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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.

Annual WHO meeting to tackle spread of substandard drugs

06-Feb-2012 - The WHO is urging countries to collaborate on tackling substandard drugs and strengthening supply chains at a new annual meeting.

FDA calls for more powers to adopt nationwide ePedigree

02-Feb-2012 - The US FDA has called for more authority to ensure any track-and-trace system is binding for industry and pre-empts state laws.

EU could make API suppliers verify starting material sources

26-Jan-2012 - Europe is considering forcing API manufacturers to verify the source of starting materials as part of GMP revisions.

PIC/S adds GDP to remit to tackle supply chain threats

17-Jan-2012 - PIC/S has strengthened promotion of global GDP harmonisation and confidentiality in a revision to its documentation.

US fake drug seizures up 200%

10-Jan-2012 - The value of counterfeit pharmaceuticals seized at US borders jumped 200 per cent in 2011 as enforcement actions took effect.

USP publishes draft supply chain integrity chapter

09-Jan-2012 - The USP has published draft supply chain integrity guidance outlining steps to stop counterfeit or adulterated drugs reaching patients.

SE Asia likely source of fake anti-malarials in Africa; study

20-Dec-2011 - Counterfeit anti-malarials containing the Viagra API were probably manufactured in Southeast Asia, researchers found.

Drug quality treaty needed to raise standards, academics say

15-Dec-2011 - A treaty on medicine quality is needed to fix the major public health problem of substandard drugs, according to academics.

FDA anti-adulteration efforts hindered by industry; GAO

28-Nov-2011 - Industry reluctance to share information on economic adulteration is hindering FDA efforts to tackle tainted ingredients, a GAO report found.

EC seeks industry feedback to shape serialisation policy

24-Nov-2011 - The EC is seeking industry comments before implementing the serialisation aspect of the falsified medicines directive.

Trust in drug source may blind wholesalers to counterfeits

15-Nov-2011 - Wholesalers’ trust in the quality of products from some countries could decrease vigilance and allow counterfeits to reach pharmacies, research found.

Avantor to add tamper-evident seals to raw material containers

20-Oct-2011 - Avantor is to offer tamper-evident seals on all its pharma raw material and excipient containers by the end of the year.

Tech needed to cut rise of fake drugs on Twitter, research says

17-Oct-2011 - Spam filtering and identification is needed to stop Twitter becoming another platform for pushers of fake or substandard drugs, researchers say.

Sproxil & Orange fight for anti-counterfeiting market in Kenya

13-Oct-2011 - Sproxil and Orange have separately expanded text messaging anti-counterfeiting services in Kenya to tackle fake drugs.

FDA releases final guidance on anti-counterfeiting excipients

12-Oct-2011 - The FDA has published final guidance on the use of excipients as anti-counterfeiting tools in solid oral dosage forms.

Ukraine votes to criminalise drug counterfeiting

26-Sep-2011 - Ukraine's parliament, the Verkhovna Rada, has voted unanimously in favour of new legislation which will criminalise the production and trafficking of counterfeit drugs.

Rx-360 begins audit sharing to raise ingredient quality

21-Sep-2011 - Rx-360 has begun its audit sharing programme to increase knowledge about suppliers and the quality of pharmaceutical raw materials.

FDA asks for powers to stop another heparin-like crisis

15-Sep-2011 - The FDA needs additional powers to update its “antiquated, domestically-focused statute” and end the “competitive advantage of non-compliance”, an agency official said.

News in brief

Counterfeiters target countries with weak laws says Antigua Pharma Society

24-Aug-2011 - Drug counterfeiters are using the Caribbean as a transport hub to ship fake pharmaceutical around the world according to the Antigua Pharmaceutical Society.

Foreign investment needed to boost UAE drug production

24-Aug-2011 - The UAE needs overseas investment to kick-start its pharmaceutical manufacturing sector and end reliance on foreign imports, the DCCI says.

HP launches ‘cloud’ track and trace system to help fight counterfeits

04-Aug-2011 - HP has launched a global authentication service it says will help identify counterfeit and stolen pharmaceuticals.

EC drafts GDP guidance to tackle supply chain threats

18-Jul-2011 - Europe has proposed draft distribution guidance in response to globalisation and threats to the pharmaceutical supply chain.

Tamper evident devices must be traceable & unique; Rx-360

18-Jul-2011 - Physical endurance, traceability and uniqueness are key characteristics for tamper evident devices used in raw material supply, according to Rx-360.

FDA must be empowered to oversee supply chain; report

13-Jul-2011 - Congress must grant the FDA additional powers to bring oversight of manufacturing inline with shifts in production practices, according to a report.

USP publishes free drug quality standards collection online

04-Jul-2011 - The USP has published a free, online collection of standards to support drug quality, particularly where regulatory resources are limited.

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