Introduction: This quiz compilation covers key aspects of food legislation relevant to M.Pharm students, focusing on BIS, AGMARK, FSSAI and the US-FDA regulatory framework. It emphasizes regulatory objectives, standard-setting, licensing, labeling, contaminants, recalls, accreditation and risk-based approaches that directly affect food safety assessment, quality control and compliance testing in pharmaceutical practice. Each question is designed to deepen understanding of statutory provisions, technical regulations and international harmonization important when interpreting test results, preparing dossiers, advising industry or conducting research. Use these MCQs to test knowledge, identify gaps and build practical competence for regulatory audits, quality assurance and multidisciplinary collaboration in food and pharma sectors.
Q1. What is the principal function of the Bureau of Indian Standards (BIS)?
- Formulation and publication of Indian Standards
- Issuing import-export permits for pharmaceuticals
- Conducting clinical trials for nutraceuticals
- Granting patents for food processing technologies
Correct Answer: Formulation and publication of Indian Standards
Q2. AGMARK certification primarily applies to which area?
- Certification of agricultural produce quality standards
- Approval of food additives for human consumption
- Licensing of food manufacturing facilities
- Registration of new drug molecules
Correct Answer: Certification of agricultural produce quality standards
Q3. The Food Safety and Standards Act that established FSSAI was enacted in which year?
- 2006
- 2008
- 2011
- 1999
Correct Answer: 2006
Q4. The US Food Safety Modernization Act (FSMA), shifting focus to prevention, was signed into law in which year?
- 2011
- 2001
- 2015
- 1996
Correct Answer: 2011
Q5. The BIS ISI mark indicates conformity to which of the following?
- Indian Standards published by BIS
- International Organization for Standardization (ISO) standards
- FDA food codes
- Codex Alimentarius guidelines
Correct Answer: Indian Standards published by BIS
Q6. For multi-state large food enterprises, which authority issues the FSSAI central license?
- Food Safety and Standards Authority of India (Central Licensing Authority)
- Local Municipal Health Officer
- Directorate General of Foreign Trade
- Ministry of Commerce
Correct Answer: Food Safety and Standards Authority of India (Central Licensing Authority)
Q7. Which government body issues AGMARK certification and maintains standards for agricultural products?
- Directorate of Marketing and Inspection (DMI), Government of India
- Bureau of Indian Standards (BIS)
- Food Safety and Standards Authority of India (FSSAI)
- National Accreditation Board for Testing and Calibration Laboratories (NABL)
Correct Answer: Directorate of Marketing and Inspection (DMI), Government of India
Q8. In US-FDA regulatory terminology, GRAS stands for which phrase?
- Generally Recognized As Safe
- Government Regulated Additive Standard
- Gradual Release Active Substance
- Guideline for Risk Assessment and Safety
Correct Answer: Generally Recognized As Safe
Q9. Which FSSAI regulation specifically addresses limits and controls for contaminants, toxins and residues in foods?
- Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011
- Food Safety and Standards (Packaging) Regulations, 2013
- Food Safety and Standards (Advertising) Regulations, 2018
- Food Safety and Standards (Import) Regulations, 2015
Correct Answer: Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011
Q10. Under US-FDA recall classifications, a Class I recall indicates which situation?
- Reasonable probability that use of the product will cause serious adverse health consequences or death
- Product is not likely to cause adverse health consequences
- Minor labeling deficiency without health risk
- Administrative suspension pending inspection
Correct Answer: Reasonable probability that use of the product will cause serious adverse health consequences or death
Q11. FSSAI licenses and registrations are issued for what range of validity periods?
- Between 1 to 5 years
- Exactly 10 years only
- Only lifetime validity
- Monthly renewals mandatory
Correct Answer: Between 1 to 5 years
Q12. Which national body accredits food testing laboratories in India used for conformity assessment?
- National Accreditation Board for Testing and Calibration Laboratories (NABL)
- Central Drugs Standard Control Organization (CDSCO)
- National Institute of Nutrition (NIN)
- Food Safety and Standards Authority of India (FSSAI)
Correct Answer: National Accreditation Board for Testing and Calibration Laboratories (NABL)
Q13. AGMARK standards typically cover which category of products?
- Primary agricultural commodities such as grains, pulses, oils and spices
- Pharmaceutical finished products
- Processed cosmetics and personal care items
- Medical devices and diagnostics
Correct Answer: Primary agricultural commodities such as grains, pulses, oils and spices
Q14. Which of the following labeling elements is mandatory under FSSAI for packaged foods?
- Declaration of net quantity, ingredient list and best-before/use-by date
- Manufacturer’s employee roster
- Full disclosure of all processing temperatures used
- Confidential supplier trade secrets
Correct Answer: Declaration of net quantity, ingredient list and best-before/use-by date
Q15. The HACCP preventive approach used in food safety stands for which phrase?
- Hazard Analysis and Critical Control Points
- Hazard Assessment and Chemical Control Procedures
- Health Audit and Consumer Protection Plan
- High Accuracy Critical Control Protocol
Correct Answer: Hazard Analysis and Critical Control Points
Q16. The current Bureau of Indian Standards Act that modernized BIS governance was enacted in which year?
- 2016
- 1992
- 1986
- 2003
Correct Answer: 2016
Q17. Under US-FDA policy, a substance can be considered GRAS if it is:
- Recognized as safe based on scientific procedures or common use in food
- Approved by a foreign regulatory authority only
- Labeled as a natural extract without toxicology data
- Used historically in animal feed exclusively
Correct Answer: Recognized as safe based on scientific procedures or common use in food
Q18. Which authority can initiate and order a food recall under FSSAI rules?
- Food Safety and Standards Authority of India (FSSAI) / Designated Licensing Authority
- Ministry of Commerce only
- Municipal Corporation without state coordination
- Any private laboratory certifying the product
Correct Answer: Food Safety and Standards Authority of India (FSSAI) / Designated Licensing Authority
Q19. AGMARK grading and certification is best described as which of the following?
- A voluntary certification scheme to assure quality of agricultural produce (except where mandated)
- A mandatory permit for all food imports into India
- An enforcement arm of FSSAI for packaged foods
- A consumer labeling standard for pharmaceuticals
Correct Answer: A voluntary certification scheme to assure quality of agricultural produce (except where mandated)
Q20. Under the US-FDA FSMA preventive control requirements, food facilities must implement which core element?
- Hazard analysis and risk-based preventive controls
- Only end-product testing with no preventive plan
- Mandatory national registration of all grocery stores
- Automatic approval of imported foods without inspection
Correct Answer: Hazard analysis and risk-based preventive controls
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