Product counterfeiting is a global public menace that cuts across all segments of production. The incidence dates back to the ages and is motivated by the huge profit to be made. Of great concern is the counterfeiting/faking of drug products used in diagnosis, prevention, treatment and management of disease(s) in humans and animals.
Trade in counterfeit drugs appears to be widespread internationally. It has captured the attention of governments and the public over the last two decades as its effects can be felt by both developed and developing countries. Despite all efforts aimed at preventing the manufacture, distribution and sale of fake drug products by Drug Regulatory Agencies (DRAs), the menace, though abated, has continued to exist till today. This article focuses on factors promoting fake drug production, sales and demand.
There is no universally uniform definition of fake drugs as every country has given varying definitions based on the angle from which the problem is viewed. According to the World Health Organization (WHO), a counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeit products may include:
- any drug product which is not what it purports to be;
- those with insufficient active ingredients; or
- those with fake packaging.
By this definition, counterfeiting may involve forgeries and close imitations of pharmaceutically-sound medicines, repackaging of expired drugs, substandard generic drugs and “gray” pharmaceuticals.
- 1 Factors Encouraging the Distribution of Counterfeit Drugs
- 2 1. Availability of sophisticated technology
- 3 2. High cost of quality drug products
- 4 3. Unorganized drug distribution network involving so many intermediaries.
- 5 4. Corruption, greed and conflict of interest
- 6 5. Inefficient cooperation between drug regulatory authorities and stakeholders
- 7 6. Weak regulations, in terms of implementation of existing drug laws and penal sanctions
- 8 7. Non-professionals in drug business
- 9 8. Demands exceeding supply/ break in steady supply of quality product
- 10 9. Illegal drug importation
- 11 10. Harsh business environment
- 12 11. Ignorance and increase in self-medication culture
Factors Encouraging the Distribution of Counterfeit Drugs
Several factors have been associated with the issue of counterfeit drugs. Some of the factors identified to promote fake drugs include but may not be limited to:
1. Availability of sophisticated technology
The culprits of drug product faking have over time developed various levels of sophisticated technology needed to manufacture almost every drug product from raw materials to labels and dosage forms. This has made it difficult for even pharmacists to identify counterfeit drug products by mere visual inspection.
2. High cost of quality drug products
When prices of drug products are high and there are significant price differentials between genuine and fake products, counterfeiting may be encouraged (as large profit can be generated from the manufacture and supply cheap counterfeit drug products to consumers who most of the time cannot afford the high priced quality drug products from reputable sources).
3. Unorganized drug distribution network involving so many intermediaries.
In most developing countries, open markets have been the major source of purchase for most medicine stores, pharmacy outlets, private and public hospitals etc. This has encouraged drug hawking in buses, kiosks and motor parks by illiterate vendors with the sole aim of making profit. On the other hand, it has made drug monitoring and product recall very difficult if not impossible.
4. Corruption, greed and conflict of interest
Corrupt practices among law enforcement personnel and the involvement of some greedy high ranking government officials in the manufacture and distribution of fake drugs has to a great extent affected the efficiency of Drug Regulatory Agencies (DRAs) in checkmating the manufacture and distribution of fake drug products. This has made it difficult for DRAs to arrest, prosecute or sanction culprits.
Ineffective cooperation existing between the drug regulatory authorities and other stakeholders like the judiciary, police and custom officials oftentimes delay arrests, judgments and sanctioning of culprits. This makes the control of drug markets and enforcement of drug laws very difficult.
6. Weak regulations, in terms of implementation of existing drug laws and penal sanctions
When drug laws are not strictly enforced, there is usually the possibility of increased manufacture and distribution of fake drugs as perpetrators have little or no fear of being apprehended and prosecuted. Even when these laws are implemented, the punishments do not seem to deter culprits from committing the same crime.
7. Non-professionals in drug business
Drugs in most third world countries are treated as general merchandise which could be obtained easily from open markets. This has greatly encouraged the involvement of non-professionals who just want to make profit at the expense of the unsuspecting public.
8. Demands exceeding supply/ break in steady supply of quality product
When demand for a particular drug product exceeds supply, counterfeiting may be encouraged as huge profit could be made from the manufacturing and distribution of the counterfeit products. Similarly, any break in steady supply of quality drug products could encourage the introduction of counterfeit drug products to meet the demand by users. In most cases, the new source may not be immediately differentiated or identified.
9. Illegal drug importation
Importation of counterfeits across national boundaries has greatly contributed to the increasingly complex problem of drug product counterfeiting. Counterfeiters resort to importing counterfeit drug products in order to have an edge over their competitors and make more profit at the expense of the consumers. In order to reduce costs, evade inspection and lower the likelihood of detection especially in countries with minimal penetrable boarders, counterfeiters have devised and employed mind-boggling concealment methods for their evil activities.
10. Harsh business environment
Harsh business environments like stringent price control, poor access to foreign exchange, unfair government policies, inflation in the domestic markets etc., discourages local manufacturing of drug products at competitive level with the importation of substandard, fake and adulterated drug products.
11. Ignorance and increase in self-medication culture
Ignorance, as a factor contributing to availability of fake drugs can be attributed to the literacy level of a given population. This is because it will be difficult for such people to differentiate genuine drug products from fake as they are easily enticed by the cheaper prices and easier accessibility from patronizing drug vendors. Some individuals still prefer to self-medicate when they are ill. They end up patronizing unlicensed drug vendors without bothering if the product is genuine or not.
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