Only multiple anti-counterfeiting strategies are able to beat increasingly sophisticated criminals, according to a seminar on anti-counterfeiting at the recent AAPS trade event in New Orleans.
“We are not dealing with a teenager using a chemistry set and a copier in a garage,” Dr Marv Sheperd, College of Pharmacy, University of Texas told in-PharmaTechnologist.
Counterfeiters are highly sophisticated, well-organised and sometimes supported by terror groups such as Hisbolah, he said.
To combat the counterfeiters, Dr Shepherd highlighted a range of strategies including: Serialisation labels, and packaging techniques.
Unique licence plate
Product serialisation, or equipping each bottle or box with a unique number, is becoming increasingly popular, said Shepherd. “It is like fitting products with a unique licence plate in the form of a two-tier bar code. Products can be rapidly authenticated by checking a central database,” he added.
Turkey was the first country to implement this system, France intends to adopt the approach next year and Germany has plans to introduce similar protection in due course.
According to a recent survey of 135 drug companies, 28 per cent have at least one product line equipped with a serialisation number, 23 per cent have this protection for more than one product and 10 per cent expect to launch programmes next year.
Other high-tech solutions include: Holograms equipped with hidden codes and nano-imagery, computer chips and micro-taggants (tags) which are invisible to the naked eye, radio frequency ID and botanical DNAA markers in inks, dyes and varnishes.
At least two types of anti-counterfeiting measures are recommended for drug packages and labels and at least one of them should be covert, he said.
Financial measures also have a role to play in fighting counterfeit crime, said Dr Shepherd. As US law enforcement agencies become more success at home, criminals are increasingly using rogue foreign websites to sell fake drugs.
To help block this route to market, the Food and Drug Administration (FDA) has set up a new task force to work with search engine companies such as Google and Yahoo to prevent the internet sale of fake drugs.
The FDA is also talking to bank card companies such as American Express about how best to prevent the sale of fake drugs.
African and Asian countries
Meanwhile, since 2000, counterfeit crime has been growing at the rate of 20 to 25 per cent per year. The World Health Organisation estimates that fake drugs account for up to 1 per cent of total consumption in developed countries and up tot 40 per cent in some African and Asian countries.
“China is the number one source of fake drugs,” said Dr Shepherd. In India fake drugs account for between 10 to 20 per cent of total consumption while in Russia the figure is up to 20 per cent.
Top targets for the counterfeiters now include not life-style drugs such as Viagra but mainstream medicines including genitor-urinary preparations, anti-infectives and cardiovascular and central nervous system preparations.