Regulatory requirements for herbal industry: Indian and international perspectives MCQs With Answer

Introduction

This quiz collection on Regulatory requirements for herbal industry: Indian and international perspectives is designed for M.Pharm students studying Industrial Pharmacognostical Technology (MPG 104T). It highlights key statutory frameworks, quality standards, and global guidance that govern production, testing, labeling, clinical evaluation and post-marketing surveillance of herbal products. Questions focus on Indian laws (Drugs & Cosmetics Act, Ministry of AYUSH rules, Schedule T), WHO recommendations (GACP, GMP), and international systems such as FDA, EMA, EU directives, and Health Canada. Use these MCQs to deepen understanding of regulatory pathways, documentation requirements, quality control, safety monitoring and permissible claims for herbal medicines across jurisdictions.

Q1. Which Indian regulatory body is primarily responsible for formulating policies and standards specific to Ayurveda, Siddha and Unani systems of medicine?

• Central Drugs Standard Control Organization (CDSCO)
• Ministry of AYUSH
• Pharmacopoeia Commission for Indian Medicine
• National Institute of Pharmaceutical Education

Correct Answer: Ministry of AYUSH

Q2. Under Indian regulations, which schedule of the Drugs and Cosmetics Rules provides Good Manufacturing Practices specifically for Ayurveda, Siddha and Unani pharmaceutical manufacturers?

• Schedule M
• Schedule Y
• Schedule T
• Schedule P

Correct Answer: Schedule T

Q3. Which WHO guideline focuses on cultivation and collection practices to ensure quality of medicinal plant materials?

• WHO Good Manufacturing Practices (GMP) for pharmaceutical products
• WHO Guidelines on Quality Control of Herbal Medicines
• WHO Good Agricultural and Collection Practices (GACP) for Medicinal Plants
• WHO Pharmacovigilance Guidelines

Correct Answer: WHO Good Agricultural and Collection Practices (GACP) for Medicinal Plants

Q4. In the United States, which law defines and regulates dietary supplements, often including many herbal products?

• Federal Food, Drug, and Cosmetic Act (FD&C Act) without amendments
• Dietary Supplement Health and Education Act (DSHEA)
• Food Safety Modernization Act (FSMA)
• Pure Food and Drug Act

Correct Answer: Dietary Supplement Health and Education Act (DSHEA)

Q5. Which international body issues monographs and assessment reports specifically for herbal medicines used as a scientific reference for regulatory purposes in Europe?

• Codex Alimentarius Commission
• European Medicines Agency Committee on Herbal Medicinal Products (HMPC)
• International Council for Harmonisation (ICH)
• Pharmacopoeia Commission of India

Correct Answer: European Medicines Agency Committee on Herbal Medicinal Products (HMPC)

Q6. For a new herbal formulation not mentioned in authoritative traditional texts in India, what regulatory requirement typically applies before marketing?

• No requirement — it can be marketed as a food
• Obtain approval as a new drug with safety and efficacy data
• Only label registration is required with state authorities
• Submission of a sample to the Pharmacopoeia Commission is sufficient

Correct Answer: Obtain approval as a new drug with safety and efficacy data

Q7. Which document provides guidance to industry on the development of botanical drug products in the United States?

• FDA Guidance: Botanical Drug Development
• USP Botanical Standards Manual
• EPA Botanical Product Guidance
• NIH Complementary Medicine Monograph

Correct Answer: FDA Guidance: Botanical Drug Development

Q8. Which of the following is a primary quality parameter regulatory authorities expect for herbal raw materials during procurement?

• Organoleptic evaluation only
• Certificate of analysis covering identity, purity and contaminants
• Just the farmer’s verbal assurance of source
• Visual inspection at the warehouse without documentation

Correct Answer: Certificate of analysis covering identity, purity and contaminants

Q9. Which international standard is commonly used to accredit testing laboratories that analyze herbal product quality?

• ISO 9001
• ISO 22000
• ISO/IEC 17025
• ISO 13485

Correct Answer: ISO/IEC 17025

Q10. Under EU Traditional Herbal Medicinal Products Directive, what is required for traditional-use registration of a herbal medicinal product?

• Full clinical trial data equivalent to a new chemical entity
• Evidence of at least 30 years of traditional use, including 15 years within the EU, plus safety data
• No data required, only proof of trade existence
• Only a toxicology report is required

Correct Answer: Evidence of at least 30 years of traditional use, including 15 years within the EU, plus safety data

Q11. Which parameter is NOT typically part of routine quality control testing mandated by pharmacopeias for herbal extracts?

• Identification (macroscopy, microscopy, chromatographic fingerprint)
• Assay of active marker compounds
• Microbial limit testing
• Consumer sensory preference testing

Correct Answer: Consumer sensory preference testing

Q12. Which Indian document compiles standards and quality specifications for classical Ayurvedic, Siddha and Unani formulations?

• British Pharmacopoeia
• Ayurvedic Pharmacopoeia of India (API)
• United States Pharmacopeia (USP)
• European Pharmacopoeia (Ph. Eur.)

Correct Answer: Ayurvedic Pharmacopoeia of India (API)

Q13. For herbal product labeling in many jurisdictions, which claim type is usually restricted and requires pre-approval?

• Structure/function or general wellness claims
• Traditional use statements with no explicit disease claim
• Direct therapeutic claims diagnosing, curing or preventing specific diseases
• Ingredient listing in Latin botanical nomenclature

Correct Answer: Direct therapeutic claims diagnosing, curing or preventing specific diseases

Q14. Which regulatory activity is essential for monitoring safety of marketed herbal products post-approval?

• Preclinical toxicology only
• Pharmacovigilance and adverse event reporting systems
• One-time stability testing at release
• Exclusive reliance on historical traditional use

Correct Answer: Pharmacovigilance and adverse event reporting systems

Q15. Good Agricultural and Collection Practices (GACP) aim to control which of the following critical risks in herbal supply chains?

• Biological identity authentication only
• Pesticide residues, heavy metals and species adulteration
• Marketing and pricing strategies
• Packaging aesthetics

Correct Answer: Pesticide residues, heavy metals and species adulteration

Q16. Which country’s regulatory framework classifies many herbal products as “natural health products” requiring pre-market notification and licensing?

• United States
• Canada
• United Kingdom
• India

Correct Answer: Canada

Q17. Stability studies for herbal dosage forms are required to determine which regulatory attribute?

• Marketing claim language
• Shelf life and recommended storage conditions
• Botanical species identification
• Supplier pricing negotiations

Correct Answer: Shelf life and recommended storage conditions

Q18. Which document or control is most important to ensure traceability of herbal raw materials from farm to finished product?

• Batch manufacturing record with supplier and lot details
• Oral confirmation by procurement officer
• Final product brochure
• Generic purchase order without lot details

Correct Answer: Batch manufacturing record with supplier and lot details

Q19. Which of the following international instruments directly addresses methods for assessing contaminants such as heavy metals and pesticide residues in herbal products?

• WHO Quality Control Methods for Medicinal Plant Materials
• ICH Q9 Risk Management Guidelines
• FDA Nutrition Facts Labeling Guidance
• European Pharmacovigilance Guidance

Correct Answer: WHO Quality Control Methods for Medicinal Plant Materials

Q20. In regulatory submissions for a herbal drug in India, which evidence is typically considered to demonstrate traditional use and support safety?

• Peer-reviewed systematic review of randomized controlled trials only
• References to authoritative classical texts, pharmacopeias and documented traditional use plus safety data
• Only marketing testimonials from consumers
• Photos of the plant taken in the wild

Correct Answer: References to authoritative classical texts, pharmacopeias and documented traditional use plus safety data

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