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Chapter- 7

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, transportation, 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 resource s:

No person shall manufacture, sell, distribute, dispensing, store, export or import ? any drug without adequately arranging such human resource and

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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 prescribed.

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 records of the narcotic and

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♦ 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 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 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 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.
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

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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 offence.
(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 the 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 elated 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, on 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 render 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 case.

40. Power to frame Rules: Government of Nepal may frame Rules in order to implement the objectives of this Act.