Herbal drug industry – current scenario, scope and future prospects MCQs With Answer

Herbal drug industry – current scenario, scope and future prospects MCQs With Answer

The herbal drug industry is rapidly evolving, driven by growing global demand for phytopharmaceuticals, traditional medicines and herbal formulations. B. Pharm students must understand the current scenario, regulatory frameworks (WHO, CDSCO, AYUSH, FDA botanical guidance), quality control, standardization techniques (HPLC, HPTLC, GC-MS, DNA barcoding), Good Agricultural and Collection Practices (GACP), safety, herb–drug interactions and clinical research approaches. Scope and future prospects include sustainable sourcing, novel dosage forms, pharmacovigilance, intellectual property, biotechnology and evidence-based validation. This topic integrates pharmacognosy, analytical chemistry and regulatory science to prepare students for industry careers and research. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which regulatory category introduced by CDSCO specifically addresses standardized single-ingredient plant-based drugs with defined bioactive marker and clinical data?

• Traditional herbal medicine
• Phytopharmaceuticals
• Herbal supplements
• Classical Ayurvedic formulation

Correct Answer: Phytopharmaceuticals

Q2. Good Agricultural and Collection Practices (GACP) primarily ensure which aspect of herbal raw materials?

• Clinical efficacy in humans
• Consistent quality and sustainability of plant material
• Marketing authorization
• Packaging aesthetics

Correct Answer: Consistent quality and sustainability of plant material

Q3. Which analytical technique is best suited for fingerprint profiling and simultaneous visualization of multiple phytoconstituents for herbal standardization?

• HPTLC (High Performance Thin Layer Chromatography)
• IR spectroscopy only
• Particle size analysis
• Osmolality testing

Correct Answer: HPTLC (High Performance Thin Layer Chromatography)

Q4. DNA barcoding in herbal drug industry is used mainly to:

• Measure antioxidant activity
• Authenticate plant species and detect adulteration
• Replace HPLC for quantification
• Determine heavy metal content

Correct Answer: Authenticate plant species and detect adulteration

Q5. Which guideline by international regulators provides specific considerations for development of botanical drug products in the United States?

• ICH Q1A stability guideline
• FDA Botanical Drug Guidance
• EMA orphan drug regulation
• WHO Good Manufacturing Practices

Correct Answer: FDA Botanical Drug Guidance

Q6. Marker-based standardization of herbal extracts refers to:

• Standardizing against a synthetic impurity
• Quantifying selected bioactive or characteristic compound(s)
• Measuring only moisture content
• Standardizing tablet hardness

Correct Answer: Quantifying selected bioactive or characteristic compound(s)

Q7. Which quality parameter assesses microbial safety in herbal formulations?

• Limit tests for heavy metals
• Microbial limit tests and absence of specified pathogens
• Disintegration time only
• pH measurement only

Correct Answer: Microbial limit tests and absence of specified pathogens

Q8. Heavy metal contamination in herbal products is commonly monitored for which elements?

• Lead, arsenic, cadmium and mercury
• Sodium and potassium only
• Iron and calcium only
• Gold and silver

Correct Answer: Lead, arsenic, cadmium and mercury

Q9. Which stability study guideline is commonly applied when evaluating shelf life of herbal formulations?

• ICH stability guidelines
• USP animal testing guidelines
• OECD reproductive toxicity guidelines
• EPA environmental guidelines

Correct Answer: ICH stability guidelines

Q10. Pharmacovigilance for herbal medicines primarily focuses on:

• Product pricing strategies
• Adverse event reporting, safety monitoring and risk management
• Manufacturing yield optimization
• Label design choices

Correct Answer: Adverse event reporting, safety monitoring and risk management

Q11. Which extraction parameter most directly affects yield and composition of herbal extracts?

• Solvent type, temperature and time
• Tablet compression force
• Marketing claims
• Glassware color

Correct Answer: Solvent type, temperature and time

Q12. HPLC is preferred in herbal analysis mainly for:

• Qualitative smell assessment
• Accurate quantification and separation of phytoconstituents
• Measuring viscosity only
• Counting microbial colonies

Correct Answer: Accurate quantification and separation of phytoconstituents

Q13. Which term describes a reproducible chemical profile used to ensure batch-to-batch consistency of herbal products?

• Pharmacokinetic curve
• Chemical fingerprint
• Marketing dossier
• Dietary reference intake

Correct Answer: Chemical fingerprint

Q14. Herb–drug interactions are often mediated by modulation of which enzyme family?

• CYP450 enzymes
• Peptidases only
• DNA polymerases
• Lipases only

Correct Answer: CYP450 enzymes

Q15. Good Manufacturing Practices (GMP) for herbal products primarily target:

• Clinical trial design
• Quality, hygiene, documentation and process control during manufacturing
• Brand logo creation
• Physician prescribing behavior

Correct Answer: Quality, hygiene, documentation and process control during manufacturing

Q16. The WHO monographs on selected medicinal plants are important because they:

• Provide marketing strategies
• Offer internationally recognized quality and safety information for herbal species
• Authorize domestic manufacturing only
• Prescribe fixed clinical protocols

Correct Answer: Offer internationally recognized quality and safety information for herbal species

Q17. Which clinical evidence type provides the highest level of evidence for efficacy of an herbal drug?

• Randomized, double-blind, placebo-controlled clinical trials
• In vitro antioxidant assays
• Traditional use claims without documentation
• Case reports only

Correct Answer: Randomized, double-blind, placebo-controlled clinical trials

Q18. Which of the following is a major sustainability concern in herbal drug industry?

• Excessive synthetic polymer use
• Overharvesting and loss of biodiversity
• Tablet color stability
• Excessive sugar in syrups

Correct Answer: Overharvesting and loss of biodiversity

Q19. Standard operating procedures (SOPs) in herbal manufacturing are essential for:

• Ensuring consistent processing, quality control and regulatory compliance
• Replacing analytical testing
• Guaranteeing therapeutic claims without data
• Designing promotional brochures

Correct Answer: Ensuring consistent processing, quality control and regulatory compliance

Q20. Which regulatory body in India is primarily responsible for approval of new drugs including phytopharmaceuticals?

• AYUSH only
• Central Drugs Standard Control Organization (CDSCO)
• Ministry of Agriculture
• Bureau of Indian Standards (BIS)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q21. A key advantage of developing standardized herbal extracts over crude plant material is:

• Lower production costs always
• Improved reproducibility, dosing accuracy and potential for clinical development
• Complete elimination of adverse effects
• No need for regulatory approval

Correct Answer: Improved reproducibility, dosing accuracy and potential for clinical development

Q22. Which assay is commonly used for preliminary screening of antioxidant potential of herbal extracts?

• DPPH radical scavenging assay
• Chromatography for fingerprints
• Glucose tolerance test
• Viscosity measurement

Correct Answer: DPPH radical scavenging assay

Q23. Residual solvent limits in herbal extracts are assessed according to which type of guideline?

• ICH Q3C guidelines on residual solvents
• WHO GACP guidelines
• Clinical trial registries
• Pharmacovigilance reporting

Correct Answer: ICH Q3C guidelines on residual solvents

Q24. In developing an herbal capsule product, which factor is crucial for ensuring bioavailability of active phytoconstituents?

• Particle size, excipient selection and dissolution profile
• Color of the capsule shell only
• Packaging design only
• Company logo placement

Correct Answer: Particle size, excipient selection and dissolution profile

Q25. Which documentation is essential part of a regulatory dossier for a phytopharmaceutical in many jurisdictions?

• Quality module, non-clinical and clinical data supporting safety and efficacy
• Only the company’s marketing plan
• Employee salaries
• Social media strategy

Correct Answer: Quality module, non-clinical and clinical data supporting safety and efficacy

Q26. Which concept helps in identifying toxic contaminants like pesticide residues in herbal raw materials?

• Pesticide residue analysis using GC-MS or LC-MS/MS
• Tablet friability test
• Visual organoleptic examination only
• pH meter calibration

Correct Answer: Pesticide residue analysis using GC-MS or LC-MS/MS

Q27. The term “phytopharmaceutical” differs from “herbal supplement” mainly because:

• Phytopharmaceuticals require demonstration of quality, safety and clinical efficacy similar to conventional drugs
• Herbal supplements are always prescription-only
• Phytopharmaceuticals have no active constituents
• Herbal supplements are always more expensive

Correct Answer: Phytopharmaceuticals require demonstration of quality, safety and clinical efficacy similar to conventional drugs

Q28. Which international body provides guidance and promotes harmonization for medicinal plant quality and safety?

• World Health Organization (WHO)
• International Olympic Committee (IOC)
• World Trade Organization (WTO)
• International Accounting Standards Board (IASB)

Correct Answer: World Health Organization (WHO)

Q29. In herbal product development, bioassay-guided fractionation is used to:

• Isolate active fractions based on biological activity to identify lead compounds
• Measure product viscosity
• Reduce microbial contamination only
• Standardize color tone

Correct Answer: Isolate active fractions based on biological activity to identify lead compounds

Q30. Future prospects of the herbal drug industry for B. Pharm graduates include careers in:

• Phytopharmaceutical research, quality control, regulatory affairs, production and clinical research
• Only retail sales
• Archaeology unrelated to pharmaceuticals
• Graphic designing exclusively

Correct Answer: Phytopharmaceutical research, quality control, regulatory affairs, production and clinical research

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