Sourcing medicines during a shortage

A shortage turns routine supply into an access problem. The registered product is unavailable, patients still need treatment, and the hospital pharmacy or importer has to find a lawful, verifiable alternative quickly. Doing that well means confirming the shortage, choosing the right legal route, defining exactly what the prescriber will accept and checking the new source as carefully as the original one.

This guide covers where shortages are published, how regulators let foreign-approved products in, how to check an alternative source and how to plan the request. It does not cover clinical choices between medicines, which belong to the prescriber.

Confirm the shortage on an official list

An official record helps in two ways. It tells the buyer how long the gap may last, and it supports the justification that many special access routes require.

FDA's shortage questions page quotes the legal definition: a period when demand or projected demand for a drug within the United States exceeds supply. It also says health care professionals, patients and professional organisations can report potential shortages online. In Europe, EMA's role rests on Regulation (EU) 2022/123, while national authorities usually handle shortages that stay within one country.

How foreign-approved products enter during a shortage

There are two broad patterns. In the first, the regulator itself arranges supply from abroad. In the second, a hospital or licensed importer uses an existing special access route, with the shortage as part of the justification.

Regulator-led measures

• United States. FDA says that when a shortage cannot be resolved quickly, it may look for an FDA-registered foreign manufacturer willing and able to redirect foreign-approved product. FDA reviews the formulation and the quality of the manufacturing site first, and its Drug Shortages Staff decides when the product is no longer needed.
• Canada. Health Canada lists among its tools the use of regulatory powers to allow drugs labelled and approved for other markets into Canada, and it keeps a list of drugs allowed for exceptional importation and sale.
• Russia. Registered medicines in packaging meant for other markets may circulate during a shortage linked to sanctions, a regime extended to 31 December 2027, as described in the Russia import guide.
• Mexico. An agreement of December 2024 lets COFEPRIS issue import permits for public sector supply of medicines authorised by reference regulators in 22 countries or by EMA. A product approved only in India does not appear to qualify, according to the Mexico import guide.

Special access routes used by hospitals and importers

Details for each country are in the guides for the United Kingdom, Colombia, Brazil, Kazakhstan and Uzbekistan. The general mechanics of these routes are explained in how named-patient supply works.

Check the alternative source carefully

Shortages attract opportunistic offers. WHO's fact sheet on substandard and falsified medical products names countries with a disrupted supply chain, and countries with increased demand for specific products, among those at risk. It also cites a 2017 WHO estimate that at least 1 in 10 medicines in low and middle income countries is substandard or falsified.

Before accepting stock from a new source, check:

• that the manufacturer is licensed in its own country and the product is approved there
• that the product moved only through licensed distributors, with invoices to show it
• the certificate of analysis for the actual batch offered, and that batch and expiry match the packs
• packaging, tamper evidence and labelling against the manufacturer's reference where available
• storage and transport records for temperature-sensitive products

The guides on verifying a medicine supplier and avoiding falsified medicines go through these checks step by step.

Define what the prescriber will accept

A foreign version of the same medicine is not always identical. Strength may be expressed differently, excipients or preservatives may differ, an injection may come with a different device, and labels will often be in another language. The prescriber and the hospital pharmacist decide whether a given product is acceptable, and many special access routes require the physician's justification anyway.

The request to the supplier should therefore state the international non-proprietary name, strength, form and pack, and list any brands or markets of origin the prescriber has already accepted. That lets the exporter search widely without offering products the hospital cannot use.

Build the justification before the permit

Most special access applications ask why the registered product cannot be used. During a shortage, a short file usually answers that question better than a general statement:

• the entry on the official shortage list, with its date and expected duration
• a written note from the local marketing authorisation holder or wholesaler that it cannot supply, which Kazakhstan's rules require where a registered analogue exists
• the quantity needed to cover the expected gap, rather than a long stockpile
• the prescriber's statement of the clinical need and of the products and strengths they accept

Keeping the quantity tied to the expected duration also makes the exit easier, since unused unlicensed stock can be hard to return or redistribute. The document checklist can be used to track each item.

Step by step: sourcing during a shortage

1. Confirm the shortage on the official list and note its reason and expected duration.
2. Check whether the regulator has announced a measure, such as an authorised import or a temporary permission.
3. Identify the special access route and who must apply, using the country guide.
4. Agree with the prescriber the acceptable products, strengths and markets of origin.
5. Ask the supplier in India for availability, batch, remaining shelf life and lead time. The lead-time estimator gives a planning range.
6. Collect documents and file the permit or notification. The document checklist lists what each route usually needs.
7. Ship under the right temperature control and record the brand, manufacturer and batch on receipt for pharmacovigilance.
8. Review supply when the shortage ends.

Plan the exit as well as the entry

Unlicensed supply during a shortage is meant to be temporary. In the United States, FDA decides when an imported product is no longer needed. In the United Kingdom, the MHRA Inspectorate has published guidance on what happens to unlicensed supply once an equivalent licensed product becomes available, which importers should read before stocking up. Ordering in smaller, repeated lots keeps the hospital from holding unlicensed stock it can no longer use.

Shortages can also be global. When the same active ingredient feeds several markets, a shortage in one country may soon appear elsewhere, including in India. Ask the exporter to confirm stock against a named batch before the permit is filed, and to say early if allocation limits apply. The guide on medicine pricing and lead times explains why scarce products often carry longer and less certain lead times.