Counterfeit and Substandard Antimalarial Drugs

What are they?

Counterfeit (fake) antimalarial drugs or substandard antimalarial drugs may contain no active ingredients, less than the required amount of active ingredients, or ingredients not described on the package label. Manufacturers of counterfeit drugs tend to copy more expensive brands of drugs and make them look like brand-name drugs. Substandard drugs are made by manufacturers trying to avoid costly quality control and good manufacturing practices.

Where can they be found?

They can be found anywhere, but they are especially prevalent in developing countries lacking effective drug regulatory agencies as well as resources required to effectively evaluate drug quality.

What other types of antimalarial drug quality issues can be found?

• Drugs with varying amounts of the active ingredient due to lack of regulations, lack of enforcement of existing regulations, or weak quality control practices.
• A tablet’s inability to release drug, due to poor formulation techniques.
• Chemical breakdown of drugs caused by storage conditions, especially in warm, humid climates.
• Contamination with other substances due to poor manufacturing procedures.
• Incorrect expiration dates resulting from repackaging of expired drugs.

How can I avoid buying counterfeit or substandard antimalarial drugs to prevent malaria when I travel to an area with malaria transmission?

• Buy the antimalarial drugs you need in your home country.
• Write down the drug's generic and brand names as well as the name of the manufacturer so in case you run out, you can look for the correct product.
• Make sure that the drug is in its original packaging.
• Inspect the packaging because many times poor quality printing indicates a counterfeited product.
• Be suspicious of tablets that have a peculiar odor, taste, or color, or ones that are extremely brittle.

The quality of commercially available drugs varies greatly in malaria-endemic countries:

• The amount of the active ingredient can vary due to lack of regulations and poor quality control practices in many of these countries.
• Some pills may release very little if any drug due to poor formulation techniques
• Chemical break-down of some drugs can occur due to poor storage conditions, especially in warm and humid tropical climates,
• Some drugs may be contaminated with other substances.
• Counterfeiters may also obtain expired drugs and repackage them with new expiration dates.

What are countries with malaria transmission doing about this problem?

With help from the Global Fund, the U.S. Agency for International Development, and CDC, countries are improving their capacity to monitor the appearance of counterfeit drugs and improve regulatory functions.

How is CDC (or CDC and its partners) addressing this issue?

CDC is currently collaborating with the London School of Hygiene and Tropical Medicine and the Georgia Institute of Technology on a project surveying and evaluating the quality of ACTs in Africa. CDC is also working with the U.S. Food and Drug Administration and Georgia Institute of Technology to evaluate new techniques to quickly identify counterfeit medicines. We are also assisting our collaborators in the Lao People’s Democratic Republic and Burma (Myanmar) by performing chemical analysis of suspect pharmaceuticals.

More on: FDA.gov: Counterfeit Medicine

More on: WHO: General Information on Counterfeit Medicines

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