Interpol Investigation Leads to Drug Seizures, Arrests in Asia

Bloomberg Business Week

Police seized more than 20 million packs of counterfeit medicines, arrested at least 33 people and closed more than 100 illegal pharmacies in a series of raids in eight Southeast Asian nations coordinated by Interpol. Counterfeit versions of Pfizer's Viagra, Bristol-Myers Squibb's Plavix and Teva's pill Plan B were among the products seized, Aline Plancon, an Interpol officer who coordinated the raid, said. The haul also included fake aspirin, antibiotics, malaria treatments and hair-loss medicines, she said.

Those fighting against counterfeit medicines face increasingly sophisticated adversaries

Of the chemicals he uncovered in various counterfeit malaria pills, Facundo M. Fernandez did not expect to find sildenafil, the active ingredient in the drug Viagra. He also didn’t expect to find the antibiotic erythromycin; one of the building blocks for making the street drug ecstasy; or metamizole, a powerful analgesic that is banned in the U.S. because it is suspected of causing serious bone marrow disorders. Yet the Georgia Institute of Technology chemist, who provides scientific support to international anticounterfeiting operations, has recently found all these chemicals and more in counterfeit malaria pills. “It’s shocking,” he says. “Sick children take these drugs. It’s terrible that they don’t receive the correct treatment. But worse, the chemicals in these counterfeits could make them sicker.”

Putting false active ingredients in fake drugs is just one trend in medicine counterfeiting. Bogus pills used to consist primarily of blanks because counterfeiters focused mostly on making the pills look like the originals. But these days, counterfeiters are increasingly adding all sorts of active ingredients to phony tablets. They slip mild pain relievers such as acetaminophen into pills just to make patients feel like they might be getting better, as was the case in fake Tamiflu seized from U.K. pharmacies in 2007. Sometimes, they add small amounts of the correct active ingredient to dupe testers who may not have equipment to accurately quantitate ingredient levels. More worrisome, some counterfeiters substitute life-threatening chemicals for the real McCoy, such as the antifreeze component diethylene glycol to replace glycerine. The toxic substitute ended up in cough medicines that killed hundreds in Nigeria, Panama, and Bangladesh in recent years.

FDA Counterfeit Drug Investigations Reach New High in 2009

At the HDMA Track & Trace Seminar (National Harbor, MD, Nov. 30-Dec. 1), David Dorsey, Acting Deputy Administrator for Policy at FDA, revealed the FY 2009 (which ended last September) figure for counterfeit-drug investigations opened by FDA’s Office of Criminal Investigations: a new record of 65. FDA cautions that this count is not a direct measure of the volume of counterfeit activity—but on the other hand, where there’s smoke there’s fire. Dorsey also said that the agency is working toward its mandated March 2010 deadline for making recommendations on a “serial numeric identifier” program for drug tracking, as specified in the FDA Amendments Act of 2007. Meanwhile, newer legislation, such as the Buyer-Matheson bill from the 2008 session (H.R. 5389) is expected to be re-introduced in the current Congress. That bill would mandate a national track-and-trace system to prevent counterfeiting and diversion. PC

China uncovers more melamine-tainted milk powder

By Rory Harrington, 11-Dec-2009

Related topics: Financial & Industry, Dairy-based ingredients

Employees from a Chinese dairy company have been taken into police custody on suspicion of selling tonnes of melamine-tainted milk powder.

Fake medicines inundate EU market

The Industry Commissioner said in an interview published in the German daily Die Welt on Monday that the trade in counterfeit medicines in the European Union had exceeded the body's worst fears.

Guenter Verheugen said the EU had seized fake tablets worth millions within a short period of time. "In just two months, the EU seized 34 million fake tablets at customs points in all member countries. This exceeded our worst fears," he said.

He told Die Welt that antibiotics, cancer treatments and Viagra were among the counterfeit medicines. Other fake drugs seized included anti-malaria medicines, analgesics and anti-cholesterol treatments.

Verheugen is Germany's commissioner to the European Union and will hold the portfolio until commissioner-designate Antonio Tajani of Italy is approved and takes office early next year.

Verheugen said the European Commission, the bloc's executive arm, was very concerned about the situation, adding that he expected the EU to take action to fight the menace of fake pharmaceutical products.

"The number of counterfeit medicines arriving in Europe ... is constantly growing. The European Commission is extremely worried," Die Welt quoted Verheugen as saying.

An EU report in July said that many of the fake pharmaceuticals seized in 2008 came from India.

Fake salt bust hints at bribery in sector

By Lan Tian (China Daily)
Updated: 2009-12-02 09:14

When Chongqing police busted a gang that processed and resold nearly 800 tons of illegal edible salt in a year, it only hinted toward the corruption that plagues the domestic salt industry functioning in an imperfect legal system, officials have said.

Of the 10 accused who stood trial in the southwest municipality on Nov 5, Xu Shouhua and Tan Zhengbing, the prime suspects, were sentenced to 13 and 12 years behind bars.

The court, which found the duo guilty of illegal operations, also fined the two 400,000 yuan ($59,000) and 150,000 yuan, respectively. The court is yet to deliver its verdict on the remaining accused in the case, which is arguably one of the largest cases of fake edible salt exposed in the country.

Police tracked down about 788.85 tons of the fake salt the gang sold since 2007.

Small packages of fake edible salt for household consumption appeared on the shelves in 15 districts and counties in Chongqing in 2007.

Police nabbed Xu at his illegal salt plant last November.

They divided the industrial salt into small packages in Chongqing, and then sold them to local wholesalers. The packages were sophisticatedly counterfeited and updated regularly, making it hard for them to be distinguished from authentic products, investigations showed.

In China, edible salt must be iodized, besides conforming to other relevant national standards. Industrial salt, which does not contain iodine, can affect people's mental and physical development, and also impairs reproductive function.

However, no cases of poisoning from the fake edible salt have been reported yet.

China implements a government monopoly on the edible salt sector with an aim to ensure the compulsory national strategy of iodizing the product to protect residents' health.

Only a few government authorized salt companies can produce and sell edible salt, according to the Edible Salt Monopoly Regulation, which was issued in 1996.

State broadcaster CCTV quoted Chen Yigen, director of the Chongqing salt administration bureau, as saying: "Deep-rooted causes behind the rampant illegal activities are inadequate supervision and an imperfect legal system."

The country has about 3,000 salt producing companies that produce 68 million tons of crude salt annually, of which only 8 million tons is processed into edible salt. All the rest is used as industrial salt.

Industrial salt kills 1, sickens 25 at food shop

By Wang Hongyi (China Daily)
Updated: 2009-10-19 07:57

The owner of a Shanghai delicatessen that sold food cooked with industrial salt, which killed one person and poisoned 25 others, was detained by police yesterday.

According to local authorities, 26 people showed symptoms of nausea, vomiting and rapid heartbeat after eating the food bought from Zhibin Delicatessen in the city's Pudong district on Saturday afternoon. One of them, a 38-year-old male surnamed Zhu, died before being sent to hospital.

Doctors from the Pudong District People's Hospital said 25 people were diagnosed with nitrite poisoning. Shanghai authorities confirmed yesterday they found industrial salt in the food.

All 25 people have been released from hospital.

The Shanghai industry and commerce bureau shut down the delicatessen, which was operating without a license. Processing equipment and more than 26 kg of processed food were confiscated.

Officials from the bureau said they would send the food for further testing. Related departments will continue to track the source of the industrial salt and its sales links.

Compared to edible salts, salts for industrial purposes are poisonous. Eating industrial salts can cause dizziness, headache, fatigue, rapid heartbeat, drowsiness, irritability, difficulty breathing, nausea, vomiting, abdominal pain and diarrhea.

The wholesale price of edible salt costs 0.8 yuan (12 US cents) per kg, while industrial salt costs 0.2 yuan per kg. Some traders make profits by selling industrial salt as edible salt to food shops.

USP and USAID Launch New Program to Improve Drug Quality

Published by Alexis Pellek on November 6, 2009 09:20

The US Agency for International Development (USAID) and the US Pharmacopeial Convention (USP) recently announced a new program designed to fight the growing problem of substandard and counterfeit drugs in developing countries. The $35-million program, called Promoting the Quality of Medicines (PQM) will work to improve the safety of medicines in approximately 30 countries worldwide by working to strengthen regulatory bodies, increasing the supply of legitimate products, detecting and reducing availability of counterfeits through testing and other methods, and raising public awareness of the dangers of substandard drugs.

“Without good quality, safe medicines to treat diseases such as HIV/AIDS, malaria and tuberculosis, the impact of other health initiatives may be weakened. The PQM program focuses on this critical aspect of combating these diseases,” Gloria Steele, USAID acting assistant administrator for global health, said in a press release.

“The lives of patients are put in serious jeopardy when they take substandard or counterfeit drugs,” Roger L. Williams, MD, chief executive officer of USP, said in a press release. “Such ‘medicines’ have health as well as economic implications. Moreover, substandard medicines contribute to the development of drug-resistant strains of infectious diseases. Such strains are a leading challenge in the fight against malaria, HIV/AIDS and tuberculosis.”

Crackdown targets counterfeit drugs

Fake medicines a growing enterprise

By Ylan Q. Mui
Washington Post Staff Writer
Friday, November 20, 2009; 2:41 PM 

NEW YORK -- In highly orchestrated raids across five continents this week, Interpol officers in Europe, drug agents in the United States and task forces from Sweden to Singapore hunted down counterfeit prescription drugs in an effort to stem a rapidly growing criminal business preying on financially pressed consumers looking for bargains.

The front line of the operation is deep in the bowels of a sprawling mail center in the industrial outskirts of John F. Kennedy International Airport. This week, federal agent Stephen Buzzeo, wielding a letter opener, ripped open a manila envelope lined with cardboard from a diaper package and pulled out three packages of what looked like diet pills, anxiety medicine and OxyContin, an often abused painkiller.

Anti-counterfeiting effort seizes 167,000 pills

By Nick Taylor, 23-Nov-2009

A five-day international anti-counterfeiting operation involving regulators, police and customs officials from 24 countries has resulted in the seizure of 167,000 counterfeit pills.

Counterfeit Drugs and Internet Smarts

More public education would help stem the problem of fake pharmaceuticals—restricting Internet trade would not.

By ROGER BATE

Whatever happened to caveat emptor? Consumers are indeed put at serious risk when they buy counterfeit drugs over the Internet. But sweeping restrictions on Web-based drug sales stand to worsen their ills.

The problem is getting worse. Take Britain, which has Europe's worst problem with H1N1 or 'swine' flu, with around 64,000 new cases every week and 182 deaths—about a third of Europe's total fatalities. The flu's pandemic status has scared many people into stockpiling the two key antiviral drugs, Roche's Tamiflu and GlaxoSmithKline's Relenza. Manufacturers have increased supply, but couldn't keep pace with soaring demand. To fill the gap, criminal gangs have sold fake versions over the Internet, defrauding millions of dollars and endangering lives. For while H1N1 thankfully has a low fatality rate, poorly-made drugs—many produced in filthy conditions in India, China and Russia—could be far more lethal.

British security software firm Sophos has found thousands of fake drug web sites and millions of bogus promotional materials, many being generated by Russian criminals. In a statement last week, the company said some criminals were claiming to be making "more than $100,000 every day" from gullible buyers of fake flu drugs. Not only will the drugs not work, the identities of the purchasers may be stolen as criminal networks use their credit card details to further defraud them.

In response, the Council of Europe is preparing a new international convention against counterfeit medical products, with a special focus on the Internet. It is expected that it will begin collecting country signatories next year. It has a laudable aim—to increase awareness of the danger of buying drugs over the Internet—and many poorer nations do need to criminalize the manufacture and sale of fake drugs and enforce those laws. However, if history is a guide, the convention may well be overly bureaucratic and wind up stifling competition, increasing drug prices, and won't be enforced by countries where fake drugs are a major problem. All that, and it will not remove the biggest threat in Europe and the U.S.: inattentive Internet shoppers.

Online gangs cashing in on swine flu-security firm

By Kate Kelland

LONDON, Nov 16 (Reuters) - Criminal gangs are making millions of dollars out of the H1N1 flu pandemic by selling fake flu drugs over the internet, a web security firm said on Monday.

Sophos, a British security software firm said it had intercepted hundreds of millions of fake pharmaceutical spam adverts and websites this year, many of them trying to sell counterfeit antiviral drugs like Tamiflu to worried customers.

Tamiflu, an antiviral marketed by Switzerland's Roche Holding (ROG.VX) and known generically as oseltamivir, is the frontline drug recommended by the World Health Organisation to treat and slow the progression of flu symptoms. GlaxoSmithKline (GSK.L) makes another antiviral for flu, known as Relenza.

Sophos said many of the gangs behind the sites were based in Russia and the top five countries buying fake Tamiflu and other medicines on the internet were the United States, Germany, Britain, Canada and France.

Sophos spokesman Graham Cluley said a "worrying trend" towards stockpiling Tamiflu had already been seen in Britain -- Europe's worst-hit country in the H1N1 pandemic so far.

"As more and more cases of swine flu....come to light, it is essential that we all resist the panic-induced temptation to purchase Tamiflu online," he said.

"The criminal gangs working behind the scenes at fake internet pharmacies are putting their customers' health, personal information and credit card details at risk."

The Geneva-based WHO, which declared H1N1swine flu a pandemic in June, updated its guidance to doctors last week to say that antiviral drugs should be given even before tests conclude that an at-risk patient has the pandemic virus.

Millions of adults risk buying 'fake' drugs

OnMedica Staff
Tuesday, 3 November 2009

Over 7 million UK adults are bypassing the health system to get hold of prescription only medicine without a prescription.

In many cases such purchases may be fake and will either not work or may cause real harm, warn pharmacists.

A survey, released today to coincide with the launch of 'The Get Real, Get A Prescription' awareness campaign, found that more than one in seven British adults (15%) admitted to obtaining medicine without a prescription.

The survey found that British people are putting too much trust in illicit websites. Of those surveyed, the majority (60%) said they were more trusting of purchases they make online today compared to five years ago.

In addition, alarmingly almost a fifth (18%) of UK adults believe people who sell prescription only medicine without a prescription, are providing a service to the general public – offering cheaper medicines to those that need it.

A third (33%) belive that what is being sold is the real thing, sourced from legitimate places and sold on.

David Pruce from the Royal Pharmaceutical Society of Great Britain said: “Pharmacists are very concerned about the increase in fake or counterfeit medicines. As expert professionals in medicines and medicines use, we know only too well that fake medication does not work and that it can cause harm.

"Stay safe by ensuring that you always get your prescriptions dispensed at a registered UK pharmacy. If you want to buy medicines online, always check that you are dealing with a genuine pharmacy. Don't go on face value – some of the illegal sites look very professional but supply dangerous fakes. Check our website for a list of sites that have been awarded the RPSGB’s internet pharmacy logo so that you can be sure that you are dealing with a UK registered pharmacy supplying genuine medicines. This campaign is important. We want the UK to be the safest place to obtain medicines.”

The campaign has been launched in a partnership between The Medicines and Healthcare Products Regulatory Agency (MHRA), the Royal Pharmaceutical Society of Great Britain (RPSGB), The Patients Association, HEART UK and Pfizer.

A hard-hitting TV advertisement, which is considered so shocking that it can only be shown after 11pm, will kick-off the campaign tonight. A national billboard poster campaign will also run nationwide in November, with a consumer roadshow touring seven cities over the next week.

EFCG: Counterfeit Medicines More Profitable than Heroin

Oct 22, 2009
By: Stephanie Sutton

The European Fine Chemicals Group (EFCG) gave an update of some of its activities at a press conference held at CPhI Worldwide (Spain) last week and revealed some disturbing facts regarding counterfeit APIs, which the group is particularly concerned about. According to the press conference, an estimated 20–30% of off-patent medicines in European Union pharmacies are falsified at the API level.   

Guy Villax, a member of the EFCG Board and CEO of Hovione (Loures, Portugal), said, "Falsified medicines is a business more profitable than heroin, and in most countries it is not legislated as a crime."  

In investigating this, Villax found that in many countries, including Canada and most of the EU, counterfeit medicine crimes are only addressed in the context of trademark and patent infringements and, according to Villax, are "not considered a more serious crime than a fake designer t-shirt." Although France, Germany and the US consider counterfeit medicines a serious crime, their laws are not specific in addressing medicines made with falsified APIs—the only country that does this is the Philippines.

So what can be done to ensure that consumers are protected? Villax explained that three bills have been proposed: a directive of the European Parliament, a drug convention of the Council of Europe and, in the US, the Drug Safety Bill. In particular, Villax noted that the fact that regulators and agencies are beginning to talk to each other is a positive development as it has led to more consistent definitions across the various bills. He said, "In the EU, a falsified medicinal product is being falsified in relation to its identity, as well as its history or source, and may include substandard or falsified ingredients or excipients. We are starting to have the right kind of law in place to address not the companies with weak compliance, because they are doing their best and are still not there yet, but the people who use wrong compliance as a business strategy. These are the people we want to get out of the market."

However, although these bills may go some way to improving the situation, Villax added that they are by no means perfect. In particular, he talked about part of the European Directive that the EFCG thinks is not going to work. Villax said, "Europe is taking a view that 'we don't need to inspect everyone. If other countries have equivalent systems of enforcement requirements we'll live with that. We'll recognize those standards.'" This is what is called the list based on evaluation by the EU.

According to Villax, this may work for certain countries, such as European countries, the United States, and Japan, but may not be appropriate for all countries. "If, for political reasons, we have recognition of equivalent standards in areas that we think may be corrupt, we may start to look at these as trade barriers," said Villax.

The penalties need to be high If the bills become law and are ratified nationally, Villax said there will be "major changes." "If the API is labelled with a different address to the true one, this will be a counterfeit crime. If anyone takes a certificate of analysis and changes the brand name or address or the expiry date, that is a counterfeit crime," said Villax. "The laws that are going to come into force will be pretty serious and involve putting people in jail," he said. "Finally we are starting to have legislation with sanctions that is in proportion with the kind of regulations out there designed to provide quality medicines."

Regulators are not the only ones taking action against counterfeiters; the pharmaceutical industry itself is also taking steps to improve the situation. "At Hovione, for instance, with our off-patent APIs, we've seen pharma companies auditing more frequently and also sharing audits," said Villax. "We've also seen more direct relationships between makers of APIs and users of APIs. There is a search for more transparency and less reliance on brokers and middlemen."

Villax also highlighted the Rx-360 consortium, which was developed by volunteers from the pharmaceutical and biotechnology industries, including suppliers, to improve the reliability and authenticity security of the pharmaceutical supply chain. Approximately 70 companies are involved in the group. "The first step the companies involved in this consortium will do is to share their audit reports," said Villax. "If each of these companies conducted 20 audits in the last year then you're going to have approximately 1000 audit reports."

The companies will also contract audits to be performed and the resulting audit report will be shared. According to Villax, this will dramatically reduce the costs and frequency of audits. "But the quality of the data that quality assurance and purchasing will have available will increase enormously," he added.  

Rx-360 was launched in the US on June 5, 2009, and will be launched in the EU on Nov. 10, 2009. Villax believes that it could be particularly helpful for generics companies. He said, "This will not solve all their obligations in terms of supplier qualifications, but it will help them enormously to meet the requirements of the legislation."

 A Glimpse in Mexico's Shadow Pharmaceutical Market

Amid Mexico’s recent influenza pandemic, the real danger that fake medication could imperil the health of the population was acknowledged. The country’s health ministry warned the public of the risks of buying medications, such as Tamiflu and Relenza, online. Armed guards protected warehouses storing medications. Pharmacies and hospitals maintained strict vigilance and were asked to keep faultless inventory records to avoid theft.   

These measures helped with a crisis, but the same underlying threats besiege the industry every day. Kroll recently conducted an in-depth investigation into the growing problems afflicting this sector in Mexico. Here are some of the key findings.

The country’s pharmaceutical industry faces substantial fraud risks. The $15.5 billion market is plagued by widespread and difficult-to-tackle problems – counterfeit goods, theft, and irregular sales practices chief among them. Overall, illicit activity amounts to about $1.9 billion per year, or 12 percent of the formal market. Counterfeiting affects all companies and represents 81 percent of the illicit market. Theft – including stealing from pharmacies and warehouses, cargo theft, and pilferage – constitutes an additional 12 percent, while the illegal sale of drug samples accounts for 5 percent...

Distrust slows supply chain

By gmiller

Created Oct 21 2009 - 8:39am

Africa's fake pharmaceuticals problem

Benin's Adjegounle market is a kingdom of street pharmacies, where 'cure' meets 'kill' on a regular basis.

By Fiacre Vidjingninou in Cotonou
Published: 12:53PM BST 15 Oct 2009

A few kilometres from Benin's conference centre where France's former president Jacques Chirac introduced a global campaign against counterfeit drugs this week, hundreds of vendors make brisk business peddling all types of bogus pharmaceuticals.

Adjegounle, the "drugs" district that spans over 1,000 square metres (more than 10,000 square feet) in the heart of Dantokpa, the largest market in the Beninese metropolis, is always packed, even on Sundays.

Aisha, 31, sits under sweltering tropical heat, sweat dripping down her face, behind her stall on which she displays all kinds of fake drugs that she is hawking.

"How can you stop us when we have done nothing wrong?" she challenged.

"Every day, I leave the market with an average of 600,000 FCFA (£839). I support my entire family," said Aisha, apparently unperturbed by the deaths and devastation that has been blamed on adulterated drugs.

At least 250 deaths and 340 cases of chronic illnesses linked to such drugs were recorded between April 2007 and June 2008 by the National Medical Centre and University of Cotonou, according to a medical thesis.

How to Stop the Counterfeit-Medicine Drugs Trade

By Peter Gumbel / Paris

The next time you're tempted to buy Viagra, Lipitor or some other medication online, ponder this: there's a high likelihood that what you buy will be fake. The pill or vaccine may contain a much smaller dosage than stated, or it may lack any active ingredient whatsoever. Worst of all, it could be toxic. According to the World Health Organization (WHO), more than 50% of drugs sold online have either been falsified or altered in some way. And Internet sales are just the tip of a much bigger problem. Falsified medicines are especially prevalent in developing countries; the WHO estimates that up to 30% of drugs sold in parts of Africa, Asia and Latin America are fake, including ones used to fight diseases like malaria and tuberculosis.

The issue has long been a preoccupation of major pharmaceutical companies, which lose as much as $75 billion in business every year to counterfeit-drug makers, according to WHO estimates. In 2002, the industry set up a Washington-based agency called the Pharmaceutical Security Industry, run by Thomas Kubic, a former FBI deputy assistant director, to try to tackle the problem. And four years later, the WHO launched an international task force dedicated to the issue. But so far, such efforts have merely highlighted the growing trade. The Pharmaceutical Security Industry tracked more than 1,800 incidents of drug-counterfeiting around the world last year, 10 times the number when it first started monitoring seven years ago. Getting governments and law enforcers around the world to work more effectively to counter the problem has proved hard. (See the top 10 product recalls.)

MHRA Response to EC Proposal

UKs Medicines and Healthcare products Regulatory Agency (MHRA) says that some requirements in the European Commission’s (EC) proposal to combat drug counterfeiting conflict with UK regulations. Most of the MHRAs concern surrounds the requirement in the EC proposal that the outer packaging of certain medicinal products to be sealed. This would reveal any subsequent of the packs. The right to opening the outer packaging would be restricted to the market authorization holder and end-user (hospital, healthcare professional or patient). 

Per the MHRA, the above requirement would prevent importers from the EU from complying with the UK regulations, as this requires products sold in the UK to have an English language leaflet and labeling. The MHRA also wants to know which drugs would be subject to the ban on repackaging. It wants an exemption for all drugs undergoing clinical trials. 

The MHRA agrees with the following parts of the EC proposal but wants more information on the practical applications: 

• Require the possibility of tracing ownership and transactions of a specific batch. This should be achieved by making a specific record (pedigree) obligatory. The record should be accessible by all actors in the distribution chain. The MHRA is concerned about overburdening the healthcare professionals if there is a requirement to collect a cumulative record.

• Require the possibility to trace each pack and perform authenticity checks, by a mass serialization feature on the outer packaging. Again, a concern on overburdening healthcare professionals.

• Make regular audits of active substance suppliers on GMP compliance by manufacturers and importers of medicinal products mandatory. Per the MHRA, this would require access to the closed part of the drug master file and is concerned about the audit process for atypical ingredients.

• Require control of active substances via sufficiently discriminating analytical techniques as a mandatory method for identification by the manufacturer of the medicinal product. The MHRA is concerned that these technologies are not yet fully developed. 

The MHRA supported many of the EC proposals without comment such mandatory audits by qualified auditors for GMP/GDP compliance, establishing an EC wide database of wholesalers documenting GDP compliance, requiring GDP certificates to be issued after each inspection of a wholesaler, turning principles of GMP for active substances into EC law, and strengthening provisions on inspections, including specific harmonized provisions for inspections in the distribution chain (e.g. wholesalers, brokers, traders, agents, business-to-business platforms).

Silver Lining In Melamine Crisis

LAST YEAR'S SCANDAL involving the deliberate contamination of Chinese milk products with melamine continues to have heartbreaking consequences. Yet this unfolding tragedy has also had a positive impact, prompting international food safety reforms and advances in analytical techniques.

Melamine is used to make plastics, laminates, fertilizers, and other products but is not approved as an ingredient in food. Milk dealers in China added the nitrogen-rich compound to boost the apparent protein content of diluted or substandard milk, according to the country's official news agency, Xinhua. The adulterated milk was then used to make powdered milk and infant formula, as well as candy, cookies, flavored milk drinks, and other foods.

In all, the contaminated milk products killed at least six Chinese infants and sickened nearly 300,000 other children last year, Xinhua reported. This year, Chinese courts handed down death sentences for two people who sold melamine-laced products, and a dairy-food company executive was sent to prison for life for her role in the scandal. Several other government officials and dairy industry workers have resigned or been fired or imprisoned.

GSK Advair shipment stolen

RESEARCH TRIANGLE PARK, N.C., Aug. 24 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) is advising that two lots of Advair Diskus(R) (fluticasone propionate and salmeterol inhalation powder) medication were stolen on August 2 from the company's distribution facility near Richmond, Virginia. Medicine in the stolen cartons could represent a health risk because it has been removed from the legitimate supply chain and the storage conditions under which the stolen products were held are unknown. Inhalers from these lots should not be dispensed, sold, or used.

The lot numbers and quantities are:

Lot 9ZP2255 - NDC 0173-0696-00, Advair Diskus 250/50, 60 Dose (14,400 inhalers)

Lot 9ZP3325 - NDC 0173-0697-00, Advair Diskus 500/50, 60 Dose (11,200 inhalers)

These lots were awaiting distribution to retail pharmacies at the time of the theft. Neither of these lots are part of the legitimate pharmaceutical supply chain. GSK has alerted its distributors and customers to the stolen lots.

Anyone who has information regarding this incident, has received suspicious or unsolicited offers for the Advair Diskus lots in question, or has received product from these lots is encouraged to contact the U.S. Food and Drug Administration (FDA) Office of Criminal Investigations at 1-800-551-3989. Patient or customer inquiries for the company should be directed to GSK's Customer Response Center at 1-888-825-5249.

GSK discourages patients from purchasing any medication sold outside of legitimate channels.

Full EU pharma chain traceability "highly feasible," say experts

19 August 2009
By Lynne Taylor

Full traceability systems within an open, cross-border pharmaceutical sector supply chain are entirely feasible for Europe, and undoubtedly across other continents too, say experts.

This is the main conclusion of an evaluation report of Pharma Traceability, a pilot of the European Union (EU) BRIDGE (Building radio frequency identification solutions for the global environment) project, published this week by the European Commission. Supported with funding of 7.5 million euros under the EU’s Sixth Framework Programme (FP6) and begun in mid-2006, the Pharma Traceability pilot is the first project to implement a global supply chain-wide traceability system based on mass serialisation techniques, aimed at ensuring patient safety in the branded and generic pharmaceutical supply chain.

The pilot was conducted by a team of five technology providers working with nine supply chain participants representing pharmaceutical manufacturing, logistics and distribution. It tracked, in a live operating environment, 15 different types of drugs in different packaging forms through their supply chain journey, from manufacturing/packaging plants in Ireland and the Netherlands, to their final destination, the pharmacy department at Bart’s Hospital in London and the London NHS Trust, all based on open system standards. The mass serialisation solution, utilising a mix of GS1 Data Matrix bar codes and radio frequency identification (RFID) electronic product code (EPC) tags at patient pack, case and pallet packaging levels, was found to meet all current worldwide pharma regulations on authentication and track-and-trace and also address the current lack of supply chain visibility of goods shipments faced by the healthcare industry, say the partners.

The data set used (product code, serial number, batch number/Lot code and expiry date), coupled with the EPC Information Services (EPCIS), not only offers the required traceability for electronic pedigree but also for recall systems and enabling electronic flow of information to back office systems, with resulting efficiency gains for inventory management and financial reconciliation systems, they say.

However, they warn, these benefits will not come cheap. They will require technology investment by all supply chain parties, not least by manufacturers, plus significant effort and focus on trading partner collaboration and stringent adherence to robust processes and their management. Staff with little or no IT skills will be required to process the relevant systems whatever time of day or night in line with often demanding timescales. There will be no room for error, not least to deliver the required levels of customer service but also to maintain the traceability trails.

Getting Real About Fakes

If companies want to cut into sales of counterfeit products, they need to understand why consumers buy them in the first place

By  PEGGY E. CHAUDHRY And  STEPHEN A. STUMPF

As the counterfeit trade booms, companies are rolling out massive campaigns to get people to stop buying fakes. But the messages they use are often off the mark.

Companies have tried everything from threatening prosecution to linking phony products with organized crime. But marketers often don't pay attention to what actually drives people in particular markets to buy counterfeits and what messages will actually work to curb demand of fake goods.

Companies, for instance, might roll out ads in a country stressing that fake products are of poor quality. But those ads might ignore the fact that local consumers have little disposable income and consider knockoffs a bargain—so they are willing to accept a price-quality trade-off. A better approach might be to stress that the phony goods, such as fake cigarettes, are funding terrorism or, in the case of counterfeit pharmaceuticals, are actually killing people.

To figure out how companies can improve their antipiracy marketing, we surveyed consumers in five large markets—Brazil, Russia, India, China and the U.S.—to see what would make them opt for knockoffs. Then we used that information to figure out what messages might get people to stop buying the illegitimate goods.

Great News:  Any fake and counterfeit drug offender faces a life sentences in India

Lagos — Any fake and counterfeit drug offender apprehended for dealing on fake and spurious pharmaceutical products faces a life sentences in India, if current moves by the country's Drug Regulatory Agency succeeds at the parliament. At the prompting of a high power delegation of National Agency for Food and Drug Administration and Control (NAFDAC) to India led by its Director-General, Dr. Paul Orhii, the Indian Drug Regulatory Authority is currently pushing through the parliament a draft legislation that would impose a life jail term on anybody who manufactures and export fake drugs to Nigeria.

Similarly, any Nigerian Drug Importer who connives with an India Drug Company to produce fake drugs will also be jailed for life upon conviction by the court.

Orhii said the Agency has also taken other tough regulatory measures in collaboration with its Indian counterpart to deal decisively with fake drug offenders.

He said during his recent visit to India, consultative meetings were held with India Drug manufacturers Association, Indian Pharmaceutical Council, Federation of Indian Chambers of Commerce and Industry as well as Indian Pharmaceutical Alliances.

FDA Warns Healthcare Professionals and Public About Stolen Asthma Drug 

FDA Issues Pharmaceutical Industry Guidance on Preventing Melamine Contamination

In a guidance issued today, the U.S. Food and Drug Administration says that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.

Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides. If ingested in sufficient amounts, melamine can result in kidney failure and death.

Although the FDA has no reason to believe that the U.S. pharmaceutical supply is contaminated with melamine, recent events involving pet and livestock food products in the United States, and milk products for infants in China, underscore the potential problem.

The guidance is an initial measure by the agency in working with pharmaceutical manufacturers, repackers, other suppliers and pharmacists to conduct melamine testing. The agency invites comments on the guidance, available online and titled "Guidance for Industry: Pharmaceutical Components At Risk for Melamine Contamination".

“The FDA urges implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry on this serious public health concern.”

The FDA identifies specific pharmaceutical ingredients in the guidance that are recommended to be screened for the presence of melamine. The guidance also recommends the use of FDA-published methods for this testing that are used to detect the presence of melamine in food proteins. These tests rely on equipment that is generally available to pharmaceutical manufacturers or contract testing labs. The agency also is developing a sampling and testing program for pharmaceutical ingredients at risk for melamine contamination.

Bayer has solution for solvent shortage in pharma

Tuesday , August 04, 2009
Phil Taylor
pharmafocus@wiley.com

German chemical company Bayer says it could have a solution to help ease the current shortage of acetonitrile, a solvent widely used in pharmaceutical manufacturing.

Bayer's Technology Services unit says it has developed a ton-scale process that allows the feedstock for acetonitrile to be purified to a quality suitable for use in pharmaceutical production.

The shortages of acetonitrile came to a head in 2008 and were prompted by two major factors - decreased output of the chemical from China and hurricane damage to a factory in Texas that was a major world supplier.

But rather than getting better as we head into the latter half of 2009, the situation is actually getting worse, with demand still tight and prices increasing.

A lot of acetonitrile comes as a by-product of production of the plastics acrylonitrile and polyacrylonitrile, which go into automotive components, machinery housings and other heavy goods. With manufacturing of these items in the doldrums as a result of the global recession, production of the chemicals used to make acetonitrile are also down.

Bayer's approach does not tackle the overarching shortage in acetonitrile feedstock, but does make more of the available supplies suitable for use in pharmaceuticals. Drug manufacturers can now buy lower-grade acetonitrile and get it processed to a pharmaceutical grade.

Using the approach, technical quality acetonitrile - known as isocratic grade - can be purified to 'gradient grade' suitable for use in high-performance liquid chromatography (HPLC) or even to pharmaceutical quality, known as 'ultra gradient grade'.

The conversion price ranges from 10 to 17 euros per litre, depending on the quality of the feedstock provided, according to Bayer.

"Upon request we can deliver the pharmaceutical quality ACN to our customers in electropolished 1m3 containers," says Dr Michael Traving, head of Bayer's pilot plant facility in Leverkusen, Germany, where the technique was developed. The plant has a production capacity of 4m3 per week.

The shortage in acetonitrile has led to concern that unscrupulous individuals might be tempted to adulterate supplies with other chemicals for financial gain.

That has prompted industry to look for alternative solvents to acetonitrile, although the implications of process changes can be costly - both in terms of time and money - as they generally require notification to the regulatory authorities.

The industry-backed supply chain security group Rx-360 recently developed an alternative analytical method for acetonitrile to detect dilution or adulteration of the solvent.

China owns up Nigerian fake drugs cargo

Chinese authorities have admitted that the fake drugs with "made in India" labels confiscated by the Nigerian government originated from China and promised to take action against the manufacturers, according to a commerce department official. The Nigerian Government Drug Regulatory Authority seized fake antimalarial generic pharmaceuticals shipped from China in May. "It is very important that the Chinese government takes strong action against the companies so that other companies think twice before doing something similar," the official said. Nigeria’s National Agency for Food And Drug Administration And Control said it has contacted Interpol to look into the fake drugs.

Astellas Recall of Lots of Several Medications Due to Stolen Transport Trailer

July 23, 2009

Astellas has issued a recall of several lots of some medications. A transport trailer carrying these items was stolen in mid-June and the items have not been recovered. Due to safety concerns should these medications come back into circulation, Astellas is recalling these specific lots of medications. No other lots of these medications are affected by this recall. The affected products and their lot numbers are listed below:

How Many Children Have to Die due to Diethyl Glycol?

CNN Repoerts that tainted pain reliever tied to children's deaths

(CNN) -- A toxic chemical added to a popular pain reliever likely killed two dozen children in Bangladesh, health officials said Tuesday.

Pharmaceutical companies usually add propylene glycol as a solvent in the syrup for paracetamol, which is sold over the counter to relieve pain and reduce fever.

But tests revealed that a drug company in eastern Bangladesh had instead added diethyl glycol to its paracetamol syrup, said Health Minister Dr. A.F.M. Ruhal Haque.

The chemical, used in textile factories and leather dying plants, causes renal failure. It is 10 times cheaper than propylene glycol, Haque said.

Twenty-five children, ages 1 to 5, have died in the past six weeks. The tainted medication killed most, if not all, of them, authorities said.

"The exact number is difficult to say," Haque said. "Some of the patients have a definite history of taking this syrup, but there are some other kids who died of kidney failure who appear not to have."

Most of the deaths have been reported in the district of Comilla, where the factory is. The plant has been shut down.

No criminal charges have been filed in the deaths, authorities added.

In 1990, paracetamol solution laced with diethyl glycol sickened 339 children throughout Bangladesh, most of whom later died.

The deaths prompted the government to ban the sale of paracetamol syrup for some time. As a result, cases of kidney failure decreased by 54 percent, according to a 1995 study by the Dhaka Children's Hospital.

Deaths from diethyl glycol added to paracetamol syrup have been reported in several other countries, including Haiti, where 85 children died in 1996.

In the United States, paracetamol is sold generically as acetaminophen. Brand names include Tylenol.

"It is important to stress that paracetamol is not to blame," Haque said. "We don't want people to be frightened. It's the solvent that was used in this case."

India set to sign pharma export deal with Nigeria

NEW DELHI: The government is set to sign an exhaustive deal with Nigeria to boost pharmaceutical exports to its eighth- largest global consumer, where the reputation of Indian drugs was recently dented by fake drugs from China bearing ‘Made-in-India’ labels.

The department of pharmaceuticals and the ministries of commerce, external affairs and health will start talks with a visiting Nigerian delegation on Monday on ways to prevent fake drugs from other countries bearing fabricated ‘Made-in-India’ labels from reaching the Rs 1,000-crore West African market for Indian generic drugs.

Orchid Chemicals and Pharmaceuticals and Medo Pharma are the biggest Indian exporters to the region. To salvage the reputation of Indian generic drug exporters and to promote sales of Indian generics, India is likely to use resources from the ‘challenge India fund’ maintained by the commerce ministry.

“Both the governments (India and Nigeria) will also discuss setting up a network of retail pharmacies in Nigeria operating with government licence, and putting an end to the existing unregulated medicine outlets,” the official, who asked not to be named, said.

The move will enable the government to put in place a fool-proof system to ensure that fake drugs are not passed off as imported generic drugs from India. Recently, a delegation of Indian authorities led by officials from the commerce ministry also visited Johannesburg to discuss the issue of fake drugs.

At the proposed talks, both the governments will identify steps to encourage Indian drug companies to set up manufacturing units in Nigeria and explore whether Indian public sector drugmakers can supply low-cost quality drugs to the Nigerian government.

The African country had seized a large consignment of fake anti-malarial drugs labelled ‘Made in India’ in May this year that was later traced to China. Three such consignments from China were also seized by the Indian authorities at the Chennai Port. India has also demanded that China should take strict action against the manufacturers whose names and addresses were printed on the confiscated cartons.

“Supply of spurious drugs to Africa is on the rise. Urgent steps have to be taken to ensure that India’s reputation as a reliable supplier of high-quality, low-cost medicines is not ruined. The sooner we act, the better for us,” the official said. Africa accounts for over 15% of India’s total generic exports worth Rs 30,000 crore annually.

Building A Better Supply Chain

Superior supply chain execution helps drive operational excellence, but it's a difficult challenge to meet. Experts share their thoughts about who is achieving top performances, and more importantly, what criteria manufacturers should focus on to improve their own supply chain capabilities. 

The University of Tennessee’s J. Paul Dittmann says successful supply chains demonstrate proficiency in these five pillars of excellence:

• Talent
• Technology
• Internal collaboration
• External collaboration
• Change management

Drugmakers keen to blow the whistle on spurious trade

P.T. Jyothi Datta

 Mumbai, July 28 Spurious drugs result in murder most foul, says Novartis head in India, Mr Ranjit Shahani, welcoming the Union Health Minister Mr Ghulam Nabi Azad’s recent statement in Parliament on a ‘whistleblower scheme’ to reward tip-offs on such medicines.

Last week, Mr Azad proposed rewards of Rs 2 lakh to Rs 20 lakh for information on the manufacture of spurious drugs. It would encourage locals and labourers to come forward with information, he had told the Rajya Sabha.

 The proposal has not been discussed with the pharmaceutical industry, but representatives are happy the issue is back on centre-stage after a gap of about five years.

Done with a profit motive, counterfeit drugs cause a “perfect murder”, observes Mr Shahani, where “you take the pill — the evidence disappears and you die of the disease and not the medicine.”

Lauding the “creative” suggestion to reward the informer, he however points out the need to keep the identity of the whistleblower confidential as in the case of the income-taxinformant-cum-whistleblower to help unearth tax evasions.

 But will people come forward despite fears of threats from the mafias operating in this segment? “History shows that by and large informers are able to steer clear of trouble. Some incidents indeed would take place but one would rather prefer this risk than allow millions of gullible patients to suffer at the hands of drugs mafia,” says Mr Harinder Sikka of Piramal Healthcare.

Mr Sikka, in his personal capacity, had filed a public interest litigation in Delhi High Court in 2007, asking the Centre to implement the Mashelkar Committee report (2003) on the issue.

The whistleblower scheme will put fear in the minds of those who have “been enjoying their extended honeymoon with regard to rampant trade in fake drugs”, Mr Sikka says.

The manufacturers will have to exercise extreme caution, as the reward is large enough to encourage insiders to blow the lid,” he adds. By cleansing the system of fake drugs, the Centre will address a menace that has caused harm to patients, hurt importers, exporters and genuine manufacturers, he says.

India still does not have an official estimate on the prevalence of spurious drugs, and priority on the issue has swung from high to being put on the backburner. The initial call for death penalty for spurious drug makers has been given a silent burial. The penalty now is life imprisonment and a fine of Rs 10 lakh.

As fake-drug makers end up tarring the entire pharma industry, all sections of the industry have welcomed initiatives to end the problem. The only concern as expressed by the Indian Drug Manufacturers’ Association’s Mr Daara Patel, on behalf of small and medium drug-makers, is that genuine drug makers should not inadvertently get caught in the net that is cast for spurious drug makers.

Become an Rx-360 Contributor and Help Us Share Important Information

One of the top benefits Rx-360 provides is shared information.  With the help of our frequent News Flash reports, electronic newsletter, and website (www.Rx-360.org), we’re able to keep our vast network up-to-date on the latest supply chain news on a regular basis. 

The information we share is available thanks to an army of volunteers that have a passion to secure the supply chain and to protect patients. We encourage you to join us! 

If you have a topic you’d like to share information on with our Rx-360 members, or if you have time sensitive information that you think should be immediately broadcasted, please email these to Martin@Rx-360.org. We will consider all submissions for publication and the material can be credited to you as the source or you can submit it anonymously.  

Counterfeit Antimalarial Drug Discovered in Ghana with Aid of USP Drug Quality and Information Program 

An International Web May Trap Pharma Counterfeiters, but It Won’t Keep Them for Long

Published by Angie Drakulich on July 22, 2009

One of the International Criminal Police Organization’s (Interpol) six priority crime research areas is drugs and criminal organizations. As reported in the New York Times on July 20, the organization is working with an informal group of researchers and government officials in Africa, Asia, and the US to track counterfeit drugs that claim to treat malaria, a disease that takes nearly 1 million lives a year. The counterfeiting of pharmaceuticals in developing countries has become rampant, as noted in my blog post last week. In 2008, the UN Office on Drugs and Crime (UNODC) estimated that more than 25 percent of medicines consumed in developing countries are counterfeit. And just today, the US Pharmacopeia (USP) issued a release that counterfeit drugs claiming to treat malaria are being removed from the Ghana market after a citizen notified the Medicines Quality Monitoring program. The monitoring program was set up by the US Agency for International Development (USAID)-supported Drug Quality and Information Program and implemented by USP.

The trend of faking pharmaceuticals is growing because of the vast amounts of money counterfeiters can make. Take this example from Martin Van Trieste, interim director of Rx-360, the new international pharmaceutical supply chain consortium: If a counterfeiter invests $2000 in faking a DVD, he may turn that into $20,000; if he invests $2000 into faking cocaine, he may turn that into $200,000; but if he invests $2000 into faking a pharmaceutical drug, he may turn that money into $2 million! At the same time, the punishment for getting caught counterfeiting pharmaceuticals is far less severe than for counterfeiting illegal recreational drugs such as cocaine, says the NYT article.

According to the Federal Food, Drug & Cosmetic Act, any person who knowingly sells, purchases, trades, counterfeits (or offers to do these things) a fake pharmaceutical product “shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.” Illegal drug counterfeiting, on the other hand, comes with an imprisonment of  “up to 20 years.” Penalties in developing countries are even more lax.

Interpol and the informal research group are using new technology involving an ion gun and mass spectrometers that can almost instantly identify what’s in a product and determine its authenticity. Interpol is also working with the UNODC, the World Health Organization, and the World Customs Organization to stop counterfeiting and drug trafficking.

These international efforts are well and good, but if the punishment doesn’t match the crime, what’s to deter counterfeiters? We don’t often hear of stakeouts of pharmaceutical counterfeiters on the news—because this crime is not a priority. If a counterfeiter can fake thousands of lots of pharmaceutical products, make several hundreds of thousands of dollars, and not get caught, what’s to stop him? Even if he does get caught, a fine of $250,000 is only a drop in the bucket compared with the money he may be bringing in. Meanwhile, thousands of individuals in need of real treatment may be getting a drug product that’s not going to help them because it’s fake. And meanwhile, a child is dying every 30 seconds from malaria.

We need a stronger system for punishing pharmaceutical counterfeiters before it’s too late.

Using Scientific Tools in an International War on Fake Drugs

Dr. Fernández’s main focus is counterfeit pharmaceutical drugs, especially in poorer countries, where government regulation is weak. He is part of an informal group of researchers and government officials spanning Africa, Asia and the United States who have teamed up with Interpol, the international police agency, to use cutting-edge technology in tracking fake drugs that claim to treat malaria. Counterfeit malaria drugs are of particular concern because of the scale and severity of the disease — it kills more than 2,000 children a day in Africa alone — and fears that fake or substandard malaria drugs are aggravating a growing problem of drug resistance.

China's medicine watchdog launches pharmaceutical safety program

www.chinaview.cn 
2009-07-18 16:30:19

BEIJING, July 18 (Xinhua) -- China's State Food and Drug Administration (SFDA) has announced a two-year campaign to improve the quality standards of pharmaceuticals from manufacture to sale.

The program is aimed at better regulating the production, distribution, pricing, advertising and application of basic pharmaceuticals across the country, according to a statement posted on the website of the administration Friday.

Pharmaceutical companies and hospitals that violate the regulations would face prosecution and the revocation of their operation licenses, according to the statement.

In addition to the administration, five central government departments will join in carrying out the campaign, including Ministry of Health, Ministry of Public Security, Ministry of Industry and Information Technology, State Administration for Industry and Commerce, and State Administration of Traditional Chinese Medicine.

FDA advocates food pigments and flavours to combat counterfeits

By Gareth Macdonald, 16-Jul-2009
Related topics: Ingredients, excipients and raw materials

Draft guidance issued by the US FDA suggests that greater use of inks, pigments, flavours and other physical chemical identifiers (PCIDs) will help combat counterfeit drugs.

IMS health recently estimated that the counterfeit drugs “market” generates almost $800bn annually and is growing at almost 6 per cent a year.

While regulatory agencies and technology developers are working on sophisticated analysis methods and tracking solutions to combat the problem, no one technology has emerged as the leader.

The Food and Drug Administration’s (FDA) new document argues that incorporating PCIDs into drug formulations could be a cost effective way of differentiating genuine products from fakes.

The agency went on to say that PCIDs used in drugs should be pharmacologically inactive and suggests that: “food additives, colorants, or excipients with established safety profiles,” would be ideal candidates.

While in common with other anti-fake labelling methods, PCIDs can be easily detected in the laboratory, their big advantage over traditional methods is that they can be readily identified by patients, healthcare practitioners and pharmacies.

The FDA also suggests that any PCIDs that are selected should be tested for potential toxicity, unless they comply with generally recognised as safe (GRAS) guidelines, as well as any interaction they have with release technology employed by the drug.

Commenting on the guidance, recently appointed FDA commissioner Margaret Hamburg said that: “Drug counterfeiting is a serious public health concern,” and added that the agency is committed to ensuring fake products are stamped out. The full draft guidance can be accessed here .

Fake medicines in West Africa a health risk for all

8 July 2009 - Counterfeit medicines not only deprive sick people of real treatment, but they make some of the world's most dangerous diseases stronger. West Africa has increasingly become the target of a range of counterfeit medication, including antibiotics, antiretroviral drugs and medicines to fight malaria and tuberculosis. Most of these fake pharmaceutical products, which appear to be genuine but contain little or no active ingredient, are imported, particularly from South and East Asia, but some come from the local pharmaceutical industry.

In a newly released report entitled Transnational Trafficking and the Rule of Law in West Africa: a Threat Assessment, UNODC looks at the impact of counterfeit medications in West Africa and how this impact is amplified by the very high demand for anti-infective and anti-malarial drugs. According to the World Health Organization's World Malaria Report 2008, Africa accounts for most of the world's malaria incidence, while West Africa has the highest estimated rate on the continent, with nearly 98 million cases of malaria per year.

As much as 50-60 per cent of anti-infective medicines tested in Asia and Africa have been found to have insufficient amounts of the active ingredients. Medicines with low levels of active ingredients pose a greater hazard than those with none, because substandard antibiotics and anti-malarial drugs can promote the development of drug resistant strains, or "super bugs" that can spread beyond the region.

A 2003 study of counterfeit chloroquine, an anti-malarial drug, showed not only that a high percentage of the sample failed to meet technical drug standards, but also that the counterfeits were spread evenly and widely, from district hospitals to local vendors and households. Groups producing these fake drugs target markets in developing countries where the capacity to detect defective products is low. This is further fueled by consumers who have virtually no purchasing power and no voice.

Smugglers replicate the packaging and even the holograms that appear on the boxes of the real products, often using the cheapest fillers with few ingredients. Medicines are also stolen for resale at lower prices, leaving consumers with no guarantee that the medicine has been handled or stored properly. Often, expiration dates are forged to lengthen the shelf life of old medicines. Supply routes for this method are similar to those for manufactured counterfeits.

The UNODC report shows that revenue gained from 45 million counterfeit anti-malarial medicines (worth $438 million), for instance, is greater than the gross domestic product of Guinea Bissau. It has been estimated that in 2010 this illegal market will raise about 75 billion dollars in revenues for smugglers, an increase of 92 per cent compared with 2005. Profits are high and the risks low. These profits fund organized crime and therefore represent a threat for all.

To combat this illegal market, UNODC is calling on rich States to stop using West Africa as a dumping ground for fake medicines. Private companies complicit in this trade should be named, shamed and banned, and codes of conduct more rigorously enforced. Governments should step up their regulatory efforts to ensure stricter control and enforcement of pharmaceutical regulations. Governments must also enforce their laws, drawing on the support of donors, regional partnerships and the support of international instruments like the United Nations Conventions against Corruption and the United Nations Convention against Transnational Organized Crime. It is time to intervene now before more lives are lost.

FDA Issues Draft Guidance for Industry on Drug Anticounterfeiting
Focus on physical chemical identifiers

The U.S. Food and Drug Administration today issued a draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug.

The draft guidance is an important step in working with manufacturers to make drug products more difficult to duplicate by counterfeiters. The agency invites comments on the draft guidance, available online and titled “Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting.”

“Drug counterfeiting is a serious public health concern,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients.”

The document is intended to provide guidance to industry regarding the use of PCIDs in solid oral dosage forms, which include pills and capsules, for anticounterfeiting purposes.

A PCID is a substance or combination of substances possessing a unique physical or chemical property used to identify and authenticate a drug product or dosage. In addition to inks, pigments, and flavors, specific chemicals may be used as molecular tags in a PCID.  In some cases, the PCID may be easily detected by wholesalers or pharmacists to determine if they have authentic products.  In other cases, special analytical instruments may be necessary to identify whether the PCID is present.

In the draft guidance, the FDA anticipates that many of the potential PCID ingredients are already used as food additives, colorants, or other types of inactive ingredients with established safety profiles.

To minimize adverse effects, the draft guidance recommends using the lowest level of PCID that ensures identification of the product. It also recommends that the PCID be a substance with no medicinal effect, and placed within the dosage form so that it does not interact with the drug’s active ingredient.

To read draft guidance click here

Outsourcing Contamination

Products that are supposed to improve one's health may actually contain harmful ingredients if they are outsourced from a country with few standards and low accountability

By Sarah Schmidt, Canwest News Serive

Gary Leong knew things weren’t right during a recent tour of a Chinese plant when he witnessed workers manufacturing glucosamine sulfate to relieve joint discomfort in the morning and fertilizer to help plants grow in the afternoon - using the same equipment. “Cross-contamination issues are huge,” says the head of scientific and technical affairs at Jamieson Laboratories, Canada’s largest manufacturer of natural health products.

Charged with guaranteeing the purity and safety of the company’s vitamins, but also facing competitors that offer them at a lower price thanks to cheaper raw materials, Leong brought Jamieson auditors to China to see if sourcing directly from China was a viable option.

Jamieson is just one of hundreds of businesses that produce natural health products and processed foods facing this choice.

The backdrop is the steady stream of safety alerts from Health Canada about unauthorized health products containing unwanted chemicals and the recent spate of high-profile recalls of tainted food products. 

UAE counterfeit trade surges amid global crisis

East Africa: Battleground on Counterfeit Drugs

By: Roger Bate

Kenya recently adopted an anti-counterfeit law, and now its neighbor Uganda is contemplating adopting similar legislation. The drive to combat counterfeit drugs is a good one, and East African nations definitely needed to initiate legislation, since counterfeit products probably harm thousands in the region. But there are problems with Kenya’s legislation and the pending legislation in Uganda, which according to many health groups, could have serious implications on the importation and production of generic drugs, which are identical to branded products.  

China drug body investigates fake "Made in India" drugs

The State Food and Drug Administration (SFDA) of China is investigating the allegation that a consignment of drugs labeled "Made in India" were, in fact, fake pharmaceuticals produced in China.

According to a report in China Daily, SFDA spokesperson Yan Jiangying said: "We are highly concerned about the case and are sending investigating officials to the Chinese provinces involved, including Guangdong."

Yan added the SFDA would continue working with the police in the joint war against fake and inferior drugs in terms of technological support and the handing-over of cases.

FDA Issues Public Health Advisory Regarding Levemir Insulin

The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.

The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots.

The agency is advising patients who use Levemir insulin to:

1. Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. Patients can locate the lot number on the side of the box of insulin and also on the side of the vial.

2. Do not use your Levemir insulin if it is from one of these lots. Replace it with a vial of Levemir insulin from another lot. If you must switch to another brand of insulin for any reason, first contact your healthcare provider as another insulin product may require adjustments in dosing.

3. Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.

4. Contact the Novo Nordisk Customer Care Center at 800-727-6500 for what to do with vials from these lots or if you have any other questions. 

For more information:
Novo Nordisk news release 
Photo

South African API Importer Accused of Fraud

The National Agency for Food and Drug Administration and Control (NAFDAC) Seizes N32 Million in Fake Anti-Malaria Drugs

Nigeria officials seized a large cache of counterfeit drugs at Kirikiri Lighter Terminal in Lagos, on Wednesday May 20, 2009. The National Agency for Food and Drug Administration and Control (NAFDAC) acting on a tip, intercepted the counterfeit anti-malarial drugs, Maloxine and Amalar tablets, which had an estimated street value of N31.1 Million.

Laboratory tests by the agency showed that the fake anti-malarials which were produced in China but labeled "Made in India," contained only sulfadioxine and no pyrimethamine.

Director General, NAFDAC, Dr. Paul Orhii, said the interception of the fake drugs may have saved hundreds of thousands of Nigerians from possible effects such as treatment failure, drug resistance, complications like anemia and death had the drugs been circulated into the open market.

FDA Uncovers a Show and Shadow Factory Related to Heparin API Production

Today, two Warning Letters were issued by the FDA which only highlighted the necessity for Rx-360 to be successful. From reading these FDA issued Warning Letters it appears that the FDA uncovered a “Show Factory” at Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd, and its “Shadow Factory” at Qingdao Kangyuan or Qingdao Jiulong.

The FDA Warning Letter stated: “The inspection revealed that the facility was not manufacturing, and did not appear to have ever manufactured, Heparin Sodium USP (or heparin sodium) for the U.S. market. The investigators also determined that, contrary to your firm’s claims, manufacturing of heparin sodium was conducted at facilities other than the one identified in your DMF. In addition, our review of information submitted to the Agency in your DMF 12281, as well as documents collected during FDA’s inspections of both your facility and of subcontractor Qingdao Jiulong, along with additional information, uncovered untrue statements and information submitted by your firm to the agency with respect to the actual manufacturer(s) of heparin sodium. “

The Warning Letter also stated: “The investigators also found that the manufacturers’ labels had been removed from the 5 kg bags during the repackaging operation and the bags were placed inside aluminum drums used to ship the heparin sodium to the U.S.; the bags were then sealed and identified with the Shanghai No. 1 label.”

Finally the Warning Letter stated: “Although this heparin sodium (148 lots) was shipped to the U.S., we note that no drug products made with these lots have been marketed in the U.S. at this time.”

The following are links to the referenced FDA Warning Letters:

• http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm136668.htm
• http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm136670.htm 

We should all be aware of these types of events and increase our diligence when selecting and auditing suppliers.