Certifications & Compliance
GMP, ISO, FSSAI and Organic Certifications for Indian Herbal Ingredients: A Buyer's Reference
15 June 2025 ·
Certifications are the vocabulary of trust in international ingredient trade. When a supplier says they are GMP-certified, ISO-compliant or FSSAI-registered, they are making a claim about their processes, their facilities and their documentation. Your job as a buyer is to know what those claims actually mean — and how to verify them.
This reference covers the four certification categories that matter most for buyers sourcing herbal and botanical ingredients from India: GMP, ISO food safety standards, FSSAI registration, and organic certification. For each one, we explain what it is, what it covers, which markets require it, what the certificate looks like, and what to check before accepting a supplier’s claim.
GMP Certification
What it is
Good Manufacturing Practice (GMP) is a system of quality controls governing how products are manufactured. It covers facility design, equipment, raw material handling, production processes, testing, documentation and personnel training. The goal is to ensure that every batch of a product is consistently produced and controlled to the quality standard appropriate for its intended use.
For herbal ingredient buyers, GMP certification is the primary signal that a supplier operates a controlled, auditable manufacturing environment — not a commodity processing shed.
The main GMP standards you will encounter
WHO-GMP The World Health Organization’s GMP guidelines are the most widely recognised international standard for pharmaceutical and nutraceutical ingredient manufacture. WHO-GMP certification from a recognised third-party auditor (SGS, Bureau Veritas, TÃœV, Intertek) is the baseline acceptable standard for most supplement and nutraceutical buyers globally.
EU-GMP (EudraLex Volume 4) The European Medicines Agency’s GMP standard. Required for active pharmaceutical ingredient (API) manufacture supplying into European pharmaceutical production. More demanding than WHO-GMP in its documentation and validation requirements. If you are sourcing for a pharmaceutical application in Europe, confirm your supplier holds EU-GMP certification, not just WHO-GMP.
US FDA 21 CFR Part 111 The US Food and Drug Administration’s GMP regulation for dietary supplement manufacturers. Indian suppliers exporting into the US supplement market should be able to demonstrate compliance with 21 CFR Part 111, though FDA does not issue certificates — compliance is demonstrated through facility registration and inspection readiness.
Schedule M (India) India’s domestic GMP standard under the Drugs and Cosmetics Act. Schedule M compliance is required for domestic pharmaceutical manufacturing in India and is the baseline for Indian government-issued GMP certificates. While less demanding than WHO-GMP or EU-GMP in some respects, a current Schedule M certificate from the state drug authority confirms the facility is legally operating under India’s pharmaceutical manufacturing framework.
GMP by third-party auditors Many Indian exporters hold GMP certification from international third-party bodies — SGS, Bureau Veritas, Intertek, TÜV Rheinland — issued against codified GMP standards. These are recognised by buyers across the EU, UK, USA, UAE/GCC and East Asia.
What to check on a GMP certificate
- Issuing body — government authority or recognised third-party auditor. Certificates from unknown local bodies warrant independent verification.
- Scope — which products or product categories are covered. A certificate scoped to one product line does not extend to all products the facility makes.
- Facility address — must match the manufacturing location you are purchasing from. A company certificate that does not name a specific facility is insufficient.
- Issue and expiry dates — GMP certificates typically run for one to three years. Confirm the certificate is current. Ask when the next surveillance audit is scheduled.
- Certificate number — allows you to request verification from the issuing body if needed.
Which markets require GMP
| Market | GMP requirement |
|---|---|
| European Union | WHO-GMP minimum; EU-GMP for pharma API |
| United Kingdom | WHO-GMP minimum post-Brexit; MHRA may require EU-GMP equivalence for pharma |
| United States | FDA 21 CFR Part 111 compliance; NSF GMP certification carries market credibility |
| UAE / GCC | WHO-GMP; some UAE importers require ESMA-recognised GMP |
| Japan | PMDA-recognised GMP or PIC/S equivalent |
| Korea | MFDS GMP recognition |
| Australia | TGA overseas GMP clearance framework; PIC/S GMP preferred |
| India (domestic) | Schedule M |
ISO Food Safety Certifications
What they are
ISO food safety certifications cover the management systems a manufacturer uses to control food safety risks across their supply chain and production processes. They are distinct from GMP, which focuses on manufacturing controls. ISO certifications focus on the system — the policies, procedures, monitoring mechanisms and continuous improvement processes that sit around manufacturing.
The two most relevant standards for herbal ingredient buyers are ISO 22000 and FSSC 22000.
ISO 22000
ISO 22000 is the international standard for Food Safety Management Systems (FSMS). It integrates HACCP (Hazard Analysis and Critical Control Points) principles with a management system framework. Certification confirms that a manufacturer has:
- Identified food safety hazards relevant to their processes
- Implemented control measures at critical points
- Established monitoring, verification and corrective action processes
- Documented their system to an auditable standard
ISO 22000 certification is issued by accredited certification bodies (SGS, Bureau Veritas, DNV, etc.) following an external audit. It is increasingly expected by EU and UK buyers as part of supplier approval processes, particularly for food-grade ingredients.
FSSC 22000
FSSC 22000 (Food Safety System Certification) is built on ISO 22000 and adds sector-specific prerequisite programmes and additional FSSC scheme requirements. It is recognised by the Global Food Safety Initiative (GFSI) — a benchmark that major food and supplement brands use to assess supplier quality systems.
GFSI recognition makes FSSC 22000 particularly valuable for suppliers selling to large food manufacturers, private label producers and retail-facing brands who require GFSI-recognised certification from their ingredient suppliers.
ISO 9001
ISO 9001 is a Quality Management System (QMS) standard — broader than food safety, covering the overall management of quality across an organisation’s processes. It is less specific to food and ingredient manufacture than ISO 22000 or FSSC 22000, but remains a common certification among Indian exporters and demonstrates a baseline commitment to documented, auditable quality management.
What to check on ISO certificates
- Accreditation body — the certification body issuing the ISO certificate must itself be accredited by an IAF (International Accreditation Forum) member body. Check the accreditation logo and number on the certificate.
- Scope statement — confirm the scope covers the relevant manufacturing activities, not just administrative or support functions.
- Certificate validity — ISO certificates are typically issued for three years with annual surveillance audits. Confirm the certificate is within its validity period.
FSSAI Registration and Licensing
What it is
The Food Safety and Standards Authority of India (FSSAI) is India’s central food regulatory body, operating under the Ministry of Health and Family Welfare. FSSAI registration or licensing is mandatory for all food business operators in India — including manufacturers, processors, importers and exporters of food products and food ingredients.
For international buyers, an FSSAI certificate from a supplier confirms two things: the supplier is legally authorised to operate as a food business in India, and the product has been manufactured under India’s food safety regulatory framework.
Registration vs licensing
FSSAI operates a tiered system:
FSSAI Registration — for small food businesses with annual turnover below ₹12 lakh. Not relevant for export-scale manufacturers.
State FSSAI Licence — for medium-scale food businesses operating within a single state, with turnover between ₹12 lakh and ₹20 crore.
Central FSSAI Licence — for large manufacturers, importers and exporters with turnover above ₹20 crore, or any business engaged in import or export of food products. Export-scale herbal ingredient manufacturers should hold a Central FSSAI Licence.
For international buyers, the Central FSSAI Licence is the relevant document. It should be requested as part of your standard documentation package.
How to verify FSSAI registration
FSSAI maintains a public database. The 14-digit FSSAI licence number on a supplier’s certificate can be verified at foscos.fssai.gov.in. This is a simple and fast verification step that confirms the licence is active and held by the entity named.
If a supplier’s FSSAI number does not return a valid result on the FSSAI portal, that is a significant compliance concern.
FSSAI and export documentation
For herbal ingredient exports from India, the FSSAI certificate is typically included in the export documentation package alongside the phytosanitary certificate, certificate of origin and commercial invoice. Some destination market customs authorities require it as part of import clearance. Even where it is not a mandatory import document, it signals to buyers that the manufacturer is operating within India’s formal food safety regulatory framework.
Organic Certification
What it is
Organic certification confirms that a product has been produced according to defined organic farming and processing standards — without synthetic pesticides, synthetic fertilisers, genetically modified organisms or prohibited processing inputs. For herbal ingredients, organic certification covers both the agricultural production (farming) and the post-harvest processing (drying, extraction, milling, packaging).
Organic certification is relevant when your product carries organic labelling claims in the destination market, or when your brand positioning requires certified organic inputs throughout the supply chain.
The standards that matter by market
EU Organic — Regulation (EU) 2018/848 The governing regulation for organic production and labelling in the European Union. For herbal ingredients imported into the EU under organic claims, the ingredient must be certified organic under EU Regulation 2018/848 by an approved control body. Indian organic exports to the EU are certified by APEDA-approved bodies and must comply with the EU organic import regime.
Control bodies operating in India and recognised for EU organic certification include: Ecocert India, OneCert Asia, SKAL International, Control Union, LACON.
USDA Organic — National Organic Program (NOP) The US Department of Agriculture’s organic standard. Indian exporters supplying certified organic ingredients to the US market must hold NOP certification from a USDA-accredited certifier. Control bodies with NOP accreditation operating in India include: CERT ID, OneCert, Control Union, ECOCERT.
India Organic — NPOP India’s National Programme for Organic Production, administered by APEDA. NPOP certification is recognised by the EU and Switzerland under equivalency agreements, meaning NPOP-certified products can enter the EU market without re-certification under certain conditions. NPOP is not recognised as equivalent by the US NOP, so US-destined organic exports require separate NOP certification.
UK Organic Post-Brexit, the UK operates its own organic regulatory framework. EU organic certification is currently accepted for imports into the UK under transitional arrangements, but buyers should confirm the current status with their regulatory adviser, as the arrangements continue to evolve.
Japanese Agricultural Standard (JAS) Organic Japan’s organic certification standard, administered by the Ministry of Agriculture, Forestry and Fisheries (MAFF). Indian exporters to Japan under organic claims require JAS certification from an accredited certification body.
What to check on an organic certificate
- Standard — confirm it matches the destination market requirement (EU 2018/848, USDA NOP, JAS, etc.)
- Scope — does the certificate cover the specific product you are purchasing, and does it cover both agricultural production and processing? Farming certification without processing certification does not cover the extract or powder you are buying.
- Certificate holder — the named entity should be the manufacturer supplying you, not a third party.
- Control body — confirm the certifying body is accredited under the relevant scheme.
- Valid season — organic certificates are typically issued annually, covering a specific growing and production season. Confirm the certificate covers the harvest year of the batch you are purchasing.
Asking for Certifications: A Practical Script
When requesting certification documents from a prospective supplier, be specific:
“Please provide the following for your [facility name / address]: current GMP certificate with issuing body and scope; Central FSSAI licence number for verification; ISO 22000 or FSSC 22000 certificate if held; and organic certificate under [EU 2018/848 / USDA NOP / specify] for [product name], covering both agricultural production and processing.”
Specificity matters. A general request for “your certifications” returns whatever the supplier wants to send. A specific request for named standards, covering a named facility and product, returns the documentation you actually need to evaluate.
How Ayris Global Manages Certification Compliance
Every manufacturer in Ayris Global’s supplier network is evaluated against certification requirements before onboarding. We maintain current copies of GMP, ISO, FSSAI and organic certificates for each facility we work with and track renewal dates to ensure you are never supplied under an expired certification.
When you submit a sourcing enquiry, we match your destination market and product specification to a supplier who holds the certifications your regulatory environment requires — before we make an introduction.
For buyers managing multiple destination markets with different certification requirements, we coordinate the documentation package so that each shipment arrives with the correct certification set for its import market.
Submit a sourcing enquiry to discuss your ingredient requirements and we will respond within one business day.