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.

Daily Times: 9 Clinics and 28 Drug Stores Shut Down for Counterfeit Drugs

In the September 2nd edition, the Pakistan Daily Times reports on Inspectors shutting down clinics in Pakistan for Counterfeit Drugs. Here are some of the highlights:

• On September 1, Pakistani drug inspectors in Rawal and in Potohar raided clinics and pharmacies, sealing nine clinics and fining 28 medical stores for sale of expired and unregistered medicines.


• Inspectors took 106 samples from these locations and submitted them for laboratory testing.

To read the story online, follow this link:
http://www.dailytimes.com.pk/default.asp?page=2009\09\02\story_2-9-2009_pg11_4

To learn more about XStream Systems and their revolutionary anti-counterfeiting technology, visit: www.xstreamsystems.net.

Markets and Markets: Global Anti-Counterfeit Market for Food and Pharmaceuticals Worth US $79.3 Billion by 2014

According to a new market research report, ‘Global Anti Counterfeit Market for Food and Pharmaceuticals (2009-2014)’, published by Markets and Markets (www.marketsandmarkets.com):

• Increasing cases of counterfeiting have resulted in implementation of anti- counterfeit technologies. Anti-counterfeit technologies are of two types namely authentication packaging and track and trace packaging technologies. North America holds a major share of the global anti counterfeit market. Asia has the highest growth rate due to untapped market and significant level of counterfeiting. Europe has a lower growth rate due to a relatively lower number of cases of counterfeiting.


• The global anti counterfeit packaging market for food and pharmaceuticals market is expected to be worth US$79.3 billion by 2014, with an estimated CAGR of 8.6% from 2009 to 2014.


• The North American packaging market is expected to account for nearly 62% of the total revenues. North America is the largest segment in the anti-counterfeit market and is expected to reach US $49 billion by 2014, accounting for nearly 62% of the revenues growing at a CAGR of 6.8%.


• Asia is the second largest market and is expected to reach US$14 billion by 2014 with a highest CAGR of 19.7%.

While XStream Systems feels that the data presented in this report is valid it believed that Markets and Markets may have overlooked significant technology solutions in their research.

Most of the report seemingly centered on packaging technologies and ignored material screening technologies such as XStream’s XT solutions which allow the end user to verify the authenticity of a material inside its sealed unit of sale container.

How large is this market if material screening technologies were included in the mix?

To view a synopsis of the report, visit:
http://blog.taragana.com/pr/marketsandmarkets-global-anti-counterfeit-market-for-food-and-pharmaceuticals-worth-us793-billion-by-2014-5427/

Business Standard: WHO to Revive Talks on Fake Drugs

Joe C. Mathew of the India Business Standard in their Saturday, September 5, 2009 edition reports on the upcoming meeting annual meeting of the World Health Organization. The World Health Organization Meeting will be tackling the fake drugs and their definition:

• The matter had to be taken out of WHO’s annual meet — the World Health Assembly (WHA) — agenda early this year due to protests from countries like India, which felt the proposed definition would harm seamless movement of genuine medicines between developing and least developed nations.


• The meeting of the WHO’s South-East Asia region, beginning in Nepal on September 7, is to revive the talks on counterfeit definition. The meeting is expected to hear various lobby groups on the possible changes that can be made to the current definition.


• The main point of contention is known to be the way ‘substandard medicine’ will be described.


• “A medicine which does not meet the quality standards is easy to be classified as a substandard medicine. But how do you classify a medicine that meets the quality standards but has been given marketing approval based on information that was deliberately false? This is the issue that needs to be tackled,” said an official.


• Representatives of the domestic drug industry said they were not aware of the development. The issue of counterfeit medicines was on the agenda of the 62nd WHA in May 2009, but was deferred till the next year’s meet due to lack of consensus.

To view the entire article visit: http://www.business-standard.com/india/news/who-to-revive-talksfake-drugs/369038/

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

Mayo Clinic: The Do’s and Don’ts of Buying Prescriptions Online

The following pointers are from MayoClinic.com about the do’s and don’ts to buying prescription drugs online:

Things to do:

• Do consult your doctor. Only take medications prescribed for you by your doctor or another health care professional who knows you. He or she can determine if a particular drug is safe for you or if another treatment would be more appropriate.
  
• Do use a licensed pharmacy. The National Association of Boards of Pharmacy can tell you whether an online pharmacy is licensed and in good standing. Some sites carry a seal of approval from Verified Internet Pharmacy Practice Sites (or VIPPS). To gain this approval, sites must maintain state licenses and allow inspections by the National Association of Boards of Pharmacy.
  
• Do insist on access to a registered pharmacist. Reputable sites offer toll-free access to registered pharmacists to answer your questions. Some online pharmacies have traditional physical locations as well. If you have questions about a medication after you begin taking it or you're concerned about drug reactions, it may be valuable to speak with a pharmacist in person.


• Do read the privacy and security policies. Before placing an order, be confident that your credit card number, personal health information and other personally identifiable information will be protected.


• Do compare prices. You may find great deals online, but there aren't any guarantees. Check your local drugstore's price—it might beat the online price. If online prices are significantly lower than your local pharmacy, you should question whether the site is legitimate.


• Do be alert for counterfeits. In some cases, drugs ordered online turned out to contain no active ingredient or to contain the wrong medicine. Reduce your risk by only using legitimate online pharmacies. Don't use any medicine that arrives in altered or unsealed packaging.

Things not to do:

• Don't use a site that bypasses prescriptions. Online pharmacies that dispense medication without a valid prescription are violating U.S. law. Don't be lured in by sites that give you a prescription if you complete an online questionnaire. Only your doctor can safely prescribe medication for you.


• Don't order medication that's not approved by the Food and Drug Administration (FDA). It's illegal to import unapproved drugs into the United States. Taking an inappropriate or unsafe drug can have life-threatening consequences.


• Don't overlook the address and phone number. Steer clear of sites that don't provide a street address and phone number or that list only foreign contact information. Use only U.S. pharmacies. International pharmacies may sell drugs that do not have FDA approval or that are illegal in the United States.


• Don't succumb to false claims. Don't buy medication from sites that advertise "miracle cures" or those that use impressive terminology to disguise a lack of good science.


• Don't keep complaints quiet. If your order doesn't arrive, you find unauthorized charges on your credit card or you have another problem with an online pharmacy, report it to the FDA. Speaking up can help promote a safer marketplace for everyone.

As offered in this blog before, it is very important to be vigilant in buying any prescription medications online.

Remember, “if a deals sounds too good to be true, it probably is” is the best advice when dealing with online products. Counterfeit and fraudulent drugs permeate the web with some estimates as high as 60% of online medications as counterfeit product. Protect yourself and your family and follow these do’s and don’ts.

For more helpful tips visit: http://www.mayoclinic.com/.

To learn more about XStream Systems revolutionary anti-counterfeiting technology and solutions visit: http://www.xstreamsystems.net/.

UPS Supply Chain Survey: Nearly Half Worry about Product Tampering and Counterfeiting

In UPS’s 2nd Annual Supply Chain Survey, conducted by Harris Interactive, there was a somewhat surprising discovery as it relates to fraudulent and counterfeit products in the supply chain.

The survey was reported in the June 2009 issue of Pharmaceutical Commerce.

In the survey, decision makers at bio-pharma and med device companies were asked a variety of questions to identify supply chain issues beyond simple transportation and delivery.

The somewhat surprising discovery was that 48% of the large company respondents (companies with revenues in excess of $1 billion annually) while 34% of smaller companies, listed product tampering and counterfeiting as one of their biggest supply chain concerns for the year.

Pharmaceutical Commerce is quoted in the June 2009 issue:

It is worth noting that nearly half (48%) of large-company respondents cited product tampering and counterfeiting as a concern, which belies the relatively quieter scene in drug pedigree, tracking and tracing as a result of the postponement of the pedigree rules in California.

This survey validates much of what XStream Systems is finding in the pharmaceutical supply chain as well. Although much of the pressure has been lifted from the delayed pedigree rules, there is a realization among decision makers that there remains a significant amount of stress with few solutions within the supply chain as it relates to fraudulent, tampered and counterfeit product. To date many key executives have seemingly ignored the threat of increased liability and brand erosion because they have few if any solutions to adequately meet the issue. Pedigree and track and trace technologies although mandated in specific states, provides minimal protection against diverted products but do nothing to decrease their liability and protect their inventories from counterfeiting or tampered products.

XStream Systems, with its revolutionary EDXRD technologies, has a technology solution that enhances the ability of the members of the supply chain to authenticate the product, within its sealed container, without destroying or degrading the medication. This solution, allows the user to authenticate and verify the contents of the product, not just the package and properly secure their inventories and overall liability.

To read the June 2009 article in Pharmaceutical Commerce, visit: http://www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=1239.

To learn more about XStream Systems and it solution, visit: http://www.xstreamsystems.net/.