Introduction
The Food Safety and Standards Act, 2006 and the Food Safety and Standards Authority of India (FSSAI) form the backbone of food regulation in India. This blog provides targeted multiple-choice questions designed for M.Pharm students to strengthen understanding of legal frameworks, regulatory roles, standards setting, licensing/registration, import controls, lab accreditation, nutraceutical regulation, and enforcement mechanisms under the Act. Questions focus on practical regulatory implications for pharmaceutical and nutraceutical professionals, including responsibilities of food business operators, product approvals, risk assessment bodies, and compliance systems. Use these MCQs to test knowledge, prepare for exams, and apply regulatory concepts in research or industry settings.
Q1. What is the primary objective of the Food Safety and Standards Act, 2006?
- To regulate pharmaceutical manufacturing
- To ensure safe and wholesome food for human consumption and protect public health
- To control agricultural pesticide use
- To standardize cosmetic products
Correct Answer: To ensure safe and wholesome food for human consumption and protect public health
Q2. In which year was the Food Safety and Standards Act enacted?
- 1954
- 2006
- 2011
- 1995
Correct Answer: 2006
Q3. Which statutory body was established under the Food Safety and Standards Act to oversee food regulation in India?
- Central Drugs Standard Control Organization (CDSCO)
- Food Safety and Standards Authority of India (FSSAI)
- Ministry of Agriculture
- Prevention of Food Adulteration Board
Correct Answer: Food Safety and Standards Authority of India (FSSAI)
Q4. Which of the following is a core scientific function of FSSAI?
- Conducting clinical trials for drugs
- Carrying out risk assessment, risk management and risk communication for food
- Issuing medical licenses
- Regulating veterinary practice
Correct Answer: Carrying out risk assessment, risk management and risk communication for food
Q5. Under the Act, who is defined as a “Food Business Operator” (FBO)?
- Only large industrial manufacturers of food
- Any person or entity engaged in any activity related to food production, storage, distribution, sale or service
- Only retailers selling packaged food
- Only importers of food products
Correct Answer: Any person or entity engaged in any activity related to food production, storage, distribution, sale or service
Q6. Under FSSAI licensing and registration regulations, which category of food business typically requires registration (not license) at the local level?
- Large manufacturers with national distribution
- Petty food manufacturers and small food businesses with turnover up to the prescribed threshold
- Importers of food products
- Caterers for multinational events
Correct Answer: Petty food manufacturers and small food businesses with turnover up to the prescribed threshold
Q7. Which historic law was repealed when the Food Safety and Standards Act came into force?
- Drugs and Cosmetics Act, 1940
- Prevention of Food Adulteration Act, 1954
- Insecticides Act, 1968
- Essential Commodities Act, 1955
Correct Answer: Prevention of Food Adulteration Act, 1954
Q8. Which of the following is NOT a function of the FSSAI?
- Framing science-based standards for articles of food
- Accrediting food testing laboratories and referral labs
- Regulating clinical trial protocols for new drugs
- Promoting food safety awareness and capacity building
Correct Answer: Regulating clinical trial protocols for new drugs
Q9. Who heads the FSSAI as the statutory head of the Authority?
- Chief Executive Officer (CEO)
- Chairperson appointed by the Central Government
- Minister of Health & Family Welfare
- Director General of Health Services
Correct Answer: Chairperson appointed by the Central Government
Q10. Which FSSAI regulation specifically addresses health supplements, nutraceuticals, food for special medical purposes and novel foods?
- Food Safety and Standards (Contaminants, Toxins and Residues) Regulations
- Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016
- Food Safety and Standards (Packaging) Regulations, 2011
- Food Safety and Standards (Import) Regulations, 2005
Correct Answer: Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016
Q11. Which authority is primarily responsible for enforcement of the Food Safety and Standards Act at the state level?
- Central Food Authority only
- State Food Safety Authority / State Food Safety Commissioner and designated officers
- Municipal Health Department exclusively
- Department of Pharmaceuticals
Correct Answer: State Food Safety Authority / State Food Safety Commissioner and designated officers
Q12. Which bodies within the FSSAI provide scientific advice and technical guidance for standard setting and risk assessment?
- Scientific Committee, Scientific Panels and Central Advisory Committee
- State Municipal Boards
- Pharmaceutical Manufacturers Association
- District Magistrate Offices
Correct Answer: Scientific Committee, Scientific Panels and Central Advisory Committee
Q13. What is required for an importer to clear packaged food products into India under FSSAI rules?
- No formalities; goods clear directly through customs
- Registration of the importer and compliance with FSSAI import clearance and lab-testing requirements
- Approval from the Ministry of Commerce only
- Only a manufacturer declaration from the exporting country
Correct Answer: Registration of the importer and compliance with FSSAI import clearance and lab-testing requirements
Q14. Which responsibility is specifically assigned to Food Business Operators under the Act?
- Issuing food safety laws
- Maintaining product traceability, implementing food safety management systems and facilitating recall when required
- Conducting national level food safety audits for other companies
- Approving novel food applications
Correct Answer: Maintaining product traceability, implementing food safety management systems and facilitating recall when required
Q15. Who regulates and approves health claims and labeling statements for nutraceuticals and health supplements?
- Food Safety and Standards Authority of India (FSSAI)
- Central Drugs Standard Control Organization (CDSCO)
- Ministry of AYUSH
- Pharmaceutical Export Promotion Council
Correct Answer: Food Safety and Standards Authority of India (FSSAI)
Q16. Which internationally recognized food safety management system is commonly recommended to be implemented by FBOs under FSSAI guidance?
- GMP only without hazard analysis
- HACCP (Hazard Analysis and Critical Control Points)
- Clinical SOPs
- Pharmacovigilance System
Correct Answer: HACCP (Hazard Analysis and Critical Control Points)
Q17. What is the Food Safety Compliance System (FoSCoS) in the context of FSSAI?
- A laboratory assay method for food contaminants
- An online portal for licensing, registration, returns and compliance management for FBOs
- A state-level inspection manual
- A distribution network for packaged foods
Correct Answer: An online portal for licensing, registration, returns and compliance management for FBOs
Q18. How does FSSAI support food testing and laboratory competence in India?
- By running all food testing labs directly at district level
- By formulating test standards, recognizing reference labs and promoting NABL accreditation of food testing laboratories
- By delegating testing entirely to private foreign labs
- By eliminating third-party testing requirements
Correct Answer: By formulating test standards, recognizing reference labs and promoting NABL accreditation of food testing laboratories
Q19. Under FSSAI packaging and labeling requirements, what does a solid green symbol indicate on a prepackaged food product?
- Product is non-vegetarian
- Product is vegetarian
- Product contains allergens only
- Product is organic certified
Correct Answer: Product is vegetarian
Q20. Which of the following is outside the regulatory jurisdiction of FSSAI?
- Standards for food additives and contaminants
- Regulation of prescription pharmaceuticals and clinical drug approvals
- Licensing and registration of food business operators
- Setting labeling requirements for packaged foods
Correct Answer: Regulation of prescription pharmaceuticals and clinical drug approvals
