American Enterprise Institute: How Safe Are Your Medicines?

A counterfeit drug has been described as the perfect murder weapon as it is very difficult to detect.

Roger Bate, the Legatum Fellow in Global Prosperity at the American Enterprise Institute and leading expert on the counterfeit drugs writes another outstanding piece on bogus medications and the deadly global problem it has become.

How Safe Are Your Medicines?, is jammed with relevant global information and statistics and is a necessary read for anyone who is part of the pharmaceutical supply chain.

Mr. Bate is a particular favorite of Secure Pharma Chain in that he clearly articulates and connects all of the many facets of this insidious criminal act and its consequences.

Here are but a few of the highlights of this first rate article published by the American Interprise Institute:

• A recent Pew poll shows that 54 percent of Americans distrust drugs made in India and 70 percent distrust drugs from China. With more and more medicines or their ingredients sourced from countries with inconsistent regulatory environments and significant levels of corruption, better-informed patients around the world are asking themselves how much they trust foreign drugs. This should be of concern to any exporting drug producer.

• A counterfeit drug has been described as the perfect murder weapon as it is very difficult to detect. Essentially a fake is a product pretending to be something it isn’t—a labeling fraud. By some estimates, perhaps hundreds of thousands of people are killed a year from fake drugs, especially in the poorest parts of Asia and much of Africa.

• Most pills do not kill as poisons, they simply do not treat the conditions and diseases they were taken to control or cure. Entities from Interpol to the World Health Organization to large pharmaceutical companies are fighting this menace. Inadequate criminal legislation means that intellectual property law sometimes offers the only remedy to such potentially lethal activities.

• A less well-known but perhaps more pernicious problem exists with substandard medicines, which are legal, often made by politically connected local companies, but do not work properly. A patient who falls victim (or his survivors, if he succumbs) may be offered no recourse, even if someone suspects something. Finding somebody to blame is notoriously difficult.

• Political ramifications are rife—a few examples from Latin America will suffice. Take the case of the Cuban doctors servicing President Hugo Chavez’s health system in Venezuela. They are bringing drugs with them from Cuba, which are suspected to be of uncertain efficacy. Stories have leaked out of patients not responding to treatments, but no one knows for sure whether medical personnel have made mistakes, or—as seems more likely—drug quality is the cause. Patient have little recourse, especially since even an investigation would imply that a key ally of President Chavez might be at fault.

• In 2003, Brazil's drug regulatory authority, ANVISA, decided to phase out the very lightly regulated class of medicines known as “similars.” These products are made by legitimate manufacturers, but they only have to show basic chemical stability. They do not have to show that they are bioavailable (they work the same way in the body) as generic drugs. Brazil’s move began when a survey found that most substandard medicines on the market were from this class. However, similars are wildly popular with the general public, which believes these are nearly as good as branded versions, just cheaper because they don't have fancy packaging. So the Brazilian government revised its plan and allowed producers a grace period—until 2014—before they would have to conform to safety standards. Argentina allows similars and has no plans to phase them out. My ongoing analysis of these medicines leads me to believe that similars have far greater variability than proven generics. In other words it is not that the manufacturers cannot make good quality products, it is just that they do not do so consistently.

• A tragic case under investigation in Peru demonstrates some of the pitfalls. Dr. Raul Cordero of the national cancer institute administered a drug to five children suffering from lymphatic leukemia, which caused an adverse effect to the central nervous system and induced coma. Four of the children died.

• Not only are these drugs a danger for the patient, they contribute to an increasing distrust of the entire healthcare system. Patients not being treated effectively may look to bogus remedies or seek “better” treatment overseas, something only the rich can afford to do.

• Competition in the drug market, as in any market, is generally a good thing. It lowers prices and enables more patients to be treated. But this is only the case where the competitors trade in products of equal efficacy and safety, and unfortunately that is increasingly not the case in many parts of the world.

As this issue continues to grow and proliferate around the globe, it is vital that all members of the pharmaceutical supply chain take measures to protect their commercial brand, inventories and most importantly the health care consumer.

The issue of substandard, adulterated, fraudulent and counterfeit medications is a problem that will only grow and will only subside until the global supply chain utilizes technology and supply chain solutions to eradicate it.

To read all of Roger Bate’s American Enterprise Institute article, visit: http://www.american.com/archive/2010/september/how-safe-are-your-medicines.

To learn more about technologies for the detection of counterfeit medications, visit: http://www.xstreamsystems.net/.

SafeMedicines: Ukraine Shut Down 149 Illegal Pharmacies in First Half of 2010

Ukrainian officials shut down nearly 150 pharmacies in the first half of 2010 because they were suspected to be selling counterfeit drugs.

SafeMedicines.Org is blogging on a report from NRCU regarding an inspection of Ukrainian pharmacies conducted by Ukraine’s State Drugs Inspectorate. Following the inspections, 149 pharmacies within Ukraine were found not to meet requirements primarily due to substandard and counterfeit medicines and were shut down.

According to the NRCU report:

• About 20 percent of newly opened pharmacies had their licenses immediately revoked as soon as they were inspected.

• "Exactly those pharmacies are the potential and real sources of the spread of substandard and counterfeit medicines among the consumers", Inspectorate Chairman Oleksiy Soloviev said.

• The licensing procedures for new pharmacies were simplified in February of this year, causing a three-fold increase in the amount of pharmacies over the last eight months, according to the news source.

As adulterated, fraudulent and counterfeit medications continue to pour into the legitimate supply chain it becomes even more important for all members of the global pharmaceutical supply chain to deploy solutions and technologies to protect their inventories and the consumer from these deadly bogus drugs.

To read the SafeMedicines blog, visit: http://www.safemedicines.org/2010/09/ukraine-shut-down-149-illegal-pharmacies-in-first-half-of-2010.html.

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

AEI: Roger Bate's Speech to Drug Policy Group

Roger Bate, long considered one of the foremost authorities on counterfeit and fraudulent medications around the globe gave a speech to Harvard Medical School, Department of Population Medicine, Drug Policy Research Group on March 3, 2010.

The American Enterprise Institute for Public Policy Research recently published the text of the speech online.

In this excellent speech, Mr. Bate explores, as the cause, consequences and possible solutions for fighting this deadly global epidemic.

Here are some interesting highlights from the speech:

· Although it's easy to buy fake drugs over the Internet, focusing on the dangers is not helpful. We should be helping people know which sites sell good drugs.

· As we've seen above most counterfeiters are most interested in the packaging--the product must look the part (whether it's a Louis Vutton purse, a Rolex watch or an antibiotic).

· Some fake drugs are hardly fake in a quality sense at all, being made in very good conditions; often midnight runs in an otherwise legitimate organization. Indeed, some obviously try to make great copies since they want repeat business. But often they're really unhygienic, even if they're made with the correct ingredients.

· (Mr. Bate’s into three drug catagories) direct, indirect and long run impacts. Drugs can kill directly; if they have heavy metal, bacterial, fungal or other contamination (over-sulfated chondroitin sulfate contaminated heparin was the cause of a hundred US deaths two years ago). Drugs without active ingredients (such as the fake Cipro we saw before) allow people to die from otherwise treatable infections (this kills the most people, tens of thousands, even hundreds of thousands in poor nations). And drugs with some active ingredient may accelerate the process of natural selection of more robust microbes to previously effective drugs.

· The few counterfeiters I've spoken with, think nothing of making Rifampicin with 25% or 40% active ingredient to pass simple dye tests (they will quote prices to you based on API concentrations), and given Rifampicin's BCS classification and its problems of solubility--anything less than good manufacture will probably encourage resistance, possibly contributing to MDR-TB.

· The economics is quite simple, the demand for drugs runs into hundreds of billions of dollars globally, and the returns to fakery can be vast.

· So why is it that such traders can flourish? Take Viagra. It costs $60/kg to buy in China or India, and one kg on prescription in 25 mg tablets in US would sell for up to $200,000. That is a vast mark up and to some it's worth the risks.

· Counterfeiting immediate etymology comes from the French contrefait, to imitate, and it is largely a legal definition, not one derived for public health. Although there is no universally agreed upon definition, the WHO’s the most widely cited. And it is largely a matter of labeling, and the faking of a label (often but not always a trademark) that defines a product as counterfeit. Some countries, such as China, require demonstration of harm from the product for a charge of counterfeiting to stick.

· …going after criminals might be the best policy action for importers into the rich world, but may not address the major problems in mid-income and poorer nations.

· NAFDAC has done a great job. As the authority in charge of combating fakes in Nigeria it has probably overseen a reduction in fakes in the past few years from maybe 40% to far less than 20%. (My own sampling using visual identification, TLC and disintegration, showed failure rates of 32% in 2007, 16% in 2009 and just now I think about 8-10%--but the counterfeiters may be coming more sophisticated and adding enough API to fool simple tests, such as assays with thin layer chromatography--but there is little doubt quality improvements have occurred across Nigeria thanks to NAFDAC).

· Corporations do a good job to defend their brands and this does help in improving quality, but they are woeful at releasing that information and make it hard to know where faking is taking place. Company lawyers prevent PowerPoint presentations and other information from being used by others to improve knowledge and scholarship in this area. The Pharmaceutical Security Institute, comprised of big Pharma, almost certainly has the best data on fake drugs but unless you're a Pharma member you can't access it.

· Probably the single biggest problem in the developing world is the lack of State support for good federal laws in China and India. Drug manufacturing is regulated by the states in both countries and the federal agents can do nothing if state agents do not wish to enforce the laws properly.

Mr. Bate in this speech and its text is probably the most up-to-date global analysis of this growing epidemic. His statistics and updates are very relevant for those involved in the pharmaceutical global supply chain.

Secure Pharma Chain Blog endorses his conclusions and encourages the integration of technologies within the various pharmaceutical supply chain as one of the more robust ways in diluting and ultimately eradicating the issue of fraudulent, adulterated and counterfeit medications.

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

To read the entire text of the speech, visit: http://www.aei.org/speech/100125.

K-V Pharmaceutical May Not Resume Sales Until 4th Quarter

K-V Pharmaceuticals announced last week that it will not resume sales until October 2010 at the earliest and may have to cut operations to stay in business.

K-V stopped all manufacturing and shipping in January 2009 after a series of product recalls and has closed its generic drug unit Ethex.

K-V pleaded guilty in February to charges it failed to inform regulators about manufacturing problems that caused some of its pills to be too large, which could have lead to accidental overdoses.

The K-V saga is a cautionary tale of a company who has suffered from a lack of product quality control, testing and verification. Had authentication technologies been in place at the point of manufacture, distribution or dispense the issue of manufacturing difficulties would have been discovered prior to the dispensing of the drug to any consumer.

XStream Systems encourages the entire pharmaceutical supply chain to employ authentication and verification technologies from end to end to protect inventories and consumers.

WSJ: U.S. Regulators Pressure Ranbaxy Over Factories

The Wall Street Journal in an article written by Rumman Ahmed and published in the February 8th edition, reports on the continued issues between the U.S. Food and Drug Administration and Ranbaxy Laboratories.

According to the story, the U.S. regulatory authority is accusing the drug maker of “an insufficient effort to meet manufacturing standards”.

U.S. sales, Ranbaxy’s biggest overseas markets have been depressed for more than a year because of manufacturing deficiencies at some of their plants.

This particular set of issues, based on substandard overseas manufacturing, energizes the need for material screening of products within the supply chain, from raw materials to dispensing, to properly protect consumers from fraud, adulteration, contamination and counterfeit products.

To read the entire Wall Street Journal article, visit:
http://online.wsj.com/article/SB10001424052748704533204575046671948801274.html.html.

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

XStream Systems Presents Quad Layer of Protection against Counterfeit Drugs

With an invitation from Pfizer Inc.. and Dr. Mohammed Abuelkhair, Head, Pharma/Medicine and Medical Products Regulation Section – Health Authority Abu Dhabi, XStream Systems had the opportunity to present at the joint Regional Conference on Fighting Counterfeit Medicines in Dubai December 15 and 16, 2009.

Representing XStream Systems were Brian Mayo, President and CTO, Patricia Earl, Vice President Business Development and Simon Irish, XStream Systems’ Director.

XStream Systems representatives had an opportunity to interact with officials from the Ministries of Health, Police, and Customs representing governments of the Middle East and North Africa region.

On the second day of the conference XStream Systems’ President formally presented the company’s vision of the “Quad-Layer Approach” that integrates molecular screening, serialization, sealants and pedigree. He shared with the attendees that this was an all-encompassing system that will deliver a seamless method of counterfeit control and product integrity assurance, and, in this regard discussed XStream Systems’ on-going collaboration with the Kodak Security Solutions and use of the Traceless System for Anti-Counterfeiting.

To view entire article visit: www.xstreamsystems.net.

CBI Probes Bulk Drugs Imported from China

The office of the Drugs Controller General of India (DCGI) is investigating bulk pharmaceutical ingredients imported in from China. The DCGI has handed over 4 cases of “alleged” unregistered bulk drugs to the Central Bureau of Investigation (CBI) with an additional 3 cases to follow.

The Directorate of Revenue Intelligence was alerted after the apex drug regulator noticed that such unregistered drugs accounted for almost half of the country’s recent bulk drugs import.

According to official sources, CBI has been asked to inquire into the import of drugs such as Roxithromycin ($81.5 per kg), Progesterone ($187.5 per kg) and Cimetidine ($14.5 per kg) by Gujarat-based Envee Drugs Pvt Ltd, and Mumbai-based firms J B Khokhani & Co and Sheetal Pharmaceuticals, respectively.

Samples of all three consignments are being tested for quality at Central Drugs Laboratory, Kolkata. The fourth case has been registered against Mumbai-based C J Shah & Co.

The products showed discrepancies in labeling, packaging and documentation. The documentation names Chinese manufacturers that have denied the products were sourced from them.

Many of the cases are labeled as chemicals, which do not undergo the same inspection as raw materials used in pharmaceuticals. This is of particular concern as these bulk drugs are used by local manufacturers to make the final medicine for domestic as well as export purposes.

The Indian drug industry is highly dependent on Chinese bulk drugs. “There is an urgent need to ensure the quality and authenticity of these drugs,” said a senior government official. India imported Rs 6,700 crore ($USD 144.23 Million) worth of mostly bulk drugs in 2007-08.

To view more on the investigation visit: www.business-standard.com.

Cargo Thefts on the Rise - Threaten Security of Pharmaceuticals

By Patricia Earl, V.P. Business Development, XStream Systems

As pointed out here by Purdue Pharma’s Chuck Forsaith, one of the key speakers at the recent 2009 National Cargo Theft Summit, Americans have an increasing issue with pharmaceuticals being stolen in transit from the manufacturer’s dock to the distributor’s dock or to the retailer. Chuck talked about why transportation – and trucking in particular – is so vulnerable to cargo theft these days and what shippers and carriers alike can do about it.

“On the street, one milligram of OxyContin is worth between 50 cents to $1, with single pill containing 80 milligrams. That means the street value of just ONE OxyContin tablet is between $40 and $80 – and Purdue Pharma typically ships 50 to 100 DRUMS worth in a single tractor-trailer load. Now you know why cargo thieves stalk the pharmaceutical industry like so many hungry wolves circling a herd of fat deer. While pharmaceuticals remain a relatively small part of the goods stolen by cargo thieves – making up just 6% of the total cargo theft “pie” as it were – the average value of a pharmaceutical cargo theft is very high, Forsaith explained; roughly $1.4 million per shipment. Overall pharmaceutical truckload shipments themselves can average anywhere from $10,000 per load (for over the counter or “OTC” products) to several million dollars (for the expensive bio-tech drugs).”

And that’s not the total picture, either, Mr. Forsaith stressed, cargo thieves have exactly zero overhead – meaning the entire shipment is 100% profit to them, no matter what they sell it for. And when it comes to potentially addictive medicines such as OxyContin, the sky’s the limit.

The National Cargo Theft Prevention Initiative created the original National Cargo Theft Strategy to combat cargo theft and this action has been sponsored by the federal government, in cooperation with private industry and state and local governments. Cargo theft incidents in the U.S present a clear and rising threat to the U.S. economy, the wellbeing and the national security of the United States of America. Since the first Cargo Theft Summit held in 2005 and subsequent gatherings held since, Cargo Theft has continued to be a rising nationwide issue with a significant economic impact on the U.S. economy and has a very high potential for use by terrorist organizations. Cargo crime accounts for an estimated direct merchandise loss of up to $ 25 billion dollars per year in the United States.

You can find more information on the website http://www.nationalcargothefttaskforce.org/.

Members of the pharmaceutical supply chain and domestic consumers should be aware of the proliferation and prevalence of counterfeit, adulterated, stolen, diverted or fraudulent medications. Distributors and dispensers should only purchase their inventories from legitimate supply chain members that utilize pedigrees and material authentication technologies to verify the medication and the chain of the transaction. Consumers need to only buy medications from licensed, known pharmacies that procure their inventories from the legitimate pharmaceutical supply chain and who use best, safe medication practices when dispensing drugs.

To learn more about material screening technology, visit: http://www.xstreamsystems.net/.

RID Pharmaceutical Execs Charged with Manufacturing Adulterated Drugs that Killed Over 25 Children

On Monday, October 12, 2009; Mizanur Rahman and his wife Sheuly Rahman, two executives from RID Pharmaceuticals were formally charged in Dhaka court with producing toxic syrup that lead to the deaths of over 25 children.

In August 2008, the Directorate of Drug Administration filed the case against five officials of Rid Pharma for the manufacturing of substandard paracetamol syrup. In July 2008, the administration seized products and halted RID Pharmaceuticals’ production of all pharmaceuticals.

Further investigation and laboratory tests confirmed the presence of the toxic chemical diethylene glycol in spurious paracetamol syrup produced by Rid Pharmaceutical Company. Diethylene glycol, normally used in the textile and leather dying industries, was allegedly used in the preparation as a cheap but deadly substitute for propylene glycol.

Rid Pharma initially denied producing the paracetamol syrup linked to children's deaths, as reported in media. Officials of the drug company were quoted in the press as saying Rid Pharma "does not produce paracetamol syrup, but only suspension".

Bail hearing is set for Oct 19, 2009.

To view entire article view: bdnews24.com

Doctor of Pharmacology Dies from Counterfeit Medication

In a sad and incredibly ironic story, a 29 year old with a doctorate in physiology and pharmacology, died recently after injecting herself with substandard buprenorphine. Buprenorphine, a drug used to treat addiction, had been purchased by the victim from an online pharmacy based in the Philippines.

Carrie John of Baltimore, a post graduate research fellow at the University Of Maryland School Of Medicine, died September 27 after diluting the drug in water from its original pill format and injecting the drug. John earlier this year co-authored and published a study on her research of "compulsions and habit formation”.

Buprenorphine is a narcotic known on the street as "bupe" and commonly used to treat heroin addiction. The woman and her boyfriend, also a post graduate researcher, apparently have been purchasing various narcotics for recreational use for the past two or three years from New Mikee Online Pharmacy, a Web site pharmaceutcal supplier based in the Philippines.

According to the boyfriend the couple used the pharmacy to buy not only buprenorphine but morphine, OxyContin and marijuana.

This terrible story is a cautionary tale to all about the evils of drug addiction and the real life danger of counterfeit, adulterated and fraudulent drugs. When a highly educated, pharmaceutical professional falls victim to both addiction and fraudulent drugs bought online, it begs the question as to what kind of risk average consumers face when drugs that are purchased online find their way into the legitimate drug supply.

To read the entire story, which appeared in the Baltimore Sun, follow the link:
http://www.baltimoresun.com/news/maryland/baltimore-city/bal-md.overdose30sep30,0,1002971.story

Caraco: FDA to Eventually Allow Manufacturing Operations

The Associated Press and several major news outlets reported that Caraco Pharmaceutical Laboratories announced on Tuesday that it has agreed to a series of measures with the FDA that will allow the company to resume manufacturing operations.

As reported on Secure Pharma Chain Blog, Caraco has had their manufacturing operations halted by the FDA after they found repeated violations of manufacturing standards and seized inventories. Recalls have been made on certain Caraco products that were found to have manufacturing defects, including oversized tablets and possible formulation errors.

The manufacturing restrictions will be in place until regulators give written notification of compliance with the agreement measures and regulations. Caraco will continue to distribute FDA-approved products manufactured by third parties.

XStream endorses the concept that all members of the pharmaceutical supply chain utilize material screening process in all points of the process; raw materials, production, quality assurance, packaging, distribution and dispensing in order to protect the supply chain and the consumer.

To learn more about XStream’s revolutionary material screening technology visit: www.xstreamsystems.net.

New England Journal Medicine: Multinational Medicines — Ensuring Drug Quality In an Era of Global Manufacturing

In the August 20, 2009 issue of the New England Journal of Medicine, Susan Okie, MD writes about the emerging health care issue regarding the quality of branded and generic drugs in the new era of a globalized pharmaceutical supply chain.

In this new global economic age, Dr. Okie describes the problem and proliferation of a major global health care epidemic due to quality control and fraudulent prescription medications that are manufactured overseas in countries with a poor record of quality processes. In the article Dr. Okie also writes about the challenge of regulation and oversight as many pharmaceutical manufacturers and providers move their supply chain overseas to make and procure medications.

One of the more disturbing examples of the potential danger of lack of quality oversight regards the super potency of Digitek in 2008:

"…FDA’s Adverse Event Reporting System (AERS) contains data on adverse reactions to medications in a self selected subgroup of an exposed population of unknown size. In April 2008, the FDA and Actavis Totowa, the manufacturer of Digitek, a widely prescribed generic digoxin, announced a nationwide recall of 800 million tablets, triggered by concern that double-thickness tablets containing twice the approved dose might have been released commercially. Between April and September 2008, AERS received reports of 2,912 serious injuries and 1,094 deaths associated with digoxin, about 80% of them linked to the recalled product. Thomas Moore and colleagues at the nonprofit Institute for Safe Medication Practices have called for systematic testing of the recalled tablets, commenting that “if many of these cases prove to be linked to manufacturing problems, then the nation has experienced a little noted drug disaster of major proportions.”

As have been reported in this blog for sometime the incidents of recalls related to lack of quality control and oversight connected to product production has spiked in the past several years and according to Dr. Okie may continue to increase due to the FDA’s lack of resources.

XStream Systems endorses the concept that both private industry and government regulatory agencies use technology such as XStream’s XT250 to screen, authenticate and verify the contents of products within the supply chain from point of production to the consumer. By using a material screening process, which verifies the material inside its unit-of-sale container, the entire supply chain mitigates its liability and ensures the consumer that the product is safe and efficacious. The current costs of the issue of poor quality medications within both the supply chain and the health care of the consumers, seems nearly impossible to effectively gauge or predict but it seems reasonable that whatever the price, the costs in both dollars and human suffering are far too high. Through proper verification within the supply chain, XStream feels that many of these incidents can be averted and the health care of the consumer protected.

To view Dr. Okie’s article in the August 20, 2009 issue of the New England Journal of Medicine, visit their website at: http://www.nejm.org/.

To learn more about XStream Systems verification technology, visit: http://www.xstreamsystems.net/.

Canadian Drug Maker Apotex Recalls Medications

CanWest News Service Reported September 17th that Canadian generic drug giant Apotex voluntarily recalled some of its drugs late Thursday following a Health Canada investigation launched last July into the company's manufacturing practices.

The investigation was initiated after U.S. regulators found "significant deviations" from good manufacturing practices during an inspection at Apotex's Toronto plant.

In a news release, Health Canada said Thursday the recall applies to three lots of drugs including:

• Apo-Amilzide (5 to 50 mg),
• Apo-Meloxicam (7.5 and 15 mg)
• Apo-Ranitidine (75 and 150 mg)

These medications are used to treat rheumatoid arthritis, osteoarthritis, excess stomach acid or liver cirrhosis.

Health Canada said that it will continue to inspect the Apotex facilities for the next few weeks to ensure that there is compliance.

It urges any Canadians currently taking the drugs to contact their family doctor.
The FDA warned Apotex in June that officials would begin blocking drugs at the border by the Toronto-based company if it did not begin complying with good manufacturing practices, which are universally accepted standards for product quality control.

To read the entire CanWest article visit: www.canada.com.

K-V Pharma: FDA Accepts Plan to Resolve Manufacturing Issue

Reuters on September 2nd reported that K-V Pharma has announced that the U.S. Food and Drug Administration had accepted its work plan to address previously identified deficiencies in its manufacturing practices. In March, the U.S. Department of Justice sued the drugmaker to block it from making and distributing adulterated and unapproved drugs, after an inspection by the FDA found the company had violated manufacturing guidelines and continued to manufacture unapproved drugs.

K-V Pharma has begun implementing certain measures set forth in the work plan but does not expect to resume product shipments before the third quarter of fiscal 2010, it said in a filing with the U.S. Securities and Exchange Commission on Wednesday.

The drugmaker said it anticipates it will request Lachman Consultants, its independent current good manufacturing practices (cGMP) expert, to conduct its certification review later this calendar year.

To view entire article visit: www.reuters.com.

Times of India: Drug Inspectors to Finally Get the Power to Arrest

The Times of India recently reported that India’s Drug Control Administration (DCA) “will soon be powered to arrest a pharmaceutical company owner for manufacturing spurious drugs or a medical shop owner for selling substandard drug and investigate the case.”

According to the article up to now, the DCA had no arrest powers, could not detain individuals for investigation or seize suspect material. The DCA has until now had to hand over all of their cases to civil police for further investigation or arrest.

XStream Systems endorses higher standards of regulatory standards, enforcement, inspection and penalties as it relates to securing the quality and standards of the pharmaceutical supply chain. It is especially important for those nations who are expanding the export of pharmaceutical products and raw materials used to make them globally.

Here are some of the interesting points and quotes from the article:

• Further, if a particular drug leads to the death of a person, the manufacturer will get life imprisonment and a fine of Rs 10 lakh will be imposed under a new amendment. The fine amount will go to the family of the victim.


• "This amendment will be a boon for the drugs inspectors. As of now even investigation is being done through correspondence with the accused or companies as there are no powers to take a manufacturer or a medical shop owner into custody for inquiry," DCA director general RP Meena told STOI. Trials of the cases would be speeded up and conviction rate would be increased with the vast powers, he added.


• Last year the DCA raided units and shops and made 48 seizures worth of Rs 1.97 crore drugs and handed over them to the police. The authorities launched prosecutions in 535 cases since 2004. Of which, 234 cases ended up in convictions and in 212 cases the accused were acquitted. For now, trials are going on in various courts in 1,012 cases.


• Also, last year 70 pharma companies were asked to stop production of drugs as they were not of standard quality. Interestingly, 84 more companies were accused of manufacturing substandard and misbranded drugs but are located in other states. "Our state requires such stringent laws as as many as 1,703 drugs manufacturing units and 50,238 medical shops are located in the state," DCA joint director K Subbi Reddy told STOI.

To view the entire story visit the following link:

http://timesofindia.indiatimes.com/NEWS/City/Hyderabad/Drug-inspectors-to-get-tonic/articleshow/4949626.cms

FDA Cracks Down on Apotex in Canada

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

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

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

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

To view article visit: www.reuters.com

Caraco to Eliminate Nearly 350 Employees Due to FDA Seizures

Caraco Pharmaceutical Laboratories has announced that it will eliminate approximately half of its employees and curb overhead by suspending all manufacturing following the seizure by the US Food and Drug Administration (FDA) of up to 33 of the company's generic drugs due to manufacturing violations. This is anticipated to impact over 350 employees.

In June 2009 the FDA seized drugs made at the company's Michigan facilities in Detroit, Farmington Hills and Wixom. The seized drugs included generic versions of heart, pain and psychiatric drugs as well as the epilepsy treatment Tegretol and a generic copy of the diabetes drug Glucophage.

Earlier in 2009 Caraco had been charged with repeated violations of FDA’s current Good Manufacturing Practice (cGMP) requirements. Beginning in January 2009, Caraco initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

XStream Systems endorses the concept of material screening of pharmaceuticals from raw materials, through the various points of production, within the distribution supply chain and at the point of dispense.

Validation at all points of the pharmaceutical supply chain from the manufacturer to the consumer verifies quality and protects against counterfeiting, fraud and adulteration.

Drug Companies Need to Improve Their Screening for Quality and Counterfeits

By: Alan Clock, Senior Vice President, XStream Systems, Inc.

Recent massive recalls on generic drugs imported from overseas contract manufacturers are making significant reverberations within the pharmaceutical industry and making the case for more stringent screening of drugs both in finished form and in raw materials.

Manufacturers in the past have seemingly been immune to this level of public scrutiny because it has often been perceived that their products are at their most pristine at the point of manufacture however with the continued proliferation of contract manufacture of product and raw material sourcing from companies located in lesser developed countries the need for more robust screening from point of manufacture through the supply chain seems obvious.

These global recalls are not just happening to the smaller generic companies that contract their manufacturing overseas but also the generic divisions of big Pharma companies are feeling the sting of substandard product within their brand.

Although the liability to the stakeholders of these impacted companies is great, the impact and consequence to the consumers of these inferior medications should remain paramount. For those in the know within the pharmaceutical supply chain, the message and actions seem clear.

XStream Systems supports the concept of screening products throughout the pharmaceutical supply chain from raw materials, to the point of manufacture, packaging, throughout the supply chain and finally at the point of dispensing to the patient.

The level of screening required is important as well, realize that all of the poor quality recently recalled product in question were passed or would have been passed on to the consumer through the process of pedigree, serialization, bar codes and RFID tags.

End-to-end screening does not have to be costly, overly time consuming or onerous to the various members of the supply chain. Current technologies exist to rapidly screen raw materials at the point of production while XStream’s XT250 has a robust solution of analytical testing of products within the sealed container in the supply chain. At the point of dispense there are a variety of technologies available currently which test for product quality and medication errors before they reach the consumer. We at XStream believe that the most effective way of protecting the product is to employ a variety of solutions at each link of the supply chain.

As the world continues to move to a global economy and the pieces of the pharmaceutical supply chain scatter beyond borders a watchful eye towards quality and security are in the interest to all of those who either make a business of or consume pharmaceuticals.

UK Recalls Multiple Generic Drugs

Violations of European standards by an outsourced Indian manufacturer have prompted the recall of multiple generic drugs in the United Kingdom.

Novartis's generics unit was one of about eight companies that recalled drugs this week because of "serious" deficiencies in so-called good manufacturing practices found during inspections of the contract manufacturer, MJ Biopharm, in India, according to the U.K. Medicines and Healthcare Products Regulatory Agency.

Novartis generic unit, Sandoz recalled fluoxetine, an antidepressant which is the generic version of Eli Lilly’s Prozac. Other drugs recalled by Sandoz included Baclofen for muscle spasms, and metformin for diabetes.

Other recalled drugs included hypertension pills amlodipine and doxazosin and pain-reliever naproxen. The other companies that recalled drugs included Strandhaven Ltd., LPC Medical Ltd., Karib Kemi Pharm Ltd., Milpharm Ltd., Greystone Ltd., Jubilant Pharmaceuticals NV and Wockhardt UK Ltd.

To view the entire article visit the Wall Street Journal Online at: www.wsj.com.

U.S. Marshal Seizes Drugs Manufactured by Caraco Pharmaceutical Laboratories

FDA acts to prevent repeated drug quality problems

Yesterday, U.S. Marshals, at the request of the Food and Drug Administration, seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities.

This action follows repeated violations of FDA’s current Good Manufacturing Practice (cGMP) requirements. Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

The FDA’s most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. FDA’s seizure is intended to lead to major changes at Caraco’s facilities.

The FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers.

"The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.

Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.

To View the entire FDA press release visit: www.fda.gov.
To view the listing of products affected by this recall visit: www.fda.gov.