Regulatory requirements for herbal medicines in India MCQs With Answer
Herbal medicines in India are governed by a specific regulatory framework covering quality, safety, labeling, manufacturing and clinical evaluation. B.Pharm students must understand the Drugs and Cosmetics Act, Ministry of AYUSH norms, Schedule T GMP standards, phytopharmaceutical regulations, Ayurvedic Pharmacopoeia monographs, GACP for raw materials, pharmacovigilance for ASU drugs, and CDSCO/DCGI roles in clinical trials. This introduction summarizes key regulatory themes—licensing, standardization, labeling, advertising restrictions, stability and export requirements—essential for pharmacists working with herbal and traditional products. Familiarity with these concepts helps ensure compliant development, quality control and patient safety in herbal therapeutics. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which central legislation primarily governs the manufacture and sale of medicines, including many herbal drugs, in India?
- Drugs and Cosmetics Act, 1940
- Food Safety and Standards Act, 2006
- Indian Pharmacopoeia Act
- Patents Act, 1970
Correct Answer: Drugs and Cosmetics Act, 1940
Q2. Which central ministry is chiefly responsible for policy, standards and regulation of Ayurvedic, Siddha and Unani medicines?
- Ministry of AYUSH
- Central Drugs Standard Control Organization (CDSCO)
- Food Safety and Standards Authority of India (FSSAI)
- Ministry of Health and Family Welfare
Correct Answer: Ministry of AYUSH
Q3. Which schedule of the Drugs and Cosmetics Rules specifies GMP requirements for Ayurvedic, Siddha and Unani (ASU) drug manufacturing?
- Schedule M
- Schedule Y
- Schedule T (GMP for ASU drugs)
- Schedule L
Correct Answer: Schedule T (GMP for ASU drugs)
Q4. Which official publication contains monographs and quality standards for classical Ayurvedic formulations?
- Ayurvedic Pharmacopoeia of India (API)
- British Pharmacopoeia
- United States Pharmacopeia
- Indian Herbal Compendium (unofficial)
Correct Answer: Ayurvedic Pharmacopoeia of India (API)
Q5. Which authority grants approval for clinical trials of new-drug category phytopharmaceuticals in India?
- Drugs Controller General of India (DCGI)
- Ministry of AYUSH alone
- State Drug Controller only
- FSSAI
Correct Answer: Drugs Controller General of India (DCGI)
Q6. What is the regulatory category for botanical drug products that are chemically characterized and developed like modern drugs?
- Phytopharmaceuticals
- Nutraceuticals
- Herbal cosmetics
- Classical Ayurvedic medicines
Correct Answer: Phytopharmaceuticals
Q7. Which authorization is mandatory for manufacturing Ayurvedic, Siddha or Unani medicines in India?
- Manufacturing license under the Drugs and Cosmetics Rules (ASU category)
- Import export registration only
- FSSAI food license
- Clinical trial permit
Correct Answer: Manufacturing license under the Drugs and Cosmetics Rules (ASU category)
Q8. What is the official program for monitoring adverse reactions to ASU drugs and herbal products?
- Pharmacovigilance Programme for ASU
- Materiovigilance Programme
- Immunization AEFI Program
- Food Safety Adverse Event Reporting
Correct Answer: Pharmacovigilance Programme for ASU
Q9. Which organization publishes and maintains Indian Pharmacopoeia monographs, including herbal entries?
- Indian Pharmacopoeia Commission (IPC)
- Ministry of AYUSH
- WHO
- CSIR
Correct Answer: Indian Pharmacopoeia Commission (IPC)
Q10. What does GACP stand for in the context of herbal raw material quality?
- Good Agricultural and Collection Practices (GACP)
- Good Manufacturing Practices (GMP)
- Good Laboratory Practices (GLP)
- Good Distribution Practices (GDP)
Correct Answer: Good Agricultural and Collection Practices (GACP)
Q11. Proprietary Ayurvedic medicines differ from classical formulations because they:
- Must comply with safety and manufacturing norms but are not required to be described in classical texts
- Do not require any quality testing
- Are regulated only by FSSAI
- Can make unrestricted therapeutic claims
Correct Answer: Must comply with safety and manufacturing norms but are not required to be described in classical texts
Q12. Which central body is primarily involved in regulation, licensing and inspection of marketed drugs including many herbal drugs?
- Central Drugs Standard Control Organization (CDSCO)
- Food Safety and Standards Authority of India (FSSAI)
- Ministry of Finance
- Indian Council of Medical Research (ICMR)
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q13. Which of the following is a mandatory labeling requirement for herbal medicines under regulatory norms?
- A complete list of ingredients with quantities
- Unsubstantiated disease cure claims in bold
- Only brand name without composition
- No manufacturing details
Correct Answer: A complete list of ingredients with quantities
Q14. Stability testing of herbal formulations is primarily performed to determine:
- Shelf life and storage conditions
- Packaging artwork design
- Marketing price
- Color preference
Correct Answer: Shelf life and storage conditions
Q15. Advertising of Ayurvedic and herbal medicines in India is:
- Restricted and certain therapeutic claims are prohibited without approval
- Completely unrestricted
- Regulated solely by FSSAI
- Allowed only on social media
Correct Answer: Restricted and certain therapeutic claims are prohibited without approval
Q16. Which authority issues manufacturing licenses for ASU drug units at the state level?
- State Licensing Authority under the Drugs and Cosmetics Rules
- Central Bureau of Investigation
- FSSAI regional office
- District Health Officer only
Correct Answer: State Licensing Authority under the Drugs and Cosmetics Rules
Q17. Which analytical technique is widely used for phytochemical fingerprinting and quality control of herbal drugs?
- High Performance Thin Layer Chromatography (HPTLC) fingerprinting
- Simple organoleptic test only
- Clinical efficacy study only
- Radiographic imaging
Correct Answer: High Performance Thin Layer Chromatography (HPTLC) fingerprinting
Q18. A product will be regulated as a ‘drug’ in India if it:
- Meets the definition of ‘drug’ under the Drugs and Cosmetics Act
- Is made only from plants
- Is sold only in Ayurvedic stores
- Has no therapeutic claim
Correct Answer: Meets the definition of ‘drug’ under the Drugs and Cosmetics Act
Q19. Which schedule of the Drugs and Cosmetics Rules deals with clinical trial requirements for new drugs?
- Schedule Y (clinical trial requirements for new drugs)
- Schedule T
- Schedule M
- Schedule Z
Correct Answer: Schedule Y (clinical trial requirements for new drugs)
Q20. The Traditional Knowledge Digital Library (TKDL), used to protect traditional medicinal knowledge from misappropriation, was developed by which organization?
- Council of Scientific & Industrial Research (CSIR)
- Central Drugs Standard Control Organization (CDSCO)
- World Health Organization (WHO)
- Food Safety and Standards Authority of India (FSSAI)
Correct Answer: Council of Scientific & Industrial Research (CSIR)
Q21. Which central law also contains provisions for regulation of cosmetics, including herbal cosmetics?
- Drugs and Cosmetics Act, 1940
- Patents Act, 1970
- Food Safety and Standards Act, 2006
- Environment Protection Act
Correct Answer: Drugs and Cosmetics Act, 1940
Q22. Foods, nutraceuticals and many herbal dietary supplements are primarily regulated by:
- Food Safety and Standards Authority of India (FSSAI)
- Central Drugs Standard Control Organization (CDSCO)
- Ministry of AYUSH
- Ministry of Commerce
Correct Answer: Food Safety and Standards Authority of India (FSSAI)
Q23. Which international guideline is commonly referenced for sustainable cultivation and collection of medicinal plants?
- WHO Guidelines on Good Agricultural and Collection Practices (GACP)
- ICH Guidelines for Pharmaceuticals
- OECD Chemical Safety Guidelines
- FAO Food Handling Code
Correct Answer: WHO Guidelines on Good Agricultural and Collection Practices (GACP)
Q24. How should a company label a non-classical, company-formulated Ayurvedic product under regulations?
- Label the product as “Proprietary Ayurvedic Medicine”
- Label it as “Classical Ayurvedic Formulation”
- Use no regulatory description on label
- Label it as a cosmetic
Correct Answer: Label the product as “Proprietary Ayurvedic Medicine”
Q25. Which test is essential to control microbiological quality of herbal formulations?
- Microbial limit test
- Only heavy metal test
- Only organoleptic test
- Colorimetric taste test
Correct Answer: Microbial limit test
Q26. Which authority registers and monitors Ethics Committees for clinical trials in India?
- Central Drugs Standard Control Organization (CDSCO)
- Ministry of AYUSH only
- FSSAI
- State Agriculture Department
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q27. In which year did CDSCO publish guidance defining pathways for phytopharmaceutical development in India?
- 2015
- 2000
- 1995
- 2022
Correct Answer: 2015
Q28. Before starting clinical trials on a new herbal formulation, which approvals are essential?
- Ethics Committee approval and regulatory permission from competent authority
- Only advertisement clearance
- Only manufacturer’s internal approval
- No approvals required
Correct Answer: Ethics Committee approval and regulatory permission from competent authority
Q29. Monographs in official pharmacopoeias for herbal drugs typically include which of the following?
- Identification tests, assay limits, purity tests and storage conditions (all of the above)
- Only marketing claims
- Only traditional uses without test methods
- Only brand-related information
Correct Answer: Identification tests, assay limits, purity tests and storage conditions (all of the above)
Q30. Which practice improves traceability and quality assurance of herbal raw materials?
- Detailed documentation of source, collection, and supply chain for raw materials
- Random anonymous procurement
- Purchasing only on price basis
- No documentation to save time
Correct Answer: Detailed documentation of source, collection, and supply chain for raw materials
