What is being done by generics manufacturers to prevent the counterfeit of pharmaceuticals?
Generics manufacturers take a variety of measures in order to prevent counterfeit pharmaceuticals from entering the legal distribution chain.
Their primary objective: safe medicines for all patients. Find out how to recognise counterfeits and how generic pharmaceuticals are made counterfeit-proof.
What are the characteristics of a counterfeit medicinal product?
A pharmaceutical is considered a counterfeit if it either does not contain the stated amount of active ingredient (too high or too low) or does not contain any active ingredient at all. It is also called a counterfeit if the preparation contains wrong or falsified ingredients. If there is an error in the documentation of the distribution channel or if genuine preparations have been stolen and put back on the market, the preparation or pharmaceutical in question is also a fake in the legal sense.
Can counterfeit pharmaceuticals be dangerous?
Yes. If a pharmaceutical preparation contains too much of the stated active substance or even another substance that has nothing to do with the stated substance, it can be life-threatening. There is a risk of overdose or poisoning. If, on the other hand, it contains too little of the active substance, this is also dangerous because the effect is impaired. Additionally, impurities contained within a pharmaceutical, e.g. through added substances, can have a damaging effect on the body.
How can a counterfeit-proof preparation be recognised?
Those who buy medicines from their local pharmacy or a legal online pharmacy receive safe medicines.
Generic manufacturers always print a code on prescription medicines. Before dispensing at the pharmacy, this code is scanned and compared. This ensures that only safe medicines enter circulation.
Prescription medicines always have an opening protection. This is a device on the package that makes it impossible to open the package unnoticed.
Generic manufacturers carry out checks at many stages of production to ensure quality and guarantee authenticity.
How can a counterfeit-proof preparation be recognised?
Since 2019, the European Anti-Counterfeiting Directive (2011/62/EU) has stipulated mandatory security features for prescription medicines. In Germany, the electronic verification system is called securPharm and is part of the European anti-counterfeiting system.
All member companies of Pro Generika have invested many millions of euros to implement these security standards and thus ensure protection against counterfeits in Germany.
Complex transformations of production processes and an extensive adjustment of all IT systems were necessary to achieve this.
Above all, there are two central measures that guarantee the authenticity of a pharmaceutical preparation:
Each package must include a unique code which is imprinted during production. Before the patients can receive their medication at the pharmacy, the package has to be scanned. The data are immediately compared with those of the manufacturer in a database. If they match, it is certain that the medicine is not a counterfeit. Passing on a counterfeit in the pharmacy is thus virtually impossible.
Along with the unique code, sealed packaging is also a mandatory requirement. This is a specific kind of seal that is attached to each package. This ensures that a package cannot be opened unnoticed.
Caution: If there is neither a code nor a seal on the packaging of a prescription medication, it may be a counterfeit.
How are counterfeits distributed?
For the most part, counterfeit medicines are sold on the black market, usually through illegal online shops. Online shops that sell prescription medication without requesting to see a prescription, or merely after filling out an online questionnaire, are illegal in any case and can therefore only sell counterfeits. It is therefore essential for consumers to only order pharmaceuticals from their pharmacy or a designated online pharmacy, and never from other online vendors!
Is it possible for a pharmacy to hand out counterfeits?
No. Through the legal distribution channel - which runs from the manufacturer via the wholesaler to the pharmacy - counterfeiting is virtually impossible. So if you buy your medicine from a local pharmacy or an authorised mail-order pharmacy, you can be relatively sure that you are getting an original product. It is important to always look for the EU safety logo when ordering from an online pharmacy. Mail-order pharmacies must display this in their national language on their website. By the way, according to German pharmaceutical law, private individuals are not allowed to obtain medicines from non-EU countries via mail order.
The German Federal Institute for Drugs and Medical Devices (BfArM) explains here how the EU safety logo can be used to distinguish reputable from dubious suppliers.
Which pharmaceuticals are most frequently counterfeited?
Anything that promises profits for criminals, is potentially being forged. In Germany, it is mainly potency, slimming or hair-growing products that are counterfeited. However, counterfeits of cancer drugs, malaria medicines or cholesterol-lowering medicines also turn up again and again around the world.
How do generics manufacturers ensure quality and authenticity along the chain of production?
Generic companies take a variety of measures to prevent counterfeit ingredients or preparations from coming into circulation. Specifically, this means:
- All ingredients must pass quality controls
On-site inspections, so-called "audits", are carried out worldwide for precursors, active ingredients, excipients, finished medicinal products, etc. Inspectors from the supervisory authorities (regional councils) check whether the quality requirements are met.
- Every delivery is checked for authenticity
Pharmaceutical companies themselves check the quality of every incoming delivery. They take "chemical fingerprints" in the incoming inspections, by which they recognise authenticity and degree of purity. All test results are archived and submitted to the authorities (EMA, BfArM, Paul-Ehrlich-Institut and local regulatory authorities) during inspections.
- Production processes are continuously monitored to ensure quality
Numerous checks and analyses are carried out from the production of the active ingredient to the packaging, e.g. to check whether the concentration of the active ingredient and the purity are correct.
- Drug packages are provided with authenticity features
The appearance of drug packaging (blisters, folding boxes, ampoules, etc.) is precisely defined. Furthermore, generic companies implement additional protective measures which they are not legally obliged to do, but which make counterfeiting even more difficult. For example, they equip packaging with individual security features, such as holograms. In addition, since 2019 all prescription medicines in the EU must be provided with an opening protection and a unique code.
- Recipients and deliveries are conscientiously documented
When delivering medicines, generic companies keep precise records of who the recipient is and what batch numbers the delivered medicines have. This makes traceability possible.
- Every suspicion of counterfeit is investigated
The manufacturers evaluate all reported adverse drug reactions (ADR) and suspected cases. They immediately report any suspicion of counterfeit medicines or active ingredients to the German drug authorities (BfArM, Paul-Ehrlich-Institut).
In coordination with the authorities, wholesalers and pharmacies are informed as soon as a counterfeit appears and how it can be recognised. They are also informed which batches of medicinal products must be withdrawn from circulation as a precaution. At the same time, the authorities inform each other throughout Europe.
What should be done in the event of a suspected counterfeit?
If you have doubts about the authenticity of a medicinal product, it is best to bring it, including the packaging, to your nearest pharmacy. There, the pharmacist can check, whether it is counterfeit or arrange for a laboratory test. The Drug Commission of the German Pharmacists (AMK) as well as the Central Laboratory of German Pharmacists (ZL) are the pharmacies' contacts for dealing with and investigating suspected cases of counterfeit medicines.