Understanding controlling authorities – functions is essential for B.Pharm students. This topic explains regulatory agencies, drug regulation frameworks, licensing, inspections, compliance monitoring, pharmacovigilance, quality control, and enforcement that govern pharmaceutical manufacture, distribution, and practice. You will study how central and state drug authorities, licensing bodies, ethics committees, and international regulators influence drug approval, clinical trial oversight, GMP/GCP compliance, post-marketing surveillance, and recall procedures. Solid knowledge of these controlling authorities enables pharmacists to ensure patient safety, legal compliance, and high-quality pharmacy practice. This focused review links classroom theory with the practical regulatory responsibilities every pharmacist must master. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary function of a national drug regulatory authority?
- Manufacture finished pharmaceutical products
- Approval of new drugs and regulation of drug safety
- Retail distribution of medicines
- Hospital clinical management
Correct Answer: Approval of new drugs and regulation of drug safety
Q2. Which authority typically issues manufacturing licenses for pharmaceutical plants?
- Clinical Trial Ethics Committee
- State Drug Control Department / Licensing Authority
- Central Medical Stores
- Pharmacy Council
Correct Answer: State Drug Control Department / Licensing Authority
Q3. Good Manufacturing Practices (GMP) primarily ensure:
- Faster marketing approvals
- Consistent product quality and patient safety
- Lower production costs
- Automatic export clearance
Correct Answer: Consistent product quality and patient safety
Q4. Pharmacovigilance functions of controlling authorities include:
- Setting retail prices of drugs
- Monitoring adverse drug reactions and safety signals
- Manufacturing APIs
- Approving hospital budgets
Correct Answer: Monitoring adverse drug reactions and safety signals
Q5. Which document specifies quality standards for dosage forms and APIs?
- Good Documentation Practice (GDP)
- Pharmacopoeia monographs (e.g., IP, USP, BP)
- Clinical trial protocol
- Prescription order
Correct Answer: Pharmacopoeia monographs (e.g., IP, USP, BP)
Q6. Which authority typically approves clinical trials of new drugs?
- Local hospital administration
- National regulatory authority in conjunction with ethics committees
- National insurance companies
- Pharmaceutical trade unions
Correct Answer: National regulatory authority in conjunction with ethics committees
Q7. The role of an ethics committee (IEC/IRB) in clinical trials is to:
- Manufacture investigational drugs
- Approve study budgets only
- Protect participant rights, safety and welfare
- Market trial results
Correct Answer: Protect participant rights, safety and welfare
Q8. A drug recall initiated by a controlling authority is usually due to:
- Change in marketing strategy
- Quality defect or safety concern
- Low sales in the market
- Expiration of patent
Correct Answer: Quality defect or safety concern
Q9. Which agency is responsible for food and drug regulation in the United States?
- EMA (European Medicines Agency)
- FDA (Food and Drug Administration)
- CDSCO
- WHO
Correct Answer: FDA (Food and Drug Administration)
Q10. Schedule M in Indian drug regulations deals with:
- Labeling requirements for cosmetics
- Standards of good manufacturing practices for pharmaceutical manufacturers
- Clinical trial compensation rules
- Import tariff for APIs
Correct Answer: Standards of good manufacturing practices for pharmaceutical manufacturers
Q11. Which function is NOT typically performed by a drug inspector?
- Inspecting manufacturing and storage premises
- Sampling for laboratory testing
- Issuing propagation permits for botanical gardens
- Checking licensing compliance
Correct Answer: Issuing propagation permits for botanical gardens
Q12. Post-marketing surveillance aims to:
- Replace preclinical testing
- Collect long-term safety and effectiveness data in real-world use
- Increase drug prices
- Limit access to generics
Correct Answer: Collect long-term safety and effectiveness data in real-world use
Q13. Which international organization provides guidelines and assistance to national regulatory authorities?
- UNICEF
- WHO (World Health Organization)
- IMF
- WTO
Correct Answer: WHO (World Health Organization)
Q14. A Market Authorization Holder (MAH) is responsible for:
- Conducting all clinical trials personally
- The safety, efficacy and quality of the marketed product
- Only manufacturing active ingredients
- Distributing exclusively to military hospitals
Correct Answer: The safety, efficacy and quality of the marketed product
Q15. Good Clinical Practice (GCP) guidelines ensure:
- Proper laboratory equipment procurement
- Ethical and scientific standards for designing, conducting and reporting clinical trials
- Faster patent approvals
- Standard drug pricing
Correct Answer: Ethical and scientific standards for designing, conducting and reporting clinical trials
Q16. Which body typically registers pharmacists and maintains the professional register?
- National drug testing laboratory
- Pharmacy Council / Professional regulatory council
- Income tax department
- Customs authority
Correct Answer: Pharmacy Council / Professional regulatory council
Q17. The Drug Controller General (e.g., DCGI) commonly handles:
- Issuing driver’s licenses
- Approving new drug applications and clinical trial permissions
- Managing hospital staffing
- Controlling veterinary services only
Correct Answer: Approving new drug applications and clinical trial permissions
Q18. Batch release testing and certificate of analysis (CoA) are part of:
- Drug advertising campaigns
- Quality control and regulatory compliance prior to product release
- Clinical ethics review
- Patent filing procedures
Correct Answer: Quality control and regulatory compliance prior to product release
Q19. Which is a key regulatory requirement for import of pharmaceutical products?
- A declaration of sales targets
- Import license and conformity with national safety/quality standards
- Local political endorsements
- Free samples to customs officials
Correct Answer: Import license and conformity with national safety/quality standards
Q20. Adverse Drug Reaction (ADR) reporting timelines to regulatory authority are critical because:
- They increase product shelf-life
- Timely reporting enables rapid risk assessment and protective action
- They determine pharmacy tax rates
- They replace clinical trial requirements
Correct Answer: Timely reporting enables rapid risk assessment and protective action
Q21. Which certification indicates laboratory competence for testing drug samples?
- NABL accreditation
- ISO food safety only
- Clinical trial registry number
- GMP certificate for manufacturing plant
Correct Answer: NABL accreditation
Q22. Drug scheduling and control of narcotics is typically managed by which type of authority?
- Pharmacovigilance committee
- Specialized drug control or narcotics bureau under national regulation
- Local pharmacies alone
- Medical device manufacturers
Correct Answer: Specialized drug control or narcotics bureau under national regulation
Q23. Which regulatory document governs labeling, packing, and leaflet information for medicines?
- Clinical trial case report form
- Labeling and patient information regulations/standards
- Employee handbook
- Tax code
Correct Answer: Labeling and patient information regulations/standards
Q24. A Notice of Violation, show-cause notice or suspension of license are examples of:
- Regulatory enforcement actions
- Promotional strategies
- Clinical trial recruitment tools
- Quality control certificates
Correct Answer: Regulatory enforcement actions
Q25. Which practice strengthens regulatory compliance in manufacturing?
- Skipping validation to save time
- Comprehensive SOPs, validation, training and documentation
- Minimizing record-keeping
- Outsourcing regulatory responsibilities entirely
Correct Answer: Comprehensive SOPs, validation, training and documentation
Q26. The role of the national pharmacopoeia is to:
- Provide trade discounts to pharmacies
- Define official standards for drug identity, purity and strength
- Manage hospital patient records
- Issue manufacturing licenses
Correct Answer: Define official standards for drug identity, purity and strength
Q27. Regulatory requirements for biosimilars primarily focus on:
- Exact chemical identity only
- Comparability in quality, safety and efficacy with reference biologic
- Lowering manufacturing costs exclusively
- Marketing royalties
Correct Answer: Comparability in quality, safety and efficacy with reference biologic
Q28. Which is a common requirement before marketing authorization for a new chemical entity?
- Demonstration of quality, safety and efficacy through preclinical and clinical data
- Only an export certificate
- Manufacturing in multiple countries
- Approval from local retail associations
Correct Answer: Demonstration of quality, safety and efficacy through preclinical and clinical data
Q29. The function of batch traceability and serialization in regulation is to:
- Increase the cost of packaging
- Prevent counterfeit products and enable recalls
- Guarantee higher potency
- Reduce reporting obligations
Correct Answer: Prevent counterfeit products and enable recalls
Q30. Which activity is essential for a B.Pharm graduate aiming to work in regulatory affairs?
- Ignoring regulatory guidelines to innovate faster
- Understanding regulations, preparing dossiers, and ensuring compliance
- Focusing solely on retail sales techniques
- Specializing only in manufacturing machinery
Correct Answer: Understanding regulations, preparing dossiers, and ensuring compliance
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