India's Fake Drugs Are a Real Problem

India’s Food and Drug Administration recently conducted a series of raids to combat counterfeit drugs. Large amounts of counterfeits were seized in these raids and several individuals were arrested.

Roger Bate, a leading authority on counterfeit drugs recently wrote an article for the Wall Street Journal on these raids and the prevalence of counterfeit drugs in this region.

Below are some of the highlighted statistics cited in the article:

• In 2009, Bate examined five essential medicines in 52 different pharmacies in Delhi and Chennai. In Dehli, 12% of the pills were substandard, as were 5% in Chennai. About 2% of the pills contained no active ingredient.


• In a more recent investigation of Delhi’s wholesalers, they discovered that 7% of all tested samples were substandard and 3.6% were likely counterfeit.


• Last year alone, counterfeit drugs were seized by authorities in Bangalore, Mumbai, Delhi, Jaipur and many other Indian cities.


• In 2008, about half of the medical products that were confiscated by European Union customs officials originated in India.


• Estimates of substandard drugs reach as high as 30% of all medicines sold in parts of Africa, Asia and Latin America. But the truth is we don't really how bad the problem has become.


• The public-health consequences of the counterfeit drug trade are serious. These products, often adulterated with road paint and chalk, look identical to the antibiotics they pretend to be.


• Thousands of people probably die every year either because they're poisoned by bad ingredients in counterfeits or because the counterfeit doesn't treat the victim's malady.

In the article, Bate discusses the huge profits to be made and the necessity for stricter enforcement and how new technology can be used to combat this deadly menace.

XStream Systems has an anti-counterfeiting solution that allows wholesalers to molecularly verify the quality and authenticity of their inventory. In a world where what you see is not always what you get, our penetrating technology authenticates the medication and not just its packaging.

To learn more about XSteam Systems Solution visit: www.xstreamsystems.net.

For the full article visit: www.wsj.com.

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

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

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

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

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

Bail hearing is set for Oct 19, 2009.

To view entire article view: bdnews24.com

India: Blowing the Whistle on Fake Drugs

In the August 30th issue of Telegraph India, the Union health minister, Ghulam Nabi Azad, was reported as announcing a “whistle blower policy”, aimed at encouraging the common man to provide information about the manufacture of fake drugs

• Based on the information gathered by the Central Drugs Standard Control Organization, the office of the Drug Controller General of India raids places suspected of manufacturing or selling such drugs


• The tip-off often comes from a member of the general public


• The government hopes that a cash reward will lead to more people coming forward with such information.

To view the article visit: www.telegraphindia.com.

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

Business Standard: Validation Check Imposed on Medicine Exports in India

The August 5th edition of the Business Standard reports on Drug Controller General of India (DCGI) requiring all pharmaceutical contracted manufacturing exports will be required to furnish validation certificates of authenticity for importing firms overseas.

• The move, initiated by the office of the Drugs Controller General of India (DCGI), is expected to boost India’s image as a supplier of quality, low cost medicines.


• According to the official directive, all contract manufacturers exporting medicines using neutral code (which do not mention the name of the manufacturing or marketing firm) will have to present certificates from the regulators of the importing country to prove the genuine nature of the importing firm. In other words, the foreign regulator will have to endorse the product name and marketing registration these companies have obtained from the regulator.


• The drug exporters hailed the intention of the DCGI, but expressed concern over the sudden implementation of the circular. “There are hundreds of medicine products that are being exported to all parts of world”, they said adding: “ If DCGI wants the credentials of all the foreign sourcing companies from respected drug regulators, the consignments will not be cleared for the next three months. It will affect our credentials and credit worthiness.”


• The exporters wanted the directive to be confined to less regulated markets, where there is scope for mischief. Indian drug exports had recently come under regulatory scrutiny in several countries due to alleged complaints of spurious and counterfeit medicines.

XStream System applauds the move by DCGI and encourages screening and validation within all points of the supply chain as an important solution to counterfeit, substandard and adulterated pharmaceuticals.

XStream’s XT250 system can be easily deployed within the supply chain to screen, validate and authenticate pharmaceuticals within their sealed, unit-of-sale container without opening, destroying and degrading the product.

To view the entire article visit: www.business-standard.com

SafeMeds Weekly: Counterfeit Drug Sentencing Less Than Adequate

In an opinion piece posted on SafeMeds Weekly on August 10, 2009, Marvin D. Shepherd, PhD discusses the issue of light sentencing given to those convicted of counterfeiting medications around the globe. Dr. Shepherd asserts that inadequate sentencing “undermines the seriousness and true threat that counterfeit drugs pose to society and public health.”

Dr. Shepherd sites several examples:

• After nearly two years under investigation, the final sentence for running an international multi-million pound counterfeit medication operation was issued in the United Kingdom. The first four convictions were made in September 2007 and on July 6, the final member of the operation received a 12 month sentence, suspended for two years, for masterminding an industrial scale conspiracy of supplying counterfeit drugs between 2002 and 2005. In total, the seven convicted members of this international counterfeit drug ring received a combined 17.5 years imprisonment-an average of 2.5 years for each participant-for their part in the U.K. distribution arm of a global ring operating from China, India and Pakistan, extending to the Caribbean and the United States.


• In March 2009, an Arizona couple received at most eight years imprisonment for running an illegal drug business netting more than $2.5 million from 2004 to 2006. In comparison, convicted members of an illegal recreational drug ring would receive mandatory minimum sentences starting at 20 years up to life imprisonment for distribution in the United States.

In this article Dr. Shepherd questions the logic of not holding those responsible for the distribution and sale of counterfeit drugs to the same severity to those who commit similar offenses with illicit drugs. Basically he believes that until this is done the individuals and organizations responsible for this very real threat will continue to flourish.

XStream Systems favors stricter and more stringent enforcement and criminal penalties across the globe for those convicted of manufacturing, distributing or selling counterfeit or adulterated medications. XStream also encourages those within the pharmaceutical supply chain to screen and test their inventories with solutions such as XStream’s XT250 which allows the user to test and authenticate product inside its sealed container without destroying product or opening the container. The XT250 is designed to be deployed and used within the supply chain onsite and does not require technical resources to operate.

To read the opinion piece and to learn more about SafeMeds Weekly, visit their site at www.safemedicines.org.

To learn more about XStream Systems, XT250, visit us at www.xstreamsystems.net.

Indian Drugmakers Seen as Benefiting from Increased FDA Regulation

The Wednesday, July 29th edition of the Wall Street Journal reports that Indian generic drug makers are most likely to benefit in the long run because of increased FDA Regulation and scrutiny. The Journal sites sources that predict that with this scrutiny by the FDA these manufacturers will be in a better position than their rivals in the United States or China when over $100 billion drugs go off patent in the next five years. Indian manufacturers have over 107 FDA approved manufacturing plants which is the highest number outside of the United States.

To read the entire story online: http://online.wsj.com/article/SB124876915285586265.html.

XStream Systems speculates that drug makers and importers/exporters globally can mitigate this advantage presumably enjoyed by Indian manufacturers by increasing their internal scrutiny and quality control measures by increasing their use of technology as they export pharmaceuticals into developed nations. Technology solutions such as XStream System’s XT250 allow the manufacturer or importer to screen and verify the quality and efficacy of medications post-manufacturer, within the pharmaceutical supply chain and its sealed unit-of-sale container.

Fake Versions of Pfizer, Glaxo, J & J, Proctor & Gamble and Wyeth Products Seized in India

Yesterday, police in Ghazaiabad, India shut down a counterfeiting ring and seized fake medicines worth at least Rs. 5 million (over $100K USD) in the raid.

The company raided was registered as Avadh Pharma and is accused of manufacturing counterfeit versions of prestigious band name medicines including: Corex made by Pfizer, Iodex made by Glaxo, Benadryl of Johnson & Johnson, Vicks vaporub made by Proctor & Gamble and Anne French hair remover made by Wyeth. Following up on a tip they received, police raided the site where they recovered 50 cartons of packaged counterfeit finished product as well as an ample supply of packing materials and equipment.

The police also recovered stationery material of the firm, mentioning its name as Avadh Pharma with UP Trade Tax registration number 0073219360 as well as fake seals of different prestigious companies.

The arrested workers were identified as Raju Chaudhary, Rudal Singh, Lal Bhai and Mukesh Sahni. They confessed that they were working for Vinod Bhardwaj, who has fleed, the official stated.

US Drug makers Express Concern with USA Trading Partner Countries

The US Trade Representative (USTR) released its 2009 Special 301 Report on Friday May 1, 2009. According to the report, US drug makers have expressed concern over the policies of a number of USA’s trading partners - including Canada, France, Germany, Italy, Japan, New Zealand and Taiwan in regards to global intellectual property protection.

“In this time of economic uncertainty, we need to redouble our efforts to work with all of our trading partners – even our closest allies and neighbors such as Canada – to enhance protection and enforcement of intellectual property rights in the context of a rules-based trading system,” said the USTR, Ambassador Ron Kirk.

The USTR Priority Watch List for 2009 names countries requiring particular scrutiny - Algeria, Argentina, Canada, Chile, France, Germany, India, Indonesia, Israel, Italy, Japan, New Zealand, Pakistan, Taiwan, Thailand and Venezuela. Canada was added to list for the first time this year, due to “increasing concern about the continuing need for copyright reform, as well as continuing concern about weak border enforcement.”

Brazil, China, India, Indonesia and Russia are listed as areas where the manufacture of counterfeit drugs is rampant.

Indonesia joins the list for its counterfeit manufacturing, its counterfeit drug trade and the introduction last year’s law on the operation of foreign pharmaceutical companies that raises “significant market access concerns;”

China is also listed due to its regulatory lapse in the enforcement of active pharmaceutical ingredients (API) – since often these ingredients are not declared as a bulk chemical intended for use in pharmaceuticals by API makers to avoid regulatory oversight.

To read a recap on the USTR Report visit Pharma Times.

It is understandable that China’s lack of regulatory control for APIs would be of particular concern to the US since China provides 40% of the APIs for drugs. The impact of this danger was felt dramatically last year when an adulterated substance added by a Chinese supplier resulted in the heparin recall and almost 100 deaths in the United States.

Counterfeit Drugs are No Joke - Counterfeit and Substandard Cancer Drugs Sold to Consumers in India

Counterfeit drugs have a serious impact on the public’s health. As those who produce the spurious drugs have become more sophisticated and organized, they have stepped up their inventory to include life-saving medications, thus intensifying the dangers to the consumer.

Reported in The Times of India this week, The State Health Department in India has uncovered a counterfeit drug ring where crucial anti-cancer drugs have been illegally manufactured, re-bottled, and sold after their expiration dates.

The initial investigation has proved that these products have reached the public and have been consumed. Officials involved in the investigation have not determined yet if any deaths have resulted in the distribution of these spurious drugs due partly to the expanse of their distribution.

Officials have stated that the criminal ring posed as at least four legitimate manufacturing facilities and those manufacturers have denied any part in the production of these medicines.

The investigation is ongoing as officials examine the numerous outlets that sell anti-cancer drugs.

Counterfeit Drug Policy Stalled in India

For the past decade, regulatory authorities and pharmaceutical companies have been battling counterfeit and substandard drugs in India. It is estimated that 10% of the drugs in India are counterfeit, which sadly results in many thousands of deaths annually.

Regulatory authorities have been pushing for stricter laws, but have met with resistance from mid-size companies and states who now hold the regulatory authority over medications in their area.

As reported in the New Ledger, the current Indian health minister, Anbumani Ramadoss from Tamil Nadu proposed amendments that would have created a central drug authority, which in principle would have administered the entire drug regulatory system, overseeing drug quality and authorizing product marketing. Unfortunately, the bill failed to pass the lower house and with elections only two months away, we will have to wait to see if the new administration will push it forward.

Meanwhile, the Food and Drug Administration (FDA) is establishing an office in India to oversee exports to the United States. This measure follows a ban on 30 drugs from India’s largest generic manufacturer, Ranbaxy, in 2008

To view the entire news article visit: http://newledger.com/2009/03/counterfeit-drug-policy-in-india/

Over 120 kgs (265 lbs) of Fake Viagra Bound for America and Europe Seized

One of the largest seizures of Fake Viagra occurred this week in India. A local organization Enforcers of Intellectual Property Rights (EIPR) supplied the police with months of data on the illegal manufacturing and aided the authorities in their investigation.

On 4:00 p.m. Saturday, February 14, 2009 Haryana (India) police raided a supposedly closed manufacturing plant and seized 200 kgs. (440 lbs.) of counterfeit medicine, including 120 kgs. (265 lbs.) of fake Viagra.

The police found evidence that the Viagra drug was being manufactured on site and found the active ingredient of Viagra, sildenafil citrate, in its raw material form as well as packaged products ready for shipping. The spurious drugs were allegedly bound for shipment to the United States, Europe, and Canada.

The Indian police arrested eight people who were working at the company called Chem Pharma Company and are likely to press charges against them and the owner of the company Mr. Bhardwaj.

The investigation is continuing and more raids and arrests are anticipated. A majority of fake erectile dysfunction (ED) medication like Viagra is thought to be produced in India, Pakistan and China. These operations often involve underground criminal organizations which have been linked to terrorist activity around the world.

Due to this recent threat to public health, XStream Systems would caution consumers to buy ED medications only from licensed pharmacists and avoid online purchases from sources other than those supported by actual brick-and-mortar pharmacies. Wholesalers and distributors should verify inventory received. Given the sophistication of this batch of counterfeit drugs molecular authentication methods would be the best countermeasure to block any counterfeit products from entering their business.

XStream Systems Stories and News for the Week of November 21, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. As counterfeits become more prevalent globally and domestically, science will play a strong role in protecting our nation’s supply chain and molecular pharmaceutical authentication will be an important part of solving this global problem:

Israel joins world effort to halt counterfeit drug sales
Inspectors went to the Tel Aviv package warehouse of the Israel Postal Company and other facilities last week, seizing drugs prohibited in Israel and others suspected of being counterfeit that had been shipped from India and China.

FDA: FDA Hosts Its First Science Writers Symposium
Recently FDA experts met with more than 50 journalists and science writers at the FDA’s first Science Writers Symposium. At this day-long event, FDA’s scientists and physicians presented on such research as the science behind the Salmonella outbreaks, melamine adulteration of food substances, and nutrigenomics – an emerging field that has the potential to prevent disease and maximize health by using genetic profiles to tailor what we eat. FDA experts also presented their novel discoveries to prevent pandemic flu, identify contaminated heparin, and analyze the safety of drug-eluting stents down to the molecular level.

FDA Warns Public of Extortion Scam by FDA Impersonators
The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic.

Daschle Accepts HHS Cabinet Post
Former Senate Majority Leader Tom Daschle has accepted President-elect Barack Obama's offer to be Secretary of Health and Human Services.

Pharmaceutical Regulatory News Headlines - Week of October 31, 2008

In the United States, Halloween is the day for Tricks and Treats. But - Globally regulatory authorities have Penalties not Treats for would be counterfeiters.

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. Global regulatory authorities are now recognizing the increasing threat these fraudulent products place on their citizens and are taking legal actions to discourage it:

Saudi Arabia: Local Markets Flooded with Counterfeit Drugs
Agreements were made on Tuesday to step up legal action against counterfeiters in Saudi Arabia to ensure consumer safety. According to Abdullah Al-Abdelgader, a pharmaceutical manufacturing director, counterfeit drugs account for around 30-40 percent of medicines sold at local pharmacies and hospitals in Saudi Arabia and expose consumers to great risk. In the Gulf area, the counterfeiting economy accounts for $13 billion, with a share of $4 billion in the Saudi market. ("Some 30-40% of Medicines Sold Locally 'Are Counterfeit', Says Manufacturer," Saudi Gazette, October 22, 2008)

FDA Oversight of Foreign Drugs Lacking
The Food and Drug Administration is failing to keep accurate data about foreign drug facilities it is supposed to oversee and often doesn't follow up warning letters with inspections, according to a report by the Government Accountability Office. The House Energy and Commerce Committee introduced a bill that would mandate foreign inspections at a rate close to that of FDA inspections of U.S. plants. U.S. companies are inspected about every 2.7 years, but the rate for foreign inspections is roughly once every 13 years. ("FDA Is Faulted for Oversight of Foreign Drugs," Wall Street Journal, October 21, 2008)

Nigeria: Government Takes Steps to Block Counterfeit Drugs
The National Agency for Food and Drugs Administration and Control (NAFDAC) has blocked 22 Indian pharmaceutical companies from importing and distributing drugs in Nigeria. The agency has outlawed the use of about 40 imported drugs in the country, describing them as potentially dangerous for human consumption. As part of its efforts to curb drug counterfeits, NAFDAC is advocating for greater public education and awareness. ("Fake Drugs: NAFDAC Bans 22 Indian Firms," AllAfrica.com, October 22, 2008)

XStream Systems thinks that its penetrating authentication technology can be an integral part of the comprehensive solution to this global problem.

XStream Systems Stories and News for the Week of October 24, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the ever growing issues of counterfeit and adulterated medications. XStream Systems thinks that its revolutionary technology that is capable of materials analysis of medications inside of sealed containers will be an important part of solving this global problem:

Demand for Foreign Products Changing FDA, Official Says
The FDA needs to shift its approach on imports to one that minimizes risk at each point in the product life cycle — from foreign manufacture to domestic use, according to Timothy Ulatowski, director of compliance in the agency’s Center for Devices and Radiological Health. The FDA will release a draft guidance soon that outlines standards for third-party certification programs for FDA-regulated products, he said. It also is preparing a draft guidance on good importer practices.

A New "Double-Dose" Pill Drug Recall Is Issued By ETHEX Corp.
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient.

FDA To Open Multiple Inspection Offices Abroad By Year-End
The U.S. Department of Health and Human Services will send the first FDA inspection teams to new offices in China, India, Europe, and Latin America before the end of 2008, according to HHS. "In the past year, we've upgraded labs and equipment, hired additional staff, and begun implementing product safety agreements with key trading partner, including China," stated HHS Secretary Mike Leavitt.

FTC Breaks Up Spam Network Which Illegally Sold Drugs Online
The Federal Trade Commission said Tuesday that it has broken up a global spam network responsible for sending billions of illegal messages encouraging consumers to buy unsafe male-enhancement and weight loss pills. The spam network, which processed credit card information in Cyprus and Georgia, used servers in China to host its websites. The FTC said the network used by this operation compromised tens of thousands of computers around the world and was capable of sending up to 10 billion spam messages per day. The bogus drugs were shipped from China and India.

Largest European Seizure: Two Million Counterfeit Pills Seized in Brussels Airport

Two million counterfeit pills have been seized in Brussels Airport. The seizure of the drugs which originated in Mumbai, Indian and were bound for West Africa is the largest confiscation of counterfeit medicine in Europe.

The three Indian shipments contained counterfeit pharmaceuticals labeled as Tramal, a painkiller, and Fansidar, an anti-malaria drug.

Africa already has the daunting task of trying to control its malaria outbreaks without further obstacles of fake treatments. Many countries, organizations, and businesses have been aiding Africa to fight malaria and therefore, counterfeit medicine is a real threat to their work. In some countries up to 60% of anti-malaria drugs are fake and are aiding in the drugs resistance to current therapies.

Furthermore, the biggest victims are the children, because according to the Worlds Health Organization (WHO) a majority of malaria deaths are children under the age of five and Fasidar is one of the drugs given to pregnant women for the prevention of malaria.

The scope and intent of this particular case leads us to ask – Is any medication safe? How can we protect our most vulnerable medications? We believe the answer can be found in pharmaceutical authentication which verifies the drug itself. With nothing added and nothing destroyed; the method can be programmed to test various oral medications.

To learn more of this fascinating technology, see XStream Systems website at http://www.xstreamsystems.net/products.html.

Ranbaxy; More Concern over Substandard Medications

This year of 2008 should go down in the history books as the year of drug safety concerns. The latest concerns are over FDA accusations that Ranbaxy Laboratories sold substandard drugs and knowingly concealed the facts.

Ranbaxy is one of India’s largest generic manufacturers and 25% of their sales are in the U.S. They have been accused of using raw materials from unapproved sources in one of their northern India plants and altering in-house testing to meet FDA standards which resulted in sub-potent, super-potent or adulterated products.

"The government has reason to believe that these violations have resulted and continue to result in the introduction of adulterated and misbranded products" into the US market, federal prosecutors said.

This coupled with earlier cases this year of adulterated heparin from China, has left consumers doubting the safety of their medications. Most troubling is that the current methods being considered would not be effective in verifying the validity or purity of the drug itself.

Incidents such as this illustrate the need for an authentication of the product as a way to protect all of the members of the Pharmaceutical Supply Chain and most importantly the consumer. Track and Trace technologies (pedigrees and RFID) will not protect the consumer from these types of incidents which we can expect to happen more frequently as we continue to increase our reliance on global sources for our medications. Only XStream Systems’ XT250 has the solution to authenticating the product inside the sealed container. This is the only solution to this clear and present danger.

Outsourcing: The Whole is Only as Good as the Sum of Its Parts!

One of the little known facts about the pharmaceutical industry is how much of its manufacturing is outsourced. Over 80% of the pharmaceutical ingredients used in the manufacture of US drugs are outsourced to foreign countries, with a majority of these ingredients coming from China and India.

Understandably, with the current news on the contamination of heparin in the US supply and the role the Chinese supplier played in this case being questioned, quality control has become a major concern. Since the whole is only as good as the sum of the individual pieces, should we not be questioning the quality and safety of all outsourced materials?

Timely testing of these ingredients should greatly reduce quality issues, adverse reactions and recalls. After all, diligence in safety of what goes in to our bodies cannot be overstated!