Understanding licensing authorities and their functions is essential for B.Pharm students. Licensing authorities regulate drug licensing, manufacturing licences, wholesale and retail sale licences, and ensure compliance with pharmaceutical laws and Good Manufacturing Practices (GMP). Key functions include licensing procedures, inspections by Drug Inspectors, registration requirements, sample collection and analysis, suspension and revocation of licences, pharmacovigilance oversight, and enforcement by state drug control units and central bodies like CDSCO. Learning these regulatory functions equips you to apply pharmacy law, prepare for inspections, manage quality systems, and support public health and drug safety. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which body is the primary central authority for regulation of new drug approvals and clinical trials in India?
- State Drug Control Department
- Pharmacy Council of India
- Central Drugs Standard Control Organization (CDSCO)
- National Pharmaceutical Pricing Authority
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q2. Which of the following is a core function of licensing authorities?
- Setting university curriculum
- Issuing and renewing drug licences
- Manufacturing drugs directly
- Marketing pharmaceutical products
Correct Answer: Issuing and renewing drug licences
Q3. Good Manufacturing Practices (GMP) are primarily enforced to ensure:
- Low production costs
- Patient safety and product quality
- Faster marketing approvals
- Exclusive patents for manufacturers
Correct Answer: Patient safety and product quality
Q4. Who is typically authorized to conduct inspections of manufacturing and retail premises?
- Drug Inspector
- Marketing Manager
- Hospital Administrator
- Patent Attorney
Correct Answer: Drug Inspector
Q5. Which authority usually issues licences for manufacture and sale of most pharmaceutical products at the state level?
- Central Drug Authority only
- State Drug Control Authority
- World Health Organization
- Food and Drug Administration of USA
Correct Answer: State Drug Control Authority
Q6. A licensing authority may suspend or revoke a licence mainly because of:
- High profitability
- Non-compliance with statutory provisions
- Expired company trademark
- Change in company logo
Correct Answer: Non-compliance with statutory provisions
Q7. Which activity is part of a licensing authority’s post-licence monitoring?
- Only issuing invoices
- Routine inspections and sample testing
- Advertising the product
- Distributing free samples
Correct Answer: Routine inspections and sample testing
Q8. Pharmacovigilance oversight by licensing authorities primarily focuses on:
- Price control of medicines
- Monitoring adverse drug reactions
- Approving manufacturing equipment
- Training marketing staff
Correct Answer: Monitoring adverse drug reactions
Q9. For a manufacturing facility, compliance with which schedule indicates adherence to GMP in India?
- Schedule X
- Schedule M
- Schedule Y
- Schedule K
Correct Answer: Schedule M
Q10. Which of the following is a typical licensing requirement assessed by authorities?
- Availability of qualified technical staff
- Number of shareholders
- Company annual profit only
- Marketing strategy
Correct Answer: Availability of qualified technical staff
Q11. When a drug inspector seizes suspected spurious drugs, the licensing authority will most likely:
- Ignore the case
- Order analysis and legal action if required
- Immediately destroy the entire factory
- Promote the product
Correct Answer: Order analysis and legal action if required
Q12. Which of the following best describes “conditional licensing” in pharmaceuticals?
- Licence granted with specific terms or restrictions
- Licence that never expires
- Licence given without application
- Licence for marketing only
Correct Answer: Licence granted with specific terms or restrictions
Q13. What role does documentation play in licensing inspections?
- Minimal importance
- Central role to demonstrate compliance and traceability
- Useful only for marketing
- Only for payroll records
Correct Answer: Central role to demonstrate compliance and traceability
Q14. Which authority is primarily responsible for regulating import of drugs into India?
- State Drug Control Authority
- Central Drugs Standard Control Organization (CDSCO)
- Pharmacy Council of India
- Ministry of Education
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q15. Licence renewal processes commonly require:
- Submission of updated compliance documents and fees
- Only a phone call
- Change of company name
- Export permissions
Correct Answer: Submission of updated compliance documents and fees
Q16. A licensing authority’s role in ensuring quality includes verification of:
- Laboratory testing facilities and procedures
- Employee social media profiles
- Advertising slogans
- Board meeting minutes only
Correct Answer: Laboratory testing facilities and procedures
Q17. Which is a likely consequence when a company fails to comply with licensing conditions?
- Issuance of a commemorative certificate
- Imposition of penalties, suspension, or cancellation of licence
- Automatic international accreditation
- Increase in product shelf life
Correct Answer: Imposition of penalties, suspension, or cancellation of licence
Q18. The function of license verification before distribution ensures:
- That products are fashionable
- That distributors hold valid licences and legal authorization
- Higher retail pricing
- Faster transportation
Correct Answer: That distributors hold valid licences and legal authorization
Q19. Which document or system helps licensing authorities track adverse events reported after marketing?
- Pharmacovigilance Program and safety databases
- Payroll systems
- Marketing brochures
- Inventory barcode only
Correct Answer: Pharmacovigilance Program and safety databases
Q20. Mutual recognition of inspection reports between authorities helps to:
- Reduce duplication and improve regulatory efficiency
- Increase paperwork unnecessarily
- Delay approvals always
- Eliminate the need for quality control
Correct Answer: Reduce duplication and improve regulatory efficiency
Q21. Which action is part of licensing authorities’ role in public health protection?
- Approving counterfeit products
- Recalling unsafe or substandard medicines
- Printing promotional posters
- Issuing export certificates only
Correct Answer: Recalling unsafe or substandard medicines
Q22. Licensing authorities evaluate facility layout primarily to ensure:
- Efficient marketing
- Prevention of cross-contamination and proper process flow
- Maximum storage of expired goods
- Attractive employee lounges
Correct Answer: Prevention of cross-contamination and proper process flow
Q23. What is the significance of sample collection by licensing authorities?
- To test product quality and verify compliance with standards
- To increase company taxes
- To advertise products
- To provide free samples to the public
Correct Answer: To test product quality and verify compliance with standards
Q24. Which of the following is an enforcement tool available to licensing authorities?
- Issuing warning letters, penalties, seizures, and prosecution
- Offering marketing advice
- Granting unlimited marketing rights
- Providing manufacturing subsidies only
Correct Answer: Issuing warning letters, penalties, seizures, and prosecution
Q25. Licensing authorities often require which of the following for personnel qualification?
- Presence of qualified technical and pharmaceutical staff
- Only marketing degrees
- No formal qualifications
- Only business diplomas
Correct Answer: Presence of qualified technical and pharmaceutical staff
Q26. When a new drug is introduced, licensing authorities assess:
- Safety, efficacy, and quality data
- Company logo design
- Retailer preferences
- Color of the packaging only
Correct Answer: Safety, efficacy, and quality data
Q27. Inter-state trade of scheduled drugs often requires checks by licensing authorities to ensure:
- Correct tax evasion
- Compliance with distribution licences and legal transport
- Only faster delivery times
- Brand popularity
Correct Answer: Compliance with distribution licences and legal transport
Q28. Transparency in licensing decisions is promoted by authorities through:
- Clear guidelines, published procedures, and appeal mechanisms
- Secretive backdoor approvals
- Random unpublished rules
- Only verbal agreements
Correct Answer: Clear guidelines, published procedures, and appeal mechanisms
Q29. The role of a licensing authority in post-market surveillance includes:
- Monitoring safety, quality, and taking corrective actions
- Designing product packaging
- Hiring sales representatives
- Issuing marketing awards
Correct Answer: Monitoring safety, quality, and taking corrective actions
Q30. Effective interaction between industry and licensing authorities helps to:
- Improve compliance, facilitate timely approvals, and enhance public safety
- Guarantee unlimited market share
- Reduce product quality requirements
- Replace laboratory testing altogether
Correct Answer: Improve compliance, facilitate timely approvals, and enhance public safety
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