Latest news with #ARTAct
Hindustan Times
5 days ago
- Health
- Hindustan Times
Estranged Mumbai couple wage a legal battle over 16 frozen embryos
Sixteen frozen embryos are at the centre of a unique custodial battle in Mumbai that raises key legal and ethical questions. Estranged Mumbai couple wage a legal battle over 16 frozen embryos In 2022, a couple from south Mumbai who were married the previous year decided to freeze embryos grown from the man's sperm and the woman's eggs. But in 2023, their marriage soured. Now, the legal battle over the embryos has reached the Bombay High Court. The woman wishes to have a child, and wants the fertility clinic currently storing them to transfer them to another clinic . Her husband has allegedly blocked the transfer. The 46-year-old woman is now before the Bombay High Court urging it to direct the concerned authorities to allow her to proceed with the transfer of her cryopreserved embryos to another clinic without the consent of her estranged husband. 'In matters so intrinsically tied to the woman's body, health and identity, the law must recognise the primacy of her informed and enduring will over procedural hurdles grounded in outdated patriarchal notions of spousal dominion,' her petition says. In her petition filed through lawyer Jamshed Mistry, the woman contended that a provision under the Assisted Reproductive Technology (Regulation) (ART) Act, 2021 that requires the consent of both spouses for transfer of the embryos, needs to make an exception for marital abandonment, separation and irretrievable breakdown of marriage. On Thursday, a division bench of Justice Revati Mohite Dere and Justice Neela Gokhale issued notices to respondents including the husband, the clinic and the National ART and Surrogacy Board in and adjourned the case till August 21. The petitioner also argued that while the ART Act allows single women to avail assisted reproductive services, it imposes 'rigid barriers' on married women deserted by their husbands. The couple married in October 2021 when the woman was 42 and her husband was 46. On January 22, 2022, they signed a joint consent form for freezing of embryos -- comprising the woman's eggs and the man's sperm -- at an IVF clinic in Kemp's Corner. They also agreed to pay an annual storage fee of ₹25,000 for the cryopreservation of the embryos. In November, 2022, the woman was found to have multiple uterine fibroids and was advised to undergo a myomectomy to remove the fibroids. In December, 2022, the woman wrote to the clinic in Kemp's Corner asking them to transfer her 16 preserved embryos to another clinic at Colaba. 'She felt more comfortable there,' her lawyer told HT. But caught up in a range of procedures, the woman did not follow up. Around the same time, the couple's relationship soured and the woman's husband allegedly deserted her on August 6, 2023. She initiated proceedings against him under the Domestic Violence Act before a magistrate. On August 9, 2023, the woman was informed by the clinic storing her embryos that her husband had, through an email, asked the clinic to put a hold on all procedures regarding the embryos. The woman claims the clinic at Kemp's Corner referenced Section 29 of the ART Act and said that consent of both the genetic contributors would be required to allow the transfer of embryos. The woman, who still needed a myomectomy, underwent the procedure in February 2024 at Breach Candy Hospital. She says she sought a written assurance from her doctors that four-five months after the myomectomy would be a good time to implant the embryos in her womb. During a mediation in their domestic violence case before a magistrate court in Mazgaon in December 2024, the woman alleged her husband demanded ₹25 lakh to allow the embryo transfer. On May 29 this year, she filed an FIR at Nagpada police station against her husband for threats, endangerment to her bodily integrity, reproductive rights and conspiracy to obstruct her medically sanctioned fertility procedure. The case is pending before the magistrate's court. No action has been taken on the FIR yet. The woman filed a petition before the Bombay high court earlier this month. The woman contended before the high court that the mandatory spousal consent required under the ART Act needs a rethink in case of marital abandonment. She stated that a woman physically and emotionally prepared for motherhood is being denied that experience by her estranged husband by his unilateral withdrawal of consent. 'Such a rigid and literal interpretation of statutory consent requirements reduces a woman's autonomy to the wilful inertia of an absconding spouse,' her petition stated. Amit Karkhanis, a lawyer who specialises in medico-legal cases, said that there is no precedent in the law for such cases but the woman may have some remedies. 'The clinic is right to ask for the consent of the husband because the genetic material with them belongs to both parties. There is an option to file an application before the family court. The woman can state before the court that her husband is refusing to give consent for transfer or embryos. If he does not come before the court, the court may even give an ex-parte order in her favour,' said Karkhanis. He said if she gets a divorce, she can get a sperm donor and create new embryos too.
The Hindu
28-06-2025
- Health
- The Hindu
Bombay High Court orders fertility clinic to preserve deceased man's sperm in landmark ART Act case
In a case that could set a key precedent for posthumous reproductive rights in India, the Bombay High Court has directed the interim preservation of a deceased 21-year-old unmarried man's frozen semen sample. Justice Manish Pitale, presiding over a Single Bench, was hearing a petition filed by the man's mother and noted that the matter raised 'important questions' regarding the interpretation and application of the Assisted Reproductive Technology (Regulation) Act, 2021 (ART Act). The petitioner moved the High Court after the fertility clinic refused to release her son's semen. She is seeking access to the sample to continue the family lineage, arguing that her son was the sole legal heir. Justice Pitale observed, 'This petition gives rise to important questions with regard to the manner in which the semen/gamete of a person is to be preserved after death, under the Assisted Reproductive Technology (Regulation) Act, 2021 and the Rules framed thereunder. This becomes particularly significant in the present case, for the reason that the deceased, being the son of the petitioner, was unmarried at the time of his death.' The Court said that the petition requires detailed consideration but cautioned that if the semen is discarded during the pendency of the matter, the very purpose of the petition would be defeated. 'In view of the above, list for further consideration on July 30, 2025, High on Board. In the meanwhile, as an interim direction, the respondent No.2 (the clinic) is directed to ensure safe-keeping and storage of the frozen semen sample of the deceased, during the pendency of the present petition.' According to the mother, her son was diagnosed in 2023 with Ewing Sarcoma, a rare form of cancer affecting bones. Before beginning chemotherapy, his oncologist had advised him to freeze his semen due to the potential impact on fertility. He subsequently deposited his sample at a fertility clinic in Mumbai. The consent form, the mother claims, gave only two options: discard upon death or hand over to a spouse. The son signed it without consulting his family. As he died unmarried and without a will on February 16, 2025, the clinic refused to release the sample. The mother requested that it be transferred to a Gujarat-based clinic but was informed that a court order was needed. She first approached the Maharashtra Public Health Department in March but received no response. She then appealed to the Union Ministry of Health and Family Welfare on April 28. On May 6, her grievance was formally rejected, prompting her to approach the High Court. The petition notes that there are no surviving male members in the family, as the father and uncles had passed away young. It also cites a dying wish conveyed by the son to his aunt — that his sperm be used to create children who could look after his mother and family. The petition asserts that 'the sperm constitutes property' and that 'parents are the legal heirs of their deceased son.'
Time of India
12-06-2025
- Health
- Time of India
Regulating Hope: India's ART Act, Global Best Practices, and the Drive for Research Excellence
Assisted Reproductive Technology ( ART ) has transformed fertility care, bringing renewed hope to countless individuals and couples facing infertility. In response to the growing demand and complexity of ART services, India introduced the Assisted Reproductive Technology (Regulation) Act, 2021—an important step toward creating a safe, ethical, and accountable environment for reproductive treatments. By setting clear standards and oversight mechanisms, the Act lays a strong foundation for responsible practice. As the field continues to evolve, there is an opportunity to build on this progress by enabling a supportive ecosystem for research, innovation, and collaboration—ensuring that India remains responsive to emerging technologies while upholding the rights and well-being of all stakeholders. The ART Act: India's Regulatory Milestone The Assisted Reproductive Technology (Regulation) Act, 2021 was introduced to regulate and supervise ART clinics and banks across India, aiming to prevent misuse and ensure that all procedures are carried out in a safe and ethical manner. To achieve this, the Act established a comprehensive, multi-tiered regulatory framework comprising the National and State ART and Surrogacy Boards , a National Registry, and designated authorities at both the central and state levels. These bodies are responsible for overseeing the registration, functioning, and monitoring of ART clinics and banks, enforcing prescribed standards, and maintaining a central database to support transparency and informed policy-making. Among the Act's key provisions are the mandatory registration of all ART clinics and banks, the requirement for written informed consent from all parties involved, and strict protocols for record-keeping and reporting. Additionally, the Act regulates the sourcing, storage, and handling of gametes, explicitly prohibits sex selection and the commercial sale of gametes or embryos, and includes safeguards to protect the rights and welfare of children born through ART procedures. Together, these measures address a wide range of ethical, medical, and legal concerns, while fostering responsible advancements in the field of reproductive medicine. Global Perspectives United States The US model relies on a combination of federal oversight (primarily through the Centers for Disease Control and Prevention and the Food and Drug Administration) and state-level regulation. Accreditation by professional bodies such as the American Society for Reproductive Medicine (ASRM) and the Society for Assisted Reproductive Technology (SART) ensures high standards of practice and transparent outcome reporting. However, there is significant variability in access and donor anonymity laws across states. Spain Spain is recognized for its progressive, patient-centric approach. The country's national law guarantees broad access to ART, including for single women and same-sex couples. Donor anonymity is strictly enforced, and a comprehensive national registry tracks all procedures and outcomes. Spain's robust oversight has made it a global destination for fertility care. China China's ART sector is tightly regulated by the government, with access limited to married couples. Clinics and banks operate under strict licensing, and there are clear restrictions on embryo storage and use. The centralized approach ensures uniform standards but limits individual choice. Japan Japan's regulatory environment is evolving, with guidelines issued by professional societies and increasing government involvement. Donor anonymity is maintained, and there is a cautious approach to expanding ART services, reflecting societal consensus and ethical considerations. India's take on Research and Innovation India's approach to research and innovation in assisted reproductive technology (ART), including emerging fields like genetic testing and embryo research is evolving. India's in vitro fertilization (IVF) industry is undergoing a significant transformation, driven by rising infertility rates, technological advancements, and increased awareness of fertility treatments. Guidelines and Regulation of ART-Related Research and ICMR India has established regulatory frameworks for ART through the Assisted Reproductive Technology (ART) Act, 2021, and the Surrogacy (Regulation) Act, 2021, which set out ethical and safety standards for ART practices. The ART Act includes strict guidelines on embryo use, prohibiting embryos from being used for purposes other than ART or research, and bans the transfer of gametes/embryos outside India for research or as a source of stem cells. Embryo donation for research is allowed only in specific cases and with written consent. Genetic testing and pre-implantation genetic testing (PGT) are mandated in certain cases to screen embryos for genetic diseases or when medically indicated, reflecting a cautious but proactive approach to integrating new technologies. However, research involving human germline gene therapy, reproductive cloning, and clinical trials with xenogeneic cells is not permitted. In vitro genome modification of embryos (not carried to term) is allowed, but only up to 14 days of fertilization. As of 2025, India does not have specific laws regulating human embryo gene editing. Instead, oversight is provided through guidelines issued by the Indian Council of Medical Research (ICMR). According to the National Guidelines for Stem Cell Research, genome editing—including methods like CRISPR-Cas9—on stem cells, germ-line cells, gametes, or embryos is allowed only for in vitro studies. Such research must be reviewed by the IC-SCR, IEC, and IBSC, and approved by the RCGM. Clinical application of germline gene editing is currently strictly prohibited. Need to Incentivize Research and Innovation There is broad recognition among policymakers and experts of the need to incentivize research and innovation in the medical field, especially in fertility and ART. The government has launched the National Policy on Research and Development and Innovation in Pharma-MedTech Sector and the PRIP (Promotion of Research and Innovation in Pharma MedTech Sector ) scheme, which aims to: Create a regulatory environment that facilitates innovation and research in product private and public investment in innovation through fiscal and non-fiscal industry-academia collaboration and support research in priority areas, including stem cell therapy and complex generics. Nitiz Murdia – Managing Director Indira IVF says, 'Experts and stakeholders in the fertility sector highlight the need for greater awareness, expanded access, insurance coverage, and government-backed initiatives to address India's fertility challenges and to support the growth of ART services and research'. References: This article is written by Nitiz Murdia, Managing Director at Indira IVF (DISCLAIMER: The views expressed are solely of the author and does not necessarily subscribe to it. shall not be responsible for any damage caused to any person/organisation directly or indirectly)
The Independent
10-04-2025
- Health
- The Independent
Woman gives birth to stranger's baby after IVF mix-up implants her with wrong embryo
A woman gave birth to another mother's baby after a f ertility care clinic mixed up their embryos. Monash IVF, which operates across Australia, discovered the mistake in February after the birth parents asked for their remaining embryos from the Brisbane clinic to be transferred to another IVF provider. An investigation the Herald Sun reports. Monash IVF said the incident was due to human error and that it follows strict laboratory safety procedures to protect embryos. 'Instead of finding the expected number of embryos, an additional embryo remained in storage for the birth parents,' the company said in a statement to the news outlet. Monash IVF apologised to the birth parents, who were notified within a week of the discovery. Australian media reported that the families involved - who have not been identified - are 'outraged' and considering legal action. 'On behalf of Monash IVF, I want to say how truly sorry I am for what has happened,' Monash IVF chief executive Michael Knaap said in the statement, adding that the company would continue to support the patients. All of us at Monash IVF are devastated and we apologise to everyone involved. We have undertaken additional audits and we're confident that this is an isolated incident.' An independent investigation is taking place into what happened, with the IVF clinic committed to fully implementing any recommendations made. The error comes after Monash IVF settled with more than 700 former patients for $56 million in August over allegations it destroyed embryos in faulty genetic screening. The class action claimed that about 35 percent of the embryos the provider classified as abnormal due to faulty testing were actually normal. Monash IVF Group said it had not admitted liability but confirmed it had settled the case through mediation. Chair of the Australian and New Zealand Infertility Council Association Rebecca Kerner told Australian broadcaster ABC she was shocked by the Brisbane clinic incident. 'My heart goes out to the poor families involved in this horrible mix-up,' Ms Kerner said. The Queensland Department of Health said it had also been made aware of the incident as the new ART regulator. 'We will work with Monash IVF to reinforce safeguards in their Queensland clinics and ensure any risks are identified and mitigated.' The ART Act was passed last September following an investigation into ART providers in Queensland by the state's ombudsman. The ombudsman report found that the collection, storage, identification and distribution of gametes and embryos was the issue with the highest number of complaints.
The Guardian
11-03-2025
- Health
- The Guardian
South Australia expands donor conception rights with new transparency laws
The South Australian government is giving donor-conceived adults access to their genetic heritage information through a donor conception register (DCR). SA Health says it is the first government agency in Australia to offer a publicly accessible online DCR, and the second to allow donor-conceived people to access information about their genetic heritage retrospectively. The changes to assisted reproductive treatment (ART) laws allow people to access information dating back to the 1970s, where that information is available and can be verified. The new laws balance the privacy of people who have donated sperm, eggs or embryos with the rights of donor-conceived people to access their genetic heritage information for their health and wellbeing, SA Health says. 'We recognise how important it is for all donor-conceived people to have access to information about their genetic heritage,' says Sinéad O'Brien, the deputy chief executive, strategy and governance, at the Department for Health and Wellbeing in South Australia. 'It can play a significant role in the development of a person's identity and self-esteem, but it can also enable them to access important medical and genetic information for things like family planning.' The ability to trace genetic heritage can be valuable for medical reasons, as it allows donor-conceived people to better understand their genetic predispositions to certain conditions. This information can help guide health decisions, including whether to undergo screening for hereditary illnesses. Australia's donor conception community, fertility clinics and stakeholders were consulted before the law changed. The final consultation report found that almost 70% of respondents supported or partially supported the proposed changes. SA Health says this shows community views have shifted since the ART Act was proclaimed in 1988 and ART regulations came into being in 2010, and that the health and wellbeing of donor-conceived people must be better supported. The consultation process, which involved direct engagement with donor-conceived people, parents, donors and experts in the field of reproductive medicine, enabled lawmakers to develop principles that provide a safe and respectful way for people to access information, O'Brien says. The changes reflect a shift away from the historical culture of secrecy surrounding donor conception, O'Brien says. 'We hope the DCR will help to further normalise donor conception in our community and encourage more openness and acceptance.' The DCR does not offer DNA testing and is not searchable, but ensures that available verified information is pre-linked for users to find information about their connections in accordance with the law. The Government proclaimed the changed Assisted Reproductive Treatment Act 1988 and the Assisted Reproductive Treatment (ART) Regulations 2024 on 28 November 2024. The changed laws, which regulate what information is held on the DCR and who may access it, became operational on 26 February 2025. Information is available only to individuals linked to a donor conception treatment in South Australia. This includes donor-conceived people aged 18 or over, donors who have contributed gametes (sperm or eggs) or embryos for use in South Australia, and parents of donor-conceived children born through ART treatment in the state. With these legislative changes, South Australia joins a small number of jurisdictions worldwide that provide retrospective access to donor conception information, where it is available. While some donors may have donated under the expectation of anonymity, the shift in legislation acknowledges that access to genetic heritage is increasingly seen as a fundamental right, and enables donor-conceived people to make informed decisions about their health, SA Health says. Learn more about changes to donor conception laws or access the DCR.
