According to the World Health Organization (WHO), a counterfeit medicine is a pharmaceutical product “which is deliberately and fraudulently mislabeled with respect to identity and/or source”. This definition of counterfeit medicines falls within the broader concept of “substandard medicine” but the two categories should not be confused. The category of substandard medicines includes medicines that may present an unintentionally incorrect package or have an incorrect quantity or ratio of ingredients. The difference with counterfeit medicines is that substandard medicines may not have an intentional attempt but result from inaccurate production due to inadequate resources and structures. Globally 10–15% of the supplied medicines are counterfeit. The prevalence is higher in developing countries in where up to 30–60% of medicines on the market are counterfeit. India is a major supplier of poor quality medicines producing 35–75% and China 20% of fake/counterfeit medicines globally.
Counterfeit/sub-standard/poor
quality medicines are a major cause of therapeutic failure, serious adverse
events, deaths, economic burden, medicine resistance, and loss of public
confidence in medicines and health services. Many factors contribute to the increased prevalence of
substandard and counterfeit medicines, including corruption. Besides, weak or absent medicine regulatory
authority, proliferation of small pharmaceutical companies, complex
transactions involving many intermediaries, a lack of good manufacturing
practices (GMP) are other reasons in most developing countries. Though the WHO
has issued guidelines for combating Counterfeit/sub-standard/or poor-quality
medicines, most developing countries are struggling to implement them.
Bangladesh context
In Bangladesh, where out-of-pocket healthcare expenditure is high for medicines, counterfeit/sub-standard/low-quality medicines pose a greater threat to public health. Such medicines range from pain killers to antibiotics to even anti-cancer medication. According to a media report in 2009, 24 children died of acute renal failure after taking adulterated Paracetamol syrups made by a local medicine company. Diethylene glycol, a chemical used in the dyeing and leather tanning industries, was detected in the syrup. In the same year, government authorities visited 193 pharmaceutical companies, examined their performance levels, and divided them into A, B, C, D, E and F categories. According to their report, companies ranked A-C produced medicines in compliance with the GMP, an international standard for medicine quality control; those ranked D-F did not.
A total of 62 companies were detected to be in non-compliance with the GMP. Just one year later in 2010, after testing 5,000 medicine samples from across the country, the Public Health and Medicine Testing Laboratory (the country’s testing authority) found that 300 (6 per cent) were either counterfeit or of substandard quality. The media reported that the percentage of counterfeit or “very poor quality” medicines had doubled. In that year, the market research firm (Business Monitor International) estimated that spurious medicines account for around $150m in Bangladesh.
In 2015, the Directorate
General Drug (Medicine) Administration (DGDA) reported that 153 medicines were
sub-standard; most manufacturers were unregistered companies. Medicine Testing
Laboratory tested 4,846 samples of medicines during the period, and based on
the results, the authority sealed ten companies. Besides, it has filed
cases against 499 medicine manufacturers and retailers and raised Tk 54.71 lakh
as fines.
In 2016, the media
reported that the authorities decided to cancel the licenses of 20 medicine
companies for failing to ensure the quality of their products. Many companies have
repeatedly and grossly failed to comply with the GMP.
In rural Bangladesh, the medicine retail market
is the target of a section of unscrupulous small-to-medium-size pharma
companies since monitoring is virtually absent due to the lack of appropriate
lab and human resource facilities of the DGDA. Medicine retail outlets (Medicine
shops) are encouraged to sell counterfeit/substandard/poor-quality medicines
under the most popular brand names in return for a fair commission from
pharmaceutical companies. By selling these low-cost substandard/counterfeit/poor-quality medicines under
well-established brand names, the retailers earn a larger profit. Village doctors,
trusted by the locals for their spiritual as well as medical advice, play a big
role as agents of the unscrupulous companies. Another concern is the
cross-border infiltration of counterfeit medicines; being a neighbouring
country of India, which accounts for a significant share of counterfeit
medicines in the global pharmaceutical market.
The top pharmaceutical companies
with nearly two-third of the market share, have to shoulder the blame against
the quality of their established brand medicines [27, 28]. As such, these
pharma companies have a stake in maintaining the goodwill and reputation of
their market products by following the prevailing rules and regulations
(regarding production and marketing of medicines in the country, such as GMP or
Code of marketing practices). Whereas, the small and medium-sized companies are
more interested in making quick profits by producing and marketing
counterfeit/sub-standard/poor quality medicines under established brand names
because it is difficult for them to compete with these big companies to produce
and market medicines at a reasonable profit. On the other hand, the regulatory
authority (DGDA), besides the shortage of human resource for health (HRH) and requisite
lab infrastructure and testing capacity, also points to the fact that even if
they take steps to control the marketing of these medicines, the loopholes in
the existing laws enable them to get a stay order from court and get back to
the business as before.
What’s the solution:“Lab
on paper”
Counterfeit/sub-standard/poor
quality medicines not only aggravate health risk of the population[1]
but also hamper the industry image. Thus, there is a need to understand the
market dynamics of counterfeit/sub-standard/poor quality medicines, the
perspectives of different stakeholders in the process and identify ways to
overcome this in a win-win situation for all. For identifying such medicines
quickly and on a mass scale (e.g., during a regulatory body raid), we need a
technique or method that can be used widely by the regulatory body or other
stakeholders, e.g., the Big pharma companies. This will help the pharma
industry and the regulatory body to design interventions which can mitigate the
situation, with positive impact on health and well-being of the people on its journey
towards achieving UHC by 2023 in Bangladesh[2].
The LMICs like Bangladesh
lack requisite lab infrastructure, costly reagents, specially trained human
resources, including uninterrupted flow of electricity and long time for assay[3].
Thus, there is an urgent need for developing cheap, simple and easy-to-use Point-of-Care
Diagnostics/ bedside diagnostics, especially in low-resource settings to reduce
morbidity and mortality from both communicable and non-communicable diseases.
Various technologies have been developed over the last decades, such as,
minilab, TruScan, TruTag etc. towards this end[4].
One such recently developed technology is Paper Analytical Device (PAD), about
the size of a playing card (a “lab on paper”). It is a “cost-effective tool for
field screening of a wide variety of pharmaceutical dosage forms in
low-resource settings”.[5]
The PAD puts the power to find fake drugs into the hands of frontline medical
professionals, and at a fraction of the cost of standard lab testing. The PAD
technology has been tested in different settings and for different
pharmaceuticals, such as, antimicrobials,[6],[7]
cancer medicines, [8],[9]
anti-malarials[10], addictive drugs[11]
etc.
[1]Newton PN, Green MD, Fernández FM.
Impact of poor-quality medicines in the ‘developing’ world Trends Pharmacol
Sci. 2010 Mar; 31(3-3): 99–101. doi: 10.1016/j.tips.2009.11.005:
10.1016/j.tips.2009.11.005
[2]
Ozawa S, Higgins CR, Yemeke TT, Nwokike JI, Evans L, Hajjou M, et al. (2020).
Importance of medicine quality in achieving universal health coverage. PLoS ONE
15(7):e0232966. https://doi.org/10.1371/journal.pone.0232966
[3] Shikha Sharma 1,†, Julia
Zapatero-Rodríguez 1,2,†, Pedro Estrela 3 and Richard O’Kennedy
1,2,*Point-of-Care Diagnostics in Low Resource Settings: Present Status and
Future Role of Microfluidics. Biosensors 2015, 5, 577-601;
doi:10.3390/bios503057
[4] Christo Hall. Technology for
combating counterfeit medicine. Pathogens and Global Health 2012 VOL. 106 NO.
2. DOI 10.1179/204777312X13419245939485
[5] U.S. Pharmacopeia (2020). USP
Technology Review: Paper Analytical Device (PAD). The Technology Review
Program. Rockville, Maryland.
[6] Myers et al. Lab on paper: assay
of beta-lactam pharmaceuticals by redox titration. Anal. Methods, 2019, 11,
4741. DOI: 10.1039/c9ay01547g
[7] Chen et al. Cost savings of paper
analytical devices (PADs) to detect substandard and falsified antibiotics:
Kenya case study. Medicine Access @ Point of Care 2021, Volume 5: 1 –11
[8] Eberle et al. Substandard
Cisplatin Found While Screening the Quality of Anticancer Drugs From Addis
Ababa,
Ethiopia. http://ascopubs.org/doi/full/10.1200/JGO.19.00365
[9] Smith et al. Paper Analytic Device
to Detect the Presence of Four Chemotherapy Drugs. J Global Oncology 2018; 4(4): https://ascopubs.org/doi/pdfdirect/10.1200/JGO.18.00198
[10] Luangasanatip et al. (2021)
Implementation of field detection devices for antimalarial quality screening in
Lao PDR—A cost-effectiveness analysis. PLoS Negl Trop Dis 15(9): e0009539.
https://doi.org/10.1371/journal.
[11] Tracy-Lynn et al. idPAD: Paper
Analytical Device for Presumptive Identification of Illicit Drugs. J Forensic
Sciences 2020; 65(4):1289-1297. https://doi.org/10.1111/1556-4029.14318
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