The Ministry of Health and Population under the Government of Nepal (the “Ministry”) issued the Infertility Management Service Operation Related Standard, 2082 (2025) (the “Infertility Management Service Standard”) on 17 Bhadra 2082 (02 September 2025). The primary objective of this standard is to ensure quality infertility management services within Nepal, addressing both the identification and treatment of infertility, while also safeguarding reproductive rights guaranteed by the constitution.
This article provides a general overview of the Infertility Management Service Standard, infertility management services to be provided, operational procedures, and infrastructure requirements for governmental, non-governmental and private health institutions involved in infertility treatment.
1. Definition
The key definitions under the Infertility Management Service Standard are as follows:
- Health Institution: A government health institution providing services such as screening, diagnosis, prevention and consultation and referral, medicinal and hormonal treatment, surgical services, I.U.I. service, I.V.F. service, and the term also includes non-governmental or private or non-profit community health institutions established in accordance with the prevailing law.
- U.I. (Intra-Uterine Insemination) Service: A technique in which human semen is cleaned, selected and placed in the human uterus in a specific manner.
- V.F. (In-Vitro Fertilization) Service: A technology in which an embryo is prepared outside the human body and implanted into the human uterus.
- Infertility: The state in which a woman and a man do not conceive even after a year of regular sexual intercourse without using any contraceptive method.
2. General Procedure and Standard for Infertility Management Services
As per the Infertility Management Services Standard, the following services will be provided based on the health institution’s standard, physical infrastructure, and available human resources, details of which are as follows:
- Screening, diagnosis, prevention and consultation and referral: These services will be provided in governmental, non-governmental, or private health institutions.
- Medicinal and hormonal treatment: These services will be provided by governmental, non-governmental, or community health institutions that have been trained on infertility management.
- Surgical services: These services will be provided by governmental, non-governmental, or community health institutions with qualified maternity and gynaecology specialists trained in infertility management.
- U.I. service
- V.F. service
3. Specific Standard for I.U.I. and I.V.F. Services
To operate an I.U.I. and I.V.F. service, health institutions must comply with certain standards, which include:
S.N. | Standards for I.U.I. Service | Standards for I.V.F. Service |
1. | The health institutions operating I.U.I. services must have a separate department with obstetrics and gynecology services, andrology laboratory, cold chain system, pharmacy, a minimum C-class laboratory and treatment services as classified by the Public Health Service Regulation, 2077 (2020). | The health institutions operating I.V.F. services must have a separate department with obstetrics and gynecology services, andrology laboratory, cold chain system, pharmacy, a minimum C-class laboratory and treatment services as classified by the Public Health Service Regulation, 2077 (2020). |
2. | The health institution must have minimum human resource, physical infrastructure, tools, equipment and consumables required as provided under the Infertility Management Service Standard. | The health institution must have minimum human resource, physical infrastructure, tools, equipment and consumables required as provided under the Infertility Management Service Standard.
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3. | The health institution must be an agreement with health institutions capable of providing intensive care. | If emergency services and intensive care units are not available, the health institutions must have agreement with at least one specialist hospital to provide such services, when required. Note: The distance between health institution (providing I.V.F. service) and hospital (with which the agreement is made) should not be more than 2 km in case of Kathmandu Valley, and within a distance of half an hour by ambulance or other means of transportation in the case of outside of Kathmandu Valley. |
4. Other Standards Related to the Operation of I.U.I. and I.V.F. Services
The Infertility Management Service Standard provides for the required standards, including but not limited to the following:
- The semen collection room, andrology laboratory, and I.U.I. rooms are located together;
- The operating room and embryology laboratory should be connected with a door and a pass box between them, while strict access controls must be maintained. Both rooms, along with the andrology laboratory, must be air-conditioned and equipped with an HVAC or Coda tower system;
- There must be a designated space for cleaning instruments, comfortable and well-equipped semen collection rooms, and environmental controls to maintain temperature, humidity, and air quality as per specified standards;
- Governmental or non-governmental, or private I.V.F./I.U.I. service provider institutions should have their own pharmacy service unit, and that pharmacy should be registered in the Department of Drug Administration; and
- Furthermore, a registered pharmacy unit, proper waste management, and educational materials on infertility management must be available to ensure comprehensive care.
5. Standards Related to Building
The Infertility Management Service Standard provides for the required building-related standards, including but not limited to the following:
- Availability of well-equipped semen collection room, andrology laboratory, and IUI room in close proximity to each other, with adequate environmental controls like air conditioning and light prevention, to ensure a sterile and comfortable setting for infertility treatments should be present;
- The building must be differently-abled friendly; and
- If the institution does not own the building, a rental agreement of at least 5 years must be made.
6. Standard Related to Donor
The Infertility Management Service Standard provides the standards for semen and oocyte donors, including but not limited to the following:
S.N. | Semen Donor | Oocyte Donor |
1. | A donor cannot donate more than ten times at intervals of less than 15 days; | A donor can donate a maximum of six times, with at least a three-month interval between donations; |
2. | The donor identity must not be revealed to the recipient; | Identity of the donor must be kept secret from the recipient; |
3. | The age of donor should be between 20 and 35 years; | Donor must be between 20 and 35 years of age; |
4. | In the case of married couples, both husband and wife must provide informed consent; | The donor must be clearly informed in an understandable language about the potential immediate and future complication before donation; |
5. | No individual should be compelled or enticed through inducement to donate. | In the case of married couples, both husband and wife must provide informed consent. |
7. Approval/License for operation of I.V.F. and I.U.I. services
- Approval/License:
A health institution willing to provide I.U.I. and I.V.F. services must obtain prior approval from the Ministry. Health institutions must be properly registered and adhere to the prescribed standards to qualify for approval. Applications for approval must be submitted with the required documentation, and the institution will be subject to on-site inspection by a designated monitoring committee.
- Renewal of approval/license:
The application for renewal must be submitted at least three months before the approval/license’s expiry date. Institutions already providing infertility services must apply for permission within 90 days of the implementation of this Infertility Management Service, which is 27 Bhadra, 2082 (December 1, 2025).
8. Services may be closed
The Ministry may immediately close the infertility management services of non-governmental or private health institutions that fail to apply for renewal, do not meet the criteria within the prescribed period, do not report regularly, or fail to follow the instructions given during monitoring.
9. Revocation of License / Approval
If non-governmental or private health institutions in operation before the commencement of this standard applied for revocation of license stating that it is unable to operate services related to infertility management, the operating license of such non-governmental or private health institution will be revoked.
10. Other standards include
- Health institutions must charge fees as per the Health Institution Operation Fee Schedule 2077; charging above the prescribed fees may result in legal action, including registration and renewal cancellation;
- A monitoring committee will oversee the quality of infertility management services, tools, equipment, and human resource management. Health institutions providing I.U.I. and I.V.F. services will be monitored twice a year or as needed;
- Information about health conditions, diagnosis, or treatment received by the service recipient of infertility services from governmental, non-governmental or private health institutions must be kept confidential;
- The Ministry, in accordance with various bodies, will make arrangements to conduct educational and fellowship programs for the production of human resources, including I.V.F specialist doctors and embryologists;
- A record form will be prepared to document infertility-related services. Health institutions must maintain records of infertility management services as per the prescribed format. If institutions spread fake news on social media, legal action will be taken. Free medical services for poor and needy citizens, constituting 10% of services, must be reported to the Ministry; and
- If any ambiguities arise regarding the application of these standards and require interpretation, the Ministry’s interpretation will be final.
Disclaimer: This article is for general informational purposes only and does not constitute legal advice, advertisement, personal communication, solicitation or inducement. No attorney-client relationship is created through this content. Gandhi & Associates assumes no liability for any consequences resulting from actions taken based on information contained herein.
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