{"time":1756910990316,"blocks":[{"id":"CX-L1s9L1y","type":"header","data":{"text":"INTRODUCTION","level":2}},{"id":"v0VnXKSUut","type":"paragraph","data":{"text":"The nutraceutical market in India has grown massively in the last decade. Consumers are shifting from traditional medicines to preventive healthcare solutions like vitamins, probiotics, herbal extracts, protein supplements, and specialized nutrition blends. But unlike everyday food products, nutraceuticals fall under a sensitive category—they are foods with specific health benefits, and hence they are regulated with strict rules by the Food Safety and Standards Authority of India (FSSAI)."}},{"id":"rbQXuCSXGN","type":"paragraph","data":{"text":"In India, nutraceuticals are governed by the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Prebiotic and Probiotic Food) Regulations, 2022. These regulations replaced the earlier 2016 rules and brought in better clarity on ingredients, maximum permissible limits, labeling requirements, and claims. Any business—whether manufacturing, importing, distributing, or marketing nutraceuticals—must hold an FSSAI Nutraceutical License before starting operations."}},{"id":"eEUVAkLn26","type":"paragraph","data":{"text":"In this blog, we will walk you through everything about Nutraceutical Product Registration in India: why it is required, who issues it, eligibility, documents, step-by-step licensing process, penalties for non-compliance, and how Lawfinity can simplify the entire journey."}},{"id":"xcm7In7PQT","type":"header","data":{"text":"WHY SUCH LICENCE/CERTIFICATE IS REQUIRED?","level":2}},{"id":"Ko1GNcFMtR","type":"paragraph","data":{"text":"There are three main reasons why a nutraceutical license is required:"}},{"id":"ZRaaJkTbFz","type":"list","data":{"style":"ordered","meta":{},"items":[{"content":"Legal Requirement: The Food Safety and Standards Act, 2006 makes it mandatory for every Food Business Operator (FBO) to obtain a license or registration before starting operations. Operating without a license is a punishable offence.","meta":{},"items":[]},{"content":"Health & Safety of Consumers: Nutraceuticals are consumed for health benefits, so they are subject to strict checks. Regulations define approved ingredients, maximum usage levels (usually not more than one Recommended Dietary Allowance), and clear labeling rules. This ensures that consumers are not misled and products remain safe.","meta":{},"items":[]},{"content":"Trade & Imports Compliance: For companies importing nutraceuticals into India, the FSSAI license is a must. Each consignment is cleared through the Food Import Clearance System, and without the proper license, imports will be held at ports.","meta":{},"items":[]}]}},{"id":"ldUP4DgLcD","type":"image","data":{"caption":"Why Such Licence/Certificate is Required ?","withBorder":false,"withBackground":false,"stretched":false,"file":{"url":"https://res.cloudinary.com/dmd2a1z29/image/upload/v1756910960/bwvleze57fppaqkxa3gr.jpg"}}},{"id":"gd5oqbuLzt","type":"header","data":{"text":"WHO ISSUES SUCH LICENCE/CERTIFICATE?","level":2}},{"id":"4kDJbQ_49Q","type":"paragraph","data":{"text":"Licenses for nutraceuticals are issued by the Food Safety and Standards Authority of India (FSSAI) through its online portal called FoSCoS (Food Safety Compliance System)."}},{"id":"KsN1lKRkSe","type":"list","data":{"style":"unordered","meta":{},"items":[{"content":"For small businesses with a limited turnover, licenses are issued by the State Licensing Authority.","meta":{},"items":[]},{"content":"For larger companies, importers, and businesses operating across states, the license comes from the Central Licensing Authority.","meta":{},"items":[]}]}},{"id":"V9JvaveSTH","type":"header","data":{"text":"ELIGIBILITY AND DOCUMENTS REQUIRED FOR SUCH LICENCE/CERTIFICATE","level":3}},{"id":"FgEBpCP1Tp","type":"paragraph","data":{"text":"A. Eligibility"}},{"id":"_3Y-El4oyr","type":"paragraph","data":{"text":"The type of license depends on the scale and nature of your nutraceutical business:"}},{"id":"WuYLccDUwH","type":"list","data":{"style":"unordered","meta":{},"items":[{"content":"Basic Registration: For petty FBOs with turnover up to ₹12 lakh per year.","meta":{},"items":[]},{"content":"State License: For businesses with turnover between ₹12 lakh to ₹20 crore and operating within a single state.","meta":{},"items":[]},{"content":"Central License: For businesses with turnover above ₹20 crore, importers, 100% export-oriented units, or those operating across multiple states.","meta":{},"items":[]}]}},{"id":"rrzGMQ1hNg","type":"paragraph","data":{"text":"B. Nutraceutical-Specific Conditions"}},{"id":"QkF9AOPevC","type":"paragraph","data":{"text":"Before applying, businesses must ensure:"}},{"id":"gzCzAxS3eo","type":"list","data":{"style":"unordered","meta":{},"items":[{"content":"Ingredients are listed in the permitted schedules of the 2022 Nutraceutical Regulations.","meta":{},"items":[]},{"content":"Vitamins and minerals do not exceed one RDA unless specifically permitted.","meta":{},"items":[]},{"content":"No banned or disallowed ingredients are included.","meta":{},"items":[]},{"content":"Labels comply with all mandatory declarations like “Not for medicinal use” and avoid disease cure claims.","meta":{},"items":[]}]}},{"id":"LCFyovqxH-","type":"paragraph","data":{"text":"If the product uses a new ingredient not in the approved list, it must be approved first under the Non-Specified Food and Ingredient Regulations, 2017."}},{"id":"1W6_YkvDju","type":"paragraph","data":{"text":"C. Documents Required"}},{"id":"EuqWwNk6Cr","type":"paragraph","data":{"text":"For a nutraceutical manufacturer, relabeller, or importer, the following documents are typically needed:"}},{"id":"5bao909eUa","type":"list","data":{"style":"unordered","meta":{},"items":[{"content":"Duly filled Form-B.","meta":{},"items":[]},{"content":"Photo ID and address proof of proprietor/partners/directors.","meta":{},"items":[]},{"content":"Incorporation certificate, MOA/AOA, or partnership deed.","meta":{},"items":[]},{"content":"List of directors/partners with details.","meta":{},"items":[]},{"content":"Premise layout and manufacturing/processing plan.","meta":{},"items":[]},{"content":"Water analysis report (if applicable).","meta":{},"items":[]},{"content":"Product label drafts as per Nutraceutical Regulations 2022.","meta":{},"items":[]},{"content":"Proof of premises ownership/lease.","meta":{},"items":[]},{"content":"Food safety management plan.","meta":{},"items":[]},{"content":"Importers: Import Export Code (IEC) and warehouse details.","meta":{},"items":[]},{"content":"Any prior approval for non-specified foods (if applicable).","meta":{},"items":[]}]}},{"id":"EL6rBTNBUe","type":"header","data":{"text":"STEP-BY-STEP SUCH LICENCE/CERTIFICATE PROCESS","level":2}},{"id":"dCEg5n7mJG","type":"paragraph","data":{"text":"The application process for FSSAI Nutraceutical License is fully online through FoSCoS:"}},{"id":"3gBuUYZtkl","type":"paragraph","data":{"text":"Step 1: Identify Business Category (Kind of Business)- Select whether you are a manufacturer, importer, relabellers, marketer, warehouse operator, or e-commerce platform."}},{"id":"AIdhhnZdrL","type":"paragraph","data":{"text":"Step 2: Determine Type of License- Decide whether you need a Basic Registration, State License, or Central License based on turnover and business model."}},{"id":"kHoj7Phm89","type":"paragraph","data":{"text":"Step 3: Create Account on FoSCoS-Register on FoSCoS and log in to start a new application."}},{"id":"efDju2URus","type":"paragraph","data":{"text":"Step 4: Fill Form B- Enter details of the business, product category (nutraceuticals/health supplements), and installed capacity (if manufacturing)."}},{"id":"D5DbepXFdF","type":"paragraph","data":{"text":"Step 5: Upload Documents- Upload the mandatory documents in PDF/JPEG format."}},{"id":"u9WvHL63eG","type":"paragraph","data":{"text":"Step 6: Pay Fees- The fee ranges between ₹100 to ₹7,500 per year depending on the license type and activity."}},{"id":"CnbRQq_-KG","type":"paragraph","data":{"text":"Step 7: Inspection (if required)- Authorities may conduct a site inspection to verify compliance with hygiene and safety standards."}},{"id":"Zaz7HqEm5M","type":"paragraph","data":{"text":"Step 8: Clarifications- Respond to any queries raised by the licensing officer on the portal."}},{"id":"UZkXBwLEQS","type":"paragraph","data":{"text":"Step 9: Grant of License- Once approved, the license is digitally signed and available for download."}},{"id":"wGwlzwsott","type":"paragraph","data":{"text":"Step 10: Post-Licensing Compliance"}},{"id":"ia9wXaHZWh","type":"list","data":{"style":"unordered","meta":{},"items":[{"content":"Display the license at your premises.","meta":{},"items":[]},{"content":"File mandatory returns where applicable.","meta":{},"items":[]},{"content":"Ensure timely renewal before expiry.","meta":{},"items":[]},{"content":"Update endorsements if you expand or add new products.","meta":{},"items":[]}]}},{"id":"wgov8JA2GU","type":"paragraph","data":{"text":"For Importers: They must obtain a Central License and clear consignments via the Food Import Clearance System."}},{"id":"PgW99kreLB","type":"paragraph","data":{"text":"For Non-Specified Products: Approval must be obtained before applying for the main license."}},{"id":"IYSBXtJdT8","type":"header","data":{"text":"PENALTY FOR OPERATING WITHOUT SUCH LICENCE/CERTIFICATE","level":3}},{"id":"2xcS3vrQnP","type":"paragraph","data":{"text":"The penalties under the FSS Act, 2006 are strict:"}},{"id":"Lh0oyKD8oH","type":"list","data":{"style":"unordered","meta":{},"items":[{"content":"Operating without license: Imprisonment up to 6 months and fine up to ₹5 lakh.","meta":{},"items":[]},{"content":"Misbranding: Fine up to ₹3 lakh.","meta":{},"items":[]},{"content":"Misleading advertisements: Fine up to ₹10 lakh.","meta":{},"items":[]},{"content":"Sub-standard food: Fine up to ₹5 lakh.","meta":{},"items":[]},{"content":"Unhygienic conditions: Fine up to ₹1 lakh.","meta":{},"items":[]},{"content":"Unsafe food: Can lead to both imprisonment and heavy fines, depending on the harm caused.","meta":{},"items":[]}]}},{"id":"pWv-6jLzl-","type":"paragraph","data":{"text":"Clearly, working without a license is not just risky for consumers but can also land businesses in serious legal trouble."}},{"id":"QMB4LX7E8Q","type":"header","data":{"text":"HOW LAWFINITY SIMPLIFIES SUCH LICENCE/CERTIFICATE PROCEDURE?","level":2}},{"id":"QHy7shiiXj","type":"paragraph","data":{"text":"At Lawfinity, we help businesses turn the complex licensing maze into a smooth process:"}},{"id":"DXueVYLukT","type":"list","data":{"style":"unordered","meta":{},"items":[{"content":"Ingredient Compliance: We analyze your product formula, map ingredients to approved lists, and check for RDA limits.","meta":{},"items":[]},{"content":"Label Review: We vet your product labels for correct declarations, caution statements, and ensure no medicinal claims slip in.","meta":{},"items":[]},{"content":"Correct License Selection: We identify whether you need a State or Central license, importer license, or additional endorsements.","meta":{},"items":[]},{"content":"Non-Specified Approval Support: If your product has a novel ingredient, we prepare the required dossiers for FSSAI approval.","meta":{},"items":[]},{"content":"End-to-End FoSCoS Filing: From documentation to application, query response, and inspections—we handle it all.","meta":{},"items":[]},{"content":"Renewals & Compliance: We track deadlines and help with renewals, amendments, and ongoing compliance.","meta":{},"items":[]}]}},{"id":"CBl_VHpOsT","type":"paragraph","data":{"text":"With Lawfinity’s expertise, businesses can focus on product development and sales while we ensure they are always 100% compliant."}},{"id":"j_KkIDyYxp","type":"header","data":{"text":"MUSINGS FROM THE AUTHOR’S INK","level":3}},{"id":"3ho9-PaFFR","type":"paragraph","data":{"text":"Getting an FSSAI Nutraceutical License is not just about filling a form online. It’s about aligning your business with science-backed regulations. The real challenges usually lie in the formulation stage—choosing the right ingredients, staying within the RDA limits, and making safe claims. Many businesses face delays not because of paperwork, but because their products don’t comply with the positive list of allowed ingredients or make claims that are prohibited."}},{"id":"U6lKrbNwd4","type":"paragraph","data":{"text":"India’s regulatory framework for Nutraceutical Product Registration is evolving rapidly, and the 2022 rules have made it more structured. If businesses embrace these regulations with the right mindset, compliance can become their competitive edge. Rather than seeing the license as a hurdle, see it as proof that your product is safe, reliable, and ready for market trust."}}],"version":"2.31.0-rc.7"}