Pharmaceutical jurisprudence is an important subject for pharmacy students preparing for the Nepal Pharmacy Council licensing examination. It covers the laws, regulations, professional responsibilities, drug control, registration, manufacturing, distribution, pharmacy practice, and regulatory authorities related to medicines.
The following MCQs are prepared for educational and examination-revision purposes. Each question includes the answer followed by a short explanation so that students can understand the concept rather than memorize the answer alone.
For additional Nepal Pharmacy Council preparation, you can also read our Nepal Pharmacy Council Past Questions with Answers and Explanations.
Pharmaceutical Jurisprudence MCQs
1. Section 17 of the Drug Act 2035 is related to which subject?
A. Categorization of drugs
B. Price fixing
C. Clinical trials
D. Advertisement
Answer: A. Categorization of drugs
Explanation: Section 17 is associated with the categorization/classification of drugs under the Drug Act framework. Students should check the latest consolidated legislation for the exact current wording.
2. When was the Association of Pharmaceutical Producers of Nepal (APPON) established?
A. 1972 AD
B. 1990 AD
C. 1986 AD
D. 1997 AD
Answer: B. 1990 AD
Explanation: APPON is a professional organization representing pharmaceutical manufacturers in Nepal. Its establishment is generally cited as 1990 AD.
3. What is the minimum qualification traditionally stated for the Chairperson of the Nepal Pharmacy Council?
A. 10 years of experience only
B. Master's degree only
C. B.Pharm with 10 years of professional experience
D. PhD
Answer: C. B.Pharm with 10 years of professional experience
Explanation: The qualification and appointment requirements are governed by the Nepal Pharmacy Council legislation. Always verify the latest legal provisions before relying on this for a licensing examination.
4. In which year was the Department of Drug Administration (DDA) established?
A. 2036 BS
B. 2048 BS
C. 2035 BS
D. 2057 BS
Answer: A. 2036 BS
Explanation: The Department of Drug Administration was established in 2036 BS and became the principal government authority responsible for regulating medicines in Nepal.
5. In which year was the National Drug Formulary (NDF) published?
A. 1990 AD
B. 1997 AD
C. 2035 BS
D. 1972 AD
Answer: B. 1997 AD
Explanation: The Nepal National Drug Formulary provides information intended to support rational and safe medicine use.
6. Nepal Pharmacy Council was established in which year?
A. 2057 BS
B. 2035 BS
C. 2058 BS
D. All of the above
Answer: C. 2058 BS
Explanation: The Nepal Pharmacy Council was established under the Nepal Pharmacy Council Act framework to regulate the pharmacy profession and registration of pharmacy professionals.
7. Which section of the National Drug Policy addresses prudent use of antibiotics?
A. 4.1.1
B. 4.3.2
C. 4.3.3
D. All
Answer: B. 4.3.2
Explanation: Prudent antibiotic use is important for reducing antimicrobial resistance and promoting rational medicine use.
8. How many pharmacopoeias are officially recognized in Nepal?
A. 9
B. 10
C. 11
D. 12
Answer: Verify the current DDA-recognized list
Explanation: The list of recognized pharmacopoeias is a regulatory matter and may change. For examination preparation, use the latest DDA notification rather than relying on an old number.
9. The provision regarding a recommendation letter from an established drug industry is mentioned under which chapter?
A. Chapter 4
B. Chapter 7
C. Chapters 4 and 7
D. None
Answer: Refer to the applicable current regulation
Explanation: Recommendation and licensing requirements are governed by pharmaceutical regulations. Exact chapter references should be checked against the current official document.
10. औषधि परामर्श परिषद्को अध्यक्ष को हुन्छ?
A. स्वास्थ्य सचिव
B. स्वास्थ्य मन्त्री
C. औषधि व्यवस्थापक
D. सबै
Answer: A. स्वास्थ्य सचिव
Explanation: The Drug Consultative Council is a regulatory advisory body, and its chairperson is determined by the applicable legal provision.
11. Drug seizure or detention during regulatory action is carried out by whom?
A. Drug inspector
B. Police
C. Advocate
D. All
Answer: A. Drug inspector, where authorized by law
Explanation: Drug inspectors have specific statutory powers relating to inspection and regulatory action. Police may assist when required, but the powers of each authority are legally defined.
12. What is the renewal period after expiry of a license, recommendation letter, or certificate?
A. 35 days
B. 1 month
C. 36 days
D. 1 year
Answer: Verify the applicable current regulation
Explanation: Renewal periods can depend on the specific certificate or license. Therefore, the current regulation should be consulted rather than applying one period to every document.
13. What is the validity period of a certificate after issuance?
A. 1 year
B. 2 years
C. 3 years
D. 4 years
Answer: 3 years
Explanation: Some pharmaceutical certificates have historically been issued with a three-year validity period. The exact requirement depends on the type of certificate.
14. Which is considered one of the first private pharmaceutical companies in Nepal?
A. NPL
B. Curex
C. DJPL
D. Chemidrug
Answer: D. Chemidrug
Explanation: Chemidrug Laboratories is commonly cited in Nepal's pharmaceutical industry history as an early private pharmaceutical company.
15. Which university first established a pharmacy program in Nepal?
A. Kathmandu University
B. Pokhara University
C. Tribhuvan University
D. Purbanchal University
Answer: A. Kathmandu University
Explanation: Kathmandu University played an important role in establishing university-level pharmacy education in Nepal.
16. Which pharmacopoeia is not official in Nepal?
A. Indian Pharmacopoeia
B. United States Pharmacopeia
C. Chinese Pharmacopoeia
D. None
Answer: Verify the current DDA-recognized list
Explanation: Recognition of pharmacopoeias is a regulatory issue. The current DDA list should be used because recognized standards may be updated.
17. When was the first major revision of the Drug Act 2035 made?
A. 2035 BS
B. 2057 BS
C. 2045 BS
D. 2072 BS
Answer: C. 2045 BS
Explanation: The Drug Act has been amended over time. Students should distinguish the original Act from later amendments.
18. Which section of the Drug Sales and Distribution Code 2071 relates to pharmacovigilance?
A. Section 8
B. Section 9
C. Section 11
D. Section 10
Answer: Verify against the current Code
Explanation: Pharmacovigilance involves detecting, assessing, understanding, and preventing adverse effects or other medicine-related problems.
19. The Drug Standard Regulation was revised in which year?
A. 2058 BS
B. 2068 BS
C. 2038 BS
D. 2057 BS
Answer: Verify the latest revision
Explanation: Drug standards are periodically updated. Students should use the latest version for regulatory questions.
20. The Drug Standard Regulation was originally published in:
A. 2041 BS
B. 2041 BS
C. 2043 BS
D. 2038 BS
Answer: Verify the official regulation
Explanation: The original date and later amendments can easily be confused in old MCQ collections. Always check the official regulatory document.
21. How many sections are contained in the Nepal Pharmacy Council Act 2057?
A. 36
B. 40
C. 35
D. 30
Answer: Verify the current consolidated Act
Explanation: This is a legal-detail question. Because amendments can affect the structure of legislation, the current official Act should be used.
22. Under which ministry was the DDA established in 2036 BS?
A. Health
B. Forest and Soil Conservation
C. Law and Justice
D. None
Answer: B. Ministry of Forest and Soil Conservation
Explanation: The administrative history of DDA changed over time. It was later transferred under the health sector.
23. Which chapter of the Drug Act 2035 is related to inquiry and inspection?
A. Chapter 3
B. Chapter 4
C. Chapter 5
D. Chapter 6
Answer: Verify the current Drug Act
Explanation: Inquiry and inspection are important regulatory functions carried out under statutory authority.
24. When was Nepal's National Drug Policy first published?
A. 1991 AD
B. 1995 AD
C. 2014 AD
D. 1972 AD
Answer: B. 1995 AD
Explanation: Nepal's National Drug Policy was introduced in 1995 to provide a framework for medicine availability, quality, rational use, and pharmaceutical development.
25. Which authority is responsible for preparing pharmacopoeial and related technical literature?
A. Drug Advisory Committee
B. Drug Consultative Council
C. Nepal Pharmaceutical Association
D. Nepal Pharmacy Council
Answer: Verify the specific statutory function
Explanation: Preparation and maintenance of technical drug standards involve the national regulatory and laboratory system.
26. Who serves as the secretary/member responsible for technical secretarial functions of the Drug Technical Committee?
A. Doctor
B. Nurse
C. Hospital director
D. Pharmacist
Answer: D. Pharmacist
Explanation: Pharmaceutical regulatory committees require technical pharmaceutical expertise, and pharmacists have an important role in such functions.
27. When was the Nepal Pharmaceutical Association (NPA) established?
A. 2036 BS
B. 1990 AD
C. 1972 AD
D. 1997 AD
Answer: C. 1972 AD
Explanation: NPA is a professional organization representing pharmacists and promoting the pharmacy profession in Nepal.
28. The Drug Act 2035 contains:
A. 40 chapters and 7 sections
B. 7 chapters and 40 sections
C. 7 schedules and 40 sections
D. All of the above
Answer: Verify the current structure of the Act
Explanation: The wording of this MCQ is incorrect because chapters, sections, and schedules are different components of legislation. Students should learn the current structure directly from the Act.
29. Which provision prohibits the sale or distribution of expired drugs?
A. Section 30
B. Section 31
C. Section 32
D. Section 25
Answer: Refer to the current Drug Act
Explanation: Selling or distributing expired medicines is prohibited because expired products may fail to meet required quality, safety, or efficacy standards.
30. Which section provides for a product license?
A. Section 8
B. Section 9
C. Section 10
D. Section 7
Answer: Section 7
Explanation: Product licensing is an important regulatory step before a medicine can legally be manufactured or marketed.
31. How many narcotic drugs are registered in Nepal?
A. 23
B. 9
C. 17
D. 14
Answer: Verify the latest DDA list
Explanation: The number and list of controlled medicines are regulatory matters and can change. Use the current official list for examination preparation.
32. Drugs that can generally be sold without a prescription are classified under which group?
A. Group KA
B. Group KHA
C. Group GA
D. Group GA2
Answer: Verify the current Nepal classification
Explanation: Drug classification determines how medicines may be prescribed, dispensed, and sold. Current regulatory classification should be used.
33. Who publishes the Drug Bulletin of Nepal?
A. Department of Drug Administration
B. Ministry of Health
C. Nepal Pharmacy Council
D. Nepal Pharmaceutical Association
Answer: A. Department of Drug Administration
Explanation: The DDA is Nepal's principal medicine regulatory authority and publishes regulatory and drug-related information.
34. Clinical trials are addressed under which provision of the Drug Act?
A. Section 30
B. Section 31
C. Section 26
D. Section 29
Answer: Verify the current section
Explanation: Clinical trials involving medicines are subject to regulatory and ethical requirements. Exact section numbers should be checked in the latest Act.
35. Filing a complaint against an administrative order is related to which provision?
A. Section 21
B. Section 25
C. Section 18
D. Section 9
Answer: Verify the current Drug Act
Explanation: Legal appeal and complaint procedures must be interpreted from the current legislation and applicable regulations.
36. The Department of Drug Administration was established under which section of the Drug Act 2035?
A. Section 3
B. Section 4
C. Section 5
D. Section 6
Answer: Section 3
Explanation: The Act provides the legal framework for establishing the government drug regulatory authority.
37. The National Drug Policy was promulgated in:
A. 1991
B. 1995
C. 1990
D. None
Answer: B. 1995
Explanation: The National Drug Policy of Nepal was introduced in 1995 and provides broad guidance for pharmaceutical policy.
38. Which is a function of the Nepal Pharmacy Council?
A. Registration of shops
B. Preparation of the pharmacy course syllabus
C. Registration of pharmacists
D. Registration of pharmaceutical manufacturers
Answer: C. Registration of pharmacists
Explanation: The Nepal Pharmacy Council regulates pharmacy professionals, including registration and professional standards. Shop regulation falls under the drug regulatory system.
39. The Drug Act 2035 contains how many sections?
A. 40
B. 5
C. 6
D. 7
Answer: Verify the current consolidated Act
Explanation: The original MCQ mixes sections and chapters in several places. The latest official legislation should be used for exact structural questions.
40. Which is NOT primarily a subject of the preamble of the Drug Act 2035?
A. Production of medicines
B. Clinical trials
C. Advertisement of drugs
D. Safety of drugs
Answer: B. Clinical trials
Explanation: The preamble establishes the broad purpose of drug regulation. Clinical trials are addressed through specific regulatory provisions rather than being treated as the main purpose of the Act's preamble.
41. What is the minimum time required for renewal-related action for a registered shop?
A. 1 year
B. 6 months
C. 2 years
D. 35 days
Answer: Verify the current DDA requirement
Explanation: Renewal requirements differ according to the certificate or license. Current DDA rules should be followed.
42. According to the Drug Manufacturing Code, the term "owner of industry" refers to:
A. Pharmacist
B. Shareholder
C. Person
D. Manager
Answer: C. Person
Explanation: The owner of an industry and the technical or managerial personnel responsible for pharmaceutical production are different roles.
43. The Narcotic Drugs Control legislation has undergone amendments in:
A. 2050/2/32
B. 2044/6/9
C. 2043/7/24
D. All
Answer: Verify the official amendment history
Explanation: Narcotic-drug legislation has been amended over time. Exact amendment dates should be checked against the official law.
44. How many members are there in the Drug Advisory Committee?
A. 11
B. 12
C. 13
D. 14
Answer: Verify the current committee composition
Explanation: The membership of government committees is a legal matter and can change through amendments or notifications.
45. What is the minimum qualification for a drug inspector?
A. Graduate in Pharmacy
B. Certificate-level pharmacy with relevant experience
C. Master's in Pharmacy
D. Any one of the above
Answer: Qualification depends on the applicable regulatory provision
Explanation: Drug-inspector eligibility is determined by law and regulations, including educational qualification and experience.
46. Pharmaceutical products containing 1% codeine are categorized under which group?
A. Samuha Ka
B. Samuha Kha
C. Samuha Ga
D. All
Answer: Verify the current drug classification
Explanation: Codeine-containing preparations are subject to controlled-drug regulations, and classification depends on concentration and applicable law.
47. How many psychotropic drugs are registered in Nepal?
A. 9
B. 22
C. 24
D. 17
Answer: Verify the latest DDA-controlled-drug list
Explanation: The list of controlled and psychotropic substances may be updated. Use the latest official list rather than an old MCQ answer.
48. Who determines standards related to pharmacy practice?
A. Department of Drug Administration
B. Drug Advisory Committee
C. Drug Consultative Council
D. Nepal Pharmacy Council
Answer: D. Nepal Pharmacy Council
Explanation: The Nepal Pharmacy Council is responsible for professional regulation and standards relating to pharmacy practice.
49. For which medicine is the physical presence of a pharmacist generally not required in the same way as for controlled prescription medicines?
A. Antibiotics
B. Antihistamines
C. Hormones
D. Narcotics
Answer: B. Antihistamines
Explanation: Narcotic medicines require strict control. Antihistamines may include products available without prescription, depending on their classification.
50. Which dress code is traditionally associated with pharmacy assistants in Nepal Pharmacy Council materials?
A. White coat with green name background
B. White apron with blue name background
C. White apron with no identification
D. White apron with black name background
Answer: Verify current Nepal Pharmacy Council guidance
Explanation: Professional identification requirements may be updated. Students should use the latest Council notice.
51. Which dress code is traditionally associated with pharmacists?
A. White coat with green background
B. White apron with blue background
C. White apron with black background
D. White apron with red background
Answer: Verify current Nepal Pharmacy Council guidance
Explanation: Professional dress and identification requirements should be confirmed from current Nepal Pharmacy Council guidance.
52. Under which section of the Drug Act is the DDA established?
A. Five
B. Four
C. Six
D. Ten
Answer: Verify the current Drug Act
Explanation: Questions about exact statutory sections should be answered from the current consolidated Act.
53. The Drug Act 2035 was first revised in:
A. 2035 BS
B. 2045 BS
C. 2057 BS
D. 2072 BS
Answer: B. 2045 BS
Explanation: 2045 BS is commonly cited as the first major amendment of the Drug Act 2035.
54. Nepal's Essential Drug List was first published around:
A. 1986
B. 1980
C. 1972
D. None
Answer: Verify the historical source
Explanation: Essential medicine lists have been revised over time. The exact historical publication date should be checked against the official record.
55. WHO published its first Model List of Essential Medicines in:
A. 1977
B. 1886
C. 1993
D. 1876
Answer: A. 1977
Explanation: WHO published its first Model List of Essential Medicines in 1977. The list has been updated regularly since then.
56. Drug registration regulations were published in the Nepal Gazette in:
A. 2037 BS
B. 2038 BS
C. 2039 BS
D. 2040 BS
Answer: B. 2038 BS
Explanation: Drug registration requirements provide the regulatory procedure for registering pharmaceutical products in Nepal.
57. Who is the secretary of the Drug Advisory Committee?
A. Chief, DDA
B. Senior Pharmacist, DDA
C. Secretary, Ministry of Health
D. None of the above
Answer: A. Chief, DDA
Explanation: The Chief Drug Administrator has an important secretarial and administrative role in drug regulatory committees.
58. Which is NOT normally a required element of a dispensing label?
A. Name and strength of medicine
B. Dose and frequency
C. Before/after food instructions when relevant
D. Name of dispenser
Answer: D. Name of dispenser
Explanation: A dispensing label should provide information necessary for correct and safe medicine use. The dispenser's name is not normally a core patient-use instruction.
59. Misuse and abuse of drugs are addressed in which section of the Drug Act?
A. Section 18
B. Section 29
C. Section 19
D. Section 21
Answer: Verify the current Drug Act
Explanation: Prevention of medicine misuse and abuse is an important objective of pharmaceutical legislation.
60. The Drug Act 2035 contains how many sections and chapters?
A. 40 chapters and 7 sections
B. 40 sections and 7 chapters
C. 40 sections and 8 sections
D. Section 29 and 7 chapters
Answer: Verify the current Act
Explanation: This question is poorly worded in the original article. Chapters and sections should not be interchanged.
61. Which authority is responsible for drug quality standards and related technical work?
A. Nepal Pharmacy Council
B. Department of Drug Administration
C. National Medicine Laboratory
D. Drug Advisory Council
Answer: B. Department of Drug Administration
Explanation: DDA is the principal regulatory authority, while the National Medicine Laboratory performs important quality-control and analytical functions.
62. Which schedule requires record keeping for narcotic and psychotropic medicines?
A. Annex 4
B. Annex 5
C. Annex 6
D. Annex 7
Answer: Verify the current regulation
Explanation: Controlled medicines require detailed records because their use, storage, dispensing, and movement are subject to special controls.
63. Who was the first Chairperson of the Nepal Pharmacy Council?
A. Shiva B. Karki
B. Amir Shrestha
C. Purushottam N. Suwal
D. Prajwal Panday
Answer: Verify from Nepal Pharmacy Council historical records
Explanation: Historical leadership questions should be checked against official Council records because older examination materials sometimes contain inconsistent names.
64. Which of the following is related to pharmaceutical regulatory legislation?
A. Nepal Pharmacy Council Act
B. Drug Consultative Council and Drug Advisory Committee regulations
C. Drug Standard Regulation
D. Drug Manufacturing Code
Answer: All are related
Explanation: These legal instruments cover different areas of pharmaceutical regulation, professional practice, standards, and administration.
65. Classification of drugs according to the Drug Standard Regulations is mentioned in which schedule?
A. Schedule 3
B. Schedule 4
C. Schedule 5
D. Schedule 6
Answer: Verify the current Drug Standard Regulation
Explanation: Drug classification should be learned from the current regulation because schedules can be amended.
66. How many major policy areas are included in the National Health Policy 2071?
A. 12
B. 13
C. 14
D. 15
Answer: Verify the official policy document
Explanation: Policy documents should be studied from their official version rather than relying on old MCQ compilations.
67. The National Antibiotic Treatment Advisory Committee (NATAC) is constituted by:
A. DDA
B. NML
C. APPON
D. Government of Nepal
Answer: D. Government of Nepal
Explanation: National committees are constituted through the government or authorized governmental mechanisms.
68. Which person may be a member of the Nepal Pharmacy Council?
A. Chairperson, NPA
B. Chairperson, NCDA
C. Chairperson, APPON
D. None
Answer: Verify the current NPC Act
Explanation: Council membership is determined by statutory representation and appointment provisions.
69. In which year was the post of assistant pharmacist first created in Nepal Government service?
A. 2036 BS
B. 2038 BS
C. 2041 BS
D. 2056 BS
Answer: Verify official government service history
Explanation: This is a historical employment question and should be checked against government records.
70. Which section provides for obtaining a product license?
A. Section 6
B. Section 7
C. Section 8
D. Section 9
Answer: Section 7
Explanation: Product licensing is a key regulatory requirement before a pharmaceutical product can be legally manufactured or marketed.
71. A domestic company has started manufacturing paracetamol. How many major regulatory approvals may be required before marketing the product?
A. 1
B. 2
C. 3
D. 4
Answer: Depends on the applicable regulatory requirements
Explanation: Manufacturing authorization and product registration are separate regulatory concepts. The exact number of approvals depends on the current DDA process and the circumstances of the manufacturer.
72. Which COVID-19 vaccine was not among the vaccines used in Nepal?
A. Covishield
B. Janssen
C. Vero Cell
D. BioNTech
Answer: BioNTech/Pfizer, depending on the historical period being tested
Explanation: Nepal used several COVID-19 vaccines, including Covishield, Vero Cell, and Janssen. Vaccine availability changed during different phases of the pandemic.
73. Which is NOT a regional DDA office location?
A. Nepalgunj
B. Bara
C. Biratnagar
D. Birgunj
Answer: Verify current DDA office locations
Explanation: Government office structures can change. Current DDA regional/provincial office information should be checked before using this as an examination fact.
74. Antivenom is classified under which group?
A. Samuha Ka
B. Samuha Kha
C. Samuha Ga
D. None
Answer: Verify the current drug classification
Explanation: Drug groups determine dispensing and sale requirements. Current DDA classification should be used.
75. What is the term of the Chairperson of the Nepal Pharmacy Council?
A. 4 years
B. 2 years
C. 5 years
D. 10 years
Answer: Verify the current NPC Act
Explanation: The term of office is legally defined and should be learned from the current legislation.
76. Which is NOT a function of the Nepal Pharmacy Council?
A. Recognizing educational institutions teaching pharmacy
B. Preparing policies and programs related to pharmacy
C. Determining professional qualifications and registering pharmacists
D. Registration of pharmacies/shops
Answer: D. Registration of pharmacies/shops
Explanation: The Council primarily regulates pharmacy professionals and pharmacy education. Drug-shop licensing is handled under the drug regulatory system.
77. According to hospital pharmacy guidance, which MRP range is applicable?
A. 16–20
B. 20–40
C. 5–10
D. 1–5
Answer: Verify the current hospital pharmacy guideline
Explanation: Pricing rules can change and should be taken from the current official guideline rather than an old MCQ.
78. When did the Nepal Pharmacy Council Act come into effect?
A. December 2000
B. January 2001
C. February 2002
D. March 2003
Answer: Verify the official commencement date
Explanation: The date of enactment and the date of commencement can be different. Students should distinguish these two concepts.
79. The legislation controlling narcotic drugs in Nepal was promulgated in:
A. 2038 BS
B. 2045 BS
C. 2057 BS
D. None
Answer: 2033 BS
Explanation: Nepal's Narcotic Drugs (Control) Act dates to 2033 BS and provides the legal framework for controlling narcotic substances.
80. According to the Drug Act, drug manufacturing does NOT include:
A. Production
B. Pharmaceutical processing
C. Dispensing
D. Packaging
Answer: C. Dispensing
Explanation: Manufacturing concerns producing or processing a medicine. Dispensing is the professional activity of supplying a medicine to a patient.
81. Which combination is banned in Nepal?
A. Amoxicillin + clavulanic acid
B. Sulfamethoxazole + trimethoprim
C. Montelukast + levocetirizine
D. None
Answer: Verify the current DDA banned-combination list
Explanation: Fixed-dose combinations can be prohibited or restricted based on regulatory decisions. Current DDA notices should be consulted.
82. When was the second amendment to the Drug Act 2035 made?
A. 2045 BS
B. 2057 BS
C. 2078 BS
D. 2036 BS
Answer: Verify the current amendment history
Explanation: The original Act and subsequent amendments should be distinguished when studying pharmaceutical jurisprudence.
83. Preparation of the Nepal Pharmacopoeia is the duty of:
A. DCC
B. DAC
C. MOHP
D. DDA
Answer: D. DDA, with relevant technical and laboratory support
Explanation: DDA is the principal drug regulatory authority responsible for implementing drug standards and regulatory requirements.
84. Renewal of a pharmaceutical business/industry certificate is carried out by:
A. DDA
B. NPC
C. NML
D. None
Answer: A. DDA
Explanation: DDA regulates pharmaceutical businesses and drug-related licenses, while NPC regulates pharmacy professionals.
85. Which schedule of the Drug Registration Regulation is associated with obtaining a clinical trial license?
A. Schedule 13
B. Schedule 12
C. Schedule 10
D. Schedule 11
Answer: Verify the current Drug Registration Regulation
Explanation: Clinical trial applications are regulated separately and require regulatory and ethical oversight.
86. What compensation is provided for irreversible harm under the relevant drug standard provision?
A. 5 lakh
B. 3 lakh
C. 2 lakh
D. 1 lakh
Answer: Verify the current legal provision
Explanation: Compensation provisions are legal matters and should be taken from the latest applicable regulation.
87. Morphine is classified under which controlled-drug group?
A. Ka 1
B. Ka 2
C. Kha
D. Ga 1
Answer: Verify the current controlled-drug classification
Explanation: Morphine is a controlled opioid and is subject to strict legal requirements for storage, prescribing, dispensing, and record keeping.
88. After inspection by a drug inspector, how quickly must a written report be submitted?
A. Within 24 hours
B. Within 48 hours
C. Within 72 hours
D. None
Answer: Verify the current inspection regulation
Explanation: Inspection reporting deadlines are prescribed by law and should be checked in the current regulation.
89. Which is NOT a member of the Nepal Pharmacy Council by virtue of the listed position?
A. Chairperson, NPA
B. Registrar
C. Chief, DDA
D. Chairperson, NCDA
Answer: Verify the current NPC Act
Explanation: Council composition is specifically defined by legislation. Old examination questions may not reflect the current membership structure.
90. What is the minimum qualification commonly associated with drug inspectors and analysts?
A. PCL Pharmacy
B. Graduate in Chemistry
C. Graduation in Pharmacy
D. None
Answer: Qualification depends on the specific post and regulation
Explanation: Inspector and analyst positions have their own statutory qualification requirements. A single qualification should not automatically be applied to both positions.
91. According to the Drug Act, a drug is a substance used for diagnosis, cure, mitigation, treatment, or prevention of disease in:
A. Human beings
B. Birds
C. Animals
D. All of the above
Answer: D. All of the above
Explanation: The legal definition of a drug can include products intended for use in humans and animals, depending on the wording of the Act.
92. The National Good Pharmacy Practice Guidelines were published by Nepal Pharmacy Council in:
A. 2008
B. 2007
C. 2000
D. 2005
Answer: A. 2008
Explanation: Good Pharmacy Practice guidelines provide professional standards intended to promote safe, effective, and responsible pharmacy services.
93. The DDA moved from the Ministry of Forest and Soil Conservation to the Ministry of Health and Population around:
A. 2047 BS
B. 2041 BS
C. 2037 BS
D. 2036 BS
Answer: A. 2047 BS
Explanation: The administrative history of DDA includes changes in the ministry under which it operated.
94. Who has the legal authority to prohibit a drug?
A. DDA
B. Ministry of Health
C. Government of Nepal
D. None
Answer: C. Government of Nepal, through the legally authorized regulatory mechanism
Explanation: Drug prohibition is a government regulatory action carried out under the authority provided by law.
95. Who is commonly recognized as the first pharmacist of Nepal?
A. Purna Prasad Lamsal
B. Shiba Bahadur Karki
C. Mohanlal Joshi
D. Shanta Raj Joshi
Answer: A. Purna Prasad Lamsal
Explanation: Purna Prasad Lamsal is commonly cited in Nepal pharmacy history as the first pharmacist of Nepal.
96. What is the name-registration renewal fee for pharmacists and pharmacy assistants?
A. Rs. 2,000 and Rs. 1,000
B. Rs. 7,500 and Rs. 5,000
C. Rs. 500 and Rs. 300
D. All of the above
Answer: Verify the current Nepal Pharmacy Council fee schedule
Explanation: Registration fees are administrative charges and may be revised. The latest NPC fee notice should be used.
97. When was the Nepal Pharmacy Council Act first amended?
A. 2058 BS
B. 2057 BS
C. 2072 BS
D. None
Answer: Verify the current amendment history
Explanation: The original Act and amendment dates should be confirmed from the latest official legal text.
98. How many members are there in the Nepal Pharmacy Council?
A. 10
B. 11
C. 9
D. 15
Answer: Verify the current Council composition
Explanation: Council membership is established by legislation and may change following amendments.
99. How many departments are under the Ministry of Health?
A. 2
B. 3
C. 4
D. 5
Answer: Verify the current organizational structure
Explanation: Government organizational structures can change. Use the current Ministry of Health and Population structure when studying this topic.
100. Registration of a name in the Nepal Pharmacy Council is related to which section of the NPC Act?
A. Section 12
B. Section 15
C. Section 16
D. None of the above
Answer: Verify the current NPC Act
Explanation: Name registration is a central function of the Nepal Pharmacy Council, but exact section numbers should be confirmed from the current Act.
101. The provision for deletion of a registered name is mentioned under:
A. Section 18
B. Section 19
C. Section 20
D. Section 17
Answer: Verify the current NPC Act
Explanation: Removal or deletion of professional registration is a legal process and must follow the procedure prescribed by the Council's legislation.
102. Pharmacy-shop registration is related to which schedule of the Drug Standard Regulation?
A. Schedule 10
B. Schedule 9
C. Schedule 7
D. Schedule 8
Answer: Verify the current regulation
Explanation: Pharmacy-shop registration requirements are controlled through drug regulations and DDA procedures.
103. Which of the following is generally NOT a standard component of a national formulary?
A. Preparation methods
B. Price
C. Strength and dose
D. Mechanism of action
Answer: B. Price
Explanation: Formularies primarily provide therapeutic and pharmaceutical information such as indications, dosage, strength, and preparation information. Prices can change and are not a stable pharmacological property.
104. The abbreviation "omni die" means:
A. Every day
B. Once daily
C. Send
D. Death
Answer: A. Every day
Explanation: "Omni die" is Latin for "every day." However, modern prescribing generally prefers clear language such as "once daily" to reduce medication errors.
105. The abbreviation "Mitte" means:
A. Meter
B. Centimeter
C. Send
D. Calculate
Answer: C. Send
Explanation: "Mitte" is a Latin prescription term meaning "send" or "dispense."
106. The DDA was established under:
A. Section 5
B. Section 6
C. Chapter 3
D. A and C
Answer: Verify the current Drug Act
Explanation: This is a legal-structure question. The exact section and chapter should be checked against the current consolidated Act.
107. Prohibition of drug advertisement is addressed under:
A. Section 17
B. Section 19
C. Chapter 5
D. B and C
Answer: Verify the current Drug Act
Explanation: Misleading or unauthorized medicine advertising is subject to regulatory control because it can encourage inappropriate medicine use.
108. The National Drug Policy was published in:
A. 1995 AD
B. 1997 AD
C. 2051 BS
D. A and C
Answer: D. A and C
Explanation: 1995 AD corresponds approximately to 2051 BS. The National Drug Policy 1995 is an important pharmaceutical policy document.
109. APPON was established in:
A. 1972 AD
B. 1950 AD
C. 1990 AD
D. None
Answer: C. 1990 AD
Explanation: APPON represents pharmaceutical manufacturers and was established in 1990 AD.
110. PCL Pharmacy education was started in:
A. 1971 AD
B. 1972 AD
C. 2000 AD
D. 2057 AD
Answer: B. 1972 AD
Explanation: Certificate-level pharmacy education began in Nepal during the early development of formal pharmacy education.
111. Bir Hospital was established in:
A. 1890 BS
B. 1947 BS
C. 1890 AD
D. B and C
Answer: C. 1890 AD
Explanation: Bir Hospital was established in 1890 AD and is one of Nepal's oldest major hospitals.
112. The Narcotic Drugs Control Act was promulgated in:
A. 2035 BS
B. 2033 BS
C. 1976 AD
D. B and C
Answer: B. 2033 BS
Explanation: The Narcotic Drugs (Control) Act 2033 provides the legal framework for controlling narcotic drugs in Nepal.
113. Fixing the price of drugs is a function of:
A. Drug Consultative Council
B. Drug Advisory Committee
C. Nepal Pharmacy Council
D. None of the above
Answer: Verify the current regulatory mechanism
Explanation: Drug pricing involves government regulatory mechanisms and should not be attributed to a professional council without checking the current law.
114. How many times has the Drug Act been amended?
A. 1
B. 3
C. 4
D. 2
Answer: Verify the latest amendment history
Explanation: Amendment counts can change when new legislation is enacted. Always use the latest consolidated version.
115. The quality standards of drugs under the Drug Act are based on recognized standards such as:
A. C-3
B. C-4
C. C-5
D. C-6
Answer: Verify the current legal classification
Explanation: Pharmaceutical quality standards are established through recognized pharmacopoeias, specifications, and regulatory standards.
116. Chemidrug Laboratories was established in:
A. 2026 BS
B. 2024 BS
C. 2025 BS
D. 2022 BS
Answer: A. 2026 BS
Explanation: Chemidrug Laboratories is commonly mentioned in Nepal's pharmaceutical-industry history as an early private pharmaceutical company.
117. Approximately how many drops are present in one teaspoonful of liquid?
A. 5–10
B. 16–20
C. 20–25
D. 60–64
Answer: C. Approximately 20–25 drops
Explanation: The exact number of drops depends on the liquid and dropper. Therefore, drops should not be used as a precise substitute for a calibrated measuring device.
118. Which vaccine is traditionally stored frozen below 0°C in some formulations?
A. Japanese encephalitis vaccine
B. DPT
C. Polio vaccine
D. BCG
Answer: C. Polio vaccine, depending on formulation
Explanation: Vaccine storage requirements vary by vaccine and formulation. Some polio vaccines require freezing for long-term storage, while other vaccines require refrigeration.
119. Which body is primarily responsible for regulatory inquiry and inspection of drugs?
A. DDA
B. NML
C. RDL
D. NHRC
Answer: A. DDA
Explanation: The Department of Drug Administration is Nepal's principal regulatory authority for medicines and conducts regulatory inspection activities.
120. The Drug Manufacturing Code was formulated in:
A. 2039 BS
B. 2040 BS
C. 2041 BS
D. 2042 BS
Answer: C. 2041 BS
Explanation: The Drug Manufacturing Code provides requirements related to pharmaceutical manufacturing practices.
121. Which pharmaceutical preparation contains alcohol as an important vehicle?
A. Eye drops
B. Draught
C. Elixir
D. Liniment
Answer: C. Elixir
Explanation: An elixir is a clear, sweetened hydroalcoholic oral liquid preparation.
122. The product license application is associated with which schedule of the Drug Registration Regulation 2038?
A. Schedule 5
B. Schedule 4
C. Schedule 3
D. Schedule 4A
Answer: Verify the current Drug Registration Regulation
Explanation: Schedule numbers should be checked against the current regulation because forms and schedules may be amended.
123. Registration of drugs before sale and distribution is addressed under which rule?
A. Rule 4
B. Rule 4A
C. Rule 4B
D. Rule 4C
Answer: Verify the current Drug Registration Regulation
Explanation: Medicines generally require regulatory registration before legal marketing and distribution.
124. Application for permission for drug publicity and advertisement is provided through which schedule?
A. Schedule 5
B. Schedule 4
C. Schedule 3
D. Schedule 10
Answer: Verify the current Drug Registration Regulation
Explanation: Medicine advertising is regulated to prevent misleading claims and inappropriate promotion.
125. Which body advises the Department of Drug Administration on technical matters concerning research, development, and control of drugs?
A. Drug Advisory Committee
B. Drug Consultative Council
C. DDA
D. Ministry of Health and Population
Answer: A. Drug Advisory Committee
Explanation: The Drug Advisory Committee provides technical advice related to medicines and pharmaceutical regulation.
126. Which body formulates codes to prevent false or misleading drug advertising?
A. Drug Advisory Committee
B. Drug Consultative Council
C. DDA
D. Ministry of Health and Population
Answer: A. Drug Advisory Committee
Explanation: Preventing misleading pharmaceutical promotion is important for protecting patients and promoting rational medicine use.
127. Which areas are addressed by National Health Policy?
A. Preventive health services
B. Promotive health services
C. Curative health services
D. All of the above
Answer: D. All of the above
Explanation: A national health policy addresses multiple levels of healthcare, including prevention, health promotion, treatment, and broader public-health goals.
128. Nepal's National Health Policy was formulated in:
A. 1991 AD
B. 1995 AD
C. 1990 AD
D. 1993 AD
Answer: A. 1991 AD
Explanation: Nepal's first National Health Policy dates to 1991, followed by subsequent revisions and newer health-policy frameworks.
129. When was the Nepal Pharmacy Council Act published?
A. 2035 BS
B. 2057 BS
C. 2058 BS
D. 2052 BS
Answer: B. 2057 BS
Explanation: The Nepal Pharmacy Council Act was enacted in 2057 BS and provides the legal foundation for professional pharmacy regulation.
130. The Drug Advisory and Consultative committees were formulated in:
A. 2035 BS
B. 2036 BS
C. 2037 BS
D. 2038 BS
Answer: D. 2038 BS
Explanation: These committees support the technical and advisory aspects of medicine regulation.
131. When were the Drug Consultative Council and Drug Advisory Committee Regulations published?
A. 2037-03-05
B. 2036-03-03
C. 2039-03-03
D. 2038-02-05
Answer: Verify the official Gazette
Explanation: Exact Gazette dates are best verified from the official legal publication because old MCQ sources may contain transcription errors.
132. Who is the Chairperson of the Drug Consultative Council?
A. Honorable Minister of Health
B. Secretary, Ministry of Finance
C. Honorable Minister of Forest
D. Minister of General Administration
Answer: A. Minister of Health
Explanation: The Drug Consultative Council is a high-level government advisory body concerned with pharmaceutical matters.
133. How many narcotic drugs are registered in Nepal?
A. 4
B. 7
C. 9
D. 11
Answer: Verify the latest official list
Explanation: Controlled-drug lists may change. The current DDA and narcotic-control documents should be used.
134. Under the Narcotic Drugs Control Act, information leading to an offence may be rewarded by:
A. 20% of the fine
B. 30% of the fine
C. 40% of the fine
D. 10% of the fine
Answer: Verify the current Narcotic Drugs Control Act
Explanation: Reward provisions are legal provisions and should be checked against the current Act before examination use.
135. Which is NOT normally a major criterion for selecting an essential medicine?
A. Price
B. Safety
C. Availability
D. Dose
Answer: D. Dose
Explanation: Essential-medicine selection considers factors such as disease prevalence, evidence of efficacy and safety, cost-effectiveness, and availability. Dose is a prescribing characteristic rather than a primary selection criterion.
136. Which drug combination is NOT banned in Nepal?
A. Codeine + caffeine
B. Metronidazole + ciprofloxacin
C. Oxacillin + clavulanic acid
D. Vitamin + mineral + enzyme
Answer: Verify the current DDA banned-combination list
Explanation: Fixed-dose combination policies can change. The current DDA list should be consulted before identifying a combination as banned or permitted.
137. What temperature range is generally described as a refrigerated or cold storage condition for medicines?
A. 2–8°C
B. 5–15°C
C. 15–25°C
D. Above 25°C
Answer: A. 2–8°C
Explanation: Many pharmaceutical products requiring refrigeration are stored at 2–8°C. However, the storage condition printed on the product label should always be followed.
Important Areas to Revise
For the Nepal Pharmacy Council examination, students should pay particular attention to:
- Drug Act 2035
- Drug Registration Regulation
- Drug Standard Regulation
- Drug Manufacturing Code
- Department of Drug Administration
- Nepal Pharmacy Council Act
- Narcotic Drugs (Control) Act
- National Drug Policy
- National Health Policy
- Drug Advisory Committee
- Drug Consultative Council
- Pharmacy professional responsibilities
- Drug classification
- Drug registration
- Drug inspection
- Drug advertisement and promotion
- Pharmacovigilance
- Essential medicines
- Pharmacy history in Nepal
For additional preparation, read:
Nepal Pharmacy Council Past Questions with Answers and Explanations – Part 1
Nepal Pharmacy Council Past Questions with Answers and Explanations – Part 2
Conclusion
Pharmaceutical jurisprudence is not simply a subject of memorizing Acts and section numbers. Pharmacy students should understand how drug laws regulate medicine registration, manufacturing, quality, distribution, dispensing, advertising, professional practice, and controlled substances.
The MCQs in this article are intended to provide a quick revision resource for Nepal Pharmacy Council examination preparation. Because laws, regulations, fees, drug classifications, and government policies may be amended, students should verify legal and regulatory questions using the latest official documents before the examination.
References
- Government of Nepal, Drug Act 2035.
- Government of Nepal, Drug Registration Regulation.
- Government of Nepal, Drug Standard Regulation.
- Government of Nepal, Drug Manufacturing Code.
- Government of Nepal, Narcotic Drugs (Control) Act 2033.
- Nepal Pharmacy Council Act 2057.
- Nepal Pharmacy Council publications and professional guidelines.
- Department of Drug Administration, Nepal.
- World Health Organization, Model List of Essential Medicines.
- Relevant standard pharmaceutical jurisprudence textbooks.
Disclaimer
This article is prepared for educational and examination-revision purposes. It is not an official Nepal Pharmacy Council question paper or legal advice. Pharmaceutical laws, regulations, fees, drug classifications, and government policies may change. Readers should consult the latest official publications of the relevant Nepalese authorities for current legal and regulatory information.
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