From Rasayana to Nutraceutical: Empirical Regulatory Translation of Ayurvedic Substrates Under the FSS (Health Supplements, Nutraceuticals) Regulations 2022 — Evidence from Dual AYUSH and FSSAI Corpora of a Single-Family Manufacturing Ecosystem in Ha
The Indian health-product regulatory landscape is structurally bifurcated: traditional-medicine manufacturers operate under AYUSH Manufacturing Licences while nutraceutical manufacturers operate under FSSAI Central Licences under the Food Safety and Standards (Health Supplements, Nutraceuticals...) Regulations 2022. The same botanical substrate can be legally manufactured as an AYUSH proprietary medicine, as an FSSAI nutraceutical, or as both by the same operator under separate licences. The regulatory-translation pathway between the two regimes has been discussed at framework level but rarely with concrete per-manufacturer bill-of-materials data on both sides of the divide. Using two recently-released open-licensed corpora covering the same extended-family manufacturing ecosystem in Haryana, India — the Dharmani AYUSH Ayurvedic corpus (214 Form-25-D formulations, 2012–2023) and the Nutriley FSSAI nutraceutical corpus (68 Central-License products, 2023–2025) — we measure the empirical substrate overlap between the two regimes. Of 353 unique Latin binomials on the Ayurvedic side and 75 on the nutraceutical side, 22 substrates appear in both regimes (29.3% of the FSSAI set, 6.2% of the AYUSH set). The overlap is dominated by canonical Rasayana substrates: Withania somnifera, Curcuma longa, Asparagus racemosus, Tribulus terrestris, Phyllanthus emblica, Piper longum, Bacopa monnieri, and related botanicals widely recognized as both classical rejuvenatives and modern-nutraceutical actives. We interpret the overlap against the FSS(HSND) 2022 Schedule VIII provision (which explicitly permits AYUSH-approved botanicals as nutraceutical ingredients), document the operational realities of dual-regime manufacturing, and argue that the bifurcated regime creates operationally inefficient but legally coherent duplication of approvals. The analysis is reproducible from the published Dharmani and Nutriley datasets.
Authors
- Vibhav Aggarwal (ORCID: https://orcid.org/0009-0000-7686-7119)
- Ashok Dixit
Institutions
- Universitas Dharmas Indonesia (ID)
Publication Details
- Journal
- Zenodo (CERN European Organization for Nuclear Research)
- Published
- 2026-07-24
- DOI
- https://doi.org/10.5281/zenodo.19682052
- Primary Topic
- Phytochemicals and Medicinal Plants
- Type
- article
- Field-Weighted Citation Impact
- 0.00