Ayurvedic medicine export from India documents and rules
Ayurvedic medicine export from India needs Indian authorisation and destination compliance. Check IEC, COPP requirements and the role of Ayush EXCIL.
Ayurvedic medicine export from India requires the appropriate manufacturing authorisation and an Importer Exporter Code (IEC), unless exempt, plus destination compliance. A Certificate of Pharmaceutical Product (COPP or CPP), where required, does not replace the importing regulator's requirements.
Confirm good manufacturing practice (GMP) requirements with the competent licensing authority for the manufacturing location. Delhi's Drug Control Cell, for example, lists manufacturing-licence and GMP-certificate applications separately.
Establish the product's status in the destination
Before applying for certificates, identify the exact formulation, intended use, proposed claims and destination. Ask the importer to confirm the applicable product category with the destination regulator. Don't assume that Indian authorisation settles how another country will classify the product. FDA, for example, classifies products by their intended use, including disease claims, rather than accepting a supplement label alone. FDA guidance
Keep two questions separate: can the product be manufactured under its Indian authorisation, and can that formulation be sold with those claims abroad? A certificate under the WHO scheme provides information about a pharmaceutical product. It does not replace the importing authority's requirements. WHO certification scheme
Separate the Indian export documents
Ayurvedic medicine exporters should distinguish each document's purpose before assembling an application. A membership certificate, manufacturing licence and product certificate answer different questions.
| Document or process | Role | What it does not replace |
|---|---|---|
| Manufacturing authorisation and GMP certification | Address manufacturing licensing and good manufacturing practices through the competent authority. Delhi example | Destination market authorisation. |
| Importer Exporter Code (IEC) | DGFT requires it for exports unless specifically exempted. IEC guidance | A manufacturing licence or foreign product approval. |
| COPP/CPP | Provides product certification under the WHO scheme, where required by the destination. WHO guidance | The importing regulator's approval. |
| Registration-cum-Membership Certificate (RCMC) | Records registration with an authorised council or other registering authority. DGFT guidance | Manufacturing authorisation or destination drug approval. |
Identify the licensing authority for the manufacturing location. Delhi's Directorate of AYUSH, for example, lists Form 24-D for a manufacturing-licence application and Form 24-E for a loan-licence application. It separately lists Form 24 E-I for a GMP-certificate application and directs applicants to e-AUSHADHI. Use these Delhi instructions only for that jurisdiction. Delhi Drug Control Cell
Use the official e-Aushadhi portal as a starting point for licence-related services. Confirm the application requirements with the competent authority rather than treating another state's instructions as your own.
For the IEC, DGFT says the code corresponds to the firm's PAN but is separately issued on application. Having a PAN alone is therefore not the same as having an issued IEC. DGFT IEC guidance
When does an Ayurvedic exporter need a COPP?
Check the destination regulator's requirements before applying. Ask which product category needs a certificate, which issuer it accepts and what the certificate must cover. WHO calls its certification scheme an international voluntary agreement. That does not mean an importing country cannot require a CPP for registration. WHO certification scheme
National authorities issue these certificates. WHO does not endorse each certified product. Do not describe a COPP as proof that an Ayurvedic medicine is "WHO-approved." WHO scheme guidance
CDSCO maintains a COPPs for Ayurvedic Products section. Historical holder and product lists do not prove that a company has a current certificate for your formulation. Request the actual certificate and check its validity and the importing regulator's acceptance conditions. Confirm the current application route with the authorities before submission.
An old holder list cannot settle those questions. Nor should it become a supplier ranking or a substitute for checking the named product.
What Ayush EXCIL does
Ayushexcil, the Ayush Export Promotion Council, supports export promotion through activities including buyer-seller meetings, training and representation to government. Its RCMC role is also connected to access to government schemes. These functions do not make council membership a manufacturing licence or permission to sell abroad. Council guidance
For membership, the council directs applicants to DGFT's e-RCMC system and the "Ayush Export Promotion Council" selection. DGFT requires an active IEC for an RCMC application. Applicants declare their mainstream business and apply to the relevant registering authority. Ayushexcil application page, DGFT e-RCMC guidance
Check whether RCMC is needed for the scheme or benefit you intend to use. Don't treat the existence of an RCMC process as proof that every shipment requires one.
Exporting Ayurvedic medicines to the United States
Classification comes first. FDA explains that dietary supplements are ingested products intended to supplement the diet. A product intended to treat, diagnose, cure or prevent disease is a drug, even if its label calls it a supplement. Removing a disease claim alone does not establish that every formulation or ingredient is lawful. FDA supplement guidance
FDA's warning page, dated 2 December 2025, states: "There are no FDA-approved ayurvedic products." It warns about heavy-metal poisoning associated with certain unapproved Ayurvedic drug products. That statement is not a ban on every botanical ingredient. FDA warning
If the product lawfully follows the food or supplement route, assess food-facility registration and shipment prior notice with the US importer. Check applicable exemptions too. FDA describes biennial renewal for facilities required to register, but registration is not product approval. This overview does not replace a product-specific ingredient, labelling and import compliance review. FDA facility and submission guidance
Before committing to shipment, ask the importer to confirm the product category and required certificates with the destination regulator. Resolve any uncertainty about the accepted certificate issuer before applying. Check the actual certificate for the named product, rather than relying on a historical holder list.
RegAffairs AI's answer on exporting Ayurvedic medicines from India covers COPP and the US example.