Vascular Closure Devices’ Sharp Rise in Unit Sales Drives the Overall U.S. Peripheral Vascular Device Market

Vascular closure devices, which include both invasive and non-invasive products, are rapidly being adopted by the medical community. The market for VCDs is expected to exhibit strong growth through to 2016, thus driving the total U.S. market for peripheral vascular devices.

Vascular Closure Devices

VCDs are used in both coronary and peripheral vascular procedures, particularly if a catheter is used during an endovascular treatment. The traditional method for achieving vascular closure is manual compression, where a healthcare worker applies pressure to the site in order to achieve hemostasis. However, manual compression is not only time consuming for healthcare employees, but also requires the patient to remain immobile for an extended period of time.

With the rise of for-profit medical centers and a shortage of available nursing labor, the medical industry has sought a safe and effective alternative to manual compression. Since VCDs were approved for use in the U.S. in the 1990s, two types of devices have been developed: invasive and non-invasive. Invasive VCDs are used percutaneously and achieve hemostasis through the use of sealants, sutures or specialized sponges, while non-invasive VCDs involve the use of a compression pad or inflatable bulb at the surface of the site to mimic the effects of manual compression. In 2009, invasive VCDs represented 85.5% of the total VCD market revenues, while non-invasive devices comprised the remaining 14.2%. While the use of both types of VCDs is expected to rise, growth in non-invasive devices will outpace, but not overtake, invasive devices by 2016.

VCDs Are Cost-Effective and Time-Efficient

VCDs offer healthcare facilities a cost-effective option for vascular closure. While price was a limiter when the devices were launched, the average selling price of the devices has decreased dramatically in recent years, and will continue to decline. Furthermore,
non-invasive VCDs are, on average, four times less expensive than their invasive counterparts, boosting their popularity.

With the general shortage of nursing labor, many hospitals are finding it cost-effective and time-efficient to employ VCDs. Non-invasive VCDs remove the need for manual pressure by a healthcare worker and therefore also lessens labor costs. In addition, the use of invasive VCDs further reduces the time necessary to perform vascular closure. Interventional cardiologists are performing peripheral procedures at an increasing rate and are opting to use VCDs in order to reduce operation times and thereby maximize the number of procedures that can be performed per day. Furthermore, the use of VCDs has the potential to allow more procedures to be performed in outpatient settings, significantly increasing patient turnaround times and decreasing costs. The cost savings and reduced times will continue to encourage healthcare facilities to adopt VCDs, especially as hospital budgets become more constrained.

Device Improvements

The relative complexity of VCDs, particularly invasive products, was initially the source of complications due to improper use. However, VCDs have gone through many design configurations since their introduction and different closure methods have been developed. Abbott Laboratories’ StarClose™ and Perclose® invasive VCDs have reduced rates of complications, such as the migration of closure agents through the vascular system. These devices close the arterial hole with a nitinol clip on the exterior of the vessel, meaning that nothing remains in the artery after the procedure.

AccessClosure’s Mynx™ invasive VCD is another device that is designed to reduce procedural complications, such as trauma to the vessel and expansion of the tissue tract. The device applies a bio-inert sealant to the surface of the artery, closing both the arterial opening and the tissue tract. In addition, the Mynx™ can be deployed through an existing procedural sheath, which further eliminates the need for a sheath exchange. The device has increased its adoption rate in recent years and shows great potential.
As manufacturers, continue to address the concerns associated with using VCDs and develop innovative solutions, these devices will account for an ever increasing proportion of vascular closure procedures.

Growth Drivers

The aging population of the U.S. has led to an increase in the number of patients with peripheral arterial disease (PAD), resulting in increasing demand for peripheral vascular procedures. Furthermore, this increase in procedure demand coincides with the rise in the number of for-profit medical centers that have lower staffing levels and a higher preference for VCDs. Between 2005 and 2010, the number of VCDs used has risen more rapidly than the number of peripheral catheterization procedures. Growth of VCD use exceeded that of catheterization procedures due to the continuing shift from manual compression to VCD use. As a result of this growth, by 2016, it is expected that over one million VCDs will be used for peripheral vascular procedures, representing an approximately 50% increase in unit volume from 2009.

Minnesotans Help Produce As Well As Benefit from Lifesaving Therapies

ANNAPOLIS, Md., Sept. 1 /PRNewswire/ -- This month, Minnesotans are recognized for their outstanding contributions to lifesaving therapies that treat critically ill individuals and for their donations of the blood component, plasma, that makes the creation of these unique therapies possible. Throughout September, Minnesota Gov. Tim Pawlenty is recognizing "Plasma Protein Therapies Month" in the North Star State, helping to raise awareness for the rare, genetic diseases treated with the therapies and valuing the contributions of voluntary plasma donors in the state.

Plasma protein therapies, which include plasma-derived therapies and recombinant blood clotting factors (a biotechnology product), are used every day to treat people with hemophilia, a blood clotting disorder that causes painful internal bleeding and debilitating joint damage; primary immunodeficiency diseases, which rob a person's ability to fight even common infections; and alpha-1 antitrypsin deficiency, also known as genetic chronic obstructive pulmonary disease (COPD). In addition, a plasma protein therapy, albumin, is used in critical care settings, when treating severe trauma, burns and during major surgery.

Plasma, a biological material that cannot be manufactured, is used to create lifesaving therapies that come solely from committed plasma donors. The state of Minnesota is home to 11 plasma collection centers. As Minnesota celebrates the generosity of its donors and raises awareness for the rare diseases that are treated with the therapies during Plasma Protein Therapies Month, we encourage everyone to donate and to help ensure a higher quality of life for patients across the United States and around the world.

"Always serious and often life-threatening, patients requiring plasma protein therapies suffer from serious diseases and disorders and need access to critical therapies manufactured from high-quality plasma from dedicated donors such as those in Minnesota," said Josh Penrod, Vice President, PPTA Source. "Donors continue to be recognized and valued as a critical component in the production of these therapies."

For more information about plasma protein therapies, the diseases they treat and donating plasma, please go to www.donatingplasma.org.

The Plasma Protein Therapeutics Association (PPTA) represents the world's leading manufacturers of plasma-derived and recombinant biological therapies, collectively known as plasma protein therapies and the collectors of source plasma. These critical therapies are infused or injected by more than 1 million people worldwide to treat a variety of rare, life threatening diseases and serious medical conditions. PPTA members produce in excess of 80 percent of the plasma protein therapies used in the United States today and more than 60 percent worldwide. PPTA is a global trade association that administers international, voluntary standards programs to help ensure the highest quality and safety of plasma protein therapies and the plasma collected to manufacture them. Additionally, PPTA works in partnership with the patient community and consumer advocates to help ensure continued access to lifesaving plasma protein therapies.

Baxter - Naughty advertisements say FDA

Federal regulators are warning Baxter Healthcare that it is overstating the benefits of Aralast, an emphysema drug, and say they have noticed that the company has a disturbing trend of overstating the effectiveness of its drugs and medical products. On August 3, the FDA sent a warning letter to Baxter CEO

Robert Parkinson, Jr., accusing the company of deceptive advertising in a physician brochure for Aralast NP. The FDA has determined that the brochure misbrands Aralast NP illegally, making overstated claims of efficacy. The FDA warning letter states that the Aralast brochure makes the drug appear to be more effective than has been demonstrated by implying that its alpha1 – antitrypsin levels have a protective effect and clinical benefits that have not actually been clinically proven. In an unusual move, the agency also admonishes the company for its trend toward misleading advertising. “[W]e are very concerned by your continued violative promotion of your products,” the letter states, and then points out that the FDA has cited Baxter for similar violations of overstated efficacy and “unsubstantiated claims of superiority” in letters on April 14, 2009 and July 7, 2008. The April 2009 warning letter cited the company for false and misleading advertising for TISSEEL, a hemostatic surgical tissue glue. Baxter claimed that TISSEEL was 97.5% effective in achieving hemostasis in patients undergoing a cardiopulmonary bypass while on Baxter’s blood thinner, Heparin. The FDA said that claim was unsubstantiated. The July 2008 warning letter chastised the company for also overstating the efficacy of FEIBA VH, a freeze-dried, sterile form of human plasma used to control bleeding in patients with hemophilia in an e-mail. The company claimed that the substance controlled bleeding in 60% of cases within 12 hours of the first infusion. The FDA said that was inconsistent with the prescribing information, which only noted a success rate of 36% with one infusion. The FDA also said the company understated the risk of serious thrombotic events. In its latest warning letter, the FDA has demanded that Baxter not only fix the misleading Aralast information, but is also requiring the company to come up with a plan in writing that will put policies and procedures in place in the company to prevent future misleading advertising problems. If the company fails to comply it could be subject to FDA regulatory action, including seizures and injunctions.

What is Recombinant - Molecular Engineering?

FDA Accepts Novozymes Master File

Novozymes Biopharma, part of Novozymes A/S, world leader in bioinnovation, announced that the US Food and Drug Administration Center for Biologics Evaluation and Research (FDA/CBER) has accepted a Type IV Master File for its recombinant albumin, albucult. The dossier which contains proprietary information on the manufacture and safety of albucult, can help support the company's customers in applications such as drug formulation and medical devices. By providing customers with access to a single source of information filed with the FDA as part of their product applications, Novozymes can help to accelerate the regulatory process for products that use albucult.
Derived from Novozymes' proprietary yeast expression technology, albucult delivers unprecedented performance and quality benefits to a range of applications including drug and vaccine manufacture, device coating, sealants, IVF media and cell therapy applications. albucult complies with the excipient monograph standard for recombinant human albumin, published in the United States Pharmacopoeia - National Formulary (USP-NF) and confers a range of unique advantages including sustainability of supply and improved biocompatibility. In addition, albucult ensures batch-to-batch consistency which can significantly reduce lot testing burden for clients.
Wayne Prestwood, principal regulatory associate at Novozymes Biopharma, comments: "The company is always looking for the most effective ways of supporting our customers' applications through regulatory processes and we are delighted to have a master file for albucult accepted by CBER. By ensuring that the information required by the FDA as part of our customers'review processes is readily available, we can help speed up their regulatory approvals, enabling their products to be delivered to market faster."

Oyster glue's secret ingredient

The natural cement produced by oysters to build extensive reef systems contains significantly more inorganic material than the glues of other marine species, and could spur development of new synthetic adhesives for biomedical devices or antifouling coatings for ships, say researchers in the US.

Jonathan Wilker and his team at Purdue University and colleagues at the University of South Carolina have been investigating how oysters bind to reefs and each other, in a bid to develop synthetic composite materials with properties that imitate the oyster glue.

The team analysed the chemical composition of oysters' adhesive using infrared spectroscopy, electron paramagnetic resonance spectroscopy and thermogravimetric analysis. They found higher protein content in the adhesive material than in oyster shell (10 per cent as opposed to 2 per cent), and evidence of protein cross-linking, iron species and radical species.

Cryospray Against Airway Tumors Leads to Unexpected Complications

Spray cryotherapy with liquid nitrogen has been used effectively for ablating esophageal tumors. Some facilities even perform the technique in an outpatient setting under sedation. However, spray cryotherapy for treating advanced airway lesions—when other treatment options are limited—is more recent, and few reports of its effectiveness have been published (J Thorac Cardiovasc Surg 2010;139:781-782).

To assess their efforts to date, thoracic anesthesiologists at Memorial Sloan-Kettering Cancer Center in New York City reviewed 24 spray cryotherapy procedures in 22 patients; all treatments involved airway-obstructing tumors. Ten of the patients (45%) experienced unexpected and serious respiratory or cardiovascular events; of these, three required reintubation and mechanical ventilation overnight. One patient suffered cardiac arrest and died in the operating room (Table).

Table. Complications From Cryospray Complication N=30 (% of procedures) Pneumothorax 2 (2.8) Hypoxemia 5 (20.8) Reintubation 3 (12.5) ST-segment changes 3 (12.5) Bradycardia 6 (25) Tachycardia 3 (12.5) Hypotension 7 (29) Death 1 (0.04)

“We did not expect to see such an incidence of cardiac complications during this procedure,” said Alessia Pedoto, MD, lead author of the study presented at the 2010 annual meeting of the Society of Cardiovascular Anesthesiologists (abstract SCA41), in New Orleans.

The spray cryotherapy technique delivered liquid nitrogen by catheter through an endoscope at 2 to 4 psi at –196 C, causing rapid freezing and thawing of tissue—resulting in cell death and hemostasis (Figures 1 and 2). A minimum of three cycles of five seconds each was administered to each patient, with a complete visual thaw between each cycle. All patients underwent general anesthesia for combined rigid and flexible bronchoscopy.

Among the 24 procedures, hypoxemia developed in five (20.8%); ST-segment changes developed in three (12.5%); bradycardia in six (25%); and hypotension in seven (29%). More than one complication occurred per procedure.

“Bleeding and pneumothorax have been reported in very small series and we had two cases of pneumothorax we thought were related to the use of jet ventilation with cryospray,” Dr. Pedoto told Anesthesiology News. “We speculate that the use of cold liquid nitrogen is associated with an increase in airway pressure when the spray is used, affecting the heart and the conduction system,” she said.

According to the researchers, spray cryotherapy is a novel technique that can be used to re-establish airway patency in patients with symptomatic airway tumors. The advantages it might offer over airway laser therapy include no fire hazard and improved hemostasis. They said that further study is needed for better selection and improved safety of patients.

QuikClot goes Japanese

WALLINGFORD, Conn.--(BUSINESS WIRE)--Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced that it has signed an exclusive distribution agreement with Nihon-Kohden, Japan's leading manufacturer, developer and distributor of medical electronic equipment . The agreement allows Nihon-Kohden the exclusive right to distribute Z-Medica’s QuikClot line of hemostatic agents to hospital, military and law enforcement markets throughout Japan. The companies have been working together since early 2009 to obtain regulatory approval. Such approval for the sale of Z-Medica’s full line of QuikClot hemostatic gauze products was approved by the Japanese Ministry of Health, Labor and Welfare in March 2010.
“We are very pleased that we have signed this distribution agreement with Nihon-Kohden because of their longstanding positive reputation and vast reach throughout the Japanese market,” said Brian Herrman, Chief Executive Officer, Z-Medica. “We believe that clinical practitioners outside of the US will find QuikClot to be a useful tool in achieving hemostasis in a fast, safe and convenient manner, and we intend to continue expanding our international distribution through best-of-breed partners such as Nihon-Kohden.”
QuikClot is a surgical gauze impregnated with kaolin, an inert material with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“We are very pleased to have this opportunity to market in Japan QuikClot which helps many patients who suffer from bleeding,” said Hiroshi Aida, General Manager of Import Business Operation, Nihon Kohden. “QuikClot also helps medical professionals with much shorter time for achieving hemostasis. It is a nice addition for our product portfolio.”
Z-Medica and Nihon-Kohden have been working together since early 2009 in order to gain the recently granted regulatory approval. The QuikClot line of products to be distributed by Nihon-Kohden in Japan include:
QuikClot Combat Gauze is a soft, white, sterile, nonwoven 3” by 12 feet rolled or z-folded gauze impregnated with kaolin. Each roll of QuikClot Combat Gauze is individually wrapped in an easy rip, military grade foil pouch. Indicated for temporary external control of traumatic bleeding, QuikClot Combat Gauze is flexible and pliable and contours to all wounds. Recommended as the number one hemostatic agent by the COTCCC (Committee on Tactical Combat Casualty Care Committee), QuikClot Combat Gauze is the only product carried by all branches of the US Military to control life-threatening hemorrhage.
QuikClot Emergency Dressing is an easy-to-use dressing which can achieve hemostasis in as little as three minutes, helping to prevent loss of life and limb. Because QuikClot requires very little training to administer, it can be effectively used by medical personnel, civilian first-responders and medical professionals in the field and in clinical environments. This dressing comes in various sizes, including a 4-ply 4” by 4” (10cm x 10cm) and a 6-ply 2”x2” (5cm x 5cm) format.
QuikClot Interventional Hemostatic Bandage consists of a soft, white, double sterile, hydrophilic pad impregnated with kaolin. It is double-wrapped in a blister package and foil pouch for aseptic technique. QuikClot Interventional Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of external bleeding from vascular access sites and percutantous catheters or tubes utilizing sheaths up to 12 Fr.
QuikClot Trauma Pad consists of a soft, white, double sterile, three-ply 12”x12” (30cm x 30cm) pad impregnated with kaolin. It is double-wrapped in a peelable foil package for aseptic technique. QuikClot Trauma Pad is indicated for temporary external use to control traumatic bleeding and is also x-ray detectable to ensure proper removal.

About Z-Medica

Z-Medica Corporation is a medical device company developing innovative hemostatic agents. The company manufactures and markets its QuikClot® family of products for hemostasis for use by healthcare professionals, first responders, law enforcement officers and the military. QuikClot products rapidly enhance the body’s natural coagulation process, helping to achieve hemostasis faster. Z-Medica’s QuikClot® Combat Gauze™ product was chosen by the Committee on Tactical Combat Casualty Care (TCCC) as the United States Military’s sole source supplier for first-line hemostatic treatment, based on tests conducted by the Naval Medical Research Center and the U.S. Army Institute for Surgical Research. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage. QuikClot® products are also widely used by first responders, in hospital emergency rooms, interventional cardiology and radiology laboratories and other healthcare environments where bleeding requires fast and effective control. Z-Medica, named one of the Top 100 Technology “Companies to Watch” in 2008 by the Connecticut Technology Council, is a privately-held company based in Wallingford, CT. More information about Z-Medica Corporation is available at www.z-medica.com.

About Nihon Kohden

Nihon Kohden is Japan’s leading manufacturer, developer and distributor of patient monitors, defibrillators, ECGs, EEGs, EP/EMGs, hematology analyzers and other medical electronic equipment, with subsidiaries in the United States, Europe, and Asia, and distributors in nearly every country in the world. Nihon Kohden is a publicly held company listed in the First Section of the Tokyo Stock Exchange. In addition to designing medical equipment for hospital and clinic use, Nihon Kohden actively contributes to the advance of medical technology.

FDA rules CollPlant wound dressing a device

The US Food and Drug Administration (FDA) has ruled that the CollPlant Holdings Ltd's (TASE: CLPT) wound dressing product, Vergenix, will undergo the certification process by the Center for Devices and Radiological Health (CDRH), which oversees medical devices.
Vergenix Wound Dressing is wound care sheet composed of pure recombinant human collagen scaffold that provides a moist wound healing environment. The product, a type I collagen, is produced by transgenic tobacco plants. It is designed to treat acute and chronic wounds, such as pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds, abrasions, and second-degree burns.
US licensing procedures for medical devices are shorter than the procedure for pharmaceuticals. CollPlant believes that while Vergenix is based on human recombinant collagen produced through advanced biotechnological techniques, the FDA decision that the CDRH will review the product is very important for the company, as the regulatory procedures are significantly simpler, shorter, and cheaper than for biological and pharmaceutical products. This is a breakthrough since Vergenix will be a pioneering product for CollPlant's subsequent products.
CollPlant's share price rose 9.9% by mid-afternoon to NIS 1.20, giving a market cap of NIS 126 million.
Published by Globes [online], Israel business news - www.globes-online.com - on August 29, 2010

US Military faces challenges from Chinese Knock-offs

As anyone who has served in combat knows, if a buddy is wounded, the first two things you need to do are make sure he can breathe and his bleeding is stopped.
For the past several years, troops serving in Afghanistan and Iraq have used an advanced Combat-Application-Tourniquet (C-A-T) developed by Composite Resources in Rock Hill, S.C. The tourniquet features a nylon strap and a plastic rod to tighten the strap to stop bleeding.
The regulation C-A-T costs about $28. But about two years ago the Army detected cheap knock offs made by a Hong Kong company that had entered the military's supply chain in Afghanistan and Iraq. The imitation sold for about $8.50.
They're accurate looking fakes, right down to the label and national stock number.
But as Col. John Kragh, a doctor at the U.S. Army Institute of Surgical Research at Fort Sam Houston, pointed out in June, the rod on the fake tourniquet "is bendable to a point where it cannot work right. It's like bending Gumby's arm."
He said the fake tourniquet could be fatal because it cannot stop bleeding. Kragh added a decentralized ordering system probably accounts for the presence of the fake tourniquets in the field, with low-level supply personnel ordering the knock offs over the Internet based on price.
The Defense Department issued a warning about the knock-offs in April, Kragh said, and the Food and Drug Administration this month put out a safety alert about the tourniquets, which are also used by civilian first responders.
The lesson here is a good deal isn't always that; it can even be deadly.

Poll Result - Which Geographical Manufacturing Area for Hemostatic Devices Causes Concern?

Controversies

2007 Chinese Export Recall

The 2007 Chinese export recalls were a series of scandals involving tainted food and products exported from China, starting with tainted pet food imported from China to the United States that poisoned pets. The recalls sparked international concern that many products made in China do not meet minimum quality standards. Soon after, the US halted imports of seafood from China after tests detected the presence of drugs unapproved in the US.China has gone on record to admit that nearly a fifth of products made in China do not reach minimum standards. Also, some children's toys made in China were found to contain excessive levels of lead, prompting widespread concern. In 2006, shipments of cough syrup and other medicines, imported from China to Panama and laden with the toxin diethylene glycol, caused mass poisonings and killed 83 people.
On December 19, 2007, The US House of Representatives passed legislation (H.R. 4040) that would significantly amend the current U.S. safety establishment for consumer products imported from China.

2008 Chinese heparin and milk scandals

In March 2008, major recalls of heparin were announced by the U.S. Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China.
The raw material for the recalled heparin batches was processed in China from pig's intestines by the American pharmaceutical firm Scientific Protein Laboratories. The U.S. Food and Drug Administration was quoted as stating that at least 81 deaths were believed linked to a raw heparin ingredient imported from the People's Republic of China, and that they had also received 785 reports of serious injuries associated with the drug’s use. According to the New York Times, "Problems with heparin reported to the agency include difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that in some cases led to life-threatening shock."
Upon investigation of these adverse events by the FDA, academic institutions, and the involved pharmaceutical companies, the contaminant was identified as an "over-sulphated" derivative of chondroitin sulfate, a popular shellfish-derived supplement often used as a treatment forarthritis. Since over-sulphated chondroitin is not a naturally occurring molecule, costs a fraction of true heparin starting material, and mimics the in-vitro properties of heparin, the counterfeit was almost certainly intentional as opposed to an accidental lapse in manufacturing. The raw heparin batches were found to have been cut from 2-60% with the counterfeit substance, and motivation for the adulteration was attributed to a combination of cost effectiveness and a shortage of suitable pigs in China.
When the FDA conducted an inspection of Baxter's Chinese Heparin supplier, it found serious deficiencies at the facility which the FDA detailed in a warning letter.
The FDA has stated that it does not have the funds nor bear the responsibility to inspect on a regular basis overseas manufacturers of active pharmaceutical ingredients such as heparin.
In November 2008, the FDA seized eleven lots of heparin from Celsus Laboratories Inc., a manufacturer in Cincinnati, Ohio.

One year later, the 2008 Chinese milk scandal refers to a food safety incident in mainland People's Republic of China involving milk and infant formula which had been adulterated with melamine, an organic base combined with formaldehyde to form plastic. The result was catastrophic - By 22 September, nearly 53,000 illnesses, over 12,800 hospitalizations, and four infant deaths had been reported, caused by kidney stones and other renal failure.The chemical appeared to have been added to milk in order to cause it to appear to have a higher protein content. The same chemical was also involved in a series of pet food recalls in 2007. In November 2009, two individuals were executed for endangering public safety and producing and selling toxic food.

2009 Made in India scandal

In June 2009, the Nigerian Government Drug Regulatory Authority (NAFDAC) reported about the detention of a large consignment of fake anti-malarial generic pharmaceuticals labeled Made in India but produced in China. The Laboratory analysis conducted by NAFDAC revealed the drugs to be fake and had it not been intercepted, about 64,200 adults would have been affected. The consignment containing Maloxine and Amalar tablets, used for the treatment of Malaria, were valued at 32.1 million Naira and were produced, packed and shipped from China. After Indian Authorities took up the matter, The State Food and Drug Administration (SFDA) of China was asked to investigate the matter[10]. In December 2009, 6 chinese traders were sentenced to death for their involvement.
In July 2009, customs officials in the South Indian port city of Chennai seized spurious cosmetics and mobile phone batteries worth Rs. 30 million, imported into India from Scheko in China. The 40 foot container was held up at the port for more than 75 days and opened on 13th July when the importer did not file a bill of entry. It was reported to contain over 187,000 batteries with Nokia holograms and stickers, and 126,000 cosmetic items including face packs, lipsticks and hair gels.

Further Reading - "These are not isolated cases," Han Yi, director of the administration's quality control and inspection department, told the state media. Underlining his concerns, officials said hundreds of bottles of fake human blood protein were found in hospitals......

Also - Federal drug regulators, in announcing Wednesday that the mystery contaminant in heparin was an inexpensive, unapproved ingredient altered to mimic the real thing, moved closer to concluding that Americans might be the latest victims of lethal Chinese drug counterfeiting.

And - There also seems to be agreement that our regulatory agencies can’t rely on China to police its own factories. The Chinese have lurched between vows of reform and disregard for American concerns about the quality of the country’s products.