Illinois State House and Senate Pass Bill to Strengthen Penalties for Counterfeiting

Illinois State’s House and Senate recently passed an anti-counterfeiting bill (SB 1631) which strengthens penalties for those possessing, selling, marketing and transporting counterfeit goods. The bill was a collaborative effort between Senate Majority Whip Ira Silverstein, House Deputy Majority Leader Lou Lang, the U.S. Chamber, the Illinois Chamber of Commerce, the International Anti-Counterfeiting Coalition (IACC), and the International Trademark Association (INTA).

Counterfeiting and piracy costs the U.S. economy approximately $250 billion annually and exposes consumers to potentially harmful products. SB 1631 would impose criminal sentences for counterfeiting of up to 20 years with additional fines of up to $15 million depending upon the level of the offense. The legislation also requires mandatory forfeiture and destruction of counterfeit goods and requires restitution to victims.

We at XStream Systems commend the Illinois' legislative branch in passing this bill to protect its citizens against counterfeits. In addition to strengthening penalties for offenders, we encourage regulators to be proactive in improving supply chain and regulatory processes which act to interdict counterfeiting as a whole.

Fake Versions of Pfizer, Glaxo, J & J, Proctor & Gamble and Wyeth Products Seized in India

Yesterday, police in Ghazaiabad, India shut down a counterfeiting ring and seized fake medicines worth at least Rs. 5 million (over $100K USD) in the raid.

The company raided was registered as Avadh Pharma and is accused of manufacturing counterfeit versions of prestigious band name medicines including: Corex made by Pfizer, Iodex made by Glaxo, Benadryl of Johnson & Johnson, Vicks vaporub made by Proctor & Gamble and Anne French hair remover made by Wyeth. Following up on a tip they received, police raided the site where they recovered 50 cartons of packaged counterfeit finished product as well as an ample supply of packing materials and equipment.

The police also recovered stationery material of the firm, mentioning its name as Avadh Pharma with UP Trade Tax registration number 0073219360 as well as fake seals of different prestigious companies.

The arrested workers were identified as Raju Chaudhary, Rudal Singh, Lal Bhai and Mukesh Sahni. They confessed that they were working for Vinod Bhardwaj, who has fleed, the official stated.

Keeping It Real Report reveals 700,000 Die Each Year from Counterfeit Drugs

Do you think that the counterfeit drugs issue is a small issue? Think again! In poorer countries they can account for as much as half of the supply chain and they claim an estimated 700,000 lives a year. In addition, their very use can undermine the effectiveness of the legitimate drug, thus adding research time and dollars to its list of victims.

A report issued this month from the International policy network gives a good overview of the problem of counterfeits in poorer nations. Below is a some highlights of an article by Franklin Cudjoe from IMANI Health on the report:

Counterfeit drugs kill over 700,000 people every year - new report

A new report from the International Policy Network and sponsored by IMANI Center for Policy & Education details the shocking burden of fake drugs in less developed countries. Fake tuberculosis and malaria drugs alone are estimated to kill 700,000 people a year. That's equivalent to four fully laden jumbo jets crashing every day.

The report lays bare the ballooning problem of counterfeit and substandard drugs, which can constitute one third of the drug supply in certain African countries. These dodgy drugs result in unnecessary death and increased levels of drug resistance.

The report highlights more shocking evidence, such as:

• Nearly half the drugs sold in Ghana, Nigeria, Angola, Burundi, and the Congo are substandard

• About two thirds of artesunate (anti-malaria) drugs in Laos, Myanmar Cambodia and Vietnam contain insufficient active ingredient.

The entire article can be viewed at: www.modernghana.com

May 2009 report can be viewed at: www.africanliberty.org.

Considering the Source – WHO cracks down on GMPs of their suppliers BIG and small.

The finished product is only as good as the sum of its parts.

We are seeing a trend of stricter enforcement of Good Manufacturing Practices (GMPs). Even larger pharmaceutical manufacturers are feeling the pinch as the quality of their pharmaceutical ingredient suppliers are put to the test.

Recently The World Health Organization (WHO) announced they would suspend tuberculosis drugs from Wyeth Pakistan because they questioned the quality of the drug. Their shift in trust of the finish product stemmed from a switch in suppliers for one of its ingredients. The outsourcing of ingredients has become a challenge for manufacturers because consistent suppliers are not always accessible.

A summary of the article appears below and you can view the entire article at American Enterprise Institute website at: www.american.com.

Consider the Source
(Tuesday, May 19, 2009; by Roger Bate; Journal of American Enterprise Institute)
A recent case reveals that it is not only generic firms from middle-income countries that have problems with good manufacturing practice.

The World Health Organization (WHO) late last month announced it was suspending approval for all tuberculosis drugs produced by the Pakistan plant of a subsidiary of the U.S. drug company Wyeth, because it was “no longer assured of the quality of the product.” The drugs had been approved by WHO, which UN agencies, national governments, and other international organizations use to guide the procurement of millions of dollars of HIV/AIDS, malaria, and tuberculosis drugs for the world’s poorest patients.

According to a letter to the company posted on WHO’s website, Wyeth failed to inform WHO that it had changed suppliers for some of its active pharmaceutical ingredients (API) and had altered storage conditions. “They had been informed on a number of occasions”—directly and through communications to all suppliers—“about the importance of informing WHO,” Matthias Stahl, medical officer in charge of assessments at WHO’s drug approval program, told us. WHO’s most recent inspection of the site, in 2005, identified serious noncompliance with Good Manufacturing Practice (GMP), and since that time only limited corrective action had been taken.

The case reveals that it is not only generic firms from middle-income countries that have problems with GMP, as we have previously discussed regarding India’s largest drug company Ranbaxy. Wyeth and Ranbaxy, which are both reputable companies, will probably resolve their particular problems soon. But as more firms source more intermediate chemicals and API from myriad countries, we may be seeing the beginning of a trend.

XStream Systems understands this dilemma. A solution that addresses brand protection and integrity is the use of EDXRD technology for molecular pharmaceutical authentication. By screening products throughout the supply chain, authenticity and quality issues can be addressed on the spot before ever reaching the consumer. To learn more of this technology and how it can help visit: www.xstreamsystems.net.

Chinese Government Busts Online Counterfeit Drug Dealers

China has often been cited as a source for the counterfeit drug trade. In answer to this, Chinese government has been issuing stricter enforcement than they did in the past. The following article is shocking both in discussing the sheer numbers of fake drugs in China and in the number of places that government officials have shut down:

China's ministries work together to bust online counterfeit drug dealers

BEIJING, May 17, 2009 (Xinhua via COMTEX) -- People using the Internet to sell counterfeit medicines in China will face severe punishment as the government amps up the fight against illegal business in the next year, according to a consensus by 13 ministry departments Friday.

The ministerial departments held the meeting to launch a year-long campaign with aims to cut off circulation channels of fake drugs, mainly through online purchasing and postal delivery.

This marked the establishment of a mechanism that will more effectively coordinate different departments' work to curb the production and sale of fake products, said Shao Mingli, vice minister of health and the head of the SFDA.

The new mechanism will enable law enforcers to crack down on fake drugs from production to circulation, by closing down Web sites that advertise fake drugs, and by suspending bank and telephone accounts of companies allegedly involved in illegal trade, Shao said.

The SFDA said in February that law enforcers investigated nearly 300,000 cases of illegal activities related to medicine and medical apparatus in 2008, including the production and sale of fake drugs. A total of 363 production places of fake drugs were closed down and 94 people were charged.

To view the entire article visit: www.tmcnet.com

For comparison as to the extent of counterfeit drugs in China you need only look at the U.S. statistics to get the full impact of the severity involved. China had 300,000 cases of counterfeits/a year vs. US number of approximately 1759 cases/a year [according to the latest figure from Pharmaceutical Security Institute's (PSI)]

Experts Warn Public of 20 Percent Increase in Counterfeits

Fake Flu Medicines and Vaccines expected to be prolific in midst of H1N1 Flu Spread.

Reuters reported yesterday that experts are predicting a dramatic increase in fake goods. The bad economy has spurred an expansion across the black market – including counterfeit medicines, which could pose a public health risk. In light of the recent epidemic of H1N1 Flu, health organizations are warning consumers of the increased risk of fake drugs.

A recap of the story highlights follows:

Experts warn crisis brings more fake goods

MANILA (Reuters) - Global trade in counterfeit goods, including medicines, CDs and DVDs, is expected to rise to nearly $1 trillion this year as economies worldwide continue to slump, security experts said on Thursday.

An estimated $800 billion in fake cigarettes, branded shoes, bags and belts, and pirated movies flowed across the globe in 2007, Stephen Sayell, vice president of Hong Kong-based Asia Risk group, told Reuters.

That figure is expected to rise 20 percent this year.

"As the global financial crisis deepens, the demand for much cheaper consumer goods rises, boosting sales of counterfeiters and movie pirates," Sayell said on the sidelines of a three-day anti-terrorism seminar in Manila.

"We expect a boom in counterfeit medicines and vaccines against flu," Enoch said, warning of potential high risk of a public health threat because of the improper use of anti-viral drugs.

In the Philippines, the health department has already issued a warning against offers by some medical facilities to provide anti-flu shots against the deadly strain of A-H1N1 virus that originated from Mexico.

Last month, the World Health Organization (WHO) warned against the proliferation of fake anti-malaria medicines in the Mekong area, blaming the counterfeit drugs for the emergence of a new strain of malaria that could spread in the region.

(Reporting by Manny Mogato; Editing by Raju Gopalakrishnan and Alex Richardson)

To view the entire article from Reuters visit: uk.reuters.com

Swine Flu (H1N1 Flu) – Is There Really Cause for Worry?

So consumers want to know about the H1N1 influenza A (otherwise known as Swine Flu) and what does it mean to them? Is it all hype or is this something they should worry about? Well…the best answer is to stay informed, be cautious and be prepared.

Authorities agree that this strain of H1N1 Flu should not be dismissed as a threat just because it has started off as mild cases. This particular flu is genetically a descendant of the Spanish flu of 1918, which started mild, but returned to infect two-thirds of the population and kill over 50 million people. Scientists believe that the current flu will return at the peak of flu season this fall and it will be a stronger more viable foe than the one that stands before us today.

The H1N1 Flu currently has around 6500 confirmed cases in 33 countries globally, of which about 3,400 are in the United States. As to date, most deaths due to this strain have occurred in Mexico. The United States has three confirmed deaths, but those individuals also had underlying health issues that contributed to a more severe case that required hospitalization.

So what about natural immunization? There is very little natural immunity to this strain. There is a possibility that individuals who are in their 90’s and above would be immune since they were most likely exposed to the Spanish Flu. However, the rest of us are probably out of luck.

So what about immunization shots? There are several pharmaceutical companies working on these shots to be delivered in the fall. The problem is that vaccines are developed in hen eggs and take about 4 months for completion. It is unlikely that a mass immunization of the population is feasible and will probably be restricted to those most vulnerable.

So what about medication treatment for those with the flu? This is where the real danger is and consumers need to be cautious. When demand exceeds supply, unscrupulous individuals take advantage of the public. No country has enough flu medication to serve its entire population. Some areas such as UK have enough to accommodate around 80% of their population. This is rare as most do not have enough to cover 50%. Some areas such as California only have enough to cover around 25% of their population.

Beware! Already the public is being spammed with individuals trying to sell Tamiflu over the internet only to steal their credit card information. Expect to see some cases of counterfeit Tamiflu as this was the case when SARS became an issue a few years ago and resulted in counterfeit flu remedies infiltrating the marketplace.

So what can a consumer do to protect themselves? The H1N1 Flu travels the same way as other flues. If you don’t have the flu yet practice good hygiene (i.e. wash your hands frequently; always cover your mouth when you cough) to lessen the spread of the disease to yourself or others. If you think you have the flu, stay home. If you suspect the H1N1 flu see your doctor and get tested. Whatever you do, don’t order medication online except through a known pharmacy. You will need a prescription from your doctor and you should only buy medication through known sources!

For pharmaceutical wholesalers, test your inventories. Pharmacists trust you to give them safe efficient medication to supply the public. Forewarned is forearmed. Be prepared - Get your security procedures in place now to ensure you have the safest medication possible for your distribution chain.

Below are some helpful links for information on the H1N1 Flu:

For General Information and preventative measures visit: http://www.cdc.gov/h1n1flu/qa.htm

To view “How Time and Mutations Engineered the New H1N1 Strain” visit: www.washingtonpost.com.

To view statistics on US confirmed cases by state visit the Center for Disease Control at:www.cdc.gov.

To view statistics on global confirmed cases visit the World Health Organization at: www.who.int.