Counterfeit Products

Counterfeit products, products of dubious quality and faulty information — especially exaggerated claims of efficacy — are often found to be widespread in the informal sector. Unlicensed manufacturers, importers, wholesalers, retailers and even persons engaged in the pharmaceutical business pose difficult challenges to dmg regulation. The DRA should not allow the informal sector to remain a loophole in regulation. Monitoring of pharmaceutical activities should cover the informal as well as the formal sector. 

In Mger, fake meningitis vaccines, administered during an epidemic in which more than 26 700 people had contracted the disease, led to the deaths of 2 500 people ). Substandard and counterfeit products are not only a problem in developing countries, but in developed countries as well (7,8,9,10,11). 

Unrenewed/expired licence Counterfeit products Illegally imported products Expired products being sold Unregistered products on the market Products stored under improper conditions... 

Examining the inspectors workloads will also help to establish reasons for the success or failure of the inspection process. EHiring their inspection of pharmaceutical establishments, inspectors may learn of the presence of unregistered products, counterfeit products, etc. Quantitative information on these and other issues is valuable as an outcome measure. 

The elimination of unsafe practices and inferior or counterfeit products, with strong action against deliberate offenders. 

ICP-MS has been employed, as discussed in Section 9.5, for the determination of platinum originating from cisplatin, carboplatin and oxaliplatin in human plasma ultrafiltrate. The method developed was successfully used to support pharmacokinetic studies in cancer patients treated with cisplatin, carboplatin or oxaliplatin.5 Counterfeit products on the drug market, which have important implications for pharmaceutical companies and human health, can be clarified by mass spectrometric isotope ratio measurements. For example, precise and accurate sulfur isotope measurements (a 54S) by MC-ICP-MS, were employed to study the isotope variation of pharmaceuticals and to detect to the origin of counterfeits by Clough el al.6... 

Identifiers substances incorporated in a product to aid manufacturers to distinguish their products from similar or counterfeit products. 

Statistically, however, legal sources of methaqualone had only been a fraction of the total Quaalude supply in the United States. In 2001, the DEA estimated the illicit, or counterfeit, production of the drug at 150 metric tons annually in the early 1980s, over 20 times the amount of legitimate methaqualone produced worldwide. 

The situation is different in cases where the client aims at closely imitating not just a model product s physical features but also its packaging in all aspects, including the product name. We are then in the realm of counterfeit products. There is no need to expand upon the ethical and legal problems associated with being an accomplice to the manufacture of products of this kind. 

Goods should be assigned an accurate status that indicates their position within the supply chain at any particular point in time. Examples could include Received, On Hold, Quarantined, Available, Planned, Picked, Dispatched, In Transit, Delivered, Rejected, Referred, and Awaiting Life Extension. Quarantined Status may apply to goods shipped without Certificate of Analysis, returned products, damaged products, incomplete products, counterfeit products, expired products, misbranded and adulterated products, or goods from an unauthorized Suppher. 

In 1999, WHO published guidelines on the detection and prevention of counterfeit and substandard products. Vigilance and reporting of counterfeit products to WHO were enhanced by setting up a liaison officer network among drug regulatory authorities and WHO. 

A considerable amount of (unpublished) work has been performed by Ciurczak on counterfeit tablets. Using the same algorithms that have been applied to discriminate between placebos and active products, counterfeit products may be easily identified. The spectral variability stems from different raw materials and manufacturing processes, even though the active may be present at the correct level. 

COUNTERFEITS Products which purport to be but which are not real pharmaceutical drugs. 

In February 2009, the British Broadcasting Corporation (BBC) reported that the Medicines and Healthcare Products Regulatory Agency (MHRA) recalled a number of medicines because counterfeit products had been introduced to the market that were found to contain between 50 and 80% of the required dose. The drugs recalled were Casodex , which is used for the treatment of prostate cancer Plavix , which is used to treat heart conditions and strokes and Zyprexa , which is used to control symptoms of schizophrenia (chemical structures are shown in Figure 11.1). 

The tests are carried out to pharmacopoeia standards (a pharmacopoeia is a technical text that contains tests for identification of products used in the pharmaceutical industry). For example, if we consider the previously mentioned products (chemical structures shown in Figure 11.1), they can be tested by HPLC-DAD under the European Pharmacopoeia (shortened to Ph Eur on packaging). Initially, the counterfeit products were identified by a wholesaler who noted a difference in the packaging by comparing results of bona fide tablets and the suspected counterfeit products, differences in the dose can be identified (see Figures 11.2 and 11.3). 

Once a pallet of product or a single item can be tracked, the associated information regarding product status in the supply chain is immediately available. Sensors can transmit product location, temperature, and quantity, as well as whether there were any changes in the status of the container or product over time. Such information can assure the customer that there was no tampering or counterfeit product supplied. 

Endeavors have been made to find a link between two data sets (sensory versus instrumental data). The common goal of these tools is to discover the components or parameters whose variation explains the variation of sensory characteristics. The most useful statistical methods used for such purpose are partial least squares regression and generalized procrustes analysis. From a practical point of view, the models can be used to complement sensory assessment in routine quality control or in product and process development work. Regression-based statistical techniques are often used in conjunction with GC to distinguish well-known brands of alcoholic beverages from less expensive ones to detect counterfeit products. 

FC Relaxometry provides novel and reliable information to the characterization of foodstuff and it has the potential to enter the armoury of methodologies currently applied in food analysis. The analysis of NMRD profiles allows the acquisition of unique information about the interaction between water molecules and macromolecules and paramagnetic systems. The NMRD profiles may represent excellent fingerprints for genuine samples and may contribute to identify finuds and counterfeit products. Last but not least the sample does not require any preparation/transformation for the acquisition of the NMRD profile and the volume necessary for this analysis is just less than 1 ml. The acquisition of a NMRD profile takes from few tens of minutes to few hours according to the number of points and the relaxation times of the given specimen. The reproducibility can be quite hi ( 0.5%). 

Santamaria-Femandez et al. investigated different approaches to identify such counterfeit products. First, they compared the discriminant power of approaches relying on S isotopic analysis for a large-scale investigation of a certain antiviral product [94]. They evaluated three different approaches dissolution of the samples followed by analysis by means of MC-ICP-MS, isolation of the API (active pharmaceutical ingredient) by high-performance liquid chromatography (HPLC)... 

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