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Ashwagandha: New root-only regulations come to India

As global demand for ashwagandha surges, a new rule in India means root materials are now the only accepted form of the botanical.

With new regulatory directives from the Government of India, the industry now faces a moment that demands greater transparency, accountability, and scientific rigor.

Ashwagandha (Withania somnifera), long revered in Ayurveda, has evolved into a globally recognized adaptogen. Its use now spans stress, sleep, cognition, sports nutrition, and healthy aging, with demand expanding rapidly across North America, Europe, Asia Pacific, and emerging markets.

According to market data, the ingredient continues to rank among the leading botanicals in the US stress-management category, reflecting its growing integration into mainstream wellness.

However, this expansion has also exposed structural differences in sourcing practices. Economic incentives have driven some suppliers to substitute or blend root material with significantly cheaper aerial parts. While this may improve margins, it introduces variability in composition and raises important questions around consistency and label accuracy.

Regulatory rationale for root only

The distinction between root and aerial parts is not merely traditional; it reflects differences in the composition of the material and how it is evaluated when it comes to the regulations.

For centuries, Ayurvedic practice has consistently emphasized the use of roots for internal consumption. This traditional knowledge is now supported by modern analytical and regulatory considerations.

Scientific literature indicates that leaves contain different concentrations of certain withanolides, compared to roots. Root-derived preparations have been more widely studied and evaluated in human clinical settings and therefore provide the reference for regulatory compliance, consistency and quality.

Reflecting this distinction, the Ministry of AYUSH issued guidance in 2021 recommending root-only use for internal applications.¹ This regulatory position is consistent with concerns raised by the American Botanical Council regarding undeclared plant-part substitution in botanical supply chains.

Detecting substitution: What the data shows

Analytical studies continue to highlight the scale of the ashwagandha plant-part substitution in the supply chain. Techniques such as high-performance liquid chromatography (HPLC) and high-performance thin-layer chromatography (HPTLC) have been used to identify plant-part-specific markers.

In a published study, researchers utilized high-performance liquid chromatography with UV detection (HPLC-UV) to analyze authenticated ashwagandha leaves (n=5), aerial parts (n=3) and roots (n=17) sourced from India and Egypt.

Additionally, 10 commercial extracts marketed as “root-derived” were tested for flavonol glycosides, chemical markers that indicate adulteration with aerial parts. Only two samples were free of these markers, revealing that most root extracts in the market were adulterated with aerial components.2

Another published study, this time using high-performance thin-layer chromatography (HPTLC), examined 584 commercial extract batches. The findings showed that 14.0% were rejected due to leaf residue and 20.4% contained incomplete root material.3 These results underline the inadequacy of current quality controls and the urgent need for robust verification mechanisms.

Recent data from NMPB, Government of India, reveals that in 2024 to 2025, 4,698 tons of ashwagandha leaves were sold compared to 4,170 tons of roots, highlighting the scale of leaf and aerial parts in the supply chain and prompting regulatory oversight.4

However, these transactions and sales are not reflected in publicly available export records. Additionally, there is a significant discrepancy in ashwagandha products on the global market, as there have been instances where ashwagandha leaf extract was mislabelled and marketed as ashwagandha root extract, raising concerns about adulteration.

These findings highlight a broader challenge: without routine and rigorous testing, plant-part identity cannot be assumed.

A decisive regulatory shift

In April 2026, Indian regulators moved from guidance to enforcement. A directive issued by the Ministry of AYUSH (T-13020/4/2022-DCC-Part (2)), mandates that only ashwagandha roots may be used in Ayush formulations, explicitly prohibiting the use of leaves and aerial parts. Manufacturers are also required to clearly declare the plant part used on product labels.5

This was followed by an advisory from the Food Safety and Standards Authority of India (F.No. RCD-15001/11/2021-Regulatory-FSSAI), which reinforced that only root and root extracts are permitted in foods and nutraceuticals under existing regulations, and directed enforcement authorities to take action against non-compliance.6

Given India’s central role in global ashwagandha supply, these measures are likely to influence sourcing standards well beyond its borders.

Raising the bar for quality assurance

For the industry, the direction is clear. Analytical verification must move from a periodic check to a consistent requirement. Techniques such as HPTLC and HPLC offer reliable tools for confirming plant-part identity and should be integrated across sourcing, manufacturing and third-party validation processes.

At the same time, greater transparency is needed in labeling and supplier documentation. Certificates of analysis that do not specify that plant part is increasingly insufficient in a regulatory environment now require greater precision.

Some manufacturers have already adopted vertically integrated supply chains and standardized extraction processes to ensure consistency from raw material to finished product. These approaches, combined with robust testing protocols, provide a framework for maintaining both quality and consumer trust.

Ashwagandha’s role in modern wellness is well established. What remains under scrutiny is the integrity of the supply chain supporting it. As regulators, researchers and responsible manufacturers align, the industry now has the tools and the mandate to ensure that what is labeled as root is, in fact, root.

The future of ashwagandha will not be defined by demand alone, but by the standards the industry chooses to uphold.

References

  1. Ministry of Ayush. Government of India. Letter (L-11011/9/2021-DCC), dated October 2021.
  2. Mundkinajeddu, D.; et al. Development and validation of high-performance liquid chromatography method for simultaneous estimation of flavonoid glycosides in Withania somnifera aerial parts. ISRN Analytical Chemistry. March 10, 2014;2014:351547.
  3. Singh, VK.; et al. Adulteration of ashwagandha (Withania somnifera) roots and extracts. Botanical Adulterants Prevention Bulletin. Adulteration of Ashwagandha (Withania somnifera) Roots, and Extracts. 2019.
  4. Correspondence from NMPB (National Medicinal Plants Board). Government of India. 2026.
  5. Ministry of Ayush. Government of India. Mandatory use of Ashwagandha (Withania somnifera) roots in Ayush products. Letter T-13020/4/2022-DCC-Part(2), dated 15 April 2026.
  6. Food Safety and Standards Authority of India. Advisory regarding non-use of Ashwagandha (Withania somnifera) leaves in crude or extract or any other form in food products. Advisory F. No. RCD-15001/11/2021-Regulatory-FSSAI, dated 16 April 2026.

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