Indian regulations for import, manufacture and sale of nutraceuticals MCQs With Answer

This quiz collection focuses on Indian regulations governing the import, manufacture and sale of nutraceuticals, tailored for M.Pharm students studying Regulatory Aspects of Food & Nutraceuticals (MRA204T). It highlights key statutes, FSSAI regulations, documentation and compliance requirements, labeling and advertising norms, novel-food approvals, import procedures and quality systems relevant to nutraceutical products. Each question challenges your understanding of legal frameworks, practical obligations for Food Business Operators (FBOs) and roles of regulatory bodies. Use these MCQs to reinforce regulatory knowledge critical for product development, registration, quality assurance and market access of nutraceuticals in India.

Q1. Which is the primary regulatory authority for nutraceuticals in India?

• Central Drugs Standard Control Organization (CDSCO)
• Food Safety and Standards Authority of India (FSSAI)
• Ministry of AYUSH
• Bureau of Indian Standards (BIS)

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

Q2. Which statute provides the legal framework for food safety including nutraceuticals in India?

• Drugs and Cosmetics Act, 1940
• Indian Penal Code
• Food Safety and Standards Act, 2006
• Prevention of Food Adulteration Act, 1954

Correct Answer: Food Safety and Standards Act, 2006

Q3. Which specific regulation categorizes and governs health supplements, nutraceuticals, functional foods and novel foods?

• Food Safety and Standards (Licensing and Registration) Regulations, 2011
• Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011
• Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Uses, Food for Special Medical Purposes, Functional Food and Novel Food) Regulations, 2016
• Food Safety and Standards (Import) Regulations, 2017

Correct Answer: Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Uses, Food for Special Medical Purposes, Functional Food and Novel Food) Regulations, 2016

Q4. Which regulation specifically governs import requirements for food and nutraceutical consignments into India?

• Food Safety and Standards (Import) Regulations, 2017
• Customs Act, 1962
• Foreign Trade Policy, 2015
• Drugs and Cosmetics Rules, 1945

Correct Answer: Food Safety and Standards (Import) Regulations, 2017

Q5. Before manufacturing nutraceuticals in India, a Food Business Operator (FBO) must obtain which of the following?

• Manufacturing permit from the Ministry of AYUSH
• FSSAI registration or license as applicable
• Central Drug License from CDSCO
• Voluntary certification from BIS

Correct Answer: FSSAI registration or license as applicable

Q6. Are novel ingredients or novel foods used in nutraceutical formulations required to obtain prior approval from FSSAI?

• No, novel foods can be marketed without any prior approval
• Yes, novel foods/ingredients require prior approval from FSSAI before use
• Approval is only required if exported outside India
• Approval is granted automatically if ingredient is approved by any foreign regulator

Correct Answer: Yes, novel foods/ingredients require prior approval from FSSAI before use

Q7. Which regulation prescribes mandatory labeling requirements for nutraceutical products sold in India?

• Food Safety and Standards (Packaging and Labelling) Regulations, 2011
• Advertising Standards Council of India (ASCI) Code
• Drugs and Cosmetics Act, 1940
• Consumer Protection Act

Correct Answer: Food Safety and Standards (Packaging and Labelling) Regulations, 2011

Q8. Which type of claim is explicitly prohibited on nutraceutical labels and advertisements under FSSAI norms?

• Structure/function claims describing physiological role
• General well‑being nutrition claims
• Claims to diagnose, treat, cure or prevent any disease
• Claims about composition and nutrient values

Correct Answer: Claims to diagnose, treat, cure or prevent any disease

Q9. Under FSSAI definitions, who qualifies as an importer of nutraceuticals?

• The domestic distributor who sells within India
• Any person or entity that brings food into India from abroad
• The manufacturer located within India
• The retail outlet that stocks the product

Correct Answer: Any person or entity that brings food into India from abroad

Q10. Which of the following documents are typically required for FSSAI clearance of an imported nutraceutical consignment?

• Manufacturer’s declaration only
• Commercial invoice, packing list, bill of lading/airway bill, certificate of analysis and sanitary/phyto‑sanitary or health certificate
• Exporter’s trade license only
• Local distributor’s purchase order only

Correct Answer: Commercial invoice, packing list, bill of lading/airway bill, certificate of analysis and sanitary/phyto‑sanitary or health certificate

Q11. Which regulation lays down standards for food product composition and permissible food additives relevant to nutraceuticals?

• Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011
• Food Safety and Standards (Advertising and Claims) Regulations, 2018
• Drugs and Cosmetics Rules, 1945
• Prevention of Food Adulteration Act, 1954

Correct Answer: Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011

Q12. Who provides scientific assessment and opinions to FSSAI on safety of novel ingredients used in nutraceuticals?

• Central Drugs Standard Control Organization (CDSCO)
• Food Safety and Standards Authority of India’s scientific panels and expert committees
• Advertising Standards Council of India (ASCI)
• Ministry of Consumer Affairs

Correct Answer: Food Safety and Standards Authority of India’s scientific panels and expert committees

Q13. Which officer has legal power to inspect, seize or detain unsafe nutraceutical consignments under FSSAI?

• Designated Food Safety Officer / Authorized Officer under FSSAI
• Local Police Constable
• Municipal Corporator
• Private quality auditor

Correct Answer: Designated Food Safety Officer / Authorized Officer under FSSAI

Q14. Which regulation or requirement mandates adoption of hygienic practices and Good Manufacturing Practices (GMP) for nutraceutical manufacturers?

• Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011 and related guidance on hygiene and GMP
• Consumer Protection Act, 2019
• Drugs and Cosmetics Rules, 1945 only
• Foreign Trade Policy guidelines

Correct Answer: Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011 and related guidance on hygiene and GMP

Q15. On what authoritative recommendations does FSSAI base the recommended daily allowances (RDAs) used for setting micronutrient limits in nutraceuticals?

• World Health Organization (WHO) guidelines only
• Indian Council of Medical Research (ICMR) nutrient recommendations and expert committees
• US FDA Recommended Daily Values exclusively
• Manufacturer submitted suggestions

Correct Answer: Indian Council of Medical Research (ICMR) nutrient recommendations and expert committees

Q16. Which regulation specifically addresses advertising and claims for foods including nutraceuticals?

• Food Safety and Standards (Advertising and Claims) Regulations, 2018
• Consumer Protection Act
• Advertising Standards Council of India (ASCI) Code only
• Drugs and Cosmetics Act, 1940

Correct Answer: Food Safety and Standards (Advertising and Claims) Regulations, 2018

Q17. Which of the following label particulars is mandatory for nutraceutical products in India?

• Brand name only
• Declaration of nutritional information, list of ingredients, net quantity, batch number, manufacturing date, best before/expiry and FSSAI license/registration number
• Manufacturer’s email only
• Suggested retail price only

Correct Answer: Declaration of nutritional information, list of ingredients, net quantity, batch number, manufacturing date, best before/expiry and FSSAI license/registration number

Q18. Which statement regarding date marking for nutraceuticals is correct under FSSAI rules?

• Nutraceuticals should use “use by” date for all products
• “Best before” is generally appropriate for nutraceuticals where shelf life is based on quality rather than safety
• Date marking is optional for all nutraceuticals
• Only manufacturing date is required; no expiry or best before

Correct Answer: “Best before” is generally appropriate for nutraceuticals where shelf life is based on quality rather than safety

Q19. For obtaining a manufacturing license for a nutraceutical unit operating solely within one Indian state, which licensing authority is normally competent?

• FSSAI Central Licensing Authority only
• State Food Safety Licensing Authority
• Directorate General of Foreign Trade
• Ministry of Health and Family Welfare headquarters

Correct Answer: State Food Safety Licensing Authority

Q20. Which type of claims are generally acceptable on nutraceutical labels provided they are substantiated and within regulatory limits?

• Claims that the product cures diabetes or heart disease
• Specific therapeutic claims stating the product treats or prevents disease
• Structure/function or nutrition‑based claims describing physiological benefits with supporting evidence
• Guaranteed medicinal effect statements

Correct Answer: Structure/function or nutrition‑based claims describing physiological benefits with supporting evidence

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