On April 16, 2026, the Food Safety and Standards Authority of India (FSSAI) issued an advisory drawing attention to the mandatory use of Ashwagandha (Withania somnifera) roots only in Ayush drugs and related products, following directions issued by the Ministry of Ayush on April 15, 2026.
Background
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 the roots of the plant as the safe and effective part for therapeutic purposes.
Despite earlier instructions issued in October 2021, 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.
The advisory is based on updated scientific evidence. In 2024, a multidisciplinary expert committee convened by the Ministry of Ayush published an updated safety dossier, recommending the exclusive use of Ashwagandha roots for health benefits.
Scientific studies have raised safety concerns regarding Ashwagandha leaves due to their higher concentrations of reactive withanolides, particularly Withaferin-A, 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.
Key Directions:
The Ministry has issued the following mandatory directions:
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Only Ashwagandha roots may be used, whether in crude form, extracts, or any other formulation, in both single-ingredient and compound Ayush drugs and products.
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The use of Ashwagandha leaves is strictly prohibited in any form across all Ayush drugs and products.
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Manufacturers must strictly comply with Rule 161 of the Drugs Rules, 1945, which requires that the specific plant part used be clearly declared on product labels.
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Licensing authorities have been instructed to take necessary enforcement measures to ensure compliance.
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The advisory strengthens consumer safety and product credibility while compelling Ayush manufacturers to align formulations with scientific evidence and regulatory standards.
[FSSAI Direction, issued on 16-4-2026]