Herbal drug standardization – AYUSH guidelines MCQs With Answer

Introduction

Herbal drug standardization under AYUSH guidelines is essential for ensuring the safety, quality and efficacy of traditional medicines. This blog presents a focused set of multiple-choice questions tailored for M.Pharm students studying Herbal and Cosmetic Analysis (MPA 204T). The questions cover regulatory frameworks, pharmacopeial monographs, GACP/GMP practices, analytical techniques (HPTLC, HPLC, GC-MS), DNA authentication, limits for heavy metals, microbial and pesticide residues, stability testing and modern quality markers. Use these MCQs to reinforce core concepts, prepare for exams and bridge practical analytical knowledge with AYUSH regulatory expectations in herbal drug standardization.

Q1. What is the primary objective of AYUSH guidelines for herbal drug standardization?

• To standardize only manufacturing processes
• To establish quality, safety and efficacy of herbal medicines through standardization
• To promote export of herbal products only
• To replace traditional knowledge with synthetic drugs

Correct Answer: To establish quality, safety and efficacy of herbal medicines through standardization

Q2. GACP in the context of herbal drug standardization stands for which of the following?

• Good Analytical and Clinical Practices
• Good Agricultural and Collection Practices
• General Accreditation of Chemical Processes
• Guidelines for Adulteration and Contaminant Prevention

Correct Answer: Good Agricultural and Collection Practices

Q3. Which authority publishes the Ayurvedic Pharmacopoeia of India (API)?

• World Health Organization (WHO)
• Ministry of AYUSH, Government of India
• Indian Council of Medical Research (ICMR)
• Pharmacy Council of India (PCI)

Correct Answer: Ministry of AYUSH, Government of India

Q4. In AYUSH standardization, a “marker compound” is best defined as:

• A contaminant that must be removed
• An inert excipient used in herbal formulations
• A chemical constituent used to assess identity, quality and consistency of a herbal drug
• An artificial dye added for appearance

Correct Answer: A chemical constituent used to assess identity, quality and consistency of a herbal drug

Q5. Which chromatographic technique is most commonly recommended in AYUSH monographs for herbal fingerprinting?

• Gas chromatography (GC)
• High performance thin layer chromatography (HPTLC)
• Size exclusion chromatography (SEC)
• Ion exchange chromatography (IEC)

Correct Answer: High performance thin layer chromatography (HPTLC)

Q6. DNA barcoding in herbal drug standardization is primarily used for:

• Quantifying active constituent concentrations
• Authenticating plant species and detecting adulteration
• Measuring moisture content
• Determining shelf-life

Correct Answer: Authenticating plant species and detecting adulteration

Q7. Which set of heavy metals is specifically emphasized for monitoring in AYUSH herbal drug quality checks?

• Iron, Zinc, Copper and Magnesium
• Lead, Mercury, Arsenic and Cadmium
• Selenium, Boron, Nickel and Cobalt
• Calcium, Potassium, Sodium and Chloride

Correct Answer: Lead, Mercury, Arsenic and Cadmium

Q8. Which international guideline is commonly referenced by AYUSH for microbial limit specifications in herbal products?

• ICH Q7
• WHO guidelines on quality control methods for medicinal plant materials
• European Medicines Agency GMP Annex 1
• US Pharmacopeia only

Correct Answer: WHO guidelines on quality control methods for medicinal plant materials

Q9. Stability testing for determining shelf-life of an herbal formulation typically includes which of the following parameters?

• Organoleptic properties, assay of active markers, moisture content and microbial limits
• Only pack size and color
• Marketing claims and sales data
• Geographical origin only

Correct Answer: Organoleptic properties, assay of active markers, moisture content and microbial limits

Q10. Which analytical technique is most appropriate for routine screening and quantification of pesticide residues in herbal raw materials?

• Nuclear magnetic resonance (NMR)
• Gas chromatography coupled with mass spectrometry (GC-MS)
• Thin layer chromatography (TLC) without detectors
• Polarimetry

Correct Answer: Gas chromatography coupled with mass spectrometry (GC-MS)

Q11. The AYUSH document that provides specific Good Manufacturing Practice requirements for Ayurvedic, Siddha and Unani drugs is titled:

• International GMP for All Pharmaceuticals
• GMP for Ayurvedic, Siddha and Unani (ASU) Drugs published by Ministry of AYUSH
• Pharmacognosy Manual of Herbal Excipients
• Guidelines for Synthetic Drug Manufacturing

Correct Answer: GMP for Ayurvedic, Siddha and Unani (ASU) Drugs published by Ministry of AYUSH

Q12. A pharmacopeial monograph for a herbal raw material typically includes which of the following sections?

• Botanical source, description, microscopy, chemical tests, assay and limits
• Only the price and market demand
• Only therapeutic claims and dosage forms
• Advertising strategy for the product

Correct Answer: Botanical source, description, microscopy, chemical tests, assay and limits

Q13. Residual solvent analysis in herbal extracts is typically performed by which method recommended in quality control?

• Ultraviolet-visible spectrophotometry (UV-Vis)
• Gas chromatography (GC)
• Polarimetry
• Flame photometry

Correct Answer: Gas chromatography (GC)

Q14. Which mycotoxin is routinely monitored in herbal raw materials due to its potent toxicity and regulatory importance?

• Patulin
• Aflatoxins
• Ochratoxin A only in liquids
• Deoxynivalenol exclusively in spices

Correct Answer: Aflatoxins

Q15. Which of the following is NOT a parameter of organoleptic evaluation for herbal drugs?

• Color
• Taste
• Odor
• Infrared spectral fingerprint

Correct Answer: Infrared spectral fingerprint

Q16. Thermogravimetric analysis (TGA) in herbal drug analysis is primarily used to determine:

• Pesticide residues composition
• Thermal stability and moisture/volatile content
• DNA barcode sequences
• Alkaloid molecular weights

Correct Answer: Thermal stability and moisture/volatile content

Q17. Which accreditation body is commonly used in India to accredit laboratories performing herbal drug analysis?

• NABL (National Accreditation Board for Testing and Calibration Laboratories)
• FDA (Food and Drug Administration)
• ISO central office only
• EMA (European Medicines Agency)

Correct Answer: NABL (National Accreditation Board for Testing and Calibration Laboratories)

Q18. In raw drug authentication for Ayurvedic botanicals, palynology is the study of:

• Leaf surface morphology
• Pollen and spore morphology
• Root alkaloid profiles
• Soil microbial flora

Correct Answer: Pollen and spore morphology

Q19. For accurate quantification of alkaloids in herbal formulations, which analytical method is preferred in AYUSH-oriented quality control?

• Thin layer chromatography without densitometry
• High performance liquid chromatography (HPLC)
• Simple pH measurement
• Gravimetric titration

Correct Answer: High performance liquid chromatography (HPLC)

Q20. Which international instrument is commonly referenced for maximum residue limits (MRLs) of pesticides relevant to herbal commodities?

• International Council for Harmonisation (ICH) Q3C
• Codex Alimentarius (Joint FAO/WHO Food Standards Programme)
• European Pharmacopoeia general notices only
• National List of Essential Medicines

Correct Answer: Codex Alimentarius (Joint FAO/WHO Food Standards Programme)

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