Drug Act 2035 and Rules made there under

Lecturer
Dinesh Kumar Yadav
BPharm , MPharm(P.U)
NPC No:G-1715
Department of Pharmacy
School of Health Science Purbanchal University
Goathgaun ,Morang
 Preamble (Objectives) of Drug Acts

• To prohibit the misuse or abuse of drugs and allied pharmaceutical

materials
• To prohibit the false or misleading information relating to efficacy and
use of drugs
• To regulate and control the production, marketing, distribution, export-
import, storage and utilization of those drugs which are not safe for the
use of the people, efficacious and of standard quality
Drug Act 2035 has been published on 2035/7/10
• There are seven chapters and forty sections in the act.
• This act was amended on 2045/07/10 and 2057/08/14.
 Provision in Act
CHAPTER-1: The Title, Extent, Commencement Definitions
1. Title, Extent, Commencement
• Drug Act 2035
• Extension of the Act: throughout Nepal
• Implementation of the Act of sections shall come into force in specified areas on such date
as Government of Nepal may, by notification in the Nepal Gazette, appoint from time to
time Act
2. Definitions
(a) "Drugs" means any substance intended to be used for or in the diagnosis.
cure. mitigation. treatment or prevention of disease in human beings, animals or
birds or any substance intended to be used for the destruction of vermin or
insects which cause disease in human beings, animals or birds or any article
intended to affect the structure or any organic function of the body of human
beings, animals or birds or such ingredients or components intended to use for
the preparation of such drugs.
 Contd:
(b) "Manufacture" means any process or part of process for making, preparing,
refining, altering, packing, repacking or labeling.
Provided that the word does not include the process of dispensing, packing or
repacking the drug before administering or selling, the drugs.
(c)"Dispensing" means the issuing of the drug in a suitable container, appropriately
labeled and compounded for the subsequent administration to the patient.
Explanation:
For the purpose of this clause "compound" means the process of mixing two or
more measured ingredients to Fabricate the into a single drug.
 Contd:
(d) "Label" means the name and the description of the drug written on the same
container of the drug.

(e) "Physician" means the physician registered pursuant to the Nepal Medical
Council Act. 2020 (1964).

(f) "Administration" means the giving or using a drug to a patient for the
improvement of his physical or mental condition at that time either by a
physician or by a person authorized by him or the act of taking or administering
such drug by the patient himself according to the prescription written by such
physician.

(g) "Department" means the Department of Drug Administration constituted

pursuant to Section 5.
Chapter II : Drugs Consultative Council and the Drugs Advisory Committee

3. Drugs Consultative Council

(1) Drugs Consultative Council shall be constituted as specified to advise
Government of Nepal on the basic principles and administrative matters relating
to drugs.
(2) The functions, duties and powers of the Drugs consultative Council shall be
as specified.
4. Drugs Advisory Committee:
(1) Drugs Advisory Committee shall be constituted as specified. to advise the
Department on the technical matters in relation to research, development and
control of drugs.
(2) The functions. duties and powers of the Drugs Advisory Committee shall be
as specified.
 CHAPTER III : Research and Control of Drugs
5. Department of Drug Administration:
(1) Government of Nepal shall establish a Department of Drug
Administration for the purpose of carrying out the objectives
of this Act.
(2) The department established in pursuant to sub- section (1)
shall carry out all the functions relating to control of drugs
under this Act and the Rules framed under this Act.
6.National Medicines Laboratories (Formerly Royal Drug Research
Laboratory) and Other Laboratories:

(1) National Medicines Laboratory (Formerly, The Royal Drug Research

Laboratory) established by Government of Nepal shall be the principal
body of Government of Nepal for the scientific research, testing and
analysis of the drugs.
(2) For the scientific research, testing and analysis of the drugs, standard
operating procedure should be as specified

(3) Any person or institution whether national or foreign may establish

other research centers or laboratories for the scientific research and
development of any drug with taking approval of Government of Nepal
CHAPTER IV: manufacture, sale, distribution and export-import of drugs

7. Obtaining the letter of recommendation for the establishment of drug industries:

Any person desirous to establish an industry for the manufacture of drugs shall
obtain a letter of recommendation from the Department as specified prior to obtain
the approval of His Majesty's Government pursuant to prevailing law.
8. Obtaining the product-license:
(1) After the establishment of drug industry by obtaining the recommendation from
the department pursuant to Section 7, the person manufacturing the drug shall
register the drug on payment of specified fee and should obtain the product license
from the Department as specified prior to the manufacture of drugs. (2) All drug
industries which have been established prior to the commencement of this Act.
shall also register the drug in the Department pursuant to sub- section (1), on
payment of specified fee and shall obtain the product license.
 Contd:
8 (Ka) Product Registrations
(1) After the production of drug industry by obtaining product license
from the department pursuant to Section 8, the person manufacturing
the drug shall register each drug on payment of specified fee and
should obtain the product registration certificate from the
Department as specified prior to the sale/distribution of drugs
(2) Any person desirous in import of drugs shall register each drug on
payment of specified fee and should obtain registration certificate of
each product from department as specified prior to import of drugs
9. Obtaining the letter of recommendation for export-import of drugs:

Any person desirous in export-import of drugs shall obtain the letter of

recommendation from the department as specified on paying the fee prior to
obtaining the export-import license pursuant to the prevailing laws.

10. Registration of name for the sale and distribution of drugs:

Any person who sells and distributes the drugs shall have to register owns name
and shop or firm in the department as specified on payment the specified fee and
shall obtain a certificate.

10 (Ka). Sale and Distribution of Registered Drugs

Registered shops/firms as pursuant to section 10 shall sale and distribute registered
drugs as pursuant to section 8 Ka
11. Period of validity and renewal of product license, a letter of
recommendation. and certificate:

(1) The period of validity of product license pursuant to Section 8,

certificate pursuant to Section 8 Ka, letter of recommendation pursuant to
section 9 and certificate pursuant to section 10 shall be two years from the
date of issuance.

(2) After the expiry of period of validity, each product license, letter of
recommendations and certificate may be renewed annually within 35 days
after expiry on payment of specified fee.

(3)If failed renew pursuant to (2), each product license, letter of

recommendations and certificate may be renewed by taking additional 50%
of the renew fee within three months of expiry.
CHAPTER V: Standard of Quality of Drugs
12. Drugs to be safe for the use of the people efficacious and of standard quality:

Every drug shall have to be safe for the use of the people, efficacious and of standard quality of
maintaining of the standard quality as specified.
13. Prohibition of manufacture. sale-distribution, export- import storage or administration of drugs
which are not of standard as specified:

No, drug, shall be manufactured, sold, distributed, exported-imported, stored or caused to be stored
or administered, which is not safe for the use of the people, efficacious, and of low standard.
14. Return of the drugs which are not safe for the use of the people, efficacious and of standard

(1) The drugs which have been marketed for sale and distribution, are not safe for the use of the
people, efficacious and of standard quality in pursuant to Section 12. the manufacturer or their agent
shall return of such drugs from the seller or distributor.
(2) The drugs which are not sale for the use of the people, efficacious and of standard quality are being
marketed for sale and distribution are happened to come into the knowledge of the administrator by
any means, he may cause the return of such drugs from seller or distributor to the manufacturer.
15. Remittance of indemnity:

If any person died or caused to injury in the health of any person due to such drugs
which are not safe for the use of the people, efficacious and of standard quality, the
manufacturer shall be responsible for it and the manufacturer shall pay the
compensation as specified to the successor of the deceased in lieu of death and to
the person who has been injured.

16. Submission of the letter of guarantee in the Department:

Any person prior to engage in safe or distribution of any drug registered pursuant to
(8 Ka) shall submit to the Department, the certified copy of the document of
guarantee given in writing by the manufacturer or representative or exporter or
importer stating that such drug is safe for the use of the people, efficacious and of
standard
17 .The drugs may be classified into different categories:
(1) The drug may be classified as specified into different categories or sub-categories.

(2) No person shall sell or distribute the drug without the prescription of a physician which has
been categorized not to be sold or distributed without the prescription of a physician while
classifying it pursuant to sub-section (1). The Pharmacist or Pharmacy Assistant or the professional
himself shall sell or distribute such drugs while selling or distributing them according to the
prescription of a physician and if somebody other than the pharmacist or Pharmacy Assistant or
the professional sells or distributes such drugs the presence of the pharmacist or Pharmacy
Assistant or the professional is compulsory.

(3) The drug which has been categorized as to be sold or distributed only in presence of a
pharmacist or Pharmacy Assistant or a professional or anyone of them while classifying them in
pursuant to sub-section (2), may be sold or distributed only by them or in their presence.

(4) Any seller may on the basis of his experience, sell the drugs other than those categorized
pursuant to sub- sections (2) and (3), in appropriate quantity .
 Explanation:
• Pharmacist means any person who is a graduate in pharmacy or post
graduate in pharmaceutics or a person recognized by the Drugs Advisory
Committee on the ground that he has experience on the matters relating to
drugs.
• Pharmacy Assistant means any person who is a certificate in pharmacy or
equivalent.
• Professionalist means the person who has acquired the qualifications as
specified by the Drugs Advisory Committee and recognized by that
Committee.
18. Prohibition of misuse or abuse of drugs:
(1) No person shall misuse or abuse of drugs.
(2) Sale and distribution of any drug in contravention to the provisions made in sub-
sections (2) and (3) of Section 17, shall be deemed to have been misused or abused
of such drug.
19. Prohibition of false or misleading advertisements relating to drugs:
(1) No person shall publish or advertise false or misleading information relating to
the use, utility or efficacy of any drug.
(2) Any person desirous to make publicity or advertisement of any drug shall obtain
the letter of permission as specified from the Department on paying the specified
fee for that purpose.
 CHAPTER VI: Enquiry and Inspection
20. The Inspector may enquire and inspect:

(1) The Inspector may inspect, enquire and search any place, wherein any drug is being
manufactured, sold, distributed or transported. or store

(2) While the Inspector is making the inspection, enquiry or search pursuant to sub-section (1)
if he has reasonable doubt that any drug is not safe for the use of the people, efficacious and
of standard quality or has reasonable grounds to believe that an offence have been committed
or is being committed in contravention of this Act or the Rules framed under this Act. The
inspector shall seal such drug found by him and entrust it to the owner, obtain a receipt from
the owner and detain the drug.

(3) On making inspection, enquiry or search or detain of the drug or on sending the sample for
testing by the inspector under this Act, he shall submit the report to the Administrator within
three days of such actions.
(4) The drug which has been detained by the inspector in pursuant to sub-
section (2), is proved from the analysis or test of research centre,
laboratory, hospital, Pharmacy or clinic that it is not safe for the use of the
people, efficacious or of standard quality such drug may be seized or
destroyed by the order of the Administrator and while issuing such order,
he may order to cancel the letter of recommendation, product license,
certificate or letter of permission given or issued under this Act.

(5) While destroying the drug pursuant to sub-section (4), the cost of such
destruction shall be borne by the manufacturer. The drug which has been
detained from the seller, if it is to be destroyed, the value of such drug
received by the manufacturer from the seller shall be reimbursed to the
seller form the manufacturer.
(6) Department may depute any professional related as necessary
21. Right to file a complaint to His Majesty’s Government against the order of the Administrator:
The person who is not satisfied with the order of the Administrator for the cancellation of letter of
recommendation, product license, certificate or letter of permission in pursuant to sub-section (4) of
section 20 may, file a complaint to His Majesty’s Government within thirty five days form the date on
which the notice of such order is issued to him.
22. Procedures to be followed while making inspection or enquiry:
A specified method and procedure is to be followed while making inspection, enquiry or search under
this Act.
23. Qualifications of the Inspector and Analyst:

(1) The followings shall be the qualification for an Inspector :

(a) Graduate in pharmacy, or
(d) Certificate in pharmacy or equivalent and five years' work experience.
(2) The following shall be the qualifications for an Analyst.
(a) Graduate in pharmacy
(b) Post Graduate in Chemistry
(b) Graduate in chemistry and three years' experience in analytical works.
24. Sending the sample of the drug for test:
The Inspector shall send the sample of the drug which has been detained or seized in the course of
inspection or enquiry .for the test or the analysis to the research center, laboratory, hospital,
dispensary or as specified and the Analyst shall also make necessary take or analysis and send the
report of that analysis to the Administrator on specified form.
CHAPTER VII : Miscellaneous
25. Government of Nepal may, prohibit the manufacture, sale, distribution, storage,
transportation or export, import, administration of the drugs:

If it is deemed necessary to prohibit the manufacture, sale, distribution, storage,

transportation or export-import of any drug, Government of Nepal may, by a notification
published in the Nepal Gazette, order to prohibit the manufacture, sale. distribution. storage.
transportation or export-import of such drugs.
26. The price of drugs may be fixed:
If it is deemed necessary , the department with taking approval of Government of Nepal may
fix the price of any drug. by a notification published in the Nepal Gazette
27 .No person is empowered to issue a prescription besides physicians:

No person shall be empowered to issue the prescription orally or in writing beside the
physicians or health workers for the drugs listed as not to be sold or distributed without the
prescription of a physician or health workers in pursuant to Section 17.
• 28. Prohibition in manufacturing, selling, distribution, dispensing, storage or export-import of drugs without
arranging the necessary materials:
No Person shall manufacture, sale, distribute, dispense, store or export- import any drug unless specified
manpower necessary materials have been arranged in appropriate quantities essential for the manufacturing,
selling, distribution, dispensing, storage, or export-import of such drugs.
• 29. Prohibition in adulteration of drugs and sale of adulterated drugs:
(1) No person shall adulterate any drug so as to minimize its effect, reduce or change its effect or cause to injury
or sell, exhibit it for sale or dispense such drugs knowingly to be so.
(2) No person shall sell any other substance stating it as 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. Obtaining the letter of permission from the Department for a clinical trial of a new drugs:
Any person desirous to have a clinical trial of any new drug, shall obtain a letter of permission, as specified for
that purpose from the Department.

Explanation
For the purpose of this Section "Clinical Trial" means the act of testing of a drug by administering it to any
patient or other person with his consent in hospital or such other health centers as specified in the letter of
permission, for the purpose of ascertaining whether or not it is proper to bring any new drug into use.
• 32. Disclosure of the system and other particulars while manufacturing any drug:
(1) While manufacturing any drug, the manufacturer shall mention the systems in the
label whether that drug is produced under Allopathic. Ayurvedic, Homeopathic or
Unani system.
(2) While manufacturing any drug the possible side effects from the administration of
such drug shall be mentioned as specified
• 33. Protection of narcotic and poisonous drugs:
(1) Drugs which have been specified as narcotic and poisonous shall be kept safely
with clear label on it as specified.
(2) The person who sells or distributes the narcotic and poisonous drugs pursuant to
sub-section (1), shall maintain a record of narcotic and poisonous drugs sold or
distributed by him in the specified form and the prescription, relating to such narcotic
and poisonous drugs written by the doctor shall be attached with such record.
• 34. Penalty:
• (1) Any person who contravenes any of the provisions of chapter 4 or commits an
offence contrary to the order made pursuant to Section 25, shall be punished with
imprisonment up to three years or fine up to rupees twenty five thousand or with
both.
• (2) Whoever misuse and abuse of drugs in contrary to section 18, adulterates the
drug or sells adulterated drug or sells any other substance stating that as a drug in
contrary to the provisions of Section 29 or sell or distributes date-expired drug in
contrary to the provision of Section 30, or in contrary to the provision of Section 33
shall be punished as follows:
– (a) If there is a possibility of risk against the life, life imprisonment or imprisonment up to
ten years and fine.
(b) If there is a possibility of damage or loss the capacity of any organ of the body,
imprisonment up to ten years and fine, and,
(c) In other conditions, imprisonment up to five year or fine or with both.
• (3) Except the provisions made pursuant to sub-section (1) and (2) person who
commits any offence in contrary to the provisions of this Act or the Rules framed
there under shall be punished with imprisonment up to one year or fine up to
rupees five thousand or with both.
• 35. Maximum limit of fine imprisonment in lieu of fine:
• (1) For the purpose of fining in pursuant to the sub- section (2) of section 34, the maximum
limit of fine shall be charged while fixing the amount of fine according to the value of
assets or up to rupees one lac whichever is more. But excessive fine shall not be fixed
which is not suitable to the condition of the offender or circumstance of offence.
• (2) While fixing the punishment in lieu of fines in pursuant to sub-section (1) the official
hearing the case, shall specify the period of imprisonment in lieu of fine which if not paid.
• (3) Where the punishment with fine has been imposed for any offence and if the
punishment with imprisonment is included in such penalty no imprisonment more that five
y-ears shall be imposed to the non-payment of fine in pursuant to sub-section (2). If the life
imprisonment has been imposed no punishment of additional imprisonment shall be
imposed.
• 36. Right to register the patent of drugs:
The right relating to the registration of patent of drugs shall be under the prevailing law.
37 .Delegation of Authority:
His Majesty's Government may delegate to any official all or any of the authority
conferred in pursuant to this Act, reserved to be exercised by the Administrator.
38. His Majesty's Government to be plaintiff:
His Majesty's Government shall be plaintiff to the cases which shall be proceeded under
this Act.
39. Investigation and filing of the case:
(1) Investigation of the case relating to the offence punishable under this Act, shall be
made by the inspector and the case shall be filed to the officer who is authorized to hear
the case after the completion of such investigation.
(2) The inspector may consult with the Public Prosecutor in the course of investigation and
filing of the case in pursuant to sub-section (1). After the filing of case the public
Prosecutor shall plead and appeal.
• 40. Power to frame Rules:
His Majesty's Government may frame Rules to carry-out the purposes of this Act
Thank You
 Case No 1
• A patients was admitted ICU ward with diagnosis of atypical pneumonia ,Clinicians advise injection
Imipenem + Cilastatin (500mg) intravenously TID .A nurse made the prescription slip to patients visitor
buy Imipenem +Cilastatin (500mg) – 3Vails from pharmacy to get the injection to your patients .
Patients visitors move towards hospital pharmacy and give the prescription to dispenser , dispenser
received the prescription and dispensed Imipenem + Clilastatin (500mg) 3 vails and made the bill with
amount 2500*3=7500.A Patients visitor paid the bill with medicine ,gave the medicine to nurse for
administration .The event was run 3 consecutively days without improvement in disease progress .4th
days of same activities one of nursing staff found that medicine was expired one month before.
• A patients visitor made the complain to police station and strike against hospital misconduct
management during patient care by nurses as well as hospital pharmacy regarding expired medicine
dispensed.
• Police and their team visit the hospital ,collect the information about the situation arrest dispenser and
seal the pharmacy for further investigation liaison DDA. Next day of further investigation police and
DDA inspector also find high cost of medicine and there have been add 100%pofit which is offence of
black marketing as per consumer protection act.
• A drug inspector made case file submitted to administrator for further action as per drug act
2035(1978).As you a drug administrator what action should charge against Hospital Pharmacy as
well as Hospital administration.?