First herbal lab licensed by the Directorate of ISM&H · NABL · AYUSH GMP

Microbial Testing for Ayurvedic & Herbal Products

Botanical raw materials are inherently susceptible to microbial colonisation during cultivation, drying, and storage — and a failed microbial result blocks GMP batch release. Auriga Research provides NABL-accredited microbial testing for Ayurvedic and herbal products, covering total aerobic count, yeast and mould enumeration, and specified-pathogen absence testing for raw herbs, churnas, asavas, arishtas, extracts, and finished Ayurvedic, Unani, and Siddha formulations.

Our testing applies the AYUSH GMP guidelines and Ayurvedic Pharmacopoeia of India microbial limits, the Indian Pharmacopoeia / USP <61> & <62> methods, and the WHO Technical Report Series No. 863 reference for medicinal plant materials. As the first herbal testing laboratory in India to be licensed by the Directorate of ISM&H, backed by the Arbro Group's unbroken NABL accreditation since 2003, Auriga is a long-established reference lab for the AYUSH sector.

Aflatoxins / mycotoxins are tested separately

Aflatoxins and other mycotoxins are chemical contaminants, not microbiological parameters, so they are not part of this microbial-count panel. Auriga tests aflatoxins B1/B2/G1/G2 and ochratoxin A by LC-MS/MS as a separate mycotoxin analysis — add mycotoxin testing to your order via the Herbal & AYUSH hub or ask your SPOC.

Microbial count & pathogens in 5–7 working days | Full panel 7–10 days

Microbial Testing Parameters

Each parameter is mapped to its method and limit so AYUSH QA and export teams can match scope to the GMP / WHO requirement at a glance.

TAMC

Total Aerobic Count

Total aerobic microbial count per IP / USP <61>; AYUSH oral limit ≤ 10⁵ CFU/g.

TYMC

Yeast & Mould Count

Total combined yeast and mould count; AYUSH oral limit ≤ 10³ CFU/g.

E. coli

Escherichia coli

Specified-pathogen absence testing — not detected (AYUSH / IP).

Salmonella

Salmonella

Absence testing — not detected per 25 g.

S. aureus

Staphylococcus aureus

Absence testing for topical and specified preparations.

P. aeruginosa

Pseudomonas aeruginosa

Absence testing for topical and specified preparations.

Bile-tolerant

Gram-Negative Bacteria

Bile-tolerant gram-negative bacteria enumeration where specified.

AYUSH GMP

GMP Limit Compliance

Compliance against AYUSH GMP / API microbial limits by route of administration.

WHO TRS 863

WHO Reference

Microbial specifications per WHO Technical Report Series No. 863 for medicinal plant materials.

USP <61>/<62>

Validated Methods

Enumeration and specified-organism tests by IP / USP <61> & <62> membrane filtration / plate methods.

AYUSH Microbial Limits — Oral Herbal Products

Parameter AYUSH GMP Limit (oral)
Total aerobic microbial count (TAMC) ≤ 10⁵ CFU/g
Total yeast & mould count (TYMC) ≤ 10³ CFU/g
Escherichia coli Not detected
Salmonella Not detected per 25 g

Topical and specified preparations carry additional absence requirements for Staphylococcus aureus and Pseudomonas aeruginosa. WHO Technical Report Series No. 863 provides the corresponding international reference.

How It Works

1

Get a Quote

Share your product type, the route of administration (oral / topical), and the regulatory target (AYUSH GMP, FSSAI, or export). Your dedicated SPOC confirms the microbial panel, the applicable limit set, and the exact sample quantity required before you dispatch anything.

2

Send Your Sample

Dispatch your sample in its sealed original packaging with a completed Test Request Form to the nearest Auriga lab. Each sample is individually bar coded and registered in YLIMS, Auriga's in-house Laboratory Information Management System, upon receipt. Testing begins within 24 hours of sample registration.

3

Testing and QA Review

Your sample is tested by IP / USP <61> & <62> methods in Auriga's NABL-accredited microbiology lab — enumeration plus specified-pathogen detection, with growth-promotion and method-suitability controls so antimicrobial herbs do not suppress recovery. Every result passes a formal internal QA review and sign-off before the report is generated.

4

Receive Your NABL Report

Your NABL-accredited test report is delivered digitally within the committed turnaround time. Reports carry Auriga's NABL accreditation under ISO/IEC 17025:2017, state the route of administration and limit basis applied, and are accepted for Ministry of AYUSH GMP, FSSAI, and EU / WHO export submissions. You can track sample status in real time through YLIMS.

Turnaround Time

Service Standard TAT Express
Total aerobic count (TAMC) + yeast & mould (TYMC) 5–7 business days — fixed by incubation
Specified pathogens (E. coli, Salmonella, S. aureus, P. aeruginosa) 5–7 business days — fixed by incubation
Method suitability / bacteriostasis validation 7–10 business days On request
Complete microbial quality panel 7–10 business days On request
Mycotoxin add-on (aflatoxins / OTA by LC-MS/MS) 5–7 business days Available

Who Needs Microbial Testing

  • AYUSH-licensed manufacturers needing batch-wise microbial data for product release and GMP compliance.
  • Herbal and Ayurvedic exporters needing EU and WHO TRS 863 microbial-limit compliance.
  • Herbal supplement and nutraceutical brands running pre-launch and batch-release testing.
  • Contract manufacturers and white-label suppliers certifying finished formulations.
  • Raw-herb and extract suppliers screening incoming material for microbial load.
  • Topical / cosmetic-Ayurvedic manufacturers needing S. aureus / P. aeruginosa absence data.
  • D2C and e-commerce herbal brands needing batch compliance for marketplace listing.
  • Importers verifying herbal raw material before India sale or re-export.
  • QA teams investigating shelf-life or storage-related microbial excursions.
  • Brands contesting a marketplace or regulatory microbial finding with accredited data.

Why Auriga for Microbial Testing

First herbal lab licensed by the Directorate of ISM&H

Auriga was the first herbal testing laboratory in India to be licensed by the Directorate of ISM&H — a long-established reference lab the AYUSH sector trusts.

AYUSH GMP + WHO TRS 863 limits

Results reported against the AYUSH GMP / API microbial limits by route of administration and the WHO Technical Report Series No. 863 international reference.

Method suitability for antimicrobial herbs

Growth-promotion and bacteriostasis / method-suitability controls run with every job, so naturally antimicrobial botanicals do not suppress recovery and produce a false pass.

Microbiology + chemistry under one roof

Microbial counts, pathogen testing, and the separate mycotoxin (aflatoxin / OTA by LC-MS/MS) analysis all in-house — one consolidated quality picture without cross-lab handover.

Export-market ready

Reports formatted for EU and WHO export submissions alongside AYUSH GMP and FSSAI — supporting both domestic licensing and export compliance.

Arbro Group NABL accreditation since 2003

Two decades of continuous ISO/IEC 17025 conformity through the Arbro Group — the audit trail AYUSH manufacturers and exporters look for.

Frequently Asked Questions

What microbial limits apply to Ayurvedic and herbal products?
The AYUSH GMP guidelines and the Ayurvedic Pharmacopoeia of India set microbial limits by route of administration. For oral herbal products the limits are: total aerobic microbial count (TAMC) ≤ 10⁵ CFU/g, total yeast and mould count (TYMC) ≤ 10³ CFU/g, E. coli not detected, and Salmonella not detected per 25 g. Topical products carry additional absence requirements for Staphylococcus aureus and Pseudomonas aeruginosa. The WHO Technical Report Series No. 863 provides the corresponding international reference. Products exceeding these limits are considered unfit for use and fail GMP batch release.
Do you test aflatoxins / mycotoxins on this microbial panel?
No — and that is a deliberate, technically correct separation. Aflatoxins and other mycotoxins (ochratoxin A, etc.) are chemical contaminants produced by moulds, not microbiological organisms, so they are not part of the microbial-count panel. Auriga does test aflatoxins B1/B2/G1/G2 and ochratoxin A by LC-MS/MS as a separate mycotoxin / chemical-contaminant analysis — ask your SPOC to add mycotoxin testing to your order, or see our Herbal & AYUSH Testing hub. Keeping the two separate avoids the common error of presenting a chemical-contaminant result as a microbiological one.
Which Auriga lab and credential back this testing?
Microbial testing is performed in Auriga's NABL-accredited microbiology laboratory under ISO/IEC 17025:2017. Auriga was the first herbal testing laboratory in India to be licensed by the Directorate of ISM&H, and is backed by the Arbro Group's unbroken NABL accreditation since 2003 — a long-established reference lab for the AYUSH sector. Reports are accepted for Ministry of AYUSH GMP batch release and for EU / WHO export submissions.
What method is used for microbial enumeration and pathogen testing?
Enumeration (TAMC, TYMC) and specified-organism (E. coli, Salmonella, S. aureus, P. aeruginosa) testing follow the Indian Pharmacopoeia and USP <61> / <62> methods — membrane filtration or plate-count for enumeration, and selective enrichment / selective media for pathogen detection — with growth-promotion and method-suitability (bacteriostasis) controls run alongside. Botanical matrices are validated for method suitability so naturally antimicrobial herbs do not suppress recovery and produce a false pass.
How long does microbial testing for Ayurvedic products take?
Total aerobic count and yeast/mould count take 5–7 business days (driven by the incubation period). Specified-pathogen absence testing (E. coli, Salmonella, S. aureus, P. aeruginosa) takes 5–7 business days. A complete microbial quality panel takes 7–10 business days. The incubation periods are fixed by the pharmacopoeial method and cannot be shortened.
What sample quantity is required for microbial testing?
A standard microbial panel needs about 25–50 g of product to allow the enumeration, the per-25 g Salmonella test, and a reserve. Provide the sample in its sealed, intact original packaging where possible (so the result reflects the marketed product), with batch / lot identification and the route of administration (oral / topical) so the correct limit set is applied. Confirm exact quantities with your SPOC for multi-parameter GMP or export panels.
Are Auriga microbial reports accepted for AYUSH GMP and export compliance?
Yes. Reports carry Auriga's NABL accreditation under ISO/IEC 17025:2017 and are accepted for Ministry of AYUSH GMP batch release and product licensing, for FSSAI nutraceutical requirements, and for export submissions referencing WHO TRS 863 and EU herbal-medicine microbial limits. Reports state the route of administration and the limit basis applied so reviewers can verify compliance directly.

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NABL-accredited microbial limits testing for Ayurvedic and herbal products per AYUSH GMP and WHO TRS 863.

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