Definitions under Drugs and Cosmetics Act MCQs With Answer

Introduction

Understanding the Definitions under Drugs and Cosmetics Act is essential for B.Pharm students preparing for pharmacy practice and regulatory roles. This concise guide clarifies statutory definitions—drug, cosmetic, new drug, misbranded, adulterated, spurious, manufacture, label, batch and sale—used in Indian pharmaceutical law and drug regulatory frameworks. Familiarity with these definitions helps in interpreting licensing, quality control, pharmacovigilance, clinical trials, labeling norms, and compliance inspections. Emphasis on key terms, schedules, and legal distinctions strengthens exam readiness and professional competence in pharmacy law. Simple explanations, practical examples, and focused MCQs build conceptual clarity for academics and regulatory responsibilities. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which of the following is the most appropriate statutory definition of a “drug” under the Drugs and Cosmetics Act?

• Any article used only for external application
• Any substance intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease
• Only chemical entities synthesized in laboratories
• Only traditional herbal preparations

Correct Answer: Any substance intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease

Q2. Under the Act, a “cosmetic” is primarily defined as a substance intended to:

• Treat or cure systemic infection
• Be applied to the human body for cleansing, beautifying, promoting attractiveness or altering appearance
• Be administered orally to improve nutrition
• Function as an injectable therapeutic agent

Correct Answer: Be applied to the human body for cleansing, beautifying, promoting attractiveness or altering appearance

Q3. The term “misbranded drug” refers to a drug which:

• Has expired beyond its shelf life
• Is sold without any packaging
• Has false or misleading labeling or lacks required label information
• Is manufactured in a foreign country

Correct Answer: Has false or misleading labeling or lacks required label information

Q4. Which definition best fits “adulterated” under the Act?

• A drug intentionally mislabeled to conceal origin
• A drug contaminated with insanitary substances or containing unsafe additives affecting purity, strength, or quality
• A drug with correct labeling but incorrect price
• A cosmetic applied internally

Correct Answer: A drug contaminated with insanitary substances or containing unsafe additives affecting purity, strength, or quality

Q5. “Spurious drug” is defined as a drug which:

• Is merely expired
• Is not labeled in English
• Is deliberately and fraudulently misrepresented as to identity, origin, or source
• Has slight defects in packaging

Correct Answer: Is deliberately and fraudulently misrepresented as to identity, origin, or source

Q6. Under the Act, “manufacture” includes which of the following activities?

• Only chemical synthesis in a plant
• Any process of making a drug including packaging, labeling, or re-labeling for sale
• Only sterile production in hospital pharmacies
• Only importation of finished products

Correct Answer: Any process of making a drug including packaging, labeling, or re-labeling for sale

Q7. The legal meaning of “label” under the Act primarily refers to:

• Any advertisement placed on television
• The display of written, printed or graphic matter on the immediate container of the drug
• Internal manufacturing records
• Shipping invoices only

Correct Answer: The display of written, printed or graphic matter on the immediate container of the drug

Q8. In the Act, “labeling” differs from “label” because it includes:

• Only the brand name
• All labels and other written, printed or graphic matter upon the wrapper, container, or accompanying the drug
• The cost price of the drug
• Manufacturing staff records

Correct Answer: All labels and other written, printed or graphic matter upon the wrapper, container, or accompanying the drug

Q9. Which of the following best describes a “new drug” under regulatory definitions relevant to the Act?

• An herbal preparation used for centuries without change
• A drug not used in the country to a significant extent and requires clinical trial data for safety and efficacy
• A generic version of a marketed drug
• A cosmetic marketed as a drug

Correct Answer: A drug not used in the country to a significant extent and requires clinical trial data for safety and efficacy

Q10. “Batch” in manufacturing terminology under the Act means:

• A collection of random units from different manufacturing dates
• A specific quantity of a drug or material produced in a process or series of processes so that it is expected to be homogeneous
• A single tablet only
• Only units released for export

Correct Answer: A specific quantity of a drug or material produced in a process or series of processes so that it is expected to be homogeneous

Q11. “Sale” under the Act includes which of the following?

• Only retail transactions
• Every transfer of drug for cash, deferred payment or other valuable consideration including barter
• Only wholesale transfers between licensed manufacturers
• Only international exports

Correct Answer: Every transfer of drug for cash, deferred payment or other valuable consideration including barter

Q12. Which term describes a drug that fails to meet pharmacopoeial standards as per the Act?

• Misbranded
• Adulterated
• Cosmetic
• Licensed

Correct Answer: Adulterated

Q13. Under the Act, which document is essential to demonstrate legal authorization to manufacture a drug?

• Prescription pad
• Manufacturing license issued by competent authority
• Label approval letter only
• Invoice copy

Correct Answer: Manufacturing license issued by competent authority

Q14. “Retail sale price” as per the Act refers to:

• The cost charged by the manufacturer to the wholesaler
• The maximum price fixed by government for over-the-counter drugs
• The price at which the retailer sells the drug to the consumer
• The export price of a drug

Correct Answer: The price at which the retailer sells the drug to the consumer

Q15. Which of the following best illustrates a “misbranded cosmetic”?

• A cream with correct ingredients and directions
• A cosmetic with claims of treating internal diseases without approval
• A cosmetic sold in unsealed packaging but with full label details
• A cosmetic imported with customs duty paid

Correct Answer: A cosmetic with claims of treating internal diseases without approval

Q16. Under the Act, an “examined” sample refers to:

• A sample only inspected visually by consumers
• A sample collected and tested in a laboratory for compliance with standards
• A sample sold at discounted rate
• A sample used only for promotional purposes

Correct Answer: A sample collected and tested in a laboratory for compliance with standards

Q17. Which definition matches “schedule” in the context of the Act?

• A list of manufacturing employees
• A set of classifications and requirements attached to the Act specifying standards, licenses, and controls
• A financial ledger used by pharmacists
• A local market price list

Correct Answer: A set of classifications and requirements attached to the Act specifying standards, licenses, and controls

Q18. “Pharmacopoeia” as referenced by the Act means:

• A private company making drugs
• An official book of standards for drugs including identity, purity and strength tests
• A journal for advertising medicines
• A retail pharmacy store chain

Correct Answer: An official book of standards for drugs including identity, purity and strength tests

Q19. Which of the following best describes “labeling for export” under regulatory definitions?

• Use of the domestic language only
• Supplementary labeling allowed when export market requires different language or information
• Removal of all manufacturer details
• Changing batch numbers after shipment

Correct Answer: Supplementary labeling allowed when export market requires different language or information

Q20. Under the Act, “clinical trial” is most closely related to which definition?

• Marketing campaign for a drug
• Systematic study of new drug in human subjects to generate safety and efficacy data
• Routine quality control testing of batches
• Only animal testing prior to manufacture

Correct Answer: Systematic study of new drug in human subjects to generate safety and efficacy data

Q21. Which describes “proprietary medicine” in context of the Act?

• A drug prepared only in government hospitals
• A trademarked or branded medicine sold under a proprietary name
• A traditional remedy not sold commercially
• A raw material used for manufacturing

Correct Answer: A trademarked or branded medicine sold under a proprietary name

Q22. The legal meaning of “labeler” is:

• The retail pharmacist who dispenses the drug
• The person or firm who places required labeling on the immediate container or wrapper of the drug
• An advertising agency promoting the drug
• Only the government regulatory authority

Correct Answer: The person or firm who places required labeling on the immediate container or wrapper of the drug

Q23. Which of the following conditions makes a drug “unwholesome” per the Act’s intent?

• Appropriate storage and intact label
• Presence of harmful microbial contamination or decomposition
• Being priced above market average
• Manufactured in small quantities

Correct Answer: Presence of harmful microbial contamination or decomposition

Q24. Under the Act, import of drugs requires attention to which defined term?

• Only retail margin
• Compliance with import licensing and quality standards specified by the Act
• Only payment of customs without documentation
• Avoiding pharmacopoeial standards

Correct Answer: Compliance with import licensing and quality standards specified by the Act

Q25. Which situation best fits the definition of “substandard drug” as per legal usage?

• A drug manufactured under full GMP with adequate strength
• A drug that fails to meet quality standards, strength or purity specified by pharmacopeial or regulatory requirements
• A drug with an attractive label
• A legal patented product

Correct Answer: A drug that fails to meet quality standards, strength or purity specified by pharmacopeial or regulatory requirements

Q26. “Label claim” under the Act commonly refers to:

• Any statement on a package regarding therapeutic benefits, dosage, composition or manufacturer
• Only the barcode printed on the package
• Internal SOPs of the company
• Only the retail price tag

Correct Answer: Any statement on a package regarding therapeutic benefits, dosage, composition or manufacturer

Q27. Which of these describes a “regulated medical device” under an expanded interpretation of the Act?

• Any product used for beautification only
• An instrument, apparatus or appliance intended for diagnosis, prevention, monitoring or treatment of disease subject to regulatory controls
• Only surgical sutures
• Only consumable cosmetics

Correct Answer: An instrument, apparatus or appliance intended for diagnosis, prevention, monitoring or treatment of disease subject to regulatory controls

Q28. The Act’s definition of “manufacturer’s responsibility” primarily includes:

• Only advertising of products
• Ensuring product safety, correct labeling, GMP compliance and retention of records
• Providing discounts to retailers
• Only distribution logistics

Correct Answer: Ensuring product safety, correct labeling, GMP compliance and retention of records

Q29. Which of the following is true about “over-the-counter (OTC) drugs” under common regulatory definitions?

• Require prescription for every sale
• Can be sold without a prescription when labeled for self-medication and safety
• Are never tested for quality
• Are the same as cosmetics

Correct Answer: Can be sold without a prescription when labeled for self-medication and safety

Q30. Under the Act, which action would classify a product as both a “drug” and a “cosmetic” leading to regulatory overlap?

• A moisturizer making no therapeutic claims
• A product applied externally that also claims to treat or prevent disease
• A purely decorative hair accessory
• Packaging material without product

Correct Answer: A product applied externally that also claims to treat or prevent disease

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