I took generic Piracetam and it does not work the same and I am convince is counterfeits. I tell you I am expert and I think you are not well inform in the drug quality because you say all China is good quality when experts in drug control knows this is not true and many people die from this. The Life Extension article you say that had a blanket about China drug quality is wrong is not wrong. There are many more than only problems of no GMP in China and India.
http://www.lef.org/p...-prtcl-158.htmlI don’t like to discuss too much here because this public forum is not very well inform important world issues. I am not concern the teen ager in this forum. Many teen ager not qualified like me to discuss and are not giving resource for their argument. LifeMirage you never provide any footnote, you discuss but you not leave any footnotes. It is good respect to give not footnotes. If you know all the piracetam are safe and quality, the footnote because this is not true by drug control experts. And I do not think you are civilize to not give any resource. I visit many internet forum and it seem many care each other but you are not concern very much the others because you don’t concern the quality and say everything is safe when is not true. You say you are employee at Life Extension and Bulknutrition. I don’t believe. I think they don’t answer because they not perform the tests. I think your not concern the quality is a worry for other people taking the counterfeits. 2004: “In China, counterfeits account for as much of 50% of certain drugs on the market.”
http://www.dddmag.co...0000&PRODLETT=ZI think the drug market bulk Piracetam is not under control, the companies selling you the drugs know they can trick you because you not concern the quality and sell you many the counterfeits or sub-standard. The counterfeits and sub-standard are sold too by famous companies too for the drugs like Sildenafil and Imuran so I know it happens with Piracetam more than them. “Last year, the Food and Drug Administration (FDA) launched some 30 investigations into cases of pharmaceutical counterfeiting, involving such popular brands as Combivir (against HIV) and Procrit (for anaemia).”
http://www.economist...tory_ID=1780818The test can tell if the drug is counterfeits or sub-standards and the experts don’t agree your opinion and also know the problem to buy the drugs on the internet: I provide many many footnote from qualified experts and not any agree your opinion. Please provide footnote evidences for support your opinion; my friend American says: “the opinion is like asshole. Everybody has one.”
If you study the drugs market like I do, you will understand the bulk drugs market. there are many problems with the manufacture of the drugs. We are unsure the quality most the drugs from China and India from GMP problems to the counterfeiting. Many people die because of the problem. “The WHO believes that 8% of bulk drugs imported into the US are counterfeit.”
I show you now much many evidences from your country.
http://www.amcham.co...1&topics_id=160Like the pharmacists, suppliers of counterfeit drugs are hardly career criminals. They are more likely to be former wholesalers or distributors for established pharmaceutical companies. "That's how they got the connections and know-how to go out on their own in the first place," says Harris. "The suppliers were salespeople before and they have relations with the pharmacies. They may sell them good products five times, and then start moving in the counterfeits." Some pharmacists also get their wares, says one company head, from more mysterious sources: through direct marketers or the Internet.Counterfeit Drugs: Rx For Danger
http://www.cbsnews.c...ain204060.shtml(CBS) A Congressional committee heard testimony Thursday on counterfeit medicines—potentially harmful pharmaceuticals that doctors may unknowingly prescribe to American patients, CBS News Correspondent Sharyl Attkisson reports.
Counterfeit medicine looks like the real thing but is made with cheaper, sometimes dangerous ingredients. In 1995, tainted cough medicine killed 89 Haitians. Now there's mounting evidence that counterfeit drugs have permeated the United States.
The House Commerce Committee Thursday accused the Food and Drug Administration of disregarding its own evidence of the growing public health risk, even after one FDA investigator warned in a 1996 internal memo that,
"We literally have no control over bulk drugs that enter the U.S.…These drugs can reach anyone including the president." Chairman Tom Bliley, R.-Va., said his committee's investigation had revealed, "the FDA's regulatory system used to protect Americans from counterfeit or substandard drug ingredients has significant holes."
Bliley said the FDA allows the import of drugs based "merely on the representations of an international broker, who could in fact be the counterfeiter."
"The FDA admits it has information on only 18 percent of the foreign drug manufacturers shipping to the U.S," Bliley added. He reports that since 1997, some 4,600 foreign drug makers have shipped medication into the U.S. without getting inspected. One possible victim of counterfeit drugs is Lynn Brown, whose doctor gave her a common antibiotic, gentamicin, for a toenail infection. She was stricken by an imbalance disorder so profound, she literally had to re-train herself to walk.
http://www.bbriefing...955/ACFB49F.pdfCounterfeit Pharmaceuticals – Update on Current Status and
Future Projections
a report by
D r A l b e r t I W e r t h e i m e r , T h o m a s M S a n t e l l a and N i c o l e M C h a n e y
Founding Director, Research Co-ordinator and Director of Research, Temple University
Center for Pharmaceutical Health Services Research, Philadelphia
C o u n t e r f e i t D r u g s
There are various types of counterfeit drugs and numerous organisations trying to obtain a workable definition for the term. Common violation of regulations include ‘look-alikes’, which contain little or no active ingredient, ‘rejects’ that have been rejected by the manufacturer or regulatory authorities for quality reasons and ‘re-labelled’ medications that have expired but have been relabelled with a much later expiry date. Each type of counterfeit drug affects the victim in a different way: the damage can be caused by a lack of active ingredient or the presence of a harmful agent. These harmful agents can cause a wide array of damage, both to the individual and to society.
Therapeutics with a lack of active ingredient or asub-therapeutic dose are harmful especially in the case of anti-infectives, which can cause bacterial and parasitic resistance.3
There are numerous ways in which countries and organisations define counterfeit pharmaceuticals, but the WHO has provided a workable definition. The WHO defines a counterfeit pharmaceutical product as one that is “deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging”.4 The counterfeit drug may have either incorrect packaging or deliberately contain an incorrect quantity of active or inactive ingredients in the drug.
It is necessary for a clear distinction to be made between the various terms for counterfeit drugs, such as ‘fake’ or ‘sub-standard’. These two terms are disparate problems that need to be dealt with differently. Although a drug that contains none, too little or too much active ingredient is ineffective in treating the specified disease and can pose a serious health risk, it is possible that a drug is not counterfeit but simply a manufacturers’ defect. This product would be spotted by local regulatory authorities enforcing a strict regulatory process and quality assurance and denied access to the open market. Unless there is a deliberate action to imitate or attempt to recreate another brand, these drugs are not considered counterfeit. Although counterfeit drugs could possibly contain the proper amount of active ingredient, they are still dangerous because they originate from a criminal intent. It is imperative that counterfeiting is recognised as being illegal; due to the widespread and circuitous route that it takes to reach the consumer it must be policed internationally.
The WHO believes that 8% of bulk drugs imported into the US are counterfeit.
http://www.uspdqi.or...alityMatrix.pdfMatrix of Drug Quality Reports on USAID-assisted Countries
By the U. S. Pharmacopeia Drug Quality and Information Program
Joyce Primo-Carpenter, M.D., BSc. Pharm. Associate Director USP Global Assistance Initiatives 12601 Twinbrook Parkway Rockville, MD 20852
China
According to the State Drug Administration, a nationwide survey on the quality of medicine carried out in 1998 found that 13.1% of the 20,000 batches tested were either counterfeit or fell below minimal pharmaceutical standards.
Sildenafil (Viagra) Chinese authorities seized about 100,000 fake anti-impotence pills from an underground factory in Jiangkou.
Drug fakes, Asia’s ‘murderous’ trade. CNN.com new June 2001. Available from: wysiwyg://74/http://www.cnn.com/20…RLD/asiapcf/east/06/16/asia.drugs/
Chinese authorities have found that for some products, the estimated average of counterfeit copies can be as high as 50%, even up to 85% for some brands. European Federation of Pharmaceutical Industries Association Available from: www.efpia.org/2_indust/counterfeitdrugs.pdf
Imuran tablets The counterfeit tablets contained the correct amount of the active ingredient azathioprine but were incorrectly labeled Azathiopring. Upon testing, these tablets failed the quality specification for disintegration time. After 4 hours in water, the tablets remained intact, whereas the genuine tablets dissolve within 45 minutes Power G. Counterfeit pharmaceuticals (GSK). Proceedings of the Global Forum on Pharmaceutical Anticounterfeiting; 2002 Sept. 22-25; Geneva, Switzerland. Greenwood Village: Reconnaissance Intl; 2002.
Zinacef tablets The genuine tablets contain the oral dosage form cefuroxime axetil. Analysis of the counterfeits revealed the injectable dose form, cefuroxime sodium, which when taken orally results in minimal absorption by the digestive system and therefore has no therapeutic benefit.
Power G. Counterfeit pharmaceuticals (GSK). Proceedings of the Global Forum on Pharmaceutical Anticounterfeiting; 2002 Sept. 22-25; Geneva, Switzerland. Greenwood Village: Reconnaissance Intl; 2002.
Albumin In September 2002, a patient died after albumin was administered intravenously by the physician. Police found the albumin bottle counterfeit. It was falsely labeled to look like a local Chinese pharmaceutical brand and contained an unknown liquid that proved fatal in the human bloodstream.
Fackler M. China’s fake drugs kill thousands. San Francisco Examiner 07/29/02. Available from:
http://www.examiner....y=n.bogus.0729wDiet pills
Drug quality problems in China’s pharmaceutical industry gained international attention when five women in Japan and Singapore died and 60 more became sick after taking Chinese-made diet pills in 2002. Shenzhen Evening News reported 192,000 deaths in China with the use of bogus or poor quality drugs in 2001. The Chinese government has started to crack down on counterfeit drug manufacturing by increasing penalties, creating an effective state drug administration, and investigating more cases. In 2001, Chinese authorities shut down 1300 factories and investigated 480,000 cases representing counterfeit drugs valued at $57 million. The PBI Asian Medical eNewsletter reported on March 4, 2003 that the Shanghai Drug Administration Bureau plans to strengthen its anti-counterfeiting efforts through increased monitoring of the drug market and by following the whole process from manufacturing to selling and tracking adverse reactions. In 2002, the Bureau inspected 14,980 drugs and found 1833 to be below quality standards. Some contained talcum powder or flour while others contained toxic materials. The Chinese government reported that during the first half of 2002, it found 70,000 cases of counterfeit drug production, exceeding the total number of cases uncovered throughout 2001. The head of the litigation department of Rouse and Co, a legal firm in China, reported progress in curbing illegal pharmaceutical manufacturers through criminal action against large scale networks; 11 people have recently been arrested and are facing prosecution. China tackles counterfeiting through an administrative raid by China’s State FDA, civil action in court, or the pursuit of a criminal case. The Shanghai Municipal FDA signed a memorandum of understanding with Pfizer which will train staff in detection and dealing with counterfeit pharmaceutical activities. The training is part of the preparation for planned SMFDA raids to shut down fake pharmaceutical production operations.
Fackler M. China’s fake drugs kill thousands. San Francisco Examiner 07/29/02. Available from:
http://www.examiner....y=n.bogus.0729w Goodman P. Not what the doctor ordered: China is awash in fake drugs. International Herald Tribune. Aug. 31, 2002-Sept. 1, 2002: 4. Fighting fake pharmaceuticals: small steps. Shanghai enforcement. Authentication News, 2003. Available from:
http://www.AuthenticationNews.info Scrip World Pharmaceutical News June 11, 2004. Issue 2960; London, UK. PJB Publications Ltd: P. 17. © 2005 The United States Pharmacopeial Convention Inc. All rights reserved 12 Scrip World Pharmaceutical News June 11, 2004. Issue 2960; London, UK. PJB Publications Ltd: P. 17.
Antimalarials
**In 2002, USP DQI under the cooperative agreement with USAID began monitoring the quality of antimalarials in the Mekong region. Early 2004, the sentinel sites staff of Yunnan Province completed round 1 testing of antimalarials (artesunate, quinine, chloroquine, SP) using basic tests (visual inspection, dissolution, and TLC). A total of 39 samples were tested. Basic test results indicated that 35 of the 39 samples were authentic, while two samples failed and two were considered doubtful. Overall, about five percent of all samples (based on unique lot/batch number) failed, but more than half (53%) of samples did not identify the manufacturing or expiration date, important quality indicators. Based on established criteria, five samples (including all failed samples) were taken for verification testing at the National Institute of Drug Quality Control of Vietnam [NIDQC] using TLC and HPLC). Testing results indicate that two artesunate lots (030101 and 030801) contained no active ingredient. USP DQI notified relevant parties (regional WHO, the Yunnan Quality Control Laboratory, colleagues in China at the Yunnan Institute of Parasitic Diseases who informed the Yunnan Health Bureau and subsequently, the regulatory body, and State Drug Administration) so that the fake products can be removed from the drug outlets. Yunnan DRA is trying to investigate the main source(s) of these fake drugs.
Fake antimalarials found in Yunnan Province, China. USP Drug Quality and Information program, 2004. Available from: www.uspdqi.org
America’s Chamber of Commerce in Taipei
http://www.amcham.co...1&topics_id=160[Investigative Report]: Taiwan's Drug Problem
By Jim Boyce A week before Hseuh Mei-hua died, the elementary school student had been suffering from a severe infection. Her parents rushed her to a nearby hospital, and stood by nervously as she was examined. They relaxed once the doctor prescribed medicine that would have their daughter "up and running in no time at all."
Five days later, the Hseuhs were planning Mei-hua's funeral and her doctor, still shaken by the girl's quick demise, was recording the cause of his patient's death as infection. No one knew that the real culprit was the very thing expected to have saved her - the medicine. It was counterfeit.
Fortunately, this is not a real case. Instead, it is the type of worst-case scenario put forth by people who fear Taiwan is awash in fake drugs and that a tragedy is imminent. It's a scenario, however, with elements that are all too believable: doctors who are unknowingly prescribing phony medicine to patients while manufacturers and suppliers laugh all the way to the bank.
How dangerous is it to ignore the possibility of such a dire scenario being realized? Hopefully, Taiwan won't find out the hard way.
What's your poison?
Though the size of the problem is debatable, there is little doubt that Taiwan is struggling to cope with an influx of counterfeit drugs. But what exactly are they? The Pharmaceutical Research and Manufacturers of America association defines counterfeit medicine as "a compound that is not made by the authorized manufacturer, but is presented to the consumer as if it were."
In many cases, fake drugs are pretty close to the real thing. But there is no way for the buyer to know for certain because they are not produced under the same quality control standards used by licensed manufacturers. They could be drugs that have been diluted to gain cost efficiencies in mass production. At worst, they could contain no medicinal ingredients whatsoever, or ingredients that have the opposite of the intended effect.
Defining the kind of fraudsters responsible for such operations, however, is not easy. This is because when it comes to fake drugs, as distinct from the illicit variety, Taiwan's pushers are surprisingly nondescript. Nobody buys pharmaceuticals from shifty-eyed street hustlers. They get them from friendly people behind counters at Mom-and-Pop drugstores. Fake drugs don't come from the Golden Triangle, after all, they come from the same suppliers that handle lots of other perfectly legal drugs.
That doesn't exonerate Taiwan's pharmacies from blame. Far from it, as most people involved in fighting the counterfeiters, from investigators to industry executives, cite pharmacies as the biggest problem. Simon Lee, a detective with the National Police Administration's Foreign Affairs Police Corps, estimates that 30% to 40% of Taiwan's pharmacies carry counterfeit drugs - although all are believed to be outside Taipei. Hospitals, on the other hand, are quite safe. Jeffrey Harris, managing director of Orient Commercial Enquiries, a security company, says there are very few cases of counterfeit medicine getting into hospital systems. "A doctor writing prescriptions is not going to use it," he says.
One reason why is the type of drugs - or rather, the packaging - that counterfeiters use. Harris, who also co-chairs AmCham's Intellectual Property & Licensing Committee, says phony medicine is almost always found in foreign-language packaging because Taiwan's high regulated drug prices encourage parallel imports: drugs are bought cheaply in another country and then sold for a substantial profit in Taiwan. Fake drugs are more easily slipped in among these parallel imports. Pharmacists, naturally, make more from the parallel imports than from the locally authorized drugs. They therefore sell their customers on the cheaper price of the "foreign" drugs, claiming there is no difference in the quality. "The consumers face a dilemma," Harris says. "They want medicine but they want to get it as cheaply as possible." This is a dilemma unlikely to be given any thought by a doctor in a hospital, who prescribes only the locally authorized versions of drugs, which are always in Chinese-language packaging.
Like the pharmacists, suppliers of counterfeit drugs are hardly career criminals. They are more likely to be former wholesalers or distributors for established pharmaceutical companies. "That's how they got the connections and know-how to go out on their own in the first place," says Harris. "The suppliers were salespeople before and they have relations with the pharmacies. They may sell them good products five times, and then start moving in the counterfeits." Some pharmacists also get their wares, says one company head, from more mysterious sources: through direct marketers or the Internet.And where do these suppliers get their drugs? Usually they are smuggled into Taiwan in powder or pill form and then packaged here. The NPA's Lee says that, in all of the fake drugs cases of which he is aware, China is the ultimate source of the fakes. Harris adds Indonesia and India as key sources, saying that most phony pharmaceuticals are hand-carried or mailed into Taiwan.
The Economist.com Imitating property is theft
May 15th 2003 | BEIJING, LONDON AND NEW YORK
From The Economist print edition
http://www.economist...tory_ID=1780818Given the costs, big business is keen that consumers should feel as strongly about counterfeiting as it does. But most customers, in the developed world at any rate, are relatively unconcerned. Some argue that counterfeiting benefits consumers, particularly in developing countries, by giving them access to lower-price goods, such as software, that they might not otherwise be able to afford. And they claim that counterfeits occasionally push brand-holders into innovating in their customers' interests. Yamaha, for example, has decided to beat China's counterfeiters at their own game by introducing a new model of motorcycle at roughly the same price as the fake Yamahas on the streets.
Nevertheless, the costs of counterfeiting far outweigh the benefits. The World Health Organisation reckons that 5-7% of pharmaceuticals worldwide may be counterfeit—with too few active ingredients, too many contaminants, fake labels or recycled packaging that covers up expiry dates. The problem is most acute in developing countries. Three years ago, a survey of shops selling artesunate, an anti-malarial drug, in Cambodia, Laos and Thailand, found that more than a third of the samples analysed had no artesunate in them at all. Even in America, counterfeit medicines are not unknown. Last year, the Food and Drug Administration (FDA) launched some 30 investigations into cases of pharmaceutical counterfeiting, involving such popular brands as Combivir (against HIV) and Procrit (for anaemia). http://www.pacificbridgemedical.com/In 1998, China’s State Food and Drug Administration (SFDA) introduced Good Manufacturing Practice (GMP) certification in order to emphasize quality and safety of pharmaceutical production. However, the certification was optional and occurrences of medical accidents and legal issues continued to arise due to poor manufacturing practices. Following China’s entry into the World Trade Organization (WTO) in 2001, as well as from the added pressure of the international drug community, the SFDA implemented a new regulation requiring GMP certification for all pharmaceutical manufacturers in China in July 2004. At that time, approximately half of the 6,000 drug manufacturers in China had already received GMP certification; the other 3,000 manufacturers were granted a six month grace period to upgrade their technology in order to meet the new standards.
Following the July 2004 announcement, the SFDA issued another notice in October 2004, which revealed future GMP requirements for IVD reagents, medicinal gases and Chinese crude drugs. Manufacturers of IVD reagents (administered as drugs) will need to meet GMP standards by January 1, 2006. Beginning January 1, 2007, medicinal gas manufacturers will require GMP certification. Finally, producers of cut crude drugs for Chinese medicine will need to obtain GMP certification by January 1, 2008. GMP standards for Chinese crude drugs will involve how the manufacturer processes and contains the prepared slices of the drugs, including the cleaning, cutting and steaming processes. Any manufacturers who fail to meet GMP standards by their respective deadline will be forced by the SFDA to stop production.
http://www.who.int/m...heets/fs275/en/Substandard and counterfeit medicines
Substandard medicines are products whose composition and ingredients do not meet the correct scientific specifications and which are consequently ineffective and often dangerous to the patient. Substandard products may occur as a result of negligence, human error, insufficient human and financial resources or counterfeiting.
Counterfeit medicines are part of the broader phenomenon of substandard pharmaceuticals. The difference is that they are deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients.
In wealthier countries the most frequently counterfeited medicines are new, expensive lifestyle medicines, such as hormones, steroids and antihistamines. In developing countries the most counterfeited medicines are those used to treat life-threatening conditions such as malaria, tuberculosis and HIV/AIDS.
The extent of the problem
The United States Food and Drug Administration estimates that counterfeits make up more than 10% of the global medicines market and are present in both industrialized and developing countries. It is estimated that up to 25% of the medicines consumed in poor countries are counterfeit or substandard.
These figures place the annual earnings from the sales of counterfeit and substandard medicines at over US$ 32 billion globally.
Trade in these medicines is more prevalent in countries with weak drug regulation control and enforcement, scarcity and/or erratic supply of basic medicines, unregulated markets and unaffordable prices. However, one of the most counterfeited drugs today is Viagra, which is sold extensively via the Internet in industrialized countries.
A World Health Organization (WHO) survey of counterfeit medicine reports from 20 countries between January 1999 to October 2000 found that 60% of counterfeit medicine cases occurred in poor countries and 40% in industralized countries.
In April 1999, reports of 771 cases of substandard medicines had been entered into the WHO database on counterfeits, 77% of which were from developing countries. Data analysis showed that in 60% of the 325 cases an active ingredient was missing from the product.
A recent study in The Lancet concluded that up to 40% of artusenate products (the best medicine to combat resistant malaria today) contain no active ingredients and therefore have no therapeutic benefits.
In 2002, GlaxoSmithKline in the United States discovered suspect bottles containing 60 tablets of Combivir (lamivudine plus zidovudine) that actually contained another medicine, Ziagen (abacavir sulfate). The company determined that counterfeit labels for Combivir tablets were placed on two bottles of Ziagen and labels on another two bottles were suspect. Both medicines are used as part of combination regimens to treat HIV infection and can cause potentially life-threatening hypersensitivity reactions in patients taking other medicines in the combination.
Consequences of substandard and counterfeit medicines
At best, the regular use of substandard or counterfeit medicines leads to therapeutic failure or drug resistance; in many cases it can lead to death.
During the meningitis epidemic in Niger in 1995, over 50 000 people were inoculated with fake vaccines, received as a gift from a country which thought they were safe. The exercise resulted in 2,500 deaths.
The consumption of paracetamol cough syrup prepared with diethylene glycol (a toxic chemical used in antifreeze) led to 89 deaths in Haiti in 1995 and 30 infant deaths in India in 1998.
Of the one million deaths that occur from malaria annually, as many as 200,000 would be avoidable if the medicines available were effective, of good quality and used correctly.
A study conducted in South-East Asia in 2001 revealed that 38% of 104 antimalarial drugs on sale in pharmacies did not contain any active ingredients and had resulted in a number of preventable deaths.
In 1999, at least 30 people died in Cambodia after taking counterfeit antimalarials prepared with sulphadoxine-pyrimethamine (an older, less effective antimalarial) which were sold as Artusenate.
Challenges
Because of a lack of regulation and enforcement, the quality, safety and efficacy of both imported and locally manufactured medicines in many developing countries cannot be guaranteed. Subsequently, smuggling and illegal importation of drugs are often rife. Substandard and counterfeit drugs are then not only sold in these countries but also exported or re-exported.
The situation is worsened by the fact that medicines exported from many industrialized countries are not regulated to the same level as those domestically consumed, while export of drugs to developing countries via free trade zones is increasing. Relabelling of products to mask details of their origin is also known to occur.
Some policy-makers now believe that drug regulation represents an unnecessary barrier to trade and should be reduced to a minimum. Pharmaceuticals, however, cannot be considered a standard commodity since consumers and prescribers are unable to assess their quality, safety and efficacy and the results can be harmful to patients’ health.
Growing international and national trade in alternative medicines, including herbal products, is also becoming more complex following rapid increases in demand. Significant quantities of herbal products are now imported by countries in Europe, North America and Asia. However, the use and production of herbal products remains largely unregulated and their safety and therapeutic value cannot always be guaranteed.
Factors encouraging counterfeiting of drugs
The production of counterfeit drugs need not occur in large infrastructures or facilities. The majority of the counterfeiters apprehended so far carried out their activities in ordinary households, small cottage industries, in backyards or under the shade of a tree.
Counterfeiting of medicines is a hugely lucrative business due to high demand and low production costs. The absence of deterrent legislation in many countries also encourages counterfeiters since there is no fear of being apprehended and prosecuted.
When prices of medicines are high and price differentials between identical products exist there is a greater incentive for the consumer to seek medicines outside the normal supply system. Poverty, then, is one of the major factors in the production and consumption of substandard products.
National action to address substandard and counterfeit medicines
Legislation forms the basis for drug regulation. Medicines need to be safe, effective and of good quality in order to produce the desired effect. Ensuring these properties requires the creation of competent national drug regulatory authorities with the necessary human and other resources to control the manufacture, importation, distribution and sale of medicines.
Governments need to develop strategies to reduce corruption and criminal activity and promote intersectoral cooperation between regulatory authorities, police, customs services and the judiciary to effectively control the drug market and enforce drug regulation.
Since the opening up of trade barriers between countries has led to an increase in counterfeiting, consistent and systematic efforts are needed at the international level. These should include the timely and appropriate exchange of information and the harmonization of measures to prevent the spread of these phenomena.
Some countries have begun to make serious efforts to address the counterfeit medicines issue. In China last year, for instance, the State Drug Administration closed 1,300 illegal factories and investigated cases of counterfeit drugs worth US$ 57million.
WHO action to address substandard and counterfeit medicines
The overall goal of WHO support has been to promote the regular availability and accessibility of affordable essential medicines of good quality. WHO provides support to countries to strengthen pharmaceutical legislation, Good Manufacturing Practices (GMP), national drug regulatory capacity and performance, to promote information exchange among drug regulatory authorities and to strengthen drug procurement. WHO also works with countries to ensure that quality assurance is built into the entire drug supply chain.Guidance materials have been prepared for countries in relation to product assessment and registration, distribution of medicines, basic tests and laboratory services. Nine GMP training workshops were held in Africa and Asia and twenty WHO GMP training modules were produced in English and translated into Spanish for Latin America. CD-ROM versions of these were translated into Chinese and Japanese and distributed to 5,800 government officials and regulatory authorities staff. The GMP modules are regularly used for training in medicine regulation, including the registration of HIV/AIDS medicines.
The WHO pre-qualification of HIV/AIDS, malaria and tuberculosis medicines is also a major contribution to improving the quality of medicines for widespread conditions. It assesses products and manufacturers and provides the list of those meeting WHO standards to countries and procurement agencies to promote the purchase of good quality medicines. Given the rising demand for assistance from countries, WHO is intensifying work in the areas of anti-counterfeiting, quality and safety control of medicines as part of its task of promoting greater access to safe, effective treatment.
http://www.gphf.org/....htm#weltweites
http://www.gphf.org/...ws/news0398.htm
Counterfeit Medicines - An unscrupulous business
http://www.gphf.org/....htm#weltweites
What is being counterfeited? Four types of medicine counterfeiting
Basically, everything is being counterfeited: active ingredients, dosage forms, package inserts, packaging, manufacturers’ names, batch numbers, expiry dates and documentation relating to supposed quality controls. Counterfeiting can be sub-divided into four different types:
1. The perfect imitation of a preparation with the same active ingredients and identical packaging. From a medical point of view, the risk associated with this is small, assuming that the quality of such preparations is correct.
2. Counterfeit drugs in packaging identical to that of a trademarked product. In general, such drugs contain the active ingredient stated; however, its quality is often poor and the quantity thereof is insufficient. The consequences of this are: lack of efficacy and - in the case of antibiotics - the development of resistances by pathogens.
3. A product looks like a genuine drug but contains no active ingredient. Even in cases where the counterfeit drug "only" contains glucose: the patient’s disease will neither be cured nor will any pain be alleviated.
4. The counterfeited drug contains harmful or poisonous substances and leads to physical injury or death.
"All you need to counterfeit drugs is a person with access to a small laboratory, a propensity for theft and a total disregard of human dignity."
(Milton Silverman, University of San Francisco)
This topic is locked
