MCQ on Regulatory Guidelines for Pharmacy Practice

🟢 Easy (1–20)

1. Which of the following is the main regulatory authority for drugs in India?
   A. WHO
   B. FDA
   C. CDSCO ✅
   D. FCI
   Explanation: CDSCO (Central Drugs Standard Control Organization) regulates pharmaceuticals in India.
2. The Drugs and Cosmetics Act was enacted in:
   A. 1950
   B. 1940 ✅
   C. 1965
   D. 1972
   Explanation: The Act was introduced in 1940 to regulate drugs and cosmetics in India.
3. Schedule H drugs should be sold only on:
   A. Verbal order
   B. Phone call
   C. Written prescription ✅
   D. Email confirmation
   Explanation: Schedule H drugs require a doctor’s prescription.
4. The abbreviation GMP stands for:
   A. Good Manufacturing Practices ✅
   B. General Medical Practice
   C. General Marketing Plan
   D. Global Medicine Protocol
   Explanation: GMP ensures drugs are consistently produced and controlled.
5. Which regulatory body oversees pharmacy education in India?
   A. MCI
   B. PCI ✅
   C. AICTE
   D. CDSCO
   Explanation: The Pharmacy Council of India (PCI) regulates pharmacy education.
6. Which Schedule lists the labeling requirements for drugs?
   A. Schedule H
   B. Schedule M
   C. Schedule G
   D. Schedule P ✅
   Explanation: Schedule P contains information on labeling and shelf life.
7. Pharmacovigilance is related to:
   A. Pricing
   B. Drug promotion
   C. Adverse drug reaction monitoring ✅
   D. Manufacturing
   Explanation: Pharmacovigilance monitors safety and adverse effects.
8. The abbreviation ADR stands for:
   A. Alternate Drug Route
   B. Adverse Drug Reaction ✅
   C. Advanced Drug Regulation
   D. Applicable Drug Rule
   Explanation: ADRs are unintended harmful effects from medications.
9. Which of the following is NOT a Schedule in the Drugs and Cosmetics Rules?
   A. Schedule X
   B. Schedule Z ✅
   C. Schedule M
   D. Schedule Y
   Explanation: There is no Schedule Z in the rules.
10. Schedule X drugs require:
    A. No control
    B. Double prescription ✅
    C. Hospital use only
    D. Over-the-counter sale
    Explanation: Schedule X includes habit-forming drugs needing strict control.
11. Which Act governs the regulation of narcotic drugs in India?
    A. NDPS Act ✅
    B. Drugs and Magic Remedies Act
    C. Patent Act
    D. FSSAI Act
    Explanation: Narcotic Drugs and Psychotropic Substances (NDPS) Act controls narcotics.
12. Good Pharmacy Practice (GPP) is a guideline issued by:
    A. WHO ✅
    B. FDA
    C. FIP
    D. ISO
    Explanation: WHO, along with FIP, issues GPP guidelines.
13. Which Schedule refers to the standards for medical devices?
    A. Schedule M
    B. Schedule G
    C. Schedule R ✅
    D. Schedule Y
    Explanation: Schedule R covers medical device regulations.
14. Which of the following deals with clinical trials in India?
    A. Schedule Y ✅
    B. Schedule H
    C. Schedule F
    D. Schedule G
    Explanation: Schedule Y outlines requirements and guidelines for clinical trials.
15. Which of the following drugs is considered OTC (Over-the-Counter)?
    A. Morphine
    B. Ibuprofen ✅
    C. Diazepam
    D. Codeine
    Explanation: Ibuprofen is available without prescription.
16. Drugs prescribed under Schedule G must carry a warning that:
    A. It may cause addiction
    B. It is to be sold on prescription
    C. It is to be taken under medical supervision ✅
    D. It is for external use only
    Explanation: Schedule G drugs require a cautionary label.
17. The abbreviation DPCO refers to:
    A. Drug Price Control Order ✅
    B. Drug Pharmacology Code
    C. Drug Prescribing Control
    D. Drug Production Control
    Explanation: DPCO is issued to regulate drug prices in India.
18. NLEM stands for:
    A. National Law on Essential Medicines
    B. National List of Essential Medicines ✅
    C. National Learning in Emergency Medicine
    D. Non-Listed Essential Materials
    Explanation: NLEM contains essential medicines for public health needs.
19. Which Schedule covers GMP requirements?
    A. Schedule G
    B. Schedule H
    C. Schedule M ✅
    D. Schedule P
    Explanation: Schedule M outlines GMP standards.
20. Who is responsible for enforcing the Drugs and Cosmetics Act at the state level?
    A. PCI
    B. State Licensing Authority ✅
    C. CDSCO
    D. WHO
    Explanation: State authorities handle enforcement within their jurisdiction.

🟡 Moderate (21–40)

21. What is the role of the Drug Controller General of India (DCGI)?
    A. Drug pricing
    B. Granting drug licenses at central level ✅
    C. Conducting pharmacy exams
    D. Hospital drug supply
    Explanation: DCGI oversees licensing, trials, and regulation at national level.
22. Which authority is responsible for approving clinical trials in India?
    A. PCI
    B. MCI
    C. DCGI ✅
    D. FSSAI
    Explanation: DCGI regulates and approves clinical trials.
23. The Indian Pharmacopoeia (IP) is published by:
    A. WHO
    B. FSSAI
    C. Indian Pharmacopoeia Commission ✅
    D. CDSCO
    Explanation: IPC publishes IP, which sets drug standards.
24. Which organization is responsible for regulating drug prices in India?
    A. CDSCO
    B. PCI
    C. NPPA ✅
    D. WHO
    Explanation: National Pharmaceutical Pricing Authority (NPPA) controls prices.
25. Which schedule contains guidelines for blood products and vaccines?
    A. Schedule C ✅
    B. Schedule H
    C. Schedule M
    D. Schedule S
    Explanation: Schedule C covers biological products like vaccines.
26. Which law prohibits misleading drug advertisements in India?
    A. NDPS
    B. Drugs and Magic Remedies Act ✅
    C. Patent Act
    D. FSS Act
    Explanation: This Act controls misleading claims about drug effects.
27. Which of the following relates to orphan drug regulation?
    A. Schedule Y
    B. US FDA guidelines ✅
    C. Schedule M
    D. GMP
    Explanation: Orphan drug guidelines are developed by US FDA and WHO.
28. Which regulatory document governs fixed-dose combinations (FDCs)?
    A. Schedule H
    B. CDSCO guidelines ✅
    C. DPCO
    D. Schedule G
    Explanation: CDSCO releases guidelines for approval of FDCs.
29. What is the minimum qualification required to be a Registered Pharmacist in India?
    A. BSc in Chemistry
    B. Diploma in Pharmacy ✅
    C. MSc in Biology
    D. Bachelor of Nursing
    Explanation: D.Pharm is the minimum requirement for registration.
30. The term “pharmacoeconomics” refers to:
    A. Drug production
    B. Drug storage
    C. Cost-effectiveness analysis of drugs ✅
    D. Clinical testing only
    Explanation: It evaluates cost vs benefits of drug therapy.
31. GCP stands for:
    A. Good Commercial Practice
    B. General Care Protocol
    C. Good Clinical Practice ✅
    D. General Clinical Procedure
    Explanation: GCP ensures ethical conduct and standards in clinical trials.
32. Informed consent is required in:
    A. Drug pricing
    B. Dispensing
    C. Clinical trials ✅
    D. Drug manufacturing
    Explanation: Consent is necessary for ethical participation in trials.
33. Which organization issues the GMP certification?
    A. WHO
    B. CDSCO
    C. State Drug Control Departments ✅
    D. PCI
    Explanation: State authorities issue GMP certification after inspection.
34. Schedule D refers to:
    A. Biological products
    B. Import and registration of foreign drugs ✅
    C. Clinical trial requirements
    D. Narcotic drugs
    Explanation: Schedule D deals with imported drugs and required documentation.
35. Drugs requiring storage below 8°C must be:
    A. Stored at room temperature
    B. Refrigerated ✅
    C. Kept in dry conditions
    D. Frozen
    Explanation: Some drugs require refrigeration for stability.
36. Which of the following is a part of prescription auditing?
    A. Stock checking
    B. Reviewing diagnosis
    C. Checking rational drug use ✅
    D. Calculating total cost
    Explanation: Prescription audits help promote rational drug therapy.
37. Barcoding in pharmacy helps in:
    A. Increasing shelf life
    B. Pricing
    C. Drug traceability ✅
    D. Branding
    Explanation: Barcoding improves drug tracking and reduces errors.
38. What is the maximum validity of a Schedule X drug prescription?
    A. 3 months
    B. 6 months
    C. 1 month ✅
    D. No limit
    Explanation: Schedule X prescriptions are valid only for 30 days.
39. Which act regulates food and drugs together in the USA?
    A. FSSAI
    B. FDA Act ✅
    C. NDPS
    D. Patent Act
    Explanation: The U.S. FDA regulates food and drug laws.
40. Which of the following promotes ethical drug promotion practices?
    A. DPCO
    B. UCPMP ✅
    C. NDPS
    D. PCI
    Explanation: Uniform Code for Pharmaceutical Marketing Practices (UCPMP) promotes ethical drug marketing.

🔴 Hard (41–50)

41. The WHO Model List of Essential Medicines is updated every:
    A. 1 year
    B. 2 years ✅
    C. 5 years
    D. 10 years
    Explanation: WHO updates the list biennially.
42. Which guideline deals with pharmacovigilance inspections in the EU?
    A. GVP Module III ✅
    B. GCP
    C. ICH Q10
    D. Schedule Y
    Explanation: Good Pharmacovigilance Practice (GVP) guidelines include inspections.
43. ICH guidelines were developed to:
    A. Increase drug costs
    B. Harmonize technical requirements ✅
    C. Promote generics only
    D. Regulate hospitals
    Explanation: ICH ensures global harmonization in drug development.
44. Which Schedule relates to the cosmetics category?
    A. Schedule X
    B. Schedule S ✅
    C. Schedule Y
    D. Schedule H
    Explanation: Schedule S defines cosmetic standards.
45. The Drug and Magic Remedies Act was enacted in:
    A. 1980
    B. 1954 ✅
    C. 1965
    D. 1945
    Explanation: Enacted in 1954 to restrict false claims.
46. Orange Book by US FDA lists:
    A. Herbal remedies
    B. Approved drug products with therapeutic equivalence ✅
    C. Packaging materials
    D. Pharmacopoeial tests
    Explanation: The Orange Book lists therapeutically equivalent generic drugs.
47. Pharmacy Practice Regulations (PPR) were introduced in India in:
    A. 2005
    B. 2010
    C. 2015 ✅
    D. 2020
    Explanation: PPR 2015 by PCI aims to standardize pharmacy practices.
48. Patent protection for drugs in India is granted for:
    A. 10 years
    B. 20 years ✅
    C. 25 years
    D. 15 years
    Explanation: Patent rights last 20 years from the filing date.
49. Which of the following is a global pharmacovigilance database?
    A. CIMS
    B. Medline
    C. VigiBase ✅
    D. PubMed
    Explanation: VigiBase is WHO’s global safety database.
50. Which ICH guideline focuses on drug quality risk management?
    A. Q1A
    B. Q6
    C. Q9 ✅
    D. Q11
    Explanation: ICH Q9 provides principles of quality risk management.