Counterfeit drugs are medicines that do not match the description on the label in some way. They may be contaminated, or may contain the wrong active ingredients, the correct active ingredient in the wrong amounts, or no active ingredients at all. Counterfeits may also be out-of-date drugs that have been repackaged with new expiration dates. Drugs can also be considered counterfeit if they contain the right ingredients in the right amounts, but they are not made by the manufacturer described on the label.
All kinds of drugs can be counterfeited, including prescription and non-prescription medicines, branded and generic, drugs for humans or animals, "lifestyle", and life-saving drugs.
Why is it so hard for the regular consumer to protect themselves?
Partly because countrefeits are so hard to detect.
Retailers use special pens that indicate certain forms of counterfeit bills. There are relatively easy tests for coin collectors and metal traders to use to identify fake gold or old coins. These tests aren't foolproof, but they catch a lot of fakes. Why isn't there something similar for drugs? Partly because the indicators of counterfeiting are much harder to find.
Counterfeit prescription drugs found recently include Lipitor, Procrit, Tamiflu, Amoxicillin, Halfan syrup and capsules, Ventolin asthma inhalers, Epogen (used by organ transplant recipients), and vaccines for meningitis. Counterfeit drugs for diabetes, cancers, epilepsy, heart disease and schizophrenia have all been seized. Fake contraceptive pills and artesunate (an anti-malarial drug), both containing 100% flour have been discovered, while another anti-malarial drug contained sildenafil, the main ingredient in Viagra.
Counterfeit drugs have been around for centuries. Cinchona bark in the 17th Century and quinine (for malaria) in the 19th Century were known to be counterfeited. (Counterfeit malaria medicines continue to be a problem today.)
Problems caused by counterfeiting
Counterfeits usually contain substandard or inactive ingredients, which means they may not help the condition for which they were prescribed, and they may even have dangerous side effects. It also means resistance to the genuine drugs can increase, and this has been especially true for malaria, HIV/AIDS, and tuberculosis in developing countries. The low levels of the active ingredients in the drugs mean that weaker causal agents are killed, but those with some drug resistance survive and multiply. For example, there has been a doubling of global deaths from malaria over the last couple of decades as the disease has become more resistant to a number of drugs.
In Africa an increase in counterfeit anti-retroviral drugs for HIV/AIDs has caused this virus to become increasingly resistant to the therapies of choice, forcing doctors to resort to more toxic second-line anti-retrovirals, which require hospitalization and can be up to 20 times more expensive, all of which makes them virtually inaccessible to many of the most vulnerable and desperate.
Scope of the problem
Counterfeit pharmaceuticals are becoming much more prevalent globally. In 2006 the IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) estimated that in developed countries such as the US counterfeit drugs account for only around 1% of the market value, but this is increasing. In many of the former Soviet countries the rate is estimated at 20%, while in developing countries 10-30% of drugs are fake. One recent study of prescription drugs on sale in Nigeria’s capital, Abuja, found 80% were counterfeit, with 7% containing dangerous ingredients. In medicines bought over the Internet, IFPMA estimates up to 50% of those sold by sites that do not divulge a physical address are counterfeit.
The volumes involved in the crime are staggering. In December 2000, for example, counterfeiters in China were caught preparing to export 43 tons of fake drugs covering seven drug companies and 17 brands of drugs. Globally, over three million counterfeits were intercepted in the last year.
The problem is deadly in many places. For example, more than 500 patients, mostly children, have died in recent times from counterfeit paracetamol syrup containing diethylene glycol, in Nigeria, Bangladesh, India, Haiti and Argentina. Even worse, the World Health Organization suggests up to 200,000 people (90% of them children) die of malaria every year as a result of unwittingly taking ineffective counterfeit drugs, and this is in addition to those dying because of growing resistance to the legitimate drugs.