Media_reports_on_pharmaceutical_counterfeiting.pdf

Media Reports on Pharmaceutical Counterfeiting
The following are abstracts of open source media reports that mention counterfeit
pharmaceuticals and related crime. The dates range from November, 1998 to May,
2000. This list does not reference every media report on counterfeiting nor does it
contain confidential or non-media information. It provides background on the various
permutations that encompass the act of pharmaceutical counterfeiting as defined by
the World Health Organization.
1. (South China Morning Post, May 26, 2000) Fake malaria medicines flooding the
Cambodian market have killed dozens of people in the past year, and the
Government has done little to stop it, officials said. The fake drugs – marketed as the
powerful malaria medicines Mefloquine and Artesunate, but actually of no medicinal
value – had accounted for the deaths of at least 30 people so far this year, according
to Dr Duong Socheath, director of the National Centre for Combating Malaria. The
fake medicines targeted the poor because they were cheaper than genuine
remedies, said Jan Rozendaal, adviser to the European Commission's malaria
control program. "Patients go for the cheaper one. They think they are saving
money," he said. Among the most high-profile victims of the faux medicines was
Sam Veasna, head of the Government's Wildlife Protection Office in the
northwestern town of Siem Reap. He contracted malaria while conducting a survey
and began taking Mefloquine, or so he thought. Instead of getting better, his
symptoms worsened and he fell into a coma, dying within six days. Health
professionals say they are shocked at the cynical trade in ineffective drugs, which
they believe are being produced in a neighboring country and shipped to the
Cambodian market.
2. (Marketletter, May 22, 2000) A lack of leadership at the US Food and Drug
Administration and weakness in its import system has left the USA vulnerable to
potentially counterfeit, substandard, contaminated or poisoned imports of bulk drugs,
House Commerce Committee chairman Tom Bliley has told FDA Commissioner
Jane Henney. In a letter detailing nearly two years of investigations by the
Committee, Rep Bliley says that the FDA "has little or no control of imported
counterfeit bulks entering the USA, providing no meaningful deterrence to trafficking
of these products." The letter details the case of imported gentamicin sulfate,
particularly that supplied by Long March
Pharmaceutical of China. From 1989 to August 16, 1994, the product was associated
with 1,974 adverse events including 96 disabilities and 49 deaths. The FDA issued
an import alert on Long March's product in September 1999, but FDA data show 254
adverse events associated with it from May 1, 1999, to January 11, 2000, including
202 serious events and 17 deaths. "I am concerned that Long March bulk drugs
and/or counterfeit gentamicin sulfate from China may still be entering the US health
care system," he says.
3. (BBC Monitoring Central Asia Unit, May 20, 2000) A large batch of out-of-date
medicines illegally imported from abroad was burned in Uzbek. The medicines were
illegally imported and are smuggled into the country. In general, they come by the
Delhi-Tashkent route. Then they are distributed throughout the Regions and sold by
chemists. Often these medicines are not suitable for their purposes. D.Nasyrova,
head of pharmacological inspections said the counterfeit medicines are labeled as
having been produced in Poland, India and Bulgaria. Government test showed the medicines were produced in India and did not have all the basic ingredients making the medicines useless. Six tons of illegally-imported medicines have been detained by customs officers over the last two years. 4. (Africa News, May 19, 2000) South African police and the Heath special investigating unit recently arrested a number of suspects involved in the distribution of counterfeit and stolen medicine. Counterfeit, expired and stolen medicine to the value of R100m was confiscated. 5. (Africa News, May 18, 2000) A senior official from Benin's health ministry, has expressed concern at the growing utilisation of counterfeit drugs, particularly among poor countries. Dr Idrissou Abdoulaye told the ongoing session of the World Health Assembly in Geneva that poor people buy these dangerous drugs because they are cheap. "Every day people die because of counterfeit drugs," The criminals are running highly sophisticated operations taking advantage of cross-border loopholes. Supplies, production, shipping, relabeling, financing, distribution are all handled in different countries. 6. (Chemical News & Intelligence, May 18, 2000) Pharmaceutical industry officials said they are seeking federal government action against a Mexican company they accuse of manufacturing counterfeit drugs and supplements. The executive director of the Association for Pharmaceutical Industry Investigations (AMIIF) filed a formal complaint with the federal Health Secretary alleging counterfeit drugs manufacturing and tax evasion by the single firm. The organization stated, "We have tested a number of these supposedly generic products currently on sale at pharmacies throughout the country and have found that are not what they claim to be and can cause damage to one's health." AMIIF warned that, according to its own independent testing, the substitute drugs are not chemically equal to the originals. 7. (USA Today, May 9, 2000) Citing information in "adverse event" reports the FDA received from doctors and others, [Representative] Bliley disclosed for the first time that 49 people may have died from 1989 through 1994 after gentamicin injections. Bliley named China-based Long March Pharmaceutical as a problem manufacturer and exporter of bulk gentamicin. He says many adverse event reports have been linked to U.S. companies that have used supplies from Long March, including Fujisawa USA. A Fujisawa spokesman says the firm no longer makes the drug. The FDA issued an "import alert" last year banning Long March gentamicin from the USA. Evidence indicates that the firm's product "may still be entering the U.S," Bliley says. Long March didn't have an immediate comment, and the Chinese Embassy didn't return phone messages. 8. (Deutsche Presse-Agentur, May 7, 2000) A fake anti-obesity drug which looks like the real thing has been found on sale in Hong Kong. Counterfeit packets of the popular drug Xenical are being sold in pharmacies in the territory and a joint Department of Health and customs investigation has been launched. 9. (The Plain Dealer, May 2, 2000) A 62-year-old man surrendered to Boston Heights police yesterday on charges that he sold fake Propecia and phony Viagra. He was charged with seven counts of aggravated theft by deception. Lab tests last summer revealed the pills were made of water and wax. 10. (The Express, April 24, 2000) In the United Kingdom an inquiry has been launched by police into the availability of dangerous prescription drugs on the Internet. Detectives at the National Criminal Intelligence Service are carrying out the probe after doctors warned that lives were at risk. 11. (Xinhua Nes Agency, April 17, 2000) China will take effective measures to strengthen supervision over the quality of medicine and stem fake products from flowing into the market, the State Drug Administration (SDA) announced here today. A sample survey of 8,501 kinds of medicine revealed that 754 failed to meet state standards. About 12 percent of the drugs available in drug stores or used in hospitals were of poor quality. 12. (M2 Presswire, April 14, 2000) The Medicines Control Agency (MCA) is conducting a national operation throughout England to combat the illegal sale of unlicensed skin lightening creams. There has been a considerable amount of counterfeit product. There has been particular concern that some products contain a high level of potent corticosteroids that can cause asthma and make the skin permanently thin. 13. (The South African Crime Pages, April 10, 2000) In South Africa the fake medicine scam in which a syndicate is selling stolen and counterfeit medicines as locally produced brand names is growing in leaps and bounds. Panic reportedly has set in at the top South African pharmaceutical companies whose brand names are being falsified and passed off as genuine products. This is suspected to be just the tip of the iceberg. The National Police Commissioner said their investigation had found the scam was being operated nationwide. The syndicate sells fake medicines from India, Pakistan and China as genuine South African products. All major pharmaceutical companies have launched their own investigations and may recall some of their products once the damage is known. Pharmaceutical companies are also concerned about the repackaging of expired medicines bearing their labels. Police have estimated pharmaceutical companies may have lost billions of rand through the scam in the last six years. The syndicate was also linked to the hijacking of trucks distributing medicines in South Africa. The medicines were repackaged and re-routed to pharmacies. Machines used for weighing and counting pills and capsules were seized at the premises. Police also confiscated stickers, labels and pamphlets bearing South African pharmaceutical brand names. 14. (Deutsche Presse-Agentur, March 29, 2000) In Vietnam ten persons received sentences of up to 20 years in prison for producing and trading over 600,000 units of fake Viagra and other drugs. The counterfeits, which included fake ampicillin and the Aids treatment drug AZT, were made from a mixture of cassava starch and anti-mould powder and were sold in several southern provinces. 15. New York Times, March 21, 2000) Federal officials said that they had, for the first time, shut down foreign Web sites involved in the fast-growing business of selling prescription drugs over the Internet to American consumers. Agents of the United States Customs Service joined Thai authorities in raiding online pharmacies based in Thailand, which officials say is a major overseas source of powerful steroids, tranquilizers and other drugs that can be bought in the United States only with a prescription. Twenty-two people were arrested in Thailand and accused of violating Thai drug laws and export laws. Six people were arrested in Albany, New York, accused of buying drugs from a Thai online pharmacy. Federal officials said they were concerned about drugs imported from dozens of online pharmacies in Mexico, Switzerland, Britain, New Zealand and elsewhere. It is unclear whether those countries will cooperate with American investigators. In 1999, the Customs Service seized 9,725 packages with prescription drugs mailed to the United States -- about 4.5 times as many as in the previous year. In the last six months, customs agents in New York, Los Angeles and Washington have seized more than 2,600 parcels of prescription drugs bought from Internet pharmacies in Thailand. Customs officials said the Thai pharmacies filled Internet orders with drugs obtained from what appeared to be a legitimate pharmacy in Bangkok. Employees took orders from the Web site, addressed envelopes, wrapped the drugs in newspaper and stuffed them inside greeting cards. Employees hid drugs in hollowed-out books, picture frames and jigsaw puzzle boxes, before shipping them to the United States, Germany, France and Japan. Parcels were sent by mail with no return addresses. The drugs were potentially dangerous because the controls over quality were lax. "A lot of this stuff is being cooked up in somebody's back room in Thailand," The drugs from overseas may be laced with all sorts of contaminants. 16. (Scrip, February 25, 2000) The Italian police are investigating the on-line sale of stolen pharmaceuticals. Since the end of last year, the Carabinieri antifraud squads (NAS) have been on the trail of Internet sites offering pharmaceutical products stolen from various locations around Italy. In one incident, an armed gang tied up staff in a warehouse near Rome and made off with some Lit5 billion ($2.5 million) worth of pharmaceuticals. Such robberies, as well as attacks on pharmacies and lorries carrying pharmaceuticals, are not uncommon in Italy, with the products generally being passed on to compliant pharmacists for resale. But now those involved are realizing the potential of the Internet as a medium for recycling stolen products. The NAS are also thought to be investigating suspicions that counterfeit and date-expired products are being offered for sale over the Internet. 17. (Africa News, February 22, 2000) Economic liberalization is to blame for the proliferation of unregistered drugs in the local market, a cabinet minister says. He said this has led to unscrupulous businessmen bringing in unregistered and counterfeit drugs into the local market. 18. (Agence France Presse, February 15, 2000) China's government, struggling to bring its wild-west pharmaceutical market under control, has banned Internet sales of medicine over safety concerns. The State Drug Administration (SDA) will temporarily prohibit sales of medication on-line. The administration acknowledged the country's pharmaceutical trade was "chaotic," with counterfeit and low-quality drugs common on the market, and warned e-commerce could allow illegal business to worsen. 19. (Business World, February 4, 2000) The Department of Health in the Philippines now has credibility problems when patients of public hospitals and clinics realized that the cheap or free antibiotics and cough preparations that came from government hospitals seldom worked or worked very poorly. Physicians and patients also know that the proliferation of fake, misbranded and adulterated medicines is of epidemic proportions more in the government hospitals than in the private ones. 20. (AFX European Focus, February 1, 2000) The number of fake medicine products on the Russian market increased by over 20 percent in 1999, the financial daily Vedomosti reported, citing official figures from the Russian ministry of health. The problem is not restricted to the most well known and effective products, it quoted Aleksandr Arzamastsev of the academy of medicine in Moscow as saying. 21. (Agence France Presse, January 21, 2000) Fake medicines are public health scourge in Congo. A burgeoning trade in contraband or outdated drugs is endangering public health in the equatorial African state of Congo, where authorities seem incapable of stamping out the traffic. 22. (AFX News Limited, January 18, 2000) The Chinese authorities have punished 132 companies for making and marketing bogus and substandard medicine, the China Daily reported. The businesses, which include manufacturers, sellers and hospitals, were found to be using fake medicines during a three-month investigation by the state drug administration, the China Daily said. The administration tested 8,350 batches of medicine from those companies and found nearly 7 percent were fake or substandard, SDA officials said. 23. (The Independent, December 27, 1999) In Bangladesh the local pharmaceutical companies are facing a serious challenge in as the market here is flooded with lower quality and cheaper smuggled Indian medicines and pesticides. According to sources, some of those drugs have been produced by fake medicine producers. Consumers are facing a serious threat due to the consumption of these medicines and pesticides. According to different sources, the smugglers can deliver inferior quality Indian medicines and pesticides within 24 hours of getting orders. The smugglers also found it easy to carry medicines in place of heavy goods from India. These low-quality medicines are not being prescribed by doctors in India itself. Sometimes the date expired smuggled medicines are updated with new expiry dates. Ranitidine, Femotidine, Canesten-V and other essential drugs are smuggled into the region. 24. (Agence France Presse, December 21, 1999) A growing racket in fake drugs must be halted with tougher legislation, India's health minister told parliament. Health and Family Welfare Minister N.T. Shanmugam told the upper house that operators making quick and illegal profits by duplicating leading pharmaceutical brands posed a huge health risk. 25. (The Oil and Gas Journal, November 29, 1999) Some of the pharmaceuticals that are available locally in states close to the Former Soviet Union are of dubious quality and origin. Many of the drugs are from the Former Soviet Union and often preparations that western physicians and patients are unfamiliar with. Also, there are counterfeit pharmaceuticals. 26. (Agency WPS, October 22, 1999) Russia is now under an avalanche of fake drugs. For the first 9 months of the year the Volgograd quality control and analysis laboratory declared 22 drugs brought to the region unfit for use. "This is too much", said the director of the regional Certification and Quality Control Center L. Kolesnikova. Besides, the flow of fake drugs into the region is increasing. 27. (Federal News Service, October 21, 1999) PREPARED TESTIMONY OF JAMES A. DAHL BEFORETHE HOUSE COMMITTEE ON THE JUDICIARY SUBCOMMITTEE ON COURTS AND INTELLECTUAL PROPERTY, SUBJECT - HEARING ON HR 2100, THE "ANTITAMPERING ACT OF 1999" In a FDA/OCI investigation counterfeit versions of a drug commonly prescribed to AIDS patients was found in commercial distribution channels. The code numbers and packaging were fraudulent and counterfeit, although the drug itself is believed to have been from a long outdated batch rejected years ago by the manufacture for quality reasons. In this case it is believed the criminals "invented" fraudulent code numbers for consumer packages. In other cases expensive prescription [devices] used for the treatment of AIDS and other serious illnesses frequently surface in packaging bearing fraudulent code numbers. In many cases these drugs have been stolen from pharmacies, hospitals, commercials shippers, and warehouses. In some instances the drugs are believed to have originated in other countries where they are often produced in unknown, unregulated or possibly unsanitary environments. These criminals typically apply bogus code numbers to the packaging to extend the life of the drug and to cover up the true source of the product. [Additionally], an undercover FDA/OCI investigation in New York involved wholesale purchases of expensive fertility drugs. Fraudulent code numbers appeared on the counterfeit packaging containing these injectible products. 28. (AP Worldstream, October 18, 1999) Bogus malaria medication is being sold in Cambodia, threatening many of the 80,000 infected people here, health officials. ''It is not poisonous,'' said Dr. Duong Vichet, director of the Cambodian Center for Combating Malaria, ''but instead of getting cured, patients can quickly die because their health continues to worsen.'' Low-priced versions of anti-malarial medicines Mefloquine and Artesunate were recently found to be fakes packaged in bottles nearly indistinguishable from those used for the real medicine, he said. 29. (Africa News, October 6, 1999) Pharmaceuticals from India have earned a bad reputation in Tanzania where patients are giving them a wide berth reportedly because of their debased and at times suspect quality. A Dr. Ngiloi, surgeon at the Muhimbili Medical Centre in Dar es Salaam , testified that many patients reject India-manufactured drugs because of their bad reputation and because they were too cheap to be trusted to cure disease. "There have been cases where drugs ordered from India arrive with black spots, or bad smell: In case of capsules, they may arrive melted or virtually empty,"Dipen Shah of the Tanzania Pharmaceutical Manufacturers Association said. He claimed that there have been cases where capsule drugs were stuffed with cassava flour instead of the necessary pharmaceuticals. India boasts of up to 20,000 pharmaceutical manufacturing industries and Tanzanians say the number is too big for the government of India to control them effectively. 30. (Africa News, September 28, 1999) All registered pharmacies will display a new emblem as a first step in curbing the proliferation of unregistered drug shops in Kenya. The head of the Green Cross project says they have been forced to introduce the new sign emblem by the proliferation of unregistered pharmacies selling counterfeit or stolen medicines. 31. (Birmingham Post, September 23, 1999) In the United Kingdom arrests have been made after police smashed what they believe to be a multi-million pound smuggling ring to import fake Viagra from India. Detectives believe the tablets were to be sold as Viagra and the packaging would also be mimicked to create the illusion that the tablets were genuine. 32. (Bangkok Post, September 13, 1999) Concern has been raised over the increased smuggling of fake medicines in provinces on both sides of the Thai-Cambodian border. The issue was discussed at yesterday's joint meeting of Thai and Cambodian health authorities at the national, provincial and local levels. The counterfeit drugs did not contain active ingredients as specified on their labels. Food and Drugs Administration secretary-general Mongkhol na Songkhla said Thailand has sought assistance from the World Health Organisation in combating counterfeit drugs, most of which are observed to be coming from countries outside the Asean region. The use of substandard drugs has been one of the main causes of drug-resistant malaria along border areas. 33. (Africa News, September 3, 1999) In South Africa pharmaceutical companies are now using their own security guards to prevent theft. Two Cape Town pharmaceutical wholesalers have been raided and stock believed to have been stolen seized in the latest round of an on-going battle against rampant medicine crime that is estimated to cost the industry close on R2-billion a year. Medicine destined for state hospitals will now also be packaged exclusively, different from that intended for the retail market, in an effort to address overwhelming theft from hospitals and clinics. One company said the company was employing its own investigators in an effort to safeguard business. Special foil, although more expensive, that was more difficult to copy is now being used as packaging. Hospitals and airports were two areas where drugs were illegally re- routed. Generic and parallel imports were routinely repackaged and stocked past its sell-by date. Manufacturer excess and bulk loose tablets or capsules were also stolen and packed for sale. International estimates are that as much as 7% of all medicines on pharmacy shelves worldwide are counterfeit. About 60% of all pharmaceuticals on the Nigerian market are believed to be counterfeit - some made locally and some imported. 34. (Xinhua News Agency, August 29, 1999) Tanzania is getting tough on fake or substandard pharmaceuticals, mostly from India, in an effort to safeguard people's health. The ministry of health was registering all pharmaceuticals and started to send full-time drug inspectors to all major ports in a bid to curb the entry of fake or substandard ones. The move comes after a number of medical practitioners and the public complained that some imported drugs were ineffective. Most complaints were directed at drugs made in India. The influx of fake pharmaceuticals has been an issue of concern of the Pharmacy Board. The Indian high commissioner to Tanzania, said earlier this week that drugs from India were used worldwide and consumers need not worry about the manufacturing processes. He said the United States purchases about 35 percent of Indian made pharmaceutical products while European countries buy another 25 percent to 35 percent. 35. (Africa News, August 9, 1999) In Nigeria multinational drug manufacturers find it difficult to tell their drugs from the fake. Counterfeiters compromise standards by reducing the active ingredients in the medicine. Counterfeiters go to the Far-East countries like Taiwan and approach a manufacturer with the genoprototype of a particular drug produced in Nigeria and say, 'look, produce this drug for me but reduce the active ingredients by 30 per cent. Let the batch number, pack and everything be the same.' These are then mixed with the original in circulation. This is how big-time faking goeson in Nigeria. 36. (Africa News, July 21, 1999) The Malawi Pharmacy, Medicines and Poisons Board has issued a warning that the country has been flooded with fake drugs which pose a threat to life. The fake medicines include pain-killers like Cafemol with labels of Pharmanova Zambia, Norol and Panadol and Tanzania Asprin from Mansoor Daya Chemicals and Shelys Pharmaceuticals and Parapain capsules from as far as India. 37. (Chemical Business Newsbase, July 20, 1999) Fake medicines and drugs including Ecstasy pills and raw materials, have been seized in raids in Malaysia. Also seized during the raid were illegal cough mixtures, fake eye drops and imitation paracetamol tablets. The raid recovered grinding machines, moulds, ovens and raw materials used to produce the pills and medicine. About 5kg of raw materials were found at the scene, enough to make one million pills. 38. (Agence France Presse, July 16, 1999) Indian drug manufacturers have launched a campaign against fly-by-night operators making quick and illegal profits by duplicating leading pharmaceutical brands. In India these fake medicines are made without any drug content -- by merely copying the size, color and shape of the dosage and package. 39. (Marketletter, June 14, 1999) A recent inspection of stateowned and private pharmacies, hospitals and outpatient clinics in the Tajikistan capital of Dushanbe has found that a number of illegal factories producing fake medicines, which are then sold in large quantities by local pharmacies. There are now numerous criminal cases against heads of pharmacies responsible for selling fake medicines, but many of them have not been carried through to their conclusion. Some pharmacies which were closed by the law enforcement agencies are still continuing to operate. 40. (Africa News, April 30, 1999) The National Medical Stores (NMS) at Entebbe has banned import of catheters from India, saying they are substandard. Counterfeit drugs are on the increase, largely from India," a Mulago hospital doctor said. 41. (Marketletter, March 15, 1999) Lower prices and fewer regulations, resulting in easy patient access to prescription drugs in Mexico, are drawing US consumers away from American pharmacies, according to a study by Marvin Shepherd, director of the Center for Pharmacoeconomics at the University of Texas' College of Pharmacy in Austin. Several other studies have reported 25% of US residents who enter Mexico as tourists buy pharmaceuticals, and that 61% traveling to Mexico to purchase medicines do so primarily because of price differences. It is not uncommon for commercial pharmacies in Mexico to dispense them without a prescription. In some cases, the report also noted, drugs produced in Mexico have been found to be counterfeit. 42. (FT Asia Intelligence Wire, November 27, 1998) Selfmedication is a way of life for Malaysians but the question that remains to be answered is, how safe and effective is this over the counter treatment. Dr.S.T. Han, regional director of World Health Organisation (WHO) for Western Pacific Region, said counterfeit drugs ranging from well-known brands to sub-standard drugs with or without active ingredients, were an increasing problem. "It represents a particular problem for self-medication because public finds it more difficult than prescribers, pharmacists and other drug sellers to identify such drugs," he said.

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