Regulatory requirements for establishing herbal drug industry MCQs With Answer

Introduction:

This blog provides an advanced set of multiple-choice questions focused on the regulatory requirements for establishing a herbal drug industry, specifically tailored for M.Pharm students studying Herbal and Cosmetic Analysis (MPA 204T). The questions cover Indian and international regulatory frameworks, quality systems (GMP/GLP/GCP), dossier and licensing expectations, pharmacovigilance, standardization and quality control methods, stability and safety testing, and good agricultural/collection practices. These MCQs are designed to deepen understanding of compliance demands that guide manufacturing, testing, registration and marketing of herbal medicines, preparing students for regulatory roles in industry and research.

Q1. Which primary Indian legislation governs manufacture, sale and distribution of drugs including many traditional herbal medicines?

• Food Safety and Standards Act, 2006
• Drugs and Cosmetics Act, 1940 and Rules, 1945
• Indian Patent Act, 1970
• Environment Protection Act, 1986

Correct Answer: Drugs and Cosmetics Act, 1940 and Rules, 1945

Q2. Which document specifically outlines Good Manufacturing Practices for Ayurvedic, Siddha and Unani (ASU) drug manufacturers in India?

• Schedule M of Drugs and Cosmetics Rules
• Schedule T of Drugs and Cosmetics Rules
• WHO GMP Guidelines for Biologicals
• FDA Current Good Manufacturing Practices (CGMP)

Correct Answer: Schedule T of Drugs and Cosmetics Rules

Q3. For quality specification of raw herbal materials, which guidance emphasizes cultivation, collection and post-harvest handling to ensure consistent quality?

• ICH Q7: Manufacture of Active Pharmaceutical Ingredients
• WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants
• ISO 9001 Quality Management Standard
• FDA Botanical Drug Guidance

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

Q4. Which pharmacopeial source is specifically important for establishing monographs and official standards for Ayurvedic formulations in India?

• British Pharmacopoeia (BP)
• Ayurvedic Pharmacopoeia of India (API)
• United States Pharmacopeia (USP)
• European Pharmacopoeia (EP)

Correct Answer: Ayurvedic Pharmacopoeia of India (API)

Q5. Which international guidance document provides principles for stability testing of pharmaceutical products applicable also to herbal drug products?

• ICH Q1A (R2) Stability Testing of New Drug Substances and Products
• WHO GACP for Medicinal Plants
• ICH Q9 Quality Risk Management
• ISO 17025 General Requirements for the Competence of Testing Laboratories

Correct Answer: ICH Q1A (R2) Stability Testing of New Drug Substances and Products

Q6. Which regulatory pathway is particularly relevant when developing a marketed herbal product as a drug in the United States?

• FDA Botanical Drug Development Guidance including IND/NDA pathway
• FSSAI Food Supplement Approval
• EMA Herbal Traditional Use Registration only for nutraceuticals
• WHO Prequalification for Herbal Products

Correct Answer: FDA Botanical Drug Development Guidance including IND/NDA pathway

Q7. Which of the following is a key dossier component required for regulatory submission of a herbal drug to demonstrate quality?

• Clinical trial site photographs
• Detailed description of the botanical raw material and quality control tests
• Market analysis and pricing strategy
• Advertising samples and promotional material

Correct Answer: Detailed description of the botanical raw material and quality control tests

Q8. Which quality system is primarily concerned with laboratory competence and the validity of analytical test results used in herbal product release?

• Good Manufacturing Practice (GMP)
• Good Laboratory Practice (GLP)
• Good Clinical Practice (GCP)
• Good Agricultural Practice (GAP)

Correct Answer: Good Laboratory Practice (GLP)

Q9. For herbal products, which contamination parameters are routinely required by regulators to ensure safety?

• Only organoleptic characteristics
• Heavy metals, pesticide residues, microbial limits and aflatoxins
• Color and viscosity only
• Only active marker compound assay

Correct Answer: Heavy metals, pesticide residues, microbial limits and aflatoxins

Q10. Which practice ensures traceability from raw plant material to finished herbal product and is critical during regulatory inspections?

• Random sampling without documentation
• Batch record-keeping and chain-of-custody documentation
• Oral declarations by suppliers
• Photographic evidence only

Correct Answer: Batch record-keeping and chain-of-custody documentation

Q11. Which regulatory requirement relates to monitoring adverse reactions and safety after marketing of herbal medicines?

• Good Manufacturing Practice (GMP)
• Pharmacovigilance and post-marketing surveillance
• Preclinical toxicology only
• Clinical trial registration only

Correct Answer: Pharmacovigilance and post-marketing surveillance

Q12. Which standard analytical technique is commonly used for fingerprinting and standardization of herbal extracts during regulatory quality assessment?

• Thermogravimetric analysis (TGA)
• High Performance Thin Layer Chromatography (HPTLC) and HPLC fingerprinting
• Karl Fischer titration only
• Atomic absorption spectroscopy only

Correct Answer: High Performance Thin Layer Chromatography (HPTLC) and HPLC fingerprinting

Q13. Which requirement is essential for a manufacturing facility before applying for a herbal drug manufacturing license?

• Having a marketing authorization in another country
• Compliance with GMP, suitable infrastructure, quality control lab and qualified personnel
• Only having a sales team and distributors
• Registration as a small business without quality systems

Correct Answer: Compliance with GMP, suitable infrastructure, quality control lab and qualified personnel

Q14. Which guideline addresses ethical and scientific standards for clinical evaluation of herbal medicines in India?

• Central Council for Research in Ayurvedic Sciences (CCRAS) Guidelines and national clinical trial guidance for ASU
• FSSAI food fortification manual
• ISO 14001 environmental standard
• IEC guidelines for advertising

Correct Answer: Central Council for Research in Ayurvedic Sciences (CCRAS) Guidelines and national clinical trial guidance for ASU

Q15. Under regulatory expectations, what is the purpose of conducting stability studies on a herbal drug product?

• To determine market demand
• To establish shelf life, storage conditions and ensure consistent quality over time
• To assess marketing strategy effectiveness
• To measure only color changes during storage

Correct Answer: To establish shelf life, storage conditions and ensure consistent quality over time

Q16. Which is an important consideration when classifying a product as a herbal drug versus a food supplement from a regulatory viewpoint?

• Only the packaging color
• The intended use, claims made, dose, route of administration and evidence required for safety and efficacy
• Only the price point
• Only the origin of raw materials

Correct Answer: The intended use, claims made, dose, route of administration and evidence required for safety and efficacy

Q17. Which international body’s monographs and quality standards are often referenced globally for herbal ingredient quality?

• World Health Organization (WHO) and various pharmacopeias such as USP/Ph.Eur
• International Monetary Fund (IMF)
• World Trade Organization (WTO)
• International Labour Organization (ILO)

Correct Answer: World Health Organization (WHO) and various pharmacopeias such as USP/Ph.Eur

Q18. During regulatory inspection, which documentation demonstrates control over manufacturing processes and batch-to-batch consistency?

• Marketing brochures
• Master manufacturing records, batch manufacturing records and in-process control records
• Employee CVs only
• Raw supplier price lists

Correct Answer: Master manufacturing records, batch manufacturing records and in-process control records

Q19. Which regulatory requirement helps prevent adulteration and substitution of herbal raw materials?

• Visual inspection only at retail point
• Validated identity tests (macroscopy, microscopy, chemical markers, DNA barcoding) and supplier qualification
• Relying solely on supplier reputation without testing
• Using only organoleptic evaluation

Correct Answer: Validated identity tests (macroscopy, microscopy, chemical markers, DNA barcoding) and supplier qualification

Q20. Which certification for analytical laboratories strengthens a regulatory submission by proving technical competence in testing herbal drug samples?

• ISO 9001 only
• ISO/IEC 17025 accreditation for testing laboratories
• GMP certificate for manufacturing only
• Local trade license only

Correct Answer: ISO/IEC 17025 accreditation for testing laboratories

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