USAID: Substandard and Counterfeit Drugs Found By Cooperative Aid Program

Fake Medications in Use in Public Hospital, Many Other Sites

In a press release from the U.S. Agency for International Development (USAID), they announced that substandard and counterfeit versions of thirteen key anti-malarial medicines were uncovered in multiple locations across Ghana by the Medicines Quality Monitoring surveillance program.

Set up by the Ghana Food and Drugs Board (FDB) in collaboration with the U.S. Pharmacopeial Convention (USP) and the U.S. Agency for International Development (USAID), the program samples anti-malarials across the public and private sectors.

The program was established in 2008 and is implemented by USP's Promoting the Quality of Medicines (PQM) initiative. USP is a scientific nonprofit organization that develops globally recognized standards for the quality of medicines. Through the PQM program, USP works in developing countries to help verify and improve the quality of medications intended to treat life-threatening neglected diseases such as malaria, HIV/AIDS and tuberculosis.

"Few people fully realize the devastation that distribution of substandard or counterfeit medications can wreak on vulnerable populations," said Stephen Opuni, M.D., chief executive officer of the FDB. "In this case some of the drugs discovered contained no active pharmaceutical ingredient, while others failed to meet required quality standards. This causes great harm in two ways: the individual patients taking the drugs get no relief, and drug-resistant strains of malaria may grow stronger. In addition, people lose confidence in the efficacy of medicines and may be reluctant to seek medical help when they need it. I'm very pleased with the outcomes we're seeing from the Medicines Quality Monitoring program."

In 2009 the same program uncovered a counterfeit version of Novartis' Coartem®, another widely used anti-malarial. In that case, an alert citizen notified the authorities after suspecting the drug he bought might be fake.

"Last year's seizure of counterfeit drugs showed the importance of public education," said Patrick Lukulay, Ph.D., director of the PQM program. "In the current case, rigorous surveillance worked very well. The fact that the fake and poor quality drugs were so widespread—found in many areas across Ghana, and in many types of outlets—underscores the need not only for continuing surveillance but also for active enforcement of anti-counterfeiting laws."

The discovery of the counterfeits—tragically, in use at a government-run hospital and private clinic, and being distributed through many pharmacies—has resulted in a nationwide recall of all thirteen drugs, including publicizing the names of the outlets where they were found.

This is intended as a strong deterrent, making pharmacy and hospital procurement personnel more vigilant about their suppliers. Manufacturers of some of the recalled medications will be required to meet with the FDB for required regulatory sanctions.

Noted Dr. Lukulay, "It's important to keep in mind that all these fake and substandard medicines were found just in one round of post-market surveillance, just of anti-malarials. The existence of many more substandard and counterfeit medications for other types of medicines and in other locations and facilities must be assumed. Public education and official collaborations between public and private sectors are both essential to protecting public health here in Ghana and in many other developing nations."

The American people, through the U.S. Agency for International Development, have provided economic and humanitarian assistance worldwide for nearly 50 years.

Secure Pharma Chain agrees with the conclusions of enhanced public education, more rigorous enforcement of laws and official collaborations between public and private standards as essential in combating this lethal crime.

The members of the global pharmaceutical supply chain (manufacturers, distributors and dispensers) need to take the lead on defeating this crime. Waiting for agencies and regulations is not an option, proactive deployment of solutions and technologies designed to interdict and protect inventories from fraudulent, adulterated, sub-standard and counterfeit medications by the commercial interests seemingly is the most effective and efficient way to eradicate this deadly epidemic.

To read the USAID press release, visit: http://www.prnewswire.com/news-releases/substandard-and-counterfeit-antimalarial-drugs-in-ghana-discovered-by-cooperative-program-of-usp-ghana-food-and-drugs-board-106891733.html

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

Washington Post: India Becomes a Hub for Fake Medicines

India, the world's largest manufacturer of generic drugs, has become a busy center for counterfeit and substandard medicines.

Rama Lakshmi, in the September 11th issue of the Washington Post writes and outstanding expose regarding the state of the pharmaceutical supply chain in India.

Beyond the borders of India, this has become a significant concern given that India is the world’s largest producer of generic drugs and now has the dubious distinction as the largest exporter of counterfeit drugs around the globe.

India currently legitimately exports $8.5 billion of pharmaceuticals, mostly to African and Latin American countries, each year.

Lakshmi does an excellent job in personalizing the Indian counterfeit drug problem with stories of locals fighting and participating in the illicit trade, along with macro industry insight.

Highlighted in the Washington Post article:

• India, the world's largest manufacturer of generic drugs, has become a busy center for counterfeit and substandard medicines. Stuffed in slick packaging and often labeled with the names of such legitimate companies as GlaxoSmithKline, Pfizer and Novartis, the fake drugs are passed off to Indian consumers and sold in developing nations around the world.

• An expert says the global fake-drug industry, worth about $90 billion, causes the deaths of almost 1 million people a year and is contributing to a rise in drug resistance.

• Estimates vary on the number of these drugs made in India. The Indian government says that 0.4 percent of the country's drugs are counterfeit and that substandard drugs account for about 8 percent. But independent estimates range from 12 to 25 percent.

• Indian officials say the clandestine industry has hurt the image of India's booming pharmaceutical industry and its exports.

• The number of people arrested for manufacturing and selling fake drugs rose from 12 in 2006 to 147 last year, and drugs worth about $6.5 million were seized over this period.

• The tricks of the trade include sticking fraudulent labels on expired products, filling vials with water, stuffing small amounts of real ingredients in packages of popular licensed brands and putting chalk power in medicine packets.

• In June, officials at Nigeria's Abuja airport caught a shipment of fake antibiotics, containing no active ingredients, with a "Made in India" label. Nigerian investigators later said that a Chinese company shipped the drugs via Frankfurt. In a similar incident last year, a shipment of fake anti-malaria drugs from China arrived in Nigeria with an Indian tag.

• Last year, Sri Lanka banned imports from four Indian companies after officials discovered substandard medicine in shipments.

• Over the years, drug companies have used holograms or embossed their logo on the packaging to protect their brands, but these have also been counterfeited in India.

• Co-writing a report on a recent survey, Barun Mitra, Director of the New Delhi-based think tank Liberty Institute said that 12 percent of sampled drugs from the capital's pharmacies were substandard. "We are behaving like ostriches with our heads in the sand and pretending that nothing is amiss even as the problem keeps growing and affecting Indian patients."

Lakshmi ends the piece with a story about an encounter with a local drug counterfeiter:

On a recent morning in the northern city of Varanasi, a young man named Ashish waited for a shipment of painkillers and postpartum pills to arrive by train.

He said his order of pills that controlled postpartum bleeding contained chalk powder but came with the brand name Methergine in a Novartis package.

The painkiller had insufficient ingredients and carried a Bidanzen Forte label inside a knockoff GlaxoSmithKline package.

"There is a lot of profit in this," said Ashish, 28, describing the extent of counterfeit drugs in Varanasi. He declined to give his surname because his operation is illegal.

"I do not think about right or wrong," he said. "I am not killing anybody. The worst is that these medicines will not show any result and the patient may have to check into a hospital."

In a growing global supply chain and with India's pivotal role in it, it is imperative that the regulatory and the individual members of the pharmaceutical supply chain's become proactive in dealing with drug counterfeiting a criminal act that impacts the health and well being of millions all over the globe.

As this story illustrates, because of their sophistication, drug counterfeiters can easily adapt to packaging centered anti-counterfeiting solutions, what they cannot do is account for authentication of the product while it is in its packaging.

Verification of the product inside its sealed container is the most effective way of protecting the supply chain and the consumer from this deadly crime.

To read the entire Washington Post story, visit: http://www.washingtonpost.com/wp-dyn/content/article/2010/09/10/AR2010091006700.html.

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

UK Recalls Multiple Generic Drugs

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

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

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

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

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