Licensing under Medicinal and Toilet Preparations Act MCQs With Answer provides B.Pharm students a focused review of licensing principles for medicinal and toiletry products. This introduction covers licensing objectives, types of licenses (manufacturing, wholesale, retail, import/export), application requirements, Good Manufacturing Practices (GMP), labeling, quality control, pharmacovigilance, inspections, renewal, transfer, and penalties for non-compliance. Emphasis on regulatory documentation, premises standards, technical staff qualifications, batch records, and recall procedures prepares students for practical regulatory roles. Clear, keyword-rich content helps build competency in regulatory affairs, pharmacy practice, and quality assurance. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of licensing under the Medicinal and Toilet Preparations Act?
- To collect revenue through licensing fees
- To ensure safety, efficacy and quality of medicinal and toilet preparations
- To promote pharmaceutical companies
- To standardize packaging designs
Correct Answer: To ensure safety, efficacy and quality of medicinal and toilet preparations
Q2. Who is normally empowered to issue manufacturing and sale licenses under the Act?
- Local municipal corporation
- Licensing Authority / Drug Control Authority
- Ministry of Finance
- Chamber of Commerce
Correct Answer: Licensing Authority / Drug Control Authority
Q3. A manufacturing license is normally required for which activity?
- Retail sale of medicines to the public
- Wholesale distribution of stationary goods
- Industrial production of medicinal or toilet preparations
- Importing medical devices only
Correct Answer: Industrial production of medicinal or toilet preparations
Q4. What is a typical statutory requirement for renewal of a license?
- Automatic lifetime validity without renewal
- Renewal as specified by the licensing authority
- Renewal only if ownership changes
- Renewal every 50 years
Correct Answer: Renewal as specified by the licensing authority
Q5. Compliance with Good Manufacturing Practices (GMP) is required for which license?
- Manufacturing license
- Retail sales permit only
- None; GMP is voluntary
- Financial audit license
Correct Answer: Manufacturing license
Q6. Which document is commonly required with a license application?
- Layout plan of premises and equipment list
- Academic transcripts of all employees
- Copies of all product advertisements
- Non-disclosure agreements with competitors
Correct Answer: Layout plan of premises and equipment list
Q7. Minimum qualification for a pharmacist-in-charge for a licensed manufacturing unit is usually:
- High school certificate
- Degree or diploma in pharmacy
- Any science degree
- No qualification required
Correct Answer: Degree or diploma in pharmacy
Q8. A wholesale license permits the licensee to:
- Manufacture active pharmaceutical ingredients
- Sell and distribute medicinal products to retailers and healthcare institutions
- Directly advertise prescription drugs to consumers
- Modify product formulations without approval
Correct Answer: Sell and distribute medicinal products to retailers and healthcare institutions
Q9. Which record is essential to maintain for each production batch under licensing requirements?
- Employee lunch rosters
- Batch manufacturing record with test results
- Marketing budget reports
- Customer complaint summaries only
Correct Answer: Batch manufacturing record with test results
Q10. Non-renewal or serious breach of licensing conditions may lead to:
- Automatic extension of the license
- Suspension or cancellation of the license
- Only a verbal warning with no action
- Tax reimbursement
Correct Answer: Suspension or cancellation of the license
Q11. Import of finished medicinal products normally requires which authorization?
- Export license from the exporting country only
- Import license issued by the licensing authority
- No authorization if quantity is small
- Certificate from the manufacturer only
Correct Answer: Import license issued by the licensing authority
Q12. Mandatory labeling requirements under the Act typically include:
- Only the brand logo
- Ingredients, strength, batch number, manufacturing and expiry dates, and usage instructions
- Proprietary manufacturing processes
- Competitor pricing
Correct Answer: Ingredients, strength, batch number, manufacturing and expiry dates, and usage instructions
Q13. Advertising restrictions under the Act generally prohibit:
- Comparative pricing for over-the-counter items
- Unsubstantiated therapeutic claims for medicated products
- Listing approved indications
- Providing manufacturer contact details
Correct Answer: Unsubstantiated therapeutic claims for medicated products
Q14. Who is typically authorized to collect samples for quality testing?
- Any employee of the manufacturer
- Drug inspector or designated officer of the licensing authority
- Local postman
- Sales representatives
Correct Answer: Drug inspector or designated officer of the licensing authority
Q15. Manufacturing or selling without a valid license may attract which consequences?
- Fines and imprisonment under the Act
- Promotion by the regulatory authority
- Mandatory award of a provisional license
- Exemption from taxes only
Correct Answer: Fines and imprisonment under the Act
Q16. Toiletry preparations under the Act are best described as:
- Prescription-only antibiotics
- Non-therapeutic consumer products such as soaps and cosmetics, unless medicated
- Only hospital-grade disinfectants
- Veterinary feeds
Correct Answer: Non-therapeutic consumer products such as soaps and cosmetics, unless medicated
Q17. Handling of controlled or scheduled substances requires:
- No special records beyond normal books
- Special permits, strict record-keeping, and regulatory controls
- Only verbal permission from a supervisor
- Registration with a trade association only
Correct Answer: Special permits, strict record-keeping, and regulatory controls
Q18. Transfer of a manufacturing license to a new owner generally requires:
- Only a private contract between parties
- Prior approval from the licensing authority
- No formal process if handed over informally
- Notification to customers only
Correct Answer: Prior approval from the licensing authority
Q19. Premises requirements for a licensed manufacturing unit commonly include:
- Shared production and storage areas with no separation
- Separate areas for raw materials, production, packaging and quality control
- Open access to public for tours at all times
- No requirement for sanitation facilities
Correct Answer: Separate areas for raw materials, production, packaging and quality control
Q20. Stability testing is primarily required to determine:
- Marketing strategies
- Shelf life and expiry dating of products
- Price elasticity
- Staff training schedules
Correct Answer: Shelf life and expiry dating of products
Q21. A product recall is initiated when:
- A new competitor product is launched
- A significant safety, efficacy or quality defect is detected
- Sales exceed forecast
- Packaging supplier changes color
Correct Answer: A significant safety, efficacy or quality defect is detected
Q22. Validation in manufacturing is required for:
- Only administrative forms
- Critical manufacturing processes, cleaning and analytical methods
- Employee social events
- Marketing emails
Correct Answer: Critical manufacturing processes, cleaning and analytical methods
Q23. Pharmacovigilance obligations under licensing include:
- Reporting adverse drug reactions to the regulatory authority
- Publishing all internal training materials publicly
- Only monitoring sales trends
- Eliminating all adverse events from records
Correct Answer: Reporting adverse drug reactions to the regulatory authority
Q24. Quality control laboratories associated with licensed manufacturers must be:
- Informal and unregistered
- Approved, adequately equipped and staffed by qualified analysts
- Operated only during weekends
- Outsourced exclusively with no oversight
Correct Answer: Approved, adequately equipped and staffed by qualified analysts
Q25. Which toiletry product would typically require medicinal registration rather than simple cosmetic classification?
- Plain bar soap
- Medicated shampoo making therapeutic claims for dandruff treatment
- Regular non-medicated sunscreen described as beauty cream
- Perfume
Correct Answer: Medicated shampoo making therapeutic claims for dandruff treatment
Q26. The statutory retention period for manufacturing and distribution records is usually:
- As specified by the licensing authority
- One week only
- Indefinitely without limit
- Until the next product launch
Correct Answer: As specified by the licensing authority
Q27. A statistically sound sampling plan during inspection ensures:
- Only expired batches are tested
- Representative testing of production batches for quality assurance
- Testing of packaging materials only
- That no samples are taken
Correct Answer: Representative testing of production batches for quality assurance
Q28. Primary responsibilities of the license holder include:
- Ensuring regulatory compliance and appointing qualified technical staff
- Avoiding any inspections forever
- Publishing competitor secrets
- Selling the license without informing authority
Correct Answer: Ensuring regulatory compliance and appointing qualified technical staff
Q29. Any significant change in product formulation or intended use typically requires:
- Immediate market launch without notification
- Prior approval from the licensing authority
- Only a press release
- No action unless challenged
Correct Answer: Prior approval from the licensing authority
Q30. Regulatory enforcement actions for serious violations can include:
- Issuing a commemorative certificate
- Seizure of goods and revocation of license
- Automatic award of additional licenses
- Granting tax incentives
Correct Answer: Seizure of goods and revocation of license
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com