As Anti-Counterfeiting Approaches Diverge, Industry Calls for Harmonized Solutions
This article was originally published in The Gold Sheet
Executive Summary
As regulatory anti-counterfeiting approaches diverge, industry seeks global harmonization. Counterfeiting grows while lack of cooperation hampers enforcement. WHO recommends measures to improve coordination. China looks to close API loophole. FDA hears from industry about pedigrees, RFID, 2D barcodes and GS1. Concerns raised about EU parallel trade. EU proposal draws industry support, though some question mandatory sealing, and questions remain about counterfeit APIs. Holograms appear to be useful tools for anti-counterfeiting in Malaysia and Nigeria. Incremental approach urged.
You may also be interested in...
Full Track-and-Trace Anti-Counterfeiting Not Feasible, Industry Tells FDA
The U.S. pharmaceutical industry is telling FDA that a full track-and-trace approach for following drugs through the supply chain is not the best way of dealing with the growing counterfeit problem. In the meantime, industry is devising a number of different approaches.
Full Track-and-Trace Anti-Counterfeiting Not Feasible, Industry Tells FDA
The U.S. pharmaceutical industry is telling FDA that a full track-and-trace approach for following drugs through the supply chain is not the best way of dealing with the growing counterfeit problem. In the meantime, industry is devising a number of different approaches.
Anti-Counterfeiting Advances Regionally Despite Global Impasse
Counterfeits or substandard generics? Clash over definitions roils global anti-counterfeiting initiative. WHO IMPACT members divide over conflicting goals: protecting brands from counterfeits; protecting generics from being branded as counterfeits; and protecting emerging markets from substandard generics. Blowup over Dutch customs seizures. IMPACT begins to regroup as anti-counterfeiting regulatory landscape grows increasingly complex. U.S. pursues slow-tracked trace-and-trace; California e-pedigree stymied. The E.U. advances with pharmacy verification approach, registers a success with EFPIA pilot. Council of Europe works to criminalize counterfeit drugs. USP and AID minilabs would empower developing regulators. One third of antimalarials were substandard. Nigeria enables consumers to check for counterfeits by cell phone. Baxter takes layered approach. A pressing need for on-dose protection seen, but it must be covert. The day of mass serialization will arrive, but there will be no panacea.