Comparison of Unregistered Medications and Unnotified Cosmetics Confiscated in Rural Versus Urban Areas in the State of Pahang, Malaysia

ABSTRACT

Introduction: The population in Pahang, both in rural and urban areas, has been targeted by irresponsible sellers distributing unregistered medications and unnotified cosmetics. TheCawangan Penguatkuasaan Farmasi Pahang(CPF Pahang) routinely conducts inspections and raids on premises selling such dangerous products. Currently, there is no publication or official study comparing the unregistered medications and unnotified cosmetics confiscated in rural and urban areas in Pahang. Methods: This is a retrospective study on the items of unregistered medications and unnotified cosmetics confiscated by CPF Pahang in 2023 and 2024. Data were obtained from Sistem Data Penguatkuasaan Farmasi (eDPF). All data were further analysed and presented in tables. Results: Pearson’s correlation test revealed a significant correlation between the number and value of confiscated items (r = 0.7, p < 0.05). Unregistered medications containing steroids were the most confiscated items in rural areas (n = 239, 28.5%), while sex stimulants were most common in urban areas (n = 65, 7.5%). The Mann-Whitney test indicated that the value of items confiscated in rural areas was significantly lower than in urban areas (p < 0.05). A significant association was found between Scheduled Poison status and location (p < 0.05), with most Scheduled Poison–containing medications identified in rural areas. Conclusion: These findings highlight the importance of tailored enforcement strategies, with rural areas requiring frequent raids to control widespread distribution, while urban areas need stricter monitoring due to the presence of high-value and high-risk unregistered medications and unnotified cosmetics.

INTRODUCTION

Pharmaceutical and cosmetic products are integral to daily life in Malaysia and play a vital role in public health. Both categories are tightly regulated under the authority of the National Pharmaceutical Regulatory Agency (NPRA) of the Ministry of Health Malaysia. The NPRA administers registration for medicines and notification procedures for cosmetics in accordance with national laws and regulations [1]. These regulatory processes are essential to safeguard consumers by ensuring that products reaching the market meet established standards of safety, quality, and efficacy.

In Malaysia, all medicines must be formally registered, while cosmetics require notification before being marketed [2]. For medicines, applicants are required to provide detailed documentation proving the product’s quality, safety, and efficacy. Cosmetic manufacturers, on the other hand, must submit product details to the NPRA to declare ingredient composition and compliance with regulatory requirements before sale.

Despite these controls, the presence of unregistered medicines and unnotified cosmetics continues to pose a growing concern. These products, which enter the market through informal or illegal channels, bypass regulatory assessments and are thus potentially unsafe for consumers [1]. Enforcement investigations and market surveillance have frequently revealed that such products are adulterated with active pharmaceutical ingredients classified as Scheduled Poisons under Malaysia’s Poisons Act 1952 [3]. The unmonitored use of these substances—such as corticosteroids, antibiotics, antihistamines, and nonsteroidal anti-inflammatory drugs (NSAIDs)—can result in severe health risks, particularly in the absence of medical supervision [4][5].

Similarly, unnotified cosmetics often contain prohibited or restricted substances such as hydroquinone and tretinoin, which can cause adverse dermatological effects, including irritation, photosensitivity, and inflammation. Hydroquinone is banned in over-the-counter cosmetic products, while tretinoin is contraindicated during pregnancy [6]. The continued sale of these unregulated products underscores weaknesses in consumer awareness and enforcement outreach.

The state of Pahang, the largest in Peninsular Malaysia, encompasses both urban and rural regions with distinct demographic and socioeconomic characteristics. The Cawangan Penguatkuasaan Farmasi Pahang (CPF Pahang) is tasked with enforcing pharmaceutical regulations within the state, carrying out inspections and raids against illicit sales of medicines and cosmetics [7]. Although CPF Pahang’s enforcement activities are consistent, limited empirical research has explored how the nature of confiscated products differs between rural and urban settings. Understanding such geographical patterns is crucial for targeted enforcement and educational strategies. Therefore, this study aims to compare the types, values, and toxicological status of unregistered medicines and unnotified cosmetics confiscated in rural and urban areas of Pahang.

METHODOLOGY

This is a retrospective cross-sectional study conducted based on the data stored in Sistem Data Penguatkuasaan Farmasi (eDPF). The eDPF is an integrated database provided by the Bahagian Penguatkuasaan Farmasi, the umbrella agency of pharmacy enforcement under the Ministry of Health Malaysia. This web-based system is only accessible to pharmacy enforcement officers in Malaysia. The CPFs in all states, including Pahang, have a pharmacy enforcement branch responsible for reporting their activities into the system. The data used in this study were obtained from the eDPF, which corresponds to the data submitted by CPF Pahang only.

During raids on premises suspected of selling unregistered medications and/or unnotified cosmetics, suspected products are confiscated by pharmacy enforcement officers. Data on the date of raids, locations, types of products confiscated, number of items confiscated, status and type of Scheduled Poisons for such items, and estimated price of the confiscated items are entered into the system. The status and type of Scheduled Poison for each confiscated item are determined by comparing them with the databases created by the Chemistry Forensic Lab of the Bahagian Penguatkuasaan Farmasi, based on the results of tested medication and cosmetic samples

Figure I shows the study flow diagram for this research. The data were obtained using universal sampling of each item confiscated by CPF Pahang during raids in 2023 and 2024 (n = 1743). From the 1,743 confiscated items, certain items such as documents (n=32) and devices (n=8) were excluded. All relevant data regarding confiscated unregistered medications and unnotified cosmetics, including type of products, location, price, and status and type of Scheduled Poison, were collected, calculated, and analysed to address the objectives of this study.

The number of raids, as well as the number and the value of confiscated unregistered medications and unnotified cosmetics, were compared between 2023 and 2024. The number of raids and confiscated items were expressed as whole number, while the value of these items was expressed in Ringgit Malaysia (RM).

The relationship between the number and the value of confiscated unregistered medications and unnotified cosmeticswas tested using Pearson’s correlation. Mean, standard deviation, R-value, and p-value were reported.

The total number of unregistered medications and unnotified cosmetics confiscated in rural and urban areas from 2023 to 2024, the total number of confiscated items containing Scheduled Poison, and the top three confiscated items containing Scheduled Poisons were tabulated and expressed as whole numbers (n) and percentages (%).

The median value of unregistered medications and unnotified cosmetics confiscated between rural and urban areas was compared using the Mann Whitney’s test. The number of unregistered medications and unnotified cosmetics was expressed as whole numbers (n), while the median and interquartile range were expressed in Ringgit Malaysia (RM), presented with a 95% confidence interval (CI), with a p value < 0.05 accepted as statistically significant. All data were further analysed and presented in tables.

The association of Scheduled Poison status of confiscated unregistered medications and unnotified cosmetics between urban and rural area was tested using the Chi-square test. The number of confiscated unregistered medications and unnotified cosmetics was expressed as whole numbers (n), and the numbers of Non-Scheduled Poison and Scheduled Poison items were expressed as whole numbers and percentages. Chi-square statistics, degree of freedom, and p-values were reported.

This study was registered in the National Medical Research Registry (NMRR ID-25-00432-PIQ).

RESULTS  

Table I shows that the majority of raids conducted by CPF Pahang were carried out in rural areas (2023, n = 50; 2024, n = 44). The number of unregistered medications and unnotified cosmetics confiscated in both areas decreased from 2023 to 2024 (2023, n = 899; 2024, n = 804). However, the total value of unregistered medications and unnotified cosmetics confiscated from raids in urban areas accounted for the majority of the overall value (2023, RM313,020; 2024, RM1,297,442).

Table II shows the relationship between the number and value of confiscated unregistered medications and unnotified cosmetics. There was a positive correlation between the two variables (r = 0.701, n = 1,703, p = 0.0001), indicating a strong relationship. Table III shows that 74.6% of the unregistered medications and unnotified cosmetics confiscated in rural areas during 2023–2024 contained Scheduled Poisons, with steroids being the most common (n = 239, 28.5%). Table IV shows that 28.9% of the unregistered medications and unnotified cosmetics confiscated in urban areas during 2023–2024 contained Scheduled Poisons, with sex stimulants being the most common (n = 65, 7.5%). Table V shows that the value of unregistered medications and unnotified cosmetics confiscated in rural areas (Median = 70.0, IQR = 85) was significantly lower than that in urban areas (Median = 193.5, IQR = 850), Z = –13.658, p = 0.0001. This suggests a tendency for higher-value unregistered medications and unnotified cosmetics to be confiscated in urban areas. Table VI indicates that the prevalence (proportion) of Scheduled Poison status among confiscated unregistered medications and unnotified cosmetics differed significantly between urban and rural areas (p = 0.0001). Therefore, there is a significant association between the Scheduled Poison status of confiscated unregistered medications and unnotified cosmetics and the raid location.

DISCUSSION

The findings of this study demonstrate clear geographical variations in the characteristics and economic value of unregistered medicines and unnotified cosmetics confiscated in Pahang. Although most enforcement raids were conducted in rural areas, the total market value of items seized in urban locations was substantially higher. This pattern suggests that illegal trade networks in urban regions may be more organised and involve products with higher profit margins. Such trends also reflect the increased purchasing power and consumer demand in urban markets.

The majority of raids conducted by CPF Pahang in 2023–2024 occurred in rural areas, reflecting wider distribution networks and easier access within less regulated settings. The higher total value of urban confiscations in 2024 compared to 2023 is consistent with national data [8], which suggests an increase in unregistered medications and unnotified cosmetics sales at the national level. Currently, the prevalence of unregistered medications sold in commercial premises in Malaysia is estimated at 2.95% [9]. In rural areas, the dominance of steroid-containing products highlights the ongoing misuse of steroid-adulterated drugs, a trend that has persisted for the past 20 years [10]. In contrast, sex stimulants were most frequently confiscated in urban areas, reflecting differing consumer demands.

Year	2023	2024
Number of raids, n	90	77
Rural	50	44
Urban	40	33
Number of unregistered medications and unnotified cosmetics confiscated, n	899	804
Rural	462	376
Urban	437	428
Value of unregistered medications and unnotified cosmetics confiscated, RM	364,433	1,328,148
Rural	51,413	30,706
Urban	313,020	1,297,442

Variables	Mean (SD)	r	p-value
Number of unregistered medications and unnotified cosmetics confiscated, n	58.16 (295.70)	0.701	0.0001
Value of unregistered medications and unnotified cosmetics confiscated, RM	993.88 (8897.01)

Description		Number, n	Percentage, %
Total number of unregistered medications and unnotified cosmetics confiscated in rural area from 2023 to 2024		838	100.0
Total number of unregistered medications and unnotified cosmetics confiscated containing Scheduled Poisons		625	74.6
Top 3 unregistered medications and unnotified cosmetics confiscated containing Scheduled Poisons
Steroids		239	28.5
NSAIDs		171	20.4
Antibiotics		87	10.4

	Number (n) and percentage (%)
	n	%
Total number of unregistered medications and unnotified cosmetics confiscated in urban area from 2023 to 2024	865	100.0
Total number of unregistered medications and unnotified cosmetics confiscated containing Scheduled Poisons	250	28.9
Top 3 unregistered medications and unnotified cosmetics confiscated containing Scheduled Poisons
Sex stimulants	65	7.5
Steroids	61	7.1
Skin peeling agents	30	3.5

Variables	Number of unregistered medications and unnotified cosmetics confiscated, n	Median value of unregistered medications & unnotified cosmetics confiscated in RM (IQR)	Odds ratio	p-value
Raid location
Rural	838	70.0 (85.0)	-13.658	0.0001
Urban	865	193.5 (850.0)

Variables	Number of unregistered medications & unnotified cosmetics confiscated, n	Non-Scheduled Poison n (%)	Scheduled Poison n (%)	X2-statistics (df)	p-value
Raid location
Rural	838	213 (25.4)	625 (74.6)	355.5(1)	0.0001
Urban	865	615 (710.0)	250 (29.0)

Several measures are required to reduce the supply and demand of unregistered medications, such as enhancing enforcement efficiency, conducting continuous public awareness campaigns, and predicting shifts in distribution tactics among illegal sellers to tackle these new strategies [1]. The strong positive correlation (r = 0.701, p = 0.0001) between the number and value of confiscations reinforces the link between enforcement volume and the economic magnitude of the illicit trade [3]. Thus, targeting major distributors or warehouses would be more effective   than focusing on smaller confiscations of products containing Scheduled Poisons. Of particular concern is the high percentage of unregistered medications and unnotified cosmetics reaching the public, rather than concentrating efforts on smaller confiscated products. The analysis revealed that 74.6% of rural-area confiscations contained these substances, with steroids being the most frequent adulterant. In contrast, 28.9% of urban-area confiscations contained Scheduled Poisons, mainly sex stimulants. These findings suggest differences in consumer demand and product availability between the two regions [11]. The statistically significant relationship between the presence of Scheduled Poisons and geographical location (p = 0.0001) emphasizes the importance of localized enforcement strategies and targeted health communication [12].

Overall, the results indicate that while rural areas experience higher frequencies of confiscations, urban areas account for a greater proportion of high-value products. These patterns highlight the multifaceted nature of the illegal pharmaceutical and cosmetic trade and support the need for continuous monitoring, consumer education, and stricter market regulation.

This study’s retrospective cross-sectional design inherently limits its ability to infer causality. The research depended on secondary data extracted from the eDPF system, where data quality relies on accurate reporting by enforcement officers [1]. Information such as the origin of the products, supply chain details, or subsequent laboratory validation was not consistently available. Furthermore, the analysis was restricted to the state of Pahang; therefore, the findings may not represent other Malaysian states with different market dynamics and enforcement capacities.

Future studies should expand to include data from multiple states to capture a national overview of the problem. Incorporating laboratory chemical analyses of confiscated items would provide stronger evidence regarding the prevalence and concentration of adulterants, particularly Scheduled Poisons [3]. Additionally, qualitative research exploring consumer motivations, awareness, and purchasing behaviour could help design effective public health interventions [12].

CONCLUSION

In summary, this study provides novel insights into the geographic distribution and characteristics of unregistered medicines and unnotified cosmetics confiscated in Pahang, Malaysia. The results show that urban areas, although fewer in the number of raids, accounted for higher-value seizures, while rural areas had a significantly greater proportion of products containing Scheduled Poisons, particularly steroids. The significant associations between product type, value, and location emphasize the importance of region-specific enforcement and consumer education. Strengthening cross-agency collaboration, maintaining continuous surveillance, and enhancing community awareness are critical to reducing the circulation of hazardous unregulated products in Malaysia.

CONFLICT OF INTEREST

The authors report no conflicts of interest. The authors are responsible for the content and writing of this article.

ACKNOWLEDGEMENT

We would like to thank the Director General of Health Malaysia for his permission to publish this article. We would also like to express our gratitude to the Deputy Pahang State Health Director, Puan Salina binti Setan for her guidance throughout this study.

REFERENCE

1. Zulkifli NW, Aziz NA, Hassan Y, Hassali MA, Bahrin NLZ. The unregistered drugs coverage in the media in Malaysia: Content analysis of the public newspapers. Res Pharm Health Sci. 2016; 3(3):196–200. https://doi.org/10.32463/rphs.2016.v02i03.38
2. Ministry of Health Malaysia. Pharmaceutical Services Programme. Control of Drugs and Cosmetics Regulations 1984 [Updated 2023 Oct 24]. Available from: https://pharmacy.moh.gov.my/sites/default/files/document-upload/control-drugs-and-cosmetics-regulations-1984_1.pdf
3. Lim LP, Bin Abdul Aziz MF. The issues and challenges of addressing the importation of unregistered pharmaceutical products in Malaysia. J Pharm Policy Pract. 2025; 18(1). https://doi.org/10.1080/20523211.2025.2523939
4. Ministry of Health Malaysia. Consumers cautioned against using cosmetic product containing scheduled poison. Pharmaceutical Services Division; 2014 Jul 9. Available from: https://pharmacy.moh.gov.my/en/news/09-jul-2014/consumers-cautioned-against-using-cosmetic-product-containing-scheduled-poison.html
5. The Star. 14 cosmetic products found to contain poison. The Star [Internet]. 2018 Oct 9. Available from: https://www.thestar.com.my/news/nation/2018/10/09/14-cosmetic-products-found-to-contain-poison
6. National Pharmaceutical Regulatory Agency (NPRA). Products containing hydroquinone. Berita Ubat-Ubatan. 2014 Dec. Available from: https://www.npra.gov.my/images/Publications/Newsletter_Berita_Ubat-ubatan/2014/BUU-Dis2014Final.pdf
7. Ministry of Health Malaysia. Pharmacy Enforcement Division – Pharmaceutical Services Programme. 2022 Jan [Accessed 2024 Jan]. Available from: https://pharmacy.moh.gov.my/en/content/pharmacy-enforcement-division.html
8. Malay Mail. Health Ministry warns of surge in online sales of illegal medicines after seizing RM37.5m worth in 2024. Malay Mail [Internet]. 2025 May 3. Available from: https://www.malaymail.com/news/malaysia/2025/05/03/health-ministry-warns-of-surge-in-online-sales-of-illegal-medicines-after-seizing-rm375m-worth-in-2024/175483
9. Abdul Karim KA, Ahmad AE, Abdullah MZ, Alias A, Setan S, Sulaiman MA. Estimated prevalence of unregistered and falsified medicinal products in Malaysia: a nationwide cross-sectional study conducted from March to November 2023. J Pharm Policy Pract. 2025; 18(1):2557879. https://doi.org/10.1080/20523211.2025.2557879
10. Ismail Z, Mohamed R, Mohd Hassan MH, Wan Su K. Usage of traditional medicines among elderly and the prevalence of prednisolone contamination. Malays J Med Sci. 2005; 12(2):50-5. https://pmc.ncbi.nlm.nih.gov/articles/PMC3349401/
11. Nawi HM, Arifin MA, Hassan MR, Nawi AM, Idris I. Knowledge, attitude and practice of unregistered medicines among patients with chronic disease at urban health clinic, Kelantan, Malaysia. Glob J Public Health Med. 2020; 2(2):235–244. https://doi.org/10.37557/gjphm.v2i2.67
12. Ong SC. Perspectives of the public on the consumption of unregistered health products in Malaysia. Int J Pharm Pract. 2020; 28(6):579–590. https://doi.org/10.1111/ijpp.12673