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Journal of Pharmaceutical Policy and Practice logoLink to Journal of Pharmaceutical Policy and Practice
. 2025 Sep 24;18(1):2557879. doi: 10.1080/20523211.2025.2557879

Estimated prevalence of unregistered and falsified medicinal products in Malaysia: a nationwide cross-sectional study conducted from March to November 2023

Khairul Anuar Abdul Karim a,CONTACT, Asyraf Elmiza Ahmad a, Mohd Zawawi Abdullah a, Asniza Alias a, Salina Setan b, Manzatul Azrul Azrie Sulaiman a, Nor Ilham ‘Ainaa Muhsin c
PMCID: PMC12462413  PMID: 41020171

ABSTRACT

Background

The global proliferation of unregistered and falsified medicinal products poses significant public health risks. In Malaysia, previous studies have shown concerning prevalence rates but are often limited to specific populations and targeted product brands, restricting the generalisability of the findings. This study aimed to determine the prevalence of unregistered and falsified medicinal products in Malaysian community pharmacies, General Practitioner (GP) clinics, and commercial premises, and to identify associated factors.

Methods

A cross-sectional study was conducted in Malaysia from March to November 2023. Medicinal products were sampled from community pharmacies, GP clinics, and commercial premises. Premises were selected using proportionate stratified random sampling and products within premises using convenience sampling. The MAL registration number and hologram on these products were analysed for registration status and authenticity. Data were analysed using descriptive and non-parametric tests (SPSS v.29), with p < 0.05 considered statistically significant.

Results

An examination of 27,137 samples from 1688 premises across Malaysia identified 270 unregistered and 30 falsified products. The prevalence of unregistered products was 0.11% in community pharmacies, 0.18% in GP clinics, and 2.95% in commercial premises. Falsified products were absent in community pharmacies and GP clinics but constituted 0.36% in commercial premises. Logistic regression revealed that region and premise category were significantly associated with the presence of unregistered and falsified products.

Conclusion

Unregistered and/or falsified medicines were present in all premise types, with higher prevalence in commercial premises. Enhanced efforts by enforcement authorities and stakeholders are necessary to improve the quality of medicine in Malaysia.

KEYWORDS: Prevalence, unregistered, falsified, medicinal products, Malaysia

Background

Substandard, unregistered, and falsified medicinal products pose a serious threat to public safety and health, have negative consequences for the nation's economy, and impact the overall healthcare system (Buckley & Gostin, 2013; Pisani, 2017; Rahman et al., 2018). The World Health Organization (WHO) defines substandard medicinal products as those that do not conform to the established quality standards or specifications. Falsified medicinal products are deliberately and fraudulently mislabelled in terms of their identity, composition, or source with the intent to deceive consumers. Such products have been reported to contain no active ingredients, incorrect formulations and excipients, and different or harmful ingredients. Unregistered medicinal products refer to those without regulatory approval for manufacturing, distribution, or sale within their respective region or country from the national or regional regulatory authorities (NRRA) (World Health Organization, 2017b). While all three categories are public health concerns, this study focuses only on unregistered and falsified products. Substandard products require laboratory or chemical analysis to detect quality defects, which was beyond the scope of this authentication-based study.

Globally, the prevalence of substandard, unregistered, and falsified medicinal products has been reported to be 10.5%. The situation is particularly alarming in low- and middle-income countries, where the prevalence has been reported to reach as high as 13% (Pisani, 2017). These issues are driven by multiple factors, including complex supply chains (Gomasta et al., 2023), limited regulatory resources, and weak regulatory frameworks (Glass, 2014). Medicinal product supply chains involve multiple stakeholders, including manufacturers, suppliers, distributors, wholesalers, and intermediaries. These multiple layers create loopholes that can be exploited to introduce substandard, unregistered, and falsified medicinal products into the market (Gomasta et al., 2023). Furthermore, regulatory and enforcement bodies in low- and middle-income countries face various challenges since many operate with limited budgets, insufficient human resources, and outdated technologies. This limitation hinders these agencies from conducting effective routine inspections, post-market surveillance, and product testing, as well as enforcing laws and regulations (Glass, 2014). The emergence of e-commerce has further exacerbated the problem by allowing sellers to distribute products without the need for a physical store (Clark, 2015). Collectively, these factors create significant challenges for regulatory and enforcement agencies in ensuring the safety, quality and efficacy of medicinal products.

The presence of substandard, unregistered, and falsified medicinal products in the market can have disastrous effects on individuals, particularly in terms of patient safety (World Health Organization, 2017a). Individuals exposed to these products may experience treatment failure, serious side effects, or, in the worst cases, death (Fantasia & Vooys, 2018). For example, the use of such products for the treatment of life-threatening diseases like malaria (Karunamoorthi, 2014), tuberculosis (Akpobolokemi et al., 2022), and HIV/AIDS (Ware et al., 2023) has contributed to drug resistance, making infections harder to treat and leading to treatment failure (Johnston & Holt, 2014). In addition, these products may contain harmful ingredients, incorrect dosages, or ineffective formulations as they have not undergone the necessary safety, efficacy, and quality checks. This lack of regulatory oversight leads to poor health outcomes and failed treatments (Buckley & Gostin, 2013; Nyika et al., 2022).

Beyond health risks, the circulation of substandard, unregistered, and falsified medicinal products imposes an economic burden on both individuals and healthcare systems (Blackstone et al., 2014; Ozawa et al., 2018). Patients who consume such products often require additional medical interventions including repeated treatment procedures, longer hospital stays, or additional procedures. This has contributed to higher medical costs for individuals (Newton et al., 2010). Moreover, public health programmes aimed at controlling diseases can be undermined by the widespread presence of these products, partly due to an erosion of public trust in the healthcare system, making achieving the programmes' goals and objectives harder (Lima & Yonamine, 2023). When individuals lose confidence in the healthcare system, they may hesitate to seek treatment or purchase needed medicine causing delays in treatment (Salami et al., 2023), or may not adhere to the treatment due to uncertainty about the medicine's effectiveness (te Paske et al., 2023).

As a middle-income country in Southeast Asia, Malaysia faces its own challenges in combating substandard, unregistered, and falsified medicinal products (Zulkifli et al., 2016). Medicinal products in Malaysia can be obtained from licensed premises, such as General Practitioner (GP) clinics or community pharmacies, and commercial premises, such as convenience stores, shopping malls, beauty shops, and others. The latter, however, only permitted to sell other than controlled medicinal products. Allowing such a diverse range of premises to sell medicinal products opens the gate for substandard, unregistered, and falsified medicinal products to enter the Malaysian market (Zulkifli et al., 2016).

To address this, Malaysia has implemented a product registration to ensure that only safe and approved medicinal products are available for sale. All medicinal products that enter the Malaysian market must be registered with the Ministry of Health (MOH) Malaysia. Upon registration, a unique Malaysia Registration number (MAL number) is assigned to each product. In addition to the MAL number, each registered medicinal product must be affixed with a security label called the Farmatag® (Ministry of Health Malaysia, 2024). These requirements give assurance to the public that the medicine's safety, quality, and effectiveness have been evaluated thoroughly before it enters the market. Additionally, these features allow customers to verify product authenticity, thereby reducing the risk of exposure to substandard, falsified or unregistered medicinal products (El-Jardali et al., 2015).

Despite these regulatory mechanisms and proactive enforcement activities by the MOH, substandard, unregistered, and falsified medicinal products continue to penetrate the Malaysian market. The Emerging Markets Network (EMHN) reported in 2013 that 5% of the medicines in Malaysia were counterfeit (Stevens & Mydin, 2013). However, this figure was based on the data collected between 2005 and 2013 and may not reflect the current situation. Furthermore, that report did not assess the prevalence of unregistered and falsified medicinal products in licensed premises like community pharmacies and GP clinics. These licensed premises are among the biggest players for medicinal products in Malaysia and are often patients' first point of contact for treatment and medicines. Without the prevalence data for such products in these settings, it is difficult to fully understand the extent of the problem and develop targeted interventions to address it effectively.

In light of these concerns, this study aims to address the gap by examining the prevalence of unregistered and falsified medicinal products and identifying the factors associated with their availability in community pharmacies, GP clinics and commercial premises across Malaysia. Substandard products were excluded from this study, as their detection requires laboratory-based quality analysis, whereas our methodology was limited to authentication checks using the MAL number and Farmatag® verification. The findings of this study provide baseline data and valuable insight into the current situation, which can help shape future policy decisions to improve the quality, safety, and effectiveness of medicinal products in Malaysia.

Method

This study adopted and adapted the procedures outlined in the WHO document titled Annex 7: Guidelines on the Conduct of Surveys of the Quality of Medicines (World Health Organization, 2016). It was tailored to the Malaysian context, including selecting sites, premises, medicines, sampling, and analysis procedures.

Study design and period

This was nationwide cross-sectional study conducted in Malaysia from March to November 2023, involving private premises including community pharmacies, GP clinics and commercial premises.

Selection of sites and premises

The study covered all thirteen (13) states and two (2) federal territories in Malaysia. The study focused on three types of private sector premises: community pharmacies, GP clinics, and commercial premises such as beauty shops, convenience stores and, and minimarkets. Public healthcare facilities were excluded because medicine procurement in the public sector is centrally managed and strictly regulated by the MOH through formal contracts and approved concession suppliers, which significantly prevents the presence of unregistered or falsified products in public sector. Premises were selected using a multistage stratified random sampling technique. The first stratum stratified Malaysian data into states and federal territories, and the second stratum further stratified these states into districts. Following stratification, a simple random sampling technique was applied to select specific premises within the identified districts.

Inclusion and exclusion criteria

The Inclusion criteria encompassed community pharmacies licensed under the Poisons Act 1952 in 2022, GP clinics registered under the Private Healthcare Facilities and Services Act 1998 in 2022, and commercial premises licensed by local authorities as of 2022. The exclusion criteria included wholesale pharmacies, community pharmacies, GP clinics, commercial premises not operational during the data collection period, and businesses without a permanent physical location, such as kiosks, carts, or flea markets.

Selection of medicines

Convenience sampling was used to select medicines encompassing controlled medicines, supplements, OTC, and traditional products. At each selected premise, Pharmacy Enforcement Officers aimed to collect at least five (5) different products from each category, where available. A minimum of twenty (20) products were sampled from each community pharmacy and GP clinic, and ten (10) products from each commercial premises. Selection was based on products that were accessible and visibly displayed on shelves or counters. No specific brands were pre-targeted, and selections were made to reflect a broad cross-section of what was publicly offered at the time of visit. if a selected premise did not have the required number of products, an alternate premise was recruited to meet the sampling quota.

Sample collection

Sample collection was conducted from March to November 2023 by State Pharmacy Enforcement Officers. Sampling was conducted overtly with Pharmacy Enforcement Officers identifying themselves and recording products in the presence of premise staff. No prior notice was given to ensure that the products available at the time of visit reflected typical operational condition. All sampling personnel were trained in sampling procedures, including selecting medicines and completing the forms. For each visited premise, the recorded data included premise category (community pharmacy, GP clinic, or commercial premise), region (north, central, south, east, and Borneo), type of premises (chain or independent), location (urban or rural), and years of operation. For each medicinal product sampled, the recorded data included product's name, indication, category, MAL registration number (if present), and the status of the security hologram label. The data were recorded and organised in pre-developed Google forms and sheets that link to MOH's Google account to ensure their security.

Sample size calculations

The required sample size for premises was determined using the formula and table published in a study entitled Determining Sample Size for Research Activities (Krejcie & Morgan, 1970). Given that in 2023 Malaysia had approximately 4083 community pharmacies, 8344 GP clinics, and over 20,000 commercial premises in 2023, the minimum sample sizes for CP, GP clinics, and commercial premises were 420, 440, and 459, respectively, with a 20% dropout rate.

Analysis of samples

The registration and authenticity status of each medicinal product were assessed based on the presence of a valid MAL registration number and an authentic Farmatag® hologram sticker. Each product's MAL registration number was verified using the NPRA's QUEST3+ online database, and the authenticity of the Farmatag® hologram was verified using an enterprise resource planning (ERP) system provided by Techno Secure Print Sdn. Bhd. A product was classified as unregistered if it did not have a MAL number or hologram on its packaging, or if the printed MAL number did not exist in the QUEST3+ system. A product was classified as falsified if its packaging mimicked that of a legitimate product and it carried a valid MAL registration number but had a counterfeit (non-authentic) hologram.

Data analysis

Data were entered into Microsoft Excel and IBM Statistical Package for the Social Sciences (SPSS) for Windows, version 29 (IBM Corp., Armonk, N.Y., USA). Logistic regression was used to examine associations between the presence of unregistered or falsified products and various factors (such as premise category, region, etc.). A p-value < 0.05 was considered statistically significant.

Results

Samples description

A total of 27,137 medicinal products were examined in this study, collected from 421 community pharmacies, 396 general practitioner (GP) clinics, and 871 commercial premises across Malaysia. Specifically, 9995 products were sampled from community pharmacies, 8916 from GP clinics, and 8226 from commercial premises. The distribution of samples by product category and geographical region is presented in Table 1.

Table 1.

Distribution of inspected, unregistered, and falsified medicinal products across community pharmacies, GP clinics, and commercial premises by product category and region (n = 27,137).

Category Variables Community Pharmacies GP Clinics Commercial Premises
    Total inspected medicinal products
Total Inspected 9995 8916 8226
Product Category Poison 5811 6881 46
Non-poison 4184 2035 8180
Region Borneo 1900 740 1413
Central 4111 5015 3256
East 1097 953 834
North 1453 1064 1467
South 1434 1144 1256
    Unregistered Medicinal Products
Total Unregistered 11 (0.11%) 16 (0.18%) 243 (2.95%)
Product Category Poison 7 (63.64%) 10 (62.50%) 33 (13.58%)
Non-poison 4 (36.36%) 6 (37.50%) 210 (86.42%)
Region Borneo 0 0 3 (1.23%)
Central 2 (18.19%) 9 (56.25%) 69 (28.40%)
East 0 0 27 (11.11%)
North 1 (9.09%) 3 (18.75%) 72 (29.63%)
South 8 (72.72%) 4 (25%) 71 (29.22%)
    Falsified Medicinal Products
Total Falsified 0 0 30 (0.36%)
Product Category Poison 0 0 0
Non-poison 0 0 30 (100%)
Region Borneo 0 0 0
Central 0 0 8 (26.67%)
East 0 0 4 (13.33%)
North 0 0 12 (40%)
South 0 0 6 (20%)
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Note: Percentages represent the distribution within each subgroup for each premise type. Non-poison refers to product that do not contain any substances listed in the First Schedule under the Poisons Act 1952 (Malaysia) such as OTC, supplements or traditional medicines.

Prevalence of unregistered medicinal products

The prevalence of unregistered medicinal products was highest in commercial premises at 2.95% (n = 243), followed by GP clinics at 0.18% (n = 16) and community pharmacies at 0.11% (n = 11). In community pharmacies and GP clinics, 63.64% and 62.5% of the unregistered products, respectively, were classified as poisons. In contrast, most unregistered products in commercial premises (86.42%) were non-poisons. Further details on the prevalence and distribution of unregistered products are presented in Table 1.

Prevalence of falsified medicinal products

No falsified medicinal products were detected in community pharmacies or GP clinics. However, falsified products accounted for 0.36% (n = 30) of the products examined in commercial premises, and all were classified as non-poisons. Regionally, the highest proportion of falsified products was reported in the North (40%), followed by the Central region (26.67%), the South (20%), and the East (13.33%). No falsified products were reported in Borneo. Detailed findings are presented in Table 1.

MAL registration number and hologram analysis

Analysis of 270 unregistered medicinal products identified that the most common issue was the absence of both a hologram and a MAL registration number (n = 124). Other issues included non-authentic holograms and invalid or mismatched MAL registration number. All falsified products (n = 30) had valid MAL registration number listed in the QUEST3+ database but displayed non-authentic holograms, which confirming their falsified status. A comprehensive breakdown of the authentication findings is provided in Table 2.

Table 2.

Analysis of MAL registration number and security label Farmatag® of unregistered and falsified medicinal products (n = 270).

MAL registration number status Security label Farmatag® status Unregistered products (n = 270) Falsified products (n = 30)
Verified in Quest3+ Non-authentic 0 30
Missing hologram 5 0
Not found in Quest3+ Genuine 39 0
Non-authentic 30 0
Missing hologram 51 0
Registered to other manufacturers 2 0
Verification uncertain 5 0
Registered under other products Genuine 2 0
MAL No. Missing Non-authentic 11 0
Missing hologram 124 0
Registered to other manufacturers 1 0
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Product indication analysis

External applications accounted for the largest proportion of unregistered medicinal products, representing 38.15% (n = 103), followed by herbal supplements and traditional products at 29.26% (n = 79), and fever, anti-inflammatory, or anti-rheumatic products at 10.37% (n = 28). These three categories constituted more than 77% of all unregistered products. A similar pattern was observed in falsified products, with external applications comprising 50% (n = 15) and fever, anti-inflammatory, or anti-rheumatic products accounting for 26.67% (n = 8). Further breakdowns by indication category are presented in Table 3.

Table 3.

Analysis of product indication among unregistered and falsified medicinal products.

Indication Unregistered products (n = 270) Falsified products (n = 30)
External Application 103 (38.15%) 15 (50%)
Herbal Supplements and Traditional Products 79 (29.26%) 3 (10%)
Fever/Anti-Inflammatory/Anti-Rheumatic 28 (10.37%) 8 (26.67%)
Cough/Cold/Allergy 14 (5.19%) 0
Women’s Health 9 (3.33%) 0
General Health 6 (2.22%) 1 (3.335)
Sexual Stimulants/Erectile Dysfunction 7 (2.59%) 0
Eye Drops/Ear Drops 3 (1.11%) 3 (10%)
Weight Loss Medications 5 (1.85%) 0
Antidiabetics 4 (1.48%) 0
Antibiotics 4 (1.48%) 0
Gastrointestinal Agents 3 (1.11%) 0
Muscle/Nerve Agents 2 (0.74%) 0
Cardiovascular 2 (0.74%) 0
Renal Medications 1 (0.37%) 0
Respiratory 1 (0.37%) 0
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Note: Percentages represent the proportion within each product category (unregistered or falsified).

Premises and factor analysis

Commercial premises accounted for the highest proportion of sites with unregistered or falsified medicinal products (11.83%, n = 103), followed by GP clinics (2.78%, n = 11) and community pharmacies (1.66%, n = 7). Logistic regression analysis showed that commercial premises were significantly more likely to contain unregistered or falsified products compared to community pharmacies (Exp(B) = 7.395, p < 0.001). Regional differences were also significant, with premises located in the Central (Exp(B) = 7.735, p = 0.001), East (Exp(B) = 11.419, p < 0.001), North (Exp(B) = 15.537, p < 0.001), and South (Exp(B) = 20.034, p < 0.001) regions having higher odds compared to those in Borneo. No significant associations were found for premise location (urban vs. rural), premise type (chain vs. independent), or operation period (p = 0.446, p = 0.203, and p = 0.423, respectively). Detailed figures are presented in Tables 4 and 5.

Table 4.

Prevalence of inspected community pharmacy, GP clinic and commercial premises with unregistered and falsified medicinal products.

Category Variables Community pharmacy GP clinic Commercial premises
Total Inspected Premises Total Count 421 396 871
With Unregistered/Falsified 7 (1.66%) 11 (2.78%) 103 (11.83%)
Area Urban 7 (100%) 8 (72.73%) 84 (81.55%)
Rural 0 3 (27.27%) 19 (18.45%)
Region Borneo 0 0 3 (2.91%)
Central 2 (28.57%) 6 (54.55%) 31 (30.1%)
East 0 0 17 (16.5%)
North 1 (14.29%) 1 (9.09%) 29 (28.16%)
South 4 (57.14%) 4 (36.36%) 23 (22.33%)
Premise Type Chain 5 (71.43%) 4 (36.36%) 22 (21.36%)
Independent 2 (28.57%) 7 (63.54%) 81 (78.64%)
Operation Period Year (Mean ± SD) 2.67 ± 1.51 12.80 ± 9.45 10.38 ± 12.32
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Note: Percentages represent the distribution within each subgroup for each premise type.

Table 5.

Logistic regression analysis of predictiors (region, premises category, location, premises type, and operation period) on the presence of unregistered or Falsifief products in premises.

Predictor B S.E. Wald df Sig. Exp(B) 95% C.I for EXP (B)
Lower Upper
Premises Category (Reference: Community Pharmacies)     44.972 2 <.001      
 GP Clinics 0.385 0.496 0.603 1 0.437 1.47 0.556 3.886
 Commercial premises 2.001 0.403 24.605 1 <.001 7.395 3.354 16.304
Premise Type (Reference: Chain) 0.294 0.231 1.621 1 0.203 1.342 0.853 2.111
Region (Reference: Borneo)     32.689 4 <.001      
 Central 2.046 0.608 11.336 1 <.001 7.735 2.351 25.447
 East 2.435 0.644 14.293 1 <.001 11.419 3.231 40.36
 North 2.743 0.617 19.784 1 <.001 15.537 4.639 52.04
 South 2.997 0.618 23.507 1 <.001 20.034 5.964 67.301
Location (Reference: Rural) −0.214 0.281 0.581 1 0.446 0.807 0.466 1.399
Operation Period −0.008 0.009 0.641 1 0.423 0.992 0.974 1.011
Constant −6.2 0.741 70.106 1 <.001 0.002    
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Discussion

The authenticity status of a medicinal product is a critical issue with significant implications for individual health and the nation's healthcare systems (Pisani, 2017). In response to this concern, the present study provides a nationwide assessment of the prevalence of unregistered medicinal products in Malaysia, focusing on the private sectors, including community pharmacies, GP clinics and commercial premises. An overall prevalence of 0.11% to 2.95% was identified based on product authentication using regulatory registration (MAL number) and security labels (Farmatag®) verification. This assessment focused solely on regulatory non-compliance rather than chemical testing, and offers a practical baseline to inform targeted enforcement and strengthen regulatory oversight.

This relatively low prevalence reflects the impact of several strategic measures implemented by Malaysian authorities to curb the circulation of unregistered and falsified medicinal products. These measures include a robust regulatory framework, strict enforcement activities, stakeholder collaboration, and continuous public education initiatives (Zulkifli et al., 2016). A key element of Malaysia's proactive approach is the requirement that all medicinal products must be registered before entering the market. Each registered product must carry a unique MAL number and be affixed with a Farmatag® hologram security label (Ministry of Health Malaysia, 2024). These elements are strictly regulated in which the MAL number is issued only after rigorous assessment by the NPRA, and Farmatag® labels can only be purchased by authorised importers or manufacturers. These dual-layer control mechanisms and requirements have effectively reduced the prevalence of unregistered and falsified medicinal products in the Malaysian market (El-Jardali et al., 2015; Enyinda & Tolliver, 2009).

In addition to regulatory requirements, proactive enforcement activities play a significant role in controlling unregistered and falsified products (Buckley & Gostin, 2013). The Pharmacy Enforcement Division (PED) under the MOH leads these efforts through the licensing control, intelligence and operation activities, random product sampling, and targeted enforcement actions to ensure compliance with the existing law (Pharmacy Enforcement Division, n.d.). This visible enforcement presence acts as a deterrent and discourages businesses from selling unregistered or falsified medicinal products (Johnson, 2019).

These efforts are further strengthened through continuous collaboration with key stakeholders, as well as consumer education initiatives. Collaboration and engagement between regulatory bodies and manufacturers, distributors, wholesalers, and retailers help ensure compliance at every step of the supply chain, which reduces the likelihood of unregistered or falsified medicinal products entering the market (Wilson, 2017). In addition, the Pharmaceutical Services Program (PSP)'s consumer education initiatives, such as the ‘Know Your Medicine’ Campaign and ‘Say No To Illegal Medicines’ Campaign, raise awareness about the risks of unregistered or falsified medicinal products and emphasise the importance of checking for the MAL registration number and Farmatag® hologram. Through these initiatives, consumers are empowered to self-verify their medicines and report any unregistered and falsified medicinal products found in the market (Abdoulaye et al., 2006).

Despite these successes, unregistered or falsified medicinal products remain prevalent in commercial premises, highlighting the vulnerability of these settings. Various factors may contribute to this issue, including gaps in supply chain integrity, differences in professional knowledge, and consumer behaviours. The complexity of the medicinal product supply chain provides opportunities for illicit products to infiltrate the market particularly through less-regulated distribution channels (Lei et al., 2023). Retailers in commercial premises may choose between a reliable but expensive supplier or a risky supplier that offers lower prices (Kumar et al., 2018). Opting for the latter practice can make them more susceptible to unregistered and falsified medicinal products. Another contributing factor is the limited staff knowledge. Staff in Licensed premises are typically trained pharmacists or healthcare professionals who are familiar with regulatory and verification tools such as the NPRA's Quest 3+ system and Farmachecker apps (Ferrario et al., 2019). In contrast, retailers in many commercial premises lack this knowledge and unfamiliar with how to verify product authenticity (Ong et al., 2020). As a result, they may unknowingly stock and sell such products.

Consumer behaviour also contributes to this problem. Consumers often seek affordable alternatives to high-cost medications and commercial premises cater to this demand by offering cheaper alternatives regardless of their authenticity or registration status (Ofori-Parku & Park, 2022). Furthermore, medicines in commercial premises are often displayed alongside non-health products, which can lead consumers to assume that all available products are legitimate. This false sense of security further contributes to the circulation of unregistered and falsified medicinal products.

The MAL registration number and Farmatag® hologram are essential components of regulatory compliance in Malaysia and serve as key tools for products' authentication by both authorities and consumers. However, the presence of unregistered and falsified products in the market indicates some challenges with these features. Most of the unregistered medicinal products found lack both of MAL number and Farmatag® hologram. The continued sale of these products suggests that the general's knowledge of this requirement remains limited, as many sellers do not realise that a product missing these features is likely unregistered. This highlights the need for continued public education to strengthen seller vigilance and awareness. In addition, counterfeiters nowadays have become increasingly skilful at replicating the MAL number, packaging and Farmatag® hologram closely resembles the original ones. This poses a significant challenge for consumers and retailers, particularly those without access to verification tools or training. The problem is further exacerbated in commercial premises, where staff often lack the necessary background to identify counterfeit security labels, allowing falsified products to circulate undetected (Bakker-’t Hart et al., 2021).

This study also found that the majority of unregistered and falsified medicinal products fall under specific therapeutic categories, including external applications, herbal supplements, and fever or anti-inflammatory medications. This pattern may be influenced by consumer preferences and the demand for accessible treatment options. Malaysians often perceive natural or alternative remedies as safer than conventional medicines, contributing to the popularity of herbal and traditional products (Ismail et al., 2020). Moreover, consumers seeking immediate relief from common ailments such as fever or colds may opt for cheaper OTC products sold at commercial outlets (Ofori-Parku & Park, 2022). These consumer behaviours create opportunities for illicit supply chain to exploit demand and allow such products to gain market traction (Mussanova, 2021).

The premise-specific analysis revealed significant differences in the prevalence of unregistered and falsified medicinal products across premise type. The commercial premises are significantly more likely to carry unregistered or falsified products compared to licensed premises, highlighting the increased risk associated with these retail environments. These findings support the need for a targeted approach and directing additional enforcement activities to commercial premise sectors.

This study has several limitations. Firstly, it did not include online retailers, which are becoming increasingly common sources of unregistered and falsified medicines. Excluding of this sector may limit the study's ability to capture the fully capture consumer exposure to unregistered or falsified medicinal products. Additionally, the study's focus solely on permanent premises, excluding the temporary or mobile vendors that are often linked to the sale of unregistered and falsified medicinal products. Their exclusion may lead to an underestimation of the overall prevalence and accessibility of such products in Malaysian market (Bakker-’t Hart et al., 2021; Ziavrou et al., 2022). Additionally, although a multistage stratified random sampling design was employed to enhance representativeness across regions and premise types, the statistical analysis did not incorporate sampling weights or account for complex survey design. This may limit the precision of population-level inferences derived from the logistic regression results.

To address these gaps, future studies should expand to include digital platforms and informal sellers where unregistered and falsified medicinal products are increasingly accessible. Additionally, future research could incorporate premise-level analysis to better understand whether specific premise types or supply chains are associated with higher concentrations of such products. Strengthened public awareness campaigns that emphasise the importance of the MAL number and Farmatag®, could empower consumers to make safer and informed choices. Finally, increasing inspection resources in high-prevalence sectors and exploring partnerships with private companies could further support national efforts to reduce the circulation of unregistered and falsified medicines and enhance public safety.

Conclusion

This study found that the prevalence of unregistered and falsified medicinal products in Malaysia is lower than global estimates but significantly higher in commercial premises compared to community pharmacies and GP clinics. These findings highlight the effectiveness of regulatory controls in licensed settings and the need for targeted interventions in more vulnerable retail environments. Strengthening enforcement, public awareness, and supply chain oversight remains essential to further reduce the circulation of such products and protect public health.

Acknowledgements

The authors would like to express their sincere appreciation to the Director General of Health Malaysia for his permission to publish this study. We also extend our gratitude to all Pharmacy Enforcement Officers nationwide for their invaluable contributions throughout the data collection and implementation phases of this study. Their dedication and support were instrumental in making this research possible.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Ethical consideration

This study's protocol was approved by the Medical Research and Ethics Committee (MREC), MOH and was granted an exemption as the study did not involve any human subjects or intervention on human subjects (NMRR ID-23-02635-KOG).

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