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  • Report: EU Anti-counterfeiting Directive Attracting Industry Praise, Scorn

    • 30 April 2012
    A rash of counterfeit drugs invading the European pharmaceutical supply chain is spurring EU legislators to develop a new anti-counterfeiting directive that has attracted both the praise and scorn of regulated industry, reports Reuters . The European Commission's planned Directive involves requiring pharmaceutical products "to be sold in tamper-proof packs from 2016, each with a unique identifier allowing them to be tracked through the supply chain," writes Reuters . ...
  • After Crackdown on Counterfeits, a 'River of Pills'

    Regulatory Focus and other media outlets reported on 24 April about China's crackdown on counterfeit medications, which found dozens of manufacturing facilities using industrial-grade gelatin in pharmaceutical capsules. Now Chinese authorities have found something else that is perhaps even more surprising: a small river filled with millions of discarded drug capsules. Gizmodo reports 300 meters of an open sewer ditch were transformed overnight into a "rainbow river,"...
  • Report: 'Track and Trace' Anti-Counterfeiting Provisions Likely Casualty of User Fee Markup

    • 25 April 2012
    A long-awaited and much-called-for plan to introduce a 'track and trace' plan to cut down on pharmaceutical counterfeiting may be cast by the wayside in the legislative markup process for new legislation, reports Reuters ' AlertNet . Track and trace programs, used by regulatory authorities to keep track of authentic drugs and trace their transmission through the supply chain, have been receiving increased attention in recent years. The US Food and Drug Administrati...
  • China Probe Into Chromium-Laced Capsules Escalates, 77M Capsules Seized

    Chinese regulatory authorities have announced the expansion of a probe into pharmaceutical capsules illicitly laced with Chromium, saying they have arrested nine more people, detained a further 45 and seized more than 77 million capsules, reports Reuters . Chromium is a heavy metal that has been associated with cancer in some circumstances. Chinese authorities originally announced on 15 April that they had found 13 pharmaceutical products-including antibiotics-to have b...
  • After Counterfeit Avastin Infiltrates Supply Chain, FDA Goes After Doctors

    The US Food and Drug Administration (FDA) is going after doctors in an attempt to protect the pharmaceutical supply chain from more instances of counterfeit medicines, reports Medscape News . There have been two instances of fake Avastin being found in the US in 2012-one in early April and another in mid-February . Both cases involved doctors deviating from approved suppliers to purchase Avastin from unauthorized wholesalers. While FDA Commissioner Margaret Hamburg ...
  • EDQM Continuing Development of New, Comprehensive Anti-Counterfeiting Strategy

    • 18 April 2012
    The European Directorate for Quality in Medicines and Healthcare ( EDQM ), the Council of Europe's (EC) pharmaceutical standards body, announced it is continuing to develop and expand a new anti-counterfeiting strategy it says will reduce pharmaceutical-related crime. In its 18 April announcement, EDQM said the multi-layer legislative strategy aims to increase, among other things, training for inspection officials from EC member states, increased inspection and testing a...
  • China Finds 13 Drugs Made With Excessive Levels of Chromium

    China's State Food and Drug Administration (SFDA) announced 15 April it had found 13 pharmaceutical products to have been manufactured with excessive levels of chromium and was suspending the sale of those products, reports The Wall Street Journal . The chromium was found to have emanated from drug-capsule manufacturers in the Zhejiang province in China, which were reported to be using industrial gelatin instead of gelatin marked for human consumption. The industrial-gr...
  • Indian Task Force Recommends Adoption of Authentication System for Pharmaceuticals

    Taking a page out of the anti-counterfeiters' playbook, a high-level Indian task force has recommended the adoption of verification technology and mobile text messaging authentication for medicines produced and sold in India, reports BioSpectrum Asia . The technology is already in use in some African countries such as Kenya and Ghana , but the adoption scale recommended by the Union Health Ministry's task force on pharmaceutical manufacturing would dwarf those in sca...
  • Hamburg Calls for New Authority, Strengthened Anti-Counterfeit Laws

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said in a statement she believes existing pharmaceutical anti-counterfeiting laws are grossly inadequate to deter illicit activity, saying counterfeiters deserve "more severe consequences." Hamburg's 10 April statement on FDA Voice , FDA's blog, made clear she believes the Federal Food, Drug and Cosmetic Act (FD&C Act) is outdated. "[The FD&C Act ] was enacted in 1938, long before there was a...
  • Report: Second Instance of Fake Avastin Highlights MHRA Troubles

    Another incident involving lots of fake bevacizumab (Avastin/Altuzan)-the second in as many months-is drawing attention to resource shortages at the UK's Medicines and Healthcare product Regulatory Agency (MHRA), reports Reuters . The British healthcare product regulator currently oversees 1,800 wholesalers in the country-second in amount only to Germany, which oversees more than 3,000 wholesalers. "We are concerned that the MHRA doesn't have sufficient resources to in...
  • New Batch of Counterfeit Cancer Drug Avastin Found in US

    The US Food and Drug Administration (FDA) warned the public 3 April of newly-found counterfeit bevacizumab (Avastin) containing no active ingredient-the second case to occur within the last two months. FDA previously warned consumers and healthcare professionals about counterfeit batches of Avastin on 14 February 2012 , when it found an unauthorized supplier selling the counterfeit drug. As many as 19 medical practices had purchased the counterfeit drug. FDA's newest s...
  • New FDA Standard on Cargo Theft Released

    The US Food and Drug Administration (FDA) released a new standard operating procedure (SOP) for staff outlining how FDA responds to cargo thefts. The 23 March SOP, FDA'S Response to Cargo Thefts , intends to "provide a general procedure for determining FDA's regulatory response when a cargo theft involving an FDA-regulated product has occurred," writes FDA. "FDA is very concerned about the increase in cargo and warehouse thefts of FDA regulated products, including pres...