Papua New Guinea (PNG) is an Island country situated in the Oceania region.
With a population of approximately 11.8 million, this Island comprises 18 provinces with a total area of 462,840 km². The archipelago has more than 600 islands.
Though the Island is not as big as many other countries in the world, the PNG pharmaceutical import system spends $65.54 million on medicines in 2023.
Filling this disparity is a combination of pharmaceutical active ingredient (API) suppliers, international procurement teams, and helpful international organizations.
This guide aims to understand not only the opportunity but also the documented challenges that exist between an API shipment from India and a functioning medicine on the shelf of a shop in Lae or Mount Hagen.
Why PNG Is Both the Most Compelling and Most Complex Pharma Market in the Pacific
Papua New Guinea is a developing country, and so is its pharmaceutical sector.
Papua New Guinea’s pharmaceutical supply chain can contribute positively to its economic growth.
It will be even more important for both vertical and horizontal integration of supply chains with regard to the Papua New Guinea medicine supply chain in 2026. This will be crucial for some API exporters.
Economic Profile and Health Sector Capacity
The country’s total GDP (as per 2024 data) is approximately $32.54 billion USD, and its per capita income is $2,572.03 USD.
In 2024, Papua New Guinea registered 3.8% GDP growth, with per capita GDP growth forecast at 0.9% in 2026 (ADB, April 2026).
Also, $125 million by the International Monetary Fund (IMF) through a stress test in 2024, limited the country’s fiscal deficit to 3.2%.
As Papua New Guinea’s National Health Plan 2021-2030 sets out an information framework.
However, the budgets provided are inadequate. The Health and healing houses are open, but not completely filled with allocated medicines.
The country has the world’s second most serious type of Tuberculosis (TB).
The country has the world’s second-highest TB Burden, with the country’s TB incidence rate of 664 for every 100,000 people in the population.
The global incidence is about 131 documented cases per 100,000.
The mean global TB successful treatment rate is 88%; in Papua New Guinea, the rate of successful treatment for bacillary TB cases in 2023 was 84%.
The poor treatment success rate stems from multiple challenges, and one of the main challenges is a disrupted supply chain.
Papua New Guinea has 85% of its population in rural settings. The most significant challenge is the last mile.
The supply chain must reach the health service facilities that can be accessed only by light plane, boat, or foot.
The Pharmaceutical Import System: How PNG Currently Procures APIs and Medicines
All Active Pharmaceutical Ingredients (APIs) must be brought into Papua New Guinea, and there are two modalities of procurement.
The first channel is the public sector procurement done by the National Department of Health (NDoH) through the Medical Supply (MS) Branch.
The MS Branch has six Area Medical Stores (AMS), of which two are in Badili (Port Moresby) and Lae.
The second channel is the private sector, and the Papua New Guinea Medicines and Cosmetics Act of 1999 and Medicines and Cosmetics Regulations of 2002 provide a framework for the PSSB import licence in Papua New Guinea.
PNG is a 100% API import-dependent country, and a burdened TB and disease country with a two-channel procurement system and a mandatory PSSB licensing requirement for all pharmaceutical imports.
Six Documented Challenges Facing API/Pharma Importers in PNG 2025-2026
The Papua New Guinea drug shortage essential medicine crisis of 2025-2026 is not one problem; it is an amalgamation of six different parts.
Each of the challenges below is documented, data-driven, and operationally significant to any API exporter or importer.
Challenge One: Regulatory Framework Still Operating Under a 1999 Act
The Medicines and Cosmetics Act 1999 is PNG’s principal piece of legislation. As of 2025, this legislation is almost 26 years old and has not been revised substantively.
The PSSB has very limited technical capacity, no eProduct registration, and there is no public PNG equivalent of Australia’s ARTG or India’s CDSCO.
Challenge Two: Foreign Exchange Shortage Directly Blocking API Procurement
Of all the barriers to entering the PNG market, the chronic foreign exchange shortages have affected pharmaceutical imports in PNG regulations 2025 2026, and it is the least publicized.
Businesses report waiting months for forex allocations to settle USD-denominated international invoices. Out of all the requirements for pharmaceutical importers, a valid purchase order and a willing overseas supplier mean little; the payment cannot be made.
There are delays of 30 to 120 days from the agreed period of the payment due to a systemic limitation on access to foreign currency, not due to the buyer’s insolvency.
Evidence of the severity of the crisis can be seen at the governance level.
BTI 2026 Papua New Guinea Country Report states that PNG’s central bank governor was removed in 2024 as a direct result of the forex crisis.
This was amid significant frustration regarding the forex shortage and disruption to critical inputs.
With the July 2024 IMF program (USD 125 million), the primary aim is to stabilize foreign currency exchanges. It is a situation that is not fully under control, but things are improving.
API exporters are required to obtain confirmed letters of credit (LC) from banks in Australia or Singapore. PNG-only banking instruments are not accepted.
Challenge Three: Cold Chain Infrastructure Failure Across the Distribution Network
PNG is in the ICH Q1A Zone IVb due to its hot, tropical climate, making the most stringent storage stability testing requirements (30°C ± 2°C / 65% RH ± 5% RH) applicable.
The cold chain pharmaceutical logistics system in Papua New Guinea which spans the 6 AMS warehouses, 18 provincial transport stores, and rural health facilities in Papua New Guinea, is grossly inadequate.
Evidence exists, and has been documented, that oxytocin and ergometrine maleate (which require a temperature range of 2–8°C) were kept in an unrefrigerated storeroom in a PNG health facility.
ICH Q1A Zone IVb requirement: All APIs shipped to PNG must have stability data showing that they have been subjected to conditions of 30°C / 65% RH for an extended period of time.
APIs in transit to PNG for less than 30 days from temperate-climate markets (Zone II: 25°C / 60% RH) are likely to be rejected based on insufficient supplier data.
Cold chain API categories at highest risk in PNG: API are likely to fail specifications if they are not shipped with refrigeration and are held in Lae Port. Telescoping delays create significant port dwell risk.
Highest risk shipments are oxytocin (for maternal health), ergometrine, and certain antibiotics, as well as vaccines. These APIs are most required for PNG’s TB and maternal health needs.
Port dwell time risk: Lae Port has congestion issues that affect the dwell time. API’s that are temperature sensitive could fail specifications before reaching the AMS due to port dwell time without refrigeration.
Challenge Four: Port and Logistics Infrastructure Constraints
Lae is PNG’s main import port. There is no direct container shipping route from India (the main API exporting country) to PNG, forcing transshipment in either Singapore, Brisbane, or Port Klang.
Each transshipment adds 10-21 days of travel time, and there is a risk that refrigerated APIs may fail specifications due to a temperature excursion.
Swire Shipping also has a 14-day cycle for a port of call from East Coast Australia. If one vessel is missed, that 14-day cycle stops, and a 2-week gap occurs.
From either Port Moresby or Lae AMS, medicines must reach 18 provincial transit stores, the majority of which can be accessed only by light plane or boat.
These other means of transport take 3-7 days to reach the stores from AMS.
Challenge Five: Public Sector Procurement and Budget Execution Failures
PNG’s public sector pharmaceutical supply chain has documented systemic failures in estimating stock.
Studies show the health staff responsible for order placing estimate or “guess” stock needs instead of using the prescribed two-step quantification SOP, resulting in over- and under orders that API exporters are unable to plan for.
Tender amounts should be considered rough until verified at the AMS level.
The stagnation of public procurement is fast-tracking the growth of the private sector pharmaceutical market.
The market is now becoming more commercially viable for API exporters working with local distributors.
Challenge Six: Quality Verification Capacity and Substandard Medicine Risk
The PSSB’s MQCL is the only centralized testing facility in a country with an importation of USD 65.54 million worth of pharmaceuticals.
There is evidence of medicines in PNG that do not meet the international pharmacopoeial standards, especially the API subcategories that are sensitive to the cold chain.
For exporters of APIs, a shipment of a non-compliant batch creates a dual risk of regulatory and reputational risk in the importation chain.
The six main challenges: a 1999 regulatory framework in need of reform, a forex payment constraint, a collapsed cold chain, a transshipment-centric logistics framework, a public procurement system grounded in guesswork, and a single, underfunded, quality testing lab, describe the operational environment for API imports into Papua New Guinea in 2026.
Now that we have identified the six main challenges, we can look at how to apply the step-by-step framework for regulatory pathway analysis.
Regulatory Navigation: What API Exporters Must Prepare for PNG Import
Exporters who want to import into Papua New Guinea are required to follow a complete legal process, comply with document specifics, and allow sufficient time to complete the import process.
The framework is rigid no shortcuts exist.
Step-by-Step: How to Navigate PNG’s Import Licensing System:
The Public Services and Safety Branch (PSSB) licensed importer is the competent authority to handle all imports.
Healthcare facilities in Papua New Guinea cannot receive goods directly from Authorized Economic Operators (AEOs).
A licensed intermediary is a must under Medicines and Cosmetics Act 1999 PNG pharmaceutical import criteria.
| Step | Responsibility | Key Requirement / Document | Timeline / Notes |
| 1. Identify a PSSB-licensed importer / local partner in PNG | API Exporter | PSSB Register request directly (no public online register available) | Variable critical first step |
| 2. Partner files / renews import licence with PSSB | PNG Licensed Importer | Form 4 (Import Licence, MCR 2002 Schedule 2) product-specific | 4-12 weeks for new product licence |
| 3. API exporter provides full documentation package | API Exporter | CoA, GMP Certificate, MSDS/SDS, Certificate of Origin (CoO), ICH Q1A Zone IVb stability data | Must be prepared before order confirmation |
| 4. PSSB reviews and approves import product | PSSB | Reviewed against MDC requirements for public sector | Variable processing timelines not publicly codified |
| 5. Shipment, customs clearance, MQCL testing (if triggered) | Importer / PNG Customs | PNG Customs import declaration + PSSB clearance | 5-15 working days port clearance; add 2-4 weeks if MQCL testing is triggered |
| 6. Distribution via AMS (public) or private channels | MSB / Private Distributor | Delivery note, cold chain confirmation | 1 day (Port Moresby) to 7+ days (remote highland provinces) |
Documentation Standards PNG Buyers and Exporters Must Use in 2026
PNG does not have an established equivalent to the ASEAN CTD API dossier format.
Based on the PSSB’s mandate under the Medicines and Cosmetics Act 1999 and the WHO-GMP as the accepted standard, we have:
With the navigation of regulation illustrated, let’s discuss the contract and compliance safeguards that protect exporters in the market.
Supply Chain Strategy: Getting APIs Into PNG Reliably in 2026
The regulation of acceptable levels of compliance is determined by the buyer type. This helps to ensure qualification during the tender stage.
| Buyer Type | GMP Standard Required | Stability Data | WHO-PQ Required? | Key Risk |
| PNG NDoH / MSB (public tender) | WHO-GMP minimum, TGA GMP accepted | ICH Q1A Zone IVb mandatory | No | MQCL may test and reject if Zone IVb data is absent |
| PNG NDoH donor-funded (UNICEF, Global Fund, ADB) | WHO-PQ preferred | ICH Q1A Zone IVb mandatory | Increasingly required check grant conditions | Non-WHO-PQ suppliers may be disqualified from donor tenders |
| PNG private sector importer / pharmacy | WHO-GMP international standard | Zone IVb strongly recommended | No | MQCL batch testing risk; validity of importer’s annual licence |
| PNG hospital pharmacy (private) | WHO-GMP or TGA GMP | Zone IVb specific | No | Cold chain documentation required for temperature-sensitive APIs |
Managing the Forex Payment Risk
What API Quality Standards Apply to PNG Market Shipments
For Papua New Guinea, and likely for the transhipment of many targeted API shipments, creating a robust shipping protocol and cold chain pharmaceutical logistics in Papua New Guinea services is important for ensuring regular shipments of APIs to PNG in 2026.
Shipping Protocol for How to Export API to Papua New Guinea from India
It is on the exporter to bear the burden of shipment cost and insurance. Also, Australia or Singapore provides a Letter of Credit (LC) with a deferred payment clause to avoid long delays in payment.
API Categories in Demand: What PNG Most Needs in 2026
| Disease Area | Priority APIs | PNG Disease Burden Basis |
| Tuberculosis | Rifampicin, Isoniazid, Pyrazinamide, Ethambutol, Streptomycin | 664 TB cases per 100,000 population (2024 WHO) second-highest globally |
| Malaria | Artemether, Lumefantrine, Artesunate, Amodiaquine | One of the highest malaria burdens in the Pacific National Health Plan (NHP) 2021–2030 priority |
| Maternal & Reproductive Health | Oxytocin (cold chain required), Ergometrine maleate, Misoprostol, Amoxicillin | High maternal mortality rate; oxytocin cold-chain pharmaceutical logistics failures documented in Papua New Guinea |
| NCDs | Metformin HCl, Atenolol, Amlodipine, Atorvastatin, Salbutamol | Increasing non-communicable disease burden; limited public access to chronic disease medicines |
| Antibiotics | Amoxicillin, Ampicillin, Gentamicin, Benzylpenicillin, Cotrimoxazole | Antimicrobial resistance (AMR) action plan active antibiotic API demand driven by treatment and stewardship procurement |
PNG Pharmaceutical Import Outlook 2026–2028
What Is Changing in 2026: The Reform Drivers
Should this legislation pass, we will see a reformation of the Medicines and Cosmetics Act 1999 in PNG.
There is a possibility of the introduction of an electronic system for the registration of medicines and, maybe, a clearer pharmaceutical imports PNG regulations 2025-2026 will open opportunities for API exporters.
To target the inspection capability, pharma-covigilance systems, and PSSSb staffing, it is important to work out PNG’s Corrective and Preventive Actions plan under the WHO IDP.
The IMF loan (2024-2027) aims to stabilize foreign exchange markets and shorten delays in payments. API exporters should notice the most changes to their operations from this loan.
Pharmaceutical imports to Papua New Guinea have doubled in value, from USD 28.17 million (2022, CEIC/UNCTAD classification) to USD 65.54 million(2023, COMTRADE broader classification).
This rapid rise indicates a real increase in the burden of disease and the increased activity of the formal private sector.
Risk-Adjusted Scenarios for API Exporters Targeting PNG 2026–2028
| Scenario | Conditions | Market Impact | API Exporter / Merchant Strategy |
| Optimistic (2026–2027) | New Medicines Bill enacted; PSSB strengthened; forex normalises under IMF programme; MQCL upgraded | More predictable licensing environment; growing private sector demand; higher market confidence | Enter early with a licensed local partner; complete product registration before Bill implementation; establish WHO-GMP documentation as baseline |
| Base Case (2026–2028) | Medicines Bill remains in draft stage; PSSB reform progresses slowly; forex situation partially resolved; MQCL operational but slow | The import process remains manageable with a strong local partner; the private sector grows faster than public procurement; pharmaceutical imports PNG continue 10–15% year-on-year growth. | Follow a partner-first strategy; focus on private sector and donor-funded procurement; maintain ICH Q1A Zone IVb documentation; use confirmed LC for all orders |
| Pessimistic (2027 onward) | Political instability; delayed Medicines Bill; forex crisis deepens again; IMF programme disrupted | Public sector procurement freezes; private sector USD settlement delays increase | Avoid direct investment exposure; maintain standby relationships with local partners; closely monitorIMF programme milestones |
FAQ Section
Q: What regulatory authority governs pharmaceutical imports in Papua New Guinea?
A: Papua New Guinea’s legislation and regulations on pharmaceuticals are over 26 years old and have not been revised.
Pharmaceutical imports PNG regulations 2025-2026, which oversees the import of pharmaceutical goods into Papua New Guinea, is the PSSB of the National Department of Health.
They operate within the ambit of the Medicines and Cosmetics Act 1999 and the Medicines and Cosmetics Regulation 2002.
WHO medicines regulatory reform Papua New Guinea 2025, which includes the development of a new Medicines Bill, which will replace the above legislation.
The draft bill will be reviewed during a workshop on the 12th of August 2025 (WHO/NDoH). The bill has not been enacted.
Q: Do API exporters need a local partner/agent to supply to Papua New Guinea?
A: Yes, it is a mandatory requirement. API exporters cannot ship directly to any health facility, hospital, or health institution in Papua New Guinea. A PSSB import-license Papua New Guinea API supplier relationship is the only legal route to import APIs into Papua New Guinea, and a supplier relationship with a PSSB-licensed importer is required.
PSSB-licensed importers do not make a public register of licensed importers available, and this register has to be requested directly from them. The most important step prior to the engagement of any other market players in Papua New Guinea is the identification of the appropriate PSSB-licensed importer.
Q: What stability data does PNG require for API imports?
A: PNG requires stability data in accordance with ICH Q1A for Zone IVb. This includes the stability data at 30 degrees Celsius + 2 degrees Celsius and 65 percent relative humidity + 5 percent relative humidity. PNG is a tropical country, so Zone IVb is applicable. Exporters that only provide Zone II stability data (25 degrees Celsius and 60 percent relative humidity) will face batch rejections by the PSSB/MQCL and will face a quality test failure at the facility level.
Q: How does PNG’s foreign exchange shortage affect API payment terms?
A: PNG forex shortage, pharmaceutical procurement kina problem, which is a problem with PNG’s local currency in foreign trade.
This has resulted in a 30 to 120 day delay in payment, even when the buyer is financially capable and has provided a valid purchase order.
The PNG kina is a non-convertible currency; all API invoices have to be in USD or AUD. Payment is to be made via a confirmed Letter of Credit issued by an Australian bank or a bank in Singapore.
PNG’s foreign banks are not to be used. The IMF ECF/EFF program is presently focused on improving the stability of the foreign exchange.
Q: What GMP standard does PNG require for API and pharmaceutical imports?
A: The minimum standard is WHO-GMP for the Ministry of National Planning, the Ministry of Health, and the National Department of Health in PNG.
The private sector will accept EU-GMP and the Therapeutic Goods Administration (TGA) GMP. For WHO-PQ, this is increasingly required for UNP-funded procurement (i.e., UNICEF, Global Fund).
The terms need to be verified for each individual grant. The PSSB’s Monitoring and Quality Control Laboratory (MQCL) will test the incoming batch against these standards.
Q: What are the most in-demand API categories for Papua New Guinea in 2026?
A: The high-demand categories in PNG are as follows: anti-TB APIs (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol). As a result of a TB incidence of 664/100,000), antimalarials (Artemether, Lumefantrine, Artesunate), maternal health APIs (Oxytocin, Ergometrine maleate require a cold chain).
General illnesses, NCD APIs (Atenolol, Amlodipine, Atorvastatin), Metformin HCl, as well as the expansion of the private sector, are also of growing demand, as well as maternal health APIs.
Q: Is Papua New Guinea a good market opportunity for Indian API exporters in 2026?
A: Yes, with a number of caveats. What constitutes a successful export of API from India to Papua New Guinea is a local partner with the PSSB license, the WHO-GMP certification, ICH Q1A Zone IVb testing, and agreed LC terms. Papua New Guinea is a 100% import-based economy in terms of all APIs; pharmaceutical imports PNG spend is growing at 14%+ annually, and there is no domestic competition.
The challenges are significant and real; however, for exporters that prepare, the challenges are by no means insurmountable.
Conclusion
Papua New Guinea is stymied by a regulatory environment that creates challenges for exporters. The geography poses a logistical barrier.
NG forex shortage and pharmaceutical procurement in Kina have negatively impacted pharmaceutical procurement, and there is a documented failed cold chain.
These present challenges are real and don’t require additional explanation.
Even with all of this, PNG relies entirely on imported pharmaceuticals to cope with a massive disease burden.
Their TB incidence rate stands at a huge 664 TB cases per 100,000, and changing this situation is expensive; pharmaceutical imports PNG spend is growing at 14%+ annually.
PNG also lacks any API production capability that could pressure pricing domestically.
For an Indian API exporter with WHO-GMP certification, ICH Q1A Zone IVb stability data, a qualified local partner, and the willingness to be patient and work in a rapidly evolving space, the Papua New Guinea medicine supply chain in 2026 is an opportunity to be the first mover in a developing market, rather than a situation that should be avoided.
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