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Why Are Oceania Island Nations Increasingly Switching to Indian APIs?

Pacific Island nations face a sharp paradox. Disease rates are among the highest in the world.

Yet, these markets remain overlooked in global pharma supply chains.

oceania island nations are switching to indian apis

For years, governments depended on expensive Western intermediaries. That model is now breaking.

India is stepping in as a reliable alternative. It supplies nearly 20% of global generic medicines and 57% of WHO-prequalified APIs.

There are countries changing their sourcing strategies, such as Papua New Guinea, Fiji, and Samoa.

India is a pharmaceutical exporter to 200+ countries and is a leader in WHO-prequalified API supply.

Statistically, the pharma imports of Papua New Guinea reached USD 28.17 million in 2023 – the highest in history.

This change is not by chance. It is cost-driven, access-driven, and supply-stable. This blog gives reasons as to why, using data.

The Problem – A Healthcare Crisis That Cannot Wait for Expensive Medicines

Pacific Island health systems face a dual burden. Non-communicable diseases are rising fast.

At the same time, infectious diseases remain widespread. This creates constant demand for essential medicines.

Healthcare budgets are limited. Supply chains are fragile. Delays or shortages have immediate consequences.

In this context, high-cost sourcing models are no longer sustainable.

  • Rising chronic disease burden

  • Continuing risks of infectious diseases

  • Limited procurement budgets

  • High dependency on imports

Collectively, the factors pose an urgent pressure on API sourcing decisions.

The NCD Epidemic: World-Record Disease Burden

Pacific Island countries are at the centre of the global NCD crisis. Diabetes rates are among the highest worldwide. Cardiovascular diseases follow closely behind. These conditions are no longer isolated. They are widespread and growing.

In countries like Fiji and the Solomon Islands, NCDs account for up to 80% of deaths. This trend is not slowing. It is accelerating each year.

Pacific Island countries hold the top 12 global positions for diabetes prevalence.

In 2024, diabetes caused over one-third of deaths in Guam, New Caledonia, and French Polynesia.

This creates continuous demand for APIs such as metformin and cardiovascular drugs. These are not optional medicines. They are life-sustaining.

  • High diabetes prevalence

  • Increasing cardiovascular disease cases

  • Long-term treatment dependency

  • Rising mortality linked to NCDs

The implication is clear. API supply must be consistent and affordable.

Communicable Disease: An Unfinished Agenda

Infectious diseases remain a major concern across the Pacific. Progress has been uneven. Several countries continue to report high case loads.

Papua New Guinea remains the most malaria-endemic country in the region. Tuberculosis, including MDR-TB, is still a serious threat. HIV/AIDS prevalence is also highest in PNG compared to other Pacific nations.

Pacific governments continue to fight malaria, TB, HIV, dengue, and drug-resistant infections.

Each of these diseases requires uninterrupted treatment. That means steady API availability. Any disruption leads to treatment failure and resistance risks.

  • Malaria remains endemic in key regions.

  • Tuberculosis cases include drug-resistant strains.

  • HIV treatment requires lifelong medication

  • Bacterial infections remain widespread

These are not short-term outbreaks. They are ongoing public health challenges.

Now that we’ve covered both disease burdens, let’s look at the structural gap that worsens the crisis.

The Access Gap – No Domestic Manufacturing, 100% Import Dependency

Pacific Island nations do not manufacture APIs. Not a single country has domestic API production capacity. Every essential drug depends on imports.

Even regulatory systems are limited. Of the nine countries studied, only Papua New Guinea has a National Regulatory Authority. Yet, no major insulin or diabetes medicines were formally registered there as of 2025.

The majority of medicines are imported using import waivers, and the most important quality filter is the WHO-GMP certification.

This makes a weak system:

  • 100% dependency on imported APIs

  • Limited regulatory infrastructure

  • Use of import waivers.

  • Quality related to external certification.

The outcome is evident. The accessibility of supply lies fully with the external partners.

Why Traditional Supply Chains Are Failing Pacific Buyers

The classic supply models were not designed to suit small markets that were located far away. They focus on size, not on accessibility. This poses a cost pressure and supply risk to Pacific buyers.

What had been successful previously is failing. Budgets are tighter. Demand is rising. And, supply chains are weak.

  • High procurement costs

  • Low flexibility for small-volume buyers

  • Weak crisis resilience

  • Lapses in documentation and compliance

These problems are not hypothetical. They have a direct impact on the availability of medicine in the region.

Western Supplier Premium: Prices Pacific Budgets Cannot Sustain

Western supply chains are highly expensive in nature. Intermediaries, compliance and logistics stack up. This causes APIs to be much more costly.

The costs may be 40-70 per cent more than their Indian counterparts of the same quality and certification level. This is unviable for Pacific health ministries. Their budgets for purchasing are fixed and constrained.

The outcome is anticipated:

  • Reduced order volumes

  • Frequent stock shortages

  • Incomplete treatment coverage

It is not only a question of price. It has a direct influence on patient outcomes.

COVID-19: The Supply Chain Collapse That Changed Everything

The pandemic demonstrated a serious inefficiency. The global demand was stressed, and Western supply chains were unable to sustain it. The Pacific Island countries were severely affected.

Shortages in medicine became the norm. Delivery timelines stretched. Purchasing processes collapsed.

India responded differently. It has remained a large-scale exporter of medicines and vaccines. Even distant markets were reached.

India has been able to sell medicines and vaccines to 150+ countries during the COVID-19 pandemic.

This transformed view in the area:

  • India showed resilience to the crisis

  • Trust was enhanced by the supply reliability

  • The Pacific buyers acquired a new partner

Here started the change of sourcing strategy.

China as a Direct Source: Why It Does Not Work for Pacific Buyers

China is a major API producer. But its model does not align with Pacific needs. Most manufacturers focus on large-volume buyers.

Small procurement orders are not prioritised. This creates access barriers for Pacific importers.

Documentation is another challenge. Pacific import pathways require specific formats. These include WHO-GMP certificates and clear English-language CoAs. Chinese suppliers often lack this standardisation.

India, with 57% of the WHO-prequalified API sources in the world, is significantly higher than China.

This results in major limitations:

  • Poor fit with low-volume purchasers

  • A small number of WHO-qualified suppliers

  • There are gaps in the documentation of import approvals

The compliance and clarity are considered as important to Pacific markets as the cost.

It is time to analyse why Indian APIs are becoming the solution of choice now that we have examined failures of traditional supply chains.

Why Indian APIs Are the Right Answer for Pacific Island Buyers

Pacific consumers require three things. Reliable quality. Affordable pricing. Consistent supply. All three are met by Indian API manufacturers.

This has not been a recent change. It is the product of Decades of size, regulation, and world trust-building.

  • Globally accepted quality certifications

  • Strong cost advantage

  • Wide therapeutic coverage

  • Alignment with global health agencies

  • Neutral geopolitical positioning

These are some of the reasons why India is a good sourcing partner to Pacific markets.

Having established the background, we are now going to examine the most important reasons.

WHO-GMP Certification at Scale – The Quality Standard Pacific NRAs Accept

The Pacific buyers are not ready to compromise on quality. The WHO-GMP certification is the first approving filter. Indian producers are in the lead.

who-gmp certification at scale

There are more than 2,050 WHO-GMP certified units in India. It is the biggest international base. These certifications are already accepted by regulators in Papua New Guinea and Fiji.

India also has 752 USFDA-approved plants and 286 EDQM-approved sites.

This scale simplifies procurement:

  • Faster approval under import waivers

  • Standardised documentation (CoA, GMP certificates)

  • Reduced regulatory friction

Buyers can source with confidence. Compliance is already aligned with Pacific requirements.

Cost Competitiveness – The Price Pacific Health Budgets Can Afford

Cost is a critical constraint for Pacific health systems. Budgets are fixed. Demand is rising. Every price difference matters.

Indian APIs offer a clear advantage. They usually cost 30-70% less than their Western counterparts of the same quality.

India’s PLI scheme attracted USD 3.5 billion in pharma investment by June 2024.

This price benefit reflects in the actual change:

  • Greater purchasing quantities on the same budget

  • Better stock availability

  • Reduced treatment gaps

Popular APIs such as metformin, artesunate, and isoniazid are always cheaper in India.

Therapeutic Portfolio Alignment – India Makes What the Pacific Needs

India’s API portfolio closely matches Pacific disease priorities. This is a key advantage. Buyers do not need to source from multiple regions.

India leads in APIs for malaria, HIV, tuberculosis, diabetes, and cardiovascular diseases. These are the exact conditions driving demand in Pacific nations.

Disease PriorityKey APIs RequiredIndia’s Position
Type 2 DiabetesMetformin HCl, GlibenclamideTop-3 global producer
MalariaArtesunate, Artemether-LumefantrineWHO-PQ dominant supplier
TuberculosisIsoniazid, Rifampicin, Pyrazinamide#1 global exporter
HIV/AIDSTenofovir, Lamivudine, DTG#1 global producer
Cardiovascular DiseaseAtorvastatin, AmlodipineLarge-scale producer
Bacterial InfectionsAmoxicillin, AzithromycinLeading antibiotic supplier

This alignment reduces sourcing complexity:

Fewer supplier dependencies

Consistent quality across therapies

Simplified procurement planning

Multilateral Donor Alignment – WHO, UNICEF, World Bank Already Use Indian APIs

Global funding agencies are usually associated with Pacific health systems. These are the WHO, UNICEF, and the World Bank. Their buying decisions are important.

multilateral donor alignment who unicef world bank already use indian apis

An important fact: these organisations are already a big source of India. The supply of WHO-prequalified medicines is based on Indian APIs.

India manufactures 67% of WHO-prequalified pharmaceutical products.

World Bank programs improved healthcare access for 340,000 people across Pacific nations.

This creates built-in trust:

Proven compliance with global standards

Alignment with donor procurement systems

Reduced risk for government buyers

In many cases, Pacific countries are already using Indian-origin APIs indirectly.

Geopolitical Neutrality – A Safe Third Path Between China and Western Premiums

The decision to source is no longer a straight commercial decision. They are also geopolitical. Countries of the Pacific reconsider dependencies.

China’s rising power has strategic implications. Western suppliers are still costly. This leaves a gap.

India provides a more-or-less alternative:

Politically neutral positioning

Good acceptance in international regulations

Affordable prices without concession

This will render India a long-term worthy partner. It does not rely heavily on any bloc.

This is not only a supply choice for Pacific buyers. It is a strategic one.

That being said, now that we have discussed the reasons why Indian APIs are the best option, we shall discuss the risks that buyers should be aware of prior to sourcing.

What Pacific Buyers Must Know Before Sourcing

Indian APIs have good benefits. Nevertheless, sourcing needs due diligence. The buyers have to evaluate risks prior to settling with suppliers. This guarantees stability of supply and regulation.

Upstream dependency risks

Climate-related storage challenges

Country-specific regulatory requirements

A structured approach helps avoid disruptions and delays.

India’s KSM Dependency on China

India is also relying on China as a source of many important raw materials. Approximately 70-74% of KSMs are imported. This poses upstream risk.

Indian API supply can be impacted by a disruption in China. The effect might not be direct, but it can have a trickle-down effect.

Buyers should mitigate this risk:

Dual-source across two qualified suppliers

Prefer manufacturers with backward integration

Check diversified KSM sourcing strategies

This adds resilience to procurement planning.

Cold Chain Compliance for Tropical Markets

The climate of the Pacific is hot and humid. This poses stability problems to some APIs. Strict handling is required for temperature-sensitive products.

The APIs that require ICH Zone IVb stability data include insulin precursors, oxytocin, and ergometrine. This means validation at 40°C and 75% humidity.

Buyers must verify:

  • Availability of Zone IVb stability data

  • Certified cold chain packaging

  • Storage labels other than basic compliance

“Store below 30°C” is not sufficient. It must be properly documented.

Registration Requirements by Country

In Pacific countries, there are variations in regulatory pathways. Papua New Guinea needs to be registered under the Medicines and Cosmetics Act 1999 through PSSB. WHO-EML and import waivers are used by other countries.

Indian exporters need to prepare documentation to suit a particular market. At this point, regulatory support is very important.

With our discussion of the risks, we can now discuss how buyers can qualify the right Indian API supplier.

How Pacific Island Buyers Should Qualify an Indian API Supplier

Selecting the right supplier is critical. Quality alone is not enough. Buyers must assess compliance, reliability, and logistics capability together.

A structured qualification process reduces risk. It also guarantees smoother regulation approval and uniform supply.

Pay attention to the certification and documentation

Check compliance history

Assess logistics readiness

Formalise quality expectations

5-Step Qualification Framework for Pacific Buyers

5-step qualification framework for pacific buyers

Step 1- Verify WHO-GMP Status

Start with certification. Ensure that the supplier is included in the WHO Prequalified API database. This is the main quality standard of Pacific imports.

Step 2- Request Complete Documentation

There should be clarity in documentation and up-to-date documentation. Ask for:

  • Valid WHO-GMP certificate (scope specific)

  • Batch Certificate of Analysis (CoA)

  • Stability (ICH Zone IVb) data

  • Drug Master File (DMF), where necessary

Premature approvals may be slowed down by incomplete documentation.

Step 3- Check Regulatory History

Check the supplier’s compliance track record. Look for:

  • US FDA import alerts are not active

  • None of the non-compliance reports of EMA in recent times

Good regulatory history is an indicator of reliability.

Step 4- Confirm Logistics Capability

Logistics are important, particularly in remote areas. Verify:

  • Refrigerated API validation

  • Experience shipping to Pacific ports like Suva, Port Moresby, and Honiara

This guarantees safe and prompt delivery.

Step 5- Establish a Quality Agreement

Both parties are safeguarded by formal agreements. Include:

  • Batch testing requirements

  • Change notification: at least 30 days’ notice

  • Deviation handling protocols

  • CAPA (Corrective and Preventive Action) commitments

This brings about accountability and uniformity. This model assists consumers in getting rid of doubt and having confidence.

Frequently Asked Questions

Q1: Are Indian APIs accepted by Papua New Guinea’s PSSB?

Yes. The Pharmaceutical Services Standards Branch (PSSB) of Papua New Guinea accepts Indian APIs. The most important one is WHO-GMP compliance.
Suppliers must provide:

Valid WHO-GMP certification
Certificate of Analysis (CoA) specific to batches
Stability data (as needed) Supporting.

In most scenarios, the medicines are imported under import waivers as opposed to complete registration. This makes WHO-GMP the primary quality standard.
To the purchasers, this makes sourcing easier. Most of the documentation expectations are already met with Indian suppliers. The MQCL (Medicine Quality Control Laboratory, opened 2017) may conduct local quality testing as part of the process

Q2: Why not source APIs directly from China?

China is a big producer of API. But its supply model is not in tune with Pacific procurement requirements.
Key limitations include:
Target large volume international consumers
Reduced level of representation in the WHO-prequalified lists
Import approval shortcomings in documentation
Pacific markets need standardised documentation. This comprises English-language CoAs and WHO-GMP certificates.
Indian suppliers are more compatible with these requirements. They are both compliant and acc

Q3: What is the typical lead time for Indian API exports to Pacific Island Countries?

Lead time depends on the product type and logistics. Nevertheless, regular schedules are foreseeable.
Typical ranges include:
Production and dispatch time of 2-4 weeks
Shipping to the Pacific ports may require 1-3 weeks
In the case of temperature-sensitive APIs, cold chains can alter timelines
PNG 18–28 days, Fiji 20–30 days, Solomon Islands 25–35 days
Delays can be minimised by experienced exporters who have shipped across the Pacific. Planning a buffer stock is also recommended.
Generally, Indian suppliers can provide standard and effective lead times to Pacific buyers.

Conclusion – The Shift Is Already Underway

Pacific Island nations face a clear reality. Disease burden is rising. Supply gaps are persistent. And traditional sourcing models are no longer sustainable.

Global institutions have already acknowledged this gap. WHO, UNICEF, the World Bank, and the Access to Medicine Foundation all highlight the same issue. Access remains uneven and fragile.

India is not a new option. It is already central to the global medicine supply for these exact diseases.

Strong alignment with disease priorities

Proven role in WHO and UNICEF procurement

Cost and compliance advantages

For Pacific buyers, the shift is already happening. Those who act now gain supply security, cost control, and regulatory confidence.

Explore Actiza’s API product catalogue. Request documentation tailored for Pacific markets. Or connect with our regulatory team to streamline your sourcing process.

About the Author

Nilesh Mendpara MD of ACTIZA PHARMA Profile Image
Nilesh Mendpara

Nilesh Mendpara is the Managing Director of Actiza Pharmaceutical PVT. LTD., based in Surat, Gujarat, India. With over 10 years of experience in the pharmaceutical industry, Nilesh is passionate about spreading pharmaceutical knowledge and staying ahead of industry trends. He holds a Master of Pharmacy (Distinction) and a Bachelor's in Pharmacy from Rajiv Gandhi University of Health Sciences. Under his leadership, Actiza Pharmaceutical aims to be the most trusted partner for pharmaceutical exports worldwide, ensuring the highest standards of quality and safety. Connect with Nilesh to explore opportunities in advancing global healthcare.

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