2. History of Pharmaceutical
Development in Nepal
Chandra dispensary 1816AD
Bir Hospital 1890
Production of modern medicine 1960's
Master plan of government 1955
Establishment of RDRL now NML 1964
Establishment of Nepal Pharmaceutical Association 2028
Role of RDRL and NPAChandra dispensary 1816AD
Bir Hospital 1890
Production of modern medicine 1960's
Master plan of government 1955
Establishment of RDRL now NML 1964
Establishment of Nepal Pharmaceutical Association 2028
Role of RDRL and NPA
3. Pharmaceutical Production
Nepal Pharmaceutical Works 1969 at Godawari but
could not be materialized
Chemidrug Industries 2026 BS
Royal Drugs Limited 2029
Gap 2029 to 2038
Manoj, Everest, Lomus, NPL (2038 to 2041)
Mushrooming of Saline manufacturing units (2038 to
2043)
Failure of saline industries
Role of Nepal Pharmaceutical lab
Increment of pharma industries (2050's)
GMP certification (2060)
4. Community Pharmacy
Sector
400 drug retailer in 2035
Before Drugs Act (DDA) period
After Drugs Act period
Orientation training and its drawbacks
5. Pharmaceutical
Association/Manpower
10 pharmacists in 2028
Certificate pharmacy in IOM (2030) initiation by Mr.
Paul David Spivey
About 2226 graduate and 4600 certificate pharmacist
till dated.
Kathmandu University for BPharm in 1994 AD
Pokhara University 2001
Tribhuban University BPharm, 2000
BPharm in Purbanchal University, 2062
Purbanchal University, 2005
29 Diploma Pharmacy colleges
Now about 2226 graduate pharmacist and 4600
certificate pharmacist (most of them are not in
pharmacy job)
6. Hospital Pharmacy
Started by British through mission
hospitals, 1950s’
Hospitals were having post of pharmacists
in 2030's
Compounding and dispensing activities
were existed up to health posts
Now no government hospital is having
hospital pharmacy
Few private and teaching hospitals are
having good hospital pharmacy (Manipal,
Dhulikhel, Model etc)
7. Forensic Pharmacy:-
Definition of Forensic Pharmacy
Forensic Forencis (Latin term)≡
A branch of pharmacy that deals
drugs and pharmaceuticals and profession of
pharmacy.
Consist of Acts, Rules, Statutes, Schedules,
Sections
Forensic Pharmacy is;
“A forum or a place inter
assembly for judicial and other
Pharmacy”
8.
9. Drug Act. 2035 (1978)
An Act made to provide for the regulation of drugs
10. • The Main objectives of
Drug Act:-
• The Main objectives of Drug Act:
To prevent misuse and abuse of drugs
To prevent misleading information
relating to use of drugs
To regulate and control the production,
marketing, distribution, sale, export-
import, storage and use of drugs which
are not safe, effective and of standard
quality
11. Preamble
Whereas, it is expedient to prohibit the
misuse or abuse of drugs and allied
pharmaceutical materials as well as the
false or misleading information relating
to efficacy and use of drugs and 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.
12. Short Title. Extent and
Commencement:chapter-1
(1) This Act may be called the "Drugs Act.
2035 (1978)".
(2) This Act shall extend throughout the
Kingdom of Nepal.
(3) Section 1 of this Act shall come into force
immediately and other sections shall
come into force in specified areas on
such date as of Nepal may, by
notification in the Nepal Gazette,
appoint from time to time
13. 2. Definitions: Unless the subject or context
otherwise requires. in this Act
(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.
14. Definition-2
(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 them into a single drug.
15. Definition 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.
17. 3. Drugs Consultative Council:
(1) Drugs Consultative Council shall be
constituted as specified to advise
NepalGovernment 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.
18. 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.
20. 5. Department of Drug
Administration:
(1) NepalGovernment 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.
21. 6. Royal Drug Research Laboratory
and Other Laboratories:
(1) The Royal Drug Research Laboratory established by
NepalGovernment shall be the principal body of
NepalGovernment for the scientific research,
testing and analysis of the drugs.
(1Ka)The procedure for scientific research, testing and
analysis of the drugs shall be as specified.
(2) 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
NepalGovernment.
23. 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 Nepal
Government pursuant to prevailing
law.
24. 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 prior to the manufacture of drugs as
specified.
(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 as specified.
25. 8ka. Product to be registered
(1) The industries manufacturing drugs
shall register their products in the
department paying fee as specified
and obtain the license for each
product.
(2) The importer desirous to import
drugs shall register the product
paying specified fee and obtain the
import registration license.
26. 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 paying the specified
fee.
27. 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 paying fee as specified.
28. 10Ka. Only the registered products
shall be sold
The shop registered under section 10
shall sell only products which are
registered under section 8Ka.
29. 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, 8ka, 9 and 10 shall be valid for two years
from the date of issuance.
(2) Each license should be renewed for every year after
paying the fee as specified within 35 days of the
expiry.
(2) If someone failed to renew the license as per sub
section (2) can renew within 3 months period of
expiration taking 25% fine to the fee specified. There
should be a genuine cause of failure of expiration of
the license. The license will be void if failed within
this period.
31. 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.
32. 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.
33. 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.
34. 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.
35. 16. Submission of the letter of
guarantee in the Department:
The manufacturer or the authorized
agent of the manufacturer shall
submit the letter of guarantee to the
department mentioning that licensed
products as per section 8Ka of the act
are safe, efficacious and of standard
quality.
36. 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 assistant pharmacist 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 the professional sells or
distributes such drugs the presence of the pharmacist 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 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 .
37. 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 certificate level in
pharmacy or equivalent and
“Professionalist" means the person who has
acquired the qualifications as specified by
the Drugs Advisory Committee and
recognized by that Committee.
38. 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.
39. 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.
41. 20. The Inspector may enquire and inspect:
(1) The Inspector may inspect, enquire and search any
place, wherein any drug is being manufactured, stored,
sold, distributed or transported.
(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 has 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 and order for stopping such activities.
42. Contd…
(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.
43. Contd…
1. (4Ka)If in case the drug analyzed as per section (4)
found to be safe, efficacious and standard quality, but
the person is defying the act and rules and there under
on carrying out production, sale, distribution, store,
transportation, import or export the administration may
order for seize the drugs and order for suspend of such
licenses for up to six months.
2. (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.
3. (6) For the purpose of this section, the department, on
its need can assign to any specialist for the purpose of
inspection and investigation.
44. 21. Right to file a complaint to Nepal Government
against the order of the Administrator:
(1) 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 or suspension of license in
pursuant to sub-section (4) and (4Ka) of
section 20 may, file a complaint to the
secretary, Ministry of Health within thirty
five days form the date on which the notice
of such order is issued to him.
(2) The decision against complaint should be
completed within 3 months.
45. 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.
46. 23. Qualifications of the Inspector and Analyst:
(1) The followings shall be the qualification for an
Inspector :
(a) Graduate in pharmacy, or
b) ………………….
c) …………………..
(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, or
(a1) Post graduate in chemistry, or
(b) Graduate in chemistry and at least 3 years'
experience in analytical works.
47. 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.
49. 25. Nepal Government may, prohibit the
manufacture, sale, distribution, storage,
transportation or export, import or administration of
the drugs:
If it is deemed necessary to prohibit
the manufacture, sale, distribution,
storage, transportation or export-
import of any drug, Nepal
Government may, by a notification
published in the Nepal Gazette, order
to prohibit the manufacture, sale.
distribution. storage. transportation
or export-import or administration of
such drugs.
50. 26. The price of drugs may be
fixed:
If it is deemed necessary , the
department with taking approval of
Nepal Government may fix the price
of any drug.
51. 27. Provision of prescriptions:
Issue of prescription by specified
doctor, integrated doctor or other
health professionals for the drugs
categorized in pursuant to Section 17
will be as specified.
52. 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 necessary
materials and manpower as specified
have been arranged in appropriate
quantities essential for the
manufacturing, selling, distribution,
dispensing, storage, or export-import
of such drugs.
53. 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.
54. 30. Prohibition on sale or
distribution of date expired drugs
No person shall sell or distribute any
drug which is date expired.
55. 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.
56. 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.
57. 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.
58. 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) In contrary to section 18, whoever abuse or misuse of drugs, whoever
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
whoever works in contrary to 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.
59. 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 lakh 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.
60. 36. Right to register the patent
of drugs:
The right relating to the registration
of patent of drugs shall be under the
prevailing law.
61. 37. Delegation of Authority:
Nepal 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.
62. 38. Nepal Government to be
plaintiff (Applicant)
Nepal Government shall be plaintiff to
the cases which shall be proceeded
under this Act.
63. 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.
(1Ka) In process of investigating case under sub-section (1) the
inspector shall have right to arrest the offender, to search any
place related to offend, to seize or hold the documents or other
material in his/her responsibility and prepare statement of
opinion of witnesses..
(1Kha) In process of investigation under sub-section (1) & (1Ka)the
inspector shall take statement of opinion of offender and put on a
fixed day to report the court, release on bail or detain for up to
25 days with prior permission of the court.
(1Ga) In process of investigating & filling the case under sub-section
(1Ka) & (1Kha) as deemed necessary the inspector may take help
from police official. In such case, it the duty of police official to
help.
(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.
64. 40. Power to frame Rules:
Nepal Government may frame Rules
to carry-out the purposes of this Act.
66. 3. Constitution of Drug
Consultative Council
(a) The following shall be the composition of council
Hon. Minister of Health Chairperson
Member, National Planning Commission Member
Secretary, Ministry of Law & Justice Member
Secretary, Ministry of Finance Member
Secretary, Ministry of Health Member
Secretary, Ministry of Ind.& Commerce Member
Chief, Royal Drug Research Laboratory Member
Three Pharmacy experts nominated by govt Member
Chief Drug Administrator Member secretary
(b) Tenure of the committee shall be three years
(c) Any foreign or Nepali expert as recognized by Council can be
an observer
(d) Nepal Government can change the composition of council
through gazette notification.
67. 4. Functions, duties and
responsibilities of council
1) On the interest of the country hence
to make the country independent by
not using the import based raw
materials, the council shall provide
advice on the matter related
principles and administrative matters
to the government to depend and
exploit the locally available plant
based resources in the production.
68. Functions contd….
2) The council shall provide advice on the following matters
also:
To develop policy on the development of drug, research,
production, sale and distribution, administration, export/import
of drugs
Formulate programme on the basis of the developed policy
To mobilize the recourses to implement the formulated
programme
To work for the coordination and cooperation between the
different government organisations
To fix the drug price
To develop basic need for the patent registration
To prohibit the manufacture, sale and distribution of drugs
To recognize the domestic or foreigh laboratories for quality
control and analysis of drugs if needed
To hear the complaints regarding the drug
To solve the problems concerning the drugs act and rules
there under
69. 5. Constitution of Drug Advisory
Committee
a. Constitution
Secretary, Ministry of Health Chairperson
Administrator, DDA Vice Chairperson
Director General, Dept of Health Services Member
Director General, Department of Livestocks Member
Chief, Royal Drug Research Laboratory Member
Representative, Ministry of Law & Justice Member
Representative, Nepal Pharmaceutical Association Member
Representative, Nepal Medical Association Member
Representative, NCDA Member
Three Pharmacy experts nominated by the NG Member
Senior Pharmacist, DDA Member secretary
(b) Tenure of the committee shall be three years
(c) Any foreign or Nepali expert as recognized by Council can be an
observer
(d) Nepal Government can change the composition of council through
gazette notification
70. 6. Functions, duties and
responsibilities of committee
1. To advice the DDA in research & development, control on drugs
2. To prepare Nepal Pharmacopoeia and related books
3. To recognize other pharmacopoeias till the Nepal Pharmacopoeia
is not developed
4. To develop the following codes
Production of drugs & allied materials, dispensing, sale & distribution,
import/export, transportation, storage and administration
To control on the abuse or misuse of drugs and allied materials
To control the false & misleading advertisement of drugs
Procedure of recall of unsafe, substandard and unefficacious drugs
Letter of guaranty
Record of narcotic and poisonous drugs (format)
Classification of drugs for prescriptive purpose and fix the conditions
Recognize the pharmacist and the person having knowledge in
pharmacy
To recognize "Byabasahi"
The committee can constitute subcommittees under the leadership of a
member.
72. 3. Letter of recommendation for establishment of
industry (Related with section 7 of the act)
The followings are the required documents
Application as per schedule 1
feasibility study report
Market aspect
Technical expects
Assets detail
Operating cost details
Working capital details
Revenue details
Financial analysis
Plant layout
Copy of citizenship certificate
Fees Rs. 2000.00
The letter is given as per schedule 2
73. 4. Product license (Related with
section 8 of the act)
Should be obtained by the industries which were
established before the enforcement of the act
The followings are the required documents
Application as per schedule 3
(Trade name, composition, pharmacological kind,
color etc information is included in schedule 3 & 4)
Copy of letter of recommendation
Copy of registration of Industry Department
Registration of the product detail in register as per
schedule 4
Fees Rs. 200.00 for each products
Product license format shall be as per schedule 5
74. 4Ka. Market Permission (Related
with section 8Ka1 of the act)
Should be obtained by the industries which were
established before the enforcement of the amended rule
within one year.
The followings are the required documents
Application as per Schedule 4Ka
Product specification
Method of analysis and quality control report from the
lab specified by department
Labeled sampled with price mentioned
Other specified by the department
Fee Rs. 200.00
Market permission format shall be as per schedule Kha
75. 4Kha. Import registration (Related
with section 8Ka2 of the act)
(1) required documents for Modern drugs
Application as per Schedule 4Ga
GMP certificate issued by the authorized body
Product specification
Method of analysis and quality control report from the
lab specified by department
Pharmacopoeial standard
Sample
Other specified by the department
Fee Rs. 2500.00 per product and for the registration
of company Rs. 50000.00
The registration license is issued as per schedule
4Nga
76. Contd…
(2) Required documents for other system
medicines
Application as per Schedule 4Ga
Details as in Granthas or Sastras
Recommendation from concern
department for patent products
Samples
Other specified by the department
Fee Rs. 2500.00 per product and for the
registration of company Rs. 50000.00
77. Exceptions for import
recommanation
(3)The products shall be registered on the register as per
schedule 4Gha and Registration certificate is issued.
(4) Whatever mentioned in the above rules the
department on the recommendation of Drug Advisory
Committee shall issue import recommendation on the
following conditions
Life saving drugs on the prescription of registered
medical practitioner
Donated drugs for government or non government
organizations
International tendered items of the government
78. 5. Import recommendation letter
(Related with section 9 of the act)
Required documents
Application as per Schedule 6
Import registration letter
Firm registration license as per section 10
of the act
Other specified by the department
Fee Rs. 200.00 per product
The registration license is issued as per
schedule 7
79. 6. Retail/Wholesale shop registration
(Related with section 10 of the act)
Required documents
Application as per Schedule 8
Copy of citizenship certificate
Certificate of Pharmacist, Pharmacy Assistant or
Byabasahi certificate
Contractual agreement
Location map
Fees
Up to one lakh capital Rs. 500.00
One to five lakh capital Rs. 1000.00
Above five lakhs Rs. 2000.00
The registration license is issued as per
schedule 9
80. 7. Permission for advertisement and publicity
(Related with section 19 of the act)
Application as per Schedule 10
Advertising material
Fees Rs. 5000.00 & Rs. 10000.00
(electronic media)
The permission is issued as per
schedule 11
81. 8. Permission for clinical trial of new
drugs (Related with section 31 of the act)
Application as per Schedule 12
Trial protocol (methodology)
The permission is issued as per
schedule 13
87. 4. Procedure for enquiry and
inspection
Take permission
If permission not granted power can
be used
Should carry out the work after
sunrise and before sunset
91. 8. Sampling of suspected drug
Shall take sample
Amount shall be specified by the
department
Shall put the sample in three
separate containers (for DDA, owner
and laboratory)
Inspector shall pay the cost of sample
92. 9. Procedure for sealing the
container
Labeling (Name, quantity, sample
code etc)
Should close the sample properly so
that there would be no deterioration
in sample
Container should be tied with thread
and sealed
93. 10. Mark the sample properly
before sampling (Inspector’s
and Owner’s)
94. 11. Inform the department if refused take
the charge by the owner or his
representative
95. 12. Report
Written report should be made to the
director within 3 days with reason of
collection of sample, reason of detain
etc)
96. 13. Issue of identity card on
appointment of inspector
97. 14. Dispatch of sealed
container to the analyst (as
specified in schedule 2)
99. 16. Power to retest or
reanalyze the sample on the
request of owner
100. 17. The owner should borne the
expenses incurred on
reanalysis
101. 18. Recognition of research
institute or laboratory
NG can recognize laboratory with the
permission from DCC
NG can revoke the permission
102. 19. Duties, responsibilities and power of
Chief Drug Administrator
Implement the decision of secretary in
pursuant to decision under section 20 of
the act
Investigate on the work and function of
inspectors
Transfer of inspectors from one area to
another
Instruct and control on the activities of the
inspectors
Perform other duties and responsibilities
given by NG
106. 3. Nepal Pharmacopoeia
Department prepares Nepal
Pharmacopoeia (NP) and related
official books. This pharmacopoeia
will be effective after approval of the
NG.
107. 4. The standard of drugs (section
12 of the act) shall be as per
NP after its approval.
108. 5. Other Pharmacopoeia shall
be recognized
Recognition of other pharmacopoeia:
Till the time NP is developed
Pharmacopoeia mentioned in
Schedule 1 will be the standard for
drugs
The government can recognize the
pharmacopoeia mentioned in
schedule 1 though the NP is effective
109. 6. Standardization of drugs
The standard of drugs shall be approved after the
approval of the DAC
The manufacture can apply for the standardization of
drugs those not included in the recognized
pharmacopoeia for which the manufacturer should
apply to the department as per schedule 2.
The department shall take consent from DAC and
approve the standard of such drugs
The department if deemed necessary may fix the
standard for quality control and analysis of such drugs
If the departments desires for the method of analysis
of drugs, it is the duty of importer to provide such
documents to the department
110. 7. Standard of drugs and implementation of
quality control & analysis methods
Once the standard and methods are
fixed as per rule 6 the department
shall implement the provisions
If any problem raised in process of
implementation of such methods the
department shall take advice from
the DAC and implement accordingly
111. 8. Remittance:
Irreversible damage of heart, liver, brain, kidney (both), lung (both) for
each Rs. 3 lakh
Irreversible damage of one lung, one kidney for each Rs. one lakh
Both eyes 2.5 lakh
Both ears 2 lakh
Nose one lakh
Tongue 1.5 lakh
Penis 1.5 lakh
One eye one lakh
One ear 70 thousand
One hand, one leg or part of one hand and leg 80 thousands
Parts of both hands and parts of both legs 80 thousands
Any other internal organs other than mentioned above one lakh
If any organ has damaged but is reversible one third amount shall be given
Abortion of less than 28 weeks 10 thousands
Abortion of more than 28 weeks 25 thousands
Birth of disable baby 15 thousands
Death 30thousands
Whatever mentioned in above the remittance will not be more than 3 lakhs
112. 9. Specimen for letter of
guarantee will be as given
in schedule 3
113. 10. Classification of drugs
Narcotic & poisonous: To be sold on the prescription
and self or presence of pharmacist or assistant
pharmacist or byabasahi is required
Examples: Pethidine.(Narcotic), Heparin (Poisonous)
Antibiotics & hormones: Narcotic & poisonous: To be
sold on the prescription and self or presence of
pharmacist or assistant pharmacist or byabasahi is
required
Example: Amoxycillin (Antibiotic), Prednisolone
(Hormone)
Can be sold on experience by any person
Example: Vitamin, antihistamines
114. 11. To be stamped as prescription
filled for Schedule Ka drugs
