Question

If the label or the container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist, it is:

• A. $ \text{Misbranded Drug} $
• B. $ \text{Adulterated Drug} $
• C. $ \text{Spurious Drug} $
• D. $ \text{Not of Standard Quality} $

Hint:

Spurious drugs misrepresent origin or identity — often involving fake or non-existent manufacturers.

Answer 1

The Correct Option is C

- According to the Drugs and Cosmetics Act, a Spurious Drug includes any drug whose labeling falsely claims it to be manufactured by a non-existent or fictitious person or company.
- This ensures protection against counterfeit or fraudulent manufacturers.

Answer 2

This question is testing the specific legal categories the Drugs and Cosmetics Act uses to classify a defective or fraudulent drug. Let's check each category against the fact given: the label names a manufacturer that is fictitious or does not exist.

1. Misbranded Drug: A drug is misbranded when its label is false or misleading in any way, when it does not carry the required directions, warnings, or list of active ingredients, or when its label or container so closely resembles another drug that it could deceive a buyer. Misbranding is about incorrect or missing information on a real product, not about the manufacturer's identity being made up.
2. Adulterated Drug: A drug is adulterated when it contains a filthy or putrid substance, is prepared, packed, or stored under insanitary conditions, contains a poisonous or harmful ingredient, or has been mixed with something that lowers its strength or quality. Adulteration is about what has happened to the physical composition of the drug, not about a fake manufacturer's name on the label.
3. Spurious Drug: Under the Act, a drug is spurious if it is manufactured under a name that belongs to a different drug, if it is an imitation of another drug, if it resembles another drug in a way likely to deceive, or if it purports to be manufactured by a person or company that is fictitious or does not exist. The situation described in the question, a label naming a manufacturer who does not exist, falls squarely under this last clause.
4. Not of Standard Quality: A drug is treated as not of standard quality when it fails to meet the strength, purity, or quality it is supposed to have under a recognized pharmacopoeial standard, for example failing an assay test. This category is about a real drug from a real manufacturer falling short of the required standard, not about a false manufacturer identity.

Only the definition of a spurious drug covers a label that names a manufacturer who is fictitious or does not exist.

Therefore, the correct answer is Spurious Drug.