AYUSH guidelines for safety monitoring of herbal drugs MCQs With Answer

Introduction:

This quiz collection focuses on AYUSH guidelines for safety monitoring of herbal drugs, tailored for M.Pharm students taking Herbal and Cosmetic Analysis (MPA 204T). It reinforces regulatory principles, pharmacovigilance structures, causality assessment, signal detection, reporting processes, and risk minimization specific to Ayurvedic, Siddha and Unani medicines. Questions combine conceptual understanding with application to real-world scenarios such as contamination, herb–drug interactions, and quality defects. The aim is to strengthen students’ ability to evaluate safety data, prepare and interpret Individual Case Safety Reports (ICSRs), and apply AYUSH-oriented monitoring strategies in clinical and post-marketing contexts. Use this set to prepare for exams and practical pharmacovigilance responsibilities.

Q1. What is the most appropriate definition of pharmacovigilance in the context of AYUSH herbal medicines?

• The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems for herbal medicines
• The mandatory clinical trial program for evaluating efficacy of traditional formulations
• The quality control tests performed only at raw-material procurement for herbal drugs
• A marketing surveillance activity focused only on consumer complaints

Correct Answer: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems for herbal medicines

Q2. Which of the following is an essential structural component recommended for an AYUSH safety monitoring network?

• Central coordinating pharmacovigilance centre, peripheral reporting centres and a national database
• Only individual academic centres responsible for all reporting
• Private marketing agencies for each manufacturer to collect adverse event data
• Exclusive use of social media monitoring without formal centres

Correct Answer: Central coordinating pharmacovigilance centre, peripheral reporting centres and a national database

Q3. Which report format is commonly used for documenting individual adverse events in herbal pharmacovigilance?

• Individual Case Safety Report (ICSR)
• Periodic Safety Update Report (PSUR)
• Quality Batch Release Certificate
• Clinical Study Protocol

Correct Answer: Individual Case Safety Report (ICSR)

Q4. According to standard pharmacovigilance definitions applied to AYUSH, an adverse drug reaction (ADR) is best described as:

• A harmful and unintended response to a medicinal product that occurs at normal doses used in humans
• An expected therapeutic effect observed when the correct dose is used
• A complaint about product taste or smell that does not affect safety
• An effect observed only in animal toxicology studies

Correct Answer: A harmful and unintended response to a medicinal product that occurs at normal doses used in humans

Q5. Which causality assessment system is widely recommended and used for evaluating suspected ADRs from herbal medicines?

• WHO-UMC causality assessment system
• Good Manufacturing Practice (GMP) checklist
• ICH E6 clinical monitoring checklist
• GCP informed consent form

Correct Answer: WHO-UMC causality assessment system

Q6. Which of the following best describes a pharmacovigilance signal?

• Information that arises from one or multiple sources suggesting a new potentially causal association or new aspect of a known ADR
• Marketing data showing increased sales of an herbal product
• Any consumer comment about product packaging
• Routine batch testing confirming expected herbal fingerprint

Correct Answer: Information that arises from one or multiple sources suggesting a new potentially causal association or new aspect of a known ADR

Q7. Which factor is NOT a common contributor to adverse reactions associated with herbal medicines?

• Therapeutic dose-range well-established by randomized clinical trials
• Contamination with heavy metals or pesticides
• Adulteration with synthetic pharmaceuticals
• Misidentification or substitution of botanical species

Correct Answer: Therapeutic dose-range well-established by randomized clinical trials

Q8. Which method is considered the most important for early detection of spontaneous ADRs in AYUSH pharmacovigilance?

• Spontaneous (voluntary) reporting by health professionals and consumers
• Only periodic review of manufacturing documents
• Exclusive reliance on pre-marketing clinical trials
• Annual market share analysis

Correct Answer: Spontaneous (voluntary) reporting by health professionals and consumers

Q9. Which of the following best describes a “serious adverse event” in herbal safety monitoring?

• An adverse event that results in death, is life-threatening, requires hospitalization or results in persistent disability
• A mild transient gastrointestinal upset resolving without care
• A cosmetic complaint about product color
• An adverse event reported only in animal studies

Correct Answer: An adverse event that results in death, is life-threatening, requires hospitalization or results in persistent disability

Q10. Which is the primary mechanism by which herb–drug pharmacokinetic interactions commonly occur?

• Induction or inhibition of drug metabolizing enzymes (e.g., CYP450) and transporters
• Instantaneous neutralization of active ingredient by water
• Physical incompatibility during tablet compression only
• Changes in product labeling

Correct Answer: Induction or inhibition of drug metabolizing enzymes (e.g., CYP450) and transporters

Q11. Which of the following is a recommended action for a central AYUSH pharmacovigilance centre upon identification of a validated safety signal?

• Initiate risk assessment, communicate risk minimization measures and consider further investigation
• Immediately withdraw all products without assessment
• Ignore the signal until a competitor reports similar events
• Only inform marketing departments to change packaging color

Correct Answer: Initiate risk assessment, communicate risk minimization measures and consider further investigation

Q12. Which dataset item is essential when completing an ICSR for an herbal adverse event?

• Suspected medicinal product name and description, adverse event description, patient age/sex, reporter contact and outcome
• Only the marketing authorization holder’s annual turnover
• Laboratory SOPs for raw material analysis only
• Social media comments without patient details

Correct Answer: Suspected medicinal product name and description, adverse event description, patient age/sex, reporter contact and outcome

Q13. Which statistical method is commonly used in spontaneous report databases for signal detection?

• Disproportionality analysis such as Proportional Reporting Ratio (PRR) or Reporting Odds Ratio (ROR)
• Kaplan–Meier survival curve analysis for marketing data
• Fourier transform for batch fingerprinting
• ANOVA for raw herb growth rates

Correct Answer: Disproportionality analysis such as Proportional Reporting Ratio (PRR) or Reporting Odds Ratio (ROR)

Q14. Which of the following is a recognized limitation of spontaneous ADR reporting for herbal medicines?

• Underreporting and incomplete information limiting causality assessment
• It captures all safety events comprehensively with no delays
• It eliminates need for any further investigations
• It guarantees product recalls when needed

Correct Answer: Underreporting and incomplete information limiting causality assessment

Q15. Which tool is commonly used alongside WHO-UMC to provide a quantitative causality score in suspected ADRs?

• Naranjo algorithm
• GMP audit checklist
• ICH Q9 risk management template
• Pharmacopoeial monograph assay

Correct Answer: Naranjo algorithm

Q16. Which risk minimization measure is most appropriate when a serious but rare ADR is causally linked to a traditional formulation?

• Update product labeling/warnings, educate prescribers and consider restricted use or contraindications
• Remove the product immediately from all stores without communication
• Increase advertising to clarify benefits
• Change the bottle cap color to alert consumers

Correct Answer: Update product labeling/warnings, educate prescribers and consider restricted use or contraindications

Q17. Which quality issue should be reported through AYUSH safety monitoring when identified in a marketed herbal product?

• Presence of undeclared heavy metals above permissible limits
• Consumer preference for syrup over tablet format
• Limited shelf display space in a pharmacy
• Positive customer review on efficacy

Correct Answer: Presence of undeclared heavy metals above permissible limits

Q18. Which of the following best describes the role of preclinical toxicology in AYUSH safety evaluation?

• To identify potential organ toxicity, genotoxicity and dose-related hazards prior to human exposure
• To replace all clinical monitoring after product launch
• To guarantee absence of herb–drug interactions in humans
• To determine packaging aesthetics for marketing

Correct Answer: To identify potential organ toxicity, genotoxicity and dose-related hazards prior to human exposure

Q19. Which barrier commonly impedes effective pharmacovigilance for AYUSH medicines?

• Perception that traditional use implies absolute safety leading to underreporting
• Abundant high-quality randomized safety trials for all products
• Excessive use of standardized electronic reporting tools by all users
• Universal mandatory reporting laws in all settings

Correct Answer: Perception that traditional use implies absolute safety leading to underreporting

Q20. Which ethical consideration is essential when collecting and sharing ICSR data for AYUSH safety monitoring?

• Protecting patient confidentiality and ensuring responsible data sharing while enabling safety assessment
• Publishing identifiable patient narratives on social media for transparency
• Selling adverse event data to marketing agencies
• Withholding serious ADRs to protect local practitioners

Correct Answer: Protecting patient confidentiality and ensuring responsible data sharing while enabling safety assessment

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