Drugs Inspectors – powers and duties MCQs With Answer

Drugs Inspectors – powers and duties MCQs With Answer

Drugs Inspectors play a vital role in pharmaceutical regulation, enforcing the Drugs and Cosmetics Act and ensuring public safety. For B. Pharm students, understanding their inspection powers, sampling authority, seizure procedures, licensing interactions, GMP verification (Schedule M), record checks, and legal duties is essential. These inspectors collect and seal samples, recommend recalls or prosecutions, prepare inspection reports, and liaise with notified drug analysis laboratories. Knowledge of chain-of-custody, documentation, and ethical obligations helps pharmacists support regulatory compliance and public health. This topic deepens practical understanding of regulatory enforcement and quality assurance in pharmaceutical practice. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary role of a Drugs Inspector in pharmaceutical regulation?

• To enforce drug laws and inspect manufacturing and distribution sites
• To manufacture drugs for government pharmacies
• To sell scheduled drugs at wholesale rates
• To approve drug prices for market

Correct Answer: To enforce drug laws and inspect manufacturing and distribution sites

Q2. Which legislation mainly empowers Drugs Inspectors in India?

• The Pharmacy Act
• The Drugs and Cosmetics Act, 1940
• The Medical Council Act
• The Food Safety and Standards Act

Correct Answer: The Drugs and Cosmetics Act, 1940

Q3. Which of the following is a core power of a Drugs Inspector during inspection?

• To collect and seal samples of drugs and cosmetics
• To set retail prices for medicines
• To issue manufacturing licenses independently
• To prescribe medicines to patients

Correct Answer: To collect and seal samples of drugs and cosmetics

Q4. When a Drugs Inspector finds suspected adulterated drugs, the usual immediate action is:

• Recommend prosecution and seize suspected stocks
• Donate the products to a hospital
• Increase production to clear stock
• Ignore and close the case

Correct Answer: Recommend prosecution and seize suspected stocks

Q5. Can a Drugs Inspector carry out inspections without prior notice?

• Yes, surprise inspections are commonly conducted
• No, inspections are always scheduled three months in advance
• Only if the manufacturer gives written permission
• Only on public holidays

Correct Answer: Yes, surprise inspections are commonly conducted

Q6. Who typically appoints Drugs Inspectors for state-level enforcement in India?

• State Government or State Drug Control Department
• Local municipal corporations only
• The World Health Organization
• Individual pharmaceutical companies

Correct Answer: State Government or State Drug Control Department

Q7. Which qualification is normally required for appointment as a Drugs Inspector?

• Bachelor of Pharmacy (B.Pharm) or equivalent degree in Pharmacy
• Only a high school diploma
• Degree in History or Literature
• Only an MBA in Marketing

Correct Answer: Bachelor of Pharmacy (B.Pharm) or equivalent degree in Pharmacy

Q8. During sampling, what important action must the Drugs Inspector take to preserve legal validity?

• Seal the sample properly and provide a receipt to the proprietor
• Consume part of the sample immediately
• Sell the sample to a third party
• Dispose of the sample on site

Correct Answer: Seal the sample properly and provide a receipt to the proprietor

Q9. Where are seized drug samples normally sent for analysis?

• Notified/state drug testing laboratories or central laboratories
• Any local retail pharmacy
• The manufacturer’s in-house lab only
• The postal department for storage

Correct Answer: Notified/state drug testing laboratories or central laboratories

Q10. Which of the following is NOT typically a duty of a Drugs Inspector?

• Granting manufacturing licenses independently
• Inspecting manufacturing premises for GMP compliance
• Checking records and accounts related to production and sale
• Preparing inspection reports and recommendations

Correct Answer: Granting manufacturing licenses independently

Q11. Compliance with which Schedule is specifically examined by Drugs Inspectors for GMP of pharmaceutical manufacturing in India?

• Schedule M
• Schedule D
• Schedule X
• Schedule T

Correct Answer: Schedule M

Q12. When a Drugs Inspector issues a show-cause notice, they are asking the licensee to:

• Explain or justify alleged non-compliance or defects
• Close the plant permanently without explanation
• Increase production immediately
• Pay a promotional fee to the inspector

Correct Answer: Explain or justify alleged non-compliance or defects

Q13. What role does a Drugs Inspector play in the licensing process?

• They inspect and recommend action to the licensing authority
• They directly approve the license without oversight
• They draft commercial contracts for manufacturers
• They distribute licenses to retailers personally

Correct Answer: They inspect and recommend action to the licensing authority

Q14. Chain-of-custody for samples means:

• Documented transfer and custody history of the sample from collection to analysis
• Keeping samples in the same room without records
• Allowing anyone to handle the sample freely
• Mixing different samples together to save space

Correct Answer: Documented transfer and custody history of the sample from collection to analysis

Q15. If a Drugs Inspector identifies mislabeled or wrongly packed medicines, the inspector should:

• Seize or detain the consignment and recommend corrective or punitive action
• Change the labels themselves and return goods
• Ignore the issue and allow sale
• Destroy the packaging without records

Correct Answer: Seize or detain the consignment and recommend corrective or punitive action

Q16. Drugs Inspectors may initiate prosecution when:

• There is credible evidence of illegal manufacture, sale, or adulteration
• A product is selling well in the market
• They receive a personal request from a manufacturer
• The expiration date is near but still valid

Correct Answer: There is credible evidence of illegal manufacture, sale, or adulteration

Q17. Which record is a Drugs Inspector most likely to inspect at a manufacturing site?

• Batch manufacturing records and quality control test data
• Employees’ social media accounts
• Local grocery receipts
• Advertising contracts unrelated to production

Correct Answer: Batch manufacturing records and quality control test data

Q18. Ethical responsibility of a Drugs Inspector includes:

• Maintaining confidentiality and avoiding conflicts of interest
• Accepting gifts for faster clearance
• Promoting specific brands publicly
• Sharing confidential samples with friends

Correct Answer: Maintaining confidentiality and avoiding conflicts of interest

Q19. Which action is within the Drugs Inspector’s purview when public health risk is imminent?

• Recommend immediate recall and seizure of implicated batches
• Delay action until public demand drops
• Transfer responsibility to a private agency without notice
• Advertise the product to increase awareness

Correct Answer: Recommend immediate recall and seizure of implicated batches

Q20. During inspection, if an inspector’s findings support regulatory action, who typically issues the final order (like license suspension)?

• The licensing authority or competent higher authority
• The inspector personally without further review
• The manufacturing unit manager
• The local postmaster

Correct Answer: The licensing authority or competent higher authority

Q21. Drugs Inspectors verify storage conditions because improper storage can:

• Compromise drug stability, potency, and safety
• Improve the taste of drugs
• Reduce production costs automatically
• Increase packaging attractiveness

Correct Answer: Compromise drug stability, potency, and safety

Q22. Which document should a Drugs Inspector carry for identification during official duties?

• Official identity card issued by the appointing authority
• Personal membership card of a private club
• A university alumni certificate
• A business card from a pharmaceutical company

Correct Answer: Official identity card issued by the appointing authority

Q23. If a Drugs Inspector needs laboratory support beyond state capacity, they may:

• Refer samples to a central or notified laboratory for specialized testing
• Ask the manufacturer to test their own samples only
• Discard the samples due to lack of capacity
• Conduct all advanced tests personally without equipment

Correct Answer: Refer samples to a central or notified laboratory for specialized testing

Q24. Which of the following is a common component of an inspection report prepared by a Drugs Inspector?

• Detailed observations, non-compliances, and recommendations
• Personal opinions on company finances unrelated to quality
• Marketing suggestions for the product
• Internal staff salary details

Correct Answer: Detailed observations, non-compliances, and recommendations

Q25. When conducting inspections of retail pharmacies, a Drugs Inspector primarily checks for:

• Valid licenses, proper storage, correct dispensing of scheduled drugs
• Customer loyalty programs
• Interior decoration standards
• Number of parking spaces

Correct Answer: Valid licenses, proper storage, correct dispensing of scheduled drugs

Q26. A Drugs Inspector’s authority to examine accounts and records helps to:

• Detect illegal manufacture or diversion of regulated substances
• Ensure the company reports higher profits
• Design new drugs for the company
• Set employee performance targets

Correct Answer: Detect illegal manufacture or diversion of regulated substances

Q27. Which of the following best describes the role of the Drugs Inspector in handling counterfeit medicines?

• Identify, seize, document evidence, and support prosecution and recall actions
• Purchase counterfeit stock for resale
• Ignore counterfeit reports unless consumers complain loudly
• Relabel counterfeit products and release them

Correct Answer: Identify, seize, document evidence, and support prosecution and recall actions

Q28. In regulated inspections, maintaining impartiality means a Drugs Inspector should:

• Avoid conflicts of interest and not accept gifts or favors
• Prefer companies that give free samples
• Only inspect large manufacturers
• Share inspection schedules with favored firms

Correct Answer: Avoid conflicts of interest and not accept gifts or favors

Q29. Which activity is often part of a post-inspection follow-up by a Drugs Inspector?

• Review corrective actions taken and close the compliance loop
• Provide marketing advice to increase sales
• Hire personnel for the inspected company
• Sell seized products at auction personally

Correct Answer: Review corrective actions taken and close the compliance loop

Q30. Why is familiarity with inspection powers and duties important for B.Pharm graduates entering industry?

• It enables them to design compliant processes, respond to inspections, and ensure patient safety
• It allows them to bypass regulations legally
• It is irrelevant to pharmaceutical practice
• It only helps in sales promotions

Correct Answer: It enables them to design compliant processes, respond to inspections, and ensure patient safety

G S Sachin

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