certifications
How to Qualify and Audit an Indian Ayurvedic Ingredient Supplier: A Step-by-Step Due Diligence Guide
10 July 2026
You have identified a potential Indian supplier for Ashwagandha extract, Boswellia, Moringa powder, or another Ayurvedic ingredient. You have received a product specification and a price. Now the question that matters for your import compliance, quality programme, and ultimately your product safety is: how do you actually know this supplier is what they say they are?
This guide walks through the eight qualification steps a procurement manager or regulatory affairs officer should complete before placing a first order with an Indian Ayurvedic ingredient supplier. Each step tells you what document or action to request, what to look for, and what a problem looks like. The red flags section at the end consolidates the warning signs that should stop the process entirely.
The companion post to this guide covers the Indian regulatory framework itself — the roles of AYUSH, FSSAI, CDSCO, and what each license type means. This guide assumes you have read that context and moves directly to the buyer-side due diligence process.
Step 1: Verify the Manufacturing License (Form 25-D)
The first document to request is the supplier’s manufacturing license. For Ayurvedic, Siddha, and Unani drug manufacturers in India, this is issued in Form 25-D by the State Licensing Authority (SLA) — the state drug controller or designated AYUSH licensing authority in the state where the facility operates.
What Form 25-D confirms: That the facility is legally licensed to manufacture the specific product categories listed on the face of the license, under the direction of qualified technical staff, at the address specified, for the period stated.
What to check on the document itself:
- Facility address: The address on the Form 25-D must match the address of the manufacturing facility you are proposing to source from. A mismatch — for example, a license for a facility in one state being presented in connection with manufacturing at a different location — requires resolution before you proceed.
- Product scope: The license specifies which product categories are covered. If you are sourcing a botanical extract and the license covers only classical Ayurvedic formulations, the license may not cover the manufacturing activity you are relying on.
- Expiry or validity: A Form 25-D license may be issued for a fixed period (historically five years in most states) or, in some states, issued as perpetually valid unless suspended or cancelled. Confirm the validity status and whether the license is current.
- Issuing authority: The license should identify the State Licensing Authority by name and state. This is what you cross-reference if you need to verify with the authority directly.
How to verify independently: The relevant state’s drug control or AYUSH directorate maintains records of licensed manufacturers. Contact details for State Licensing Authorities are published by the Ministry of AYUSH and by state government health department websites. For high-value sourcing relationships, direct verification with the SLA is the appropriate level of diligence.
Step 2: Validate GMP Certification
GMP certification is the quality systems credential that tells you whether the manufacturing facility operates to a recognised international standard — not just that it holds a license to operate.
The three tiers to understand:
Schedule T is the Indian domestic GMP standard under the Drugs and Cosmetics Rules 1945. It is the mandatory baseline for obtaining a Form 25-D manufacturing license. For most international markets, Schedule T compliance alone is not sufficient as a standalone export credential — it confirms domestic regulatory compliance, not international quality equivalence.
WHO-GMP certification is issued after facility inspection confirming compliance with World Health Organisation Good Manufacturing Practice guidelines. It is the internationally accepted baseline required by most importing countries for herbal ingredient imports from India. For buyers in the EU, UK, UAE and GCC, Japan, Korea, ANZ, SEA, and Latin America, a current WHO-GMP certificate is the minimum documentation baseline for supplier qualification. As of July 2025, WHO-GMP applications in India must be submitted through the ONDLS (Online National Drugs Licensing System) portal — physical applications are no longer accepted.
EU-GMP is the pharmaceutical-grade standard administered by EU member state competent authorities. It is the appropriate requirement when an ingredient is entering a European pharmaceutical manufacturing supply chain rather than a food supplement or cosmetic application. Far fewer Indian manufacturers hold genuine EU-GMP certification; those who do represent a meaningfully differentiated tier.
What to check on the GMP certificate:
- Issue date and expiry date: Certificates have validity periods. An expired certificate is not a valid credential. Confirm the certificate is current at the time of each order, not just at initial qualification.
- Scope of manufacture: The certificate should specify what manufacturing operations and product categories it covers. A WHO-GMP certificate covering tablet manufacture is not necessarily valid for extract production or spray-drying operations. Match the scope to what you are actually sourcing.
- Issuing body: WHO-GMP certificates for Indian Ayurvedic manufacturers are issued by CDSCO (Central Drugs Standard Control Organisation) or by state drug regulatory authorities after joint inspection. A certificate issued by an unrecognised or unclear body warrants verification.
- For US-bound suppliers: Confirm FDA facility registration and ask for evidence of cGMP compliance (21 CFR Part 111 for dietary supplement ingredients) verified by third-party audit. FDA registration is a facility notification requirement, not an inspection-based approval — third-party audit evidence is the more meaningful quality signal.
Step 3: Request and Assess the Certificate of Analysis
The Certificate of Analysis (COA) is the per-batch document that tells you whether the specific material you are receiving meets the specification you agreed to. It is not interchangeable between batches and should never be treated as a generic product-level document.
What a credible COA must include:
Batch identification: The COA must reference the specific batch or lot number of the material being supplied. A COA with no batch number, or a batch number that does not match the shipping documents, is an immediate concern.
Testing laboratory: The testing laboratory must be NABL-accredited (National Accreditation Board for Testing and Calibration Laboratories). NABL is an autonomous body under the Government of India that evaluates laboratories against the international standard ISO/IEC 17025:2017, and is a signatory to the ILAC Mutual Recognition Arrangement — meaning NABL-accredited test reports are accepted by regulatory bodies globally. NABL accreditation is parameter-by-parameter, not lab-wide: confirm that the specific parameters on the COA are within the lab’s NABL accredited scope, not just that the lab holds a NABL certificate for some testing. As of 2024, NABL moved to a four-year accreditation cycle with yearly surveillance — confirm the lab’s accreditation is current.
Parameters by ingredient category:
For standardised botanical extracts (Ashwagandha, Boswellia, Turmeric, Tulsi):
- Identity confirmation: correct species and plant part (HPLC profile or botanical microscopy)
- Active compound assay: withanolides (Ashwagandha), boswellic acids (Boswellia), curcuminoids (Turmeric) — to declared specification percentage
- Moisture content
- Heavy metals: arsenic, cadmium, lead, mercury — to ICH Q3D limits or the limit specified by your destination market regulator
- Microbial limits: total aerobic plate count, total yeast and mould count, absence of E. coli, Salmonella, Staphylococcus aureus
- Pesticide residue: multi-residue screening to EU MRL or destination market limits
For herbal powders (Moringa, Amla, Triphala):
- Botanical identity
- Moisture and ash content
- Heavy metals and microbial profile as above
- Pesticide residue
- Absence of adulterants
What to check beyond the data: Review the test dates against the batch manufacture date. A COA where testing was completed months after manufacture requires explanation. Check whether the values reported are within specification — a COA that lists results but no specification limits gives you data without context.
Step 4: Confirm Ingredient Source and Traceability
For Ayurvedic ingredients, the raw plant material is the starting point of quality. Where the herb was grown or collected, under what conditions, and whether the correct species was harvested are all questions that determine the identity and potency of what you eventually receive.
Ayurvedic Pharmacopoeia of India (API) reference: The Ayurvedic Pharmacopoeia of India is the official compendium of standards for Ayurvedic drugs, published by the Ministry of AYUSH. It defines the accepted botanical source species, plant parts, and quality standards for classical Ayurvedic raw materials. When a supplier describes their Ashwagandha root as meeting API standards, that is a specific claim — the API monograph specifies that Ashwagandha raw material derives from Withania somnifera Dunal, from the roots, with defined physicochemical parameters. Ask suppliers to reference the relevant API monograph for the ingredient they are supplying and to confirm their raw material meets those standards.
GACP compliance: WHO Good Agricultural and Collection Practices (GACP) guidelines for medicinal plants provide technical guidance on obtaining quality medicinal plant materials for herbal products. GACP covers site selection, cultivation methods, harvest timing, post-harvest handling, drying, storage, and documentation. In India, the National Medicinal Plants Board (NMPB), in collaboration with WHO, developed India-specific GACP guidelines in 2009. GACP compliance is not a mandatory certification requirement for most markets, but it is a meaningful signal of raw material supply chain discipline — particularly relevant for high-value standardised extracts where active compound levels are sensitive to harvest conditions.
Ask the supplier: Is their raw herb sourced from contracted cultivators or from open market procurement? If contracted, do those farms have documentation of cultivation practices? For wild-harvested materials, what collection protocols apply and are those protocols documented?
Cultivated versus wild-harvested: Many Indian medicinal herbs are sourced from both cultivated and wild-harvested sources. Wild-harvested material carries additional quality risks: variable active compound levels depending on growing conditions, species misidentification risk when collection is by non-specialist gatherers, and sustainability concerns for species under collection pressure. For wild-harvested materials, request species verification documentation and ask whether collection is from designated collection areas with managed harvesting protocols.
Traceability records: A supplier with good traceability practices should be able to tell you, for a given batch, which geographical region or farm the raw herb came from, when it was harvested, and how it was stored before processing. This level of traceability supports your own supply chain documentation for markets that require ingredient origin disclosure.
Step 5: Check Organic and Halal Certification Status
If your intended product requires organic or Halal positioning in your destination market, the supplier’s certification status is a binary qualification gate — either they hold valid, applicable certification or they do not. This step should be completed before any other commercial discussion proceeds.
Organic certification — NPOP:
India’s national organic certification system is the National Programme for Organic Production (NPOP), administered by APEDA (Agricultural and Processed Food Products Export Development Authority). NPOP sets standards for organic cultivation, harvesting, and processing of agricultural products including medicinal herbs and botanical ingredients.
There are two documents to request:
The NPOP scope certificate confirms that the supplier’s organic farming operations or sourcing relationships are certified under NPOP. Check the certification body (which must be APEDA-accredited), the scope (which products and operations are covered), and the validity period.
The Transaction Certificate (TC) is a per-shipment document, now mandatory under the updated NPOP framework (DGFT Public Notice 39/2024-25, effective from July 2025). The TC is issued through APEDA’s Tracenet system and confirms that a specific consignment of organic product is covered under the scope of the supplier’s NPOP certification. A scope certificate alone is not sufficient to export a batch as certified organic — the TC for that specific shipment must accompany it.
Organic recognition by market:
EU market: NPOP certification is recognised as equivalent to EU organic standards under a bilateral agreement. NPOP-certified Indian organic ingredients can enter the EU organic supply chain without separate EU organic certification. Transaction Certificates are required per batch.
US market: NPOP is not recognised as equivalent to USDA National Organic Program (NOP). Suppliers targeting US organic buyers require separate USDA NOP certification from a USDA-accredited Certifying Agent. Ask specifically whether the supplier holds USDA NOP in addition to NPOP — many suppliers have prioritised the EU market and hold only NPOP.
UK market: The UK has maintained organic equivalence arrangements with India post-Brexit, but the specific terms of ongoing recognition should be confirmed with the relevant UK authority at the time of sourcing, as the framework continues to evolve.
Other markets: Japan (JAS organic), Korea (KAS), and ANZ (ACO or equivalent) each have their own organic recognition frameworks. NPOP is not universally equivalent — confirm the specific recognition status for your destination market before representing ingredients as certified organic.
Halal certification:
For UAE and GCC buyers, Halal certification is a market access requirement for many ingredient categories. The critical question is not just whether the supplier holds a Halal certificate, but whether the certifying body that issued it is recognised by the destination market authority.
For the UAE: ESMA (Emirates Authority for Standardisation and Metrology) maintains a list of recognised Halal certification bodies. A Halal certificate from a body not on the ESMA recognised list does not satisfy UAE Halal import requirements. Verify the certifying body against the current ESMA list, not against a generalised claim of Halal compliance.
For other GCC markets: Saudi Arabia, Qatar, Kuwait, Bahrain, and Oman each have their own recognised body lists. Confirm destination-market-specific recognition.
Halal certification for herbal ingredient manufacturers covers the manufacturing process, ingredient inputs, and facility hygiene — not only the plant material itself. A botanically Halal raw material produced in a facility with non-Halal processing risk (shared equipment, cross-contamination) may not hold a valid Halal certificate. Confirm the scope of the certificate covers the full manufacturing process for the ingredient you are sourcing.
Step 6: Request the Free Sale Certificate and CoPP
These two export-facing documents together confirm the product’s regulatory status in India and the manufacturer’s standing with Indian regulatory authorities.
Free Sale Certificate (FSC):
The Free Sale Certificate confirms that the product is legally manufactured and sold freely in India — that it is not a controlled, restricted, or prohibited product. It is issued by the State Licensing Authority or by the Ministry of AYUSH, and it is required by customs authorities in most importing countries as part of the import clearance documentation.
What to check: The FSC should be current (not more than one to two years old, depending on the importing country requirement), should specify the exact product name and description, and should bear the issuing authority’s letterhead and signature. An FSC that covers a general product category rather than the specific ingredient you are importing may not satisfy customs requirements in destination markets that require product-specific documentation.
Common gap: FSCs are sometimes presented as perpetually valid. Most importing country customs authorities or regulatory bodies require FSCs to be recent — confirm what your destination market’s specific requirement is for FSC age.
Certificate of Pharmaceutical Products (CoPP):
The CoPP is issued in the WHO-recommended format and establishes the product’s approved status in India and the manufacturer’s GMP standing. For Ayurvedic drug categories, the CoPP is issued by CDSCO (Central Drugs Standard Control Organisation) under DCGI (Drugs Controller General of India) authority. As of July 15, 2025, all CoPP and WHO-GMP applications must be submitted through the ONDLS (Online National Drugs Licensing System) digital portal — physical applications are no longer accepted at any CDSCO zonal or sub-zonal office.
The CoPP is issued per product, not per manufacturer. A manufacturer may hold CoPPs for specific formulations or product categories while not holding one for every ingredient they manufacture. Confirm whether the ingredient you are sourcing has a CoPP, and which body issued it.
Several importing country markets — particularly in Southeast Asia, Latin America, and parts of the Middle East — require the CoPP as part of the product registration or import permit application. If your destination market requires it, confirm the supplier holds it before committing to the sourcing relationship.
Step 7: Conduct or Commission a Facility Audit
Documentation tells you what a supplier claims. An audit tells you whether what they claim corresponds to what exists on the ground. For any first-time sourcing relationship involving ingredients that will enter your finished product supply chain, a facility audit — either conducted by your own team or commissioned from a recognised third-party inspection body — is the appropriate level of diligence.
Remote desk audit versus on-site audit:
A remote desk audit reviews documentation: the quality manual, SOPs, batch manufacturing records, training records, calibration records, and corrective action logs. It can be completed without travel and provides a reasonable initial-stage assessment. Its limitation is that documentation compliance and manufacturing reality can diverge significantly.
An on-site audit involves physical inspection of the manufacturing facility by a trained auditor. It is the only way to verify that the physical premises match what is described in the documentation, that stated SOPs are actually followed in practice, and that storage and handling conditions are as represented. For high-value or regulated supply chains, an on-site audit before first order placement is standard practice.
Commissioning a third-party audit:
The internationally recognised inspection bodies with established India operations include SGS, Bureau Veritas, Intertek, and TUV SUD. Each operates a network of India-based auditors across multiple states and can conduct GMP audits against WHO-GMP, EU-GMP, or cGMP (21 CFR Part 111) standards depending on your requirement.
To commission an audit: contact the inspection body directly, provide the supplier name and facility address, specify the product category and applicable GMP standard, and request a formal audit scope proposal. Lead times for scheduling vary by geography within India and by the inspection body’s current availability — typically two to six weeks for initial scheduling.
What the audit should cover for an Ayurvedic ingredient supplier:
- Manufacturing premises: layout, construction standards, cleanliness, pest control, drainage and waste disposal
- Raw material receipt and incoming inspection: identity testing for incoming herbs, quarantine procedures, approved supplier management
- Batch manufacturing records (BMRs): completeness, accuracy, traceability of in-process steps
- Standard Operating Procedures (SOPs): whether they exist for all key operations and whether production staff can demonstrate awareness of them
- Quality control laboratory: equipment calibration, analyst qualifications, reference standards management, NABL accreditation status
- Staff: qualification records, hygiene training, health monitoring
- Storage and handling: temperature and humidity controls, segregation of approved and rejected materials, labelling practices
- Finished goods testing and release: who authorises batch release, against what specification, using what test methods
Request the full audit report: Some buyers request only a pass/fail certificate or a summary. Always request the full audit report, including any non-conformances raised and the corrective action plans submitted and verified. Knowing what was found and how it was resolved tells you significantly more than a summary grade.
Step 8: Evaluate Sample Before Committing to Bulk
Physical sample evaluation before first order commitment is standard practice in ingredient sourcing and should not be skipped because documentation appears complete. Documentation and product quality are related but distinct — a supplier may be document-compliant while producing material that does not meet your formulation requirements.
Request the sample alongside these documents:
When requesting a sample, simultaneously request the following documentation to accompany it:
- COA for the sample batch (batch-specific, from NABL-accredited lab, with the parameters listed in Step 3)
- Certificate of Origin confirming Indian origin of the specific batch
- Specification sheet with declared assay ranges, particle size (where relevant), and physical appearance description
Test the sample independently: Send the sample to your own quality laboratory for verification testing. At minimum, confirm botanical identity and active compound assay independently. If your formulators will use the material, have them assess it for sensory properties, solubility (for extracts), flow characteristics (for powders), and compatibility with your formulation matrix.
Confirm manufacturing parameters: For standardised extracts, confirm the extraction solvent used (water, ethanol, or other), the extraction ratio (for example, 10:1 means ten kilograms of raw herb to produce one kilogram of extract), and whether the extract is standardised to a specific active compound percentage. These parameters affect your finished product claims and stability.
Stability data: For long-term supply relationships, request the supplier’s stability data for the ingredient under your intended storage conditions. For ingredients with a specified shelf life, understand the basis of that shelf life claim.
Red Flags: When to Stop the Qualification Process
The following specific observations should each independently prompt you to pause and seek resolution before proceeding. In combination, they indicate a supplier relationship that carries unacceptable documentation and quality risk.
On licensing and registration:
- Supplier cannot produce Form 25-D on request, or requests more than a few business days to provide it
- Form 25-D address does not match the facility address
- Form 25-D product scope does not cover the ingredient category being supplied
- No Import Export Code (IEC) from DGFT — required for any Indian export transaction
On GMP certification:
- WHO-GMP certificate is expired
- WHO-GMP certificate scope does not cover the specific manufacturing operations for your ingredient (for example, covers tablet manufacture but not extract production)
- Certificate is presented without an identifiable issuing authority
- Supplier cannot name the inspection body that issued the certificate
On COA and testing:
- COA has no batch number — a document without batch reference is not a COA, it is a generic specification sheet
- Testing laboratory is not NABL-accredited, or the parameters listed are outside the lab’s accredited scope
- COA is presented as valid for multiple future shipments — COAs are per batch, not blanket documents
- Heavy metals or pesticide data is absent from the COA
On organic and Halal certification:
- No Transaction Certificate for organic shipments (mandatory since July 2025 under updated NPOP framework)
- Halal certifying body is not on the ESMA recognised list for UAE buyers
- Supplier presents organic or Halal certificates but cannot produce them in original form or cannot confirm the certifying body contact details for verification
On facility audit:
- Supplier refuses third-party audit access without explanation
- On-site audit reveals manufacturing address differs from licensed address
- Audit identifies critical non-conformances with no corrective action plan on file
On Free Sale Certificate and CoPP:
- FSC is undated, or older than the importing country’s stated acceptance period
- FSC covers a different product than what is being supplied
- CoPP is required by your destination market regulator but supplier does not hold one for the ingredient
On responsiveness:
- Supplier takes more than five to seven business days to respond to a standard documentation request without explanation
- Supplier provides documents that do not match each other (for example, facility name on COA does not match facility name on Form 25-D)
- Supplier offers to arrange any document on request, implying that documents are produced to order rather than maintained as part of ongoing regulatory compliance
Sourcing Ayurvedic ingredients and need a supplier who can produce complete, current documentation on request? Ayris Global works exclusively with verified Indian producers who hold the licensing and certifications relevant to your destination market. Contact our sourcing team or learn more about our quality standards and supplier verification approach.
Summary: The Eight-Step Qualification Checklist
Before placing a first order with an Indian Ayurvedic ingredient supplier, complete the following:
- Form 25-D manufacturing license — verified for correct facility address, product scope, and current validity
- GMP certificate (WHO-GMP minimum; EU-GMP for pharmaceutical supply chains) — confirmed for current validity, scope match, and credible issuing authority
- Certificate of Analysis for a reference batch — batch-specific, from a NABL-accredited laboratory, covering identity, assay, heavy metals, microbials, and pesticide residue
- Ingredient traceability documentation — API reference compliance, GACP supply chain information, cultivated versus wild-harvested source confirmation
- Organic certification (if applicable) — NPOP scope certificate plus Transaction Certificate per shipment; USDA NOP separately for US market
- Halal certification (if applicable) — from an ESMA-recognised certifying body for UAE and GCC markets
- Free Sale Certificate and CoPP — current, product-specific, from the appropriate issuing authority
- Facility audit — on-site preferred; commission through SGS, Bureau Veritas, Intertek, or TUV SUD with full report (not summary certificate alone)
When all eight steps are complete and no red flags remain unresolved, you have a documented basis for placing a first order and for defending the sourcing decision to your quality and compliance functions.
Frequently Asked Questions
What is Form 25-D and how do I verify it is genuine?
Form 25-D is the manufacturing license issued by a State Licensing Authority to Ayurvedic, Siddha, and Unani drug manufacturers under Rule 154 of the Drugs and Cosmetics Rules 1945. It specifies the facility address, the product categories licensed, and the license validity period. To verify it is genuine, request the original, check the issuing State Licensing Authority name, the license number, and the expiry date, and cross-reference with the relevant state AYUSH or drug control directorate. A license that lists a different facility address from the one you are being supplied from, or that covers different product categories than the ingredient you are sourcing, is a document mismatch requiring resolution before proceeding.
Which GMP standard should I require from an Indian Ayurvedic supplier — Schedule T, WHO-GMP, or EU-GMP?
The answer depends on your destination market and intended product category. Schedule T is India’s domestic baseline, mandatory for holding a manufacturing license, but not internationally recognised as a standalone qualification. WHO-GMP is the minimum internationally accepted standard and is required by most markets including the EU, UAE, Japan, Korea, ANZ, SEA, and Latin America for import clearance. EU-GMP is the pharmaceutical-grade benchmark for ingredients entering European pharmaceutical manufacturing supply chains. For most international herbal ingredient buyers, WHO-GMP with a current validity date from a credible inspection authority is the appropriate minimum requirement.
What parameters should a Certificate of Analysis for Ayurvedic herbal ingredients include?
A credible COA must be batch-specific, issued from a NABL-accredited laboratory, and cover at minimum: botanical identity verification, active compound assay values (withanolides for Ashwagandha, curcuminoids for Turmeric, boswellic acids for Boswellia), heavy metal limits (arsenic, cadmium, lead, mercury), microbial load (total aerobic count, E. coli, Salmonella, Staphylococcus), and pesticide residue screening. A COA without a batch number, from a non-NABL-accredited lab, or without identity confirmation is insufficient for import compliance.
What red flags should make me stop the supplier qualification process?
Stop if any of the following occur: the supplier cannot produce Form 25-D or the address does not match the facility; the GMP certificate is expired or scope-limited; the COA has no batch number or comes from a non-NABL-accredited lab; organic shipments lack Transaction Certificates; Halal certifying bodies are not recognised in your destination market; the supplier refuses third-party audit access; or documents across different files do not match each other. Any single one of these is sufficient reason to pause and resolve before proceeding.
How do I commission a third-party facility audit of an Indian Ayurvedic supplier?
Contact an internationally recognised inspection body with India operations — SGS, Bureau Veritas, Intertek, or TUV SUD are established options. Provide the supplier name, facility address, product categories, and applicable GMP standard. The audit scope for an Ayurvedic ingredient supplier should cover manufacturing premises, raw material receipt and identity testing, batch manufacturing records, SOPs, quality control laboratory systems, staff qualifications, storage conditions, and finished goods release procedures. Always request the full audit report including non-conformances and corrective action status, not a summary certificate alone.
Related Reading: What is AYUSH? The Indian Regulatory Framework Every International Herbal Ingredient Buyer Needs to Understand · GMP, ISO, FSSAI, and Organic Certification: A Buyer’s Guide · CoA, MSDS and Phytosanitary Certificates Explained
Ayris Global connects international buyers with verified, document-complete Indian Ayurvedic and herbal ingredient suppliers. To discuss your sourcing programme and documentation requirements, contact us at sourcing@ayrisglobal.in or visit our For Buyers page.