Herbal Product Development in India: 10 Questions on Extracts, Testing, Stability and Regulation

1. What is a drug extract ratio (DER), and why does it not give the marker dose?

Short answer: the drug extract ratio is the quantity of herbal drug used per quantity of extract obtained, so a 10:1 extract used about 10 kg of plant material for each 1 kg of extract. It records the input, not the output. Two extracts with the same DER can hold very different amounts of marker, so a specification must state both.^[1]

The European Medicines Agency (EMA) quality guideline for herbal medicinal products also separates the genuine DER (native extract only) from the total DER (extract plus any excipients).^[1] A 10:1 native extract diluted with an equal weight of carrier has a total DER of 5:1, which is why a DER on a certificate of analysis should always say which one it is.

How strength is controlled depends on the extract type:

Source: EMA guideline, Rev. 3 (2022), sections 3.1 and 4.^[1] An active marker is generally accepted to contribute to activity; an analytical marker is used for control whatever its activity.^[1]

Scope note: the guideline is written for herbal medicinal products in the EU. FSSAI food supplements are not bound by it, but it is the clearest published set of definitions and a sound benchmark for an Indian extract specification. For a worked example of a dose tied to one extract, see our ashwagandha root-extract capsule worked example.

2. What tolerance applies to marker content at release and over shelf life?

Short answer: under the EMA herbal quality guideline, constituents with known therapeutic activity should be within ±5% of the declared value at release. Where no such constituents are known, the marker-based content is also held to ±5%, widening to ±10% only with justification. Over shelf life the same ±5% (or justified ±10%) band applies.^[1]

• At release: declared value ±5% for constituents with known therapeutic activity; for products controlled by active or analytical markers, ±5%, or up to ±10% if justified.^[1]
• Over shelf life: known-activity constituents within ±5% of the declared assay value (±10% only in exceptional, justified cases); active and analytical markers within ±5% of the initial batch value, or ±10% if justified. Wider ranges need adequate justification and should not be the norm.^[1]
• Markers alone are not enough when the constituents responsible for activity are not known. The guideline then asks for stability-indicating tests such as TLC or HPLC fingerprints, showing that the proportions stay comparable to the initial chromatogram.^[1]

For an FSSAI health supplement, these are design targets rather than legal limits. FSSAI’s own rules on label values and overages are covered in our FSSAI nutraceutical regulations explainer.

3. How is a stability study for a herbal supplement designed?

Short answer: the finished product is stored under defined conditions, usually an accelerated arm and a real-time arm, and re-tested at set intervals for markers, physical properties, sensory quality and microbial load. The two examples below show how the design limits what a shelf-life claim can rest on, and why one total figure can hide a weaker compound.^[2][3]

Two lessons follow. First, the 24-month figure was extrapolated from six months of accelerated data only, so it is an estimate until real-time data confirm it.^[2] Second, in the purple tea study the anthocyanins, the colour-giving compounds, fell more than twice as fast as total polyphenols.^[3] A single total-polyphenol result would have hidden the faster loss, so track the most labile marker as well as the total.

Related: do herbal extracts lose bioactives in beverages? and FRL’s shelf-life study service.

4. Which identity test should come first for a herbal material?

Short answer: start with a chromatographic fingerprint such as HPTLC. In a 2024 study of 51 processed herbal ingredients, HPTLC identified 49, DNA metabarcoding 33 and conventional DNA barcoding 16. The authors proposed HPTLC first, then DNA barcoding, then metabarcoding, because HPTLC still works on processed samples where DNA cannot be recovered.^[4]

The samples were Traditional Chinese Medicine ingredients bought on the European market, not Indian herbs, but the problem is the same for any dried, powdered or extracted material.^[4]

None of the three measures strength. That needs a separate, validated quantitative assay of the marker, often by HPLC against a reference standard (see question 6). For a recall that turned on identity testing, read our tainted supplement recall analysis.

5. How common is adulteration in Indian herbal powders?

Short answer: common enough to test every lot. A DNA barcoding study of 107 single-drug herbal powders bought in Tamil Nadu found 49 (46%) adulterated. In about 59% of those the labelled species was entirely replaced, and about 41% were mixtures. The rate varied sharply by herb, so it is not a national figure.^[5]

• The 107 powders covered 65 species and were authenticated with the rbcL DNA barcode.^[5]
• About 29 of the adulterated samples were full substitutions and about 20 were mixtures; many substitutes were taxonomically unrelated to the labelled herb.^[5]
• Of 17 tulsi (Ocimum tenuiflorum) powders from 17 manufacturers, 88% (15) were authentic.^[5]
• About 95% of the samples came from small companies in the unorganised sector.^[5]

The sample came from one state’s market, so it shows that substitution happens, not how often it happens across India. A supplier’s certificate of analysis is not a substitute for an identity test on receipt.

6. What does ICH Q2(R2) require of a marker assay?

Short answer: ICH Q2(R2) asks you to show that an analytical procedure is fit for its intended purpose. For a marker assay that means evidence of specificity or selectivity, a validated range (including the response, such as linearity), accuracy and precision. Validation shows that the method works; it does not show that the extract meets its specification.^[6]

• Characteristics: specificity/selectivity, range (response and lower range limit), accuracy and precision.^[6]
• Response: a minimum of five concentrations across the range is recommended to assess linearity.^[6]
• Specificity in a plant matrix: shown by absence of interference or by comparison with an orthogonal procedure.^[6]
• Status: final adoption by the EMA’s CHMP on 14 December 2023; in effect from 14 June 2024.^[6]

The guideline is written for release and stability testing of medicines.^[6] For a food supplement it is the recognised benchmark when you need to show that a marker result can be trusted.

7. Why do herbal extract powders flow badly, and what do excipients change?

Short answer: the extract itself often flows and compresses poorly, and the diluent then decides whether the blend can be filled or compressed consistently. In a 2025 study, a black pepper extract had an angle of repose of 48°, a compressibility index of 35% and a Hausner ratio of 1.54, and changing the diluent changed tablet hardness, friability and disintegration sharply.^[7]

The study made 600 mg tablets containing 100 mg of the aqueous extract, testing microcrystalline cellulose (MCC PH102), spray-dried lactose and dibasic calcium phosphate alone and in blends.^[7]

Source: Monton and Suksaeree (2025), Tables 4, 5 and 7.^[7] Spray-dried lactose had the best powder flow of the three diluents, yet gave weak, friable tablets.^[7] Good flow and good tablets are different properties.

The study concerned tablets. For capsules the lesson is to measure flow and bulk density on the real extract lot, because a clean marker assay says nothing about fill-weight consistency. The capsule worked example shows how this feeds a fill specification.

8. Why did regulators restrict ashwagandha leaves, and what has the court said?

Short answer: in April 2026, FSSAI and the Ministry of Ayush told manufacturers to use ashwagandha roots only. FSSAI’s 16 April advisory says Schedule IV of the 2016 regulations permits only roots and root extracts, so leaves in any form are not allowed. On 12 May 2026 the Karnataka High Court stayed both documents for eight petitioner companies.^[8][10][11]

What the regulators said

• FSSAI advisory, 16 April 2026 (F. No. RCD-15001/11/2021-Regulatory-FSSAI): only ashwagandha (Withania somnifera) roots and their extracts are permitted in health supplements, nutraceuticals and the other categories of the 2016 regulations; leaves in crude, extract or any other form are not. Deviations attract action under the Food Safety and Standards Act, 2006.^[8]
• Ministry of Ayush direction, 15 April 2026, to Ayush drug manufacturers: use only roots, do not use leaves in any form, and comply with Rule 161 of the Drugs Rules, 1945, which requires the plant parts used to be stated on the label.^[9]

The Ministry gave three reasons:^[9]

• Its earlier letter of 6 October 2021 against leaf use had not been followed by some manufacturers.
• A 2024 multidisciplinary expert committee safety dossier recommended using roots for health benefits.
• Published studies report possible safety concerns for leaves because of higher levels of reactive withanolides, particularly withaferin A.

What the court said

On 12 May 2026, Justice S.R. Krishna Kumar stayed the FSSAI advisory and the Ayush direction insofar as they apply to the petitioners; other businesses remain bound by them.^[10][11] The petitioners argued that Schedule IV lists Withania somnifera (serial number 432) as a permitted plant without limiting the plant part, and that FSSAI cannot restrict it by advisory without amending the 2016 regulations.^[10][11] The matter was listed for 8 June 2026.^[10] We found no report of a later order as of 3 November 2026, so check the current position before launch.

Safety context

Caution is not limited to India. Denmark’s food authority banned ashwagandha in food supplements on the basis of a 2020 Technical University of Denmark report, a decision that Indian researchers have criticised.^[19] A case series from Iceland and the US described five people with liver injury attributed to ashwagandha-containing supplements; none developed liver failure, and liver tests returned to normal in four.^[18] For a product team this makes root-only sourcing, a declared plant part and identity testing the baseline. For the clinical evidence on one root extract, see our explainer of the Lopresti 2019 ashwagandha study.

9. What is the Ayurveda Aahara route, and how does it differ from a nutraceutical?

Short answer: Ayurveda Aahara is an FSSAI food category for foods made to the recipes, ingredients or processes of the authoritative Ayurveda texts listed in Schedule A of the 2022 regulations. Packs carry the words “AYURVEDA AAHARA”, a logo and the warning “ONLY FOR DIETARY USE”. A nutraceutical follows FSSAI’s separate health supplement and nutraceutical rules.^[12]

For limits, categories and labelling on the nutraceutical side, see our FSSAI nutraceutical regulations explainer; for the drug side, see quality and compliance requirements for AYUSH herbal products.

10. Can an AYUSH product claim nutraceutical value?

Short answer: no. On 18 April 2024 the Ministry of Ayush said that Ayurvedic and related drugs or products may not claim nutraceutical value. The two sit under different laws: Ayush drugs under the Drugs and Cosmetics Rules, nutraceuticals under FSSAI food regulations. Decide the route first, then write the claims for that route.^[16]

• The same announcement said the Ministry does not grant manufacturing licences or approvals for Ayush drugs; a state licence is not Ministry approval, so “approved by the Ministry of Ayush” is an inaccurate claim.^[16]
• A 2026 review notes that a nutraceutical claiming to treat or mitigate disease is reclassified as a drug, that FSSAI claims fall mainly under the Advertising and Claims Regulations, 2018, and that state drug control authorities can act on borderline products.^[17]

No published test draws the line for every product, so classify each one with a qualified regulatory adviser before launch. The full route comparison is in our AYUSH licence vs FSSAI explainer.

For brands & formulators

Most herbal launch problems trace back to one of these ten questions: an extract bought on DER alone, a marker without a tolerance, a stability plan that tracks the wrong compound, a powder nobody measured or a route chosen after the label was printed. FRL’s herbal formulation team works through them in that order:

• Specification: extract type, DER (genuine or total), marker and tolerance, written so a supplier can be held to it.
• Testing plan: identity first, then a validated strength assay, with clear acceptance criteria for each incoming lot.
• Stability design: accelerated and real-time arms that track the most labile marker in your actual pack.
• Format trials: excipient and fill or compression trials on the real extract lot, then pilot and contract manufacturing.
• Route check: FSSAI, Ayurveda Aahara or Ayush licence, and claims to match, through our regulatory and scientific research team.

See how this fits FRL’s wider herbal product development work, or contact us with your brief.

In this series

• Herbal product development process: the pillar guide: seven stages from claim to launch.
• 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 (this page): You are here.
• Herbal formulation development service: work with our team on your product.

1. 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 DER definition, genuine and total DER, standardised, quantified and other extracts, active and analytical markers, release and shelf-life tolerances, and stability-indicating tests).
2. 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 the 40 °C/75% RH design, 0–6 month testing and the 24.08-month estimate from a 10% degradation threshold).
3. Food Research Lab. (2026). Functional characterization and shelf-life evaluation of purple tea beverage [Inside the Lab]. https://www.foodresearchlab.com/insights/inside-the-lab/purple-tea-beverage/ (cited for the 90-day polyphenol and anthocyanin results).
4. 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 the 49/33/16 identifications of 51 samples and the HPTLC-first tiered strategy).
5. 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 powders adulterated, the substitution and mixture shares, the tulsi results and the unorganised-sector share).
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 scope, validation characteristics, five concentrations for linearity, specificity and the adoption and effective dates).
7. 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 extract’s flow properties and the hardness, friability and disintegration results by diluent).
8. 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). https://fssai.gov.in/upload/advisories/2026/04/69e0d84fcac2f… (cited for the roots-only reading of Schedule IV and the enforcement statement).
9. Ministry of Ayush. (2026, April 15). Mandatory use of Ashwagandha (Withania somnifera) roots in Ayush products (T-13020/4/2022-DCC-Part(2)) [Enclosed with the FSSAI advisory]. https://fssai.gov.in/upload/advisories/2026/04/69e0d84fcac2f… (cited for the roots-only direction, Rule 161 labelling, the October 2021 letter, the 2024 safety dossier and the withaferin A rationale).
10. LiveLaw News Network. (2026, May 21). Karnataka High Court stays FSSAI advisory, AYUSH directive restricting use of ashwagandha leaves. LiveLaw. https://www.livelaw.in/law-firms/litigation/karnataka-hc-stays-fssai-advisory-ayush-directive-restricting-use-ashwagandha-leaves-535180 (cited for the stay limited to the petitioners, the petitioners’ arguments and the 8 June 2026 listing).
11. 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, eight petitioners and Schedule IV serial number 432).
12. 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 5 May 2022 notification, the Schedule A definition, exclusions and the labelling requirements).
13. Food Safety and Standards Authority of India. (2026, May 6). Implementing the process for prior approval and risk assessment through the single window system (ePAAS) [Office order, File No. SSDIV2-PA050(11)/2/2025-Standard-FSSAI]. https://www.fssai.gov.in/upload/advisories/2026/05/69fb29a607ad7Order%20dt%2006.05.2026.pdf (cited for ePAAS-only approval applications from 1 June 2026).
14. Mani, R., & Beillard, M. J. (2022). India’s FSSAI rolls out re-operationalized nutraceutical regulations (GAIN Report IN2022-0108). USDA Foreign Agricultural Service. https://agriexchange.apeda.gov.in/ImportRegulations/Indias%20FSSAI%20Rolls%20Out%20ReOperationalized%20Nutraceutical%20RegulationsNew%20DelhiIndiaIN20220108.pdf (cited for the categories covered and the 2022 re-operationalisation by direction).
15. Food Safety and Standards Authority of India. (2024, August 30). Direction under Section 16(5) of the Food Safety and Standards Act, 2006 regarding re-operationalisation of draft FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2022 (F. No. SS-T003/3/2024-Standard-FSSAI). https://fssai.gov.in/upload/advisories/2024/08/66d1af4da0dee… (cited for re-operationalisation from 1 July 2024).
16. Koe, T. (2024, May 1). AYUSH products should not claim nutraceutical value, says Indian regulator. NutraIngredients. https://www.nutraingredients.com/Article/2024/05/01/ayush-products-should-not-claim-nutraceutical-value-says-indian-regulator (cited for the Ministry of Ayush announcement of 18 April 2024, the separate legal frameworks and the statement that the Ministry does not license manufacturers).
17. 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 drug reclassification of therapeutic claims, the 2018 claims and 2020 labelling regulations, and the role of state drug control authorities).
18. Björnsson, H. K., Björnsson, E. S., Avula, B., Khan, I. A., Jonasson, J. G., Ghabril, M., Hayashi, P. H., & Navarro, V. (2020). Ashwagandha-induced liver injury: A case series from Iceland and the US Drug-Induced Liver Injury Network. Liver International, 40(4), 825–829. https://doi.org/10.1111/liv.14393 (cited for five cases of liver injury, no liver failure, and normalisation in four).
19. Patwardhan, B., Chaturvedi, S., Tillu, G., Deshpande, S., & Hegde, B. M. (2024). Danish ban on Ashwagandha: Truth, evidence, ethics, and regulations. Journal of Ayurveda and Integrative Medicine, 15, 101028. https://doi.org/10.1016/j.jaim.2024.101028 (cited for Denmark’s ban based on a 2020 DTU report and the criticism of that decision).