A Complete Guide for Indian API Exporters and Pacific Pharma Buyers
Vanuatu sits at a unique regulatory intersection in 2025-2026.
It has no functioning National Regulatory Authority (NRA) to formally register pharmaceutical products, yet it has a Ministry of Health actively managing medicine procurement.
A National Drug and Therapeutics Committee oversees its Essential Drugs List[1] , and as of July 2024, a new ASYCUDA Pharmaceutical Module is digitising medicine import administration.
For Indian API suppliers seeking to enter this market, understanding the difference between what Vanuatu has and what it lacks and how to work within that gap It is the most critical commercial intelligence available.
This blog provides exactly that, with verified regulatory data current to 2025-2026.
Vanuatu’s Pharmaceutical Regulatory Architecture What Exists and What Doesn’t
Vanuatu’s pharmaceutical regulatory framework is real, but it operates with significant structural gaps.
Before any Indian API exporter or Pacific pharma buyer can navigate this market, they must map exactly which bodies exist, what authority they hold, and where the system’s technical limits begin.
The Three Regulatory Bodies and Their Roles
Vanuatu’s pharmaceutical sector operates through three overlapping bodies:
| Regulatory Body | Primary Role | Regulatory Power |
| VMPS (under MoH) | Regulation of medicine and monitoring of compliance | High implementing authority |
| NDTC | NEDL oversight and promotion of rational drug use | Advisory policy guidance |
| Pharmacy and Poisons Board | Approval for imports and pharmacy licenses | Moderate registration and licensing |
Together, they form Vanuatu’s pharmaceutical regulatory framework, yet none individually replicates the full technical capacity of a classical NRA.
The Critical Gap: No Full NRA Capacity
Though the VMPS and Pharmacy and Poisons Board exist, Vanuatu lacks the ability to fully evaluate pharmaceutical products and conduct the same functions of a formal NRA.
Vanuatu lacks a trained workforce for evaluation, lacks a batch-testing laboratory, and lacks any means to detect substandard or falsified medicines within the country.
The absence of this capability was acknowledged at the 2019 WHO Pacific Regulatory Meeting[2].
The Vanuatu panelists then noted there was no capability to detect or verify the presence of substandard or falsified medicines in Vanuatu, and that any testing for such would need to be done in Australia by way of costly testing that is done only when requested.
There is a persistent workforce crisis, and the Vanuatu Medical Supply System Study[3] (University of Canberra/UNFPA) identified that “… the low numbers and poor skills of pharmacy staff” was one of the factors contributing to the problems of “constructing a reliable medical supply system”.
Frequent staff turnover means that Vanuatu’s capacity to regulate the sector relies on external systems beyond the country’s reach and means.
The National Essential Drugs List (NEDL):
For API suppliers, Vanuatu’s NEDL is the most significant document in the country’s pharmaceutical system.
It is developed and maintained by the NDTC, and it indicates which medicines are officially procured by Vanuatu’s health system. Thus, the NEDL provides a direct procurement opportunity for APIs.
Although Vanuatu’s NEDL (the most recent publication was in 2014)[4] is routinely updated during the NDTC meetings, it is designed to be in close alignment with the WHO Essential Medicines List.
It also considers Vanuatu’s burden of NCDs and communicable diseases.
Therefore, Vanuatu’s NEDL is included in the list of APIs available for procurement of antidiabetics, antimalarials, cardiovascular medicines, anti-infectives, and anti-TB APIs.
Vanuatu’s NEDL includes a wider role for the NDTC beyond mere listing.
According to the description of the function of the Vanuatu Ministry of Health Principal Pharmacist, the NDTC is also responsible for the following National Medicines Policy priorities and key indicators in all health facilities:
For API suppliers, these indicators are of primary concern.
Stock-out days and NEDL prescribing are the most direct indicators of supply gaps and the most consistent procurement demand for APIs.
| Micro-Summary: Vanuatu has three pharma regulatory bodies, VMPS, NDTC, and the Pharmacy and Poisons Board, but no full NRA capacity. No dossier reviewers, no QC lab, high staff turnover. The NEDL is the commercial gateway: APIs aligned to it have a direct procurement pathway. WHO-GMP and WHO-PQ are the de facto quality standards. The system relies on supplier documentation, not in-country verification. |
The Regulatory Barriers- What Actually Stops API Suppliers from Entering Vanuatu
When it comes to Vanuatu’s regulatory gaps, they are not just administrative; there is also a commercial aspect.
These four documented barriers represent the real obstacles that Indian API exporters and Pacific pharma buyers must understand and navigate in 2025-2026.
Barrier 1: No Formal Product Registration System
Unlike PNG (which has the PSSB under the Medicines and Cosmetics Act 1999), Vanuatu has no formal product registration database or approval certificate system for APIs or finished medicines.
A supplier cannot ‘Register’ an API in Vanuatu in the traditional regulatory sense.
Instead, medicines enter via import waivers assessed against WHO-GMP certification and NEDL alignment. This creates legitimate doubt:
Suppliers who are used to more controlled API registration processes in larger, more regulated markets are used to a fundamentally different system that favors formal dossier submission over the preparation of documentation.
Barrier 2: WHO-GMP Is the Gate, But Verification Capacity Is Absent
WHO-GMP certification is a de facto standard for quality in Vanuatu, and the Ministry of Health benchmarks WHO Prequalification for import clearance quality assessment.
However, Vanuatu has no in-house capacity to:
The system relies entirely on the exporting country’s certification, making supplier reputation and documentation quality the only practical quality assurance mechanism available to Vanuatu buyers.
Verification Capability Status in Vanuatu Certificate of Analysis review No independent lab capacity Manufacturing site inspection Not conducted no inspectors WHO-GMP certificate verification Relies on originating country certification Substandard/falsified medicine detectionNo in-country capacity Batch testing External (Australia) high cost, rarely conducted
Barrier 3: Fragmented Procurement: Small Orders, Intermediary Dependency
Vanuatu’s small population (approximately 340,000) means pharmaceutical order volumes are tiny by global standards. This creates a domino effect of challenges for procurement:
Barrier 4: Regulatory Staff Capacity and Continuity
In Vanuatu, one individual occupies multiple positions: the head of the NDTC, the head of procurement, the supervisor of provincial pharmacies, the compliance officer, and the liaison officer for pharmaceutical suppliers.
This creates a situation where high turnover in this role means there is less knowledge of the regulatory processes and inconsistency in communications and timelines for approvals for Indian API suppliers who want to establish a long-term relationship in the Vanuatu market.
At the WHO DPS Subregional Regulatory Meeting in February 2023, Pacific Member States said that the inability to develop sustainable regulatory authorities in most PICs was due to inadequate human and financial resources, and that this was the reason why the WHO subregional regulatory platform was created (WHO WPRO / WHO DPS Subregional Regulatory Meeting, February 2023).
For API suppliers, the situation is problematic. There is no system to cope with the disruption of the regulatory staff.
The person who approves the product may be one person, and the person who deals with procurement and compliance may be someone else, and there may be no memory system to cope with this disruption.
| Summary: Four real barriers block API export to Vanuatu: no formal product registration, absent WHO-GMP verification capacity, fragmented small-order procurement, and high regulatory staff turnover. What’s Next?: Now that we’ve established the barriers Indian API exporters face, let’s examine what these regulatory gaps mean in direct human health terms and why the solution matters urgently. |
What Regulatory Gaps Mean for Medicine Access in Vanuatu
Regulatory opacity leads to failure of access to medicine.
When there are no regulations, there are associated problems in accessing medical care.
It can be clearly seen that Vanuatu lacks regulations, and this negatively impacts people’s lives.
The Lancet Western Pacific 2024[5] studied the reasons why patients in Pacific lower-middle-income countries, such as Vanuatu, are unable to access essential medicines.
Heavily fragmented procurement, coupled with disorganized and poorly established quality import controls, is the cause.
The Access to Medicine Foundation (September 2025) confirms that no insulin or diabetes medicines have been formally registered in Vanuatu by any major manufacturer.
This means Vanuatu’s diabetes patients, in a country where diabetes is a leading NCD cause of death, depend entirely on ad hoc import waiver procurement for their lifelong daily medication.
This is not a theoretical regulatory problem. It is a documented access failure:
Now that the stakes are clear, let’s move to the practical solution: the step-by-step API export pathway that works within Vanuatu’s regulatory system as it actually exists.
| Micro-Summary: The human consequence: low essential medicine availability, no formally registered insulin, and patients dependent on ad hoc import waivers. The system is navigable, but only with the right documentation strategy and partner relationships. Now that the stakes are clear, let’s move to the practical solution: the step-by-step API export pathway that works within Vanuatu’s regulatory system as it actually exists. |
The Practical Pathway for Indian API Suppliers Entering Vanuatu
The entry path for Indian API suppliers is not ‘registration’; it is qualification through the WHO-GMP import waiver pathway.
Given Vanuatu’s regulatory architecture, this 5-step process works with the system as it actually exists in 2025-2026.
5-Step API Entry Pathway for Vanuatu (2025-2026)
Step One : NEDL Alignment
Identify which APIs correspond to Vanuatu’s National Essential Drugs List (NEDL). Products on the NEDL can be ordered directly from the NDTC.
Important APIs are:
Step Two : Verification of WHO-GMP Certification
It is mandatory to submit and verify the valid WHO-GMP certificates for the use of a particular API.
The WHO Prequalification Certification is the primary accepted quality verification by the Ministry of Health, Vanuatu.
Certificates must be current, valid, clearly mention the APIs used, and showcase the right factory address that goes with the export declaration.
Step Three: Documentation of ASYCUDA Pharmaceutical Module
Starting in July 2024, medicines imported into Vanuatu will be managed by the Ministry of Health through the ASYCUDA Health Pharmaceutical Module.
Exporters must ensure all import declarations include:
Incomplete ASYCUDA submissions cause clearance delays and are now visible to the MoH in real time.
Step Four: Importer Partnership
No direct manufacturer-to-government API supply is currently operational in Vanuatu.
Identify a licensed Vanuatu pharmaceutical importer/distributor as the in-country partner.
The ASYCUDA declarations are submitted by the importer holding the import license.
The Central Medical Store (CMS) operated by the Ministry of Health is a public sector entity.
Step Five: Documentation Package Completeness
Each shipment requires a complete documentation package:
| Document | Standard/Requirement |
| WHO-GMP certificate | Valid, scope-specific, current |
| Batch Certificate of Analysis | To BP/USP standards |
| ICH Zone IVb stability data | 40°C/75% RH Vanuatu tropical climate |
| Packing list and commercial invoice | Per import declaration requirements |
| ASYCUDA Pharmaceutical Module import declaration | Electronic submission mandatory since July 2024 |
Keep documentation bilingual (English/French) where possible. Vanuatu is a bilingual nation.
This reduces processing friction at the Ministry level.
The ASYCUDA Pharmaceutical Module: What Changed in July 2024
The launch of the ASYCUDA Health Pharmaceutical Module on July 16, 2024, was a major recent change for the import of active pharmaceutical ingredients (APIs) in Vanuatu.
Now, the process of importing medicines is wholly electronic. The Ministry of Health is then empowered to monitor medicine imports instantaneously.
For Indian API exporters, this entails:
This is a compliance-enabling development. Exporters with complete, accurate documentation packages will clear faster and establish stronger relationships with Vanuatu’s MoH.
Those with incomplete dossiers will face more transparent and more immediate rejection.
The practical entry path for Indian API exporters is a 5-step WHO-GMP import waiver pathway: NEDL alignment → WHO-GMP verification → ASYCUDA Pharmaceutical Module documentation → licensed importer partnership → complete documentation package.
The July 2024 ASYCUDA launch digitised this process, making compliant exporters faster to clear and non-compliant submissions more visibly rejected.
| What’s Next?: Now that we’ve covered the immediate entry pathway, let’s look at the structural regulatory changes coming that will reshape this market and why 2025-2026 is the optimal window for Indian API suppliers to establish their position. |
How the WHO Pacific Subregional Platform Will Change Vanuatu’s Framework
With the advent of the WHO Pacific subregional regulatory cooperation platform, Vanuatu’s regulatory sphere has now changed.
It is a very significant change. For Indian API suppliers, this is not a distant development. It is an active opportunity in 2025-2026.
The WHO Subregional Regulatory Cooperation Platform
The WHO Pacific subregional regulatory cooperation platform was endorsed by Pacific Health Ministers at the 13th Pacific Health Ministers Meeting in French Polynesia and reaffirmed at the WHO DPS February 2023 regulatory meeting in Suva.
The platform is designed to allow smaller PICs, including Vanuatu, to:
Use reliance mechanisms from qualified NRAs (PNG’s PSSB, Australia’s TGA, WHO-PQ) rather than building a standalone NRA capacity that is unsustainable at Vanuatu’s scale.
What This Means for Indian API Suppliers
When the subregional platform becomes fully operational, WHO-PQ status and TGA reliance decisions will be formally honoured across member PICs, including Vanuatu.
Indian API suppliers that already hold WHO-PQ status for their target APIs will automatically gain regulatory standing in Vanuatu without additional country-specific registration. The strategic implications:
The 2025-2026 timeframe is ideal because ASYCUDA has streamlined import processing, formalization of the WHO Pacific subregional regulatory framework is underway.
There is a documented and pressing need for Vanuatu’s NEDL alignment procurement.
Frequently Asked Questions
Q1: Does Vanuatu require formal API product registration before import?
No. Vanuatu does not have a formal API product registration system. There is no registration database, no approval certificate, and no dossier submission procedure in the classical sense.
API export to Vanuatu operates via an import waiver pathway assessed against WHO-GMP certification, NEDL alignment, and documentation completeness submitted through the ASYCUDA Pharmaceutical Module.
Approach Vanuatu as a documentation-driven import approval market, not a registration market.
Q2: What documentation does an Indian API supplier need to export to Vanuatu?
In exporting APIs from India to Vanuatu, suppliers must provide proper documents with each shipment.
The documents include: A current WHO-GMP Certification for APIs, Certificates of Analysis (CoA) for each batch as per BP/USP standards, ICH Zone IVb Stability Data denoting storage conditions of 40ᵒC/75% Relative Humidity (RH).
With these documents, like a Commercial Invoice and Packing List as per the details of the Import Declaration, an ASYCUDA Pharmaceutical Module Import Declaration, since the electronic submission became compulsory as of July 2024, an Importer License Number, which can be obtained from Vanuatu’s in-country importer partner, and Documentation in English and French, as Vanuatu requires bilingual documentation, are also required.
Q3: What is the National Essential Drugs List (NEDL) and why does it matter for API suppliers?
The National Essential Drugs List (NEDL), as maintained by the NDTC and the Ministry of Health of Vanuatu, is the official list of medications that the health system of Vanuatu is authorized to procure.
For Indian API exporters, it is the commercial path. APIs that correspond to NEDL-listed medicines have direct NDTC procurement authority and a clearly established demand pathway.
APIs outside the NEDL face uncertain procurement prospects regardless of documentation quality.
The NEDL is aligned to the WHO Essential Medicines List priorities; antidiabetics, antimalarials, anti-infectives, cardiovascular APIs, and anti-TB medicines are all included.
Q4: How will the WHO Pacific subregional regulatory platform affect Vanuatu’s API market?
When the WHO Pacific subregional regulatory cooperation platform becomes fully operational, it will formalize reliance mechanisms across member Pacific Island Countries, including Vanuatu.
WHO-PQ status and TGA reliance decisions will be formally honoured, meaning Indian API suppliers holding WHO Prequalification for their target APIs will gain automatic regulatory standing in Vanuatu (and across other member PICs) without country-specific registration.
This makes building WHO-PQ credentials now in 2025-2026 a long-term structural market access strategy, not just a Vanuatu-specific tactic.
Conclusion: Navigate the Gap, Enter the Market
Vanuatu’s absence of a formal NRA is not a barrier to market entry. It is a different kind of regulatory system that rewards preparation, WHO-GMP credibility, and documentation completeness.
Indian API exporters with WHO-PQ status, NEDL-aligned portfolios, and clear ASYCUDA-compliant documentation packages can access this market now.
The July 2024 ASYCUDA Pharmaceutical Module has made the import pathway more transparent, faster for compliant shipments, and more immediately consequential for incomplete submissions.
Those who also engage early with the WHO Pacific subregional regulatory platform will hold structural regulatory standing across multiple Pacific Island Countries.
Simultaneously turns a single-country documentation investment into a multi-market regulatory asset.
The 2025-2026 window is optimal:
Review Actiza‘s NEDL-aligned API portfolio, request WHO-GMP documentation packages for Vanuatu import waivers, or contact our Pacific regulatory team for country-specific entry guidance.
1. https://cdn.who.int/media/docs/default-source/essential-medicines/national-essential-medicines-lists-(neml)/afro_neml/seychelles-neml-2024.pdf?sfvrsn=72a7371b_1
2. https://cdn.who.int/media/docs/default-source/wpro—documents/dps/other-meeting-documents/rs-2019-ge-10-fji-eng.pdf
3. https://pmc.ncbi.nlm.nih.gov/articles/PMC3471189
4. https://cdn.who.int/media/docs/default-source/essential-medicines/national-essential-medicines-lists-(neml)/wpro_neml/vanuatu-2014.pdf
5. https://www.thelancet.com/journals/lanwpc/article/PIIS2666-6065(24)00256-6/fulltext
