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Nutraceutical Regulation and Registration in India (FSSAI)

The Indian population's increasing trust in immunity-boosting supplements has significantly transformed buying behaviors and market dynamics. Vitamin capsules, chewable tablets, and gummies exemplify consumers' receptive approach to healthcare products. Preventive healthcare has emerged as a crucial defense line during the pandemic, establishing the nutraceutical sector as resilient economically. India's rich herbal and Ayurvedic tradition underpins many nutraceutical products, with Ayurvedic variants focusing on plant-based compounds and principles for holistic well-being. In 2017, India's nutraceutical market represented 2% of the global market, valued at approximately $5 billion in 2019. Anticipated CAGR: 15% (2023-2028). Amid the pandemic, annual industry growth reached 25%, supported by rising Foreign Direct Investment (FDI).

Nutraceutical Regulation Registration India (FSSAI)

This article outlines the nutraceutical regulation and registration in India (FSSAI)

Nutraceutical Regulatory Framework India

The Food Safety and Standards Authority of India (FSSAI) plays a pivotal role in the regulation and registration of nutraceuticals in India. As the primary regulatory authority for food safety and quality in India, the FSSAI oversees and ensures the proper manufacturing, labeling, distribution, and consumption of nutraceutical products.

Health supplement Product classification India

  1. Dietary Supplements: Products to enhance the diet with extra nutrients.

  2. Functional Foods: Offer health benefits beyond basic nutrition.

  3. Nutritionally Fortified Foods: Enriched with additional nutrients.

  4. Herbal & Ayurvedic Nutraceuticals: Derived from traditional ingredients, following Ayurvedic principles.

  5. Probiotics & Prebiotics: Live microorganisms for gut health.

  6. Sports Nutrition: Supports athletes with supplements and energy products.

  7. Medical Foods: Formulated for specific medical dietary management.

Nutraceutical product Registration process in India

  1. Application Submission: Submit an online application through the FSSAI portal.

  2. Product Details: Provide comprehensive details about the nutraceutical product, including its ingredients, formulation, intended use, and safety data.

  3. Safety Assessment: Furnish scientific evidence demonstrating the safety and efficacy of the product, especially for novel ingredients.

  4. Label Approval: Ensure that the product label adheres to FSSAI's labelling regulations, including accurate nutritional information and claims.

  5. Manufacturing Facility Details: Provide information about the manufacturing facility, equipment, and quality control measures.

  6. Ingredients Source: Document the source and quality of ingredients used in the product.

  7. Packaging Information: Submit packaging details that comply with FSSAI standards.

  8. Review and Approval: FSSAI reviews the application, assesses the product's safety and efficacy, and grants registration if requirements are met.

  9. Compliance and Surveillance: After approval, maintain compliance with ongoing surveillance and audits by FSSAI to ensure product quality and safety.

Document required for nutraceutical registration

  1. Product formulation and manufacturing process details.

  2. Proof of safety and efficacy.

  3. Lab analysis reports of the product.

  4. Details of the manufacturing facility and equipment.

  5. Proof of source and quality of ingredients.

  6. Packaging and labeling information.

  7. Declaration of conformity to FSSAI regulations.

Health supplement Labelling requirement

The label of a nutraceutical product should comply with FSSAI's labeling regulations, which include information about.

  1. Product name.

  2. List of ingredients and allergens.

  3. Nutritional information.

  4. Manufacturing and expiry dates.

  5. Usage instructions.

  6. Country of origin.

  7. FSSAI license/registration number.

Nutraceutical Quality Control: FSSAI enforces quality control measures to ensure that nutraceutical products meet the specified standards and are safe for consumption.

Monitoring and Surveillance: FSSAI monitors the nutraceutical market to identify potential safety issues, misleading claims, and non-compliance with regulations. It takes corrective actions when necessary to protect public health.

Health supplements Import and Export

Imported nutraceutical products must also comply with FSSAI regulations. The importer needs to have a valid Importer Exporter Code (IEC) and obtain an FSSAI import license.

Fee structure and timeline associated with nutraceutical registration in India

  • Applicants should furnish a dossier with a complete application form and government fees of Rs. 50,000. The Food Authority will convene an expert committee for preliminary scrutiny and claim approval.

  • The timeline for obtaining the FSSAI Advertisement & Claims Approval for Food Supplements & Nutraceuticals is approximately one to eight days.



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