Classification of pharmaceutical products MCQs With Answer

Classification of pharmaceutical products MCQs With Answer is an essential study resource for B. Pharm students aiming to master drug categorization by chemical class, pharmacological classification, therapeutic class, origin, dosage form, and regulatory status. This introduction explains key classification systems — ATC coding, Biopharmaceutics Classification System (BCS), legal schedules, biologics versus small molecules, and OTC versus prescription distinctions — to build conceptual depth for rational prescribing, pharmacy practice, and regulatory exams. Emphasis is on mechanisms of action, target organs, physicochemical properties (solubility, permeability, lipophilicity), and clinical implications such as narrow therapeutic index and controlled substances. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which classification groups drugs primarily by their mechanism of action?

  • Therapeutic class
  • Chemical class
  • Pharmacological class
  • Commercial class

Correct Answer: Pharmacological class

Q2. Who is responsible for maintaining the Anatomical Therapeutic Chemical (ATC) classification system?

  • World Health Organization (WHO)
  • Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Indian Pharmacopoeia Commission (IPC)

Correct Answer: World Health Organization (WHO)

Q3. Which BCS class describes drugs with high solubility and high permeability?

  • Class I
  • Class II
  • Class III
  • Class IV

Correct Answer: Class I

Q4. Which classification explicitly distinguishes drugs as OTC or prescription-only?

  • Regulatory/legal classification
  • Chemical classification
  • Pharmacodynamic classification
  • Source-based classification

Correct Answer: Regulatory/legal classification

Q5. Under the Indian Drugs and Cosmetics rules, which schedule lists drugs that are sold only on prescription?

  • Schedule H
  • Schedule G
  • Schedule X
  • Schedule M

Correct Answer: Schedule H

Q6. In the ATC system, which main anatomical group letter denotes the cardiovascular system?

  • C
  • N
  • J
  • A

Correct Answer: C

Q7. Which classification groups drugs according to the disease or condition they treat?

  • Therapeutic class
  • Chemical class
  • Pharmacokinetic class
  • Source-based classification

Correct Answer: Therapeutic class

Q8. Which classification describes drugs as natural, synthetic, or semisynthetic?

  • Source-based classification (natural, synthetic, semisynthetic)
  • Pharmacological class
  • Dosage form classification
  • Therapeutic class

Correct Answer: Source-based classification (natural, synthetic, semisynthetic)

Q9. Which of the following is an example of a biologic product?

  • Insulin (recombinant)
  • Aspirin
  • Metformin
  • Amoxicillin

Correct Answer: Insulin (recombinant)

Q10. Which statement best defines a biosimilar?

  • A biological product highly similar to an already approved biological reference product with no clinically meaningful differences
  • A small-molecule generic identical to the innovator drug
  • An herbal extract used as an alternative to biologics
  • A new original biologic with a different mechanism

Correct Answer: A biological product highly similar to an already approved biological reference product with no clinically meaningful differences

Q11. Which classification is primarily based on the chemical functional group present in the drug molecule?

  • Chemical class
  • Therapeutic class
  • Dosage form classification
  • Regulatory classification

Correct Answer: Chemical class

Q12. Which characteristic is NOT associated with BCS Class II drugs?

  • High aqueous solubility
  • High permeability
  • Low solubility
  • Permeability-limited absorption

Correct Answer: High aqueous solubility

Q13. Classification by route of administration groups drugs into which categories?

  • Oral, parenteral, topical, inhalational
  • Analgesics, antibiotics, antivirals, antifungals
  • Synthetic, natural, semisynthetic, recombinant
  • OTC, prescription, controlled, investigational

Correct Answer: Oral, parenteral, topical, inhalational

Q14. Which drug is a classic example of a narrow therapeutic index drug requiring careful monitoring?

  • Warfarin
  • Paracetamol
  • Amoxicillin
  • Ranitidine

Correct Answer: Warfarin

Q15. Which classification deals with substances controlled for abuse potential and legal restrictions?

  • Controlled substances/legal schedules
  • Therapeutic class
  • Chemical class
  • Dosage form classification

Correct Answer: Controlled substances/legal schedules

Q16. Losartan is classified pharmacologically as which of the following?

  • Angiotensin II receptor antagonist
  • Beta blocker
  • Calcium channel blocker
  • ACE inhibitor

Correct Answer: Angiotensin II receptor antagonist

Q17. Vaccines are best classified under which product category?

  • Biologicals / vaccines
  • Small-molecule generics
  • Herbal medicines
  • Topical antiseptics

Correct Answer: Biologicals / vaccines

Q18. The WHO Model List of Essential Medicines organizes entries mainly by what?

  • Therapeutic use and public health relevance
  • Market price and brand popularity
  • Manufacturer country
  • Dosage form color

Correct Answer: Therapeutic use and public health relevance

Q19. Which of the following is an example of a chemical class of antibiotics?

  • Beta-lactams
  • ACE inhibitors
  • NSAIDs
  • Antihypertensives

Correct Answer: Beta-lactams

Q20. Classifying drugs as hepatotoxic or nephrotoxic is an example of classification by what criterion?

  • Target organ toxicity
  • Chemical functional group
  • Regulatory status
  • Dosage form

Correct Answer: Target organ toxicity

Q21. Which label indicates a medicine that can be sold without a prescription?

  • OTC (over-the-counter)
  • Rx-only
  • Schedule H
  • Controlled

Correct Answer: OTC (over-the-counter)

Q22. In the ATC classification, which letter denotes antiinfectives for systemic use?

  • J
  • C
  • N
  • G

Correct Answer: J

Q23. Which physicochemical parameter is commonly used as a measure of lipophilicity?

  • Log P (partition coefficient)
  • pKa
  • Molar mass
  • Aqueous solubility (mg/mL)

Correct Answer: Log P (partition coefficient)

Q24. Which of the following best exemplifies an antiseptic rather than an antibiotic?

  • Chlorhexidine
  • Amoxicillin
  • Ciprofloxacin
  • Azithromycin

Correct Answer: Chlorhexidine

Q25. Enalapril belongs to which pharmacological class?

  • ACE inhibitors
  • Beta blockers
  • Diuretics
  • Nonsteroidal anti-inflammatory drugs

Correct Answer: ACE inhibitors

Q26. Which of these drugs is commonly taught as having a narrow therapeutic index?

  • Digoxin
  • Ibuprofen
  • Amoxicillin
  • Cetirizine

Correct Answer: Digoxin

Q27. Monoclonal antibodies are categorized under which product type?

  • Biologics
  • Small-molecule generics
  • Herbal extracts
  • Radiopharmaceuticals

Correct Answer: Biologics

Q28. Grouping drugs into tablets, capsules, suspensions, and injections is an example of classification by what?

  • Dosage form
  • Chemical class
  • Therapeutic class
  • Source-based classification

Correct Answer: Dosage form

Q29. The distinction between generic and brand-name medicines falls under which classification category?

  • Proprietary/generic (commercial) classification
  • Pharmacodynamic classification
  • Chemical functional group classification
  • Target organ classification

Correct Answer: Proprietary/generic (commercial) classification

Q30. Which BCS class is characterized by low solubility and low permeability?

  • Class IV
  • Class I
  • Class II
  • Class III

Correct Answer: Class IV

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