{"id":383568,"date":"2026-05-07T17:00:33","date_gmt":"2026-05-07T11:30:33","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=383568"},"modified":"2026-05-07T16:43:46","modified_gmt":"2026-05-07T11:13:46","slug":"fssai-advisory-ashwagandha-root-use-only-in-ayush-products","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2026\/05\/07\/fssai-advisory-ashwagandha-root-use-only-in-ayush-products\/","title":{"rendered":"What Ayush manufacturers need to know about Ashwagandha products: FSSAI issues Advisory"},"content":{"rendered":"<div style=\"text-align: justify; line-height: 150%;\">\n<p style=\"margin-bottom: 3%;\">On <span style=\"font-weight: bold;\">April 16, 2026<\/span>, the Food Safety and Standards Authority of India (FSSAI) issued an advisory drawing attention to the <span style=\"font-weight: bold;\">mandatory use of Ashwagandha (<span style=\"font-style: italic;\">Withania somnifera<\/span>) roots only<\/span> in Ayush drugs and related products, following directions issued by the Ministry of Ayush on <span style=\"font-weight: bold;\">April 15, 2026<\/span>.<\/p>\n<h2>Background<\/h2>\n<p style=\"margin-bottom: 3%;\">Ashwagandha is one of the most widely used medicinal plants in Ayurveda and other Ayush systems, valued for its adaptogenic, anti-stress, and rejuvenating properties. Both traditional use and scientific evidence recognize <span style=\"font-weight: bold;\">the roots<\/span> of the plant as the safe and effective part for therapeutic purposes.<\/p>\n<p style=\"margin-bottom: 3%;\">Despite earlier instructions issued in <span style=\"font-weight: bold;\">October 2021<\/span>, the Ministry observed that some manufacturers continued to use Ashwagandha leaves in crude, extract, or derivative forms. This ongoing non-compliance led to the issuance of a renewed and more explicit advisory.<\/p>\n<p style=\"margin-bottom: 3%;\">The advisory is based on updated scientific evidence. In <span style=\"font-weight: bold;\">2024<\/span>, a multidisciplinary expert committee convened by the Ministry of Ayush published an <span style=\"font-weight: bold;\">updated safety dossier<\/span>, recommending the exclusive use of Ashwagandha roots for health benefits.<\/p>\n<p style=\"margin-bottom: 3%;\">Scientific studies have raised safety concerns regarding Ashwagandha leaves due to their higher concentrations of reactive withanolides, particularly <span style=\"font-weight: bold;\">Withaferin-A<\/span>, which may pose risks when consumed long-term or in concentrated forms. In contrast, Ashwagandha roots have a well-established history of safe use and are supported by stronger pharmacological evidence.<\/p>\n<h2>Key Directions:<\/h2>\n<p>The Ministry has issued the following mandatory directions:<\/p>\n<ol style=\"list-style-type: decimal;\">\n<li>\n<p><span style=\"font-weight: bold;\">Only Ashwagandha roots<\/span> may be used, whether in crude form, extracts, or any other formulation, in both single-ingredient and compound Ayush drugs and products.<\/p>\n<\/li>\n<li>\n<p><span style=\"font-weight: bold;\">The use of Ashwagandha leaves is strictly prohibited<\/span> in any form across all Ayush drugs and products.<\/p>\n<\/li>\n<li>\n<p>Manufacturers must strictly comply with <span style=\"font-weight: bold;\">Rule 161 of the <a href=\"https:\/\/www.scconline.com\/DocumentLink.aspx?q=JTXT-0002863070\" target=\"_blank\">Drugs Rules, 1945<\/a><\/span>, which requires that the specific plant part used be clearly declared on product labels.<\/p>\n<\/li>\n<li>\n<p>Licensing authorities have been instructed to take <span style=\"font-weight: bold;\">necessary enforcement measures<\/span> to ensure compliance.<\/p>\n<\/li>\n<li>\n<p style=\"margin-bottom: 3%;\">The advisory strengthens consumer safety and product credibility while compelling Ayush manufacturers to align formulations with scientific evidence and regulatory standards.<\/p>\n<\/li>\n<\/ol>\n<p style=\"margin-bottom: 3%;\">[FSSAI Direction, issued on 16-4-2026]<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p style=\"font-style: italic;\">FSSAI has issued an advisory in line with directions from the Ministry of Ayush mandating the root-only use of Ashwagandha in Ayush products.<\/p>\n","protected":false},"author":67525,"featured_media":383569,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[4,1193],"tags":[103859,103856,103858,100392,86445,103860,103857],"class_list":["post-383568","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislationupdates","category-notifications","tag-ashwagandha-leaves-prohibition","tag-ashwagandha-roots","tag-ayush-drug-compliance","tag-drugs-rules","tag-fssai-advisory","tag-herbal-product-safety","tag-ministry-of-ayush-directions"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FSSAI Advisory on Ashwagandha: Use roots only in Ayush Products | SCC Times<\/title>\n<meta name=\"description\" content=\"FSSAI advisory on 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