Low-quality and counterfeit pharmaceuticals

(This entry was written in 2013. It will be updated in 2016.)



Until recently, detecting low-quality and counterfeit pharmaceuticals required access to complex testing equipment, often unavailable in developing countries where these problems abound. The enormous amount of trade in pharmaceutical intermediaries and active ingredients raises a number of issues, from the technical (improvement in manufacturing practices and analytical capabilities) to the ethical and legal (for example, India ruled in favor of manufacturing life-saving drugs, even If it violates US patent law).

In the developing world, where there is less regulatory oversight, the problem of counterfeit drugs is the most widespread. “According to the World Health Organization, 200,000 people a year die because ineffective, fake, and substandard malaria drugs don’t clear their systems of the parasite. And because these pills often contain small amounts of active ingredient—enough to abate some symptoms but not cure disease—they contribute to drug-resistant strains.” (Source)

What are counterfeit drugs and why are they dangerous?


WHO Fact Sheet on spurious/falsely-labelled/ falsified/counterfeit (SFFC) medicines (World Health Organization)

Counterfeit medicine (FDA)

Counterfeit Pharmaceutical Inter-Agency Working Group Report to the Vice President and Congress (White House) – pdf document

Fact Sheet on counterfeit drugs (National Association of Boards of Pharmacy)

Pharmaceutical crime (Interpol)

Counterfeit drugs in the developing world

Counterfeit drugs

Cracking down on counterfeit drugs (NOVA Next)

Counterfeit drugs continue to threaten lives in developing countries(Scientific American)

Exposing and eradicating the dark world of fake pharmaceuticals (Forbes)

Pill of Goods: International counterfeit drug ring hit in massive sting (Scientific American)

India’s market in generic drugs also leads to counterfeiting (Washington Post)

The Fatal Consequences of Counterfeit Drugs (Smithsonian Magazine)

How fake drugs cause the spread of untreatable TB in developing countries(Washington Post)

New technologies to detect counterfeit drugs

Simple New Test to Combat Counterfeit Drug Problem in Developing Countries(Science Daily)

How To Detect Counterfeit Drugs (Popular Science)

How one startup is fighting counterfeit drugs in developing countries — one cellphone at a time (Med City News)

Rwanda’s approach proves perfect antidote to counterfeit drugs (The Guardian)

Swiss technology battles fake drugs (Swiss Broadcasting Corporation)

The PADS Project
(Paper Analytical Device)

Reilly Fellow Marya Lieberman is the research head of the Notre Dame half of The PADs Project.

The PADs Project is a collaborative multidisciplinary research effort with the goal of developing simple inexpensive chemistry-based tests that can be used by most anyone, anywhere to help determine if a pharmaceutical is real or fake.

A PAD is a piece of paper, about the size of a business card, that has been impregnated with a chemical reagent(s). When an analyte (e.g. a suspicious antibiotic) is applied to the PAD it will interact with the reagents in such a way that, if the sample is legitimate, certain colors will be produced. If the analyte is a counterfeit, then the wrong colors (or no colors) will form. (from the PADS website)