CNBC Video: Combating Counterfeit Drugs

The following short video report appeared on CNBC on July 6th as a precursor to their major network story titled, Crime Inc. Counterfeit Goods.

The expose’ premiers Wednesday, July 14, 2010 9pm eastern on CNBC. Although it is a global report on the criminal act of counterfeiting in general, pharmaceutical counterfeiting is obviously one of the more relevant, sizeable, profitable and dangerous aspects of this growing world wide issue.

Secure Pharma Chain Blog encourages media making the industry and consumers aware of the dangers and prevalence of this deadly scourge.

India's Fake Drugs Are a Real Problem

India’s Food and Drug Administration recently conducted a series of raids to combat counterfeit drugs. Large amounts of counterfeits were seized in these raids and several individuals were arrested.

Roger Bate, a leading authority on counterfeit drugs recently wrote an article for the Wall Street Journal on these raids and the prevalence of counterfeit drugs in this region.

Below are some of the highlighted statistics cited in the article:

• In 2009, Bate examined five essential medicines in 52 different pharmacies in Delhi and Chennai. In Dehli, 12% of the pills were substandard, as were 5% in Chennai. About 2% of the pills contained no active ingredient.


• In a more recent investigation of Delhi’s wholesalers, they discovered that 7% of all tested samples were substandard and 3.6% were likely counterfeit.


• Last year alone, counterfeit drugs were seized by authorities in Bangalore, Mumbai, Delhi, Jaipur and many other Indian cities.


• In 2008, about half of the medical products that were confiscated by European Union customs officials originated in India.


• Estimates of substandard drugs reach as high as 30% of all medicines sold in parts of Africa, Asia and Latin America. But the truth is we don't really how bad the problem has become.


• The public-health consequences of the counterfeit drug trade are serious. These products, often adulterated with road paint and chalk, look identical to the antibiotics they pretend to be.


• Thousands of people probably die every year either because they're poisoned by bad ingredients in counterfeits or because the counterfeit doesn't treat the victim's malady.

In the article, Bate discusses the huge profits to be made and the necessity for stricter enforcement and how new technology can be used to combat this deadly menace.

XStream Systems has an anti-counterfeiting solution that allows wholesalers to molecularly verify the quality and authenticity of their inventory. In a world where what you see is not always what you get, our penetrating technology authenticates the medication and not just its packaging.

To learn more about XSteam Systems Solution visit: www.xstreamsystems.net.

For the full article visit: www.wsj.com.

The National: Tighter Controls on Fake Drugs Sought

The Regional Conference on Fighting Counterfeit Medicines recently held in Dubai, examined the issue and solutions to fighting counterfeit medications. The conference, sponsored by Pfizer, attracted representatives from 15 countries.

XStream Systems President and Chief Technology Officer, Brian Mayo presented XStream’s revolutionary material screening technology at the conference.

Reported by Mitya Underwood and published by The National the following are some excerpts from the article:

• The UAE must tighten its border controls and increase co-operation between enforcement agencies if it hopes to turn back the rising tide of counterfeit drugs, officials said yesterday.


• The Ministry of Health said it would work with customs and free zone officials to stop fake medicines and medical equipment from entering the country or passing through its ports.


• Dr Amin al Amiri, the chief executive of medical practices and licensing, said the ministry would ask customs officials to stop clearance for medicines and equipment until it had approval for each consignment.


• Speaking at the Regional Conference on Fighting Counterfeit Medicines, Dr al Amari said the ministry hoped to reduce the UAE’s role in the global trafficking of illegal products. He declined to say how much counterfeit material was coming into or passing through the country.


• Figures from the European Commission’s Taxation and Customs Union recently showed that the UAE was the origin of almost nine per cent of all counterfeit medicines seized at European borders in 2008. The UAE was the third largest importer after India and Syria.


• Dr al Amiri said in addition to increased inspections and raids, a federal pharmaceutical law would be introduced to tighten penalties and introduce jail terms and larger fines.


• Dr Mohammed Abuelkhair, the head of drugs and medical products registration at the Health Authority-Abu Dhabi, said the law should deter pharmacies from knowingly stocking counterfeit drugs and stop importers from targeting the UAE market.

To read the entire article, visit: http://www.thenational.ae/apps/pbcs.dll/article?AID=/20091216/NATIONAL/712159821/1010

INTERPOL and World Health Organization: International Operation Combats Online Supply of Counterfeit and Illegal Medicines

In a related story to a previous blog, INTERPOL and the World Health Organization's International Medical Products Anti-Counterfeiting Taskforce (IMPACT) coordinated a 24 country wide operation named Operation Pangea II in response to an ever-increasing number of websites supplying dangerous and illegal medicines and the dangers of buying medicines online.

"Our primary goal in Operation Pangea II is to protect the public by removing counterfeit and illicit medicines from the market, by shutting down illegal sales on the web, and by prosecuting those potentially putting lives of innocent consumers at risk," said INTERPOL Secretary General Ronald K. Noble.

Medicine regulators, police and customs officials around the world worked closely together during the crackdown from November 16th though the 20th, focusing on the three principal components used by illegal websites to conduct trade – the Internet Service Provider (ISP), payment systems and the delivery services.

During the operation, Internet monitoring revealed 751 websites engaged in illegal activity, including offering controlled or prescription only drugs, 72 of which have now been taken down. In addition, more than 16,000 packages were inspected by regulators and customs, 995 packages were seized and nearly 167,000 illicit and counterfeit pills - including antibiotics, steroids and slimming pills, confiscated.

The operation received significant support from the Permanent Forum on International Pharmaceutical Crime (PFIPC) the World Customs Organization, the UK's Medicines and Health Care products Regulatory Agency (MHRA), the US Food and Drug Administration (FDA) and Immigration and Customs Enforcement (ICE), the Royal Canadian Mounted Police and Health Canada.

Countries involved in Operation Pangea II were - Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, UK and the USA.

To read more about this international operation, visit: blog.taragana.com.

New French Crackdown on “Counterfeit Tourism”

As reported in several major European publications, new laws have customs officials in France starting to crackdown on what they are calling “counterfeit tourism” – that is people from other countries who buy or bring in counterfeit goods while they are visiting France.

This is a significant shift in the enforcement of anti-counterfeiting laws. While other country’s police and customs authorities only target suppliers of counterfeit goods, in France, the authorities are now focusing on those who buy fake goods or bring counterfeit products into the country.

These new laws mean that French tourists could now be fined up to a maximum of €300,000 ($450,000) or face up to three years in jail if they are found to be in possession of or purchasing fake goods.

While certainly outside a traditional law enforcement tactic, this is seen as a significant step in changing the perception of the purchase of counterfeit goods with consumers. As with some crimes, many feel that the issue of fake goods is a “victimless” crime and do not understand the macro consequences of safety, health and economic well being that are impacted heavily by counterfeit goods.

It will be interesting to observe the enforcement, repercussions and effectiveness of these new laws in France.

Markets and Markets: Global Anti-Counterfeit Market for Food and Pharmaceuticals Worth US $79.3 Billion by 2014

According to a new market research report, ‘Global Anti Counterfeit Market for Food and Pharmaceuticals (2009-2014)’, published by Markets and Markets (www.marketsandmarkets.com):

• Increasing cases of counterfeiting have resulted in implementation of anti- counterfeit technologies. Anti-counterfeit technologies are of two types namely authentication packaging and track and trace packaging technologies. North America holds a major share of the global anti counterfeit market. Asia has the highest growth rate due to untapped market and significant level of counterfeiting. Europe has a lower growth rate due to a relatively lower number of cases of counterfeiting.


• The global anti counterfeit packaging market for food and pharmaceuticals market is expected to be worth US$79.3 billion by 2014, with an estimated CAGR of 8.6% from 2009 to 2014.


• The North American packaging market is expected to account for nearly 62% of the total revenues. North America is the largest segment in the anti-counterfeit market and is expected to reach US $49 billion by 2014, accounting for nearly 62% of the revenues growing at a CAGR of 6.8%.


• Asia is the second largest market and is expected to reach US$14 billion by 2014 with a highest CAGR of 19.7%.

While XStream Systems feels that the data presented in this report is valid it believed that Markets and Markets may have overlooked significant technology solutions in their research.

Most of the report seemingly centered on packaging technologies and ignored material screening technologies such as XStream’s XT solutions which allow the end user to verify the authenticity of a material inside its sealed unit of sale container.

How large is this market if material screening technologies were included in the mix?

To view a synopsis of the report, visit:
http://blog.taragana.com/pr/marketsandmarkets-global-anti-counterfeit-market-for-food-and-pharmaceuticals-worth-us793-billion-by-2014-5427/

FDA Issues Guidance on Anti-Counterfeiting Techniques: Physical-Chemical Identifiers for Drugs

The Food and Drug Administration continues in its efforts to regulate and provide guidance on anti-counterfeiting solutions. This press release from July 13, describes their latest efforts on providing guidance on physical-chemical identifiers (PCIDs) which are added to medications by the manufacturers to make drugs more difficult to counterfeit and adulterate.

XStream supports and believes that a variety of solutions and techniques are vital in protecting the pharmaceutical supply chain and healthcare consumer from fraudulent, adulterated and counterfeit medications. PCIDs are one component of a secure pharmaceutical supply chain.

Currently the FDA is seeking comments on this guidance:

The FDA July 13 issued a draft guidance on PCIDs used by manufacturers to make drugs more difficult to counterfeit and to make genuine versions of drugs easier to identify.

The draft “Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anti-Counterfeiting” is intended to provide guidance on the use of PCIDs in pills and capsules.

According to the agency, PCIDs have unique physical or chemical properties used to identify and authenticate a drug product or dosage. The substances include inks, pigments and flavors, as well as various chemicals that can be used as molecular tags to form a PCID. The FDA anticipates that many of the potential ingredients for PCIDs already are used as food additives, colorants or other “inactive ingredients with established safety profiles.”

The draft guidance recommends using the lowest level of PCID possible to ensure identification of the product. The PCID also should be a substance with no medicinal effect and no potential to interact with the drug’s active ingredient, according to the FDA.

Comments on the draft guidance may be submitted electronically at http://www.regulations.gov. The comments, due by Oct. 12, should be identified with docket number FDA-2009-D-0212.

Pharma Execs Ask - How Can I Halt Counterfeit Drugs?

That’s the question of many in the pharmaceutical industry. How can I secure my brand? How can I be sure that counterfeits don’t infiltrate my supply chain? How can I minimize my risk? And……What are the breaking technologies available in pharmaceutical authentication and supply chain security?

To discuss these questions, leading executives are planning to attend The Center for Business’ Premier Forum on Anti-Counterfeiting and Anti-Diversion Strategies October 20-21, 2008 in Vienna, VA. Regulatory officials, pharmaceutical organizations, and solution providers will be presenting various perspectives on the problem.

Alan Clock and John Lundquist from XStream Systems will be speaking on authentication technologies and how they can be implemented and integrated with existing safeguards to provide a comprehensive solution against counterfeit, adulterated and tampered drugs.

If you would like to register or would like more information on the event, please visit www.cbinet.com.

What Measures Can Ensure the Integrity of Purchased Pharmaceuticals?

The integrity of our pharmaceutical supply chain is being questioned! Diversion, counterfeited products and adulterated ingredients have left consumers, regulators, and dispensers clamoring for more stringent anti-counterfeiting methods. Furthermore, the recent heparin recalls have emphasized the need for protection not only of the finished product, but also of the raw materials used in the production of medications.

In the May issue of Pharmacy Times, James C. McAllister, a health-systems consultant, addresses the security responsibilities of all players within the supply chain to combat these threats.

Mr. McAllister states, “Solving this dilemma will be challenging. Collaboration of pharmacists, manufacturers, wholesalers, and distributors, as well as regulatory agencies at the state and national level, should begin expeditiously.”

He moves forward to suggest that manufacturers bear all recall costs and financial responsibility for the quality of their drugs. For distributors and manufacturers, he asks that the FDA levy heavy economic sanctions on those selling substandard drugs. His proposal is a wake up call to the risks that are present – Those who risk our health – Risk their wealth.

Which begs the question - How do your anti-counterfeiting methods measure up?