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Why you should buy this report?

The Indian probiotics Market is projected to expand at a CAGR of 13.56%, reaching a market size of US$961.856 million by 2025. With its powerful institutions and trade alliances, India has emerged as the world’s second-fasted growing economy and is forecasted to be one of the top three economic forces by 2025.

This report is a comprehensive resource for studying end-to-end regulations on probiotics in India. The objective of this report is to enable a Regulatory go-to-market strategy and ensure compliance.

Table of Contents
  1. LIST OF ABBREVIATIONS
  2. REGULATORY STATUS
    1. Governing Regulatory Body
    2. Governing Laws
  3. PRODUCT DEFINITION
  4. REGISTRATION REQUIREMENTS
    1. Product Registration Process and Flowchart for Novel Food
    2. Documents to be Submitted
    3. Submission/ Delivery Mode
    4. Submission Fees
    5. Timeline
    6. Amendments/Changes to Registration
  5. INGREDIENTS AND THEIR LIMITS
  6. LABELING REQUIREMENTS
    1. Specific Labeling Requirements for “Food with Added Probiotic Ingredients”
    2. Requirements for Date Marking on the Label
    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. Regulatory Elements Shared with Codex Alimentarius
    24. Labeling Elements that are Specific and Different Compared to other Asian Markets
    25. Requirements for Veg/Non-Veg Logo on the label
    26. Other Specific Elements, if any
    27. 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 Rf equirements
    14. Labeling Requirements oNon-Retail Container
  8. ADVERTISING AND CLAIMS
    1. Approval of New Claims
  9. IMPORT REGULATIONS
    1. Import Documentation
    2. Import Procedure
    3. Import Timeline and Fee
    4. Import License Validity
  10. LOCAL AGENT REQUIREMENTS
  11. REFERENCES
  12. ANNEXURES
    1. Annex I - List of Permitted Additives
    2. ANNEX II - Schedules on Claims
    3. ANNEX III - Legal Metrology Package Commodities Rules, 2011
Summary
  • Product definition and governing laws in India
  • Information on product registration through a flowchart
  • Precise information on documentation required, ingredients and their limits, health authority fees, timelines for registration and submission mode
  • Regulations applicable on labeling, claims and advertising
  • Information on import regulations, and the requirement/qualification of a legal representative

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