Where this page comes from
This page is not a list of complaints. It sets out the reasoning behind a document I have already filed. The proposal runs to fourteen pages, in Nepali, titled as suggestions for national policy and legislation for the safe, ethical and scientific regulation of IVF/ART services in Nepal. It was prepared for and submitted to the Government of Nepal through its public suggestion collection system in 2082/2083, to the ministry responsible for health as it was then constituted. It proposes a specific institutional design, a transitional timetable and a penalty structure, because anyone asking a government to regulate a field owes it a draft it can argue with.
The proposal is based on my own work experience, my specialist study of clinical embryology, things I observed directly in laboratories in Nepal, information from colleagues who worked in other laboratories, incidents reported in the national press, and study of regulatory systems elsewhere, including India's. I stated in the document itself, and I repeat here, that its purpose is not to target any individual or any institution.
I hold that restraint on this page too. I name no centre, no hospital, no doctor and no individual anywhere in what follows, and I do not identify anyone indirectly. Where I refer to matters that have been in the news, I attribute them to the reporting rather than restating them as established fact. Where I describe something I saw myself, I say so, and I do not extend it to centres I have never worked in.
My qualifications are the whole of my standing to write this: M.Sc. Clinical Embryology (gold medal, first position, highest CGPA, SEART / Shridhar University, 2023–2025) and M.Sc. Biotechnology (Tribhuvan University), with laboratory practice in ICSI, embryo culture and grading, vitrification, semen analysis, andrology, and ART laboratory quality management. I speak for no institution and hold no committee role. What follows is a professional argument, offered as such.
Why the laboratory, and why this is not an ordinary clinical service
An IVF laboratory is more than a technical facility attached to a clinic. It is the environment in which human gametes and embryos are handled at their most vulnerable stage. Temperature, pH, air quality, control of volatile organic compounds, culture conditions, witnessing protocols and documentation are clinical standards, not administrative preferences. A lapse in any one of them can have consequences that are invisible in the moment and decisive in the outcome.
Assisted reproduction is therefore unlike most of the services a health regulator licenses. In an ordinary clinical encounter the patient is present, can describe what happened, and can seek a second opinion on the same body. Here, the decisive part of the treatment happens in a room the patient will never enter, to material that cannot be replaced, and the consequence may not surface for years — or may surface in a person who has not yet been born. Nobody outside that room can reconstruct afterwards what conditions the cells were held in unless the laboratory itself recorded it.
So the quality of an IVF service cannot be assessed from outside by looking at a waiting room, a price list or a brochure. It can only be assessed by looking at the laboratory: its equipment and calibration, its media and how they are handled, its witnessing and identification steps, its records, and the qualification of the person doing the work. In my professional opinion this is also why inspection of an ART centre cannot be conducted like ordinary hospital inspection. If the inspecting team contains nobody who understands clinical embryology, inspection becomes paperwork.
In my proposal I put this as a single sentence: the laboratory is the centre point of IVF. Every regulatory ask on this page follows from that. If the state licenses a centre without being able to see into its laboratory, it is licensing the part of the service that matters least.
Where Nepal's regulation actually stands
Any discussion of ART in Nepal that still begins “there are no rules at all” is out of date, so let me set out what does exist before arguing about what does not. A test-tube-baby (IVF) centre has needed a licence from the ministry responsible for health since the Public Health Service Regulations, 2077 (2020): Rule 12, read with Schedule 9(1)(L), which places these centres with the ministry rather than with a province or a local level. That ministry was reorganised in May 2026 and is now the Ministry of Health and Food Safety (स्वास्थ्य तथा खाद्य स्वच्छता मन्त्रालय); I use its current name throughout this page, including where I describe decisions it took under its previous name. Rule 14 provides for inspection, and Rules 13 to 17 make the licence a periodically renewable permission backed by powers to order compliance, not a one-off approval. The state has had this machinery for years. That makes the question an enforcement question rather than a novelty question, and it is a stronger starting point for the ministry than a blank page would be.
The machinery has been used, and it has found problems. When the ministry reported on its monitoring in 2023, only nine centres nationally held an operating permit while more than fifty were providing services. I cite that only as the ministry's own report of its own findings at that time; I do not have, and will not invent, a current count of centres, cycles or practitioners.
On 17 August 2025 (1 Bhadra 2082) the ministry endorsed Nepal's first service-specific standard for infertility management, reported in English as the Standard for the Operations of Infertility Management Services (IVF), 2082. I treat that English title as a press rendering rather than an official translation, and I would encourage anyone relying on the instrument to obtain the Nepali text from the ministry. On the ministry's own account of it, a health facility must obtain prior ministerial permission before providing these services, must employ trained embryologists, and must meet stated standards for the laboratory. Reporting of the Standard also describes ministry-set fees, a requirement that ten per cent of services be free for poor patients, and routine inspection by a ministry committee, with non-compliance able to cost a centre its licence. The same reporting describes donor provisions: an age range of 20 to 35, a cap on how often a person may donate, confidentiality of the donor's identity, written mutual consent where a donor is married, a medical examination for infectious disease, records kept against citizenship details, and a requirement that providers coordinate to avoid the same donor being used at more than one centre. I set out those donor provisions as they have been reported in the press, because the primary text of the Standard is not published and I have not read it. I do not cite clause numbers from it for that reason, and everything I say about its detail should be read with that qualification.
The Standard is a welcome start, and I said so in my proposal. My argument is about what a standard can and cannot do. A standard issued under ministerial authority can create an administrative basis for permission and inspection. It cannot easily assign clear criminal or civil liability, and it is liability that is missing when the questions are donor misuse, the exploitation of minors, false records, non-medical sex selection, hidden surrogacy, false advertising or professional unfitness. National reporting has characterised the 2082 Standard the same way, as guidance that remains without statutory backing. That is the reporting's legal characterisation rather than mine, but it matches the structural point: an administrative instrument is not where criminal liability lives.
Two days after the Standard, on 19 August 2025, a single bench of the Supreme Court issued an interim order in a writ petition that is still pending, directing that the collection, storage and transfer of women's eggs not be permitted until the petition is decided, together with a direction for effective government monitoring of the practice. Precision matters here, because overstating it helps nobody. It is an interim order and not a final judgment, it is confined to eggs rather than to the sector as a whole, and it is not self-executing. It also contains no judicial direction to legislate, and I do not claim that it does. Nepal already has the clearest possible evidence that a court order is not a substitute for a statute. In July 2016 a division bench directed the Government to ban commercial surrogacy outright and to enact a law permitting altruistic surrogacy for infertile Nepali married couples. Ten years later no such law exists, so neither limb of that order is operational.
Two things are genuinely absent, and they are the substance of my ask. The first is primary ART legislation: a statute passed by Parliament rather than a standard issued under ministerial authority. As of the middle of 2026 there is none. Reporting in July 2026 described a decision not to prosecute in an egg-extraction case involving minors, and quoted investigating officers and legal experts saying that specific statutory provisions addressing reproductive tissue trade are lacking and that the absence of primary legislation continues to leave room for exploitation. I take that as reported, not as a finding of my own. It is what the absence of primary legislation looks like in practice. The second absence is a dedicated statutory regulator. In the published framework, licensing and monitoring of these centres sit with the ministry and with the general public-health licensing machinery, not with a standing specialist body of the kind the United Kingdom's Human Fertilisation and Embryology Authority represents, holding its own powers of licensing, inspection, data collection and enforcement.
On professional registration the sweeping version of this argument is wrong, so it is worth being exact. A statutory register does exist. The Nepal Health Professional Council keeps a register of health professionals under the Nepal Health Professional Council Act, 2053, and M.Sc. Medical/Clinical Embryology is among the qualifications the Council recognises. Under that Act, practising a listed health profession without being registered is already prohibited (section 20). What is missing is the connection. The licensing criteria for a test-tube-baby centre in the 2077 Regulations (Schedule 8, item 24) require the centre to have an embryology laboratory; they do not require that a registered embryologist run it, and nothing published ties a named registered person to a named licensed laboratory. Nor, on the reporting of the 2082 Standard, does “trained embryologist” mean “registered embryologist”. And the register cannot be searched from outside, so an inspector, a journalist or a patient has no way to check. The result is that a centre's licence does not, in practice, depend on who actually handles the embryos.
One statute is often cited in this area and should not be. The Right to Safe Motherhood and Reproductive Health Act, 2075 (2018) contains no reference to assisted reproductive technology, IVF or surrogacy. It mentions infertility once, inside the definition of morbidity at section 2(p), which carries a right to examination, counselling and treatment at section 20. That is a right to care, and it matters. It is not a framework for regulating laboratories, donors, embryos or storage, and it should not be cited as though it were one.
There is, however, a process now moving, and it is worth describing accurately rather than hopefully. In late July 2026 the ministry published a notice inviting comment, within seven days, on draft bills to amend three health statutes, one of them the 2075 Act. That window closed on 12 Shrawan 2083, 28 July 2026, and on the reporting the bill's scope is maternity leave, safe abortion, skilled birth attendants, respectful maternity care and disaster provisions. It does not touch assisted reproduction, and I do not present it as a route to ART reform. The genuinely relevant development is a different one. At a ministerial-level meeting on 24 July 2026 (8 Shrawan 2083), the ministry is reported to have decided to draft an operating procedure for IVF services and to pursue a separate ART Act. So far as I am aware that is the first public commitment by the Government of Nepal to a dedicated ART statute, and I take it as reported rather than as something I have been told. It is welcome, and it is precisely the moment at which laboratory expertise should be in the room, because the content that most needs drafting is laboratory content: culture conditions, witnessing, traceability, donor records, competency.
What I have seen from inside the laboratory
I entered this field in Nepal with real excitement, believing I had found the place where my laboratory training and my interest in reproductive biology came together. What I found was harder than I expected, and it is the reason I went on to study clinical embryology formally and then to write a policy proposal rather than simply move on.
In my own early professional exposure I encountered practices that concerned me: poor handling of laboratory media, questionable counselling approaches, weak documentation, an absent consent culture, inappropriate use of donor samples, careless attitudes toward patient material, and an overconfidence that did not match the sensitivity of the work. When I asked basic scientific questions about media, protocols or procedures, I rarely received clear answers. Conversations seemed to orbit entirely around achieving a positive result, with very little reflection on how that result was being reached.
That testimony needs bounding. It is my experience of the places where I worked early in my career. It is not a description of every centre in Nepal, and I make no such claim. What it establishes is narrower and still important: that these things are possible here, that nothing I encountered at the time prevented them, and that nobody outside the laboratory was in a position to notice.
Nothing on this page asserts bad faith. Many people in this sector work carefully, and some of them are better placed than I am to describe their own laboratories. But good faith is not a control system. Frameworks exist in other countries because the field is too sensitive to depend on personal honesty alone, not because practitioners cannot be trusted individually.
So I would rather turn the wider picture into questions than into accusations. Are all IVF laboratories in Nepal maintaining verifiable quality standards? Are the people handling gametes and embryos qualified and practising within a recognised professional framework? Are donor cycles tracked centrally, so that the same donor cannot be used at several centres without anyone knowing? Are patients receiving accurate success-rate information rather than marketing figures? Are gametes and embryos fully traceable from collection to transfer? These are not attacks on the field. They are the responsibility of anyone who works in it.
I cannot answer them for the sector, and that is the finding. The ministry receives annual self-assessment reports from licensed institutions under the 2077 Regulations and can inspect through appointed public health inspectors, so it is not true that nobody knows anything. But there is no published national dataset on ART activity or outcomes in Nepal, and no publicly searchable record of who is registered to do this work. On donor use there is something, but not enough: the 2082 Standard is reported to require records kept against a donor's citizenship details and coded records at the centre, and to require providers to coordinate so that the same donor is not used at more than one centre. Coordination between competitors is not a registry. There is no national record and no mandatory prior clearance, so the obligation rests on the parties with the least interest in enforcing it. These are not questions anyone can answer from outside a laboratory today, and a regulator that could answer them for the sector as a whole would already be well past the effective monitoring the Supreme Court's interim order asks for.
Qualification, registration, and what can actually be verified
Let me remove one argument from the table at the outset, because it is often made in this debate and I will not make it. This is not about nationality. I studied clinical embryology in India myself. A properly qualified embryologist from any country is an asset to Nepal, and Nepal should want them. The variable that matters is not where a person is from. It is whether their qualification, their demonstrated competence and their registration can be verified by someone other than the employer who hired them.
Handling gametes and embryos is not a matter of theoretical knowledge. ICSI, embryo culture and grading, vitrification and thawing, sperm preparation, laboratory quality control and record-keeping are practised skills with narrow margins and delayed, often untraceable, consequences for error. It is my professional opinion, stated plainly in my proposal, that three months of training, an online certificate, or experience alone is not adequate preparation for procedures of that sensitivity.
What I proposed instead is a pathway anyone can check. An M.Sc. in Clinical Embryology or an equivalent full-time programme as the standard route. For those coming from M.Sc. Biotechnology, life sciences or reproductive biology, recognised full-time practical training together with certified laboratory experience. Verified competency in the specific procedures listed above rather than a general certificate. For people already practising, a mandatory competency examination within one to two years, with no independent responsibility for sensitive gamete and embryo work until it is passed. And continuing professional development, certified every two to three years, because this field changes. Transitional arrangements are necessary and I said so. They must not become a permanent legitimisation of unqualified practice.
Registration is what turns this from my opinion into an enforceable requirement, and Nepal already keeps the register. A register defines the qualification, records who holds it, and can tie a named responsible person to a named licensed laboratory. What has not been done is to connect it to the licence and to make it checkable. As long as neither is true, “trained embryologist” means in practice whatever a particular employer says it means: verified by nobody outside that employer, and unavailable to an inspector, a journalist or a patient who wants to confirm it. A licensing regime that states a professional requirement without connecting it to the register the state already maintains is doing half of the work it was written to do.
The fix is not expensive. It requires that a centre's licence name the registered professional responsible for its laboratory, that renewal be conditional on that person still being registered and still being there, and that the register be published in a form someone outside the centre can search. None of that requires new science, new money or a new profession. It requires joining two things Nepal already has.
Donors, traceability, and the child who is not yet born
One thing should be said about where this stands before I argue about rules. Since 19 August 2025 an interim order of the Supreme Court has directed that the collection, storage and transfer of women's eggs not be permitted until the petition before it is decided. On the most recent reporting, in late July 2026, that order was still in force and the petition had not been decided. What follows is therefore about the rules that should govern donor programmes if and when they resume, and about the records already created before they stopped, which do not stop mattering because a practice was paused.
Some of what follows is already in the 2082 Standard, and I want to say so before I ask for it. On the reporting of the Standard (the primary text is not published, so this is press paraphrase and not my reading of the instrument), donors must be between 20 and 35, their identity must be kept confidential, a married donor's spouse must consent in writing, donors must be examined for infectious disease, forced or incentivised donation is prohibited, records must be kept against a donor's citizenship details, and providers must coordinate so that the same donor is not used at more than one centre. It also caps how often a person may donate: reportedly six times for eggs, with a three-month interval, and ten times for sperm, with a fifteen-day interval, although some English-language reports of the same document say one donation only. That conflict is one more reason the Nepali text needs to be published. My own proposal's donor age range of 20 to 35 is the same as the Standard's, and I say that rather than claim it as an innovation. So the question is not whether Nepal has donor rules. It is whether these ones can be enforced, and two features of them cannot. A limit counted in donations tells nobody how many families a donor's genes reached, which is the number that matters for consanguinity. And a limit enforced by asking competing centres to coordinate among themselves is not enforced at all: there is no national registry against which a donor's claim can be checked, no way for one centre to detect that the same donor was used at another, and no statutory penalty for breach. That is what primary legislation and a registry would fix, and it is what my proposal changes.
My central donor proposal is a principle: one donor, one recipient family. India's Assisted Reproductive Technology (Regulation) Act, 2021 is instructive here, and not in the direction usually assumed. In a population of well over a billion, section 27 forbids a bank from supplying the sperm or oocytes of a single donor to more than one commissioning couple, and limits an egg donor to a single donation in her lifetime, of no more than seven oocytes, with twelve months' insurance in her favour. Nepal has no statutory equivalent at all: what limits exist here sit in a ministerial standard rather than in an Act, and duplication across centres is left to providers to coordinate between themselves. So “one donor, one recipient family” is not an unusually strict Nepali invention. It asks Nepal to meet a minimum already in force in its nearest comparator. And Nepal's much smaller gene pool is a reason to be at least as strict as India, not a reason to differ from it: in a small population, permissive limits produce a real risk of unknowing consanguinity between people who will never be told how they were conceived, and they compromise the country's genetic and forensic integrity as well as individual families. So: limits counted by recipient family and by live births rather than by number of donations; exceptions only with the prior approval of a national board; and prior clearance from a national donor registry as a condition of every donor cycle, so that the same donor cannot be used at different centres without anyone knowing.
Beyond what the Standard already provides, I proposed the protections it does not reach: an absolute prohibition on donation by minors; screening for HIV, hepatitis B, hepatitis C and syphilis; genetic disease, mental health and family history assessment; independent counselling and written informed consent; and donor confidentiality held in a secure national record rather than in a notebook at a single centre. The difference between a notebook and a record system is the whole of the enforcement question.
Egg donation needs more protection than sperm donation, and the reason is clinical rather than sentimental. It involves hormonal stimulation, repeated ultrasound, needles, sedation or anaesthesia, needle aspiration and the possibility of subsequent health complications. Sperm donation involves none of that. I therefore proposed insurance cover for ovarian hyperstimulation syndrome, bleeding, infection and hospitalisation, which India's Act already contains as twelve months' insurance in the oocyte donor's favour; mandatory post-procedure follow-up; a prohibition on excessive retrieval in a single cycle, on distributing one donor's eggs to many families, and on sending material to different centres; and specific safeguards against the recruitment of economically vulnerable women, students, workers and dependents. The reporting that prompted the current litigation, and the Central Investigation Bureau inquiry into clinics harvesting the eggs of teenage girls that has been reported in the national press, both concern exactly this asymmetry of risk and power. I take those as matters reported by the press, not as facts I can attest to, and it is precisely because I cannot attest to them that I want a system in which someone can.
None of this works without records. Paper files, centre-specific notebooks and verbal assurances are not sufficient for a decision whose consequences last a lifetime. I proposed a national donor and embryo record system with retention for at least thirty years, or long enough for a person born through ART to exercise their rights as an adult, with data security, access control, audit logs and backup. The person with the strongest interest in that record is the one who cannot yet ask for it.
That is why I treat the child as a rights-holder rather than a treatment outcome. A child born through ART should have clear legal guardianship, a proper birth record, access to their own health information and to genetic-risk information relevant to them, freedom from discrimination on account of how they were conceived, and a regulated route by which an adult can seek health or identity information. Donor confidentiality is legitimate and should be protected, but it has to be balanced against a person's access to health information about themselves, and that balance is a matter for a statute rather than for each centre's discretion.
On preimplantation genetic testing my position is an ethical one, and I state it as such rather than as a legal conclusion about any particular practice. PGT has real clinical value for chromosomal disorders and known hereditary conditions. Using the same technology for non-medical sex selection, for family balancing, or for trait selection on personal preference is not a clinical service; it is the misuse of science to serve social preference. I proposed that PGT be restricted to medical indications, with an absolute prohibition on non-medical sex selection, that embryo samples not be sent abroad without permission, and that liability for non-medical sex selection attach to the centre, the physician, the clinical embryologist, the testing laboratory and any broker involved. Nepal's settled policy against sex selection is already visible in section 17 of the 2075 Act, which prohibits identifying the sex of a fetus in the womb and sex-selective abortion, and makes those offences under section 25(h)–(i). That is a different question from testing an embryo before transfer, but it indicates both where the country's policy already sits and that Nepal has been willing to back that policy with a penalty.
Honest reporting to patients
When clinics compete on packages rather than protocols, when success rates are quoted as marketing figures rather than as clinical data, and when hope is the product, we are no longer practising medicine as it was intended. We are operating a service industry built on the hope of vulnerable couples. Infertility is not a character failure; it is a medical condition, and in Nepal it is still misunderstood, frequently blamed on women, and rarely discussed with the sensitivity it deserves. That is exactly the emotional position in which a person is least able to interrogate a percentage on a poster.
Claims such as high success, guaranteed baby, or a bare figure like eighty per cent are not necessarily false. They are unfalsifiable, because the denominator is never stated. So I proposed a uniform national definition set, reported by every centre: clinical pregnancy rate per cycle started; pregnancy rate per embryo transfer; live birth rate per cycle started; results broken down by age group; own eggs and donor eggs reported separately; cancelled cycle rate; miscarriage rate; multiple pregnancy rate; and the rate of ovarian hyperstimulation syndrome and other serious adverse events. Alongside that, an advertising rule: any published figure must state whether it is a pregnancy rate or a live birth rate, whether it is own-egg or donor-egg, and whether it is first-cycle or cumulative. And a flat prohibition on guaranteeing success, which no honest practitioner in this field can do.
Consent has to be substance rather than signature collection. I proposed separate consent forms for each procedure, all available in simple Nepali; written cost and refund information before treatment begins; and an express rule that consent obtained under pressure, fear, confusion or financial inducement is invalid. Alongside it, a stated set of patient rights: the real chance of success and of failure; a copy of one's own records; written rights over the storage, destruction, donation or other use of one's embryos and gametes; confidentiality and dignity; protection from false advertising, coercive packages, unnecessary tests and unclear fees; a route to complain and be heard fairly; and a second opinion.
Money belongs in the same section, because in this field it is a clinical safety issue and not only a consumer one. A patient who is told a new charge halfway through a stimulated cycle is not in a position to decline it. I proposed a minimum fee-disclosure framework: a written estimate before treatment; itemisation of counselling, tests, stimulation drugs, the procedure, the laboratory, cryopreservation and storage, PGT and transfer; a prohibition on introducing new fees mid-treatment; and concessionary or free treatment for poor and marginalised patients up to a defined share, with the claimed concessions audited rather than merely declared.
What I have asked the Government of Nepal for
The core ask is a national ART/IVF Act covering the whole chain rather than a piece of it: IVF, IUI and ICSI; egg collection and embryo transfer; sperm and egg donation; embryo and gonadal tissue banking; fertility preservation; PGT-A and PGT-M; ART banks; the national donor registry; laboratory standards; professional qualification; and patient rights. The reason it must be an Act is accountability. Without a statute it is difficult to attach clear penalties and clear responsibility to donor misuse, the exploitation of minors, false records, non-medical sex selection, hidden surrogacy, false advertising and professional unfitness. Those, not paperwork, are the harms the public is worried about.
Second, a National ART Professional Board, technically autonomous rather than merely administrative, sitting under the ministry responsible for health (since May 2026 the Ministry of Health and Food Safety, स्वास्थ्य तथा खाद्य स्वच्छता मन्त्रालय). I proposed a composition that puts the relevant expertise in the room: at least one qualified clinical embryologist, a gynaecologist experienced in reproduction and infertility, a male-infertility and andrology expert, a genetics expert, a bioethics expert, a child-rights or family-law expert, a public-health regulatory representative, a laboratory-quality or biomedical-engineering expert, and a patient or consumer-rights representative. Its functions would be to set licensing standards, to register embryologists and run their competency examination, to operate the national donor registry, to monitor PGT and embryo storage, to investigate complaints and conflicts of interest, and to recommend suspension or revocation where warranted.
Third, tiered classification and licensing, so that a centre's permission matches its actual capability. A Tier 1 centre would provide IUI, sperm preparation and basic infertility counselling, and expressly not egg collection, ICSI, embryo culture, transfer or storage. A Tier 2 centre would provide IVF, ICSI, egg collection, embryo culture, transfer, cryostorage and PGT sampling. An ART Bank would handle donor selection, health screening, registration, and the storage and supply of sperm and eggs. No centre should operate without a licence; the licence should state which services are permitted; and the licence number, the responsible embryologist's name, the chief physician's name and a complaint contact should be publicly displayed. A national website should publish which centres are registered and which are suspended. Renewal should be conditional on laboratory inspection, record audit, reconciliation against the donor registry, success-rate reporting and a complaints check, not on the passage of time.
Fourth, inspection that carries real expertise. An inspection team for an ART centre should include a clinical embryologist, an infertility specialist, a laboratory-quality or biomedical-engineering expert, a public-health regulator and a legal or bioethics expert. I proposed five inspection types: an annual announced audit; unannounced inspection on complaint or on risk; special audit of PGT-A and of donor gametes; audit of success-rate claims and advertising; and an incident-specific audit after any adverse event. Without embryology expertise on the team, an inspection can confirm that a laboratory exists without being able to say whether it works.
Fifth, a graded penalty table, so that consequences are proportionate and predictable rather than arbitrary. An administrative error should attract a written warning, a correction order and re-inspection. A serious record error should attract a fine, licence suspension and a mandatory audit. A breach of donor limits should attract suspension or revocation together with professional action against the individuals responsible. The use of a minor or a coerced donor should attract criminal action, protection for the victim and closure of the centre. Non-medical sex selection should attract criminal action with liability on both the testing laboratory and the centre. Hidden surrogacy should attract criminal investigation and suspension or revocation. False success-rate or guarantee advertising should attract a fine and a public correction notice, and suspension on repetition.
Sixth, surrogacy. The position today is that commercial surrogacy is prohibited, on the strength of a Supreme Court order and a Cabinet decision rather than a statute, while the Court's 2016 directive told the Government to legislate for altruistic surrogacy by infertile Nepali married couples. That law has never been written, so that limb is not operational either. My proposal asks that the prohibition on commercial surrogacy be maintained and made real rather than nominal until a dedicated surrogacy statute exists, that centres not perform transfers for surrogacy or advertise, broker or contract for it, and that suspected concealed surrogacy be reported to the board. I do not think the answer is a hurried provision inside an ART Act; it is a considered separate statute.
Seventh, conflict of interest. This is a small sector in which private investment plays a large part. That is not a scandal but a structural fact any credible regulator has to manage. Anyone involved in licensing, monitoring, investigation, awards, public recommendations, committee membership or policy formulation should disclose their own centre, company, supplier, referral network or family relationship. Someone with a financial or professional relationship with a centre should not sit on its inspection or investigation. Where a person is to be honoured for a contribution to reproductive health at a public or governmental event, the awarding body should as a matter of routine verify the licence, professional qualification and ethical record of any candidate. I said in the proposal, and I repeat, that this provision is aimed at no individual and is about the procedure, not about any past award. Its purpose is to protect public trust and the professionals who are doing good work.
Eighth, how the policy itself is made. The views of centre operators and administrators alone are not a sufficient evidence base, because they are the regulated party. I asked for a multidisciplinary process with the mandatory participation of clinical embryologists; a confidential channel for current and former staff, who are usually the only people who know what a laboratory actually does; systematic collection of patient and donor experience; and explicit use of reported incidents and of investigation or court findings in drafting. Nepal can learn from India, Belgium, Australia and others on donor registries and ART law. On donor limits specifically, India's statute is the useful reference and not the cautionary one: it already applies one donor to one commissioning couple and a single lifetime egg donation, and Nepal's far smaller gene pool is a reason to be at least as careful rather than less.
Finally, a twenty-four-month transition, because a law with no implementation sequence is a law that will be waited out. In the first three months: form a national ART task force, list every IVF and IUI centre, require pre-approval for new donor cycles, and take an inventory of stored gametes and embryos. Within six months: launch the donor registry, begin embryologist registration, standardise consent forms, and issue a directive on medical indications for PGT. Within twelve months: submit the ART/IVF Act to Parliament, re-license all centres, and bring the success-rate reporting framework into force. Within eighteen months: begin competency examinations for existing practitioners and implement laboratory audit in full. Within twenty-four months: complete the national ART record system, online reporting, a public licence list, and regular audit and penalties.
There is a concrete next step available now, and it is not the one I would have named a month ago. The ministry's late-July 2026 consultation on draft bills amending three health statutes, one of them the Right to Safe Motherhood and Reproductive Health Act, 2075, closed on 28 July 2026, and on the reporting that bill does not address assisted reproduction at all. What matters instead is that at a ministerial-level meeting on 24 July 2026 (8 Shrawan 2083) the ministry is reported to have decided to draft an operating procedure for IVF services and to pursue a separate ART Act. That is the architecture I proposed, and it is the first public commitment to a dedicated statute that I am aware of. My ask is therefore specific and modest: that the drafting of both instruments include clinical embryology expertise from the start rather than after the text is settled, because the operating procedure can carry the licensing conditions, the register-to-licence link and the record obligations immediately, while the Act carries the liability. My full proposal exists in Nepali, I will provide it to any ministry, committee or parliamentary body that wants it, and I am willing to answer technical questions on the laboratory content on the record. I would rather be argued with than ignored.
What happens if this waits
Let me be unambiguous about the objective. The aim is not to close IVF and ART services in Nepal. It is to make them safe. The pain of couples living with infertility is real, it is often carried in silence, and they deserve treatment they can trust. IVF remains one of the significant achievements of modern medicine, and that legacy is worth protecting. That is precisely why it should not be left to protect itself.
But services cannot keep expanding while the risk sits with the people least able to carry it: the patients who came hoping for a child, the economically vulnerable women who become donors, the children who will be born and will one day want to know something about their own health, and the country's genetic and forensic integrity. Many of these harms are not the kind that can be corrected later. Traceability, once lost, cannot be reconstructed; a donor's health damage is not returned to her; and a person who asks about their genetic origins in twenty years' time cannot be given somewhere to ask retrospectively. Technology advances quickly. Ethics has to advance with it, and in a regulated field ethics is another word for enforceable standards.
If Nepal now enacts a clear ART/IVF Act, establishes a national donor registry, requires registered and examined embryologists, audits laboratories, controls PGT, and writes down donor rights, children's rights and a penalty structure, then this sector can become safe, credible and respected, and can compete on quality instead of on claims. If it is delayed, irregularity becomes entrenched and much harder to unwind, and genuine specialists and honest providers lose public trust along with everyone else. Weak regulation does not only fail patients. It also punishes the centres that are doing this properly, because nothing distinguishes them.
Early in my career I was discouraged from studying further. I studied further anyway, because I concluded that the discomfort I felt in the laboratory was not an emotional reaction but a legitimate professional concern. Filing a policy proposal is the same decision in a different form. I would rather be argued with than ignored, and I would rather this framework be improved by people who know more than I do than defended by me unchanged. IVF was invented for a clear purpose: a healthy child, by a safe, evidence-based and ethical route. That purpose has not changed. The only question is whether we are still honouring it.
A note on what this page is. It sets out my professional opinion and general information about the regulation of assisted reproduction in Nepal. It is not medical advice to any individual, it is not a legal opinion, and no part of it should be read as a comment on any particular centre, practitioner or patient. Regulation in this area is developing and there is litigation pending, so anyone relying on the legal position should confirm the current requirements with the ministry responsible for health, reorganised in May 2026 as the Ministry of Health and Food Safety, rather than with a summary, including this one.