Herbal Product Development Process: Seven Stages From Plant to Shelf (India, 2026)

The herbal product development process in seven stages

The herbal product development process turns a plant and a product idea into a batch that can be sold, tested and defended. It differs from ordinary food development in one way that shapes every stage: the active ingredient is a natural material whose identity, plant part and strength vary from lot to lot, so each decision has to be backed by evidence about the material you actually buy.

This guide is the hub for our herbal product development series for India. It sets out the seven stages in the order they should be closed, what evidence closes each one, and where each stage is covered in depth.

Table 1. The seven stages and what closes each one

The order matters. A claim decided late can move a product to a different regulator, and a dose chosen before the extract is fixed may have no evidence behind it.

Stage 1: Decide the claim and the regulatory route

In India the intended use and the claim decide which law a herbal product falls under. A product that claims to treat, cure, prevent or mitigate a disease is treated as a drug, and unclear boundaries between food and drug are a recurring problem for manufacturers.^[1] There are three routes in practice:

• Ayush (ASU) drug. An Ayurveda, Siddha or Unani medicine made under a state manufacturing licence under the Drugs and Cosmetics Rules, 1945.^[16]
• FSSAI nutraceutical or health supplement. A food with general well-being or nutritional wording and no treatment claim; manufacturers are licensed by FSSAI’s central licensing authority.^[13]
• Ayurveda Aahara. A food made to a recipe or process from the authoritative Ayurveda texts, with its own label words and logo.^[15]

Write the intended use and the draft claim down before any formulation work. Our AYUSH licence vs FSSAI guide compares the three routes in full; for quality and GMP on the Ayush route, see our AYUSH guidelines for herbal products.

Stage 2: Specify the plant part and the extract

Plant part first

The same plant can be permitted in one part and barred in another. FSSAI’s advisory of 16 April 2026 states that, under Schedule IV of the 2016 nutraceutical regulations, only ashwagandha roots and their extracts are permitted and that leaves in any form are not.^[2] It followed a Ministry of Ayush letter of 15 April 2026 that directed Ayush drug makers to use roots only and to declare the plant part on the label under Rule 161.^[2] The Karnataka High Court stayed both documents on 12 May 2026 in an interim order that covers only the petitioners, and listed the matter for 8 June.^[3][4] We found no later order, so check the current position before relying on it.

Then the extract

The European Medicines Agency (EMA) quality guideline for herbal medicinal products describes three kinds of extract: standardised (adjusted to a defined content of constituents with known activity), quantified (adjusted to a defined range of active markers by blending batches) and other extracts (not adjusted, but controlled by analytical markers).^[5] It is written for EU medicines, not Indian food supplements, but it is the clearest published benchmark for an extract specification.

A drug extract ratio (DER) records how much plant material went into the extract. It does not say how much marker reaches the consumer, so a specification needs both.^[5] Our herbal product development Q&A explains the difference between genuine and total DER.

Table 2. What a herbal extract specification should state

Stage 3: Prove identity and strength

Supplier paperwork is not proof of identity. A DNA barcoding study of 107 single-drug herbal powders bought in Tamil Nadu markets found 49 (46%) adulterated, many with taxonomically unrelated species.^[7]

No single test answers every question. In a 2024 comparison of three methods on 51 processed herbal samples, high-performance thin-layer chromatography (HPTLC) identified 49, DNA metabarcoding 33 and DNA barcoding 16; the authors recommend a tiered strategy that starts with HPTLC.^[8] The DNA methods identified fewer of these processed samples, so match the test to the material: raw plant, powder or finished extract.

Strength is a separate question. The marker assay, often HPLC, must be validated to show it is fit for its intended purpose, covering characteristics such as specificity, range, accuracy and precision under ICH Q2(R2).^[6] Our guide to standardised extracts, HPLC and DNA testing sets out which test to use when, and our background page on marker substances in herbal preparations explains marker types. For a recall that turned on identity testing, see our tainted supplement recall analysis.

Stage 4: Set the dose and choose the dosage form

The dose belongs to the extract

Clinical doses are not transferable between extracts by matching milligrams. Lopresti et al. (2019) gave 240 mg once daily of one standardised ashwagandha extract, Shoden, for 60 days to adults with mild stress; it was standardised to 35% withanolide glycosides.^[9] The paper calls it a root extract, but its maker describes Shoden as a root and leaf extract.^[10] A root-only product therefore needs a written bridging rationale, or its own evidence, before it borrows that dose. Our Lopresti 2019 study explainer covers the trial in detail.

The format follows the dose

Once the dose fixes how much extract goes into each serving, choose the format: capsule, tablet, powder, liquid, gummy or a food format. Each brings its own problems. Dry plant extracts often flow poorly: an unblended black pepper extract had a Hausner ratio of 1.54, classed as very poor flow, and diluents improved it.^[11] Measure flow and bulk density on the real extract lot before choosing a capsule size or tablet process.

Our sector pages cover oral solid dosage forms, powdered forms and liquids and syrups; for a chewable format, see how to formulate a gummy supplement.

Stage 5: Prove stability and shelf life

The shelf life printed on the pack must rest on a stability study of the final product in its final pack, tracking the declared marker. The EMA guideline sets a benchmark of ±5% of the declared value for marker content at release and over shelf life, widened to ±10% only with justification. Where the constituents responsible for activity are not known, it asks for stability-indicating fingerprints such as TLC or HPLC.^[5] For an FSSAI health supplement these are design targets, not legal limits.

A published accelerated study of a herbal food supplement stored samples at 40 ± 2 °C and 75 ± 5% relative humidity, tested them at 0, 2, 4 and 6 months, and estimated a shelf life of about 24 months from a 10% degradation threshold.^[12] Treat an estimate of that kind as provisional until real-time data on the same pack confirm it, and choose packaging that keeps moisture out of hygroscopic extracts.

Stage 6: Scale up and choose who manufactures

A formula that works at the bench can drift at scale through blend segregation, moisture uptake and fill-weight variation. Our article on herbal supplement manufacturing scale-up covers those failure points. Run pilot batches against the same specification and methods used in development, so the commercial batch is judged by the same rules.

Who makes the product also decides who holds the licence. Manufacturers of products under the FSSAI nutraceutical regulations are licensed centrally, whatever their turnover.^[13] On the Ayush route, a brand with no factory of its own can apply for a loan licence under Rule 153A to use a licensed manufacturer’s facility.^[16] If you are choosing between a stock formula and your own, our guide to private-label herbal supplements in India compares the options.

Stage 7: Finalise the label, claims and launch file

Each route has its own label must-haves. FSSAI nutraceuticals carry the statement “NOT FOR MEDICINAL USE”,^[14] and their claims and labels fall under the Advertising and Claims Regulations, 2018 and the Labelling and Display Regulations, 2020.^[1] An Ayush drug label lists each ingredient with its botanical name, plant part and quantity, and carries the words “Ayurvedic medicine” or the Siddha or Unani equivalent (Rule 161).^[16] Ayurveda Aahara products carry “AYURVEDA AAHARA”, the logo and “ONLY FOR DIETARY USE”.^[15]

Before launch, assemble the technical file: the extract specification, supplier certificates checked against your own identity and assay results, method validation, the stability protocol and data, and a written claim review. Our FSSAI nutraceutical regulations explainer covers category limits and label rules on the food route.

The process applied: an ashwagandha root-extract capsule

Figure 1 shows the process applied to one product: a once-daily ashwagandha root-extract capsule sold as an FSSAI food supplement. The extract step closes the plant part, DER and marker (stage 2). The dose and capsule steps test the 240 mg trial dose against the chosen extract and check flow and fill (stage 4). Stability sets release and shelf-life limits (stage 5), and the route step confirms the FSSAI claim and label (stages 1 and 7).

Our ashwagandha capsule development worked example follows that product from brief to a stability-ready specification. It is a model project, not client data.

Where herbal projects usually go wrong

Most delays come from a decision taken out of order. Five recur:

• Borrowing a trial dose for an extract that was not tested.^[9][10]
• Trusting a certificate without an independent identity test.^[7]
• Specifying a DER without a marker, so strength cannot be checked.^[5]
• Letting the claim drift towards treatment wording late in development, which changes the route.^[1]
• Assuming the powder will run on the capsule or tablet machine without measuring flow.^[11]

Conclusion

The herbal product development process works when its seven stages are closed in order: claim and route, plant part and extract, identity and strength, dose and format, stability, scale-up, then label and launch. Each stage needs evidence on the material you will actually use, not on the herb’s name. Settle the claim and the plant part first, because they decide what the rest of the work must prove.

For brands & formulators

Food Research Lab’s herbal formulation development team can take a herbal product through these stages: route and claim review, extract specification, dose and format selection, and stability planning. We run identity, marker and stability testing or arrange it through accredited partner laboratories, and plan pilot and commercial batches through our herbal manufacturing service.

For route and label questions, our regulatory and scientific research team can review the intended use, ingredients and draft claims. See also our herbal product development sector page, or contact us with your brief.

In this series

• Herbal product development process (this guide): You are here. The seven stages and where each is covered.
• AYUSH licence vs FSSAI: which regulatory route a herbal product takes in India.
• Standardised extract, HPLC and DNA testing: how to prove identity and strength.
• The ashwagandha stress study (Lopresti 2019) explained: what one trial does and does not support.
• Ashwagandha capsule development: a worked example: one product from brief to stability-ready specification.
• Private-label herbal supplements in India: stock formulas versus your own.
• Herbal product development in India: 10 questions: short answers on extracts, testing, stability and regulation.
• Herbal formulation development service: work with our team on your product.

1. Takle, S. P., & Mahajan, U. (2026). Regulatory landscape of nutraceuticals in India: Current status, challenges, and a roadmap for harmonization. International Journal of Pharmaceutical Sciences, 4(5), 4880–4890. https://doi.org/10.5281/zenodo.20284587 (cited for therapeutic claims reclassifying a product as a drug, unclear food–drug boundaries, and the Advertising and Claims Regulations, 2018 and Labelling and Display Regulations, 2020).
2. Food Safety and Standards Authority of India. (2026, April 16). Advisory regarding non-use of Ashwagandha (Withania somnifera) leaves in crude or extract or any other form in food products (F. No. RCD-15001/11/2021-Regulatory-FSSAI; encloses Ministry of Ayush letter T-13020/4/2022-DCC-Part(2) of 15 April 2026). https://fssai.gov.in/upload/advisories/2026/04/69e0d84fcac2fAdvisory%20on%20non%20use%20of%20ashwagandha%20leaves%20in%20crude%20or%20extract%20or%20any%20other%20form%20in%20food%20products-%20reg.pdf (cited for Schedule IV permitting only ashwagandha roots and their extracts, leaves not permitted, and the Ministry of Ayush roots-only direction with Rule 161 plant-part labelling).
3. LiveLaw. (2026, May 19). Karnataka High Court stays FSSAI advisory restricting use of ashwagandha leaves in health supplements. https://www.livelaw.in/high-court/karnataka-high-court/karnataka-high-court-stays-centre-advisory-ashwagandha-leaves-nutraceuticals-534813 (cited for the interim stay limited to the petitioners in W.P. Nos. 14990/2026 and 15010/2026 and the 8 June 2026 listing).
4. Jha, S. (2026, May 20). Karnataka HC temporarily stays FSSAI ban on ashwagandha leaves. The South First. https://thesouthfirst.com/health/karnataka-hc-temporarily-stays-fssai-ban-on-ashwagandha-leaves/ (cited for the 12 May 2026 order date).
5. European Medicines Agency, Committee on Herbal Medicinal Products. (2022). Guideline on quality of herbal medicinal products/traditional herbal medicinal products (EMA/HMPC/CHMP/CVMP/201116/2005 Rev. 3). https://www.ema.europa.eu/en/documents/scientific-guideline/final-guideline-quality-herbal-medicinal-productstraditional-herbal-medicinal-products-revision-3_en.pdf (cited for the three extract types, the drug extract ratio, marker tolerances of ±5% (±10% if justified) at release and over shelf life, and stability-indicating fingerprints).
6. International Council for Harmonisation. (2023). ICH Q2(R2) guideline on validation of analytical procedures (EMA/CHMP/ICH/82072/2006, Step 5). European Medicines Agency. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q2r2-guideline-validation-analytical-procedures-step-5-revision-2_en.pdf (cited for validation of an analytical procedure as fit for its intended purpose, including specificity, range, accuracy and precision).
7. Balaji, R., & Parani, M. (2022). DNA barcoding of the market samples of single-drug herbal powders reveals adulteration with taxonomically unrelated plant species. Diversity, 14(6), 495. https://doi.org/10.3390/d14060495 (cited for 49 of 107 Tamil Nadu market samples (46%) adulterated, many with taxonomically unrelated species).
8. Mück, F., Scotti, F., Mauvisseau, Q., Thorbek, B. L. G., Wangensteen, H., & de Boer, H. J. (2024). Three-tiered authentication of herbal traditional Chinese medicine ingredients used in women’s health provides progressive qualitative and quantitative insight. Frontiers in Pharmacology, 15, 1353434. https://doi.org/10.3389/fphar.2024.1353434 (cited for identification of 49, 33 and 16 of 51 processed samples by HPTLC, DNA metabarcoding and DNA barcoding, and the HPTLC-first tiered strategy).
9. Lopresti, A. L., Smith, S. J., Malvi, H., & Kodgule, R. (2019). An investigation into the stress-relieving and pharmacological actions of an ashwagandha (Withania somnifera) extract: A randomized, double-blind, placebo-controlled study. Medicine, 98(37), e17186. https://doi.org/10.1097/MD.0000000000017186 (cited for the 240 mg once-daily, 60-day design in adults with mild stress, the Shoden extract and its 35% withanolide glycoside standardisation).
10. Sherman, A. (2026, September 8). Arjuna publishes ashwagandha safety study, highlights weight of clinical validation. NutraIngredients. https://www.nutraingredients.com/Article/2026/09/08/arjuna-publishes-ashwagandha-safety-study-highlights-weight-of-clinical-validation/ (cited for the manufacturer’s description of Shoden as a root and leaf extract).
11. Monton, C., & Suksaeree, J. (2025). Understanding the effect of diluents on powder flow and tablet properties of poorly compressible black pepper extract using mixture design approach. International Journal of Food Science, 2025, 8655112. https://doi.org/10.1155/ijfo/8655112 (cited for the Hausner ratio of 1.54 (very poor flow) for unblended black pepper extract and improved flow with diluents).
12. Dorni, A. I. C., Venkatesan, U., Srinivasan, R., Moorthy, S., & Raja, K. (2023). Evaluation of stability and determination of shelf life of an herbal food supplement: Naturovita. Journal of Pharmacognosy and Phytochemistry, 12(1), 219–225. https://doi.org/10.22271/phyto.2023.v12.i1c.14580 (cited for storage at 40 ± 2 °C and 75 ± 5% RH, testing at 0, 2, 4 and 6 months and a shelf life of about 24 months from a 10% degradation threshold).
13. Food Safety and Standards Authority of India. (2021). Order: Food businesses manufacturing products covered under the Health Supplements, Nutraceuticals… Regulations, 2016 to be covered under the purview of Central Licensing Authorities (File No. 15(31)2020/FoSCoS/RCD/FSSAI; revised 1 November 2021). https://www.fssai.gov.in/upload/advisories/2021/11/617f7648ce58aOrder_Nutra_License_16_09_2021_Revised_01_11_2021.pdf (cited for central licensing of nutraceutical manufacturers regardless of turnover).
14. Food Safety and Standards Authority of India. (2021). Compendium: Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 (Version I, 29 September 2021). https://fssai.gov.in/upload/uploadfiles/files/Compendium_Nutra_29_09_2021.pdf (cited for the “NOT FOR MEDICINAL USE” label statement).
15. Press Information Bureau, Ministry of Ayush. (2022, July 29). Ayurvedic Aahar products [Press release]. https://pib.gov.in/PressReleasePage.aspx?PRID=1846185 (cited for the Ayurveda Aahara Regulations, 2022: scope and the “AYURVEDA AAHARA”, logo and “ONLY FOR DIETARY USE” label requirements).
16. Ministry of Health and Family Welfare, Central Drugs Standard Control Organisation. (2016). The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 [as amended up to 2016]. https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf (cited for state manufacturing licences for ASU drugs, the Rule 153A loan licence and Rule 161 labelling).