Classes of drugs and cosmetics prohibited from import MCQs With Answer

Classes of drugs and cosmetics prohibited from import MCQs With Answer is a focused study area for B.Pharm students on regulatory controls, banned substances and import restrictions. This introduction covers key concepts such as the Drugs and Cosmetics Act, CDSCO oversight, NDPS Act, import licenses, and categories like narcotics, psychotropics, counterfeit drugs, unapproved APIs, and cosmetics with prohibited ingredients (mercury, high‑potency steroids, certain hydroquinones). Understanding documentation, customs enforcement, and public safety rationale is essential for pharmacists involved in quality assurance, regulatory affairs, and import clearance. Clear knowledge of these classes helps prevent public harm and legal penalties. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which Indian law primarily governs the import of drugs and cosmetics?

  • Drugs and Cosmetics Act, 1940
  • Food Safety and Standards Act, 2006
  • Narcotic Drugs and Psychotropic Substances Act, 1985
  • Environment Protection Act, 1986

Correct Answer: Drugs and Cosmetics Act, 1940

Q2. Which regulatory body in India is chiefly responsible for approving drug imports?

  • Central Drugs Standard Control Organization (CDSCO)
  • Food Safety and Standards Authority of India (FSSAI)
  • Central Pollution Control Board (CPCB)
  • Insurance Regulatory and Development Authority (IRDA)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q3. Which class of substances is tightly restricted for import under the NDPS Act?

  • Narcotics and psychotropic substances
  • Vitamins and minerals
  • Over‑the‑counter analgesics
  • Cosmetic colorants

Correct Answer: Narcotics and psychotropic substances

Q4. Which of the following is commonly prohibited in cosmetics for safety reasons?

  • Mercury compounds
  • Sodium chloride
  • Glycerin
  • Natural oils

Correct Answer: Mercury compounds

Q5. Topical corticosteroids intended for cosmetic skin lightening and sold without prescription are typically classified as:

  • Banned or restricted cosmetic ingredients
  • Safe cosmetic additives
  • Benign moisturizers
  • Authorized food additives

Correct Answer: Banned or restricted cosmetic ingredients

Q6. Which schedule in Indian Rules contains stringent controls on certain habit‑forming drugs and imposes special record‑keeping?

  • Schedule X
  • Schedule H
  • Schedule M
  • Schedule Y

Correct Answer: Schedule X

Q7. Imported drugs that are unapproved by the national regulator are generally considered:

  • Prohibited or restricted until approval is granted
  • Automatically approved on arrival
  • Permitted for sale without labeling
  • Free from customs inspection

Correct Answer: Prohibited or restricted until approval is granted

Q8. Which document is essential for legal import of controlled psychotropic drugs into India?

  • Import license/permission from the competent authority
  • Manufacturer’s promotional brochure
  • Local retail invoice
  • Self‑declaration by courier

Correct Answer: Import license/permission from the competent authority

Q9. Cosmetics that make therapeutic claims (e.g., cure acne) are often treated as:

  • Drugs and hence subject to drug import controls
  • Harmless cosmetics exempt from regulation
  • Food products
  • Household chemicals

Correct Answer: Drugs and hence subject to drug import controls

Q10. Which of the following is an example of a cosmetic substance commonly restricted due to carcinogenic concerns?

  • Certain azo dyes not approved for cosmetics
  • Vitamin E
  • Sucrose
  • Dimethicone

Correct Answer: Certain azo dyes not approved for cosmetics

Q11. Counterfeit or spurious drugs imported into the country are classified as:

  • Prohibited and subject to seizure
  • Allowed after repackaging
  • Automatically eligible for sale
  • Considered legitimate generics

Correct Answer: Prohibited and subject to seizure

Q12. Which authority issues import clearances for vaccines and biologicals in India?

  • CDSCO (Central Drugs Standard Control Organization)
  • FSSAI
  • State Food Authorities
  • Ministry of Finance

Correct Answer: CDSCO (Central Drugs Standard Control Organization)

Q13. High levels of which heavy metal in cosmetics are a common reason for import prohibition?

  • Lead
  • Calcium
  • Sodium
  • Potassium

Correct Answer: Lead

Q14. Which action is most likely taken by customs when an import contains unlabelled steroids in topical creams?

  • Seizure and referral to regulatory authorities
  • Immediate release without checks
  • Donation to charity
  • Conversion to non‑regulated products

Correct Answer: Seizure and referral to regulatory authorities

Q15. APIs (Active Pharmaceutical Ingredients) imported without proper registration or approval are considered:

  • Prohibited or controlled imports
  • Free samples for marketing
  • Cosmetic ingredients
  • Food additives

Correct Answer: Prohibited or controlled imports

Q16. Which list maintained by DGFT can include drugs and cosmetics that are restricted or prohibited for import?

  • Negative list / restricted items list
  • Consumer wish‑list
  • Promotional product list
  • Tourist items list

Correct Answer: Negative list / restricted items list

Q17. Use of unapproved preservatives or antimicrobials in cosmetics can lead to import prohibition due to:

  • Microbial safety and toxicological risk
  • Color preferences of consumers
  • Packaging aesthetics
  • Export benefits

Correct Answer: Microbial safety and toxicological risk

Q18. Which of the following categories often requires a free sale certificate or certificate of pharmaceutical product for import?

  • Finished pharmaceutical products
  • Household cleaners
  • Stationery items
  • Personal gadgets

Correct Answer: Finished pharmaceutical products

Q19. Cosmetics containing high concentrations of hydroquinone are commonly restricted because of:

  • Potential toxicity and regulatory ban in many jurisdictions
  • Pleasant fragrance
  • High nutritional value
  • Low production cost

Correct Answer: Potential toxicity and regulatory ban in many jurisdictions

Q20. Which outcome is a direct consequence of importing banned drugs or cosmetics?

  • Seizure, legal action and fines
  • Automatic market approval
  • Tax rebate reward
  • Priority customs clearance

Correct Answer: Seizure, legal action and fines

Q21. Which process can customs use to verify the safety of an imported drug or cosmetic suspected to be prohibited?

  • Laboratory testing and regulatory assessment
  • Visual appeal scoring
  • Retail price comparison
  • Social media polling

Correct Answer: Laboratory testing and regulatory assessment

Q22. Which ingredient class is expressly inappropriate for cosmetic use because it imparts systemic hormonal effects?

  • Anabolic steroids and certain potent corticosteroids
  • Plant‑derived emollients
  • Vitamin C
  • Mineral oil

Correct Answer: Anabolic steroids and certain potent corticosteroids

Q23. Import of investigational new drugs for clinical trials generally requires:

  • Permission from regulatory authorities (e.g., CDSCO) and ethics approval
  • No documentation
  • Only a courier manifest
  • State police approval

Correct Answer: Permission from regulatory authorities (e.g., CDSCO) and ethics approval

Q24. Which is a major public health reason for prohibiting certain cosmetics and drugs from import?

  • Risk of toxicity, misuse, antimicrobial resistance and adverse reactions
  • High consumer demand
  • Attractive packaging
  • Seasonal market trends

Correct Answer: Risk of toxicity, misuse, antimicrobial resistance and adverse reactions

Q25. Which of these is often required to accompany imported pharmaceutical consignments to prove identity and quality?

  • Batch‑wise Certificate of Analysis (CoA)
  • Retail shelf price tag
  • Celebrity endorsement
  • Generic recipe book

Correct Answer: Batch‑wise Certificate of Analysis (CoA)

Q26. Products adulterated with undeclared antibiotics or steroids to enhance cosmetic effects are classified as:

  • Prohibited and adulterated products
  • Natural cosmetics
  • Medical devices
  • Food supplements

Correct Answer: Prohibited and adulterated products

Q27. Which label or marking requirement helps prevent import of prohibited pharmaceutical products?

  • Clear disclosure of active ingredients, manufacturer, batch and country of origin
  • Attractive brand logo only
  • Handwritten expiry date without batch details
  • No label to reduce printing costs

Correct Answer: Clear disclosure of active ingredients, manufacturer, batch and country of origin

Q28. Which international document may be needed by regulators to permit import of certain controlled substances for medical use?

  • Import authorization and NDPS permits supported by international control schedules
  • Vacation itinerary
  • Local business card
  • Unregulated shipment receipt

Correct Answer: Import authorization and NDPS permits supported by international control schedules

Q29. Which is NOT typically a reason to prohibit cosmetic import?

  • Use of approved, safe, and labelled natural oils
  • Presence of banned heavy metals
  • Undeclared prescription drugs
  • Microbial contamination

Correct Answer: Use of approved, safe, and labelled natural oils

Q30. For a B.Pharm professional involved in imports, which skill is most important to prevent prohibited consignments?

  • Understanding regulatory requirements, documentation and ingredient safety
  • Graphic design for packaging
  • Retail merchandising
  • Social media marketing

Correct Answer: Understanding regulatory requirements, documentation and ingredient safety

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