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Counterfeit and Substandard Drugs in Tanzania

In several countries, counterfeit and substandard pharmaceuticals are a severe public health concern. This is a global issue, but it is especially prevalent in African countries, where more than 30 % of the pharmaceuticals supplied are counterfeit or substandard. Many reasons contribute to the emergence of this issue, which differ from country to country. Online business, light sanctions for drug infringers, ignorance, and an absence of meaningful collaboration amongst players are all variables

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0% found this document useful (0 votes)
125 views6 pages

Counterfeit and Substandard Drugs in Tanzania

In several countries, counterfeit and substandard pharmaceuticals are a severe public health concern. This is a global issue, but it is especially prevalent in African countries, where more than 30 % of the pharmaceuticals supplied are counterfeit or substandard. Many reasons contribute to the emergence of this issue, which differ from country to country. Online business, light sanctions for drug infringers, ignorance, and an absence of meaningful collaboration amongst players are all variables

Uploaded by

Petro Karungamye
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Forensic Science International: Reports 7 (2023) 100302

Contents lists available at ScienceDirect

Forensic Science International: Reports


journal homepage: www.sciencedirect.com/journal/forensic-science-international-reports

Mini review

Counterfeit and substandard drugs in Tanzania: A review


Petro Karungamye a, b, *
a
Department of Chemistry, The University of Dodoma, Tanzania
b
School of Materials Energy Water and Environmental Sciences (MEWES), The Nelson Mandela African Institution of Science and Technology (NM-AIST), Tanzania

A R T I C L E I N F O A B S T R A C T

Keywords: In several countries, counterfeit and substandard pharmaceuticals are a severe public health concern. This is a
Counterfeit drugs global issue, but it is especially prevalent in African countries, where more than 30 % of the pharmaceuticals
Substandard drugs supplied are counterfeit or substandard. Many reasons contribute to the emergence of this issue, which differ
Counterfeit fighting
from country to country. Online business, light sanctions for drug infringers, ignorance, and an absence of
Health effects
meaningful collaboration amongst players are all variables involved. The Tanzania Food and Drugs Authority
Analytical methods
(TFDA), Tanzania Police Force, Weights and Measures Agency Tanzania Fair Competition Commission (FCC),
Tanzania Bureau of Standards (TBS) and Tanzania Revenue Authority (TRA) Customs are all involved in the fight
against counterfeit drugs in Tanzania. Despite this, more work needs to be done to control the supply of
counterfeit and substandard pharmaceuticals, which have major health and economic effects. Based on the
public health and economic consequences of these low-quality pharmaceuticals, strong international cooperation
is required to address the issue. This includes tighter state licensing oversight of pharmaceutical suppliers. In
order to identify these products at various supply chain stages, advanced technologies should be used. Finally,
consumers must be educated on how to recognize counterfeit pharmaceuticals and their effects.

Introduction of the characteristics summarized in Table 1.


The WHO describes substandard pharmaceuticals as genuine drug
There are two types of medications that are of poor quality. One is of items that do not meet the quality standards that have been set for them.
substandard, while the other is a counterfeit. Substandard products are A substandard product, according to the United States Pharmacopoeia,
the result of a lack of expert knowledge, poor manufacturing processes, is one that is legally branded or generic but does not meet international
or insufficient infrastructure, whereas counterfeits are the ’products’ of strength, purity, quality, or packaging criteria [2]. The potential for
criminals [1]. Different definitions for counterfeit pharmaceuticals have enormous financial gain is the main driving force behind counterfeiting,
been given, but all agree that they are the consequence of premeditated and those who engage in it are adept at quickly adapting to various
criminal action [2]. Counterfeit or phony pharmaceuticals have their situations and products where they can maximize their profits [5]. More
identity and/or source purposefully and fraudulently mislabeled. Both than 100,000 people have died as a result of counterfeit drugs world­
branded and generic products can be counterfeited [3]. wide, which are thought to bring in about $75 billion annually for
The World Health Organization (WHO) defines a counterfeit phar­ criminal enterprises [7,8].
maceuticals as “one which is deliberately and fraudulently mislabeled At the WHO Conference of Experts on Rational Drug Use in 1985, the
with respect to identity and/or source” [4]. Counterfeiting can apply to presence of counterfeit pharmaceuticals in international trade was first
both branded and generic products [5]. Counterfeit pharmaceutical acknowledged as a problem [9]. Before this incident, developing coun­
products may include products with the right ingredients but false tries—the least lucrative markets in the world—were primarily affected
packaging that lists the incorrect ingredients, no active ingredients, or by the risks and difficulties posed by pharmaceutical counterfeiting, and
insufficient active ingredients. It also includes those that contain fewer the industry placed a regrettably low priority on the issue. Addressing
or no active ingredients than those listed, as well as those that have been the complex problem of pharmaceutical counterfeiting in the developing
adulterated, substituted, completely misrepresented, or sold under a world was fundamentally too difficult and expensive. But things have
false brand name [6]. A counterfeit medication might include any or all drastically changed on a global scale. Today, pharmaceutical

* Correspondence to: The University of Dodoma, P.O.Box 338, Dodoma, Tanzania.


E-mail address: [email protected].

https://doi.org/10.1016/j.fsir.2022.100302
Received 18 July 2022; Received in revised form 17 November 2022; Accepted 4 December 2022
Available online 5 December 2022
2665-9107/© 2022 The Author(s). Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-
nc-nd/4.0/).
P. Karungamye Forensic Science International: Reports 7 (2023) 100302

Table 1 Table 3
Characteristics of counterfeit drugs. Some factors influencing the occurrence of counterfeit medications.
Drug characteristics Factor Explanations Reference

Types Active ingredient Packaging and Importing Weak penal sanctions: Counterfeiters are opportunistic [17]
labelling criminals motivated by profits yet
1 Same as genuine drug Same as genuine Illegally with limited legal penalties
drug Weak or absent national The use of under-qualified staff, the [18,19]
2 Incorrect amount Same as genuine Legally drug regulatory illegal delivery of certain drugs and
drug authorities: services, and an inability to fulfill
3 Do not contain Same as genuine Legally quality standards and obtain official
drug registration are all common
4 Replaced by harmful substances Same as genuine Legally practices in the private health care
drug sector in developing countries,
5 Same as genuine drug Counterfeit Legally according to critics.
6 Incorrect amount Counterfeit Legally Drug laws are not being Countries do their best, but still the [17].
7 Different active ingredient or Counterfeit Legally enforced properly. counterfeiting industry is well-
harmful substances organized and will even kill
8 Do not contain Counterfeit Legally government officials if necessary.
Lack of control of drugs It has been claimed that drugs made [20]
for export. for export in high-income countries,
counterfeiting affects every continent, and no medicine is immune [10]. including those used in
humanitarian aid, have a
When it comes to counterfeit pharmaceuticals the database separates
substandard control standard than
developing and developed countries [11]. Up to 15 % of all drugs sold those made for domestic use.
are reportedly counterfeit, with this figure exceeding 50 % in some re­ Sale of drugs over One of the key contributors of [21]
gions of Africa and Asia [9,12,13]. Government regulatory agencies, internet counterfeit drugs is internet
pharmaceutical companies, healthcare providers, and consumers are all distribution channels, such as online
pharmacies, which have become
concerned about the problem of counterfeit pharmaceutical products
increasingly popular in recent years.
[14]. Sadly, many buyers are unaware of
In reports from developed countries, all groups of pharmaceuticals the consequences of purchasing
are mentioned with nearly equal frequency. Contrary to popular belief, lower-cost drugs on the internet or
the most expensive pharmaceuticals are not usually counterfeited. It is prescription drugs without even a
prescribed medication, which could
worth noting that counterfeiters choose antibiotics and antiparasitics, result in a counterfeit product.
the pharmaceuticals that are most required in developing countries Corruption and conflict of A pharmaceutical company may be [20,22].
[15]. The market for different types of counterfeits is summarized in interest: granted a sales license in a corrupt
Table 2. country without having to go
through all of the proven compliance
The purpose of this paper is to review the literature and information
verification processes. In one study
that is currently available in peer-reviewed articles and online infor­ in Kenya, for example, half of the
mation resources about the issue of counterfeit and substandard medi­ drugs tested were substandard
cines in Tanzania. despite the fact that they all had an
official sales license.
Widespread self- Patients usually start self-treatment [23]
Factors facilitating the occurrence of counterfeit prescription. with drugs bought in the private
sector prior to actually seeking
Counterfeit medications are made possible by a variety of circum­ medical care from institutions if
stances in different countries (Magili, 2013; Nayyar et al., 2012). Some their results are not satisfactory.
Long travel times, rude and insulting
common factors are summarized in Table 3;.
staff, scarce opening hours, long
In many places, the information regarding counterfeit drugs is kept waiting times, a lack of diagnostic
confidential. It was reported in the United States that obtaining citable facilities, and poor building
accurate information about the scope of the counterfeit drug problem conditions are all common reasons
was extremely difficult. The information that pharmaceutical for not visiting a government health
facility.
Difficult in quality Only one out of every six countries, [2].
testing. according to the WHO, has
Table 2
completely operational drug
Types of counterfeit drugs and their main markets [11]. regulatory frameworks. Even
Type of counterfeit Main markets, distribution relatively simple chromatographic
or pharmacopeial techniques for
Fake copies of genuine international Sold in developed and middle-income quality management are not
known brands (Correct ingredient) countries commonly available in some
Distributed via the internet or other non- countries.
medical channels Scarcity of political will It is critical to maintain political will [1].
Fake copies of genuine international Sold in middle-income countries and cooperation from and financial support for
known brands (Without or less Informal and formal pharmaceutical stakeholders: coordinated action from various
ingredient) distribution channels are used to distribute agencies. Police, scientists, the
the products. pharmaceutical industry,
Fake copies of generic drugs (Without Sold mainly in low-income countries governments, and the WHO can all
or less ingredient) Distributed mainly via informal channels work together to combat these
Unregistered drugs without or Sold mainly in low-income countries issues, according to the findings.
incorrect ingredient Distributed mainly via informal channels Expensive drugs with Since the price of genuine [17,18].
Registered drugs with wrong or Mostly sold in low and middle-income large profit margins: prescription medications may be out
incorrect ingredient countries with a weak regulatory system of reach for a large part of the
Formal channels, including public-sector population mostly in developing
outlets, are used to disseminate the
(continued on next page)
product

2
P. Karungamye Forensic Science International: Reports 7 (2023) 100302

Table 3 (continued ) severity and danger of this global threat.


Factor Explanations Reference
Counterfeits in Tanzania
countries, counterfeiters frequently
target them. As a result, patients are
more likely to use less expensive According to the Confederation of Tanzania Industries (2017),
generic drugs rather than more Tanzania also suffers from counterfeits in the pharmaceuticals. Falsified
expensive, genuine drugs. antiretrovirals were discovered at a district hospital in 2012 by the
regulatory authorities [38,39]. Up to 80 % of the pharmaceuticals are
imported in Tanzania and most of the counterfeit pharmaceuticals are
Table 4 also imported using illicit trading routes or channels. Apart from im­
Drugs Post Marketing Surveillance (PMS) in Tanzania from 2015 to 2020. ported drugs, some types of medicines manufactured locally have been
Year Samples analyzed Pass % Pass Reference counterfeited. The data for counterfeit and substandard medicines im­
ported into Tanzania up to 2015 [40] shows general increase as seen in
2015/2016 234 223 95.3 [45]
2016/2017 360 344 95.5 [46] Fig. 1.
2017/2018 150 142 94.7 [47] Half of substandard human medicines entering the country are said
2018/2019 133 133 100 [48] to be fake [41]. The most counterfeited drugs are antimalarials, followed
2019/2020 387 372 96.1 [49]
by antibiotics [42]. The study conducted in Tunduma and Dar es Salaam
to evaluate the knowledge and perceptions on counterfeit drugs reveals
corporations have is kept highly confidential [13]. that the majority of people can spot the counterfeit drugs because of the
poor packing, physical quality, and labeling. According to the labels on
Effects of counterfeits/substandard drugs the counterfeit drugs, 3 % were suspected to come from Kenya, 14 %
Unknown origin, 11 % from Tanzania, 17 % from Korea, 7 % from India
Counterfeit and substandard drugs affect people, manufacturing in­ and 48 % from Italy [43]. One of the challenges may be a lack of law
dustries, drugs regulatory authorities, and countries’ economies in enforcement and sanctions, as well as lacking legislation and weak au­
general [24]. The World Health Organization (WHO) uses the slogan thorities, which allows for the flourishing of illegal counterfeiting en­
"Counterfeit Drugs Kill" in its anti-counterfeiting campaign. [11]. They terprises. The penalty for drug counterfeiting in Tanzania is 5
increase mortality and morbidity by substituting lethal ingredients for million/= Tshs and two years in prison, which seems insignificant when
the API [25]. According to reports, some counterfeit pharmaceuticals contrasted to the profit made by the counterfeiters [44]. 95.2 % of
contain starch, chalk, and a variety of toxic active ingredients. [17,26]. regulatory institution workers interviewed believe that the Act is inef­
For instance, in 1990, cough syrup containing paracetamol that was fective and inadequate in combating counterfeit drugs and 76 % propose
made with the toxic diethylene glycol solvent instead of propylene the punishment to be increased [16]. Despite serious regulatory irreg­
glycol caused the deaths of 109 children living in two cities in Nigeria ularities such as selling controlled pharmaceuticals, selling loose tablets,
(Ibadan and Jos) [27,28]. Therefore, the toxic components in counterfeit selling unregistered drugs, as well as a near total shortage of competent
pharmaceuticals put patients at risk of developing unexpected adverse sales staff, research on pharmaceutical shops in rural Tanzania discov­
drug reactions and causing death or morbidity. ered that the shops operate with government’s tacit authorization [19].
Subtherapeutic amounts of API in the drug product cause drug
resistance [29]. The use of counterfeit antimicrobial agents has negative Post Marketing Surveillance (PMS)
consequences for public health, including the rapid emergence of anti­
microbial resistance [27]. This is especially true in developing countries, In Post Marketing Surveillance (PMS) conducted by the Government
where antibiotics, antimalarials, and antiretroviral drugs are in short authority responsible for medicines, it shows more than 90 % of
supply, resulting in the emergence of drug-resistant pathogens [30]. analyzed drugs passing quality control tests in the laboratory. Results
Poor quality artemisinin derivatives limit combination therapy for from 2015 to 2020 are summarized in the Table 2.
tuberculosis, HIV/AIDS, and malaria, and similarly, poor quality TB The data in Table 2 gives assurance to consumers on how the quality
drugs not only result in treatment failure but also increase the incidence of pharmaceuticals available in the Tanzanian market is monitored and
of drug resistance [31,32]. safety of the public from counterfeit and substandard medical products.
Counterfeit pharmaceuticals erode trust in the health-care systems The data from these surveys are being used to streamline and improve
[31]: as a result of the repercussions of these counterfeit drugs, often the country’s pharmaceutical regulatory structure.
among patients who were initially skeptical of these essentially "west­
ern" systems [24]. This increases the workload for health professionals
and health-care providers, such as clinics and pharmacies, as they work
to restore this trust [33]. Due to incorrect ingredients, the consequences
can range from unexpected to allergic reactions [34]. Furthermore, it is
impossible to assume that counterfeit API products will be subthera­
peutic, because they may contain more than the stated amount, which
increases the risk of adverse effects for drugs with narrow therapeutic
indices [35]. They have financial ramifications for patients and their
families, the country, and genuine medicine providers, as a result of a
workforce that is frequently too ill to work or care for their families [11,
36]. They reduce market share and business opportunities for manu­
facturers of genuine pharmaceutical products [29]. The governments
also lose a significant amount of tax revenue [34]. Different
anti-counterfeiting institutions must be established by the governments,
which costs a lot of money that could be used for other government
services [37]. All of these effects are cause for concern and should raise
public, healthcare provider, and government agency awareness of the Fig. 1. Counterfeit and substandard medicines reported to be imported into
Tanzania up to 2015.

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P. Karungamye Forensic Science International: Reports 7 (2023) 100302

What should be done?

Fighting counterfeit pharmaceuticals demands the engagement of


various actors at the local, and worldwide levels [31]. Each of these
stakeholders is responsible to improve public awareness of the issue
[35]. Studies shows that little is known to health-care professionals and
the general public regarding counterfeit and substandard drugs. This
situation necessitates initiatives to increase their knowledge and atti­
tudes regarding counterfeit and substandard medicines [24]. To attain
this it requires accredit personnel and standardized training [43] which
can involve television and radio programs, to raise public knowledge of
the dangers of counterfeit pharmaceuticals [51]. Tanzania was the first
Fig. 2. Counterfeit and substandard pharmaceuticals shown by the TMDA to
African country to put in place well-functioning, regulatory system for
the media [50].
medical items however, this requires cooperation with other countries
[52]. Because the punishments are unsatisfactory to stop counterfeiters,
Special drug inspection it is necessary that drug regulations be modified to include additional
punishments to deter counterfeiters. Government needs to make sure
Tanzania Medicines and Medical Devices Authority (TMDA) under­ that drug control laws are followed [16]. The scope of "counterfeit
took a special pharmaceuticals inspection on the market in 2019/20 in medicinal items, illegal or impermissible actions; enforcement methods;
collaboration with other government organs. Some medications were and relevant punishments" must be clearly stated. Legislation must
removed from the market as a result of this inspection because they were include mechanisms for recalling products from the market, suspension
counterfeit or substandard. Several counterfeit pharmaceuticals were or termination of distributor licenses for deliberately or carelessly
found and removed from the market including Gentrisone cream 10 g, allowing counterfeit products to access the legal system, and the ability
Cold cap Capsules, Sonaderm cream, Novidam (Homidium chloride) to confiscate counterfeit products [53]. There is still a clear lack of po­
Tablets, Trypamidium samorin, Chloroquine Phosphate 250 mg, Sul­ litical will to address this gravely underappreciated issue [15]. If there is
phadoxine/Pyrimethamine, Sulfamethoxazole 400 mg/Trimethoprim to be a coordinated attempt to strengthen drug control and reduce the
80 mg, and Temevac NDV Strain I-2 [49]. The figure shows some frequency of drug counterfeiting, political will and a strong commitment
pharmaceutical products which were shown to media. from the government are required [16].
These findings reveal that, despite the government’s efforts to
regulate substandard and counterfeit pharmaceuticals, they continue to Conclusion
exist in the country. As a critical step toward limiting the market for
counterfeit medicines and as part of post-marketing surveillance, the Counterfeit pharmaceuticals are really a worldwide problem. This
public should really be trained to identify counterfeit drugs for common organized criminality has a deterring impact on the community and the
diseases such as malaria through simple observations. pharmaceutical industry all around the world. The main reasons for this
include a lack of a complete standardized definition of counterfeit drugs

Fig. 3. Samples of genuine and counterfeit drugs confiscated in Tanzania.

4
P. Karungamye Forensic Science International: Reports 7 (2023) 100302

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