Drawing on the comments from the industry in the likes of the International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT), the US Food, Drug Administration (US FDA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Drucker presented the current conditions of drug counterfeiting problem and provided insights on combating the growing trend to delegations who are experiencing the effects of the problem at the ground level.
“Consumers are driving the demand for more blockbuster ‘lifestyle’ medicines and that demand has created for illicit use,” said Drucker.
“There is an easy access to these drugs as consumers are more aware of them and embrace internet shopping. There is a growing self-prescribing culture that reduces prescription costs.”
Against this backdrop, Drucker said illegal drug dealers who deal with drugs such as cocaine and heroin are switching to dealing with counterfeit drugs.
“Illegal drug dealers see that there is money to be made in drug counterfeiting. They see low risks of being caught and low penalties when they are caught. It costs less to procure the materials that are easily available.”
“With advancing technology, these perpetrators are also harnessing sophisticated systems to replicate fake drugs that mirrors closely to the real ones.”
While the groups behind the counterfeit drugs remain unknown to the industry at large, Drucker said such syndicates are highly sophisticated, organized and not “the small time businesses”.
“Organised criminals, networks of criminal ‘contacts’, pseudo businessmen and terrorist organizations are most likely to be attracted to form drug counterfeiting rings and these drugs shakes the foundation of the healthcare system,” he said.
“This concerns the safety of public health. How far can we work on validation of drugs on a day to day basis? There is a need for testing systems for reliability of drugs in the industry.”
He said a weak supply chain management provides a chance for counterfeit drugs to subtly enter the chain.
Drug RepackagingRepackaging of drugs is one avenue for counterfeit drugs to enter into the chain. Drucker said repackaging of drugs is accepted in the industry as it lowers drug prices, demand for more products can be generated and companies need to repackage drugs to suit different market preferences.
“Some markets would prefer the drugs to be packaged in bottles, whereas others prefer to be packaged in unit doses or blister packaging.”
Securing the repackaging environment, Drucker said adhering to the strict repacking rules set by the EFPIA and Pharmaceutical Research and Manufacturers of America (PhRMA) on labeling is important.
Both advocate stricter licensing controls, increased penalties and fine systems for companies that do not comply with the regulations, implement unique numbering systems, and encourage use of overt, covert, tamper-evident technologies such as radio frequency identification (RFID) for drug traceability.
“Regulators agree on key principles revolving legislation, regulations, enforcement, technology and communications to strengthen the weak links in the supply chain,” said Drucker.
“On the regulatory level, infrastructures are developing to detect and react to situations that include the national agencies. There is also an international focus on countries with weak regulatory infrastructures.”
“Regulators are also developing investigative systems that are similar to narcotics and monetary counterfeiting that utilize policing infrastructures like the Interpol.”
However, Drucker concluded that counterfeiting is a global problem that is limited not only to drugs.
“Get the fundamentals first. Secure the supply chain, increase penalties for counterfeiting, increase enforcement and auditing of the supply chain, inform public of risks and foster better communications and cooperation within the public and private sectors,” he concluded.
“Know that technology is not a silver bullet but a tool for detection and support in investigation and prosecution.”PA
