Drugs Enquiry Committee – recommendations MCQs With Answer

Drugs Enquiry Committee – recommendations MCQs With Answer

The Drugs Enquiry Committee evaluates drug safety, investigates adverse drug reactions, and issues evidence‑based recommendations for regulatory actions such as label changes, restricted use, recalls, suspensions, or withdrawal. B.Pharm students should master pharmacovigilance, signal detection, post‑marketing surveillance, clinical trial phases, Schedule Y, and the role of regulatory authorities (CDSCO/DCGI). Understanding how committees assess causality, risk‑benefit, real‑world pharmacoepidemiology, and manufacturing compliance prepares students for careers in drug safety, regulatory affairs, and quality assurance. This concise guide emphasizes practical committee outcomes and decision pathways to deepen your regulatory insight. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary role of a Drugs Enquiry Committee?

• To manufacture drugs for the national market
• To evaluate drug safety data and recommend regulatory actions
• To set drug prices for pharmacies
• To approve medical college curricula

Correct Answer: To evaluate drug safety data and recommend regulatory actions

Q2. Which type of recommendation is most likely from a Drugs Enquiry Committee after detecting serious safety concerns?

• Increase advertisement of the drug
• Withdraw the drug from the market
• Reduce the drug’s manufacturing cost
• Merge the drug with another company

Correct Answer: Withdraw the drug from the market

Q3. Who typically implements the Drugs Enquiry Committee’s recommendations in India?

• Individual hospitals
• Central regulatory authority such as CDSCO/DCGI
• State medical councils
• Medical device manufacturers

Correct Answer: Central regulatory authority such as CDSCO/DCGI

Q4. Which of the following is NOT a common regulatory action recommended by such committees?

• Labeling updates with new warnings
• Issuing prescriber education materials
• Mandating direct-to-consumer advertising
• Restricting use to specialist centers

Correct Answer: Mandating direct-to-consumer advertising

Q5. When are Drugs Enquiry Committee recommendations most often made?

• Before any human testing
• Only during manufacturing audits
• After periodic review of post‑marketing safety and ADR reports
• Only during patent renewal

Correct Answer: After periodic review of post‑marketing safety and ADR reports

Q6. What is pharmacovigilance in the context of committee work?

• The study of drug manufacturing processes
• The monitoring and prevention of adverse drug reactions in real use
• Marketing strategies for pharmaceuticals
• Drug pricing and reimbursement review

Correct Answer: The monitoring and prevention of adverse drug reactions in real use

Q7. Which data source is most commonly used for signal detection leading to committee review?

• Spontaneous adverse event reporting databases
• Drug marketing budgets
• Physician salary reports
• Pharmacy retail counts only

Correct Answer: Spontaneous adverse event reporting databases

Q8. Which set best describes possible regulatory actions a committee can recommend?

• Advertising boosts, tax cuts, trademark changes
• Label change, restricted use, recall, withdrawal
• Price increase, packaging redesign, celebrity endorsements
• Hospital accreditation, curriculum change, licensing doctors

Correct Answer: Label change, restricted use, recall, withdrawal

Q9. What is an important characteristic of the committee’s composition?

• Only industry executives
• Predominantly marketing staff
• Multidisciplinary experts including clinicians, pharmacologists, pharmacists and statisticians
• Only legal advisors

Correct Answer: Multidisciplinary experts including clinicians, pharmacologists, pharmacists and statisticians

Q10. Which types of evidence do committees consider when forming recommendations?

• Advertising claims and sales forecasts only
• Clinical trial data, post‑marketing reports, epidemiology, and mechanistic studies
• Social media trends exclusively
• Patent length and manufacturing location

Correct Answer: Clinical trial data, post‑marketing reports, epidemiology, and mechanistic studies

Q11. What does “signal detection” mean in pharmacovigilance?

• Identifying a manufacturing defect in packaging
• Recognizing a potential new safety concern from collected data
• Measuring drug potency in the lab
• Assessing market demand for a drug

Correct Answer: Recognizing a potential new safety concern from collected data

Q12. Which regulatory action represents the most severe response to a confirmed public health risk?

• Issuing a press release
• Class III recall
• Withdrawing the product from the market
• Changing the pill color

Correct Answer: Withdrawing the product from the market

Q13. What is a risk minimization measure commonly recommended by committees?

• Increasing tablet size
• Adding contraindications and monitoring requirements to labeling
• Eliminating manufacturing quality checks
• Extending patent duration

Correct Answer: Adding contraindications and monitoring requirements to labeling

Q14. Which phase of clinical trials is focused on post‑marketing safety monitoring?

• Phase I
• Phase II
• Phase III
• Phase IV

Correct Answer: Phase IV

Q15. In India, which regulatory guidance outlines requirements for clinical trial conduct and reporting?

• Schedule M
• Schedule Y
• Schedule H
• Schedule K

Correct Answer: Schedule Y

Q16. Who is primarily responsible for reporting adverse drug reactions in a hospital setting?

• Patients only
• Pharmaceutical sales representatives
• Healthcare professionals (doctors, nurses, pharmacists)
• Hospital cafeteria staff

Correct Answer: Healthcare professionals (doctors, nurses, pharmacists)

Q17. What does PvPI stand for?

• Pharmaceutical Validation for Public Initiatives
• Pharmacovigilance Programme of India
• Public Vaccination and Prevention Initiative
• Pharmacy Vendor Partnership International

Correct Answer: Pharmacovigilance Programme of India

Q18. Expedited reporting of fatal or life‑threatening serious unexpected adverse drug reactions is typically required within how many days?

• 30 days
• 15 days
• 7 days
• 90 days

Correct Answer: 7 days

Q19. Which recall classification indicates the highest risk of causing serious adverse health consequences or death?

• Class III
• Class II
• Class I
• No classification

Correct Answer: Class I

Q20. Why is benefit‑risk assessment central to committee decisions?

• It helps determine manufacturing costs
• It balances therapeutic benefits against potential harms to inform regulatory action
• It calculates expected profit margins
• It schedules marketing campaigns

Correct Answer: It balances therapeutic benefits against potential harms to inform regulatory action

Q21. What is the role of pharmacoepidemiology in committee evaluations?

• Studying individual case reports exclusively
• Analyzing drug effects and safety patterns in large populations
• Designing drug manufacturing plants
• Assessing advertising effectiveness

Correct Answer: Analyzing drug effects and safety patterns in large populations

Q22. What is a “black box” warning?

• A minor editorial note in the brochure
• The strongest safety warning placed on a drug label indicating serious risks
• A recommendation to change the drug color
• A financial penalty for noncompliance

Correct Answer: The strongest safety warning placed on a drug label indicating serious risks

Q23. If a manufacturing site repeatedly fails GMP inspections, what action might a committee recommend?

• Increase production quota
• Suspend the manufacturing license until corrective actions are implemented
• Reduce employee salaries
• Change the brand name

Correct Answer: Suspend the manufacturing license until corrective actions are implemented

Q24. Where are Drugs Enquiry Committee recommendations typically recorded and shared?

• In the committee’s minutes and official recommendation reports to the regulator
• Only in private emails between members
• On social media posts by the chairperson
• In pharmacy sales invoices

Correct Answer: In the committee’s minutes and official recommendation reports to the regulator

Q25. Which independent body primarily monitors safety during ongoing clinical trials?

• Drug advertising board
• Data Safety Monitoring Board (DSMB)
• Local pharmacy association
• Clinical trial marketing team

Correct Answer: Data Safety Monitoring Board (DSMB)

Q26. What is the main purpose of a labeling change recommended by a committee?

• To increase the drug’s price
• To update prescriber and patient information about new safety findings or contraindications
• To change the company logo
• To modify the manufacturing address

Correct Answer: To update prescriber and patient information about new safety findings or contraindications

Q27. When a committee recommends withdrawal, what is a key regulatory responsibility to protect patients?

• Silence the recommendation until stock expires
• Communicate risks and manage patient transition to safe alternatives
• Increase promotional activities to clear inventory
• Ignore manufacturing records

Correct Answer: Communicate risks and manage patient transition to safe alternatives

Q28. A recommendation to limit distribution of a drug only to accredited centers is known as which strategy?

• Open market expansion
• Restricted distribution program
• Mass public release
• Universal prescribing policy

Correct Answer: Restricted distribution program

Q29. Which epidemiological metric is commonly used to quantify how often adverse events occur in a population exposed to a drug?

• Market share percentage
• Incidence rate
• Advertising reach
• Gross profit margin

Correct Answer: Incidence rate

Q30. Which national body has legal authority to enforce committee recommendations in India?

• Medical Council of India
• Central Drugs Standard Control Organization (CDSCO)
• Reserve Bank of India
• Food Corporation of India

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

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