Why you should buy this report?

The Indian food supplement market can turn out to be a lucrative business opportunity for many manufacturers and distributors. Increasing consumer awareness about preventive healthcare, rising purchasing power and an increase in lifestyle diseases are all contributing to the market’s expected growth.

This comprehensive report is a single point solution to study end-to-end regulations imposed on Food Supplements in India. The objective of this report is to provide precise information on the Regulatory landscape of India, to enable a Regulatory go-to-market strategy and ensure compliance.

Table of Contents
  1. LIST OF ABBREVIATIONS
  2. GOVERNING BODY
  3. PRODUCT DEFINITION & CLASSIFICATION
  4. GOVERNING REGULATIONS
  5. PRODUCT REGISTRATION
    1. Process and Flowchart
    2. Documents
    3. Submission Mode
    4. Submission Fees
    5. Registration Timelines
    6. Amendments/Changes to the Registration
  6. LABELING REQUIREMENTS
    1. Specific Labeling Requirements for “Health Supplements”
    2. Regulatory Controls on Label in India
    3. Requirements for Front of Pack Labeling
    4. Requirements for Trademark/Brand Name
    5. Requirements for Pictorial Graphics on the Label
    6. Requirements for Details of Manufacturer/Importer/Distributor on the Label
    7. Requirements for Technological Processes on the Label
    8. Requirements for Quantitative Ingredient Declaration (QUID) on the Label
    9. Requirements for List of Ingredients and Exemptions, If Any
    10. Requirements for Allergen Labeling
    11. Requirements for Reconstitution (added water) and its Declaration on the Label
    12. Requirements for Country of Origin on the Label
    13. Requirements for Date Marking on the Label (shelf life, best before, manufacturing date)
    14. Requirements for Storage Conditions on the Label
    15. Requirements for Net Weight Declaration on the Label
    16. Requirements for Traceability Code/Lot Number/Batch Number Declaration on the Label
    17. Requirements for Nutritional Information on the Label
    18. Requirements for Instructions for Use on the Label
    19. Requirements of the FSSAI Logo on the Label
    20. Requirement for Multilingual (multi language) Labeling
    21. Requirement for Font Size on the Label
    22. Prohibited Elements on the Label
    23. Requirements for Veg/Non-Veg Logo on the Label
    24. Other Specific Elements, if any
    25. All Regulatory Requirements for Food Labels in India
  7. NEW LABELING REGULATION APPLICABLE FROM DECEMBER 2021
    1. Requirements for Declaration of Non-Veg Logo
    2. Requirements for Date Marking on the Label
    3. Requirements for Name of Food
    4. Requirements for List of Ingredients
    5. Requirements for Nutritional Information
    6. Requirements for Calculation of Nutrients
    7. Requirements for Declaration Regarding Food Additives
    8. Requirements of the FSSAI logo on the Label
    9. Requirements for Allergen Labeling
    10. Requirement on Net Quantity, Retail Sale Price and Consumer Care Details
    11. Requirements for Front of Pack Labeling or PDP
    12. Other Specific Mandatory Elements
    13. Exemptions from Certain Labeling Requirements
    14. Labeling Requirements of Non-Retail Container
  8. INGREDIENTS
  9. ADVERTISING AND CLAIMS
    1. Approval of New Claims
  10. IMPORT REGULATIONS
    1. Import Documentation
    2. Import Procedure
    3. Import Timeline and Fee
    4. Import License Validity
  11. LOCAL AGENT REQUIREMENTS
  12. REFERENCES
  13. ANNEX
Summary
  • Product definition and classification criteria in India
  • Information on product registration through flowcharts
  • Precise information on documentation required, health authority fees, timelines for registration and submission mode
  • Provides details of prohibited ingredients to check formulation compliance
  • Regulations applicable on labeling, claims and advertising
  • Information on import regulations, and the requirement/qualification of a legal representative

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