Question:medium

Which of the following description defines a misbranded drug?

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Legal distinctions for problematic drugs: - Label/Color faults $\implies$ Misbranded - Filth/Decomposition $\implies$ Adulterated - Imitation/Fake Identity $\implies$ Spurious
Updated On: Jul 4, 2026
  • If it has been substituted wholly or in part by another drug or substances
  • If it is not labelled in the prescribed manner
  • If it purports to be the product of a manufacturer of whom it is not truly a product
  • If it is has been prepared, packed or stored under insanitary conditions where it may be rendered injurious to health
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The Correct Option is B

Solution and Explanation

Understanding the Concept: Under Section 17 of the Drugs and Cosmetics Act, 1940, legal definitions categorize substandard pharmaceutical items into three distinct legal groups to protect public health:
• Misbranded Drug (Section 17): Focuses primarily on deceptive appearance, faulty labeling, coloring, or design. A drug is misbranded if it is colored, coated, powdered, or polished to conceal damage, or if its label fails to carry the required medical statements or layout details.
• Adulterated Drug (Section 17A): Focuses on contamination, decomposition, or insanitary preparation environments.
• Spurious Drug (Section 17B): Focuses on deliberate substitution, counterfeiting, or imitation of another brand name/manufacturer.

Step 1:
Match definitions to the corresponding options.
* Option A describes an adulterated or spurious action depending on intent. * Option B states "If it is not labelled in the prescribed manner." This matches the statutory definition of a Misbranded drug under Section 17. * Option C describes a counterfeit layout, which falls under the legal definition of a Spurious drug. * Option D describes a product manufactured under filth or unsanitary conditions, which falls under the legal definition of an Adulterated drug.
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