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Hot Topics > 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.

‘Game changer’: latest GDP rules spell full traceability for APIs

26-Mar-2015 - Makers and distributors of APIs (active pharmaceutical ingredients) will have to track their products throughout the supply chain and meet rules on cold chain transport and outsourcing under revised guidance...

WHO calls for proactive strategies to combat falsified, substandard medicines

23-Mar-2015 - The WHO’s latest report on substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products has the organization divvying up certain responsibilities for controlling the fraudulent products between countries.

EU safety logo set to tighten net on dodgy food supplement sales

10-Mar-2015 - The Danish and Austrian authorities have warned against toxic food supplements ahead of an EU-wide safety logo set to crack down on illegal retailers posing as online pharmacies.


Switzerland rejects allegations it offers drug fakers easy route to the EU

12-Feb-2015 - The increase in dodgy erectile dysfunction drugs seized in Switzerland does not mean the country is a weak point for counterfeiters shipping to Europe according to Swissmedic.

Think you’re on track for 2018 EU serialisation? No you’re not

04-Feb-2015 - Most pharmaceutical companies are already behind on preparations for the EU Falsified Medicines Directive’s serialisation requirements for 2018, says one services firm.

News in brief

30 months for smuggler of Roche cancer drugs which lacked API

26-Jan-2015 - A second man has received a prison sentence after counterfeit vials of a Roche cancer drug containing no API were seized in 2012.

FDA blocks Australia site from importing tainted Cialis as Lilly claims innocence

12-Jan-2015 - The US FDA has published an import alert for an Australian manufacturing site of Eli Lilly after the agency found that its Cialis pills were tainted with the active ingredient...

Illicit vendors using YouTube to advertise fake drugs, says MHRA

08-Jan-2015 - Regulatory enforcement saw fewer counterfeit drug websites in 2014 but sellers are turning to YouTube and social media sites to advertise their products, according to the MHRA.

Not prepared for track & trace? US FDA grants amnesty until May

05-Jan-2015 - The US FDA will give drugmakers and distributors until May to comply with new track and trace laws in order to minimise disruptions in the supply chain.

Anti-counterfeiting: EMD Serono lets patients scan meds on iPhone

16-Dec-2014 - Patients and pharmacists can now use smartphones to check biologics are genuine with a new Merck Serono tech launched to combat counterfeiters' growing interest in high-value biopharma drugs.

news from the edqm 50th anniversary conference

Food supplements are Europe's real counterfeit drug problem says AIFA expert

15-Oct-2014 - Drug active ingredients in food supplements are Europe’s real falsified medicines problem according to the head of AIFA’s counterfeit prevention team.

Dispatches from EDQM conference

EDQM set to fight fakes and forge closer ties with EMA

07-Oct-2014 - Counterfeit drugs and collaboration will be key topics for the EDQM say delegates at the organisation's 50th anniversary conference on Monday.

India accuses American Enterprise Institute researchers of "smear campaign"

29-Sep-2014 - The Indian Government has accused the authors of a paper analysing the quality of drugs sold in Africa of leading an attack on the Indian drug industry, but researcher Roger...

GS1 offers guide for adhering to new US supply chain security law

24-Sep-2014 - As the US Drug Supply Chain Security Act (DSCSA) traceability requirements become mandatory in 2015, standards group GS1 is offering a 137-page guideline to help manufacturers follow the new stipulations.

Gangsters imported fake drugs from Asia says Europol

02-Sep-2014 - Millions of fake pharmaceuticals seized earlier today were imported from Asia by an organised crime group that planned to sell them online say European law enforcement agencies that co-ordinated the...

WHO and USP programme to help manufacturers of key drugs

19-Jun-2014 - The WHO, the United States Pharmacopeial Convention (USP) and the US Agency for International Development (USAID) will work with regulators to help countries manufacture a key tuberculosis drug.

Two more Roche biologics stolen, say Italian authorities

11-Jun-2014 - Vials of two Roche biologics have been stolen and distributed illegally from Italy, say authorities.

US FDA proposes rule to tighten supply chain by destroying illegal imports

07-May-2014 - The US FDA is proposing a new rule that would allow the agency to destroy a drug valued at $2,500 or less that has been refused admission into the US. 

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.


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...

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