Classify the Product Before Choosing Certification
The same plant can enter several regulatory categories. A preparation treating disease may qualify as a medicine, whereas a botanical beverage generally follows food rules. A cream promoted for cleansing or beautifying can fall under cosmetics legislation. Ingredients alone do not settle classification; intended use, formulation, claims and applicable definitions matter.
West Bengal businesses should document the product’s purpose, composition, dosage form and proposed label before certification. This prevents an ISO certificate intended for food production from being mistaken for authorisation to manufacture Ayurvedic medicines.
Producers of raw herbs and extracts face another distinction. Supplying botanical ingredients to an overseas manufacturer may require specifications and traceability different from those for finished consumer products. Consequently, certification scope should identify operations and products, not simply describe the business as herbal.
Meet Indian Licensing Requirements First
Statutory licensing and voluntary certification serve different purposes. A statutory licence grants permission under applicable law. A standard specifies requirements; certification confirms conformity within scope; accreditation establishes the competence of a laboratory or certification body for specified activities.
Ayurvedic Medicines and Domestic GMP
The Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945, regulate relevant Ayurvedic, Siddha and Unani medicines. Manufacturers require the applicable authorisation from the competent licensing authority. Schedule T addresses Good Manufacturing Practices for these medicine categories, including premises, sanitation, materials, production controls, personnel and records.
West Bengal applicants should follow the competent state licensing process. The Ministry of Ayush’s e-AUSHADHI system opened fresh applications for Ayurveda, Siddha, Sowa-Rigpa and Unani licences in April 2026 and issued mandatory processing instructions in June. Existing licence holders also have a legacy-record process. Manufacturers should follow the current portal instructions rather than rely on superseded filing methods.
Herbal Foods and Cosmetics
Herbal teas, eligible supplements and nutraceuticals may fall under the Food Safety and Standards Act, 2006, with the relevant FSSAI licence and product regulations. Ayurveda Aahara has specific regulations; those provisions exclude Ayurvedic medicines and certain other categories.
Meanwhile, cosmetic products follow the Drugs and Cosmetics Act and Cosmetics Rules, 2020, including relevant manufacturing and quality controls. An Ayurvedic medicine licence does not automatically cover a herbal face cream or food supplement. Likewise, FSSAI permission cannot replace a medicinal manufacturing authorisation.
Use GMP as the Manufacturing Foundation
Good Manufacturing Practice requires manufacturers to control how they receive materials, produce batches, clean equipment, investigate defects and release finished products. For herbal medicines, botanical variability makes accurate identity checks important.
Domestic GMP Compared With WHO Expectations
Schedule T governs applicable Indian Ayurvedic medicine manufacturing requirements. The World Health Organization separately publishes GMP guidance for herbal medicines addressing botanical materials, cross-contamination, sanitation, documentation and quality control. WHO guidance can inform international buyer expectations, but WHO does not automatically issue certificates to every factory following its recommendations.
A manufacturer claiming WHO-GMP conformity should identify the certifying or inspecting authority, applicable criteria and certificate scope. Where an eligible product requires a Certificate of Pharmaceutical Product for export purposes, its issuing procedure and supporting manufacturing evidence must be checked separately. Neither that certificate nor GMP documentation guarantees admission to every overseas market.
Compare AYUSH Quality Certification Marks
The Quality Council of India’s voluntary AYUSH product certification scheme distinguishes two levels. The AYUSH Standard Mark reflects compliance with applicable domestic regulatory requirements. The AYUSH Premium Mark adds criteria aligned with WHO GMP and relevant product quality expectations.
An eligible manufacturer should check which products appear within the certification scope. A certificate for one formulation does not automatically cover the entire factory’s catalogue, and neither mark substitutes for government licensing.
The Separate Ayush Quality Mark Programme
The Ayush Quality Mark initiative launched in December 2025 and operates through the Ayush Export Promotion Council. Its identified categories include medicinal products, botanicals, herb cultivators and certain AYUSH services.
The programme is distinct from the earlier Standard and Premium marks. Under its published criteria, the Premium Mark can support eligibility for recognition of covered products, whereas the Standard Mark alone does not establish that eligibility. Applicants should inspect the specific product-category criteria and authorised mark-use agreement before claims. Recognition under this voluntary programme does not itself constitute foreign regulatory approval.
Which ISO Standards Are Relevant?
ISO standards address different management systems or technical activities. Their relevance depends on the product and the proposed certification scope, and manufacturers should not present them all as mandatory.
ISO 9001: Quality management processes, supplier assessment, customer requirements, corrective actions and internal review across eligible businesses.
ISO 22000: Food safety management for relevant herbal foods, beverages and supplements, including hazard controls and traceability.
ISO 22716: Good Manufacturing Practices for cosmetics, particularly herbal personal care products.
ISO 14001: Environmental management of resources, waste and operational impacts.
ISO 45001: Occupational health and safety management for processing and manufacturing workplaces.
ISO/IEC 17025: Competence of testing laboratories for defined analytical methods and measurements.
ISO 9001 certifies a management system, not every bottle or formulation. Similarly, ISO 22000 does not replace an FSSAI licence, while ISO 22716 does not authorise medicinal production.
ISO/IEC 17025 usually concerns laboratory accreditation rather than manufacturer-wide product certification. A herbal business using an accredited laboratory should verify that its accreditation scope actually includes the required analytical method and matrix. A laboratory’s general accreditation claim cannot establish that every possible herbal test falls within its recognised competence.
Apply HACCP and Botanical Sourcing Controls
For herbal foods, Hazard Analysis and Critical Control Points helps identify hazards during drying, grinding, extraction, blending and packaging. ISO 22000 incorporates food safety management principles, including hazard analysis, but HACCP implementation and ISO certification are not identical activities. Neither is universally mandatory for every Ayurvedic medicine or cosmetic.
Good Agricultural and Collection Practices can strengthen medicinal plant sourcing. Correct species identification, suitable harvesting methods, responsible agricultural inputs and appropriate drying conditions reduce the risk of substitution or contamination.
Supplier documentation should trace material from cultivation or collection through processing and delivery. Because manufacturers cannot always remove pesticides, mould toxins or misidentified plant material during final production, incoming quality control deserves attention before production.
Test Herbal Ingredients and Finished Products
Testing requirements depend on the product category, standards, destination and contract. Manufacturers should establish specifications that match intended use rather than commission the same testing panel for every product.
Relevant assessments may include:
Botanical identity: Authentication and checks for substitution, adulteration or incorrect plant parts.
Heavy metals: Suitable assessment for lead, arsenic, cadmium and mercury where applicable.
Microbiological quality: Testing related to contamination and hygienic manufacturing.
Pesticide residues: Evaluation linked to cultivation and supply-chain risks.
Aflatoxins and other mycotoxins: Assessment where drying or storage presents fungal hazards.
Residual solvents: Relevant checks for materials prepared through solvent extraction.
Marker compounds: Analytical measures supporting consistency between suitable batches.
Stability: Evidence for storage conditions and proposed shelf life.
There is no universal contaminant limit for every herbal product and destination. Therefore, laboratories and quality teams must select the applicable legal or contractual specifications. A Certificate of Analysis reports results for a sample; it does not prove manufacturing authorisation or automatically certify all future batches.
Assess Export Rules Country by Country
Export readiness involves more than obtaining a domestic licence or an ISO certificate. Importing countries may classify the same preparation differently according to ingredients, therapeutic claims, dosage form and intended use.
United States and European Markets
In the United States, the Food and Drug Administration applies different requirements to dietary supplements, foods, cosmetics and drugs. FDA facility registration is not proof of product approval. Moreover, ordinary dietary supplements generally do not receive FDA premarket approval, although other notification and safety obligations may apply.
Within the European Union, herbal medicines may face medicinal authorisation or registration requirements, while supplements and cosmetics follow different regimes. Ordinary herbal cosmetics do not acquire CE marking merely because they contain botanical ingredients. Businesses selling cosmetics in Great Britain must also assess its separate responsible-person and notification rules.
Gulf Markets and Export Documents
Gulf destinations can impose product registration, labelling and importer obligations. One country’s acceptance should not be extended automatically to another.
Depending on product classification and destination, exporters may prepare manufacturing licences, Certificates of Analysis, product specifications, certificates of origin, batch records, GMP documentation or relevant pharmaceutical certificates. The importing authority and buyer determine which additional records matter. An Indian export registration cannot replace an importing country’s market-entry requirements.
When Does Organic Certification Matter?
Organic certification concerns defined agricultural production and handling controls. It can be relevant to medicinal plants, herbal teas, botanical ingredients and qualifying processed products, particularly where purchasers request organic sourcing.
India’s National Programme for Organic Production provides standards and certification arrangements administered through recognised bodies. Overseas acceptance depends on applicable recognition arrangements and destination-specific import rules.
Organic operators should maintain cultivation records, input declarations, traceability and separation between qualifying and non-qualifying material. An organic mark does not prove therapeutic effectiveness, replace contaminant testing or authorise herbal medicines. Moreover, an organically grown herb can still deteriorate through poor drying or unsuitable storage.
Prepare for Certification Audits and Ongoing Costs
Manufacturers should select certification only after defining product classification, statutory permissions and the desired scope. A gap assessment can then compare existing procedures with the chosen requirements.
Common preparation records include:
Applicable manufacturing licences and site details.
Product and raw material specifications.
Supplier assessment, purchasing and traceability records.
Cleaning, production and equipment maintenance procedures.
Batch documentation, laboratory reports and corrective actions.
Staff training, internal audits and complaint or recall procedures.
An appropriate certification body reviews the evidence and follows its scheme’s assessment process. Depending on the findings, applicants may need to correct nonconformities before certification. Subsequent surveillance or reassessment supports continued conformity.
Costs depend on scheme, scope, facility size, audit complexity, testing and corrective work. Certificate validity also varies, so manufacturers should obtain clear written confirmation from the responsible certification body instead of assuming a universal renewal cycle.
Prevent Misleading Claims and Choose Suitable Support
Common errors include displaying a certificate beyond its stated scope, treating laboratory accreditation as product approval and claiming that international marks guarantee exports. Businesses should verify the issuing body’s accreditation, certificate status, certified locations and covered products before using logos in marketing.
For regulated Ayurvedic medicines, an ayurvedic licence consultant in west bengal may assist with product classification, manufacturing documentation, licensing procedures and certification preparation. However, professional assistance cannot guarantee a statutory licence, certification decision or foreign regulator’s acceptance.
Conclusion
Herbal businesses in West Bengal should establish the correct product category and Indian manufacturing permissions before selecting international quality certifications. GMP, AYUSH marks, ISO systems, laboratory testing, and organic certification address different concerns, so one certificate cannot substitute for the others. Exporters must also match product documentation and claims to each destination’s rules. The soundest certification choice is one whose verified scope meets an actual regulatory requirement, technical risk or buyer expectation.
FAQs
1. Which international certifications suit herbal businesses in West Bengal?
Suitable standards depend on business activity. ISO 9001 addresses quality management, ISO 22000 supports food safety systems, and ISO 22716 concerns cosmetic manufacturing practice. Ayurvedic medicine manufacturers may consider relevant AYUSH marks and GMP recognition. Each business should confirm its product category, certification scope and buyer requirements first.
2. Is ISO certification compulsory for Ayurvedic medicine manufacturers?
No universal ISO certification requirement applies simply because a business manufactures Ayurvedic medicines. Applicable Indian manufacturing licences and Schedule T GMP obligations remain the primary regulatory concerns. Certain customers or overseas arrangements may additionally request specific ISO certification. Manufacturers should distinguish contractual expectations from legal requirements before investing in assessment.
3. How does domestic GMP differ from WHO-GMP guidance?
Domestic Schedule T requirements apply to relevant Ayurvedic, Siddha and Unani medicine manufacturing in India. WHO guidance addresses international quality principles for herbal medicines, including botanical materials and manufacturing controls. Following WHO recommendations does not mean WHO has certified the factory, nor does it automatically establish permission to export medicines.
4. How do AYUSH Standard and Premium marks differ?
The voluntary AYUSH Standard Mark reflects applicable domestic regulatory compliance, while the Premium Mark requires additional quality criteria aligned with WHO GMP and relevant product requirements. Certification covers specified products and activities. Neither mark replaces statutory licensing, and an importing country may still require separate approval, documentation or testing.
5. Which ISO standard applies to herbal food supplements?
ISO 22000 often suits businesses seeking certification of their food safety management systems. Its relevance depends on whether the products legally qualify as foods or supplements and on the proposed scope. HACCP-based controls and FSSAI obligations remain important; ISO certification alone cannot authorise manufacture or sale.
6. Is an Indian Ayurvedic licence sufficient for exporting medicines?
No. An Indian manufacturing licence addresses domestic legal authorisation, while importing countries apply their own product classification and market-access rules. Exporters may need additional approvals, GMP evidence, product specifications or pharmaceutical certificates. The destination authority’s requirements should shape preparations before packaging, labelling or shipment arrangements become final.
7. What laboratory tests may international herbal buyers request?
Depending on the product and destination, buyers may request botanical authentication, heavy metal analysis, microbial testing, pesticide residues, mycotoxins, solvent residues or stability information. Relevant limits and analytical methods vary. Manufacturers should agree specifications before testing and verify that the selected laboratory can perform the required methods competently.
8. Does organic certification replace GMP and product safety testing?
No. Organic certification addresses specific cultivation, sourcing and processing controls within a defined scheme. GMP regulates manufacturing practices, while laboratory tests assess relevant product characteristics and contaminants. An organically certified ingredient can still require identity checks, hygienic handling and appropriate testing before use in medicines, foods or cosmetics.
9. How can manufacturers verify a certification body’s credentials?
They should check the body’s current accreditation, the relevant accreditation organisation, the precise scheme and the scope of authorised certification. Certificate identifiers, site details and validity should also match the applicant’s claims. Accreditation for one management system does not establish permission to certify unrelated products, laboratories or processes.
10. What should a herbal manufacturer check before applying for certification?
First establish the product’s legal classification, manufacturing authorisation and relevant Indian standards. Next identify the intended market, buyer expectations and certification scope. Review supplier controls, batch records, testing arrangements and staff competence. Finally, verify the certification body’s authority, likely costs and the continuing obligations that follow successful assessment.
