Offences and penalties under cosmetic regulations MCQs With Answer

Introduction: Offences and penalties under cosmetic regulations MCQs With Answer is a focused quiz resource designed for M.Pharm students studying Herbal Cosmetics (MPG 204T). This collection emphasizes practical regulatory knowledge: definitions of offences such as misbranding, adulteration, manufacture without licence and prohibited claims, along with the regulatory actions and penalties authorities can apply. The questions test comprehension of both legal concepts and enforcement mechanisms relevant to herbal and cosmetic products — including licensing, recall powers, prohibited ingredients, and evidence required for prosecution. Use these MCQs to reinforce classroom learning, prepare for exams, and build confidence in handling real-world regulatory issues in cosmetovigilance and quality compliance.

Q1. Which central legislation primarily governs cosmetics regulation in India?

• Food Safety and Standards Act, 2006
• Drugs and Cosmetics Act, 1940
• Pharmacy Act, 1948
• Essential Commodities Act, 1955

Correct Answer: Drugs and Cosmetics Act, 1940

Q2. Which authority is primarily responsible at the national level for regulation and approval of cosmetics in India?

• Central Pollution Control Board (CPCB)
• Central Drugs Standard Control Organization (CDSCO)
• Food Safety and Standards Authority of India (FSSAI)
• Indian Council of Medical Research (ICMR)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q3. Which of the following best describes ‘misbranding’ of a cosmetic?

• Intentional addition of a toxic ingredient
• Manufacture in an unregistered facility
• Labeling or advertising that is false or misleading about composition, function or claims
• Failure to maintain batch records

Correct Answer: Labeling or advertising that is false or misleading about composition, function or claims

Q4. ‘Adulteration’ of a cosmetic typically refers to which situation?

• Using botanical names on labels
• Presence of prohibited or harmful substances or deviation from prescribed quality standards
• Manufacturing under Good Manufacturing Practices
• Using natural fragrance instead of synthetic

Correct Answer: Presence of prohibited or harmful substances or deviation from prescribed quality standards

Q5. Which act is an offence under cosmetic regulations?

• Manufacture of cosmetic in a licensed establishment complying with GMP
• Sale of cosmetic with false therapeutic claims implying cure of disease
• Labeling with proper ingredient declaration
• Submission of required sample for testing on request

Correct Answer: Sale of cosmetic with false therapeutic claims implying cure of disease

Q6. Which of the following is a common regulatory action that can be taken against a non-compliant cosmetic product?

• Issuance of a health advisory only without product action
• Immediate award of compensation to consumers
• Seizure and detention of the product pending legal action
• Granting temporary market exemption

Correct Answer: Seizure and detention of the product pending legal action

Q7. Which claim on a cosmetic label would most likely subject the product to regulatory offence for making a drug claim?

• “Moisturizes dry skin”
• “Improves skin texture temporarily”
• “Cures fungal infections of the skin”
• “Enhances natural glow”

Correct Answer: “Cures fungal infections of the skin”

Q8. Which of the following ingredients is commonly listed as prohibited or restricted in cosmetics due to toxicity concerns?

• Vitamin E
• Glycerin
• Mercury and its compounds
• Aloe vera gel

Correct Answer: Mercury and its compounds

Q9. What is a primary evidentiary requirement for initiating prosecution against a manufacturer for an adulterated cosmetic?

• Social media complaints only
• Analytical laboratory test reports of seized samples and manufacturing records
• Oral testimony from a single customer without samples
• Supplier invoices alone

Correct Answer: Analytical laboratory test reports of seized samples and manufacturing records

Q10. Which is NOT typically a penalty or regulatory consequence for violating cosmetic regulations?

• Cancellation or suspension of manufacturing licence
• Imprisonment and monetary fines under applicable law
• Forced reformulation, labelling correction or product recall
• Automatic approval for future products without inspection

Correct Answer: Automatic approval for future products without inspection

Q11. If a cosmetic product contains an undeclared pharmaceutical active ingredient, this is classified as:

• Proper labeling
• Misbranding and adulteration
• Standard practice for herbal products
• Acceptable if in trace amounts

Correct Answer: Misbranding and adulteration

Q12. Which administrative remedy allows regulators to prevent distribution of a non-compliant cosmetic pending investigation?

• Issuing a market authorization
• Issuing a stop-sale or detention order
• Granting tax incentives
• Providing voluntary compliance guidance only

Correct Answer: Issuing a stop-sale or detention order

Q13. In the context of herbal cosmetics, which practice most directly increases the risk of regulatory action for adulteration?

• Using authenticated herbal raw materials with certificates
• Substituting declared herbs with cheaper, undeclared synthetic actives
• Conducting stability studies per guidelines
• Maintaining batch-wise manufacturing records

Correct Answer: Substituting declared herbs with cheaper, undeclared synthetic actives

Q14. What distinguishes a cosmetic from a drug under typical regulatory frameworks?

• Cosmetics are always sterile products
• Drugs make therapeutic or disease-treatment claims, whereas cosmetics are intended for cleansing, beautifying, or altering appearance
• Cosmetics require clinical trials for approval
• Drugs cannot be sold over the counter

Correct Answer: Drugs make therapeutic or disease-treatment claims, whereas cosmetics are intended for cleansing, beautifying, or altering appearance

Q15. Which of the following is an example of a misbranding offence specific to herbal cosmetics?

• Accurately listing botanical names and percentages
• Claiming “100% pure herbal” while containing undeclared synthetic preservatives
• Providing manufacturer contact details on the label
• Using recyclable packaging

Correct Answer: Claiming “100% pure herbal” while containing undeclared synthetic preservatives

Q16. Regulatory recall of a cosmetic product is typically based on which grounds?

• Non-compliance with aesthetic packaging preferences
• Evidence of serious health risk, adulteration, or gross misbranding
• Manufacturer’s desire to launch a new design
• Low market demand

Correct Answer: Evidence of serious health risk, adulteration, or gross misbranding

Q17. Which of the following actions by a manufacturer can help prevent enforcement action related to cosmetics?

• Operating without product specifications
• Maintaining validated analytical methods, batch records and complying with GMP
• Making unsubstantiated therapeutic claims in advertisements
• Using unverified suppliers without qualification

Correct Answer: Maintaining validated analytical methods, batch records and complying with GMP

Q18. In regulatory inspections, which document is most important to demonstrate quality control for a herbal cosmetic?

• Sales invoices only
• Master formula, batch manufacturing record and quality control test reports
• Advertising brochures
• Employee ID cards

Correct Answer: Master formula, batch manufacturing record and quality control test reports

Q19. Which of the following is a likely consequence for repeated non-compliance with cosmetic regulations by a manufacturer?

• Increased regulatory scrutiny, higher penalties and possible prosecution
• Reduction in inspection frequency
• Automatic product registration renewal
• Award of industry recognition

Correct Answer: Increased regulatory scrutiny, higher penalties and possible prosecution

Q20. Which enforcement mechanism ensures consumer protection when a cosmetic is found hazardous after market release?

• Voluntary use of product by consumers
• Regulatory recall, public warning, seizure and prohibition of further sale
• Delisting from e-commerce platforms only without regulator involvement
• Issuing promotional discounts to deplete stock

Correct Answer: Regulatory recall, public warning, seizure and prohibition of further sale

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