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1.
The law regarding the registration of names and shops or firms for drug sale and distribution is outlined in which section of the Drug Act?
2.
In Nepal, the Department of Drug Administration (DDA) was initially formed under the authority of which ministry?
3.
In which year did the Royal Drug Research Laboratory come under the jurisdiction of the Ministry of Health and Population?
4.
In which section of the Drugs Act is the categorization of drugs and the dispensing of drugs under the supervision of a pharmacist, assistant pharmacist, or professional person addressed?
5.
Under which section of the Drugs Act is it stated that drugs of substandard quality should be prohibited?
6.
Who presides over the Drug Advisory Committee as its chairperson?
7.
Select the correct option, regarding the connection between Drug Registration Rules 2038 and Drug Act 2035:
8.
Which entity is responsible for suggesting drug pricing policies to the Government of Nepal?
9.
The first pharmaceutical industry in Nepal, Chemi Drug, was founded in which year?
10.
In the Drug Registration Rules of 2038 BS (1981 AD), how many rules and schedules are specified?
11.
As per the Drug Standard Regulation 2043 BS, select the correct count of recognized pharmacopoeias/encyclopedias in Nepal:
12.
How many individuals serve as members in the Drug Advisory Committee?
13.
The requirement that drug inspectors must obtain permission before inspection is explicitly stated in which rule of the 2040 BS Regulation?
14.
In which schedule of the Drug Standard Regulation, 2043 BS are Nepal’s recognized pharmacopoeias/encyclopedias listed?
15.
To obtain a recommendation letter for the exportation or importation of drugs, which section of the Drug Act should be referred to?
16.
As per regulations, how many members constitute the Drug Consultative Council?
17.
Which year marks the promulgation of the Drug Registration Regulation in Nepal?
18.
The year of promulgation for the Drug Advisory Committee and Consultative Council Regulation corresponds to which of the following?
19.
Latest edition (3rd) of Nepalese National Formulary was formulated in:
20.
The provisions of Section 18 of the Drugs Act cover:
21.
What is the main subject of Rule no 4 in the Drug Consultative Council and Drug Advisory Committee Regulation 2037 BS?
22.
The function of which of the following is to offer advice to the Government of Nepal on theoretical and administrative aspects of drugs?
23.
Who is the designated Member Secretary of the Drug Advisory Committee?
24.
What is the official tenure for members of the Drug Consultative Council?
25.
Section 23 of the Drug Act outlines that a Drug Analyst shall have the following qualifications, except:
26.
Who is the designated Member Secretary of the Drug Consultative Council?
27.
What is the focus of Section 27 in the Drug Act?
28.
Which regulatory rule and schedules of the Drug Registration Rule 2038 govern the licensing for drug promotion and advertisement?
29.
Under which schedule is the Drug Advisory Committee formed?
30.
According to the Drugs Act, which section demands that a letter of guarantee be submitted to the DDA by the manufacturer or importer?
31.
Identify the rule that governs the submission of completed inspection reports to the drug administration authority: (Drug Enquiry and Inspection Regulation,2040 BS):
32.
Which rule and schedules of the Drug Registration Rules are applicable for registering the name and shop or firm for the purpose of selling and distributing drugs?
33.
Which section of the Drug Act outlines the provisions granting inspectors the power to conduct inquiry and inspection?
34.
The founding year of Royal Drug Limited is:
35.
Which year marks the renaming of the Royal Drug Research Laboratory to the National Medicine Laboratory (NML)?
36.
Under which ministry does the DDA operate currently, and since when?
37.
The legal framework for developing and enforcing the Nepal Pharmacopoeia and related Encyclopedia is outlined in: (Drug Standard Regulation, 2043 BS)
38.
The responsibility of providing technical advice on drugs to the Department of Drug Administration lies with:
39.
Which rule and schedules of the Drug Registration Rules specify the requirements for registering a drug before its sale and distribution?
40.
Among the following which year marks the establishment of Nepal Chemist and Druggist Association (NCDA)?
41.
The provisions in Chapter 6 of the Drug Act pertain to which area?
42.
The Act specifies that complaints filed under Section 21 against an administrator's order must be resolved within how many days?
43.
The Drug Standard Regulation 2043 BS divides all approved drugs into how many primary classification groups?
44.
The Drug Act specifies the provisions for the Drug Research Laboratory under which section?
45.
When considering Nepal's first pharmaceutical industry, which of the following is correct?
46.
The prohibition of false and misleading advertisements and the licensing of drug advertisements are governed by which section of the Drug Act?
47.
What is the date when the Drug Act 2035 BS was authenticated?
48.
Select the correct option, regarding the connection between Drug Registration Rules 2038 and Drug Act 2035:
49.
What is the official tenure for members of the Drug Advisory Committee?
50.
Under which section of the Drug Act is it stated that drugs must meet quality standards before consumption?
51.
Which rule of the Drug Standard Regulation 2043 BS in Nepal governs the acceptance of international pharmacopoeias and medical encyclopedias as authoritative references?
52.
According to Rule 3 of the Drug Registration Rules 2038 (1981), which schedule must be followed when applying for a recommendation letter to establish a drug industry?
53.
The Preamble of the Drug Act 2035 BS emphasizes all of the following except:
54.
The Drug Act outlines the rules for manufacturing, selling, distributing, exporting, and importing drugs in:
55.
While performing inquiry, Inspector shall send sample to the Analyst as per …………….. of Drug Act:
56.
Identify the year in which Nepal's Department of Drug Administration began operations:
57.
What specific provision does Rule 13 of the Drug Enquiry and Inspection Regulation, 2040 BS, cover?
58.
What is the subject of Section 29 in the Drug Act 2035?
59.
When was the most recent Hospital Pharmacy Service Guideline enacted?
60.
Which section of the Drug Act outlines the validity period of certificates issued under the Act?
61.
Identify the rule that outlines the regulatory powers and operational duties of the Drug Administrator? (Drug Enquiry and Inspection Regulation,2040 BS):
62.
The legal provision that empowers drug inspectors to suspend questionable pharmaceutical products during inspection is contained in (Drug Enquiry and Inspection Regulation,2040 BS):
63.
To carry out a clinical trial, which section of the Drug Act is applicable?
64.
According to the Drug Act, the recommendation letter required to set up a drug industry is mentioned under which schedule?
65.
When Nepal implemented the Drug Standard Regulation in 2043 BS (1986 AD), what was the total number of rules and schedules included?
66.
As outlined in the Drug Act 2035, Chapter 3 corresponds to which of these areas?
67.
The National Health Policy was first enacted in which year, and when was the most recent version introduced?
68.
In Nepal, which body is tasked with advising the government on drug patent-related matters?
69.
Under the Drug Act, the provisions for making necessary arrangements of resources before conducting drug-related activities are mentioned in:
70.
National Medicines Laboratory (NML) was first established as………………. in the year…………….
71.
Certificates granted under Sections 8, 8A, 9, and 10 of the Drug Act remain valid for what period?
72.
Identify the year of enactment for the Narcotic Drug Control Act:
73.
When was the Nepal Pharmacy Council officially formed?
74.
In which year was the Drug Act officially introduced?
75.
According to Rule 3 of the Drug Registration Rules 2038 (1981), recommendation letter to establish a drug industry shall be provided as per the format specified by which of the following schedule?
76.
When collecting evidence during a drug inspection, how many separate samples of the same product are required by regulation? (Drug Enquiry and Inspection Regulation,2040 BS):
77.
What year did Nepal proclaim the Pharmacy Council Act?
78.
Under the Drug Act, Section 26 addresses:
79.
The first edition of the National List of Essential Medicines was published in the year and included how many medicines?
80.
All of these are tasks handled by the Department of Drug Administration (DDA) EXCEPT:
81.
Which schedule of the Drug Registration Rules 2038 specifies the fees related to the rules?
82.
As per Section 23 of the Drug Act, which qualification is not mandatory for a Drug Inspector?
83.
In the latest edition of NLEM (2021 AD), there are a total of ………….. medicines included:
84.
Which body advises the Government of Nepal on granting recognition to native or foreign research laboratories?
85.
The rules concerning date-expired drugs are found under which section of the Drug Act?
86.
Which rule and schedules of the Drug Registration Rules are applicable for the recommendation letter required for the export and import of drugs?
87.
In the Drug Registration Rules, which rule and schedules outline the process for registration prior to the importation of drugs?
88.
When is World Pharmacist Day recognized each year?
89.
Which section of the Drug Act is concerned with setting up the Department of Drug Administration?
90.
Under Section 15 of the Drugs Act, which topic is addressed?
91.
Where in the Drug Enquiry and Inspection Regulation, 2040 BS, would an inspector find the step-by-step protocol for obtaining drug samples?
92.
The parties legally entitled to receive drug inspection samples under Drug Enquiry and Inspection Regulations 2040 BS are:
93.
Under which section of the Drug Act are the provisions related to the patent registration of drugs mentioned?
94.
For drugs lacking established standards in official references (e.g., BP, USP), the application process for standardization in Nepal is governed by:
95.
Identify the rule that governs a drug inspector's power to seize suspended drugs when the drug keeper fails to receive them (Drug Enquiry and Inspection Regulation,2040 BS):
96.
What is the founding year of the Nepal Pharmaceutical Association?
97.
What year did Nepal proclaim its National Drug Policy?
98.
Under Section 21, complaints against an administrator's order are addressed to whom?
99.
What is the main subject of Rule no 3 in the Drug Consultative Council and Drug Advisory Committee Regulation 2037 BS?
100.
Who presides over the Drug Consultative Council as its chairperson?
101.
Which year is linked to the enactment of the Consumer Protection Act?
102.
According to the Drug Act, the renewal period for certificates is how long?
103.
Certificates with a validity period of 2 years under the Drug Act include which of the following?
104.
In……….. Drug Inquiry and Inspection Regulation was proclaimed.
105.
Drug Act 2035 BS comprises of total number of ……………… Chapters and………………. Sections:
106.
Where in the Drug Act can provisions concerning narcotics and poisonous substances be found?
107.
The authority of the Government of Nepal to restrict drug-related activities, including manufacture and consumption, is outlined in which section of the Drug Act?
108.
To comply with the Drug Enquiry and Inspection Regulation, 2040 BS, how many rules and schedules must authorities follow?
109.
The chapter addressing the quality standards of drugs under the Drugs Act is:
110.
Which entity is responsible for advising the DDA on granting recognition to pharmacists or persons with expertise in drugs?
111.
Select the earliest enacted legislation from the following options:
112.
If someone feels the administrator's order is unjust after an inquiry, under which section of the Drug Act can they seek redress?
113.
Which of the following is NOT associated with Sections 5 and 6 of Chapter 3 of the Drug Act 2035?
114.
Which entity is responsible for advising the DDA on the formulation of the Nepal Pharmacopoeia?
115.
Which rule of the Drug Standard Regulation, 2043 BS mandates that locally produced drugs must meet Nepal Pharmacopoeia standards?
116.
The establishment of the Drug Consultative Council is specified under which schedule?
117.
Section 8A of the Drug Act addresses which of the following provisions?
118.
Under which chapter of the Drug Act 2035 BS can the Drug Advisory Committee and Drug Consultative Council be found?
119.
Obtaining a product license under the Drug Act is detailed in which section?
120.
To be a Drug Inspector or Analyst, a person shall possess specified qualifications which is mentioned in ………………… of Drug Act:
121.
Which body is tasked with providing guidance to the DDA on matters related to the recognition of Pharmacopoeia or literatures from other countries?
122.
Under which rule of the Drug Registration Rules and section of the Drug Act is the recommendation letter for a drug industry establishment specified?
123.
According to the Drug Standard Regulation 2043 BS, the classification of drugs into categories and sub-categories is provided under:
124.
According to Nepal’s Drug Standard Regulation 2043 BS, the Letter of Guarantee required under Section 16 of the Drug Act must follow the format provided in:
125.
As per Section 10A of Drug Act a person shall…………………………
126.
Select the correct series for all seven editions of National List of Essential Medicines?
127.
Which rule and schedules of the Drug Registration Rules govern the issuance of a product license for drug manufacturing?
128.
To legally conduct a clinical trial for a new drug, which rule and schedules of the Drug Registration Rules 2038 must be referred to for licensing?
129.
Which authority is responsible for recognizing a professional person other than a pharmacist or assistant pharmacist, as mentioned in Section 17 of the Drugs Act?
130.
Which year marks the promulgation of the Drug Standard Regulation?
