Drugs Act, 2035 (1978)


Published: 1978

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Drugs Act, 2035 (1978) 1
Drugs Act, 2035, (1978)
Date of Authentication and Publication
2035.7.8 (25 October 1978)
Amending Acts:
1. The Drugs (First Amendment) Act, 2045 (1988) 2045.7.10 (26 November 1988)
2. The Drugs (Second Amendment) Act, 2057 (2000) 2057.8.14 (29 November 2000)
Act number 21 of the year 2053 (1978)
An Act Made to Make Provisions relating to Drugs
Preamble: Whereas, it is expedient to prevent the misuse or abuse of drugs and allied
pharmaceutical substances and false or misleading information relating to the efficacy and use of
drugs and to control the production, sale, distribuion, export, import, storage and consumption of
those drugs which are not safe for public consumption, efficacious and of standard quality;
Now, therefore, His Majesty King Birendra Bir Bikram Shah Dev has, with the aid
and advice of the National Panchayat, enacted this Act.
Chapter- 1
Preliminary
1. Short title, extent and commencement: (1) This Act may be called as the
“Drugs Act, 2035 (1978)”.
(2) This Act shall extend to the whole of Nepal.
(3) Section 1 of this Act shall come into force immediately, and other
sections shall come into force in such area and on such date as Government of
Nepal may, by notification in the Nepal Gazette, appoint from time to time.
Notifications on the commencement of the Act:
(a) Sections 3 and 4 of this Act have been appointed to commence forthwith to the whole of Nepal (the Nepal Gazette dated 2037.3.5 (18 June 1980). (b) Sections 2, 25, Sub-section (1) of section 34, sections 38 and 39 of this Act have been appointed to commence forthwith to the whole of the Nepal (the Nepal Gazette dated 2040.3.13 (27 June 1983).
(c) Sections 7, 8, 9, 10, 11 and 37 of this Act have been appointed to commence to the whole of the Nepal on 2040.12.6 (19 March 1984) (the Nepal Gazette dated 2040.12.6 (19 March 1984). (d) Sections 20, 21, 22, 23, 24, 28, 29, 30, 33 and Sub-sections (2) and (3) of Section 34 of this Act have
been appointed to commence to the whole of the Nepal on 2043.4.1 (16 July 1986) (the Nepal Gazette dated 2043.2.12 (26 May 1986).
(e) Sections 12, 13, 14, 15, 16, 17, 18, 19, 32, 35 and 36 o f this Act have been appointed to commence to the whole of the Kingdom of Nepal on 2046.5.26 (11 September 1989) (the Nepal Gazette dated 2046.5.26 (11 September 1989).
(f) Section 26 of this Act has been appointed to commence on 2049.8.1 (16 November 1992) (the Nepal Gazette dated 2049.8.1(16 November 1992).
2
2. Definitions: In this Act, Unless the subject or the context otherwise requires,-
(a) “Drug” means any substance to be used for the diagnosis, cure, mitigation,
treatment or prevention of a disease in a human being, animal or bird or to be
used to destruct vermin or insects which cause diseases in the human being,
animal or bird or any substance used to affect the s ructure or any organic
function of the body of a human being, animal or bird or allied ingredients or
components to be used for the preparation of such sbstance.
(b) “Manufacture” means the process of making, prepa ing, refining, altering,
packing, repacking or labeling a drug or any or all of the processes followed
in this respect.
Provided that, this term does not include the process of dispensing,
packing or repacking a drug prior to its consumption or sale.
(c) “Dispensing” means the issuing of a drug in a suitable container, appropriately
labeled and compounded for its subsequent consumption by a
patient.
Explanation: For purposes of this Clause, “compound” means the process of
mixing two or more specific ingredients to fabricate them into a single drug.
(d) “Label” means the name and other related description of a drug written on the
container of that drug.
(e) “Doctor” means a (doctor) registered pursuant to the Nepal Medical
Council Act, 2020 (1964).
(f) “Consumption” means the giving or administering of a drug either by a
(doctor) or by a person authorized by the (doctor) t a patient with intention
to bring about improvement in his/her physical or mental condition at
that time or the taking or administering of such drug by the patient
him/herself according to the prescription written by such doctor.
(g) “Department” means the Department of Drugs Administration constituted
pursuant to Section 5.

3
(h) “Administrator” means the Head of Department.
(i) “Inspector” means a person deputed by the Department for purposes of
Chapter-6♣
(j) “Prescribed” or “as prescribed” means prescibed or as prescribed in the Rules
framed under this Act.

Chapter- 2
Drugs Advisory Council and Drugs Advisory Committee
3. Drugs Advisory Council: (1) A Drugs Advisory Council shall be constituted as
prescribed to advise Government of Nepal on theoretical and administrative
matters relating to drugs.
(2) The functions, duties and powers of the Drugs Advisory Council shall
be as prescribed.
4. Drugs Advisory Committee: (1) A Drugs Advisory Committee shall be
constituted as prescribed to advise the Department on echnical matters related
with the research, development and control of drugs.
(2) The functions, duties and powers of the Drugs Advisory Committee
shall be as prescribed.
Chapter- 3
Research and Control of Drugs
5. Department of Drug Administration: (1) Government of Nepal shall
establish a Department of Drug Administration for the implementation of the
objectives of this Act.
(2) The Department established pursuant to Sub-section (1) shall carry
out all the functions related with the control of drugs under this Act and the Rules
framed there under.

♣ Amended by the First Amendment.
4
6. Drug Research Laboratory and Other Laboratories: (1) The Drug
Research Laboratory established by Government of Nepal shall be the principal
body of Government of Nepal to perform scientific research, testing and analysis
of drugs.
♦(1a)The procedures to be followed by the Royal Drug Research Laboratory
established pursuant to Sub-section (1) in performing scientific research, testing
and analysis of drugs shall be as prescribed.
(2) Any native or foreign person or institution may, with the approval of
Government of Nepal , establish any other research centre or laboratory for
the scientific research and development of any drugs.

Chapter- 4
Manufacture, Sale, Distribution, Export and Import of Drugs
7. Recommendation letter to be obtained to establish drug industry: Any
person who intends to establish an industry to manufact re any drugs shall obtain a
recommendation letter from the Department as prescribed, prior to the obtaining of
approval of the Government of Nepal pursuant to the prevailing law.
8. Product license to be obtained: (1) After the establishment of a drug industry
by obtaining recommendation of the Department pursuant to section 7 and before
the manufacturing of that drug, the drug manufacturer shall obtain the product
license from the Department as prescribed, by paying the prescribed fees.
(2) Any drug industry which has already been established prior to the
commencement of this Act shall also obtain the product license pursuant to Sub-
section (1), -------- by paying the prescribed fees. ♦8A.

Registration of drug: (1) Any drug manufacturing industry shall, prior to the
♦ Inserted by the Second Amendment. Amended by the Second Amendment. Deleted by the Second Amendment. ♦ Inserted by the Second Amendment.
5
sale and distribution of each drug manufactured by it, register the drug with the
Department, as prescribed, and obtain the drug regist ation certificate, by paying
the prescribed fees.
(2) Any person who intends to import a drug shall, prior to its
importation, get each drug of a licensed company which it intends to import
registered with the Department, as prescribed, and obtain the registration license,
by paying the prescribed fees.
9. Recommendation letter to be obtained for exportation or importation
of drug: Any person who intends to export or import a drug shall, prior to
obtaining the export or import license pursuant to the prevailing law, obtain a
recommendation letter from the Department, as prescribed, on payment of the
prescribed fees.

10. Registration of name for sale and distribution of drug: Any person who
sells and distributes a drug shall get his/her name nd shop or firm registered with
the Department, as prescribed, and obtain a certificate, on payment of the
prescribed fees. ♦10A. Sale and distribution of registered drugs only: Any person who has obtained
the certificate pursuant to Section 10 shall sell and distribute only the drugs
registered pursuant to Section 8A. ♣11. Validity period and renewal of product license, recommendation letter
and certificate: (1) The license as referred to in Section 8, the certificate as
referred to in section 8A♦, the recommendation letter as referred to in Section 9
and the certificate as referred to in section 10 shall remain valid for two years from
the date of its issue.
(2) Each license, recommendation letter and certificate shall be got
Inserted by the First Amendmend . Inserted by the First Amendmend . ♦ Inserted by the Second Amendment. ♣ Amended by the First Amendment.
6
renewed for each year within thirty five days of the expiry of its validity period.
♦(3) If the renewal is not made within the specified time limit pursuant to
Sub-section (1), and an application is made, s tting out the reasons for the
failure to have renewal, within thee months after the date of expiry of the time
limit, the Department shall make renewal by charging a additional fee of twenty
five percent of the renewal fee. The license, recommendation letter or certificate
not renewed even within that time limit shall ipso facto be invalid.
Chapter- 5
Quality Standard of Drugs
12. Drugs to be safe for public consumption, efficacious and of quality
standard: Each drug shall be safe for public consumption, efficacious and of quality
standard in such a manner as to keep on maintaining its prescribed quality standard.
13. Prohibition on manufacture, sale, distribution, export, import, storage
or consumption of drug not conforming to prescribed standard: No
person shall manufacture, sell, distribute, export, import, store, or cause to do
same or cause the consumption of, a drug which is not safe for public
consumption, efficacious and of quality standard.
14. Return of drug which is not safe for public consumption, efficacious and
of quality standard: (1) If a drug which has already been marketed for sale and
distribution is not safe for public consumption, efficacious and of quality standard
pursuant to Section 12, the manufacturer or his/her ag nt shall get back such drug
from the seller or distributor.
(2) If it comes to the knowledge of the Administrator in any manner that
a drug which is not safe for public consumption, efficacious and of quality
standard has been marketed for sale and distribution, he/she may cause the seller or
distributor of the drug to return the drug to its manufacturer.
♦ Inserted by the Second Amendment. Amended by the Second Amendment. ♦ Inserted by the Second Amendment.
7

15. Provision of compensation: If a drug manufactured in such a manner that it is
not safe for public consumption, efficacious and of quality standard results in the
death of, or causes injury to the health of any person, the drug manufacturer shall
be responsible for it and provide compensation, as pre cribed, to the successor to
the deceased for such death and to that person in the event of such injury.
16. Submission of letter of guarantee to Department: A drug manufacturer
him/herself or his/her authorized agent or exporter or importer shall submit to the
Department a certified copy of the document issued by the manufacturer
guaranteeing that the drug registered pursuant to Section 8A is safe for public
consumption, efficacious and of quality standard.
17. Categorization of drugs: (1) The drugs may be classified into categories or ub-
categories, as prescribed.
(2) No person shall sell or distribute such drugs without prescription of a
doctor as categorized not to be sold or distributed without such prescription
pursuant to Sub-section (1). The pharmacist or pharmacy assistant♦ or
professional person himself shall sell or distribute such drugs on prescription of a
doctor; and the presence of a pharmacist or pharmacy assistant♦ or professional
person shall be compulsory where a person other an the doctor, pharmacy
assistant♦ or professional person sells or distributes such drugs.
(3) The drugs categorized as to be sold or distributed only in presence of
a pharmacist or pharmacy assistant♦ or professional person or any of them while
making categorization pursuant to Sub-section (2) may be sold or distributed only
by them or in their presence.
(4) Any seller may, based on the experience, sell in a reasonable quantity
Amended by the Second Amendment. ♦ Inserted by the Second Amendment. ♦ Inserted by the Second Amendment. ♦ Inserted by the Second Amendment. ♦ Inserted by the Second Amendment.
8
the drugs other than those categorized pursuant to subsections (2) and (3).
Explanation: “Pharmacist” means a person who has done graduation in
pharmacy or graduation in pharmaceutics or and been recognized by the Drugs
Advisory Committee, "pharmacy assistant" means a person who has passed
certificate level or equivalent in pharmacy♦ and "professional person" means a
person who has possessed the prescribed qualifications and been recognized by the
Drugs Advisory Committee.
18. Prohibition on misuse or abuse of drugs: (1) No person shall misuse or abuse
drugs.
(2) Sale and distribution of any drug in contravention of the provisions
contained in Sub-sections (2) and (3) of Section 17 shall be deemed to have
misused or abused such drug.
19. Prohibition on false or misleading advertisement of drugs: (1) No person
shall make a false or misleading publicity or advertis ment about the use, utility
or efficacy of any drug.
(2) Any person who intends to make publicity or advertisement of any drug
shall obtain the license, as prescribed, from the Department, by paying the fees
prescribed for the same.
Chapter- 6
Inquiry and Inspection
20. Powers of Inspector to make inquiry and inspection: (1) The Inspector may
inspect, enquire and search any place where a drug is being manufactured, stored♦
sold, distributed or transported.
(2) If, in making inspection, inquiry or search pursuant to Sub-section
(1), the Inspector suspects that any drug is not safe for public consumption,
efficacious or of quality standard or has a reasonable ground to believe that any
Amended by the Second Amendment. ♦ Inserted by the Second Amendment. ♦ Inserted by the Second Amendment.
9
activity is being carried out in contravention of this Act or the Rules framed under
this Act, the Inspector may seal the drug which he/s has found, hand over its
custody to its owner, receive a receipt from that owner, withhold such drug and
give order to immediately stop such activity.
(3) If the Inspector makes inspection, inquiry or search pursuant to this
Section or stops a drug or sends sample of that drug for testing, he/she shall submit
a report thereon to the Administrator within three days.
(4) If the drug, which has been withhold by the Inspector pursuant to Sub-
section (2), is proved, from the analysis or test by a research center, laboratory, hospital,
pharmacy or clinic, that it is not safe for public consumption, efficacious or of quality
standard, such drug may be seized or destroyed by order f the Administrator; and the
Administrator may, while issuing such order, order to cancel the recommendation letter,
product license, certificate or license issued under this Act.
♦(4a) If, in carrying out analysis or test pursuant to Sub-section (4), any drug is
found to be safe for public consumption, efficacious and of quality standard but the
person manufacturing, selling, distributing, storing, transporting, exporting or importing
such drug is held to have committed any activity in violation of this Act or the Rules
framed under this Act, the Administrator may seize such drug and control the
manufacturing, sale, distribution, storage, transportati n, export or import of such drug or
suspend the license or certificate or recommendation letter of such person for a period not
exceeding six months.
(5) The manufacturer shall bear the expenditures incurred in destroying the drug
pursuant to Sub-section (4) If the drug seized from the seller and stopped is to be
destroyed, the value of such drug received by the manufacture from the seller shall also be
got reimbursed by the manufacturer to the seller.
♦(6) The Department may, as per necessity, depute any expert in the concerned
subject to assist in the inquiry and inspection as referred to in this section.
Amended by the Second Amendment. ♦ Inserted by the Second Amendment. ♦ Inserted by the Second Amendment.
10
21.
Filing complaint against order of Administrator: (1) A person who is not
satisfied with an order issued by the Administrator t cancel or suspend the product
license, recommendation letter, certificate or license pursuant to Sub-section (4)
and (4a) of section 20 may file a complaint before the Secretary at the Ministry of
Health within thirty five days after the date of receipt of such order.
(2) The complaint filed pursuant to Sub-section (1) shall be decided within
three months.
22. Procedures to be followed while making inspection or inquiry: The
methods and procedures, as prescribed, shall be followed while making inspection,
inquiry and search under this Act. ♣23.

Qualifications of Inspector and Analyst: (1) The Inspector shall possess the
following qualifications:
(a) Graduation in pharmacy, or
(b) -----
(c) -----
(d) Having passed certificate level or equivalent in pharmacy and
gained at least five years of experience in pharmacy related works.
(2) The Analyst shall possess the following qualific tions:
(a) Graduation in pharmacy, or ♦(a1) Master's degree in chemistry, or
(b) Graduation in chemistry and gained at least three years of
experiences in drug analysis.

Amended by the Second Amendment. ♣ Amended by the First Amendment. Amended by the Second Amendment. Deleted by the Second Amendment. Deleted by the Second Amendment. Amended by the Second Amendment. Amended by the Second Amendment. ♦ Inserted by the Second Amendment. Amended by the Second Amendment.
11
24. Sending sample of drug for test: The Inspector shall send the sample of a drug,
which has been withheld or seized in the course of inspection or inquiry, to the
research center, laboratory, hospital, dispensary or clinic, as prescribed, for test or
analysis; and the Analyst shall also carry out necessary test or analysis and send a
report thereof to the Administrator, as prescribed.
Chapter- 7
Miscellaneous 25.

Powers of Government of Nepal to prohibit manufacture, sale,
distribution, storage, transportation, export, import or consumption of
drugs: If Government of Nepal thinks it necessary to prohibit the manufacture,
sale, distribution, storage, transportation, export, import or consumption of any
drug, it may, by a notification in the Nepal Gazette, issue order to prohibit the
manufacture, sale, distribution, storage, transportati n, export, import or
consumption of such drugs.
26. Powers to fix price of drug: The Department may, if it deems necessary, fix the
price of any drug, by obtaining approval of the Government of Nepal. If the Department
so fixes the price of any drug, a notice thereof shall be published in the Nepal Gazette♦.
27. Provisions relating to prescription: The provisions relating to the issuance of
prescription by the prescribed doctor or recognized (integrated) doctor or health
worker about the drugs categorized pursuant to Section 17 shall be as prescribed.
28. Prohibition on manufacture, sale, distribution, dispensing or storage
without making arrangement of required human resource♦ or
resources: No person shall manufacture, sell, distribute, dispensing, store, export
or import any drug without adequately arranging such human resource and
Amended by the Second Amendment. ♦ Inserted by the Second Amendment. Amended by the Second Amendment. ♦ Inserted by the Second Amendment. Inserted by the First Amendmend .
12
other♦ necessary materials related with such activity as prescribed for the
manufacture, sale, distribution, dispensing, storage, export or import of such
drug.
29. Prohibition on adulteration in drugs and sale of adulterated drugs: (1)
No person shall adulterate any drug so as to root out or lessen or change its effect
or be injurious or sell or offer to sell such drug or dispense it to any one for
treatment with knowledge of such adulteration.
(2) No person shall sell any other substance representing it to be a drug.
30. Prohibition on sale or distribution of date expired drugs: No person shall
sell or distribute any drug which is date expired.
31. License to be obtained from Department for clinical trial of new drug:
Any person who intends to carry out a clinical trial of any new drug shall obtain license
from the Department, as prescribed, for such trial.
Explanation: For purposes of this section “clinical trial” means the testing of a new drug
by administering it to any patient or other person with his/her consent in a hospital or
similar other clinic as prescribed in the license in order to ascertain whether it is
appropriate to bring that drug into use.
32. Disclosure of system of drug and other particulars while manufacturing
drug: (1) While manufacturing any drug, its label shall set out the matter which of
the Allopathic, Ayurvedic, Homeopathic or Unani systems that drug belongs to.
(2) While manufacturing any drug, the possible side effects from the
consumption of that drug shall be mentioned as precribed.
33. Narcotic and poisonous drug to be kept safely: (1) A clear label shall be
put on the prescribed narcotic and poisonous drug, and such drug shall be kept
safely.
(2) Any person who sells and distributes the narcotic and poisonous drugs
as referred to in Sub-section (1) shall maintain reco ds of the narcotic and
♦ Inserted by the Second Amendment. Inserted by the First Amendment .
13
poisonous drug sold or distributed by him/her in the prescribed format; and a
prescription relating to such narcotic and poisonous drug written by a doctor shall
be attached with such records.
34. Penalties: (1) Any person who violates Chapter 4 or an order as referred to in section 25
shall be punished with imprisonment for a term not exceeding three years or a fine not
exceeding Twenty Five Thousand Rupees or with both.
(2) Any person who makes an improper use of or misuses a drug
contrary to Section 18♦ or adulterates a drug or sells an adulterated drugo sells
any other substance representing it to be a drug contrary to section 29 or sells or
distributes a date-expired drug contrary to section 30 or does any act contrary to
section 33 shall be punished as follows:
(a) in the event of the possibilit y of a risk of claiming life, life
imprisonment or imprisonment for a term not exceeding ten years and
a fine;
(b) in the event of the possibility of disempowerment or deprival of
capacity of any organ of the body, imprisonment fora term not
exceeding ten years and a fine; and
(c) in other conditions, imprisonment for a term not exceeding five years
or a fine or both.
(3) Except as mentioned in Sub-sections (1) and (2), a person who commits
any act contrary to this Act or the Rules framed un er this Act shall be punished
with imprisonment for a term not exceeding one year or a fine not exceeding
Five Thousand Rupees or both.
35. Ceiling of fine and imprisonment in lieu of fine: (1) For the purpose of
imposing a fine pursuant to Sub-section (2) of Section 34, such fine shall not exceed the
Amended by the Second Amendment. ♦ Inserted by the Second Amendment. Amended by the Second Amendment. Amended by the Second Amendment.
14
amount in controversy (Bigo) or One Hundred Thousand Rupees whichever is higher.
Provided, however, that such excessive fine shall not be set as is not suitable to the
condition of an offender or the circumstance of the off nce.
(2) While setting the punishment of fine pursuant to Sub-section (1), the
judicial authority shall also specify in his/her decision the term of imprisonment, in
lieu of the fine, which the offender has to serve for his/her failure to pay that fine.
(3) Where the punishment of fine is imposed for an offence and there is
also a provision of punishment of imprisonment for such offense, punishment of
imprisonment shall not be set for a term exceeding five years for the failure to pay
the fine under Sub-section (2). If punishment of life imprisonment is imposed, no
additional imprisonment shall be imposed.
36. Right to register patent of drug: The right related with the registration of patent of
a drug shall be as per the prevailing law.
37. Delegation of authority: Government of Nepal may delegate to any official all or
any of the powers conferred to the Administrator pursuant to this Act.
38. Government to be the plaintiff : Government of Nepal shall be plaintiff in the
cases of under this Act.
39. Investigation and filing of case: (1) The Inspector shall investigate any case related
with an offense punishable under this Act and file th case with the Judicial Authority
after completion of such investigation. ♦(1a) In investigating a case pursuant to Sub-section (1), the Inspector
shall have the powers to arrest a person involved in the offense, search any place
whatever related with the offense, take custody of a document or other goods
related with the offense and execute a deed of public inquiry (sarjamin).
♦(1b) In making investigation pursuant to Sub-sections (1a) and (1b), the
Inspector may get the accused to make deposition and, o reasonable grounds,
Amended by the Second Amendment. ♦ Inserted by the Second Amendment. ♦ Inserted by the Second Amendment.
15
release him/her on personal bail, security or guarantee or detain him/her for a
period not exceeding twenty five days, by obtaining prior permission of the
Judicial Authority. ♦(1c) In doing any activity as referred to in Sub-sections (1a) and (1b), the
Inspector may, as per necessity, seek assistance of the police personnel. If such
assistance is sought, the police personnel shall rende necessary assistance.
(2) In investigating and filing a case pursuant to Sub-section (1) the
Inspector may seek opinion of the Government Attorney. After the filing of a case,
the Government Attorney shall plead and appeal the cas .
40. Power to frame Rules: Government of Nepal may frame Rules in order to imple ent
the objectives of this Act.
♦ Inserted by the Second Amendment.