Ranbaxy Probed Over Counterfeit Medicine

In an article that appeared in the Washington Times, the Justice Department is investigating whether Ranbaxy Laboratories Ltd., which supplies generic drugs to the U.S. market and to President Bush's global AIDS initiative, has falsified data, followed sub-par manufacturing practices and distributed counterfeit medicine.

The filing stated that "allegations from reliable sources indicate a pattern of systematic fraudulent conduct" by the company. The allegations include that in its application process, the company submitted fabricated data to the Food and Drug Administration for generic drugs to be distributed in the U.S. and anti-retroviral drugs to be distributed in other countries as part of the President's Emergency Plan for AIDS Relief.

This is yet another example of potentially counterfeit product distributed widely in the global pharmaceutical supply chain that would have passed all Track and Trace methods of interdiction. These products have been distributed and consumed because pedigree or tracing processes do not authenticate the medication inside the container.

XStream Systems XT250 would have been able to discover the fraudulent and counterfeit material before they were distributed and dispensed because the technology verifies the molecular structure of the medication inside the sealed container.

To learn more about the XT250, visit our website at www.xstreamsystems.net.

To read more of the Washington Times article click here.

Making a Killing: The Deadly Implications of the Counterfeit Drug Trade

This book written by Roger Bate and published by American Enterprise Institute for Public Policy Research is an excellent encapsulation of the growing danger that is facing consumers globally. In his book Bate masterfully researches the history, scope, globalization, causes and current solutions on the issue of counterfeit pharmaceuticals.

Unfortunately this is an issue that far too few industry and government thought leaders are aware of, adequately educated on or are taking the proper steps to protect their company or constituents against.

Bate recommendations seem to be fixed primarily on dated technologies such as e-pedigrees and RFID as the answer to protecting the drug supply chain. Regrettably he seems unaware of other technologies like XStream Systems' XT250 that can authenticate medications inside a sealed container and which teamed with or in a standalone fashion can properly protect inventories throughout the global and domestic pharmaceutical supply chain. Here’s hoping that as Bate follows up on this well written book, he goes beyond his excellent foundation of the issue and deeper and further in researching potential solutions.

All-in-all, Making a Killing is an excellent book that is a must read for everyone involved in the healthcare industry and the pharmaceutical supply chain.

Ranbaxy; More Concern over Substandard Medications

This year of 2008 should go down in the history books as the year of drug safety concerns. The latest concerns are over FDA accusations that Ranbaxy Laboratories sold substandard drugs and knowingly concealed the facts.

Ranbaxy is one of India’s largest generic manufacturers and 25% of their sales are in the U.S. They have been accused of using raw materials from unapproved sources in one of their northern India plants and altering in-house testing to meet FDA standards which resulted in sub-potent, super-potent or adulterated products.

"The government has reason to believe that these violations have resulted and continue to result in the introduction of adulterated and misbranded products" into the US market, federal prosecutors said.

This coupled with earlier cases this year of adulterated heparin from China, has left consumers doubting the safety of their medications. Most troubling is that the current methods being considered would not be effective in verifying the validity or purity of the drug itself.

Incidents such as this illustrate the need for an authentication of the product as a way to protect all of the members of the Pharmaceutical Supply Chain and most importantly the consumer. Track and Trace technologies (pedigrees and RFID) will not protect the consumer from these types of incidents which we can expect to happen more frequently as we continue to increase our reliance on global sources for our medications. Only XStream Systems’ XT250 has the solution to authenticating the product inside the sealed container. This is the only solution to this clear and present danger.

Cargo Theft: A Major Rx Supply Chain Issue

The June 23, 2008 issue of Drug Topics contains an article about the ever increasing issue of cargo theft and its impact on the drug supply chain.

Given the high dollar value of pharmaceutical shipments, shipments of all types of medications lead the list of targets for transit thieves.

Much of the article is based on a presentation at a National Boards of Pharmacy meeting by FBI Special Agent Ryan Toole. The article states, “….in 2005 there were reported thefts of $14 million worth of Lipitor (atorvastatin, Pfizer) and Viagra (sildenafil citrate, Pfizer), and $29 million worth of Novartis products. However, Toole said, there's a long list of types of drugs stolen, including those for acid reflux, cancer, depression, hypertension, stroke, and many other conditions.”

Obviously once these products are stolen, these medications often make their way back into legitimate channels via non-legitimate enterprises in a variety of formats. The major concern is what happens to the product once it is in the hands of the thieves. Once in the hands of a thief, the products and their containers can be altered, contaminated, diluted or diverted. It is, however, certain that at some point these products will ultimately find their way to the hands of a consumer in a format that may not be safe for consumption.

These types of thefts make the case for an authentication technology that can verify the molecular structure of the material inside the sealed container such as the XStream Systems’ XT250™ Material Identification System. Operating in conjunction with Track and Trace processes or as a standalone technology, the XT250 protects the inventories within each step in the supply chain from receiving products that have been highjacked and altered.

View the article in full at this link to Drug Topics.

The Challenges of Product Safety in a Global Market Place

Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs Administration recently spoke at the Import Safety Summit and posted his view of import safety in his newsletter Andy’s Take:

“You are aware that an increasing number of products – especially those affecting your health, like food and medical products – are being imported from beyond our borders. This has raised great concern recently about FDA’s ability to ensure the safety of those products. This week, I attended a summit with hundreds of industry leaders to collectively address the challenges of product safety in a global market place.

My take is that the challenge of imported product safety will increase because as American consumers, we have come to expect - and even demand – year round variety in the food we eat. And because the production of many of the drugs and medical devices we use is now a global enterprise. So if we are going to want safety in all these products, it will require a collective effort, through collaboration with industry and international regulatory counterparts. This is to build safety in to the production of food and medical products as well as to create systems that assure their safety through distribution and consumption.

That’s why the FDA is accelerating initiatives like our participation in a groundbreaking program with partners in the European Union and Australia. Through a new pilot program we will jointly plan, allocate, and conduct certain inspections of facilities in developing countries that manufacture the starting materials for many of the drugs you take. If this program is successful, it could be expanded to include other types of drug manufacturing facilities. By leveraging the resources of each agency and sharing vital information, the number of foreign facilities in our inspection data base expands while allowing FDA to target its resources on products that we believe present the highest risk to US consumers.”

We at XStream System agree with Commissioner vonEschenbach on the importance of safety throughout the distribution chain and believe that the molecular pharmaceutical authentication possible with the XT250™ Material Identification System will further the industry’s ability to ensure safety to the consumer.

Inter-Industry Summit Discusses Import Safety in Washington DC

A representative from XStream Systems attended a unique event in Washington DC this week. The event, titled the Inter-Industry Import Safety Summit, was an unusual partnership of twelve industry associations and their membership. The impetus behind the summit was an effort to promote a “robust exchange of ideas and information that will further help our industries assure the safety of consumer products regardless of where they are made.”

The gathering of nearly 350 people included speeches by government officials including Michael Leavitt, Secretary of Health and Human Services and Andrew von Eshenbach, Commissioner of the Food and Drug Administration.

Secretary Leavitt, at the Summit, made a significant announcement regarding the U.S. collaborating with the European Union and Australia on inspections of overseas manufacturers of drug ingredients as a way to check more plants. Regulators from the countries will inspect different plants and then share their findings under a pilot program to alleviate duplication and inefficiencies in this process.

In a Medical Products Panel discussion during the Summit, executives from J&J, HDMA, Barr Labs, MedImmune, Schering-Plough and Bayer discussed pharmaceutical safety and the effects of counterfeit and adulterated medications within the Global Supply Chain. The Panel was chaired by Commissioner von Eshenbach from the FDA.

Significant in the Panel discussion was that most were of the opinion that technology needed to be part of the solution of counterfeit and adulterated products within the supply chain and those current initiatives to date with Track and Trace technology is effective to a point but only tracks the transaction of the product.

The industry associations which sponsored the Summit were:

• American National Standards Institute
• Biotechnology Industry Organization
• Consumer Healthcare Products Association
• Food Marketing Institute
• Generic Pharmaceutical Association
• Grocery Manufacturers Association
• Healthcare Distribution Management Association
• National Fisheries Institute
• National Restaurant Association
• Pharmaceutical Research and Manufacturers of America
• Retail Industry Leaders Association
• Toy Industry Association, Inc

XStream Systems to Present at Anti-Counterfeiting Conference

XStream Systems, Inc. announced today that it is scheduled to present at an Anti-Counterfeiting and Anti-Diversion conference which will be held on October 20 -21, 2008 in Vienna, Virginia.

The Center for Business Intelligence (CBI) has organized an annual conference to examine this extremely topical and important issue near the nation’s capitol.

The program of the conference is focused on preparing industry thought leaders for pending Federal Legislation and in the discussion of combating the illicit trade of pharmaceuticals by implementing security measures and tracking system.

XStream will be presenting a break out titled; Materials Authentication and Verification within the Pharmaceutical Supply Chain: Working with and Moving Beyond Track and Trace.

“We are excited about discussing the alternative solutions that work with and go beyond the capabilities of Track and Trace technologies to a group of influential industry stakeholders, “stated Alan Clock, SVP of XStream Systems. “No one product or solution will totally protect the global and domestic drug supply, the attendees of this conference will have a major influence in shaping the protection of the medications on which we all rely.”

To find out more about the CBI Conference or XStream Systems, visit the sites below:
http://www.cbinet.com/show_conference.cfm?confCode=PC08089&field=speakers
http://www.xstreamsystems.net/news.html