Delhi · Gurugram · Bangalore · Baddi · Bahadurgarh

Nutraceutical Microbiology Testing India | FSSAI 2016 | NABL Accredited

A Salmonella or E. coli failure on a health supplement triggers immediate FSSAI surveillance hold, automatic marketplace delisting, and FBO licence consequences under Section 32 of the FSS Act. Backed by the Arbro Group's unbroken NABL accreditation since 2003, Auriga Research delivers microbiological testing for nutraceuticals and dietary supplements covering the full FSSAI safety panel and pharmacopoeial pathogen control.

Microbial safety in nutraceuticals is governed by the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, FSMP, Functional Food and Novel Food) Regulations 2016, with pharmacopoeial pathogen control referencing USP <61> / <62> and IP 2018 for AYUSH-licensed and pharma-boundary supplements. Our scope covers Total Plate Count, yeast and mould, coliforms, E. coli, Salmonella, Staphylococcus aureus, Clostridium perfringens, and PCR pathogen confirmation. Probiotic strain enumeration (Lactobacillus, Bifidobacterium, Saccharomyces) and bacterial endotoxin by LAL assay are also in scope.

Sample handling follows ISO 7218 — sterile collection, validated transport conditions, and accelerated incubation cycles where ISO methods permit, with full audit trail in YLIMS.

Reports in 7–10 working days | Express: 5 days available
Get a Quote Call +91-7428116100

Testing Parameters

Each parameter is mapped to its ISO / USP / IP method so QA and regulatory teams can match scope to FSSAI / pharmacopoeial requirements at a glance.

ISO 4833-1

Total Plate Count (TPC)

Aerobic mesophilic colony count at 30 °C / 72 h on PCA. FSSAI limit: < 10⁵ cfu/g for finished health supplements.

ISO 21527

Yeast & Mould

Yeast and mould enumeration on DRBC / PDA at 25 °C / 5 days. FSSAI limit: < 10³ cfu/g. Critical for botanical and herbal supplements.

ISO 7251

Total Coliforms / E. coli

MPN method or VRBA selective media. FSSAI limit: coliforms < 10 cfu/g; E. coli absent in 1 g.

ISO 6579-1

Salmonella

BPW pre-enrichment → RVS / MKTTn selective enrichment → XLD / HE agar isolation → biochemical and serological confirmation. FSSAI limit: absent in 25 g.

ISO 6888-1

Staphylococcus aureus

Baird-Parker agar with coagulase confirmation. FSSAI limit: absent in 1 g. Indicator of post-process contamination.

ISO 15213

Clostridium perfringens

Tryptose Sulphite Cycloserine (TSC) agar, anaerobic conditions. Indicator of soil / water contamination in botanical raw materials.

USP <61>

Microbial Enumeration

Total Aerobic Microbial Count (TAMC) and Total Yeast and Mould Count (TYMC) per USP <61> for nutraceutical products at the pharma boundary.

USP <62>

Specified Microorganisms

USP <62> tests for Salmonella, E. coli, Staphylococcus aureus, Pseudomonas aeruginosa, and bile-tolerant Gram-negatives. Required for AYUSH-licensed supplements.

AOAC 989.10

Lactobacillus / Probiotic Strains

Selective media enumeration for declared probiotic strains (Lactobacillus, Bifidobacterium). Supports CFU claim verification on probiotic labels.

PCR / 16S rRNA

Pathogen Confirmation

Molecular confirmation of Salmonella, Listeria, Cronobacter sakazakii by PCR and 16S rRNA sequencing. Available for follow-up after presumptive plate isolation.

Endotoxin LAL

Bacterial Endotoxin

LAL assay per USP <85> / IP 2018 for nutraceutical products at the pharma boundary or where parenteral pathway is part of the dossier.

Aflatoxin

Mycotoxin Screen

Aflatoxin B1, B2, G1, G2 and ochratoxin A by HPLC-FLD for botanical and grain-based nutraceutical raw materials (linked test for mould contamination).

How It Works

1

Get a Quote

Share your product type and the parameters you need tested. Your dedicated SPOC will confirm the testing scope, the applicable method, and the exact sample quantity required for your specific panel before you dispatch anything.

2

Send Your Sample

Dispatch your sample 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 against the confirmed validated method by Auriga's scientific team. Every result passes through 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 and are accepted by FSSAI under the Health Supplements Regulations 2016, BIS, and international buyers. You can track your sample status in real time through YLIMS at any point in the process.

Turnaround Time

Panel Standard TAT Express
TPC + yeast & mould 5–7 working days 4 days
FSSAI safety panel (TPC, Y&M, coliforms, E. coli, Salmonella, S. aureus) 7–10 working days 5 days
USP <61> / <62> pharmacopoeial pathogen panel 10–14 working days On request
PCR pathogen confirmation (Salmonella / Listeria / Cronobacter) + 3 days 24 h on request
Bacterial endotoxin (LAL) 5–7 working days Available
Probiotic enumeration (single strain) 7–10 working days Available

Who Needs This Testing

  • Nutraceutical manufacturers running routine batch release microbial testing for FSSAI compliance under the Health Supplements Regulations 2016.
  • D2C supplement brands launching on Amazon, Flipkart, Blinkit, Zepto, and BigBasket — marketplaces require microbial safety data before listing.
  • Botanical and herbal supplement brands needing FSSAI safety panel plus aflatoxin / ochratoxin screening on raw material batches.
  • AYUSH-licensed nutraceutical and traditional medicine brands needing IP 2018 / USP <61>/<62> pathogen control alongside FSSAI safety panel.
  • Probiotic supplement brands needing both pathogen exclusion and strain-specific viable cell enumeration for claim substantiation.
  • Brand owners responding to a marketplace delisting, FSSAI surveillance failure, or consumer complaint with an NABL-accredited counter-report.
  • Contract manufacturers and CDMOs running raw material qualification, in-process control, and finished-product release microbiology.

Why Auriga for Microbiology Testing

Unbroken NABL accreditation since 2003

Arbro Group has held NABL ISO/IEC 17025 accreditation continuously since 2003 — covering the full ISO 4833, ISO 21527, ISO 6579, and ISO 6888 microbiological scope.

Dual NABL + FSSAI notification

Reports carry evidentiary weight under the FSS Act 2006 for licence applications, surveillance responses, and marketplace listing reviews.

In-house pathogen confirmation

PCR and 16S / 18S rRNA sequencing for Salmonella, Listeria, Cronobacter, and probiotic strain ID — no partner-lab dependency on positive enrichments.

Full FSSAI + USP / IP scope

Both food-side (FSSAI) and pharma-side (USP <61>/<62>, IP 2018) microbial control on the same sample — supports AYUSH-licensed nutraceuticals at the pharma boundary.

Five regional labs

Delhi, Gurugram, Bangalore, Baddi, and Bahadurgarh — sterile sample receipt, validated transport conditions, and dedicated microbiology suites at multiple sites.

Express service for surveillance & launch

Express turnaround of 5 days on the FSSAI safety panel; rapid PCR confirmation on request for FSSAI surveillance hold recovery.

Frequently Asked Questions

What microbiological tests are required for nutraceuticals?
Under FSSAI Health Supplements Regulations 2016, finished nutraceutical products must comply with microbiological limits for: Total Plate Count (TPC), Yeast and Mould, Total Coliforms, E. coli, Salmonella, Staphylococcus aureus, and Clostridium perfringens. Probiotic and live-microorganism supplements require additional viable cell enumeration of declared strains.
What FSSAI limits apply for microbial contamination?
FSSAI Health Supplements Regulations 2016 set limits (per gram): TPC < 10⁵ cfu/g, yeast and mould < 10³ cfu/g, coliforms < 10 cfu/g, E. coli absent in 1 g, Salmonella absent in 25 g, Staphylococcus aureus absent in 1 g. Where products overlap with the pharmaceutical boundary (e.g., AYUSH-licensed supplements), IP 2018 / USP <61> / <62> apply with additional pathogen exclusions.
What methods are used for microbiological testing?
TPC by plate count agar at 30 °C / 72 h per ISO 4833-1; yeast and mould by DRBC / PDA per ISO 21527; coliforms and E. coli by MPN or VRBA per ISO 7251 / ISO 4831; Salmonella by selective enrichment in BPW → RVS → XLD per ISO 6579-1; Staphylococcus aureus by Baird-Parker agar per ISO 6888-1. PCR confirmation by 16S / 18S rRNA sequencing is available for pathogen identification.
How long does nutraceutical microbiology testing take?
Standard turnaround is 7–10 working days (most tests have a 5-day incubation window per ISO methods). Pathogen confirmation can extend testing by 2–3 days if positive enrichment requires identification. Express service compresses to 5 working days where the incubation cycle permits. Bursting bacterial testing (rapid PCR screen for pathogens) is available on request for surveillance response.
What sample quantity is required for microbiology testing?
Send at least 100 g of finished product in sealed retail packaging. Sealed packs preserve the actual microbial state at the point of sale. Open or repacked samples can introduce environmental microflora and invalidate the test against FSSAI limits. For probiotic products, dispatch under cold chain (2–8 °C) to preserve viable counts. Multiple flavour variants or batch codes require separate samples.
What is the regulatory consequence of microbial failure?
Microbial failure (especially Salmonella or E. coli) renders the product unsafe under Section 59 of the FSS Act 2006, attracting penalties up to seven years imprisonment and ten lakh rupees fine where harm is established. Substandard contraventions under Section 51 (high TPC, yeast and mould) attract fines up to five lakh rupees and an FSSAI improvement notice. Marketplaces automatically delist pending re-analysis. FBO licence suspension under Section 32 is the routine outcome for repeat or severe failures.
How often should microbiological testing be repeated?
For stable formulations, each manufacturing batch should be released against the microbial spec — this is the basis for FSSAI compliance and shelf-life claims. Annual independent verification against FSSAI limits supports surveillance defence. Retest is mandatory after changes in: (a) the manufacturing site or process; (b) the formulation or preservative system; (c) the packaging (especially primary packaging); (d) where stability data shows microbial growth approaching limits before end of shelf life.

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NABL-accredited microbiological testing for nutraceuticals. FSSAI 2016 safety panel, pharmacopoeial pathogen control, and PCR confirmation in-house.

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