Introduction: The prohibition of manufacture and sale of certain drugs is a vital topic for B.Pharm students, covering drug regulation, banned drugs, controlled substances, and public health protection. Understanding the legal framework—such as national drug acts, regulatory bodies like CDSCO/DCGI, schedules and classifications, recalls, and enforcement actions—helps pharmacists ensure drug safety, pharmacovigilance, and compliance with good manufacturing practices (GMP). This topic also explores reasons for prohibition: toxicity, lack of efficacy, contamination, misuse potential, and counterfeit risks. Mastery of these concepts equips future pharmacists to support regulatory decisions, reporting, and ethical dispensing. ‘Now let’s test your knowledge with 30 MCQs on this topic.’
Q1. Which authority is primarily responsible for approving new drugs and regulating manufacture and sale of pharmaceuticals in India?
- Central Drugs Standard Control Organization (CDSCO)
- State Drug Inspectors
- Pharmacy Council of India
- National Institute of Nutrition
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q2. Which central legislation governs the prohibition, manufacture, and sale of drugs in India?
- The Food Safety and Standards Act
- The Narcotic Drugs and Psychotropic Substances Act
- The Drugs and Cosmetics Act
- The Medical Council Act
Correct Answer: The Drugs and Cosmetics Act
Q3. What is a common regulatory reason to prohibit manufacture and sale of a specific drug?
- High production cost
- Lack of profitable market
- Severe safety concerns or proven toxicity
- Low advertising budgets
Correct Answer: Severe safety concerns or proven toxicity
Q4. Which schedule of drug classification typically relates to stronger prescription-only medications requiring special record keeping (in many regulatory systems)?
- Over-the-counter (OTC)
- Schedule H or equivalent prescription-only
- Herbal supplements
- Cosmetic agents
Correct Answer: Schedule H or equivalent prescription-only
Q5. Under drug prohibition policies, what is a “recall”?
- Promotion of a drug to prescribers
- Process to withdraw a marketed product due to safety or quality issues
- Renewal of a manufacturing license
- Annual safety review meeting
Correct Answer: Process to withdraw a marketed product due to safety or quality issues
Q6. Which action is NOT typically a regulatory response to discovery of an unsafe drug?
- Market recall
- Issuing safety alerts and contraindications
- Increasing advertising budgets
- Suspending manufacturing license
Correct Answer: Increasing advertising budgets
Q7. Which organization typically coordinates pharmacovigilance and adverse drug reaction reporting at a national level?
- Local pharmacies only
- National pharmacovigilance center (e.g., PvPI/NPVC)
- Private marketing agencies
- Hospital administration alone
Correct Answer: National pharmacovigilance center (e.g., PvPI/NPVC)
Q8. What is one major public health rationale for prohibiting certain drugs?
- To limit competition among manufacturers
- To prevent widespread harm from adverse effects or abuse
- To promote local pharmaceutical exports
- To reduce taxation revenues
Correct Answer: To prevent widespread harm from adverse effects or abuse
Q9. Which category of drugs is most likely to be controlled under narcotics legislation rather than standard drug regulation?
- Antacids
- Narcotic analgesics and psychotropic substances
- Topical antifungals
- Vitamins
Correct Answer: Narcotic analgesics and psychotropic substances
Q10. In regulatory enforcement, what is a “seizure” related to prohibited drugs?
- Administrative record keeping
- Confiscation of banned or adulterated drug stocks by authorities
- Approval of generic competitors
- Label redesign
Correct Answer: Confiscation of banned or adulterated drug stocks by authorities
Q11. Which GMP (Good Manufacturing Practice) deficiency commonly leads to prohibition of a drug batch or product?
- Using approved raw materials
- Lack of validated manufacturing processes and contamination control
- Clear product labeling
- Proper documentation of clinical trials
Correct Answer: Lack of validated manufacturing processes and contamination control
Q12. What is an example of a proactive regulatory measure to prevent sale of banned drugs?
- Strengthening border controls and import checks
- Reducing inspection frequency
- Eliminating adverse event reporting
- Allowing free online sales without verification
Correct Answer: Strengthening border controls and import checks
Q13. Which professional responsibility is crucial for pharmacists when a drug is prohibited or recalled?
- Sell remaining stock quickly
- Immediately stop dispensing, quarantine stock, notify authorities and customers as required
- Ignore recall notices until asked by customers
- Increase dispensing of alternatives without counseling
Correct Answer: Immediately stop dispensing, quarantine stock, notify authorities and customers as required
Q14. Which is a common trigger for regulatory re-evaluation and potential prohibition of an approved drug?
- New evidence of severe adverse reactions from post-marketing surveillance
- Low manufacturing costs
- High global sales volume
- Positive marketing campaigns
Correct Answer: New evidence of severe adverse reactions from post-marketing surveillance
Q15. The Narcotic Drugs and Psychotropic Substances Act primarily aims to:
- Regulate cosmetic safety
- Control illicit production, possession, and trafficking of narcotics and psychotropics
- Set pricing for generic drugs
- License pharmacies
Correct Answer: Control illicit production, possession, and trafficking of narcotics and psychotropics
Q16. What role does stability testing play in preventing prohibition of a drug product?
- It ensures aesthetic packaging only
- It verifies shelf-life and ensures product remains safe and effective during storage
- It increases marketing costs
- It shortens the approval process
Correct Answer: It verifies shelf-life and ensures product remains safe and effective during storage
Q17. Which of the following is an effect of illegal manufacture and sale of banned drugs on public health?
- Improved medication adherence
- Increased risk of toxicity, resistance, and therapeutic failure
- Higher confidence in supply chains
- Better clinical outcomes
Correct Answer: Increased risk of toxicity, resistance, and therapeutic failure
Q18. What documentation is critical for a manufacturer to defend against prohibition actions?
- Validated batch records, quality control data and stability studies
- Only marketing brochures
- Unofficial email discussions
- External advertisements
Correct Answer: Validated batch records, quality control data and stability studies
Q19. Which practice increases the likelihood of counterfeit or banned drugs entering the market?
- Stringent regulatory inspections
- Poor supply-chain security and lack of serialization
- Robust pharmacovigilance
- Traceability systems
Correct Answer: Poor supply-chain security and lack of serialization
Q20. Which type of evidence most often leads regulatory agencies to prohibit a drug?
- Anecdotal marketing claims
- Rigorous post-marketing safety data showing unacceptable risk-benefit ratio
- Celebrity endorsements
- Long-term profitability
Correct Answer: Rigorous post-marketing safety data showing unacceptable risk-benefit ratio
Q21. What is an example of a temporary prohibition measure regulators may use?
- Permanent ban without review
- Issuing a suspension of manufacturing license pending investigation
- Allowing unlimited distribution
- Immediate market expansion incentives
Correct Answer: Issuing a suspension of manufacturing license pending investigation
Q22. How should adverse drug reactions be reported to support prohibition decisions?
- Kept confidential within the pharmacy
- Reported promptly to national pharmacovigilance programs and regulatory authorities
- Only shared on social media
- Ignored unless patients complain loudly
Correct Answer: Reported promptly to national pharmacovigilance programs and regulatory authorities
Q23. Which laboratory finding would most strongly justify prohibition of a marketed drug batch?
- Minor cosmetic variation in color
- Presence of a toxic impurity above acceptable limits
- Different font on label
- Slight change in marketing slogan
Correct Answer: Presence of a toxic impurity above acceptable limits
Q24. What is the pharmacist’s role when a drug is recalled due to contamination?
- Continue dispensing until stock runs out
- Quarantine affected lots, notify patients and return or dispose as per authority guidance
- Offer contaminated products at a discount
- Discard without documentation
Correct Answer: Quarantine affected lots, notify patients and return or dispose as per authority guidance
Q25. Which international practice helps reduce manufacture and sale of banned drugs?
- Closed information sharing between regulators
- Global regulatory harmonization and information exchange
- Unregulated online markets
- Decentralized manufacturing without oversight
Correct Answer: Global regulatory harmonization and information exchange
Q26. Which is a legal consequence for entities that manufacture and sell prohibited drugs?
- Tax rebates
- Penalties, license revocation, criminal prosecution and product seizure
- Increased marketing privileges
- Automatic re-approval
Correct Answer: Penalties, license revocation, criminal prosecution and product seizure
Q27. Why is clear labeling and packaging important in preventing prohibited drug circulation?
- It improves shelf aesthetics only
- Reduces medication errors, aids identification and deters counterfeiters
- It is irrelevant to safety
- It increases production cost only
Correct Answer: Reduces medication errors, aids identification and deters counterfeiters
Q28. Which monitoring activity helps detect banned drug circulation early?
- Ignoring pharmacy complaints
- Active market surveillance, testing and pharmacovigilance analysis
- Reducing batch testing frequency
- Deleting adverse event databases
Correct Answer: Active market surveillance, testing and pharmacovigilance analysis
Q29. When a drug is prohibited due to teratogenicity risks, what counseling is essential for pharmacists?
- No counseling required
- Advise against use in pregnancy, explain risks, and suggest safer alternatives
- Recommend doubling the dose for efficacy
- Suggest over-the-counter substitutes without prescription
Correct Answer: Advise against use in pregnancy, explain risks, and suggest safer alternatives
Q30. Which quality system component helps prevent future prohibition of drugs by ensuring consistent product safety?
- Poor record-keeping
- Comprehensive quality management system including CAPA (corrective and preventive actions)
- Avoiding audits
- Ad-hoc testing only when convenient
Correct Answer: Comprehensive quality management system including CAPA (corrective and preventive actions)
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