Avoiding falsified and substandard medicines

A falsified medicine can look exactly like the real one and still contain the wrong ingredient, the wrong dose or nothing active at all. A substandard medicine is genuine but fails its quality standards. Both put patients at risk and waste scarce budgets. Specialty, orphan and shortage medicines are attractive targets because they are expensive and hard to find, and urgent demand tempts buyers to skip checks.

This guide explains how WHO defines the problem, how falsified products enter supply chains, what regulation already does and the practical controls a hospital, importer or NGO can apply to every order.

How WHO defines the problem

The World Health Assembly adopted three working definitions at its seventieth session on 29 May 2017, which WHO publishes on its definitions page. They are now the common language for regulators and buyers.

The middle category matters for named-patient supply. A genuine medicine imported under a named-patient or special access route is not registered in the destination, but the route itself is the legal permission. The approval document, the batch paperwork and the supply chain behind it are what separate a lawful import from an unregistered one.

How big the problem is

The WHO fact sheet, last updated in December 2024, says WHO estimated in 2017 that about 1 in 10 medical products in low and middle income countries is substandard or falsified. It puts the cost at about USD 30.5 billion a year and notes that these products are found in every country and in every product type. They are often sold online or through informal markets.

WHO publishes alerts on specific falsified products, which it lists on its medical product alerts page. The list includes high-value specialty medicines, for example a July 2026 alert on falsified daratumumab. Regulators also share reports through the WHO Global Surveillance and Monitoring System, launched in 2013.

Enforcement data shows the scale of the trade. Interpol's Operation Pangea XVII, which ran from December 2024 to May 2025 across 90 countries, led to 769 arrests, the dismantling of 123 criminal groups and seizures of about 50.4 million doses worth some USD 65 million. About 13,000 websites, social media pages and channels were shut down.

How falsified products reach buyers

Falsified medicines rarely enter through a manufacturer's own distribution. They usually come in where the chain is long, opaque or rushed.

• Shortages. When a product is out of stock, unknown sellers appear with immediate availability. The shortage sourcing guide covers how to source in a shortage without opening that door.
• Online sellers. WHO notes that many falsified products are sold online, often by sites that are not licensed where they sell.
• Long trading chains. Each extra trader between the manufacturer and the buyer is another place where stock can be swapped, relabelled or stored badly.
• Diverted or stolen stock. Genuine packs that left the legal chain can be mixed with fakes, and storage history is lost.
• Poor storage in transit. A genuine product held outside its labelled conditions can become substandard. The temperature excursion guide explains how to read logger data.

What regulation already does

The EU Falsified Medicines Directive

Directive 2011/62/EU amended the EU medicines code to keep falsified products out of the legal supply chain. It tightened rules for wholesalers and active substance imports and created a common logo for legally operating online sellers. Delegated Regulation (EU) 2016/161 then set out two safety features, a unique identifier and an anti-tampering device, which apply to most prescription medicines placed on the EU market from 9 February 2019. Pharmacies and hospitals verify the identifier before supply.

These features only apply to packs made for the EU market. A pack made for India, the Gulf or Africa may carry a different code or none, so the absence of EU features is not by itself a sign of falsification. The right check is whether the pack matches what the manufacturer issues for its market of origin.

Controls at the source

In India, a supplier of medicines needs a state wholesale drug licence, and exports of products not approved in India need a CDSCO NOC. The supplier verification guide shows how to check those licences, and the Indian export rules guide explains the NOC system.

Practical controls for every order

These steps work for a hospital pharmacy, a licensed importer or an NGO procurement team.

1. Source only through licensed channels. Verify the supplier's licences before the first order and re-check them every year.
2. Ask for the chain of custody. The supplier should name the manufacturer and show how the stock reached it, for example through the manufacturer's or authorised distributor's invoice.
3. Ask for the batch certificate of analysis. It should come from the manufacturer and match the batch number and expiry date on the packing list.
4. Check the regulatory paperwork. Make sure the destination import approval names the same product, strength, quantity and consignee as the invoice.
5. Inspect on arrival. Compare packs with genuine reference packs or the manufacturer's artwork. Look at print quality, spelling, batch and expiry printing, seals, leaflets and the physical product.
6. Read the temperature record. For cold chain products, review the logger file before release to stock.
7. Quarantine anything suspect. Do not use, sell or return it until the manufacturer has confirmed the batch.

Warning signs on the pack and in the deal

What to do with a suspect product

Stop use and keep the product, its outer packaging and any shipping documents. Photograph the pack, the labels and the batch details. Contact the marketing authorisation holder or manufacturer and ask it to confirm the batch number and pack design. Report the case to the national regulator of the country where the product is held, since regulators share reports with each other and with WHO.

Tell the supplier in writing, giving the batch details, so that other stock from the same source can be traced and held. If a patient has already received the product and had a harmful effect, report that as an adverse event as well. The adverse event reporting guide explains what such a report needs.

Before the next order, a checklist of documents for the destination can be built with the document checklist tool.