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.

2010, the Year That Counterfeit Drugs Becomes a $75B Global Business

Alan Clock, SVP, XStream Systems, Inc.

In 2005, the Center for Medicines in the Public Interest (CMPI), released a report projecting global counterfeit drug sales to reach $75 billion in 2010. At the publication of the report, this projection was a 92% increase from the 2005 estimate of $39 billion of worldwide counterfeit drug sales.

Most global experts then and now do not dispute this estimate. In fact, many would not argue the point that today, this estimate may be entirely too conservative and the real financial impact and overall number is much higher.

In 2010, we as a society face a global health catastrophe that will impact people of all countries, race, religion and economic strata.

What will be the key factor that will turn this issue around in the new decade?

"The business of selling fake prescription drugs to unsuspecting consumers is burgeoning, and is a global industry," stated Peter Pitts in 2005, senior fellow for health care studies at the Pacific Research Institute and director of the CMPI. "Nearly $39 billion, or 11 per cent of global pharmaceutical commerce will be counterfeit this year (2005)," added Mr. Pitts. "By 2010, that number will nearly double. We must enact controls to strengthen the security of our health care system from outside threats."

At the time that this report was published, Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs at the U.S. Food and Drug Administration stated. "The increasing flow of counterfeit drugs represents a significant public health threat. We must step up our efforts to safeguard the drug supply -- we certainly should not weaken those controls."

Even with these dire predictions and public support for action in 2005, there has been little appreciable progress in the domestic and international efforts to stem the flow of this worldwide health care crisis. Regulatory, law enforcement and industry efforts to date have been inconsistent overall and seemingly lack an overall perspective of the severity and impact of this issue.

One of the most startling examples of the deadly impact of the global counterfeit medication epidemic is the World Health Organization’s (WHO) estimate that nearly 2,000 children die each day in Africa as a result of bogus drugs. Counterfeit medications in underdeveloped countries not only do not treat illness and disease but are now a major factor in creating drug resistant strains of deadly diseases such as malaria, tuberculosis and HIV/AIDS.

With the proliferation of counterfeit medications and the impact to people all over the world, the issue, in its extreme, is only now beginning to garner important public awareness.

The public awakening to this deadly scourge is the first critically important step in motivating public and industry leadership to move forward and take action.

With a motivated and aware public, elected and industry leaders will be encouraged to step up their efforts to protect their constituents, businesses and customers.

When properly inspired, these leaders will look to strengthening regulatory authority and in expanding their technology/ processes to thwart these nefarious sources of a deadly criminal act.

To learn more about technologies that are used to combat counterfeit medications, visit: www.xstreamsystems.net.

FDA Warns Consumers Internet Flu Drugs May Not Be What you Think!

Agency goes Covert to Pull the Plug on Fake and Unapproved H1N1 Drugs

Friday, the Food and Drug Administration issued a warning against purchasing drugs over the Internet that claim to diagnose, prevent, treat, or cure H1N1 influenza virus. The FDA has gone undercover to secretly purchased Tamiflu, an antiviral drug used to treat the H1N1 flu, online. Afterwards, the samples were analytically tested to determine their quality and authenticity.

The two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009H1N1 influenza virus are Tamiflu (oseltamivir phosphate) and Relenza (zanamivir).

What they found in the purchased online samples was shocking. One package contained nothing more than talc and acetaminophen. Four contained various levels of oseltamivir but were not approved for use in the United States. Several of the products purchased did not even require a prescription from a health care professional. Additionally, the products did not arrive in a timely enough fashion to treat someone infected with the H1N1 influenza virus, or with an immediate exposure to the virus.

FDA warned consumers that purchasing prescription drugs online results in products that are from an unknown origin, uncertain quality, and could pose an undue risk to your health. Consumers are urged to purchase their prescriptions from only licensed pharmacies approved for distribution of these medicines.

To view entire FDA warning visit:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186861.htm.

To view the FDA consumer guide to purchasing drugs online visit:
http://www.fda.gov/Drugs/ResourcesForYou/ucm080588.htm.

FDA: Supplier Audits, Qualification Needed to Protect Supply Chain

At the Parenteral Drug Association-FDA 2009 Joint Regulatory Conference the FDA was on record stating that manufacturers should secure their supply chains through testing and anticipate risks to head off issues like the recent contamination of imported ingredients.

Steven Wolfgang, FDA Consumer Safety Officer is quoted as saying, “ the FDA is looking more closely at quality management systems as a first step toward that goal.”

This reinforces XStream’s position that material screening should be done throughout the supply chain to verify and authenticate materials from raw materials, to production, through distribution and to the point of dispense. Material screening is the most effect way to make certain that the product is protected and maintains it effectiveness to the consumer.

XStream’s XT250 solution allows the entire supply chain to quickly screen products, within the supply chain, inside it unit-of-sale container without degradation or the destruction of the material.

To view more about the FDA statement, follow this link: http://www.fdanews.com/newsletter/article?articleId=120738&issueId=13038

To learn more about XStream’s XT250 system, visit: www.xstreamsystems.net.

FDA Instructs Pharma Companies to Watch for Melamine

Pharmaceutical-Technology.com reported in its August 7, 2009 on-line edition on FDA guidance and instructions on protection to the pharmaceutical supply chain, specifically as it relates to Melamine. Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides.

Here are some highlights from the article:

• The US Food and Drug Administration (FDA) warned drug companies to scrutinize certain pharmaceutical ingredients for the presence of melamine and has issued industry guidance on how to protect against contamination.


• The FDA has stressed that there is no evidence that melamine, which if ingested in significant amounts can lead to kidney failure or death, has entered the pharmaceutical chain but that recent contaminations in pet food and in infant milk in China have proven the need to be vigilant.


• The FDA has released guidance as an initial measure with pharmaceutical manufacturers, re-packers, other suppliers and pharmacists to conduct melamine testing.


• The FDA identified specific pharmaceutical ingredients recommended for screening, and has also recommended specific FDA-published methods for this testing.


• "The FDA urges the implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain," Hamburg said.

XStream’s authentication and verification technology tests the product inside its sealed, unit-of-sale container and can protect the pharmaceutical supply chain by screening inventories at the point of production, distribution and dispense without destroying the medication or disrupting the container by opening.

To learn more about XStream Systems, visit us at www.xstreamsystems.net.

To read the article in full, follow the link below:
http://www.pharmaceutical-technology.com/news/news61460.html?WT.mc_id=DN_News

FDA Cracks Down on Apotex in Canada

Apotex has experienced a high number of rejected batches and FDA is cracking down on this generic brand company in Toronto. XStream endorses a comprehensive materials analysis process within the supply chain to protect end users to appropriate quality and control.

Canada's Apotex Inc could face a freeze on new drug applications in the United States as well as a ban on products entering the country after the U.S. Food and Drug Administration warned it of a number of
manufacturing breaches at a Toronto factory.

The June 25 warning, which followed a late 2008 inspection of the Etobicoke, Ontario facility, cited a number of manufacturing deviations from U.S. manufacturing codes.

Among the breaches, the agency charged that Apotex did not thoroughly investigate the failure of batches of some drugs and also noted an unusual high number of rejected batches.

To view article visit: www.reuters.com