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Counterfeiting

Counterfeit medicines are now being found with unnerving frequency, even in the legitimate supply chains of developed markets such as the US and Europe. For manufacturers, regulators and other healthcare stakeholders that raises many issues, including the threat to public safety, the need to improve supply chain security and corporate accountability.

Discovery of tampered vials leads to Roche cancer drug recall

16-Apr-2014 - Roche has recalled nine batches of breast cancer drug Herceptin after tampered vials were discovered in the UK, Finland and Germany.

UPDATE

Sugar in place of APIs discovered in EU's largest fake drug seizure

14-Apr-2014 - Fake aspirin and anti-diarrhoeal medicines were amongst the largest counterfeit drugs haul discovered to be destined for the European Union, a French customs official says.

Counterfeit crackdown: EDQM launches fake drug database

02-Apr-2014 - Collating drug counterfeiting cases from across Europe into a central database will help law enforcement authorities catch criminals trying to flood the region with fake medicines, according to the EDQM.

Portable tech advancing fight against counterfeits, says MHRA

01-Apr-2014 - Making API detecting technologies more portable has been a major development in the fight against counterfeit drugs, according to the MHRA, though the biggest threat comes from online sellers.

EU votes to let customs stop and destroy fake drugs shipped through Europe

03-Mar-2014 - Plans to give customs officers the power to seize and destroy suspected fake medicines as they move through the EU have been welcomed by industry group EFPIA.

Pfizer, Lilly and other giants team up to fight counterfeits

30-Jan-2014 - Big pharma rivals are joining forces to pursue a new generation of sophisticated counterfeiters, according to Pfizer and Eli Lilly.

Brazil gives drugmakers 3 years to set up 2D track and trace system

17-Dec-2013 - Firms selling drugs in Brazil have three years to implement track and trace systems capable of monitoring drugs from the factory floor to the pharmacy under a new plan approved...

News in brief

Rx-360 welcomes new US track and trace laws

02-Dec-2013 - A drug industry supply chain group has welcomed the introduction of new US laws designed to make it easier to track pharmaceuticals through the supply chain.

update

Happy Thanksgiving - US track and trace plans signed into law

28-Nov-2013 - The US FDA has started work on a national track and trace system for pharmaceuticals after President Barack Obama signed the Drug Quality and Safety Act into law last night.

US set for track and trace after Senate passes quality and security Bill

19-Nov-2013 - US authorities will soon have a new system capable of tracking drugs from the factory floor to the pharmacy shelf after the Senate passed the “Drug Quality and Security Bill”...

Johnson & Johnson to pay $2.2bn in Risperdal misbranding case

05-Nov-2013 - In one of the largest healthcare fraud settlements in US history, Johnson & Johnson has pleaded guilty to introducing a misbranded drug and must pay approximately $2.2bn (€1.6bn) to resolve criminal...

Comment

Unregistered vs fake - How terminology sparked a media war in Ghana

21-Oct-2013 - In calling an unregistered product ‘fake,’ the Ghanaian FDA has sparked a media war with industry, but are critics using this as an excuse to knock the regulators whilst importers...

Swiss intercept 400kg of counterfeit Xanax en route to Egypt

21-Oct-2013 - Airport customs in Zurich, Switzerland announced Friday that they intercepted more than a million counterfeit drugs labelled as Pfizer’s Xanax.

Ghana FDA defends blanket ban after calling Bliss' anti-malaria drug 'fake'

14-Oct-2013 - The Ghanaian FDA has defended its decision to ban all imports from India' Bliss GVS amid growing industry concerns about the speed of the agency's decision making.

Drugs are not fake, says Indian drugmaker 'baffled' by Ghana FDA ban

08-Oct-2013 - Bliss GVS says allegations of supplying fake medicines and a blanket ban imposed on its products by the Food and Drugs Authority Ghana (FDA) are both “harsh” and “baffling.”

Update

California to amend track and trace law to deal with ‘drop shipments’

19-Sep-2013 - The California Board of Pharmacy is proposing to amend the state pharmaceutical track-and-trace legislation to exempt wholesalers from e-pedigree requirements in cases where manufacturers directly ship drugs to pharmacies.

Microsoft's Cloud Platform to Help EU Fight Fake Drugs

15-Jul-2013 - The EFPIA has selected software firm Solidsoft for its anti-counterfeit European Medicines Verification System (EMVS) powered by Microsoft's cloud-based platform Windows Azure.

Rwanda Sets Example for East Africa in Rooting Out Counterfeit Drugs

11-Jul-2013 - Simple steps to secure Rwanda’s pharma supply chain may serve as an example for other larger African countries looking to curtail the spread of falsified or substandard drugs, experts say....

News in brief

FDA Cracks Down on Illegal Websites

01-Jul-2013 - The US FDA has taken action against websites illegally selling drugs as part of an international anti-counterfeiting operation.

Pfizer Sells On-Line to Dampen Fake Viagra's Rise

07-May-2013 - Pfizer has begun selling Viagra online in order to counter the trade in fake versions of its erectile dysfunction drug.

DISPATCHES FROM INTERPHEX

AlpVision's iPhone Tech Offers Authentication in War on Counterfeits

07-May-2013 - In the war against counterfeits, regulators have concentrated on serialisation and ePedigree and missed an opportunity on product authentication, according to AlpVision.

update

Sanofi Starts Semisynthetic Malaria Drug Production

17-Apr-2013 - Sanofi has started making artemisinin using a novel semisynthetic method it says will strengthen the global supplies of malaria drugs.

MHRA: Full Force of UK Law Against Drug Counterfeiters

02-Apr-2013 - The global rise in counterfeit medicine and illegal online pharmacies is a regulatory ongoing battle, according to the MHRA.

Raman Spectroscopic Device in Fight Against Counterfeit Drugs

27-Feb-2013 - As an FDA commissioned report on counterfeit drugs is released the potential to detect them may lie in a handheld API analyzing device.

update

Denmark asks API users to register; EU sets out GMP assessment criteria

29-Jan-2013 - Danish companies that make, use, distribute or import APIs will need to register by March 1 or cease operations according to the Danish Health and Medicines Authority (DKMA).

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