Pharmacovigilance in India: national programmes and roles MCQs With Answer

Pharmacovigilance in India: national programmes and roles MCQs With Answer

This quiz-focused blog presents targeted multiple-choice questions on pharmacovigilance in India designed for M.Pharm students preparing for exams and professional practice. It reviews the structure, national programmes, reporting mechanisms, stakeholders, databases and regulatory context that shape drug safety monitoring. Questions emphasize the Pharmacovigilance Programme of India (PvPI), roles of the National Coordination Centre and ADR Monitoring Centres, Individual Case Safety Reports (ICSRs), signal detection, industry responsibilities, and international standards such as ICH E2B and VigiBase. Each MCQ is followed by the correct answer to reinforce learning and help students deepen their conceptual and practical understanding of pharmacovigilance systems in India.

Q1. What does PvPI stand for?

• Pharmacovigilance Programme of India
• Pharmaceutical Vigilance and Policy Initiative
• Patient Vaccination and Pharmacology Institute
• Provincial Pharmacovigilance Implementation

Correct Answer: Pharmacovigilance Programme of India

Q2. Where is the National Coordination Centre (NCC) for PvPI located?

• All India Institute of Medical Sciences (AIIMS), New Delhi
• Central Drugs Standard Control Organization (CDSCO), Mumbai
• Indian Pharmacopoeia Commission (IPC), Ghaziabad
• World Health Organization (WHO) Country Office, New Delhi

Correct Answer: Indian Pharmacopoeia Commission (IPC), Ghaziabad

Q3. What is the primary objective of PvPI?

• To approve new drugs and issue marketing licences
• To collect, analyse and act on adverse drug reaction (ADR) data to safeguard patient safety
• To manufacture generic medicines for government procurement
• To provide medical treatment for ADR patients

Correct Answer: To collect, analyse and act on adverse drug reaction (ADR) data to safeguard patient safety

Q4. Which global database receives safety reports contributed by PvPI?

• FAERS (FDA Adverse Event Reporting System)
• VigiBase maintained by the Uppsala Monitoring Centre
• EMA EudraVigilance
• WHO Vaccine Safety Net

Correct Answer: VigiBase maintained by the Uppsala Monitoring Centre

Q5. What is the main function of an ADR Monitoring Centre (AMC) under PvPI?

• To grant marketing authorizations to pharmaceutical companies
• To collect, document and forward Individual Case Safety Reports (ICSRs) to the NCC
• To manufacture medicines for adverse event management
• To conduct clinical trials for new molecules

Correct Answer: To collect, document and forward Individual Case Safety Reports (ICSRs) to the NCC

Q6. Which software/tool is commonly used by national centres to manage and transmit ICSRs to the Uppsala Monitoring Centre?

• MedDRA Explorer
• VigiFlow
• SPSS Signal Miner
• Excel Safety Tracker

Correct Answer: VigiFlow

Q7. Who holds primary legal responsibility for establishing and maintaining a pharmacovigilance system for a marketed medicine in India?

• National Coordination Centre (NCC)
• Marketing Authorization Holder (MAH)
• Individual clinicians who prescribe the drug
• State Drug Inspector

Correct Answer: Marketing Authorization Holder (MAH)

Q8. Which international guideline defines the electronic transmission standard for Individual Case Safety Reports (ICSRs)?

• ICH E2B (R3)
• ICH Q9
• GCP E6(R2)
• ISO 9001

Correct Answer: ICH E2B (R3)

Q9. Which part of Indian regulatory framework specifically addresses reporting of adverse events during clinical trials?

• Schedule Y of the Drugs and Cosmetics Rules
• Indian Pharmacopoeia Volume I
• National List of Essential Medicines
• Pharmacy Practice Guidelines

Correct Answer: Schedule Y of the Drugs and Cosmetics Rules

Q10. What does PSUR stand for in pharmacovigilance?

• Product Safety Use Report
• Periodic Safety Update Report
• Pharmacovigilance Safety Utilization Record
• Post-marketing Safety User Review

Correct Answer: Periodic Safety Update Report

Q11. Which statement best differentiates an AEFI from an ADR?

• An AEFI is any adverse event related to medicines other than vaccines, while ADRs are only vaccine-related
• An AEFI specifically refers to adverse events following immunization (vaccines) and is managed by immunization surveillance, whereas ADRs encompass adverse reactions to all medicinal products
• AEFI refers to adverse events in animals and ADRs refer to humans
• AEFI and ADR are interchangeable terms describing the same concept

Correct Answer: An AEFI specifically refers to adverse events following immunization (vaccines) and is managed by immunization surveillance, whereas ADRs encompass adverse reactions to all medicinal products

Q12. Which disproportionality measure is commonly used by the Uppsala Monitoring Centre for signal detection?

• Odds Ratio (OR)
• Proportional Reporting Ratio (PRR)
• Information Component (IC)
• Hazard Ratio (HR)

Correct Answer: Information Component (IC)

Q13. Who typically performs the initial causality assessment of an individual ADR report submitted to an AMC?

• Central Drugs Standard Control Organization (CDSCO) only
• Pharmacists at community pharmacies without a formal tool
• ADR Monitoring Centre (AMC) staff using WHO-UMC or other validated causality assessment methods
• Pharmaceutical sales representatives

Correct Answer: ADR Monitoring Centre (AMC) staff using WHO-UMC or other validated causality assessment methods

Q14. Which mobile facility has been promoted by PvPI to facilitate consumer reporting of suspected ADRs?

• MedWatch India App
• ADR PvPI mobile app
• Indian Drug Safety Tracker
• VaccineWatch Mobile

Correct Answer: ADR PvPI mobile app

Q15. In which year was the Pharmacovigilance Programme of India (PvPI) launched?

• 1998
• 2005
• 2010
• 2018

Correct Answer: 2010

Q16. Which organization maintains VigiBase, the WHO global database of ICSRs?

• Central Drugs Standard Control Organization (CDSCO)
• Uppsala Monitoring Centre (UMC)
• Indian Pharmacopoeia Commission (IPC)
• European Medicines Agency (EMA)

Correct Answer: Uppsala Monitoring Centre (UMC)

Q17. Which of the following is NOT a core responsibility of PvPI?

• Collecting and analysing spontaneous ADR reports
• Generating national safety signals and communicating risks
• Approving marketing authorizations for new drugs
• Conducting capacity building and training for AMCs

Correct Answer: Approving marketing authorizations for new drugs

Q18. What is an Individual Case Safety Report (ICSR)?

• A standardized report containing details of a single suspected adverse reaction associated with one or more medicinal products
• A quarterly financial statement from a pharmaceutical company
• A marketing brochure for a drug product
• A batch manufacturing record for drug production

Correct Answer: A standardized report containing details of a single suspected adverse reaction associated with one or more medicinal products

Q19. Which causality assessment method is recommended and commonly used by PvPI and many AMCs in India?

• WHO-UMC causality assessment system
• Karnofsky Performance Scale
• APACHE II scoring
• Glasgow Coma Scale

Correct Answer: WHO-UMC causality assessment system

Q20. Which stakeholder is primarily responsible for submitting Periodic Safety Update Reports (PSURs) and establishing a local pharmacovigilance system?

• Healthcare professionals only
• Marketing Authorization Holder (MAH)
• Patients and caregivers
• National Coordination Centre (NCC) alone

Correct Answer: Marketing Authorization Holder (MAH)

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