certifications
What is AYUSH? The Indian Regulatory Framework Every International Herbal Ingredient Buyer Needs to Understand
5 July 2026
When international buyers ask which Indian herbal ingredient supplier is “certified,” they are usually thinking about one or two certificates — GMP, maybe organic. What they are less often prepared for is the question underneath: certified by whom, under what law, and does that certification actually address what your destination market regulator cares about?
India’s regulatory framework for herbal ingredients is more structured than most buyers expect, and understanding it correctly is not bureaucratic detail — it directly determines whether your ingredients can be imported legally, whether your supplier’s documentation will satisfy your customs broker, and whether your finished product can make the claims you intend to make.
This guide explains how the Indian regulatory system is structured for Ayurvedic and herbal ingredient manufacturers, what each regulator actually controls, which documents matter for international trade, and what organic certification means for Indian-origin botanical ingredients.
The AYUSH Ministry: What It Is and What It Controls
AYUSH stands for Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy. The Ministry of AYUSH was established by the Government of India in November 2014 as a dedicated central ministry for traditional medicine systems — before that, these systems were governed by a smaller department that sat inside the Ministry of Health.
The Ministry of AYUSH does not issue manufacturing licenses directly. That function sits with State Licensing Authorities (SLAs) — typically the State Drug Controller or a designated AYUSH licensing authority in each Indian state. What the Ministry does is set national standards, issue policy guidelines, maintain quality frameworks, and issue certain export-facing certifications including the Free Sale Certificate (FSC) and the Certificate of Pharmaceutical Products (CoPP) for Ayurvedic manufacturers.
The legal foundation for AYUSH regulation is the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945, specifically Chapters IV-A and the associated rules covering Ayurvedic, Siddha, and Unani (ASU) medicines. Rule 158-B sets out the conditions for licensing Ayurvedic manufacturers. Schedule T sets the Good Manufacturing Practice standard that licensed facilities must meet.
For a buyer sourcing herbal ingredients from India, what this means practically is that a legitimate AYUSH-regulated manufacturer will hold:
- A manufacturing license issued in Form 25-D by their State Licensing Authority
- A GMP certificate confirming Schedule T compliance, also issued by the SLA or an authorised inspection authority
- For export, a Free Sale Certificate confirming the product is legally manufactured and sold in India
These documents, taken together, confirm that the supplier is operating within India’s formal regulatory framework. Their absence — or the supplier’s inability to produce them on request — is a meaningful red flag.
The Three-Regulator Structure: AYUSH, FSSAI, and CDSCO
One of the most common sources of confusion for international buyers is that India does not have a single regulator for all herbal ingredient-adjacent products. Three different regulatory bodies have jurisdiction, and which one applies depends on the product category and the claims being made:
Ministry of AYUSH: Ayurvedic medicines and traditional herbal formulations
AYUSH jurisdiction covers products classified as Ayurvedic, Siddha, or Unani medicines under the Drugs and Cosmetics Act. This includes classical formulations referenced in the Ayurvedic Pharmacopoeia of India (API) or recognised classical texts, and proprietary Ayurvedic medicines. Products under AYUSH that make therapeutic or health claims are regulated as medicines — meaning the manufacturing license, GMP compliance, and labelling rules are all stricter than the food regulatory equivalent.
For buyers sourcing botanical extracts — Ashwagandha, Boswellia, Turmeric extract, Tulsi, Moringa — the supplier’s primary license is typically an AYUSH manufacturing license if the product is positioned as an Ayurvedic ingredient.
FSSAI: Food supplements, nutraceuticals, and herbal food ingredients
The Food Safety and Standards Authority of India governs products classified as food under the Food Safety and Standards Act 2006. This includes herbal ingredients sold as food supplements or nutraceuticals — products intended for oral consumption that make nutritional or general wellness claims but not disease-prevention or therapeutic claims.
The boundary between AYUSH and FSSAI jurisdiction is the claim. The same botanical extract — Ashwagandha, for example — can be sold by the same Indian manufacturer under both frameworks: as an Ayurvedic ingredient (AYUSH-licensed) to buyers who will make therapeutic use claims, and as a food supplement ingredient (FSSAI-licensed) to buyers who will make general wellness claims.
In May 2024, the AYUSH Ministry issued a directive explicitly prohibiting AYUSH-licensed products from claiming “nutraceutical value” — clarifying that this terminology belongs to the FSSAI regulatory domain. This boundary enforcement is becoming more active, not less. Buyers should be aware that a supplier holding only an AYUSH license may not be the right source for ingredients destined for a product that will be classified as a dietary supplement in the destination market.
CDSCO: Phytopharmaceuticals and pharmaceutical-grade botanical ingredients
The Central Drugs Standard Control Organisation is India’s apex drug regulator for pharmaceuticals, medical devices, and cosmetics. For herbal ingredients, CDSCO’s jurisdiction covers phytopharmaceuticals — a specific category defined in Rule 122E of the Drugs and Cosmetics Rules as “purified and standardised fractions containing a minimum of four bioactive phytochemical compounds of an extract of a medicinal plant for therapeutic use.”
Phytopharmaceuticals are treated as new drugs under Indian law, meaning they require formal drug approval from CDSCO — a higher regulatory bar than either AYUSH or FSSAI licensing. Most botanical extracts sold for supplement use do not meet this definition and are not regulated under CDSCO. But if a buyer is sourcing a highly standardised, pharmaceutical-grade botanical fraction intended for therapeutic applications, the correct regulatory framework is CDSCO, not AYUSH.
CDSCO also regulates herbal cosmetics when imported (requiring Form 42/43 registration), though domestic herbal cosmetics for external use are regulated at the state level.
The 2024 inter-ministerial review
Recognising that the AYUSH/FSSAI/CDSCO boundary generates genuine regulatory uncertainty, the Indian government formed an inter-ministerial committee in early 2024 to assess how these frameworks should be clarified. The committee — comprising representatives from the Ministry of Health, Ministry of AYUSH, Department of Pharmaceuticals, FSSAI, and CDSCO — released recommendations in November 2024 proposing clearer boundaries: simple supplements under FSSAI, high-potency formulations potentially shifting to CDSCO, and botanicals with health claims moving toward AYUSH jurisdiction. These proposals are not yet enacted into law, but they signal the direction of regulatory evolution. Buyers sourcing at scale should monitor these developments, as reclassification could affect the licensing and documentation requirements for specific ingredients.
GMP Requirements: Schedule T, WHO-GMP, and What Buyers Should Require
Good Manufacturing Practice compliance is the central quality requirement for any Indian herbal ingredient supplier operating in regulated global markets. Understanding what each GMP standard actually covers — and which standard your destination market requires — is essential.
Schedule T: The domestic baseline
Schedule T of the Drugs and Cosmetics Rules 1945 is the Indian GMP standard for Ayurvedic, Siddha, and Unani manufacturers. It sets requirements for manufacturing premises location and surroundings, building standards, water supply, waste disposal, container cleaning, raw material storage, finished goods storage, working space, personnel hygiene, machinery, equipment, manufacturing records, and quality control infrastructure. Schedule T GMP is the mandatory baseline for obtaining and maintaining an AYUSH manufacturing license. Without Schedule T compliance, a facility cannot legally operate as an AYUSH manufacturer in India.
For international buyers, Schedule T GMP compliance is a necessary but not sufficient signal. It confirms the supplier is operating within India’s regulatory framework but does not address the specific requirements of your destination market regulator.
WHO-GMP: The international export baseline
WHO-GMP certification — based on World Health Organisation Good Manufacturing Practice guidelines — is the internationally recognised standard that most importing countries require from Indian herbal ingredient exporters. It is issued to Indian Ayurvedic manufacturers after facility inspection confirming compliance with WHO-level quality systems. Many importing country authorities treat WHO-GMP as the minimum credential for granting import clearance to Indian herbal ingredients.
For buyers in the EU, UAE and GCC, Japan, Korea, ANZ, and most other markets where Ayris Global operates, a current WHO-GMP certificate from a credible inspection authority is a baseline documentation requirement. Its absence should be a supplier qualification barrier.
EU-GMP: The pharmaceutical-grade benchmark
EU-GMP — administered by national competent authorities of EU member states — is the most stringent GMP standard applicable to herbal ingredient manufacturers supplying pharmaceutical supply chains in Europe. It requires facility inspection by an EU regulatory authority, a significantly more demanding process than domestic GMP certification. Indian manufacturers holding genuine EU-GMP certification represent a premium tier within the supplier landscape. For ingredients entering European pharmaceutical manufacturing — as opposed to food supplement or cosmetic supply chains — EU-GMP may be required at the point of use.
US FDA registration and cGMP (21 CFR Part 111)
Suppliers exporting to the United States must be registered with the US FDA. For botanical ingredients used in dietary supplements, compliance with 21 CFR Part 111 (Current Good Manufacturing Practice for dietary supplements) is the relevant standard. FDA registration is a registration of a facility’s existence, not an inspection outcome or product approval. Buyers should look for suppliers who can demonstrate cGMP compliance verified by third-party audit from recognised bodies including NSF International, SGS, Bureau Veritas, or Intertek — as this is a more meaningful quality signal than registration alone.
The Ayush Premium Mark: Voluntary quality differentiation
The Quality Council of India (QCI), working with the Ministry of AYUSH, administers a voluntary certification scheme called the Ayush Premium Mark, introduced in 2009. It tests products for identity, purity, strength, and safety against international or national guidelines. As of recent data, very few manufacturers hold this certification — making those who do a genuinely differentiated tier. International buyers who encounter suppliers promoting the Ayush Premium Mark should treat it as a credible positive signal, not standard background noise.
Export Documentation: What to Request Before Placing an Order
A compliant AYUSH-regulated Indian herbal ingredient supplier should be able to produce the following documents without significant delay:
Manufacturing license (Form 25-D) — Issued by the State Licensing Authority. Confirms the facility is legally licensed to manufacture the specific product categories listed.
GMP certificate (Schedule T / WHO-GMP) — Current certificate with valid date. Confirm the issuing body and whether it covers the specific manufacturing operations relevant to your ingredient (extraction, powder processing, encapsulation, etc.).
Certificate of Analysis (COA) — Per batch. Should cover identity verification, assay values for active compounds, heavy metal content, microbial limits, and pesticide residue. Produced from testing at a NABL-accredited laboratory.
Free Sale Certificate (FSC) — Confirms the product is legally manufactured and freely sold in India. Issued by the AYUSH Ministry or the relevant State Licensing Authority. Required by most importing country customs authorities.
Certificate of Pharmaceutical Products (CoPP) — For Ayurvedic drug categories, the CoPP is issued by CDSCO in WHO format. It establishes the product’s regulatory status in India and the applicant’s standing as a legitimate manufacturer. Required by several destination markets for drug category products.
Certificate of Origin — Confirming Indian origin. Required for customs clearance and for access to preferential tariff rates under applicable Free Trade Agreements.
For organic ingredients, two additional documents are mandatory:
NPOP certificate — The supplier’s organic certification under India’s National Programme for Organic Production, issued by an APEDA-accredited Certification Body. Confirms the ingredient meets NPOP organic production standards.
Transaction Certificate (TC) — Per shipment. Mandatory under the updated NPOP framework (DGFT Public Notice 39/2024-25, effective from July 2025). Issued through APEDA’s Tracenet system. Without a TC, a shipment cannot be exported as certified organic.
Organic Certification: NPOP, USDA NOP, and What the Equivalence Agreement Actually Means
India’s organic certification system for export is administered by APEDA (Agricultural and Processed Food Products Export Development Authority) under the National Programme for Organic Production (NPOP). NPOP sets standards for organic cultivation, harvesting, processing, and handling of agricultural products including medicinal herbs and botanical ingredients.
What NPOP covers and what it does not
NPOP certification covers the agricultural production of the raw plant material — it confirms the source herbs were grown without synthetic pesticides, chemical fertilisers, or genetically modified organisms under a certified organic system. It does not certify the manufacturing process at a processing or extraction facility independently; that is addressed by GMP certification. A claim of “organic ashwagandha extract” from an Indian supplier involves two distinct certification streams: NPOP organic certification for the raw herb, and GMP certification for the extraction process.
EU equivalence: What it means and its limits
India and the European Union have a bilateral equivalence agreement under which NPOP certification is recognised as equivalent to EU organic standards. This is commercially significant: NPOP-certified Indian organic botanical ingredients can enter the EU organic supply chain — and be labelled as organic in EU markets — without separate EU organic certification. This reduces compliance cost and process complexity for EU-bound organic ingredient buyers considerably.
Two important limits apply. First, equivalence applies to unprocessed and processed organic plant products within the scope of the agreement — buyers should confirm their specific ingredient category is covered. Second, the EU now requires Transaction Certificates for every batch under the EU 2018/848 regulation, which aligns with India’s own TC requirement under the updated 2025 NPOP framework.
US market: Separate NOP certification required
NPOP certification is not recognised as equivalent to the USDA National Organic Program for the United States market. While India and the US have a limited MoU covering certain unprocessed plant-based products, the NOP equivalence is narrower than the EU arrangement and does not extend to processed botanical ingredients as a general rule. Indian suppliers targeting US organic buyers require separate USDA NOP certification from a USDA-accredited Certifying Agent — a distinct process with its own inspection, documentation, and annual renewal requirements.
Buyers sourcing for multiple markets — EU and US, for example — should specifically ask whether their supplier holds both NPOP and USDA NOP certification, or only one. Many Indian suppliers have prioritised the EU market and hold NPOP but not NOP.
Jurisdiction Decision Map: Which Regulator Applies to Your Ingredient
The following framework helps buyers determine which Indian regulatory authority is most relevant to the specific ingredients they are sourcing:
Ingredient is a classical Ayurvedic formulation (tablet, powder, extract) referenced in the Ayurvedic Pharmacopoeia of India — Primary regulator: AYUSH. Supplier should hold Form 25-D manufacturing license from State Licensing Authority.
Ingredient is a botanical extract or herb powder destined for dietary supplement or nutraceutical use in the destination market — Primary regulator: FSSAI (if marketed without therapeutic claims) or AYUSH (if marketed with traditional medicine or therapeutic claims). Many suppliers hold both licenses; confirm which is relevant for your intended use.
Ingredient is a highly standardised botanical fraction with defined minimum levels of multiple bioactive compounds, intended for pharmaceutical use — Primary regulator: CDSCO (phytopharmaceutical under Rule 122E). Higher documentation burden; fewer Indian manufacturers operate in this category.
Ingredient will be used in a cosmetic product for external use — Primary regulator: State drug/cosmetic authority for domestically manufactured products; CDSCO for imported cosmetics.
Common Compliance Gaps Buyers Discover in Due Diligence
Based on the documentation requirements above, the most common gaps that emerge when buyers conduct proper supplier due diligence on Indian herbal ingredient manufacturers include:
Certificates that have expired but are still being presented as current. GMP and organic certificates have validity periods and require renewal following re-inspection. Always check the issue date and expiry date on the certificate face, and cross-reference with the issuing body’s records.
WHO-GMP certificates issued for one product category or facility area that are being presented as covering a broader range of manufacturing activities. The certificate should specify the scope of manufacture it covers.
NPOP certificates without accompanying Transaction Certificates for individual shipments. The TC is now a mandatory per-shipment document under the 2025 NPOP framework — a NPOP scope certificate alone is not sufficient to export a specific consignment as organic.
Free Sale Certificates that are outdated or cover only a subset of the products being supplied. FSCs should be current and specific to the product being exported.
NABL-accredited lab test reports that are not batch-specific. COAs should reference the specific batch or lot being supplied, not be generic product-level documents.
Sourcing verified, document-complete Indian herbal ingredient suppliers? Ayris Global works exclusively with producers who hold the licensing and certification relevant to your destination market and can provide complete, current documentation on request. Contact our sourcing team or view our quality standards.
Documentation Checklist by Market
| Market | Minimum documentation to request |
|---|---|
| European Union | Form 25-D license, WHO-GMP, COA (NABL), FSC, CoPP, NPOP + TC for organic |
| United States | Form 25-D license, WHO-GMP, FDA facility registration, cGMP audit (third party), COA, FSC, USDA NOP for organic |
| UAE / GCC | Form 25-D license, WHO-GMP, COA, FSC, Certificate of Origin (for CEPA preference), Halal cert (ESMA-recognised body) |
| United Kingdom | Form 25-D license, WHO-GMP, COA, FSC, Certificate of Origin |
| Japan | Form 25-D license, WHO-GMP, COA, FSC; additional MHLW-specific documentation depending on classification |
| South Korea | Form 25-D license, WHO-GMP, COA, FSC; MFDS import requirements vary by product category |
| Australia / NZ | Form 25-D license, WHO-GMP, COA, FSC; TGA requirements for therapeutic goods classification |
| Southeast Asia | Form 25-D license, WHO-GMP, COA, FSC; destination-country regulator requirements vary significantly |
| Latin America | Form 25-D license, WHO-GMP, COA, FSC; ANVISA (Brazil) and COFEPRIS (Mexico) specific requirements |
Summary
The AYUSH Ministry, FSSAI, and CDSCO form a three-part regulatory architecture for Indian herbal ingredients. Understanding which regulator applies to your specific ingredient — and which documents flow from that regulatory relationship — is the foundation of effective supplier due diligence. GMP compliance is the manufacturing quality baseline; WHO-GMP is the international export credential. Organic certification via NPOP is recognised in the EU but requires separate USDA NOP certification for the US market. Free Sale Certificates, batch-specific COAs, and Transaction Certificates for organic shipments are non-negotiable documentation requirements for legitimate international trade.
The Indian herbal ingredient sector has a formal, government-backed regulatory infrastructure. Buyers who understand it are better positioned to ask the right questions, verify the right documents, and identify suppliers who are genuinely compliant from those who are presenting an appearance of compliance.
Frequently Asked Questions
What is the AYUSH Ministry and why does it matter for ingredient sourcing?
The Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy) is the Indian government body that regulates the manufacture, sale, and export of Ayurvedic and traditional herbal medicines. Established in November 2014, it sets national quality standards and oversees the licensing framework administered by State Licensing Authorities. For international buyers, AYUSH Ministry oversight means your Indian supplier’s manufacturing license, GMP certificate, and export documentation trace back to a formal government regulatory authority.
What is the difference between Schedule T GMP and WHO-GMP for Indian herbal suppliers?
Schedule T is the Indian domestic GMP standard for Ayurvedic, Siddha, and Unani manufacturers under the Drugs and Cosmetics Rules 1945. WHO-GMP is the internationally recognised certification that most importing countries require as a baseline for import clearance. Schedule T compliance is mandatory to obtain a manufacturing license in India; WHO-GMP is the international credential built on top of that domestic compliance and is what destination market regulators and buyers typically require as documentation.
Which Indian regulator — AYUSH, FSSAI, or CDSCO — covers herbal ingredients I am sourcing?
Jurisdiction depends on how the finished product will be classified in the destination market. Raw botanical ingredients and Ayurvedic formulations with therapeutic claims fall under AYUSH. Herbal ingredients sold as food supplements or nutraceuticals without disease claims fall under FSSAI. Phytopharmaceuticals — standardised plant-based fractions meeting the definition in Rule 122E of the Drugs and Cosmetics Rules — fall under CDSCO. Many Indian ingredient suppliers hold compliance documentation across more than one regulator.
What documents should I request from an AYUSH-licensed Indian herbal ingredient supplier?
At minimum: the manufacturing license (Form 25-D from the State Licensing Authority), a current WHO-GMP certificate, a batch-specific Certificate of Analysis from a NABL-accredited laboratory, a Certificate of Origin, and a Free Sale Certificate. For organic ingredients, the NPOP scope certificate and a Transaction Certificate for the specific shipment are additionally required. For UAE and GCC markets, Halal certification from an ESMA-recognised body is also necessary.
Is NPOP organic certification from India recognised in the EU and USA?
NPOP is recognised as equivalent to EU organic standards under a bilateral agreement, meaning NPOP-certified Indian organic ingredients can enter the EU organic supply chain directly. NPOP is not recognised as equivalent to the USDA National Organic Program. Indian suppliers targeting US organic buyers require separate USDA NOP certification from a USDA-accredited certifying agent. Under India’s updated 2025 NPOP framework (DGFT Public Notice 39/2024-25), a Transaction Certificate is now mandatory for every organic export shipment.
Related Reading: GMP, ISO, FSSAI, and Organic Certification: A Buyer’s Guide · CoA, MSDS and Phytosanitary Certificates Explained · How to Evaluate an Indian Herbal Ingredient Supplier
Ayris Global connects international buyers with verified, document-complete Indian herbal ingredient suppliers. To discuss regulatory compliance requirements for your sourcing programme, contact us at sourcing@ayrisglobal.in or visit our For Buyers page.
