CONSUMER PROTECTION ACT 2054

AN act made to make provision relaAng to protecAon of consumer

1.Short 'tle and Commencement
This act may be called consumer protecAon act 2054
It shall comes into force on baisakh 1,2055
2.Defina'ons:
3.Forma'on of Consumer Protec'on council:
1. A consumer protecAon council shall be formed in order to formulate
policies relaAng to the protecAon of the rights and interests of
consumers .
2. The council menAoned in sub secAon 1 shall comprise of the
following chairperson and members:
a.Minster /minster of state for supplies: Chairperson
b. ………..
c. Secretary,Ministry of Supplies -Member
d. Secretary,Ministry of Industry-Member
e. Secretary,Ministry Agriculter -Member
f. Secretary,Ministry of Home-Member
g. Secretary,Ministry of Commerce -Member
h.Director to general standard of weights and measures Department -
Member
i.President,FederaAon of Nepalese Chambers of Commerce and Indstry:
Member
j.Three ReperesenAves nomieted by gov of Nepal from non gov
organizaAon associated with rights and interest of consumer: Members
k. Two women ReperesenAves nomieted by gov of Nepal from among
women working in the fields associated with the rights and interest of
consumer-Members
l.An officer of Government of Nepal Designated by Government of
Nepal: Member Secretary
3.Member nominated under clauses j and k of sub sec 2 shall have a
tenure of two years and may be re nominated for one more term
4.The chairperson and members of the council shall receive meeAng
allowances as prescribed by gov of Nepal.
4.Func'ons Du'es and Powers of the Council:
5. procedures rela'ng to the mee'ngs of the council.
6.Protec'on and Promo'on of Consumer Rights .
7.Prohibi'on to influence Demand ,Supply, or Price .
8.Power to Systema'ze and control supply of Consumer Goods and
Services .
9.Par'culars to be Men'oned in Consumer Goods .
10.Prohibited ac'ons Regarding Consumer Goods or Services .
11.Standards of Consumer Goods or Services .
12.Price list to be kept.
13.Power of Government of Nepal to conduct Inquiry and Inspec'ons
.
14.Power to Appoint or Designate Inspec'on Officer .
15.Powers Of Inspec'on Officers to Inspect, Inquiry or Search.
16.Tes'ng of Consumer Goods
17.Sub Standard Consumer Goods to be Confiscated.
18.Penal'es
19.Government of Nepal to be the Plain'ff
20. Inves'ga'ons and Filing of Lawsuits.
21. Summary Trail Procedure to be Adopted .
22.Claims for compensa'on may be made
23.Compensa'on CommiZee.
24.Realiza'on of Compensa'on
25.Appeal
26. Power to Ini'ate Lawsuits Under the Prevailing Laws.
27. Power to Form Sub- CommiZees.
28. Delega'on of Powers.
29.Immunity For Ac'ons Taken With Bona Fide Mo'ves
30.Power to Frame Rules
 Categorization of drugs: DRUG ACT 2035
(1) The drugs may be classified into categories or subcategories, 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 than 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 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 α been recognized by the
Drug Advisory Committee, "pharmacy assistant" means a person who has
passed certificate level or equivalent in pharmacy and "professional person"
means a person who has
manner as to keep on maintaining its prescribed quality standard.

34. Penalties of Drug act 2035 or1978:

(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 drug or 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 possibility 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 for a 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 under this Act shall be punished with
imprisonment for a term not exceeding one year or a fine not exceeding Five Thousand
Rupees" or both.
Drug act 2035 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 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/she 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
Subsection (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 of 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, transportation, 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.
3. Formation of Drug Consultative Council: 2037
(1) For the purposes of Section 3 of the Act, there shall be formed a Drug
Consultative Council consisting of the following members:
(a) Honorable Minister of Health -Chairperson
(b) Member, National Planning Commission-Vice chairperson
(c) Secretary, Ministry of Law and Justice -Member
(d) Secretary, Ministry of Finance -Member
(e) Secretary, Ministry of Health-Member
(f)Secretary, Ministry of Industry and Commerce-Member
(g) Chief, National Medicine Laboratory -Member
(h)Three persons nominated by Government of Nepal from amongst the persons
having knowledge on drugs-Member
(i)Chief Drug Administrator, Department of Drug Administration -Member
Secretary
(2) The term of office of the members nominated pursuant to Clause (h) shall be
three years; and Government of Nepal may, if it so wishes, renominate them or
remove them from office even prior to expiration of their term of office.
(3) The Council may, if it considers necessary, invite any native or foreign expert
or any officer to attend as an observer the meeting of the Council.
(4) Government of Nepal may, if it considers necessary, make alteration or
changes in the number of members. by a Notification publishes in the Nepal
Gazette.
4.Functions,duties and Powers of Council:
(1) It shall be the duty of the Council to provide advice to the Government of Nepal on
theoretical and administrative matters relating to drugs, taking
(2) In addition to providing advice pursuant to Clause (1). the Council may also provide
advice to the Government of Now bolt the following matters.
(a)To develop policy on the development, research, production, sale, distribution,
consumption, export and import of the drugs,
b) To formulate programme corresponding to the determined policies,
(c). To make provision of administrative and technical matters for the implementation of
the formulated programme,
(d) To make coordination and harmonization amongst various offices of the Government
of Nepal,
(e) To fix price of drugs,
(f) To fix basic matters on patents of drugs,
(g) To prohibit the production, sale, distribution, storage and transportation of any drugs,
(h) To give recognition to any native or foreign research laboratory or laboratory, if so
required, for purposes of test or analysis of drugs and similar other activities,
(i)To take necessary action on complaints filed with the Government of Nepal on drug
related matters,
(i) To implement the Act or the rules framed under the Act or to resolve problems that
come across in the course of implementation.
5. Formation of Drug Advisory Committee:
(1) For the purposes of Section 4 of the Act, there shall be formed a Drug Advisory
Committee consisting of the following members:
(a) Secretary, Ministry of Health - Chairperson
(b) Administrator, Department of Drug Administration- Vice Chairperson
(c) Director General, Department of Health Services-Member
(d) Director, Nepal Standards Fixation Committee
(e) Chief, National Medicine Laboratory - Member

(1)

Representative, Ministry of Law and Justice

-Member

(g) Representative, Nepal Medical Association

Member

Nepal

Pharmaceutical

(h) Representative, Association

- Member

(i) Representative, Nepal Chemists and Druggists Association

- Member

j) Three persons nominated by Government of Nepal from amongst the persons having
gained knowledge on drugs

-Member

(k) One senior officer designated by the Department of Drug Administration -Member
Secretary

(2) The term of office of the members nominated pursuant to in Clause (j) of sub-rule (1)
shall be three years; and Government of Nepal may, if it so wishes, re-nominate them or
remove them from office even prior to expiration of their term of office.
(3) The Committee may, if it considers necessary, invite any native or foreign expert or
any officer to attend as an observer the meeting of the Committee.

(4) Government of Nepal may, if it considers necessary, make alteration changes

(modification) in the number of members, by a notification publishes in the Nepal
Gazette.

Functions, duties and powers of Committee:

(1) It shall be the duty of the Committee to give advice to the Department of Drugs
Administration on technical er

er

SFC

the Committee may also give advice on the following

matters:

matters as to the research, development and control of drugs. In addition to giving advice
pursuant to sub-rule (1), (2)

(a) To formulate the standards of drugs, fix other scientific and technical methods for the related
test or analysis.

(b) To prepare Nepal pharmacopeias and other related literatures,

(c) To give recognition to pharmacopeias or literatures of other countries for purposes of work
until the pharmacopeias or literatures as referred to in Clause (b) are approved and enforced by
the Government of Nepal,

(d) To formulate codes for purposes of doing, or

causing to be done, the following acts:

(1) To produce, dispense, sell, distribute, export, import, transport, storage and consume any
drugs or ingredients thereof so that such drugs or ingredients are publicly safe, efficacious and
qualitative.

(2) To prevent the improper use or misuse of drugs or ingredients thereof,

(3) To prevent false or misleading publicity or advertisement on the use and utility of drugs or
ingredients thereof,
(4) To return the drugs which are not publicly safe, effective and qualitative proposed to be or
already sold and distributed to the manufacturer of such drugs

(5) To issue by the manufacturer of a drug a guarantee letter that the drug is publicly safe,
effective and qualitative, prior to the sale and distribution of the drug,

(6) To safely retain narcotic and poisonous drugs, sell and distribute such drugs and maintain
records of the drugs so sold and distributed and prescribe format thereof,

(e) To prepare basic matters on classification of systems and groups or sub-groups of drugs, and
prescribe necessary terms on the production, sale, distribution, export, import, use, storage and
consumption of the drugs as per such classification,

(f) To give recognition to pharmacists or persons

having experiences on drugs,

(g) To prescribe qualifications of and give

recognition to professionals,

(h) To form sub-committees of any member or member secretary or members of the Committee
for the performance of the functions prescribed by the Committee