020 on Wednesday, which will regulate medical procedures used to help people achieve pregnancy. 

In India, ART clinics and banks are predominantly private, contributing to a multibillion-dollar industry that has grown without any oversight or established treatment and service norms. Clinics frequently make exaggerated promises about treatment success rates, fail to offer sufficient information about the risks, side effects, expenses, and alternatives to operations, and encourage overtreatment. Oocyte donors have died as a result of alleged negligence in some situations.

Many of the technologies, however, are often invasive to women’s bodies, are often medically dangerous for both the woman and the child born as a result of ART, are occasionally experimental in nature, and are not backed by strong evidence of effectiveness and safety. These dangers and disadvantages, particularly for women, are magnified in an atmosphere where fertility services are driven by unbridled economic objectives. 

Biomedical research interests, business interests, and occasionally consumer interests all collide in the market for reproductive body parts. While the selling of solid organs is prohibited in most countries, semen, ova, blood, and other bodily fluids and tissues are exempt due to their regenerative properties. Furthermore, due to the notion of individual autonomy, transactions in these body parts remain generally unregulated. 

Moreover, human sex selection uses sophisticated technologies of semen separation that were originally developed for cattle breeding. There have also been non-invasive ways of foetal sex determination in the first trimester (from 6 weeks) of pregnancy. Market incentives that favour sex selection, as well as libertarian ideologues, have contributed to the blurring of ethical lines.

“As of today, anyone can open a fertility or assisted reproductive technology (ART) clinic; no permission is required to do so. There has been, consequently, a mushrooming of such clinics around the country,” the draft bill said. “In view of the above, in public interest, it has become important to regulate the functioning of such clinics to ensure that the services provided are ethical and that the medical, social and legal rights of all those concerned are protected,” it added. 

For these very reasons, the formulation of the Assisted Reproductive Technology Regulation Bill, 2020 and its discussion was necessary as there was no formal law to enforce justice with regards to all said possible complications. 


What is ART 2020?

The Bill defines ART as any process for obtaining a pregnancy by handling sperm or oocytes (immature egg cells) outside the human body and transferring the gamete or embryo into a woman’s reproductive system. Gamete (sperm or oocyte) donation, in-vitro fertilisation and gestational surrogacy are examples of ART services. ART services will be supplied by (i) ART clinics that conduct ART-related treatments and procedures, and (ii) ART banks that store and distribute gametes.

The Indian Council of Medical Research established the National Guidelines for Accreditation, Supervision, and Regulation of ART Clinics in India in 2005, laying out certain standards that must be fulfilled by every ART facility functioning in India. These rules, however, were not backed by legislation. Following that, the Assisted Reproductive Technology Bill was drafted in 2008, and it was changed several times. Fortunately, the Union Cabinet approved the final version, which was submitted in the Lok Sabha on September 14, 2020. 

According to a recent survey, the Indian Council of Medical Research (ICMR) estimates that there are 125 such clinics in India’s capital city, based on the number of applications received for the National ART Registry. Officials, on the other hand, believe that the true figures are in the range of 250-300.

The Bill will help establish a national board that will formulate a code of conduct for clinic operators to follow. It will also establish minimum criteria for laboratory and diagnostic equipment, as well as policies to be followed by clinics and banks’ human resources. Within three months of receiving notice of the proposed legislation, states and union territories will be required to establish State Boards and State agencies.

The Health and Family Welfare Ministry has released a statement stating a national registry and registration authority will maintain a database to assist the national Board in performing its tasks.


Why ART 2020?

With the proliferation of ART centres everywhere, offering a wide range of services, several ethical and legal difficulties have arisen. There was no organization or regulatory framework in place to oversee these technologies, which led to the commercialization and codification of women’s body parts.

Due to rising rates of infertility in couples, lengthy and difficult adoption procedures, and the desire to have one’s biological child, India has outpaced Western countries in the growth of ART clinics and allied services, becoming one of the major hubs of reproductive tourism. The fertility industry is an important aspect of the country’s developing medical tourism industry, which grew by 30% in 2000 and 15% between 2005 and 2010. Around 150,000 foreigners sought treatment in India in 2004 alone. The significant rise in membership of the Indian Society for Assisted Reproduction (ISAR), which was founded in 1997, is another indicator of the ART industry’s expansion in India. ISAR membership increased from 184 in 1997 to over 600 in 2005, which may be a conservative estimate. According to news sources, the number of overseas consumers visiting ART clinics is increasing, and Indian ART providers are employing aggressive marketing methods.

The Assisted Reproductive Technology (Regulation) Bill will regulate and supervise ART clinics and ART banks, prohibit any misuse, and ensure that ART services are provided in a safe and ethical manner. A Rajya Sabha standing committee report on the ART Bill 2020 also underlined the need for standard operating procedures to maintain “consistent costs” and “global quality standards” across India for this and other fertility operations and services.


Provisions within ART 2020

Under this bill, the following are the provisions it constitutes:

·     A National Board shall be established under the terms of this law to advise the Central Government on policy concerns relating to assisted reproductive technology. 

·       There is a provision for forming a state board to implement the National Board’s policies and plans for clinics and banks in the state.

·       It also requires that fertility clinics and banks be registered with a National Registry. 

·       Clinics and banks that are registered under the requirements of this bill must provide counselling and services on assisted reproductive technology, as well as make sure that clients are informed of their legal rights. The services are available to women under the age of 50 who are legally married and men under the age of 55 who are legally married.

·      No services should be provided without the couple’s consent, which can be revoked prior to embryo transfer. The law also requires banks and clinics to keep track of utilised and unused oocytes, sperms, and embryos.

·       The Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, among other provisions, forbids pre-natal sex determination.

·    The Chapter establishes the offence and consequences for violating the Bill’s requirements. It explicitly prohibits ART Clinics and Bills from offering or facilitating any form of sex-selective ART, and imposes a penalty of five to ten years in prison or a fine of Rs.10 lakh to Rs.20 lakh, or both, if they do so.

·   The bill also punishes a number of practises, including abandoning or exploiting a child born through ART, selling, purchasing, trading, or importing human gametes or embryos, transferring a human embryo into a male person or an animal, exploiting a commissioning couple, woman, or donor, and using intermediaries to obtain donors, by imposing fines ranging from 5 lakh to 10 lakh for the first offence, but increasing the penalty to imprisonment for subsequent offences.


Issues with the ART

While this bill aims to empower its users, even after 16 years it has proven to have multiple points of flaw:

1.       The bill allows a married heterosexual couple and a woman over the age of marriage to utilise ARTs. It excludes single men, cohabiting heterosexual couples, and LGBTQI individuals and couples from receiving ARTs. The law also violates their right to privacy. The Supreme Court of India concluded in Justice K S Puttaswamy v Union of India that an individual must be able to manage matters of home and marriage, the sanctity of family life, and sexual orientation, all of which are parts of privacy. Furthermore, denying homosexual couples the ability to have children is denying their validity, which was recognised by the Supreme Court when it struck down section 377 of the Indian Penal Code. Furthermore, international citizens have unrestricted access to ARTs. Foreigners may use ART, but Indian nationals in loving relationships are not permitted to do so. This clearly fails to encapsulate the Constitution’s genuine spirit. 

2.       The bill does not provide adequate protection for oocyte donors. The bill makes no provision for female counselling. Though her written approval is required to perform the ART operations, she is not able to withdraw her consent before or during the procedure, unlike the commissioning couples. Furthermore, the amount and length of the insurance coverage to be secured in favour of the oocyte donor by the commissioning parents are not specified.

3.       The bill necessitates pre-implantation. Before implantation, the embryo is genetically tested to see if it has any pre-existing, heritable, or genetic diseases, however these disorders are not officially described anywhere. Furthermore, unlike prior draughts of the bill, this one does not include any regulatory measures for research on donated gametes or embryos.

4.       While the Bill defines the term ART, it does not specify certain technical treatments that fall under it, such as in-vitro fertilisation, intracytoplasmic sperm injection, and others.



A bill to regulate ARTs has been in the works for a long time. However, this iteration will accomplish little to govern the reproduction industry or address the numerous legal, ethical, medical, and societal difficulties associated with ART use. The government must allow for genuine and widespread public consultation on the Bill, and develop legislation that is sensitive to ART users’ rights and health.

Riddhima is a political science student at Delhi University, an avid reader and someone who has spent a lot of time travelling and living in different cities around the world. She speaks, reads, and writes around 4 different languages and hopes to be able to continue to learn more. She hopes to grow in the policy space with special focus on China.