Regulatory aspects in food and drug safety are essential for B. Pharm students to ensure public health, quality control, and legal compliance. This concise introduction focuses on key regulators and standards — FSSAI, FDA, FPO, MPO, AGMARK — and explains licensing, labeling, permissible limits, Good Manufacturing Practices (GMP), HACCP, sampling, testing, recalls, and penalties. You will learn about registration types, inspection procedures, risk assessment, food additives, microbial criteria, shelf-life, import/export controls, and documentation requirements that bridge pharmaceutical and food sectors. Mastering these topics strengthens skills in quality assurance and regulatory affairs for careers in industry and public health. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which Indian authority is primarily responsible for regulating food safety, licensing, and standards?
- Central Drugs Standard Control Organization (CDSCO)
- Food Safety and Standards Authority of India (FSSAI)
- Directorate General of Foreign Trade (DGFT)
- Pharmacy Council of India (PCI)
Correct Answer: Food Safety and Standards Authority of India (FSSAI)
Q2. The FPO (Fruit Products Order) 1955 mainly regulates which category of products?
- Dairy and milk products
- Processed fruit products like jams, squashes, and juices
- Spices and condiments
- Meat and poultry products
Correct Answer: Processed fruit products like jams, squashes, and juices
Q3. AGMARK certification in India relates to quality standards for which sector?
- Pharmaceutical formulations
- Agricultural and horticultural produce
- Processed meat products
- Cosmetics and toiletries
Correct Answer: Agricultural and horticultural produce
Q4. The Meat Product Order (MPO) in India is concerned primarily with:
- Standards and licensing of meat and meat products
- Regulation of fruit-based beverages
- Certification of organic crops
- Approval of pharmaceutical excipients
Correct Answer: Standards and licensing of meat and meat products
Q5. Which of the following is a core objective of FSSAI regulations relevant to B. Pharm students?
- Regulate prescription drug pricing
- Ensure food safety, quality, and standardized labeling
- Approve medical device clinical trials
- License cosmetic manufacturing only
Correct Answer: Ensure food safety, quality, and standardized labeling
Q6. What does HACCP stand for and why is it important in regulatory compliance?
- Hazard Analysis and Critical Control Points; it identifies and controls biological, chemical, and physical hazards
- Health and Consumer Compliance Protocol; it audits retail outlets
- Hazard Assessment for Chemical Control Procedures; it sets pesticide limits
- Hygiene and Cleanliness Certification Program; it certifies staff training
Correct Answer: Hazard Analysis and Critical Control Points; it identifies and controls biological, chemical, and physical hazards
Q7. Under FSSAI rules, which logo/mark is mandatory on packaged food labels in India?
- AGMARK logo
- FSSAI logo and license/registration number
- ISO 9001 symbol
- US FDA approval seal
Correct Answer: FSSAI logo and license/registration number
Q8. Which agency in the United States is responsible for regulating food safety and recalls at the federal level?
- Centers for Disease Control and Prevention (CDC)
- Environmental Protection Agency (EPA)
- Food and Drug Administration (FDA)
- Occupational Safety and Health Administration (OSHA)
Correct Answer: Food and Drug Administration (FDA)
Q9. FDA’s GRAS concept refers to:
- Generally Recognized As Safe; substances generally considered safe for intended use
- Government Regulation of All Substances; mandatory approval of all additives
- Guideline for Rapid Approval of Substances; fast-track drug approval
- General Requirements for Analytical Standards; testing methods only
Correct Answer: Generally Recognized As Safe; substances generally considered safe for intended use
Q10. Which of the following is a typical requirement on food labels under FSSAI for packaged foods?
- List of ingredients, nutritional information, net quantity, manufacturer details, and FSSAI license number
- Only the price and expiry date
- Manufacturer’s tax identification number only
- Certificate of AGMARK for all processed foods
Correct Answer: List of ingredients, nutritional information, net quantity, manufacturer details, and FSSAI license number
Q11. Which regulation emphasizes Good Manufacturing Practices (GMP) for food businesses in India?
- FSSAI Regulations (Food Safety and Standards Regulations)
- Pharmacy Act
- Companies Act
- Customs Act
Correct Answer: FSSAI Regulations (Food Safety and Standards Regulations)
Q12. Which of the following best describes a Class I recall as per FDA classification?
- Use of product is unlikely to cause adverse health consequences
- Use of product may cause temporary or reversible adverse health consequences
- Use of product will cause serious adverse health consequences or death
- Product requires labeling updates only
Correct Answer: Use of product will cause serious adverse health consequences or death
Q13. Maximum Residue Limits (MRLs) are primarily concerned with:
- Acceptable levels of pesticide or veterinary drug residues in food commodities
- Maximum salt content in packaged snacks
- Maximum allowable microbial count for canned goods
- Maximum permissible packaging weight
Correct Answer: Acceptable levels of pesticide or veterinary drug residues in food commodities
Q14. Which document is essential for a food business in India before commencing production under FSSAI?
- FSSAI registration or license (state/central) as applicable
- Pharmacopoeial monograph
- ISO 14001 certificate
- Import-export code only
Correct Answer: FSSAI registration or license (state/central) as applicable
Q15. AGMARK certification is administered by which government department in India?
- Department of Pharmaceuticals
- Department of Agriculture and Farmers Welfare (DG(S)A/AGMARK)
- Ministry of Health and Family Welfare
- Ministry of Commerce
Correct Answer: Department of Agriculture and Farmers Welfare (DG(S)A/AGMARK)
Q16. Which of the following activities is typically part of regulatory inspections by FSSAI or FDA?
- Review of labeling, hygiene practices, sampling of products, and documentation audit
- Issuing patents for food formulations
- Providing marketing strategies to companies
- Conducting clinical trials for foods
Correct Answer: Review of labeling, hygiene practices, sampling of products, and documentation audit
Q17. In the context of food regulations, “adulteration” commonly means:
- Enhancing nutritional value of food with vitamins
- Adding or substituting substances to reduce quality, or contaminating food with harmful substances
- Packaging food in recyclable materials
- Labeling food with nutritional facts
Correct Answer: Adding or substituting substances to reduce quality, or contaminating food with harmful substances
Q18. Which regulatory requirement helps prevent cross-contamination and ensures product safety in manufacturing?
- Good Manufacturing Practices (GMP) and sanitation controls
- Annual marketing audits
- Tax filing requirements
- Trademark registration
Correct Answer: Good Manufacturing Practices (GMP) and sanitation controls
Q19. For imported food products, which regulatory activity is critical at ports of entry?
- Label translation only
- Customs valuation without inspections
- Document verification, sampling, and laboratory testing for compliance
- Issuance of marketing permits
Correct Answer: Document verification, sampling, and laboratory testing for compliance
Q20. Which of the following best explains the “Best Before” date on food labels?
- Indicates food will be unsafe after this date
- Indicates recommended period for peak quality, not necessarily safety
- Is only required for pharmaceuticals
- Denotes the manufacturing date
Correct Answer: Indicates recommended period for peak quality, not necessarily safety
Q21. Which body issues standards for testing methods and specifications that regulators may reference?
- Pharmacopoeia Commission only
- Bureau of Indian Standards (BIS) and recognized reference laboratories
- Stock exchanges
- Local trade unions
Correct Answer: Bureau of Indian Standards (BIS) and recognized reference laboratories
Q22. In regulatory terms, “traceability” of a food product means:
- Ability to track the product forward and backward through the supply chain
- Keeping recipes secret from authorities
- Limiting distribution to local markets only
- Using transparent packaging
Correct Answer: Ability to track the product forward and backward through the supply chain
Q23. Which of the following is an enforcement action commonly taken by FSSAI for non-compliance?
- Issuing licenses without inspection
- Seizure of products, suspension of license, monetary penalties, or prosecution
- Awarding subsidies to the non-compliant business
- Automatic renewal of license
Correct Answer: Seizure of products, suspension of license, monetary penalties, or prosecution
Q24. Which concept integrates food safety management into an organization and is often required for export markets?
- Hazard Assessment for Export Control (HAEC)
- Food Safety Management System (e.g., ISO 22000, HACCP)
- Only local business registration
- Intellectual property rights
Correct Answer: Food Safety Management System (e.g., ISO 22000, HACCP)
Q25. Which of the following correctly identifies a typical content of a food testing laboratory report used for regulatory compliance?
- Only the laboratory’s logo and no results
- Sample identification, test methods, results, detection limits, and analyst signature
- Marketing statements about the product
- Proprietary recipe details
Correct Answer: Sample identification, test methods, results, detection limits, and analyst signature
Q26. Under FSSAI, who is responsible for ensuring that food sold by a business is safe and compliant?
- Only the final retailer
- The food business operator (FBO) across production, storage, distribution and sale
- Only the government inspectors
- Only the consumers
Correct Answer: The food business operator (FBO) across production, storage, distribution and sale
Q27. Which regulatory element specifically addresses allergen declaration on food labels?
- Mandatory allergen labeling under food regulations requiring clear declaration of common allergens
- Allergen lists are optional and discouraged
- Allergens must be encrypted in QR codes only
- Allergen labeling is governed solely by AGMARK
Correct Answer: Mandatory allergen labeling under food regulations requiring clear declaration of common allergens
Q28. What is the primary purpose of microbial limits specified in food standards?
- To determine packaging aesthetics
- To ensure microbiological safety and acceptability of food products
- To set retail price bands
- To regulate advertising language
Correct Answer: To ensure microbiological safety and acceptability of food products
Q29. Which of the following is a valid reason for product recall under food regulations?
- Change in packaging color for branding
- Presence of undeclared allergen or contamination posing health risk
- Seasonal discount promotion
- Relocation of manufacturing site without informing consumers
Correct Answer: Presence of undeclared allergen or contamination posing health risk
Q30. For a B. Pharm student aiming for a role in regulatory affairs, which skill set is most relevant?
- Understanding of food/drug regulations, documentation, quality systems, risk assessment, and auditing
- Only knowledge of sales and marketing techniques
- Exclusive focus on clinical surgery skills
- Graphic design for labels only
Correct Answer: Understanding of food/drug regulations, documentation, quality systems, risk assessment, and auditing
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com