chhatramani/nepal_legal_acts_corpus_english huggingface dataset:
Human Trafficking and Transportation (Control) Act, 2007

26. Provision of security: If a person filing a complaint under Section 5 makes a request for security to the nearest police office, showing reasonable cause that he/she may face retaliatory action due to the complaint filed with the police or due to the statement or Amended by the Act to Amend Some Nepal Acts to Maintain Gender Equality and End Gender-Based Violence, 2072. testimony given in a court or due to any assistance provided to the victim by a human rights defender deployed for the protection of women's human rights, such police office shall arrange for any or all of the following measures:-

(a) Providing security while coming and going to the court during the proceedings of the case,

(b) Keeping or arranging to keep under police protection for a specified period,

(c) Placing in the centre. Inserted by the Act to Amend Some Nepal Acts to Maintain Gender Equality and End Gender-Based Violence, 2072.26a. Provision of daily and travel allowance to witnesses: (1) A witness appearing in court on behalf of the Government of Nepal in a case under this Act shall be provided with daily and travel allowance equivalent to that received by a non-gazetted first class government employee under prevailing law by the concerned Government Attorney Office.

(2) If a government employee appears in court as a witness or expert in a case under sub-section (1), the office where he/she is posted shall provide the daily and travel allowance that he/she is entitled to under prevailing law. 27. Proceedings in camera: (1) The proceedings and hearing of a case related to an offence under this Act shall be conducted in camera.

(2) When proceedings and hearing are conducted in camera under sub-section (1), only the parties to the case, their legal practitioners, and persons permitted by the court may enter such chamber. 28. Government to be the plaintiff: A case under this Act shall be a government-plaintiff case, and such case shall be deemed to be included in Schedule-1 of the Transformed by the Act to Amend, Consolidate, Adjust and Repeal Some Nepal Laws, 2074 and amended by the Act to Amend Some Nepal Acts relating to the Civil Code, 2075. Criminal Procedure Code, 2074. 29. Power to frame rules: The Government of Nepal may frame necessary rules for the purpose of implementing this Act. 30. Repeal and saving: (1) The Body Mutilation and Sale (Control) Act, 2043 is hereby repealed.

(2) The acts and proceedings done under the Act mentioned in sub-section (1) shall be deemed to have been done under this Act.
Pokhara Academy of Health Sciences Act, 2016

Pokhara Academy of Health Sciences Act, 2072

Certification and Publication Date
2072.10.12

Amending Acts

1. Act to Amend Some Nepal Acts to Make them Consistent with the Constitution of Nepal, 2075 2075.11.19

Act No. 12 of the year 2072

An Act Made to Provide for Matters Relating to Pokhara Academy of Health Sciences

Preamble: Whereas, it is desirable to make necessary provisions for the establishment and operation of the Western Regional Hospital, Pokhara as an Academy of Health Sciences, in order to provide for high-level studies and research in the field of health sciences, produce skilled manpower needed by the country, and make quality health services easily accessible to the general public in health services,

The Legislature-Parliament, pursuant to Sub-section (1) of Article 296 of the Constitution of Nepal, has enacted this Act. Chapter-1
Preliminary

1. Short Title and Commencement: (1) This Act may be called the "Pokhara Academy of Health Sciences Act, 2072".

(2) This Act shall come into force immediately. 2. Definitions: Unless the subject or context otherwise requires, in this Act,-

(a) "Hospital" means the hospital established pursuant to Section 16.

(b) "Hospital Management Committee" means the Hospital Management Committee constituted pursuant to Section 17.

(c) "Vice-Chancellor" means the Vice-Chancellor under Section 20.

(d) "Executive Council" means the Executive Council constituted pursuant to Section 11.

(e) "Chancellor" means the Chancellor under Section 18.

(f) "Dean" means the Dean under Section 21.

(g) "Prescribed" or "as prescribed" means prescribed or as prescribed in the rules made under this Act.

(h) "Director" means the Director under Section 22.

(i) "Backward Region" means the region prescribed pursuant to the prevailing law.

(j) "Academy" means the Pokhara Academy of Health Sciences established pursuant to Section 3.

(k) "Academic Council" means the Academic Council constituted pursuant to Section 9.

(l) Amended by the Act to Amend Some Nepal Acts to Make them Consistent with the Constitution of Nepal, 2075.(l) "Ministry" means the Ministry of Health and Population.

(m) "Teacher" means a person appointed to teach and conduct research at the Academy.

(n) "Educational Institution" means the educational institution established pursuant to Section 15.

(o) "Assembly" means the Assembly constituted pursuant to Section 7.

(p) "Pro-Chancellor" means the Pro-Chancellor under Section 19.

(q) "Service Commission" means the Service Commission constituted pursuant to Section 13. Chapter-2
Establishment, Form, and Functions, Duties and Powers of the Academy

3.
Pokhara Academy of Health Sciences Act, 2016

Chapter-2
Establishment, Form, and Functions, Duties and Powers of the Academy

3. Establishment of Academy: (1) The Pokhara Academy of Health Sciences is established for the purpose of conducting high-level study, teaching and research in the field of health sciences, and making quality health services easily accessible to the general public in health services.

(2) The principal office of the Academy shall be located in Kaski District.

(3) The Academy shall be called "Pokhara Academy of Health Sciences" in the English language. 4. Academy to be an Autonomous Body: (1) The Academy shall be an autonomous body with perpetual succession.

(2) The Academy shall have its own separate seal for its business.

(3) The Academy may, like a person, acquire, use, sell or otherwise dispose of movable and immovable property.

(4) The Academy may, like a person, sue and be sued in its own name.

(5) The Academy may, like a person, enter into contracts, exercise rights under contracts, and discharge liabilities. 5. Form of the Academy: The Academy shall have the following organizations, and their collective form shall be the form of the Academy: -

(a) Assembly,

(b) Academic Council,

(c) Executive Council,

(d) Faculties,

(e) Research Centres,

(f) Educational Institutions,

(g) Hospital,

(h) Other bodies as prescribed. 6. Functions, Duties and Powers of the Academy: (1) The functions, duties and powers of the Academy shall be as follows: -

(a) To conduct and cause to be conducted study, teaching, training and research on various subjects related to health,

(b) To provide quality and accessible health services,

(c) To make agreements with domestic and foreign universities, educational institutions and hospitals for conducting study, teaching, training and research programs on various subjects related to health,

(d) To produce skilled manpower required for quality health services,

(e) To coordinate with domestic or foreign universities, educational institutions or hospitals to strengthen various programs operated by the Academy and enhance the quality of such programs,

(f) To establish, expand and strengthen relations with domestic and foreign universities, academies and international organizations related to health, and exchange mutual cooperation and experience,

(g) To organize and cause to be organized workshops, conferences, seminars, interactions and health camps on various subjects related to health,

(h) To publish and cause to be published various books, pamphlets, bulletins and awareness posters related to health,

(i) To perform and cause to be performed other functions as prescribed.

(2) The functions, duties and powers of the Academy shall be exercised and performed through the organizations of the Academy. Chapter-3
Formation and Functions, Duties and Powers of the Assembly

7.
Pokhara Academy of Health Sciences Act, 2016

Chapter-3
Formation and Functions, Duties and Powers of the Assembly

7. Formation of Assembly: (1) There shall be an Assembly as the supreme body of the Academy.

(2) The formation of the Assembly shall be as follows: -

(a) Chancellor -Chairperson

(b) Pro-Chancellor -Vice-Chairperson

(c) Member, National Planning Commission (looking after health sector) -Member

(d) Vice-Chancellor -Member

(e) Two persons nominated by the Assembly, on the recommendation of the Executive Council, from among the Vice-Chancellors of universities offering higher education in health sciences and other health science academies -Member

(f) Secretary, Ministry -Member

(g) Secretary, Ministry of Finance -Member

(h) Amended by the Act to Amend Some Nepal Acts to Make them Consistent with the Constitution of Nepal, 2075.Secretary, Ministry of Education, Science and Technology -Member

(i) One person nominated by the Assembly from among the Deans -Member

(j) One student studying at the Academy, on the recommendation of the Executive Council -Member

(k) Amended by the Act to Amend Some Nepal Acts to Make them Consistent with the Constitution of Nepal, 2075.Chief, Pokhara Metropolitan City -Member

(l) Two teachers, including at least one woman, nominated by the Executive Council, on the recommendation of the Academic Council, from among the teachers -Member

(m) One person nominated by the Assembly, on the recommendation of the Executive Council, from among the heads of educational institutions -Member

(n) Four persons, including at least two women, nominated by the Assembly, on the recommendation of the Executive Council, representing Dalit, Indigenous/Janajati and backward classes -Member

(o) Two persons, including at least one woman, nominated by the Assembly, on the recommendation of the Executive Council, from among donors -Member

(p) One person nominated by the Assembly from among the employees working at the Academy -Member

(q) Dean -Member-Secretary

(3) The term of office of nominated members under Sub-section (2) shall be three years.

(4) If the office of a nominated member falls vacant for any reason, another person shall be nominated to that office for the remaining period according to the same procedure by which it was previously filled.

(5) The procedure relating to meetings of the Assembly shall be as prescribed. 8.
Pokhara Academy of Health Sciences Act, 2016

8. Functions, Duties and Powers of the Assembly: The functions, duties and powers of the Assembly shall be as follows: -

(a) To approve policies, plans and programs of the Academy,

(b) To approve the annual budget of the Academy,

(c) To approve rules of the Academy,

(d) To award scholarships, degrees, certificates, medals and prizes on behalf of the Academy,

(e) To award honorary degrees as prescribed,

(f) To guide and provide necessary directions to various bodies under the Academy,

(g) To provide necessary suggestions to the Government of Nepal in the course of formulating national health and education policies,

(h) To approve the annual report of the Academy,

(i) To discuss and approve the audit report of the Academy,

(j) To make or cause to be made necessary arrangements regarding the establishment of educational institutions,

(k) To perform and cause to be performed other functions as prescribed. Chapter-4

Formation and Functions, Duties and Powers of the Academic Council

9. Formation of Academic Council: (1) There shall be an Academic Council as the body to systematize and regularize the educational, academic and research activities of the Academy.

(2) The formation of the Academic Council shall be as follows: -

(a) Vice-Chancellor -Chairperson

(b) Five persons nominated by the Assembly, on the recommendation of the Executive Council, from among the chairpersons of various subject committees of the Academy -Member

(c) Dean -Member

(d) Heads of bodies relating to curriculum and examination of the Academy -Member

(e) Two teachers, including at least one woman, nominated by the Assembly, on the recommendation of the Executive Council, from among the teachers -Member

(f) Two persons, including at least one woman, nominated by the Assembly, on the recommendation of the Executive Council, from among persons who have made outstanding contributions to the health sector -Member

(g) Director -Member-Secretary

(3) The term of office of nominated members under Sub-section (2) shall be three years.

(4) If the office of a nominated member falls vacant for any reason, another person shall be nominated to that office for the remaining period according to the same procedure by which it was previously filled.

(5) The procedure relating to meetings of the Academic Council shall be as prescribed. 10.
Pokhara Academy of Health Sciences Act, 2016

10. Functions, Duties and Powers of Academic Council: The functions, duties and powers of the Academic Council shall be as follows: -

(a) To formulate necessary policies, plans and programs to systematize and regularize the educational, academic and research activities of the Academy and submit them to the Assembly for approval,

(b) To conduct and cause to be conducted study and research programs to provide education at various subjects and levels related to health sciences,

(c) To determine the qualifications of teachers required for the Academy,

(d) To determine the standard of study, research, training and coaching programs operated by the Academy and approve the curriculum,

(e) To select students,

(f) To determine examination standards,

(g) To conduct examinations and publish results,

(h) To recommend to the Assembly to award degrees to students who succeed in study programs operated by the Academy,

(i) To recommend to the Assembly to award honorary degrees, scholarships, medals and prizes on behalf of the Academy,

(j) To prepare quality textbooks,

(k) To evaluate study, research, training and coaching programs operated by the Academy,

(l) To determine fees for study, training and research,

(m) To implement and monitor decisions related to the Academic Council approved by the Assembly,

(n) To perform other functions as prescribed. Chapter-5

Formation and Functions, Duties and Powers of the Executive Council

11. Formation of Executive Council: (1) There shall be an Executive Council to function as the executive body of the Academy.

(2) The formation of the Executive Council shall be as follows: -

(a) Vice-Chancellor -Chairperson

(b) Dean -Member

(c) One person from among the heads of educational institutions who are members -Member

(d) Two teachers, including at least one woman, from among the teachers -Member

(e) Director -Member-Secretary

(3) The nomination of members under clauses (c) and (d) of Sub-section (2) shall be made by the Pro-Chancellor on the recommendation of the Vice-Chancellor.

(4) The term of office of members nominated under Sub-section (3) shall be three years.

(5) The procedure relating to meetings of the Executive Council shall be as prescribed. 12.
Pokhara Academy of Health Sciences Act, 2016

12. Functions, Duties and Powers of the Executive Council: The functions, duties and powers of the Executive Council shall be as follows: -

(a) To implement and cause to be implemented the decisions and directions of the Assembly,

(b) To prepare draft rules required for the Academy and submit them to the Assembly for approval,

(c) To prepare policies, plans, annual programs, progress reports, annual budget, audit reports and other proposals of the Academy and submit them to the Assembly for approval,

(d) To monitor and evaluate the activities performed by subordinate bodies and give directions to such bodies as necessary,

(e) Subject to the policy directions of the Assembly, to operate, supervise and protect the fund and movable and immovable property of the Academy, sell or lease them out:

Provided that, while selling immovable property received from the Government of Nepal, approval of the Government of Nepal shall be obtained.

(f) To appoint and promote teachers and employees required for the Academy on the recommendation of the Service Commission,

(g) To accept various types of donations received by the Academy,

(h) To perform and cause to be performed other functions as prescribed. Chapter-6

Formation and Functions, Duties and Powers of the Service Commission

13. Formation of Service Commission: (1) There shall be a Service Commission to recommend for the appointment and promotion of teachers and employees of the Academy.

(2) The Service Commission shall consist of the following members: -

(a) Person designated by the Assembly -Chairperson

(b) Secretary of the Public Service Commission or a representative designated by him/her -Member

(c) One person appointed by the Executive Council from among the teachers -Member-Secretary

(3) The term of office of the Chairperson and Member-Secretary under clauses (a) and (c) of Sub-section (2) shall be four years.

(4) The functions, duties and powers of the Service Commission shall be as prescribed.

(5) The procedure relating to meetings of the Service Commission shall be as prescribed. Chapter-7

Faculties, Educational Institutions, Hospital and Other Bodies

14. Provision relating to Faculties and Research Centres: (1) The Academy may establish Faculties and Research Centres.

(2) The formation and functions, duties and powers of Faculties and Research Centres established under Sub-section (1) shall be as prescribed. 15. Establishment and Operation of Educational Institution: (1) The Academy may establish educational institutions as necessary for the purpose of conducting study and research on various subjects related to health sciences.

(2) The operation of educational institutions established under Sub-section (1) shall be as prescribed. 16.
Pokhara Academy of Health Sciences Act, 2016

15. Establishment and Operation of Educational Institution: (1) The Academy may establish educational institutions as necessary for the purpose of conducting study and research on various subjects related to health sciences.

(2) The operation of educational institutions established under Sub-section (1) shall be as prescribed. 16. Establishment and Operation of Hospital: (1) The Academy shall establish a hospital for conducting high-level study and research in the health sector and providing quality and accessible health services.

(2) The Western Regional Hospital established and operated pursuant to the prevailing law at the time of commencement of this Act shall be deemed to have been established under Sub-section (1).

(3) The operation and management of the hospital shall be as prescribed. 17. Hospital Management Committee: (1) There shall be a Hospital Management Committee for the smooth operation and cause of operation of the hospital.

(2) The formation and functions, duties and powers of the Hospital Management Committee shall be as prescribed. Chapter-8

Office Bearers, Teachers and Employees of the Academy

18. Chancellor: (1) The Prime Minister shall be the Chancellor of the Academy.

(2) The Chancellor shall be the head of the Academy.

(3) The Chancellor may inspect the Academy. 19. Pro-Chancellor: (1) The Minister or Minister of State for Health shall be the Pro-Chancellor of the Academy.

(2) The Pro-Chancellor may inspect the Academy as necessary and give directions to the Academy. 20. Vice-Chancellor: (1) The Vice-Chancellor shall be the chief office bearer working full-time at the Academy.

(2) A committee shall be constituted by the Chancellor, chaired by the Pro-Chancellor and comprising two other members of the Assembly, to recommend for appointment to the post of Vice-Chancellor, and the Chancellor shall appoint the Vice-Chancellor on the recommendation of that committee. 21. Dean: (1) The Vice-Chancellor shall appoint the Dean to work as the head of the educational and academic activities and faculty of the Academy.

(2) The Dean shall be a full-time office bearer of the Academy.

(3) The appointment under Sub-section (1) shall be as prescribed. 22. Director: The Vice-Chancellor shall, on the recommendation of the Dean, appoint the Director to work as the administrative head of the hospital. 23. Provision relating to Term of Office, Service, Conditions and Functions, Duties and Powers of Office Bearers: (1) The term of office of the Vice-Chancellor, Dean and Director shall be four years.

(2) There may be other office bearers as prescribed, other than those mentioned in Sub-section (1), in the Academy.

(3) The appointment, service, conditions and functions, duties and powers of office bearers under Sub-section (1) or (2) shall be as prescribed. 24.
Pokhara Academy of Health Sciences Act, 2016

24. Power to Remove from Office: (1) If one-fourth of the members present at the time submit a written application to the Chancellor stating that the Vice-Chancellor has not fulfilled his/her official responsibilities or has not acted in accordance with the conduct befitting the office or has not performed his/her duties honestly, the Chancellor shall constitute a three-member investigation committee comprising a member of the Assembly as chairperson, another member, and the Secretary of the Ministry.

(2) If the investigation committee under Sub-section (1) recommends that the Vice-Chancellor has not fulfilled his/her official responsibilities, has not worked honestly, or has not performed his/her duties, and if that matter is passed by a meeting of the Assembly, the Chancellor shall remove such Vice-Chancellor from his/her office.

(3) After the investigation committee is constituted under Sub-section (1), such office bearer shall be automatically suspended from his/her office until a decision is made by the Assembly under Sub-section (2).

(4) The provision relating to removal of other office bearers of the Academy other than the Vice-Chancellor from office shall be as prescribed.

(5) Before recommending the removal of an office bearer of the Academy under Sub-section (2), the investigation committee shall give him/her an opportunity to submit a defense against the allegations made against him/her. 25. Teachers and Employees of the Academy: (1) There shall be teachers and employees in the Academy in the required number.

(2) The appointment of teachers and employees of the Academy shall be made on the recommendation of the Service Commission as prescribed.

(3) The functions, duties and powers, remuneration, facilities and other terms of service of teachers and employees of the Academy shall be as prescribed. Chapter-9

Fund, Accounts and Audit of the Academy

26. Fund of the Academy: (1) The Academy shall have a separate fund.

(2) The fund under Sub-section (1) shall consist of the following amounts: -

(a) Amount received from the Government of Nepal,

(b) Amount received from educational fees and service fees,

(c) Amount received as grants or loans from domestic or foreign individuals, associations, institutions or foreign governments,

(d) Amount received from other sources.

(3) Before receiving any amount from foreign individuals, associations, institutions or governments under clause (c) of Sub-section (2), the Academy shall obtain the approval of the Government of Nepal.

(4) The amount of the fund of the Academy shall be deposited by opening an account in a commercial bank.

(5) All expenses of the Academy shall be borne from the fund under Sub-section (1).

(6) The operation of the fund and account of the Academy shall be as prescribed. 27.
Pokhara Academy of Health Sciences Act, 2016

27. Accounts and Audit: (1) The accounts of income and expenditure of the Academy shall be kept in accordance with the prevailing law.

(2) The audit of the Academy shall be conducted by the Auditor General. Chapter-10

Miscellaneous

28. Not to Grant Affiliation: The Academy shall not grant affiliation to any educational institution. 29. Power to Merge Other Institutions: (1) If any institution related to health sciences established and operated pursuant to the prevailing law wishes to merge with the Academy, the Academy may merge such institution into the Academy.

(2) The basis and procedure for merging an institution under Sub-section (1) shall be as prescribed. 30. Duty to Act in Accordance with National Policy on Health and Education: The Academy shall work in accordance with the national policy on health and education approved by the Government of Nepal. 31. Provision relating to Reservation: (1) While admitting students at various levels up to bachelor's degree in each academic session, the Academy shall make provision for reservation of ten percent of seats for economically disadvantaged Nepali students who have passed the Amended by the Act to Amend Some Nepal Acts to Make them Consistent with the Constitution of Nepal, 2075.School Leaving Certificate examination or equivalent from a community school of the backward region and have permanent residence in that region.

(2) Priority shall be given to students from women, Dalit, Indigenous/Janajati, Madhesi and backward classes in the seats reserved under Sub-section (1) in the backward region.

(3) While making reservation under Sub-section (1), students shall be selected through competition. 32. Priority to be Given While Admitting Students: While admitting students at various levels, the Academy shall give priority to persons who have provided service in health institutions in backward regions for a prescribed period. 33. Scholarship to be Provided: (1) The Academy shall provide full scholarship to needy students in at least twenty-five percent of the total number of students admitted in each academic session.
Pokhara Academy of Health Sciences Act, 2016

33. Scholarship to be Provided: (1) The Academy shall provide full scholarship to needy students in at least twenty-five percent of the total number of students admitted in each academic session. Explanation: For the purpose of this section, "needy" means students who have studied in a community school and passed the Amended by the Act to Amend Some Nepal Acts to Make them Consistent with the Constitution of Nepal, 2075.School Leaving Certificate examination or equivalent, and who are recommended as needy by the concerned local level on a prescribed basis.

(2) Considering the twenty-five percent under Sub-section (1) as one hundred percent, scholarship shall be provided only to students from women, Dalit, Indigenous/Janajati, Madhesi and backward classes in forty-five percent of that number.

(3) The Academy may provide partial scholarship to needy students.

(4) The basis for providing scholarship under Sub-sections (1) and (2) shall be as prescribed.

(5) Any body or institution may provide scholarship to any student for study at the Academy. 34. Duty to Work at Prescribed Place: (1) A student who has studied under reservation or scholarship under this Act shall work in a backward region for a period prescribed by the Academy.

(2) If the body or institution providing scholarship to a student has set a condition requiring the student to work at a certain place for a certain period in return for receiving such scholarship, the student shall work according to that condition, and if no such condition has been set, the student shall work for the period under Sub-section (1).

(3) A student admitted under the priority of the Academy pursuant to Section 32 shall work in a backward region for a period prescribed by the Academy.

(4) The Academy shall provide a permanent certificate of academic qualification to a student studying under reservation under Sub-section (1) of Section 31 and under priority or scholarship under Sections 32 and 33 only after such student has worked for the full period mentioned in Sub-section (1), (2) or (3).

(5) The Academy may make necessary arrangements to encourage other students studying at the Academy, other than those studying under reservation, priority or scholarship under Sections 31, 32 and 33, to work in health institutions in backward regions after their studies. 35. Annual Report: (1) The Academy shall submit an annual report of its activities performed during the year to the Government of Nepal within three months of the end of each fiscal year.

(2) The report under Sub-section (1) shall include, among other things, a brief description of the work done by the Academy during the year and the achievements of the Academy. 36.
Pokhara Academy of Health Sciences Act, 2016

36. Delegation of Powers: (1) The Assembly may delegate some of its powers under this Act to the Academic Council, Executive Council or Vice-Chancellor as necessary.

(2) The Academic Council, Executive Council or Service Commission may delegate some of its powers under this Act to any office bearer or subordinate body of the Academy as necessary. 37. Acts not to be Invalidated: Any act done by the Academy shall not be invalidated merely on the ground that the office of any office bearer or member of the Academy is vacant or that there is a defect in the appointment or nomination of any office bearer or member of any organization of the Academy. 38. Provision relating to Monitoring and Directions: The Government of Nepal may monitor the activities of the Academy and give necessary directions, and it shall be the duty of the Academy to comply with such directions. 39. Contact with Government of Nepal: The Academy shall contact the Government of Nepal through the Ministry. 40. Oath to be Taken: A person appointed to the office of an office bearer of the Academy shall take an oath in the prescribed format before assuming the charge of his/her office. 41. Employees may Remain in Academy: (1) Among the employees of the Nepal Health Service working at the Western Regional Hospital, Pokhara at the time of commencement of this Act, those who wish to work at the Academy shall submit an application to the Ministry within six months from the date of commencement of the rules relating to employee service made under this Act.

(2) If the Ministry grants approval for an employee who submits an application under Sub-section (1) to remain as an employee of the Academy, such employee shall be deemed to be an employee of the Academy.

(3) The service period served in the health service by an employee who remains in the Academy under Sub-section (2) shall be counted towards the service period of the Academy. 42. Power to Make Rules: (1) The Academy may make necessary rules for the implementation of this Act.

(2) Notwithstanding anything contained in Sub-section (1), while making rules on matters that impose additional financial burden on the Government of Nepal, approval of the Ministry shall be obtained. 43. Power to Make Standards: To make the activities of the Academy effective and qualitative, the Government of Nepal may make necessary standards relating to health and education, and it shall be the duty of the Academy to comply with such standards. 44.
Drugs Act, 1978

Drug Act, 2035

Royal Seal and Date of Publication
2034.7.8

Amending Acts

1. Drug (First Amendment) Act, 2035 2035.7.10
2. Drug (Second Amendment) Act, 2057 2057.8.14

Ratification and Publication Date

3. Republic Strengthening and Some Nepal Laws Amendment Act, 2066 2066.1.17
4. Some Nepal Laws Amendment, Consolidation, Adjustment and Repeal Act, 2074 2074.6.30
5. Some Nepal Acts Amendment to Make Compatible with the Constitution of Nepal Act, 2075 2075.11.19
6. Drug (Third Amendment) Act, 2079 2079.03.31
7. Some Nepal Acts Amendment Act, 2082 2082.04.14

Act No. 21 of the year 2035



An Act Made to Provide for Matters Relating to Drugs

Preamble: Whereas it is desirable to prevent the improper use or misuse of drugs or drug intermediates, to prevent false or misleading publicity regarding their utility and use, and to control the production, sale-distribution, export-import, storage and consumption of drugs that are not safe for the public, free from side effects and of quality;

Therefore, this Act is enacted by His Majesty King Birendra Bir Bikram Shah Dev, with the advice and consent of the National Panchayat. Chapter-1
Preliminary

1. Short Title, Extent and Commencement: (1) This Act may be called the "Drug Act, 2035".

(2) It shall extend throughout Nepal Deleted by the Republic Strengthening and Some Nepal Laws Amendment Act, 2066..

(3) Section (1) of this Act shall come into force immediately, and the other sections shall come into force in the area and from the date specified by the Government of Nepal by notification in the Nepal Gazette, from time to time. Amended by the First Amendment. 2. Definitions: Unless the subject or context otherwise requires, in this Act,-

(a) "Drug" means any substance used to affect the physical structure or process of a human being, animal or bird for the diagnosis, treatment or prevention of disease affecting human beings, animals or birds, for curing or alleviating disease, or for destroying insects that cause disease in human beings, animals or birds, and includes any intermediate substance applied to such substance.

(b) "Production" means the process of making, preparing, processing, converting, packaging, repackaging or labeling a drug, or any or all processes adopted in relation thereto. Provided that the said term shall not include the process of dispensing, packaging or repackaging a drug prior to its consumption or sale.

(c) "Dispensing" means the act of preparing a mixture, placing it in a suitably labeled container, and giving the drug to a patient for consumption.
Drugs Act, 1978

Provided that the said term shall not include the process of dispensing, packaging or repackaging a drug prior to its consumption or sale.

(c) "Dispensing" means the act of preparing a mixture, placing it in a suitably labeled container, and giving the drug to a patient for consumption. Explanation: For the purpose of this clause, "mixture" means the process of properly combining two or more specified quantities of substances to make a single drug.

(d) "Label" means the name and description of the drug written on the container containing the drug.

(e) "Medical Practitioner" means a medical practitioner registered under the Nepal Medical Council Act, 2020.

(f) "Consumption" means the act of administering or using a drug to a patient by a medical practitioner or a person authorized by such medical practitioner, or the act of the patient himself taking or using such drug according to a prescription written by such medical practitioner, with the intention of improving the immediate physical and mental condition of the patient.

(g) "Department" means the Department of Drug Administration constituted under Section 5.

(h) "Director General" means the head of the Department.

(i) "Inspector" means Amended by the First Amendment. a person appointed by the Department Amended by the Some Nepal Acts Amendment to Make Compatible with the Constitution of Nepal Act, 2075. or the Provincial Government for the purpose of Chapter-6.

(j) "Prescribed" or "as prescribed" means prescribed or as prescribed in the rules made under this Act. Chapter-2
Drug Advisory Council and Drug Consultative Committee

3. Drug Advisory Council: (1) A Drug Advisory Council shall be constituted as prescribed to advise the Government of Nepal on policy and administrative matters relating to drugs.

(2) The functions, duties and powers of the Drug Advisory Council shall be as prescribed. 4. Drug Consultative Committee: (1) A Drug Consultative Committee shall be constituted as prescribed to advise the Department on technical matters relating to drug research, development and control.

(2) The functions, duties and powers of the Drug Consultative Committee shall be as prescribed. Chapter-3
Drug Research and Control

5. Department of Drug Administration: (1) For the purpose of implementing the objectives of this Act, the Government of Nepal shall establish a Department of Drug Administration.

(2) The Department established pursuant to sub-section (1) shall carry out all functions relating to drug control in accordance with this Act and the rules made under this Act. 6. Amended by the Republic Strengthening and Some Nepal Laws Amendment Act, 2066.
Drugs Act, 1978

6. Amended by the Republic Strengthening and Some Nepal Laws Amendment Act, 2066. Nepal Drug Research Laboratory and other Research Laboratories: (1) The Nepal Drug Research Laboratory established by the Government of Nepal Amended by the Republic Strengthening and Some Nepal Laws Amendment Act, 2066. shall be the principal organ of the Government of Nepal for scientific research, testing and analysis of drugs. Added by the Second Amendment.(1a) The procedure to be adopted by the Nepal Drug Research Laboratory established under sub-section (1) for scientific research, testing and analysis of drugs shall be as prescribed.

(2) Any domestic or foreign person or institution may, with the approval of the Government of Nepal, establish other research laboratories or laboratories for scientific research and development of any drug. Chapter-4
Production, Sale-Distribution and Export-Import of Drugs

7. Requirement to Obtain Recommendation Letter for Establishing Drug Industry: Any person, before obtaining approval from the Government of Nepal under the prevailing law to establish an industry for the production of drugs, must obtain a recommendation letter from the Department as prescribed. 8. Requirement to Obtain Production License: (1) After establishing a drug industry upon obtaining the Department's recommendation under Section 7, before producing drugs, the person producing drugs must pay the prescribed fee and obtain a production license (Product License) from the Department Amended by the Second Amendment. as prescribed.

(2) Drug industries already established prior to the commencement of this Act must also pay the prescribed fee and obtain a production license under sub-section (1) Deleted by the Second Amendment.. Added by the Second Amendment.8a. Requirement to Register Drug: (1) Before selling or distributing each drug produced by any industry, the industry producing such drug must pay the prescribed fee and register such drug with the Department as prescribed and obtain a drug registration certificate.

(2) A person wishing to import drugs must, before importing each drug of a company holding a license obtained by him, pay the prescribed fee and register with the Department as prescribed and obtain a registration certificate. 9. Requirement to Obtain Recommendation Letter for Export-Import of Drugs: A person wishing to export or import drugs must, before obtaining a license for export or import under the prevailing law, pay the prescribed fee Added by the First Amendment. and obtain a recommendation letter from the Department as prescribed. Added by the Third Amendment.9a.
Drugs Act, 1978

Added by the Third Amendment.9a. Emergency Use of Drug or Vaccine: (1) Notwithstanding anything contained in this Act or prevailing law, for the prevention, control or eradication of an infectious disease spreading in the form of an epidemic, the Department shall register drugs or vaccines listed with the World Health Organization or registered by the drug regulatory authority of the concerned country or to which such regulatory authority has granted emergency use authorization, for emergency use in Nepal, on the recommendation of the Drug Consultative Committee.

(2) For the import of a drug or vaccine registered under sub-section (1), the Department shall issue a recommendation letter under this Act for granting a license under the prevailing law.

(3) While issuing a recommendation letter under sub-section (2), the Department may specify the quantity to be imported or prescribe necessary conditions regarding the use, sale or distribution of such drug or vaccine.

(4) If it becomes necessary to prohibit the use of a drug or vaccine imported or being used, sold or distributed under this section due to its effects, or if the authority that listed, registered or permitted the use of such drug or vaccine under sub-section (1) prohibits it, the Department may cancel the registration of such drug or vaccine. 10. Requirement to Register Name for Sale-Distribution of Drugs: A person selling or distributing drugs must register his name and shop or firm with the Department as prescribed, pay the prescribed fee Added by the First Amendment. and obtain a certificate. Added by the Second Amendment.10a. Only Registered Drugs to be Sold or Distributed: A person who has obtained a certificate under Section 10 shall sell or distribute only drugs registered under Section 8a. Amended by the Some Nepal Acts Amendment Act, 2082.11.
Drugs Act, 1978

Added by the Second Amendment.10a. Only Registered Drugs to be Sold or Distributed: A person who has obtained a certificate under Section 10 shall sell or distribute only drugs registered under Section 8a. Amended by the Some Nepal Acts Amendment Act, 2082.11. Validity Period and Renewal of Production License, Recommendation Letter and Certificate: (1) A production license, recommendation letter and certificate shall be valid for the following periods from the date of issue:-

(a) Production license under Section 8: five years,

(b) Certificate under Section 8a: three years,

(c) Recommendation letter under Section 9: three years, and

(d) Certificate under Section 10: three years.

(2) Before the expiry of the period under sub-section (1), the concerned person shall pay the prescribed fee and submit an application to the Department for renewal of each production license, recommendation letter and certificate.

(3) A person who is unable to submit an application under sub-section (2) may, within thirty days from the date of expiry of the period under sub-section (1), submit an application to the Department for renewal of each production license, recommendation letter and certificate along with double the fee, stating the reason therefor.

(4) Upon necessary inquiry into the application received under sub-section (2) or (3), the Department may renew the production license, recommendation letter and certificate for another period.

(5) A production license, recommendation letter or certificate not renewed under this section shall automatically be cancelled. The Department shall inform the concerned person of such cancellation.

(6) Notwithstanding anything contained in this section, if for the renewal of a production license, recommendation letter or certificate whose validity period expired before the commencement of this section, an application for renewal is made within three months of such expiry, it shall not be deemed a bar to renewal under this section upon payment of an additional twenty-five percent fee. Chapter-5
Standard of Drugs

12. Drugs to be Safe for the Public, Free from Side Effects and of Quality: Every drug shall be safe for the public, free from side effects and of quality, maintaining the prescribed standard. 13. Prohibition on Production, Sale-Distribution, Export-Import, Storage or Consumption of Drugs Not of Prescribed Standard: Production, sale-distribution, export-import, storage or causing consumption of drugs that are not safe for the public, free from side effects and of quality shall not be permitted. 14.
Drugs Act, 1978

13. Prohibition on Production, Sale-Distribution, Export-Import, Storage or Consumption of Drugs Not of Prescribed Standard: Production, sale-distribution, export-import, storage or causing consumption of drugs that are not safe for the public, free from side effects and of quality shall not be permitted. 14. Recall of Drugs Not Safe for the Public, Free from Side Effects and of Quality: (1) If a drug that has reached the market for sale-distribution is not safe for the public, free from side effects and of quality under Section 12, the person producing it or his representative shall recall such drug from the person selling or distributing it.

(2) If the Director General becomes aware in any manner that a drug which is not safe for the public, free from side effects or of quality has reached the market for sale-distribution, he may cause such drug to be recalled by the person producing it from the person selling or distributing it. 15. Compensation to be Paid: If the death of any person occurs or health is harmed due to a drug produced in a manner that is not safe for the public, free from side effects and of quality, the person producing the drug shall be liable, and the person producing the drug shall pay compensation as prescribed to the rightful heir of the deceased in case of death, and to the person harmed in case of harm. Amended by the Second Amendment.16. Guarantee Document to be Submitted to the Department: A certified copy of a document written guaranteeing that a drug registered under Section 8a is safe for the public, free from side effects and of quality shall be submitted to the Department by the person producing the drug himself, or his authorized representative, or the exporter or importer. 17. Drugs May be Classified into Groups: (1) Drugs may be classified into groups or sub-groups as prescribed.

(2) Where classification into groups is made under sub-section (1), drugs classified as not to be sold or distributed without a medical practitioner's prescription shall not be sold or distributed by anyone without a medical practitioner's prescription.
Drugs Act, 1978

When selling or distributing such drugs according to a medical practitioner's prescription, the pharmacist Added by the Second Amendment. or pharmacy assistant or the dealer himself shall sell or distribute, and if anyone other than the pharmacist Added by the Second Amendment. or pharmacy assistant or dealer sells or distributes such drug, the presence of the pharmacist Added by the Second Amendment. or pharmacy assistant or dealer shall be mandatory.

(3) Where classification into groups is made under sub-section (2), drugs classified as to be sold or distributed only by the pharmacist Added by the Second Amendment. or pharmacy assistant or dealer, or only in the presence of any one of them, may be sold or distributed by him or only in his presence.

(4) Drugs other than those classified under sub-sections (2) and (3) may be sold by any seller in reasonable quantities based on experience. Explanation: "Pharmacist" means a person who has obtained a Bachelor's degree in Pharmacy or a Master's degree in Pharmaceutics, or has acquired experience related to drugs and is recognized by the Drug Consultative Committee Added by the Second Amendment.. "Pharmacy Assistant" means a person who has passed a certificate level or equivalent in Pharmacy. "Dealer" means a person who has obtained qualifications as prescribed by the Drug Consultative Committee and is recognized by that Committee. 18. Prohibition on Improper Use or Misuse of Drugs: (1) No person shall improperly use or misuse a drug.

(2) If any drug is sold or distributed contrary to sub-sections (2) and (3) of Section 17, it shall be deemed to be an improper use or misuse of such drug. 19. Prohibition on False or Misleading Publicity of Drugs: (1) No person shall engage in false or misleading publicity or advertisement regarding the use, utility or effectiveness of a drug.

(2) A person wishing to publicize or advertise any drug shall pay the prescribed fee and obtain a permission letter from the Department as prescribed. Chapter-6
Inspection and Investigation

20.