In 2021, the Parliament passed the Assisted Reproductive Technology (Regulation) Act, 2021 (hereinafter referred to as ‘ART Act’) which received the assent of the President on 18.12.2021 and came into force on 25.01.2022 vide the notification in the Gazette of India No. CG-DL-E-21012022-232818.
The aim of the ART Act is regulation and supervision of the Assisted Reproductive Technology Banks, prevention of misuse, and safe and ethical practices of Assisted Reproductive Technology Services for addressing the issue of reproductive help where Assisted Reproductive Technology is required for becoming a parent or for freezing gametes, embryos, embryonic tissues for further use due to infertility, decease or social or medical concerns and regulation and supervision of Research and Development and for matters therewith or incidental thereto.
What is Assisted Reproductive Technology?
Assisted Reproductive Technology (hereinafter, referred to as ART), as per law, means and involves all the techniques that are appointed to obtain a pregnancy by handling the sperm or the oocyte outside the human body and transferring the gametes or embryos into the reproductive system of a woman.
What is the meaning of an ‘Assisted Reproductive Technology Bank’?
As per law, an Assited Reproductive Technology Bank means an organization that is responsible for the collection of gametes, storage of gametes and embryos, and supply of gametes to ART Clinics or their patients.
What kind of clinics are ‘Assisted Reproductive Technology Clinics’?
As per the Act, any premises equipped with the requisite facilities and any practitioner registered with the National Medical Commission for carrying out procedures relating to Assisted Reproductive Technology are treated as Assited Reproductive Technology Clinics.
What is the meaning of a commissioning couple?
An infertile married couple who approaches an Assisted Reproductive Technology Clinic (ART Clinic) or an Assisted Reproductive Technology Bank (ART Bank) for obtaining the services authorized by such clinics or banks for the purpose of bearing a child is referred to as a commissioning couple.
What is the meaning of infertility?
As per the ART Act, infertility means the inability to conceive a child after one year of unprotective intercourse or other proven medical condition preventing a couple from conception.
Which authority regulates Assisted Reproductive Technology in India?
The ‘National Assisted Reproductive Technology and Surrogacy Board’ constituted under Section 15(1) of the Surrogacy (Regulation) Act, 2021 is the National Board that regulates Assisted Reproductive Technology in India and exercises and discharges the following functions: –
- To advise the Central Government on policy matters related to surrogacy.
- To review and monitor that the provisions of the ART Act and the Surrogacy (Regulations) Act, 2021 are being implemented.
- To lay down a code of conduct for persons working at surrogacy clinics.
- To set minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by the surrogacy clinics.
- To oversee the performance of various bodies constituted under the Act and to take appropriate steps to ensure their effective performance.
- To supervise the functioning of ‘State Assisted Reproductive Technology and Surrogacy Boards’ and such other functions as may be prescribed by the Central Government.
Which authority regulates Assisted Reproductive Technology at the State level in India?
The ‘State Assisted Reproductive Technology and Surrogacy Board’ constituted under Section 24(1) of the Surrogacy Act, 2021 acts as the State Board for the purposes of the ART Act and has the responsibility to follow the policies and plans laid by the National ART Board for ART Clinics and Banks in the State. Further, the ART Board is responsible to follow the policies and plans made by the National Board and take into account its recognition, and policies and regulating and coordinating enforcement and implementation of such policies and guidelines for assisted reproduction. The functions undertaken by the State Boards are as follows:
- To review the activities of the appropriate authorities functioning in the State or UTs and recommend appropriate action against them.
- To review and monitor that the provisions of the ART Act and the Surrogacy (Regulations) Act, 2021 are being implemented.
- To send such consolidated reports of the activities undertaken in the State or UT to the Board and the Central Government or perform any other function as may be prescribed by the Central Government or the National Board.
What is the National Assisted Reproductive Technology and Surrogacy Registry?
The Central Government under Section 9 of the ART Act has established a registry called the National Assisted Reproductive Technology and Surrogacy Registry which consists of scientific and other technical information pertaining to surrogacy. The National Board discharges functions as prescribed under Section 11 of the Act, mentioned hereinunder: –
- It acts as a central database in the country through which the details of all the clinics and banks of the country including the nature and types of services provided by them, the outcome of the services, and other relevant information obtained on regular basis.
- It assists the National Board in its functioning by providing the data generated from the central database of the Registry.
- The data generated from the National Registry is utilized by the National Board for making policies, and guidelines and to help in identifying new research areas and conducting research in the area of assisted reproduction and other related fields in the country.
Who is an Appropriate Authority for the purposes of the ART Act and the Surrogacy Act?
For the purposes of the ART Act and the Surrogacy Act, the Central and State Governments appoint Appropriate ART and Surrogacy Authorities for each Union Territories and state.
The appropriate authority under Section 13 of the ART Act discharges the following functions: –
- To grant, suspend or cancel the registration of a clinic or bank.
- To enforce the standards to be fulfilled by the clinic or bank.
- To investigate complaints relating to the breach of the provisions of this Act, and take appropriate legal actions regarding misuse of ART by any person and also to initiate independent investigations in such matters.
- To recommend to the National Board and State Boards the modifications required in the rules, in accordance with changes in technology or social conditions.
- To take action after investigation of complaints received by it against the ART clinics or banks or discharge any other function as may be prescribed by the Central Government.
What are the powers of an Appropriate Authority under the ART Act?
Under Section 14 of the ART Act, the Appropriate Authority exercises the powers in respect of the following matters, viz.
- Summoning of any person who is in possession of any information relating to violation of the provisions of this Act.
- Production of any document or material object relating to the first clause.
- Searching of any place suspected to be violating the provisions of this Act.
How do you register an Assisted Reproductive Technology Surrogacy Clinic?
Any Assisted Reproductive Technology Clinic or Bank cannot be established and run unless such clinic or bank is duly registered under the ART Act.
Under Section 15(2), the application for registration of an ART clinic or bank is to be filed to the National Registry through the Appropriate Authority designated in the city. The process of registration is mainly online.
The clinic or bank which is conducting ART (partly or exclusively) is mandatorily required to be registered within a period of sixty (60) days from the date of establishment of the National Registry. It is provided under the Act that if any ART clinic or bank has not registered itself within 6 (six) months, then its authority to conduct any such ART-related counseling or procedure will cease to exist.
The registration of the ART clinics or banks is subject to satisfaction of the Appropriate Authority. Such clinics or banks should be able to provide such facilities and maintain such equipment and standards which can include specialized manpower, physical infrastructure, and diagnostic facility that are mandated by the National or State ART Boards. Registration of ART clinics or banks can be done at the following website: –
NARTSR | Dashboard (artsurrogacy.gov.in)
Any registration is granted only after an inspection of the premises of the ART clinics or banks by the State Board and the registration is valid for a period of 5 (five) years and such registration is required to be displayed at a conspicuous place at the clinic or the bank.
What can be done if the registration of the ARTS Clinic or Bank is not being provided by the Appropriate Authority within the prescribed period?
As per Section 16(1) of the ART Act, the Appropriate Authority on receipt of the application for registration must grant registration within 30 (thirty) days. The Authority can reject the application if the same does not conform to the provisions of the ART Act, along with the Rules and Regulations made thereunder. Before rejecting the application, the Appropriate Authority has to give full opportunity to remove any defect in the application and also provide an opportunity for a hearing in the matter.
It is also provided that if registration is neither granted nor rejected within 30 (thirty) days, then the Appropriate Authority must cite reasons for failure to process the application for registration.
If in case the application for registration has been rejected, suspended, or canceled by the Appropriate Authority, then the ART clinic or bank has a right to appeal under Section 19 of the ART Act before the State Government if the order under appeal is of the Appropriate Authority of a State. If the order under appeal is against the Appropriate Authority of a Union Territory, then the appeal must be made before the Central Government.
If the ART clinic or bank is not satisfied with the order of the State Government or the Central Government, then it shall have the right to file a writ petition before the jurisdictional High Court against the order of the State or Central Government.
The ART and Surrogacy clinics and banks are subject to inspection by which authority?
As per Section 20 of the ART Act, the National Board, National Registry and the State Board have powers to inspect any premises of the ART clinic or bank and call for any document or material from it.
What are the duties of the ART clinic and banks?
The ART clinics and banks, as per Section 21, are required to perform the following duties:
- The clinics and banks are supposed to ensure that the commissioning couple, woman, and donors of gametes are eligible to avail assisted reproductive technology procedures, subject to such criteria as may be prescribed by law.
- The clinics are mandated to obtain donor gametes from the banks and such banks will ensure that the donor has been medically tested for potential diseases.
- The clinics are required to provide professional counseling to the commissioning couple and the woman about all the implications and chances of success of the ART procedures in the clinic.
- The clinic helps the commissioning couple or woman to arrive at an informed decision that is in their respective best interests.
- The clinics make the commissioning couple and the woman aware of the rights of a child born through ART.
- The clinics and banks must ensure that information about the commissioning couple, woman and donor will be kept confidential and the information about the treatment will not be disclosed to anyone except to the database maintained by the National Registry.
- Each clinic and bank is required to maintain a grievance cell to ensure that consumer grievances arising out of their services do not go unattended.
- The clinics must apply the ART services ‘only’ to a woman over the age of 21 and below 50 years, and to a man over the age of 21 and below 55 years.
- The clinics are required to issue a “discharge certificate” to the commissioning couple or the woman stating details of the ART procedure performed on them.
- All the clinics and banks must cooperate and make available their premises and any other material or document for inspection by the National Board.
Is Written Consent of all parties a necessary pre-requisite for initiating surrogacy proceedings?
ART Clinics cannot perform any treatment or procedure without the written informed consent of all the parties seeking ART. Further, clinics mandatory require insurance coverage of such amount as may be prescribed for a period of twelve months in favor of the oocyte donor by the commissioning couple or woman from an insurance company recognized under the Insurance Regulatory and Development Authority Act, 1999.
The intending couple or woman is also required to sign an affidavit to be sworn before a Metropolitan Magistrate or a Magistrate of First-Class giving a guarantee of compensation for specified loss, damage, complications, or death of oocyte donor during the process of oocyte retrieval.
The clinics cannot use any human reproductive material except in accordance with the provisions of the ART Act to create human embryos or use the in-vitro human embryos for any purpose without the specific informed consent in writing of all the concerned persons like the donor and the commissioning couple. The above-given consent can be withdrawn by any of the commissioning couples at any time before the human embryos or gametes are transferred to the concerned human uterus.
What are the duties of the ART clinics and banks with respect to maintaining records?
The ART clinics and banks are duty bound to keep the records relating to such clinics and banks as mentioned under: –
- All clinics and banks are required to maintain detailed records of all donor’s oocytes, sperm, or embryos (used or unused), and the manner and technique of their use for a period of 10 years, after which the records will be transferred to the National Registry database.
- All the information possessed by ART clinics regarding the progress of the commissioning couple or woman, information about the number of donors (sperm and oocyte), screened, maintained, and supplied, etc. must be transmitted to the National Registry through an online medium.
What are the duties of ART clinics while using human gametes and embryos?
As per Section 24 of the ART Act, ART clinics and banks are duty-bound to perform the under-mentioned duties while using human gametes and embryos: –
- The clinics must retrieve oocytes in accordance with the procedure established by law.
- Not more than three oocytes or embryos can be placed in the uterus of a woman during the treatment cycle.
- A woman must not be treated with gametes or embryos derived from more than one man or woman during any one treatment cycle.
- Any clinic must never mix semen from two individuals.
- The embryos must not be split and used for twinning to increase the number of available embryos.
- The collection of gametes posthumously must be done only if prior consent of the commissioning couple is available.
- The clinic must not use an ovum that is derived from a fetus, in any process of in-vitro fertilization.
What test is allowed to screen human embryos?
The ‘pre-implantation genetic’ testing is allowed to be used to screen human embryos for known pre-existing, heritable, or genetic diseases only.
If in case pre-existing, heritable, or genetic diseases are found in the embryos, the commissioning couple or woman can donate embryos to an approved research laboratory where the embryos suffer pre-existing, heritable, or genetic diseases.
Can an ART clinic offer to provide a couple or woman with a child of pre-determined sex?
Under Section 26 of the ART Act, no ART clinic can offer to provide a couple or woman the child of a pre-determined sex and the same is also subject to the provisions of the Pre-complication and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994.
It is also prohibited for anyone to do any act at any stage to determine the sex of the child to be born during the process of the ART, support, or yield fractions enriched in sperm of x or y variation.
It is also prohibited for any person to knowingly provide, prescribe or administer anything that can ensure or increase the probability that an embryo shall be of a particular sex or that can identify the sex of an in-vitro embryo, except to diagnose, prevent or treat the sex-linked disorder or disease.
Which body conducts the screening process and what are its responsibilities in this regard?
‘Screening’ essentially means the genetic test that is performed on embryos produced through in-vitro fertilization.
The screening of gamete donors, the collection, screening, and storage of semen; and provision of oocyte donor, can be done only by an ART bank, registered as an independent entity under the ART Act.
The ART bank must fulfill certain responsibilities in this regard, which are mentioned hereinunder: –
- Obtain semen from males between 21 years of age and 55 years of age, both inclusive.
- Obtain oocytes from females between 23 years of age and 55 years of age.
- Examine the donors for such diseases as may be prescribed.
An ART bank must not supply the sperm or oocyte of a single donor to more than one commissioning couple. An oocyte donor should donate oocytes only once in her lifetime, and not more than seven oocytes can be retrieved from the oocyte donor. All unused oocytes are to be preserved by the banks for use on the same recipient or given for research to an organization registered under the ART Act, after seeking written consent from the commissioning couple.
A bank must obtain all necessary information in respect of a sperm or oocyte donor, including the name and the Aadhaar number.
What are the standards and duration for the storage of human gametes and embryos?
The standards for the storage and handling of gametes and human embryos in respect of their security, recording, and identification are to be such as prescribed by the Central Government.
The gamete of a donor or embryo should be stored for a period of not more than ten years. At the end of such period, such gamete or embryo will be allowed to perish or be donated to a research organization registered under the ART Act for research purposes, with the consent of the commissioning couple or individual.
Is any sale pertaining to human gametes, zygotes, and embryos allowed under the law?
As per Section 29 of the ART Act, any sale, transfer, or use of gametes, zygotes, and embryos, (or any its part), or information related thereto, directly or indirectly to any party within, or outside India is strictly prohibited under law.
However, there is an exception to this rule. In case the transfer is of own gamete or embryos and is intended for personal use, the same can be done after obtaining a certificate from the National Board.
Is the transfer of any gametes or embryos outside India, for research purposes allowed?
The use of any human gametes and embryos or their transfer to any country outside the limits of India for research is absolutely prohibited. However, research on human gametes or embryos within the Indian territory can be performed in accordance with the law.
What are the rights of a child born through ART?
A child born through ART will be deemed to be a biological child of the commissioning couple, and the said child will be entitled to all the rights and privileges available to a natural child only from the commissioning couple, under any law for the time being in force.
A donor will have to relinquish all parental rights over the child which may be born from his or her gamete.
Is sex-selective ART practice banned in India?
Yes, any clinic must not issue, publish, distribute, or communicate any advertisement in any manner including the internet, regarding facilities of sex-selective assisted reproductive technology. Doing so is a punishable offense.
Anyone who is found guilty of sex-selective ART practice will be punishable with imprisonment for a term which is not less than five years but may extend to ten years or with a fine which shall not be less than ten lakh rupees but may extend to twenty-five lakh rupees or with both.
What are the offenses that can be committed by a registered medical practitioner in terms of ART procedure?
Any registered medical practitioner is bound to perform certain duties, and under any circumstances, the person must not: –
- Abandon, disown or exploit (or cause to be abandoned, disowned, or exploited) the child born through ART.
- Sell human embryos or gametes or run an agency, a racket, or an organization for selling, purchasing, or trading in human embryos or gametes.
- Import, or help in getting imported the human embryos or human gametes.
- Exploit the commissioning couple, woman, or gamete donor in any form.
- Transfer a human embryo into a male person or an animal.
- Sell any human embryo or gamete for the purpose of research.
- Use any intermediates to obtain gamete donors or purchase gamete, donors.
The ART Act has made the above-mentioned acts punishable under the law. Anyone found guilty of the commission of any of these acts is punishable with a fine which is not less than five lakh rupees but may extend to ten lakh rupees for the first contravention; and for subsequent contravention, will be punishable with imprisonment for a term which is not less than three years but may extend to eight years and with fine which is not less than ten lakh rupees but can extend to twenty lakh rupees.
Which court will take cognizance if an offense under ART Act has been committed?
Courts can only take cognizance of an offense punishable under the ART Act if a complaint is made to it by the National Board or the State Board, or by an officer authorized by it.
No court inferior to that of a Metropolitan Magistrate or a Judicial Magistrate of the first class can try any offense punishable under the ART Act. Further, all offenses under this Act are cognizable and bailable.
In addition, it is pertinent to add that where an offense under the ART Act has been committed by any clinic or bank, the executive head of such clinic or bank will be deemed to be guilty of an offense and will be liable to be proceeded against and punished accordingly, unless he/she proves that the offense was committed without their knowledge or that he/she exercised all due diligence to prevent the commission of such offense.
