Regulation and dispensing of herbal drugs MCQs With Answer

Introduction: This blog provides a focused set of multiple-choice questions on the regulation and dispensing of herbal drugs tailored for M.Pharm students studying Herbal and Cosmetic Analysis (MPA 204T). The questions cover Indian and international regulatory frameworks, classification of herbal products, licensing and manufacturing requirements, labeling and advertising restrictions, pharmacovigilance, quality and standardization, clinical trial and safety data expectations, and practical dispensing considerations. Each MCQ is designed to test applied knowledge required for regulatory compliance and rational dispensing of herbal medicines. Answers are provided to aid self-assessment and to reinforce core regulatory and professional responsibilities for pharmacists working with herbal products.

Q1. Which statement best defines a “classical” herbal formulation in the Indian regulatory context?

• Formulations prepared only in private clinics without written records
• Formulations that are newly invented using modern synthetic APIs
• Formulations described in authoritative traditional texts and prepared according to classical recipes
• Any herbal mixture marketed as a health supplement without documentation

Correct Answer: Formulations described in authoritative traditional texts and prepared according to classical recipes

Q2. Which central authority is primarily responsible for policy, regulation and development of Ayurveda, Siddha, Unani and Homoeopathy systems in India?

• Central Drugs Standard Control Organization (CDSCO)
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of AYUSH
• Ministry of Health and Family Welfare

Correct Answer: Ministry of AYUSH

Q3. Which principal legislation governs the manufacture and sale of medicinal products, including many herbal medicines, in India?

• Indian Penal Code, 1860
• Drugs and Cosmetics Act, 1940 and Rules, 1945
• Food Safety and Standards Act, 2006
• Medical Council of India Regulations

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

Q4. Which of the following information is typically mandatory on the label of an Ayurvedic/herbal marketed drug under Indian rules?

• Manufacturer’s name, batch number, manufacturing and expiry dates, and complete list of ingredients
• Only the brand name and a marketing slogan
• Celebrity endorsement statement
• Unsubstantiated therapeutic claims without references

Correct Answer: Manufacturer’s name, batch number, manufacturing and expiry dates, and complete list of ingredients

Q5. Which advertising claim is generally acceptable for herbal products without additional regulatory approval?

• Guaranteed cure for cancer
• Claims of ability to replace prescribed anti-hypertensive drugs
• General health or structure–function claims (e.g., “supports digestion”) where not misleading
• Claims of 100% safety for all populations including infants and pregnant women

Correct Answer: General health or structure–function claims (e.g., “supports digestion”) where not misleading

Q6. What licence is required under Indian regulations to legally manufacture Ayurvedic or herbal products for sale?

• Import licence from FSSAI
• Manufacturing licence issued by the State Licensing Authority under the Drugs and Cosmetics Rules
• No licence is required for herbal products
• Trademark registration only

Correct Answer: Manufacturing licence issued by the State Licensing Authority under the Drugs and Cosmetics Rules

Q7. Which pharmacopoeia is considered the primary source of official monographs for classical Ayurvedic raw materials and formulations?

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

Correct Answer: Ayurvedic Pharmacopoeia of India

Q8. Which guideline set provides Good Manufacturing Practices tailored for AYUSH medicinal products?

• ICH Q7 for Active Pharmaceutical Ingredients only
• Generic food industry GMP documents
• GMP Guidelines issued by the Ministry of AYUSH (Ayush GMP)
• No GMP guidance exists for herbal products

Correct Answer: GMP Guidelines issued by the Ministry of AYUSH (Ayush GMP)

Q9. What characterizes “Patent & Proprietary” (P&P) Ayurvedic formulations?

• They are always described verbatim in classical texts
• They are traditional single-herb preparations only
• Formulations not found in classical texts and often combined with novel excipients or claims
• They are unregulated home remedies

Correct Answer: Formulations not found in classical texts and often combined with novel excipients or claims

Q10. Which authority issues clinical trial guidelines specifically for clinical research on traditional medicine systems in India?

• World Trade Organization (WTO)
• Ministry of AYUSH
• Reserve Bank of India
• No guidelines are available for traditional medicine trials

Correct Answer: Ministry of AYUSH

Q11. Which type of adulteration is a major regulatory concern for marketed herbal products?

• Presence of undeclared synthetic pharmaceuticals such as sildenafil or corticosteroids
• Use of glass containers for packaging
• Use of natural colors derived from plants
• Providing leaf illustrations on the label

Correct Answer: Presence of undeclared synthetic pharmaceuticals such as sildenafil or corticosteroids

Q12. Which factor is NOT typically used to scientifically determine the shelf-life of a herbal formulation?

• Accelerated and real-time stability data
• Packaging material interactions and barrier properties
• Storage temperature and humidity studies
• Manufacturer’s commercial preference without stability studies

Correct Answer: Manufacturer’s commercial preference without stability studies

Q13. What is the name of the programme that monitors adverse reactions to Ayurveda, Siddha and Unani medicines in India?

• National Food Survey Programme
• Pharmacovigilance Programme for Ayurveda, Siddha and Unani Drugs under Ministry of AYUSH
• National Nutraceutical Safety Board
• There is no pharmacovigilance for traditional medicines

Correct Answer: Pharmacovigilance Programme for Ayurveda, Siddha and Unani Drugs under Ministry of AYUSH

Q14. Which authority regulates herbal products marketed in India as foods, dietary supplements or nutraceuticals?

• Ministry of Defence
• Central Drugs Standard Control Organization (CDSCO)
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of Corporate Affairs

Correct Answer: Food Safety and Standards Authority of India (FSSAI)

Q15. When dispensing a prescription-only herbal medicine, which piece of information is essential to record in the pharmacy dispensing log?

• Patient name, prescriber details, name of medicine, dosage and date dispensed
• The marketing budget of the manufacturer
• Social media profiles of the patient
• Number of competitors selling similar products

Correct Answer: Patient name, prescriber details, name of medicine, dosage and date dispensed

Q16. Which Indian law explicitly prohibits misleading advertisements for diseases and health conditions that may involve herbal remedies?

• Companies Act, 2013
• Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
• Right to Information Act, 2005
• Meteorological Act

Correct Answer: Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954

Q17. For approval of a new proprietary herbal drug with therapeutic claims, which data package is generally expected by regulators?

• Only a company brochure and images of the product
• Standardization data, preclinical toxicology, and well‑designed clinical trial evidence
• Only ancient text references without any modern data
• Financial statements of the manufacturing company

Correct Answer: Standardization data, preclinical toxicology, and well‑designed clinical trial evidence

Q18. Which warning statement is commonly required on herbal topical or orally dispensed products to protect public safety?

• “Guaranteed no side effects ever”
• “Keep out of reach of children”
• “Use in any dose you prefer”
• “Can be used as a complete replacement for prescribed medication”

Correct Answer: “Keep out of reach of children”

Q19. What is the principal mechanism of clinically important herb–drug interactions that pharmacists must consider?

• Herbs always increase vitamin levels only
• CYP enzyme induction or inhibition affecting drug metabolism
• Herbs never interact with synthetic drugs
• Herbal products only change the color of tablets

Correct Answer: CYP enzyme induction or inhibition affecting drug metabolism

Q20. Which international organization has published guidelines on good agricultural and collection practices for medicinal plants to ensure quality of raw herbal materials?

• International Monetary Fund (IMF)
• World Health Organization (WHO)
• World Trade Organization (WTO)
• International Olympic Committee (IOC)

Correct Answer: World Health Organization (WHO)

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