The Fake Drug Menace

In China Counterfeiters are turning out bogus 'life-saving' medicines.

In Part 1 of a two-part special report, Straits Times correspondent Grace Ng focus on the huge underground trade in China of fake pharmaceutical drugs and the dangers it poses to the population.

Ms. Ng writes an excellent essay with personal stories, statistics and examples of the danger posed to the consumer.

Some of the highlights of Ms. Ng’s story include:

• The estimate from the US-based Centre for Medicine in the Public Interest shows global sales of counterfeit drugs almost doubling in the past five years.

• The World Health Organisation also believes that in some developing regions, more than 30 per cent of medications sold are fake. Online retailing has only made it worse: As much as half of what is offered online could be fake.

• Interpol secretary-general Ronald Noble has described this trade as more deadly than terrorism. While 65,000 people have died in the past 40 years as a result of terrorism, fake medicine has killed 200,000 people in China in one year alone, he said at a recent conference on anti-counterfeiting in Africa.

• The world's second largest economy [China] is also one of the main sources - possibly the biggest - of counterfeit drugs.

• A significant share of the revenue from the global sale of fake drugs is pocketed by Chinese manufacturers, who are becoming increasingly savvy in exploiting online sales and technology to grow their business.

• Chinese counterfeiting syndicates used to make most of their money from sales in Africa, inundating countries like Nigeria with fake anti-malarial drugs that were labeled 'Made in India'.

• Investigations have also revealed the technological savviness and sophistication of Chinese manufacturers. Not only do they have the laser printers and chemical labs to churn out perfect replicas of genuine drug packaging, down to the holograms, but they are also using major websites to market their wares aggressively.

As this outstanding article points out, China has become the epicenter of bogus medications and the threat to consumers’ world wide continues to grow.

Consumers around the globe must be made aware of the very real threat to their health and well being while members of the pharmaceutical supply chains must take proactive efforts to protect their brands and inventories.

To view the entire Straits Times story, visit: http://admpreview.straitstimes.com:90/vgn-ext-templating/v/index.jsp?vgnextoid=29b07cac3afec210VgnVCM100000430a0a0aRCRD&vgnextchannel=f511758920e39010VgnVCM1000000a35010aRCRD


To learn about solutions used to combat counterfeit medications, visit: http://www.xstreamsystems.net/

‘Made in India,’ Faked in China

China is implicated in key fake-drug rings recently broken up across the Middle East and Latin America. Beijing must do more to clamp down on the entire fake industry, which flourishes within its borders.

Roger Bate a Legatum Fellow at the American Enterprise Institute and Tom Woods President of Woods International write an excellent article in The American, the Journal of the American Enterprise Institute about the huge role that China is playing in polluting the pharmaceutical supply chains around the globe by producing massive amounts of fake drugs that often times with lethal consequences.

Mr. Bate, a long time favorite of Secure Pharma Chain, along with Mr. Woods once again provides insightful analysis into one of the most insidious and deadly crimes of the 21st century.

Highlights of The American article include:

• Chinese manufacturers are faking drugs, endangering patients' lives, and undermining legitimate brands, especially those from India. Indian companies provide vast amounts of generic drugs to mid-income and developing nations. By some estimates, 80 percent of HIV drugs for the developing world come from India, and probably half the anti-malarials and antibiotics, too.

• From the counterfeiters' perspective, faking Indian drugs makes sense. Even in those categories where Indian products do not dominate the market, they may still be copied. In part this is because Western brand owners are more likely to go after those faking their brands, whereas Indian drug makers have smaller margins and hence spend less on brand enforcement.

• Criminals often manage to bypass… inspections by inserting their fake versions further along the distribution chain. So more often tip-offs from underworld contacts, probably disaffected parts of criminal networks, provide the greatest likelihood of intercepting fakes.

• Of course, sometimes the fakes make it to market, often with lethal effect. In 2009, our Nigerian colleague Thompson Ayodele came across another fake of an Indian drug in a Lagos pharmacy, this time an antibiotic. Later, we found out it too had been made in China. It is impossible to know how many patients had taken this fake antibiotic before authorities were alerted.

• Chinese gangs do not discriminate—every major drug company and every country has probably had drugs faked by the Chinese. China is implicated in key fake-drug rings recently broken up across the Middle East and Latin America. In fact, Chinese operators will fake in or for any location and they will fake anything popular. Take Artesunat, the brand of a Vietnamese anti-malarial made by the Ho Chi Minh–based company Mekophar Chemical Pharmaceutical, which is also widely faked. Ongoing research shows that fake Artesunat was found in Nigeria, Ghana, Kenya, Uganda, Tanzania, and Thailand; and it was all the handiwork of Chinese counterfeiters.

• Beijing must do more to clamp down on the entire fake industry, which flourishes within its borders.

Clearly China has become the primary incubator and exporter of the counterfeiting drug trade which now stretches beyond the globe. China must do more to protect supply chains from a criminal act that can cause death and create health care catastrophes among entire populations. All members of the pharmaceutical supply chain must take proactive steps to interdict and eradicate these deadly fakes and protect the consumer.

To read Mr. Bate and Mr. Woods article, visit: http://www.american.com/archive/2010/december/made-in-india-faked-in-china

To learn more about pharmaceutical anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/

Chinese Court Jails Four for Fake Medicine

Chinese gang sentenced to jail for selling expired and bogus medications.

According to a story in the Shanghai Daily, four members of a group that sold expired medicine and produced fake prescription drugs without a license were given jail sentences ranging from eleven months to five and a half years yesterday.

According to the Shanghai Daily story:

• The drugs produced by the gang were tested and found to be fake. Fortunately, none of them were sold thanks to quick action by the police.

• The Putuo District People's Court heard that the gang collected expired medicine around the city at low prices and then sold them outside Shanghai, after changing the production and expiration dates on the labels.

• Zhang Dezhi, 45, from Liaoning Province, and Zhang Wenzhong, 48, from Anhui Province, who do not have licenses to sell or produce drugs, began to collect medicines around the city last year, the court heard.

• Police seized more than 3,100 boxes of medicine in Zhang Dezhi's home in Shanghai on February 3 and intercepted more than 20,000 boxes on their way to Shen-yang. They were estimated to be worth around 550,000 yuan (US$82,614).

• Police later confiscated medicine valued at 230,000 yuan from Wang's home in Shenyang, and drugs in Zhang Wenzhong's residence in Shanghai valued at more than 400,000 yuan.

• In addition to collecting and selling the drugs, Zhang Dezhi also produced fake drugs by buying in cheap and inferior medicines and attaching false labels of more expensive brands.

Hopefully this is a sign that as reported previously in Secure Pharma Chain, Chinese officials are becoming proactive and more diligent in aggressively prosecuting a lethal crime that impacts the lives of their population and that they export around the world.

China and India have become the epicenter of a global counterfeit drug issue that is worth billions annually and is estimated to kill and impact the health of millions.

To read the entire Shanghai Daily story, visit: http://english.eastday.com/e/101126/u1a5572554.html

To learn more about anti-counterfeiting solutions, visit: http://www.xstreamsystems.net/.

China Launches New Product Piracy Crackdown

According to Bloomberg News and the Associated Press, China's government is launching a new six-month crackdown on rampant copying and counterfeiting of software, medicines and other goods.

According to the reported announcement:

• The announcement comes amid complaints by industry groups that piracy of software and some other goods is growing despite repeated government pledges to stamp it out.

• Cabinet officials said the crackdown will target a wide array of products from illegally copied computer software to corn that is falsely labeled as organic.

• Fake or illegally copied music, designer clothes, medicines and other goods are widely available in China. Industry groups say Chinese piracy costs legitimate producers billions of dollars a year in lost sales.

China leads the way in fraudulent, adulterated, sub-standard and counterfeit medications that is exported to the developed and underdeveloped nation’s pharmaceutical supply chains.

Hopefully this announcement is a serious effort on behalf of the Chinese government to protect consumers around the globe from this potentially lethal crime.

To read the entire Bloomberg News story, visit: http://www.bloomberg.com/news/2010-11-30/china-launches-new-product-piracy-crackdown.html

To learn more about pharmaceutical anti-counterfeiting solutions, visit: http://www.xstreamsystems.net/.

ICE: Chinese Counterfeit Drug Distributor Sentenced to Prison

Chinese national convicted of dealing in counterfeit drugs in Texas sentenced to prison and deportation.

U.S. Immigration and Customs Enforcement released a press release on November 15th detailing the sentence of 12 months and a day in prison for conspiring to distribute counterfeit pharmaceuticals, and trafficking in pharmaceuticals with false labeling and counterfeit trademarks to Kum Leung Chow.

The sentence was announced by U.S. Attorney José Angel Moreno, Southern District of Texas.

Kum Leung Chow, aka Lawrence Chow, 59, pleaded guilty to the federal charges on June 28 and sentenced on Monday to 12 months in prison by U.S. District Judge Kenneth M. Hoyt. Chow was arrested on Jan. 27 and has been in federal custody since that date and will remain in custody to serve out his sentence. Chow is subject to deportation after he completes his sentence.

The ICE HSI investigation began in January 2009 and revealed that Chow used a Hong Kong-based company named Kingdom International Enterprises LTD to obtain and distribute counterfeit Viagra and Cialis pharmaceutical drugs in the United States. Viagra and Cialis are prescription drugs that are FDA-approved and used to treat erectile dysfunction. They are registered trademarks on the principal register in the U.S. Patent and Trademark Office. Viagra is manufactured and distributed exclusively by Pfizer Pharmaceuticals, while Cialis is manufactured and distributed exclusively by Eli Lilly.

Chow offered boxes containing four Viagra tablets and boxes containing eight Cialis tablets for $10 a box on two Internet websites. The retail cost for each Viagra tablet is about $20, while each Cialis tablet is about $15.20. Working in an undercover capacity, ICE agents purchased about 1,120 Viagra tablets and about 360 Cialis tablets from Chow via the Internet on March 25, 2009, and April 28, 2009. Shipping documents accompanying the pharmaceuticals indicated they were exported from mainland China and Hong Kong.

The pharmaceuticals were later analyzed by the trademark holders and the FDA Forensic Chemistry Center which indicated the pharmaceuticals were counterfeit. These counterfeit pharmaceutical products may have harmed the public if law enforcement were not involved in monitoring the Internet.

Chow has been in federal custody since he was arrested Jan. 27; he will remain in custody to serve out his sentence.

The investigation of Chow was conducted by agents with the U.S. Immigration and Customs Enforcement (ICE) Office of Homeland Security Investigations (HSI), and the Food and Drug Administration's (FDA) Office of Criminal Investigations. Assistant U.S. Attorney Samuel Louis, Southern District of Texas, prosecuted the case.

Continued enhanced enforcement is critical in dealing with the deadly criminal act of counterfeit medications.

All stakeholders of the pharmaceutical supply chain must take steps from bogus drugs ending up in their inventories.

To read the entire ICE Press Release, visit: http://www.ice.gov/news/releases/1011/101115houston.htm

To learn about technologies that can detect fraudulent and counterfeit drugs inside their sealed container, visit: http://www.xstreamsystems.net/.

Pharmalot: FDA Commish 'Feels Very Encouraged' About China

Ed Silverman in his excellent blog, Pharmalot offers his opinions and commentary on comments made by FDA Commisioner Margaret Hamburg during her recent tour of China.

Some of Mr. Silverman’s commentary includes:

· There she is in Shanghai, touring some facility with Chinese government officials who, of course, will do their best to make sure she doesn’t catch a whiff of a contaminated active ingredient or come within 100 miles of a gray market supplier. And there is international diplomacy to consider, after all - who buys all that US government debt?
· Despite being labeled a paper tiger by a pair of Congressman who are angry over the lack of progress into the Heparin probe the FDA commish was all smiles as she explained her view of the relationship between her agency and its Chinese equivalent.
· “I leave feeling very encouraged by the partnership we’ve developed here,” Hamburg tells the Associated Press. “This is a priority for China as it is for the United States.” She adds the two agencies are pursuing a “common agenda” to improve manufacturing practices and regulate supply chains.
· The FDA has set up offices in three Chinese cities and is cooperating in training and joint inspections, among other areas. But as the AP notes, more than 20 million imports of FDA-regulated products are expected this year, and less than 1 percent are inspected. Earlier this year, the FDA began using an automated system to sort through millions of foreign shipments and identify food and drugs that are most likely to be contaminated.
· But “we will never have the resources physically and financially to inspect all those facilities,” Hamburg readily concedes. “It is not a simple problem to eliminate in terms of the practice of bad actors who are willing to put human health at risk to make more money. It is an area we are continuing to monitor very carefully.”

Clearly it does not appear that the US and the FDA is coming into this process with a strong hand.

It seems doubtful that in the near term unless there is some epic tragic event that disables or kills a large population within a developed nation that the Chinese will cooperate or make the necessary changes within their system to demand a higher level of regulatory and industry compliance to basic good standards and practices.

As China continues to produce more and more raw materials and finished pharmaceutical products that are consumed around the globe, it is vital that the members of the global pharmaceutical chain (manufacturers, distributors and dispensers) verify the quality of the products within their inventories to protect both their businesses and more importantly the consumer.

To read the entire Pharmalot blog post: http://www.pharmalot.com/2010/08/fda-commish-feels-very-encouraged-about-china/#more-25617.

To learn more about pharmaceutical supply chain authentication solutions, visit: http://www.xstreamsystems.net/.

FDA a Paper Tiger: China and the Heparin Probe

Ed Silverman on July 22nd blogs in Pharmalot about the questions being raised in Congress and within the media of the FDA’s lack of holding Chinese officials accountabile in tracking down the issue of the deadly Heparin issue that killed dozens in the US several years ago.

In this excellent blog post, Mr. Silverman highlights:

· ...how hard is the agency trying to get China to cooperate when problems arise? Not hard enough, according to a congressional probe that reveals the FDA repeatedly asked the Chinese government for help in pursuing an investigation into contaminated heparin, but was “severely hampered” by a lack of cooperation.

· You may recall that contaminated heparin made in China was linked to 81 deaths in 2007 and 2008 and the episode sparked a firestorm of criticism at the FDA for its failure to monitor medicines made there. Since then, the heparin scandal has faded from view, but the congressional probe revives the matter - and portrays the agency as a paper tiger.

· “It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why,” Joe Barton, the top Republican on the House Energy and Commerce Committee, tells the Wall Street Journal. He and Mike Burgess, another Texas Republican who is the ranking member on the Subcommittee on Oversight & Investigations, blast the FDA for not pressing the Chinese or acting on info obtained over the past two years . The probe, by the way, comes as FDA commish Margaret Hamburg prepares for her first trip to China.

· An FDA spokeswoman tells the Journal that “there are serious limitations on what the FDA can do to pursue civil and criminal investigations in foreign countries, especially without the cooperation of the foreign government.” In a June 16 letter to the congressmen, the FDA wrote that it was “denied full access” to manufacturers of raw heparin in China.

· Chinese security authorities told a US official in Beijing in June 2008, that China wasn’t investigating the heparin episode as a criminal or administrative matter, he tells the paper.

This excellent blog brings to light the ability of the US government to properly investigate serious issues with quality, adulteration, fraud and counterfeiting with an important trading partner where a significant number consumer and health care products and their raw materials originate.

The lack of regulatory cooperation between nations is a serious concern to all within health care and its consumers.

Given the inability of the regulatory authorities to work together and properly vette and secure the global supply channels. Secure Pharma Chain believes that it is critical for all members of the global pharmaceutical supply chain to take measures to protect its inventories and brand by deploying technologies that validate the authenticity and efficacies of its products.

To read the entire Pharmalot blog, visit: http://www.pharmalot.com/2010/07/china-stymies-fda-probe-into-contaminated-heparin/#more-25075

To learn about supply chain validation solutions, visit: http://www.xstreamsystems.net/.

Bloomberg: India May Send Officials to Inspect China Drug Units

In a story written by Thomas Abraham for Bloomberg News, India may be sending health officials to China to inspect manufacturing units of bulk drug suppliers to the South Asian nation.

The Press Trust of India is citing an un-named government official, that this action may be necessary to prevent cheap imports.

According to the Press Trust of India, “Indian Health officials want to verify drugs supplied to India are made at units certified by government agencies.”

To read the entire story, visit: http://www.bloomberg.com/apps/news?pid=20601091&sid=aC4k5.Pgfv.g.

This is an ironic twist given that both India and China’s pharmaceutical industries and supply chains have a notorious reputation around the globe.

Secure Pharma Chain Blog endorses any amount of increased regulatory scrutiny within either country to protect health care consumers around the globe.

To learn more about solutions that protects the pharmaceutical supply chain, visit: http://www.xstreamsystems.net/.

WSJ: House Committee Investigation Faults FDA for Not Pursuing Heparin Contamination Leads

An April 30th Wall Street Journal article reports that the House Energy and Commerce Committee investigated and faulted the Food and Drug Administration for not pursuing “particular and plausible leads which could have fingered those responsible in China for playing a role in the contaminated heparin crisis two years ago.”

House members, Joe Barton (R-TX) and Mike Burgess (R-TX) sent a letter to the FDA in which they spelled out findings from the investigation, and said that the FDA has not pressed the government of China regarding Chinese companies involved.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing concerns by foreign pharmaceutical companies have been discovered within the supply chain that could have been detected at various points of the supply chain by readily available material authentication solutions.

To read the entire Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748703572504575214420823549694.html

To learn more about material authentication solutions, visit: www.xstreamsystems.net.

Breitbart: China Faces New Health Scare Over 'Bad Vaccines'

In a story posted on Breitbart.com, the various recent incidents of fraudulent, mis-handled, adulterated and counterfeit consumer products that have negatively impacted the healthcare of the Chinese consumer is chronicled.

Several of these deadly stories of corruption and greed have been previously reported in Secure Pharma Chain Blog.

This is an excellent read for the uninitiated as it relates to the dangers that exist when supply chains are not tightly controlled, regulated and enforced.

The stories of fraudulent vaccines, tainted Heparin, poisoned baby formula and various other deadly consumer products are all too commonplace in China. It would appear to the casual observer that instead of being isolated incidents these incidents of deadly consumer products seem to be on the rise.

Of concern to many is the fact that as the global economy expands, the reality is that a good many of the products that are consumed around the globe have raw materials and/or are manufactured in China. These products are now part of the various supply chains and can be found on the shelves of retailers everywhere.

Secure Pharma Chain Blog encourages industry leaders, governments and consumers require that the inventories of the supply chains that service their basic needs of food, medications and other goods are safe, secure, authenticated and fit for consumption.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.

To read the entire story, visit: http://www.breitbart.com/article.php?id=CNG.1b07d1be69ebdf895fab113ba26ecde7.321&show_article=1.

Six Chinese Sentenced to Death for Selling Fake Drugs Labeled “Made in India”

Six Chinese traders who exported fake anti-malaria drugs to Africa Labeled as “Made in India” have been sentenced to death. Chinese officials have offered apologies to India, but no further information on the traders’ identities was given.

The issue became a major controversy last June when Nigeria's National Agency for Food and Drug Administration and Control said it had seized a large consignment of spurious anti-malaria drugs worth $210,000.

Indian officials had received complaints that drugs exported from China but mislabeled as manufactured in India were being exported to South Africa, Ghana, Ivory Coast and other parts of Africa.

To view the entire article visit: timesofindia.indiatimes.com.

China News: UN Concerned About Clandestine Drugs Manufacturing in Guinea

In an article which appeared in chinanews.cn on August 5th, the United Nations is quoted as voicing concern over evidence recently uncovered in Guinea, suggesting that clandestine narcotics operations are producing illicit drugs on a large scale in the small West African country.

Here are some of the significant points from the UN:

• UN spokesperson Michele Montas told reporters that the UN Office on Drugs and Crime (UNODC) and Interpol, investigated a haul of chemicals seized by government forces in mid-July, revealed quantities far in excess of the legitimate demands of the country.


• "Among the evidence -- the best found by the UN in West Africa to date -- were tools for making counterfeit antibiotics, substances used to produce ecstasy, and solvents commonly used in cocaine and heroin processing," Montas said.

The UNODC launched an initiative last month to tackle the scourge in the region, which sees 1 billion U.S. dollars worth of cocaine pass through its borders annually.

To read the report online: http://news.xinhuanet.com/english/2009-08/06/content_11834912.htm

SafeMeds Weekly: Counterfeit Drug Sentencing Less Than Adequate

In an opinion piece posted on SafeMeds Weekly on August 10, 2009, Marvin D. Shepherd, PhD discusses the issue of light sentencing given to those convicted of counterfeiting medications around the globe. Dr. Shepherd asserts that inadequate sentencing “undermines the seriousness and true threat that counterfeit drugs pose to society and public health.”

Dr. Shepherd sites several examples:

• After nearly two years under investigation, the final sentence for running an international multi-million pound counterfeit medication operation was issued in the United Kingdom. The first four convictions were made in September 2007 and on July 6, the final member of the operation received a 12 month sentence, suspended for two years, for masterminding an industrial scale conspiracy of supplying counterfeit drugs between 2002 and 2005. In total, the seven convicted members of this international counterfeit drug ring received a combined 17.5 years imprisonment-an average of 2.5 years for each participant-for their part in the U.K. distribution arm of a global ring operating from China, India and Pakistan, extending to the Caribbean and the United States.


• In March 2009, an Arizona couple received at most eight years imprisonment for running an illegal drug business netting more than $2.5 million from 2004 to 2006. In comparison, convicted members of an illegal recreational drug ring would receive mandatory minimum sentences starting at 20 years up to life imprisonment for distribution in the United States.

In this article Dr. Shepherd questions the logic of not holding those responsible for the distribution and sale of counterfeit drugs to the same severity to those who commit similar offenses with illicit drugs. Basically he believes that until this is done the individuals and organizations responsible for this very real threat will continue to flourish.

XStream Systems favors stricter and more stringent enforcement and criminal penalties across the globe for those convicted of manufacturing, distributing or selling counterfeit or adulterated medications. XStream also encourages those within the pharmaceutical supply chain to screen and test their inventories with solutions such as XStream’s XT250 which allows the user to test and authenticate product inside its sealed container without destroying product or opening the container. The XT250 is designed to be deployed and used within the supply chain onsite and does not require technical resources to operate.

To read the opinion piece and to learn more about SafeMeds Weekly, visit their site at www.safemedicines.org.

To learn more about XStream Systems, XT250, visit us at 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

China, South Korea, Brazil and Turkey-Top Countries for Counterfeit Drugs

At a recent meeting in Istanbul, the Association of Rearch-Based Pharmaceutical Companies [Araştirmaci Ílaç Firmalan Demiği (AIFD)], met to discuss developments in the fight against counterfeit drugs in Turkey and throughout the world.

Turkey is the fourth largest market for counterfeit medicines according to a speech by Cengiz Gümüştüs, head of Esfor Security Consultants and former member of the Turkish National Police and Interpol. Turkey arrests for counterfeit drugs numbered 68 in 2008. Other countries with serious problems in counterfeit pharmaceuticals are China, South Korea and Brazil.

According to Gümüştüs: “In Turkey, counterfeit drugs are marketed over the Internet, pushed by street vendors or by counterfeit drug smugglers who we call “pouchers”. Our law enforcement units are waging an effective effort against counterfeit drugs and making wide-scale raids. However, the success of this effort ultimately depends on the collaboration between the state, industry and the society.”

The Association of Research-Based Pharmaceutical Companies consists of 39 pharmaceutical companies with a focus on biotechnology and R&D, including Abbott, Actelion, Alcon, Astra Zeneca, Amgen, Astellas, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Chiesi, Daiichi-Sankyo, Eczacıbaşı–Baxter, Ferring, Fresenius Kabi, Fresenius Medical Care, Gilead, GlaxoSmithKline, İ.E. Ulagay, Indentis, Johnson & Johnson, Lilly, Lundbeck, Merck Serono, Merck Sharp & Dohme, Nestle, Novartis, Novo Nordisk, Nutricia Klinik Beslenme, Pfizer, PharmaSwiss, Pierre Fabre, Reckitt Benckiser, Sanofi Aventis, Schering-Plough, Servier, Solvay İlaç Türkiye, UCB Pharma, Wyeth, who are responsible for the greater part of new drug research worldwide.

For more information visit the AFID website at: www.afid.org.tr

China Denies Branding as Fake Drug Center

China says it has been unfairly dubbed as the center of fake drugs. This branding has arisen out of the numerous problems with raw materials sourced from China. However, Chinese officials think it is the overseas companies that are to blame, stating that some companies are sourcing their raw material through illegal suppliers.

"The problem lies in the fact that some overseas companies have an implicit deal with underground factories or illegal manufacturers in China, so the product involved has problems," Bian Zhenjia, director of the drug safety supervision department under the State Food and Drug Administration, told a press conference.

In 2008, heparin was recalled after reports of deaths and hundreds of adverse reactions. The cause was linked to an adulterated substance found in the raw material traced to a dozen Chinese suppliers, some of whom were not even registered as pharmaceutical suppliers.

While China might deny the name, they have suffered the effects of counterfeiting domestically as well as abroad. Last year, they recalled several Chinese herbal medicines and recalled a diabetes drug in January that was linked to two deaths in Xinjiang. Samples showed the medicine contained six times the normal amount of a chemical ingredient used to lower blood sugar.

China's own regulatory authority, State Food and Drug Administration (SFDA) counted 329,613 cases of distribution of unlicensed drugs and medical products in 2007, according to the China Daily newspaper.

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)]

Chinese Heparin Producers Get Warning Over Falsified Information

FDA issues letters to two more Chinese manufacturers regarding tainted Heparin

It reads like a bad sequel as more companies have been named in the tainted heparin scandal…

Two Chinese companies have been issued warnings from the FDA for falsifying information on Heparin. Shanghai No. 1 Biochemical & Pharmaceutical said they were manufacturing heparin, when in fact they were purchasing it from two outside companies. One supplier is no longer producing the medicinal product.

The other supplier, Qingdao Jiulong Biopharmaceuticals was also given a warning letter. Jiulong was found to have produced 19 lots of heparin contaminated with Over-Sulfated Chondroitin Sulfate (OSCS), a substance implicated in the U.S. deaths last year. The FDA further faulted them for not investigating how the substance got into the blood thinner and for exporting medicinal products without regulatory approval.

This warning letter was in response to the FDA’s inspection of Jiulong in August 2008. Jiulong told investigators that they did not ship directly to the United States. However, during inspections at U.S. facilities purchase orders were discovered indicating that the plant had been shipping heparin sodium to the U.S. since 2005. FDA also stated that in the past, the firm supplied heparin to Amphastar Pharmaceuticals Inc., a California company that supplies pre-filled syringes.

This story illustrates why analytical screening should be conducted throughout the supply chain – to ensure the quality of: those products supplied to your company, those products you supply to others, and ultimately the finished product consumed by the patient.

China's Bad Medicine and Its Impact on the US

The Wall Street Journal features an informative editorial by Roger Bate in today's issue on the counterfeiting drug trade in China. Roger Bate is an expert on counterfeit drugs and is the author of the book “Making a Killing: The Deadly Implications of the Counterfeit Drug Trade.”

Mr. Bates discusses the scope of the problem in China and what the Chinese government can do to combat the issue. The black market is a huge enterprise in China employing as many as 5 million Chinese citizens in the counterfeit market. This is an alarming fact seeing as China is the fourth largest pharmaceutical exporter and supplies 40% of the global supply of active pharmaceutical ingredients (API).

The scope of Chinese counterfeiting has been felt globally as shown in these most recent incidents cited by Mr. Bates: In the United Kingdom in March of this year, Chinese counterfeit pharmaceuticals amounting to $745,000 were seized. In January of this year, two people died and nine were hospitalized due to counterfeit diabetes drugs in Xinjiang province. Last year hundreds suffered adverse reactions and at least 95 died due to a chemical ingredient that is believe to have been deliberately adulterated by Chinese suppliers.

In his paper “The Problems and Potential of China’s Pharmaceutical Industry” Bates further discusses the problem and why the world should be concerned. He states:

“With more Americans opting to procure drugs directly from overseas, often by purchasing over the Internet, understanding the causes of the counterfeit and substandard problem in China—and what can be done to combat it—has never been more important.”

To combat counterfeit drugs, he stresses the importance of collecting reliable information and coordinating consistent unbiased regulatory enforcement.

To view the editorial visit the Wall Street journal at www.wsj.com.

To view the paper "The Problems and Potential of China’s Pharmaceutical Industry” by Roger Bates and Karen Porter, visit the American Enterprise Institute for Public Research at: www.aei.org

Dallas Man Convicted for Distributing Counterfeit Drugs: Viagra, Cialis, Levitra

Richard Fletcher, 57, of Dallas Texas has been convicted of distributing counterfeit drugs and trafficking in pharmaceuticals bearing false labeling and counterfeit trademarks.

He used the Internet to obtain and distribute counterfeit versions of Viagra®, Cialis® and Levitra® pharmaceutical drugs. These drugs are used to treat erectile dysfunction. Their patents are held by Pfizer Pharmaceuticals, Eli Lilly, and Bayer Corporation respectively.

Fletcher offered the medication over the internet at a discounted price of $1 - $1.40 a tablet. This rate was far below the normal retail price of $11 - $13 a tablet.

The U.S. Immigration and Customs Enforcement (ICE), a division of U.S. Department of Homeland Security, began an investigation in October 2007. Undercover ICE agents posing as customers purchase prescriptions through his website between February and June of 2008. The drugs were later analyzed by the trademark holders and the FDA's Forensic Chemistry Center, and determined to be counterfeit. Also found during the investigation was proof that Fletcher purchased the counterfeits from China and engaged in discussions with Chinese individuals on how to evade detection and seizure of the product.

During this time, agents were also contacted by U.S. Customs and Border Protection (CBP) who had seized 960 Viagra tablets in package addressed to Fletcher at a mail facility in California. The counterfeit Viagra and Cialis tablets obtained as a result of the investigation are valued at more than $46,000.