{"id":43315,"date":"2022-05-13T11:44:42","date_gmt":"2022-05-13T06:14:42","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=43315"},"modified":"2024-12-11T18:16:41","modified_gmt":"2024-12-11T12:46:41","slug":"how-to-start-an-herbal-medicine-business-in-india","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/how-to-start-an-herbal-medicine-business-in-india\/","title":{"rendered":"How to Start an Herbal Medicine Business in India?"},"content":{"rendered":"\n<p class=\"has-drop-cap\">Herbal medical business falls under the purview of AYUSH ministry. AYUSH stands for Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy. Registration under AYUSH is mandatory for those who aspire to engage in the business of herbal medicine in India. Let&#8217;s explore the legalities around this business and the licenses provided by the AYUSH ministry in detail. <\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/how-to-start-an-herbal-medicine-business-in-india\/#What_is_herbal_medicine\" >What is herbal medicine?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/how-to-start-an-herbal-medicine-business-in-india\/#Market_Analysis_of_herbal_medicines_from_Indias_perspective\" >Market Analysis of herbal\nmedicines from India&#8217;s perspective<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/how-to-start-an-herbal-medicine-business-in-india\/#Licenses_need_to_set_up_herbal_medicine_business_in_India\" >Licenses need to set up herbal\nmedicine business in India<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/how-to-start-an-herbal-medicine-business-in-india\/#Role_of_GMP_Certification_for_Herbal_Medicine_Production_Business\" >Role of GMP Certification for\nHerbal Medicine Production Business &nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/how-to-start-an-herbal-medicine-business-in-india\/#What_is_GMP\" >What is GMP?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/how-to-start-an-herbal-medicine-business-in-india\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_herbal_medicine\"><\/span>What is herbal medicine?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Herbal medicine (aka phytomedicine or\nbotanical medicine) originated from a plant&#8217;s roots, seeds, flowers, leaves,\nberries, etc., for medicinal purposes. Herbalism has been in effect since the\n19th century. The advancements in analysis, quality control, and clinical\nresearch has expedited growth of herbal medical sector in India.&nbsp; <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Market_Analysis_of_herbal_medicines_from_Indias_perspective\"><\/span>Market Analysis of herbal\nmedicines from India&#8217;s perspective<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ul>\n<li>In\n2019, the Indian medical plant market stood at Rs 4.2 billion and is projected\nto thrive at a CAGR of 38.5% by 2026. The net global herbal trade is presently\nassessed at US$ 120 billion.<\/li>\n\n\n\n<li>India&#8217;s\nshare in the international export of herbs has witnessed a marginal decline\nowing to dated and quality control procedures, lack of advanced processing,\nR&amp;D, standardization in products and legal framework in the trade of\nmedicinal plants. The export of herbs and other key extracts of medicinal herbs\nis increasing every passing year. <\/li>\n\n\n\n<li>In\n2017-2018, India shipped around US$ 330.18 million of herbs at a healthy growth\nrate of 14 per cent compared to the preceding year. <\/li>\n\n\n\n<li>Also,\nexports of productive extracts of medicinal herbs and herbal items in FY\n2017-2018 stood at US$ 456.12 million, registering a growth rate of almost 13\nper cent over the last year. India has witnessed an increasing demand in\nEuropean and other developed countries for herbal\/value-added extracts of\nmedicinal herbs. <\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Licenses_need_to_set_up_herbal_medicine_business_in_India\"><\/span>Licenses need to set up herbal\nmedicine business in India<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>AYUSH ministry handles the licensing and post-registration compliances for the herbal medicine business in India. The <a href=\"https:\/\/corpbiz.io\/ayush-license\" title=\"AYUSH License\"><strong>AYUSH license<\/strong><\/a> serves as a fundamental permit for such businesses in India. Presently, the competent authority under the AYUSH ministry confers the three types of production licenses<\/p>\n\n\n\n<p><strong><em>1. Complete Manufacturing License.<\/em><\/strong><\/p>\n\n\n\n<p><strong><em>2. Loan License.<\/em><\/strong><\/p>\n\n\n\n<p><strong><em>3. Contract Manufacturing \/ Third party\nmanufacturing \/ White label Manufacturing \/ Product to Product manufacturing.<\/em><\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Complete Manufacturing License <\/h3>\n\n\n\n<p>refers to a comprehensive manufacturing\nlicense. The license also legalizes the marketing efforts for such products.\nThat means production and marketing will be possible after securing this very\nlicense. The requirements and paperwork for this license may vary state-wise.\nThe applicant looking to set up herbal item production unit in India has to\nmeet the following prerequisites: <\/p>\n\n\n\n<p>\u00b7 Minimum size of the production premises\nshould be not less than 1200 sqft if dealing with one category of drug. More\nspace would be required in case of the inclusion of additional categories. <\/p>\n\n\n\n<ul>\n<li>The production premises should have <a href=\"https:\/\/corpbiz.io\/gmp-certification\" title=\"GMP Certification\"><strong>GMP certification<\/strong><\/a> in place. <\/li>\n\n\n\n<li>The availability of 2 Ayurvedic experts and 2 Pharmacist is mandatory<\/li>\n\n\n\n<li>The availability of required machinery set up is compulsory <\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Loan License <\/h3>\n\n\n\n<p>A loan License\nrefers to a production permit where you liaise with a GMP certified production\nfacility to manufacture your products. It is ideal for an entity that lacks\nadequate resources to set up a full-fledged production facility. After availing\nof this license, you can commence a production undertaking with your certified\nfacility. <\/p>\n\n\n\n<p>The alteration of the certified partner\nis also possible in this regard. But for this purpose, you need to follow the\nentire licensing procedure again. The license allows the licensee to sell the\nproduct under their name without disclosing the detail of the certified\nfacility. The loan license seeks applicant to meet the following requirements\nbefore coming into effect; <\/p>\n\n\n\n<ul>\n<li>The\nproposed premises should have one room for handling official affairs, one room\nfor storing raw material, and one room for storing finished goods. <\/li>\n\n\n\n<li>The\nproposed liasoing facility should belong to the state where the applicant&#8217;s\nbusiness is registered<\/li>\n\n\n\n<li>Other\npaperwork.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Contract \/ Third-Party\nManufacturing License <\/h3>\n\n\n\n<p>This license permits\nbusinesses to utilize the production license of another GMP-certified\nmanufacturer to produce the herbal medicines. In such a case, you only need to\nindulge in marketing activities. The license helps you allocate resources in\nareas other than manufacturing, thereby ensuring higher ROI. <\/p>\n\n\n\n<p>To get started\nwith such kind of business model, the third-party manufacturer is the one who\nhas to deal with the licensing requirement upfront. Also, the obligation for\nproduct approval is in the hand of the third-party manufacturer. <\/p>\n\n\n\n<p>The profit\nmargin for the licensee will be entirely dependent on the fact which party\ndeals with the raw material procurement.\n<\/p>\n\n\n\n<p><strong><em>Note: Under this license, either party is\nliable to disclose their exact status\/role on the product labeling. <\/em><\/strong><\/p>\n\n\n\n<p><strong><em>The licensee, in this case, has to bear\nthe following expenses: <\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>Cost\nof manufacturing herbal medicines <\/li>\n\n\n\n<li>Product\napproval fees <\/li>\n<\/ul>\n\n\n\n<p><strong><em>Notable\nfacts<\/em><\/strong><\/p>\n\n\n\n<ul>\n<li>Licensee in\nthis case has to draw an arrangement with the liaison facility that confirms its\nownership status over products in question. <\/li>\n\n\n\n<li>Unlike loan\nlicense, where there is a mandate that either party should belong to same\nstate, this license nullifies such a requirement.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Role_of_GMP_Certification_for_Herbal_Medicine_Production_Business\"><\/span>Role of GMP Certification for\nHerbal Medicine Production Business &nbsp;<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>In order to get increased recognition in\nthe international herbal markets, one has to align their facility with the\nguidelines of the GMP standards and accordingly obtain the GMP license. Apart\nfrom ensuring quality production, GMP also aids drug production facilities to\ninstil a credible image in other markets and therefore reap increased sales.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_is_GMP\"><\/span>What is GMP?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>GMP is an abbreviation for Good\nManufacturing Practice, &amp; the term is used worldwide for administering the\ncontrol and quality of pharmaceutical items, including herbal medicines. <\/p>\n\n\n\n<p>It underpins various directions around the quality assurance approach. GMP Certification takes various parameters into account that may influence the quality of the final product in one way or another. GMP certification is all about the continual improvement of the <strong>quality management system<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Quality_management_system\"><strong>[1]<\/strong><\/a><\/sup> of the production facility. <\/p>\n\n\n\n<p>GMP certification seeks to standardize\nthe following to ensure better quality management and production. <\/p>\n\n\n\n<ul>\n<li>Record\nKeeping<\/li>\n\n\n\n<li>Paperwork<\/li>\n\n\n\n<li>Sanitation<\/li>\n\n\n\n<li>Equipment\nverification<\/li>\n\n\n\n<li>Workplace\nhygiene<\/li>\n\n\n\n<li>Grievance\ncontrol <\/li>\n\n\n\n<li>Human\nresource<\/li>\n\n\n\n<li>Process\nhygiene<\/li>\n\n\n\n<li>Quality\ncontrol <\/li>\n<\/ul>\n\n\n\n<p>The fundamental object of GMP\ncertification is to curtail the threshold of risk relating to the production of\nmedicinal items. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>There is an array of compliances that one has to meet for setting up a herbal medicine business in India. If compliance handling is not your concern, then you can opt for <strong>Complete Manufacturing License<\/strong>, where there would be no profit-sharing. Similarly, if your budget is low, then you can apply for the rest of the licenses, which mitigates the need for establishing a production facility.  <\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/ayush-loan-license-meaning-documents-and-benefits\/\">AYUSH Loan License: Meaning, Documents, and Benefits\n<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Herbal medical business falls under the purview of AYUSH ministry. AYUSH stands for Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy. Registration under AYUSH is mandatory for those who aspire to engage in the business of herbal medicine in India. Let&#8217;s explore the legalities around this business and the licenses provided by the AYUSH ministry [&hellip;]<\/p>\n","protected":false},"author":22,"featured_media":43318,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[701],"tags":[2344],"acf":{"service_id":"257"},"authorName":"Pankaj Tyagi","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-42.jpg","authorDescription":"Pankaj has a diverse experience of writing research papers, blog, and articles during his college time. Earlier, he was working as a tax consultant in a financial firm, but his interest in writing drives him to pursue a career in the writing field.","postViews":5939,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/43315"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/22"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=43315"}],"version-history":[{"count":14,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/43315\/revisions"}],"predecessor-version":[{"id":67786,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/43315\/revisions\/67786"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/43318"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=43315"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=43315"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=43315"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}