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. 2025 Oct 23;18(1):2574651. doi: 10.1080/20523211.2025.2574651

The safety of herbal medicines in low- and middle-income countries (LMICs): current landscape and promoting the pharmacovigilance practices

Muhammad Akhtar Abbas Khan a,b,CONTACT, Madiha Khalid c,d, Obaidullah Malik b
PMCID: PMC12551009  PMID: 41142770

ABSTRACT

About eighty-eight percent of people worldwide rely on traditional and complementary medicine for their primary healthcare needs, with many pharmacies in developed countries offering plant-based over-the-counter medications. However, the increasing use of medicinal products, especially when combined with pharmaceuticals, poses health risks that are often underreported, particularly in low- and middle-income countries. Before 2012, Pakistan had no specific laws or regulatory bodies to oversee the manufacturing of herbal and alternative medicines. The establishment of the Drug Regulatory Authority of Pakistan (DRAP) in 2012 marked the beginning of regulatory oversight for herbal medicines for licensing, enlistment and Pharmacovigilance (PV). In 2015, DRAP created a national pharmacovigilance centre, and by 2018, it became a full member of the WHO's Program for International Drug Monitoring (PIDM). The Pharmacovigilance Rules of 2022 require all therapeutic product manufacturers to report adverse drug reactions (ADRs) and mandate the submission of Periodic Benefit Risk Evaluation Reports (PBRER) for various drugs. However, there are provisions allowing for PBRER submission waivers in certain cases. While Pakistan's pharmacovigilance system currently focuses on pharmaceutical and biological medicines, there is a pressing need to expand its scope to include herbal and traditional products. Strengthening the system involves setting robust quality and safety standards, conducting scientific research, regulating manufacturing practices, and ensuring proper labelling of herbal medications.

KEYWORDS: Pharmacovigilance, adverse drug reactions, herbal medicines, OTC drugs, LMICs, medicine safety

1. Introduction

The natural origins and potential health benefits of herbal medicines have led to their tremendous rise in popularity in recent times. The rising acceptance of plant-based diets and lifestyles is another element driving the market expansion of herbal medicines. About 88% of people worldwide admit to using traditional and complementary medicine and depending on it for their basic healthcare needs, for instance, a large number of developed countries now sell over-the-counter medications made from plants in their pharmacies (Bareetseng, 2022; Ekor, 2014; Ng et al., 2022; Toklu, 2016; World Health Organization, 2019).

The growing population's interest in herbal remedies, its purported health benefits, and consumers’ perceptions that they are safer (Sethi et al., 2025; Skalli et al., 2022) and more affordable than allopathic treatments have all contributed to the growth of the herbal medicine market globally all through ages. During COVID-19 in Qatar, 51.7% of the population reported using herbal medicines, with women showing a higher rate of use (Alsheikh et al., 2025). The biggest market for herbal products is found in the United States of America (USA), with Europe, Australia, and Canada following closely behind. More than 25% of prescription medications in the USA alone contain active ingredients derived from plants. According to a 2017 market research analysis, the global market for herbal products is expected to grow at a Compound Annual Growth Rate of 6.5% to reach USD 104.78 billion by 2026. According to Fortune Business Insights, the industry is projected to be worth USD 216.40 billion in 2023 and is expected to grow to USD 437 billion by 2032 (Bareetseng, 2022; Fortune Business Insights, 2024).

There is a health risk associated with the growing use of medicinal products, particularly when combined with allopathic medicines (González-Trujano et al., 2024). This risk is underreported, particularly in developing countries. Most documented adverse events related to the use of herbal drugs can be attributed directly to either improper usage or poor-quality products. A recent study in Singapore’s Traditional Chinese Medicine clinics found that patients using Chinese herbal medicine together with Western prescription medicines had a significantly higher likelihood of reporting adverse events than herbal use alone (Ng et al., 2024). Through Pharmacovigilance, essential medications are ensured to be available on the market, reducing the burden of adverse drug reactions, and promoting public health (Khan et al., 2024). Even though many countries lack pharmacovigilance mechanisms for monitoring herbal medicines, the World Health Organization (WHO) collaborating Centre for International Drug Monitoring (PIDM) in Uppsala has been compiling reports of adverse events involving herbal medicines globally (WHO, 2021). Approximately 128,000 reports, or 0.6% of all VigiBase reports, containing herbal medicines from 1968 to 2019 were found to have at least one herbal ingredient listed as a ‘suspected’ or ‘interacting’ drug. The VigiBase database is a valuable source of information relevant to PV for herbal medications, despite its heterogeneous nature (Hunsel et al., 2022). Also, the WHO developed ‘WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance system’ in response to the growing global significance and risks associated with the use of herbal medicines. These guidelines offer recommendations for the monitoring of herbal safety within the existing pharmacovigilance framework (World Health Organization, 2004). A systematic review and meta-analysis revealed varying risks associated with herbal medicines, with adverse event (AE) reporting rates differing significantly based on the source of the reporter. The reported rates of AEs from herbal medicines ranged from as low as 0.03% to as high as 29.84%, with a median pooled estimate of 1.42% (Kongkaew et al., 2024). The aim of this review is to examine the current challenges surrounding the safety and regulation of herbal medicines in low- and middle-income countries (LMICs) with focus on Pakistan and to propose practical solutions for strengthening herbal pharmacovigilance and regulatory systems.

2. Current regulations for herbal medicines in Pakistan

Pakistan is a country with potential in the global trade of medicinal plants, ranking 9th in terms of imports (11,350 tonnes) and 10th in terms of exports (8100 tonnes) (Rauf & Khan, 2014). Approximately 6000 plant species are recognised to exist in Pakistan, with 600–700 of them having therapeutic use. Many people in Pakistan's indigenous population depend on medicinal plants for their livelihood. About 130,000 homoeopaths, 3584 hakems, and 455 vaids are recorded. Herbal therapies are provided by around 457 Tibbi-e-Unani clinics and dispensaries (Jan et al., 2019).

2.1. Regulatory framework for herbal medicines

Prior to 2012, Pakistan lacked any particular laws or regulatory bodies to regulate the manufacturing of alternative and herbal medicines. The safety, effectiveness, and quality of such medicines have been raised in light of the absence of regulation. Public health may be at danger if there were inadequate control and a weak regulatory framework allowing inferior and counterfeit products to reach the market. However, a new era of regulation of herbal medicines has begun with the establishment of the Drug Regulatory Authority of Pakistan (DRAP) in 2012 (An Act to Establish Drug Regulatory Authority of Pakistan, 2012); Rasheed et al., 2019). The DRAP Act, 2012 mandates that the DRAP regulate therapeutic product manufacturing, registration / enlistment, quality assurance and control, post-market surveillance, import, export, storage, distribution, and sale, including complementary and alternative medicine. The Act aims to safeguard public health by guaranteeing the efficacy and safety of therapeutic commodities, including alternative medicines. As a result, ‘the Alternative Medicines and Health Products (Enlistment) Rules, 2014’ were notified (Alternative Medicines and Health Products (Enlistment) Rules, 2014).

The Health and OTC (non-drugs) division of DRAP currently executes a number of operations that help in the management and regulation of Alternative Medicines and Health Products (AMHP), such as (a) enlisting domestic and foreign manufacturers and importers of AMHP and (b) maintaining an approved list of manufacturers and importers of AMHP by reviewing the credentials, qualifications, production sites, and quality control protocols of companies seeking to produce or import AMHP (Drug Regulatory Authority of Pakistan, 2025). By enlisting these manufacturers and importers, the Division ensures the quality and safety of alternative medicines for consumers. DRAP has enlisted approximately 72,000 products, both imported and local, since 2014. The total number of importers enlisted with DRAP is 934, while 576 local manufacturers have enlisted themselves (Drug Regulatory Authority of Pakistan, 2025).

In recent years, Pakistan has made considerable improvements to its pharmacovigilance system. In 2015, the Drug Regulatory Authority of Pakistan (DRAP) established a national pharmacovigilance centre. In 2018, the centre joined the WHO’s Program for International Drug Monitoring (PIDM) as a full member. It has been regularly sending WHO Individual Case Safety Reports (ICSRs) ever since (Khan et al., 2022).

The Pharmacovigilance Rules, 2022 cover all therapeutic products manufacturers to report the ADRs. Sub-rule 8 of Pharmacovigilance Rules, 2022 places an obligation on the registration holder to submit Periodic Benefit Risk Evaluation Report (PBRER) for various categories of drugs. However, this sub-rule also recognises that there are instances where the submission of PBRER may be waived. This exemption may be applied when the obligation is laid down as a condition of registration or when required by concerned authorities based on concerns related to pharmacovigilance or the tacking of periodic safety reports. However, it is important to note that the determination as to whether a specific alternative drug requires PBRER remains at the discretion of the relevant Board or committee (Pharmacovigilance Rules 2022, 2022). Despite underreporting, Pakistan is still striving to enhance PV systems at the federal, provincial, public health programme, and hospital levels.

3. Safety and quality of herbal medicines

The variety of herbal products is a challenge for herbal pharmacovigilance. Chemical substances present in herbal medicines have the ability to ward off illnesses and ailments. But the myth that herbal medications are completely safe and that patients should take them for self-medication has spread throughout the world due to their immense popularity. This practice frequently results in negative outcomes and side effects.

3.1. Safety of herbal medicines in high and low and middle-income countries

In low- and middle-income countries (LMICs), the safety of herbal medicines remains precarious due to fragmented pharmacovigilance systems, widespread underreporting of adverse reactions, and heavy reliance on unregulated traditional remedies exacerbating risks like herb-drug interactions and contamination, as seen in regions like Africa and Asia (Asiamah et al., 2025; Kiguba et al., 2023). A cross-sectional analysis of herbal medicine dossiers submitted to TMDA revealed significant gaps in safety data required for market authorisation. Manufacturers must provide adequate evidence on product safety to enable evidence-based regulatory decisions and prevent repeated reviews of applications (Mssusa et al., 2023). Another study conducted in Tanzia revealed that the Tanzania Medicines and Medical Devices Authority (TMDA) have policies and a legal framework for herbal medicine regulation with a functional pharmacovigilance system, but faces challenges such as underreporting, limited training, and poor dissemination of information. It received 18 reports with 40 suspected ARs. Among MAHs, only 64% had PV systems, 29% had AR collection mechanisms, 39% had qualified PV staff, and while 64% had quality systems, most were inadequate (Mssusa et al., 2025).

In contrast, high-income countries (HICs) benefit from robust PV frameworks, such as those aligned with EMA or FDA guidelines (Khan et al., 2023), enabling systematic monitoring, standardised reporting, and integration of herbal products into national drug safety databases, though challenges like incomplete data on long-term effects persist. Moreover, while HICs increasingly apply risk communication tools, labelling requirements, and public safety campaigns (Bernardo & Perwaiz, 2022; Menniti-Ippolito & Firenzuoli, 2022; Teng, 2022), LMICs continue to struggle with informal markets, unregistered products, and weak dissemination of pharmacovigilance information.

In recent years, regulatory authorities have increased their focus on herbal products. A 2004 EU Directive on Traditional Herbal Medicinal Products mandated that member states establish a registration system for traditional herbal remedies. This system allows for marketing authorisation of these products, provided they are intended for minor conditions that do not require medical supervision (Aronson, 2022). The herbal medicine classification system is weaker in some countries like Kuwait (Alostad et al., 2019). Pharmacovigilance regulations for the industry are defined by each country’s specific guidelines, such as the Australian Regulatory Guidelines for Complementary Medicines and the MHRA’s newly released pharmacovigilance procedures post-Brexit (Australian Government, 2020; Medicines and Healthcare Products Regulatory Agency, 2022). These regulations outline the responsibilities of sponsors or marketing authorisation holders of approved, registered, or listed medicines, including herbal medicines, to carry out pharmacovigilance-related activities. Although there are international drug monitoring guidelines, protocols and establishments, pharmacovigilance for herbal and traditional medicines (H&TMs) is still in its infancy. The extent of this disparity differs throughout WHO member countries that are involved in the global PV initiative; some don't have any pharmacovigilance systems for H&TMs, while others have sophisticated systems (Skalli et al., 2024).

Laboratory analyses frequently confirm that herbal medicines have been compromised deliberately by adding allopathic components (Alyas et al., 2024). Numerous contaminations of herbal medications have been discovered in recent studies. In low- and middle-income countries, metals, microorganisms, mycotoxins, pesticides, and leftover solvents have all been identified as prevalent contaminants of herbal medicinal products. The most prevalent bacterial species were discovered to be Salmonella species, moulds, Candida albicans, and Escherichia coli (Opuni et al., 2023). It has also been discovered that several herbal products contain sildenafil (Moser et al., 2022; Oh et al., 2006). Additional research has revealed harmful levels of heavy metal contamination in Pakistani herbal medicines, including iron, cadmium, nickel, lead, cobalt, zinc, chromium, and copper (Anwar et al., 2024; Soomro et al., 2021). Such reports drawing attention to consumer health risks and safety concerns, necessitating the swift formulation and implementation of laws that effectively control and regulate herbal medicines.

3.2. Safety of Unani system of medicine

The Unani system of medicine is practiced by all countries of the south east Asia including India and Pakistan (Lloyd, 2009). In terms of medicinal plant exports, India ranks second in the world. India has a well-established pharmacovigilance system for traditional medicines including herbal products. In 2007, the Government of India launched a National Pharmacovigilance Program for Ayurveda, Siddha, and Unani Drugs (NPP-ASU). As a national coordination centre, the Indian Pharmacopoeia Commission oversees a vertical nationwide Pharmacovigilance Programme of India to ensure the safety of drugs and pharmaceuticals (Kalaiselvan & Ruknuddin, 2022). Absence of reporting lines for ADRs linked to herbal medicines and subsequently leading to underreporting have been witnessed in some countries of the region like Nepal, Iran (Shrestha et al., 2020; Zarei, 2022).

4. Challenges and solutions

Despite continued breakthroughs and improvements in regulations, there are still a lot of impediments in Pakistan that prevent consumers from getting safe, high-quality herbal products, like: (a) The quality of herbal medicines can be affected by external factors such as adulteration, contamination, and misidentification, as well as internal factors like complexity and non-uniformity of ingredients. To address these issues, Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP) must be implemented in order to prepare standard herbal products from standard herbal extract. (b) The analysis of herbal products thus presents specific and complicated problems, emphasising the necessity for suitable analytical techniques for their identification and standardisation as well as the detection of impurities and adulterants. (c) More studies and investigational research are required to determine the evidence-based effectiveness, safety, molecular effects, and clinical therapeutic effect of several commonly used herbs and herbal products. (d) The general public believes that taking herbal medicines is safe and doesn't require consultation; yet, there is a pressing need to increase awareness of the risks associated with using these treatments, as well as the extent of their effectiveness and safety in the local population. (e) A general lack of knowledge among medical and health professionals regarding the safety and potential for interactions with herbal medicines, necessitating comprehensive and standardised training for all medical and health personnel (El-Dahiyat et al., 2023; Shanableh et al., 2025). (f) People who take herbal treatments for any reason should make sure the products they are buying are safe and include what they are supposed to, which might or might not include a particular herb or amount of a certain herbal component. Consumers should also be given evidence-based information about dosage, contraindications, and efficacy. (g) The pharmacovigilance system in Pakistan currently emphasises medicinal products having pharmaceutical and biological ingredients. Nevertheless, the herbal and traditional medicine industry must report adverse drug reactions (ADRs) to the National Pharmacovigilance Center (NPC). The promotion of safety in these traditional medicines also requires attention. The promotion of safety in herbal medicines is essential, given the increasing popularity of these products. Herbal medicines often contain natural ingredients that have been used for centuries to treat various ailments. However, it is crucial to establish robust quality and safety standards for these products. This can be achieved by conducting thorough scientific research, regulating manufacturing processes, and ensuring that herbal medications meet appropriate labelling requirements. (h) Collaboration is also essential between practitioners of traditional medicine, healthcare professionals, researchers, investors, and media, national and international regulators. Since India and Pakistan utilise many of the same herbs, they should work together to exchange safety data on these shared medicinal plants. According to Khan et al., SAARC countries should establish a mechanism to exchange medicine safety data (Khan et al., 2022a). The pharmacovigilance framework for herbal medications can be reinforced by promoting dialogue and creating structures for exchanging data on adverse effects and safety issues.

5. Conclusion

In Pakistan, the majority of the population only has access to or can afford herbal medication as a basic component of the healthcare system. Consumers should be informed about the dosage, side effects, and effectiveness of the herbal medications they use. Harmonising laws around the globe is necessary to accomplish this goal and ensure that herbal medicines are produced and marketed responsibly. Such legislation should permit the appropriate use of an herb if sufficient scientific evidence of its benefits is available, in order to encourage its usage and realise its potential benefits for the treatment and promotion of public health. However, functional pharmacovigilance procedures must be established in light of potential safety risks, to monitor the safety of herbal medicine. Regular training programmes and collaboration among stakeholders are needed to overcome problems in pharmacovigilance and enable the continuing use of herbal medications without compromising patient safety.

Authors’ contributions

MAAK conceptualised the idea, conducted the literature review, and wrote the initial draft. MK and OM synthesise data and revise the manuscript. All contributors checked and accepted the final version of the manuscript.

Disclosure statement

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

References

  1. Alostad, A. H., Steinke, D. T., & Schafheutle, E. I. (2019). A qualitative exploration of Bahrain and Kuwait herbal medicine registration systems: Policy implementation and readiness to change. Journal of Pharmaceutical Policy and Practice, 12(1), 32. 10.1186/s40545-019-0189-7 [DOI] [PMC free article] [PubMed] [Google Scholar]
  2. Alsheikh, R., Alsharif, F. R., Alwisi, N., Nazar, Z., Syed, M. A., Qotba, H. A., Al-Mansoori, L., Shi, Z., & Shaito, A. A. (2025). Prevalence, patterns, drivers, and perceived benefits of herbal medicine use in COVID-19 patients in Qatar. Journal of Pharmaceutical Policy and Practice, 18(1). 10.1080/20523211.2025.2533258 [DOI] [PMC free article] [PubMed] [Google Scholar]
  3. Alternative Medicines and Health Products (Enlistment) Rules . (2014). Pub. L. No. S.R.O. 412 (I)/2014, 2014 1 (2014).
  4. Alyas, A. A., Aldewachi, H., & Ibrahim Aladul, M. (2024). Adulteration of herbal medicine and its detection methods. Pharmacognosy Journal, 16(1), 248–254. 10.5530/pj.2024.16.36 [DOI] [Google Scholar]
  5. An Act to Establish Drug Regulatory Authority of Pakistan . (2012). Pub. L. No. No. F. 9(12)/2012-Legis, 183 1.
  6. Anwar, M. S., Khan, A., Ahmad, L., Khan, A., Mateen, A., Jahan, S., Ullah, U., AlMasoud, N., Alomar, T. S., Rauf, A., Khan, F. U., & Ain Nawaz, N. U. (2024). Quantification of toxic heavy metals, trace elements and essential minerals contents in traditional herbal medicines commonly utilized in Khyber Pakhtunkhwa, Pakistan. Heliyon, 10(3), e25384. 10.1016/j.heliyon.2024.e25384 [DOI] [PMC free article] [PubMed] [Google Scholar]
  7. Aronson, J. K. (2022). The historical development of pharmacovigilance for herbal medicines. In Barnes J. (Ed.), Pharmacovigilance for herbal and traditional medicines (pp. 3–13). Springer International Publishing. [Google Scholar]
  8. Asiamah, G. A., Forkuo, A. D., Turkson, B. K., Mireku-Gyimah, N. A., Antwi, A. O., Ansah, C., & Gyimah, L. S. (2025). Pharmacovigilance of herbal medicines in Ghana – knowledge, perception and practice. Scientific African, 29, e02917. 10.1016/j.sciaf.2025.e02917 [DOI] [Google Scholar]
  9. Australian Government . (2020). Australian Regulatory Guidelines for Listed Medicines and Registered complementary medicines. https://www.tga.gov.au/resources/resource/reference-material/applications-registered-complementary-medicines
  10. Bareetseng, S. (2022). The worldwide herbal market: Trends and opportunities. Journal of Biomedical Research & Environmental Sciences, 3(5), 575–584. 10.37871/jbres1482 [DOI] [Google Scholar]
  11. Bernardo, K., & Perwaiz, S. (2022). Pharmacovigilance for herbal products: A Canadian perspective. In Barnes J. (Ed.), Pharmacovigilance for herbal and traditional medicines (pp. 307–315). Springer International Publishing. [Google Scholar]
  12. Drug Regulatory Authority of Pakistan . (2025). Provisionally enlistments of health & OTC products. https://www.dra.gov.pk/e-services/online-data-verification/provisionally-enlistments-of-health-otc-products/
  13. Ekor, M. (2014). The growing use of herbal medicines: Issues relating to adverse reactions and challenges in monitoring safety. Frontiers in Pharmacology, 4, 177. 10.3389/fphar.2013.00177 [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. El-Dahiyat, F., Abu Hammour, K., Abu Farha, R., Manaseer, Q., Momani, A., & Allan, A. (2023). The impact of educational interventional session on healthcare providers knowledge about pharmacovigilance at a tertiary Jordanian teaching hospital. Journal of Pharmaceutical Policy and Practice, 16(1), 10.1186/s40545-023-00561-0 [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Fortune Business Insights . (2024). Food supplements /herbal medicine market. https://www.fortunebusinessinsights.com/herbal-medicine-market-106320
  16. González-Trujano, M. E., Ventura-Martínez, R., Silveira, D., & Déciga-Campos, M. (2024). Editorial: Pharmacological interaction between drugs and medicinal plants, volume II. Frontiers in Pharmacology, 15, 10.3389/fphar.2024.1372366 [DOI] [PMC free article] [PubMed] [Google Scholar]
  17. Hunsel, F., Gattepaille, L., Westerberg, C., & Barnes, J. (2022). Reports for herbal medicines in the global suspected ADR database VigiBase. In Barnes J. (Ed.), Pharmacovigilance for herbal and traditional medicines: Advances, challenges and international perspectives (pp. 279–290). [Google Scholar]
  18. Jan, H., Jain, S., Bussmann, R., Wali, S., Sisto, F., & Ahmad, L. (2019). Complementary and alternative medicine research, prospects and limitations in Pakistan: A literature review. Acta Ecologica Sinica, 40(6), 451–463. 10.1016/j.chnaes.2019.12.005 [DOI] [Google Scholar]
  19. Kalaiselvan, V., & Ruknuddin, G. (2022). Pharmacovigilance for Indian traditional medicines. In Barnes J. (Ed.), Pharmacovigilance for herbal and traditional medicines (pp. 347–356). Springer International Publishing. [Google Scholar]
  20. Khan, M. A. A., Hamid, S., & Babar, Z. U. D. (2022a). Pharmacovigilance practices in South Asian Association for Regional Cooperation countries: The need for collaboration. Journal of Pharmaceutical Health Services Research, 13, 378–386. 10.1093/jphsr/rmac046 [DOI] [Google Scholar]
  21. Khan, M. A. A., Hamid, S., & Babar, Z. (2023). Pharmacovigilance in high-income countries: Current developments and a review of literature. Pharmacy, 11(1), 10. 10.3390/pharmacy11010010 [DOI] [PMC free article] [PubMed] [Google Scholar]
  22. Khan, M. A. A., Hamid, S., Ur-Rehman, T., & Babar, Z. U. D. (2022b). Assessment of the current state of pharmacovigilance system in Pakistan using indicator-based assessment tool. Frontiers in Pharmacology, 12(January), 1–12. 10.3389/fphar.2021.789103 [DOI] [PMC free article] [PubMed] [Google Scholar]
  23. Khan, M. A. A., Sara, T., & Babar, Z. U. D. (2024). Pharmacovigilance: The evolution of drug safety monitoring. Journal of Pharmaceutical Policy and Practice, 17(1), 10.1080/20523211.2024.2417399 [DOI] [PMC free article] [PubMed] [Google Scholar]
  24. Kiguba, R., Olsson, S., & Waitt, C. (2023). Pharmacovigilance in low- and middle-income countries: A review with particular focus on Africa. British Journal of Clinical Pharmacology, 89(2), 491–509. 10.1111/bcp.15193 [DOI] [PubMed] [Google Scholar]
  25. Kongkaew, C., Phan, D. T. A., Janusorn, P., & Mongkhon, P. (2024). Estimating adverse events associated with herbal medicines using pharmacovigilance databases: Systematic review and meta-analysis. JMIR Public Health and Surveillance, 10, e63808. 10.2196/63808 [DOI] [PMC free article] [PubMed] [Google Scholar]
  26. Lloyd, I. (2009). Traditional and complementary systems of medicine. In The energetics of health (pp. 13–27). Elsevier. [Google Scholar]
  27. Medicines and Healthcare Products Regulatory Agency . (2022). Guidance on pharmacovigilance procedures. https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures
  28. Menniti-Ippolito, F., & Firenzuoli, F. (2022). The Italian phytovigilance spontaneous reporting scheme. In Barnes J. (Ed.), Pharmacovigilance for herbal and traditional medicines (pp. 291–295). Springer International Publishing. [Google Scholar]
  29. Moser, D., Hussain, S., Yaqoob, M., Rainer, M., Jakschitz, T., & Bonn, G. K. (2022). Fast and semiquantitative screening for sildenafil in herbal over-the-counter formulations with atmospheric pressure solid analysis probe (ASAP) to prevent medicinal adulteration. Journal of Pharmaceutical and Biomedical Analysis, 214, 114720. 10.1016/j.jpba.2022.114720 [DOI] [PubMed] [Google Scholar]
  30. Mssusa, A. K., Holst, L., Kagashe, G., & Maregesi, S. (2023). Safety profile of herbal medicines submitted for marketing authorization in Tanzania: A cross-sectional retrospective study. Journal of Pharmaceutical Policy and Practice, 16 (149), 10.1186/s40545-023-00661-x [DOI] [PMC free article] [PubMed] [Google Scholar]
  31. Mssusa, A. K., Holst, L., Maregesi, S., & Kagashe, G. (2025). Pharmacovigilance systems for safety monitoring of herbal medicines: Assessment of the national regulatory authority, manufacturers and marketing authorisation holders in Tanzania. Journal of Pharmaceutical Policy and Practice, 18(1), 10.1080/20523211.2024.2438223 [DOI] [PMC free article] [PubMed] [Google Scholar]
  32. Ng, C. Y. J., Zhao, Y., Wang, N., Chia, K. L., Teo, C. H., Peh, W., Yeo, P., & Zhong, L. L. D. (2024). A multi-center cross-sectional study of Chinese Herbal Medicine-Drug adverse reactions using active surveillance in Singapore’s Traditional Chinese Medicine clinics. Chinese Medicine, 19(1), 44. 10.1186/s13020-024-00915-z [DOI] [PMC free article] [PubMed] [Google Scholar]
  33. Ng, J. Y., Kim, M., & Suri, A. (2022). Exploration of facilitators and barriers to the regulatory frameworks of dietary and herbal supplements: A scoping review. Journal of Pharmaceutical Policy and Practice, 15(1), 55. 10.1186/s40545-022-00447-7 [DOI] [PMC free article] [PubMed] [Google Scholar]
  34. Oh, S. S. Y., Zou, P., Low, M. Y., & Koh, H. L. (2006). Detection of sildenafil analogues in herbal products for erectile dysfunction. Journal of Toxicology and Environmental Health. Part A, 69(21), 1951–1958. 10.1080/15287390600751355 [DOI] [PubMed] [Google Scholar]
  35. Opuni, K. F. M., Kretchy, J.-P., Agyabeng, K., Boadu, J. A., Adanu, T., Ankamah, S., Appiah, A., Amoah, G. B., Baidoo, M., & Kretchy, I. A. (2023). Contamination of herbal medicinal products in low-and-middle-income countries: A systematic review. Heliyon, 9(9), e19370. 10.1016/j.heliyon.2023.e19370 [DOI] [PMC free article] [PubMed] [Google Scholar]
  36. Pharmacovigilance Rules 2022 . (2022). Pub. L. No. S.R.O. 540(I/2022).
  37. Rasheed, H., Hoellein, L., Bukhari, K. S., & Holzgrabe, U. (2019). Regulatory framework in Pakistan: Situation analysis of medicine quality and future recommendations. Journal of Pharmaceutical Policy and Practice, 12(1), 23. 10.1186/s40545-019-0184-z [DOI] [PMC free article] [PubMed] [Google Scholar]
  38. Rauf, A., & Khan, H. (2014). Medicinal plants: Economic perspective and recent developments. World Applied Sciences Journal, 31(11), 1925–1929. 10.5829/idosi.wasj.2014.31.11.14494 [DOI] [Google Scholar]
  39. Sethi, S. S., Bhardwaj, T., Sethi, S. K., Kaur, S., Rimpi, & Baldi, A. (2025). Advancing herbal medicine safety: The need for a global pharmacovigilance approach. Naunyn-Schmiedeberg’s Archives of Pharmacology, 398(10), 13499–13514. 10.1007/s00210-025-04066-2 [DOI] [PubMed] [Google Scholar]
  40. Shanableh, S., Zainal, H., Alomar, M., & Palaian, S. (2025). Educational intervention impact assessment on pharmacovigilance knowledge, attitude and practice among hospital pharmacy practitioners in Dubai. Journal of Pharmaceutical Policy and Practice, 18(1), 10.1080/20523211.2025.2509223 [DOI] [PMC free article] [PubMed] [Google Scholar]
  41. Shrestha, S., Danekhu, K., Sapkota, B., Jha, N., & KC, B. (2020). Herbal pharmacovigilance in Nepal: Challenges and recommendations. F1000Research, 9, 111. 10.12688/f1000research.22133.1 [DOI] [Google Scholar]
  42. Skalli, S., Caro-Rojas, A., Rostom, H., & Elhawary, M. A. (2024). A framework for promoting safety monitoring of herbal medicines: The international society of pharmacovigilance special interest group on herbal and traditional medicines. Drug Safety, 47(6), 515–520. 10.1007/s40264-024-01440-6 [DOI] [PubMed] [Google Scholar]
  43. Skalli, S., Wang, J., & Hugman, B. (2022). Pharmacovigilance of herbal medicines: The vigilance of tomorrow. In Mukherjee P. K. (Ed.), Evidence-based validation of herbal medicine (pp. 239–250). Elsevier. [Google Scholar]
  44. Soomro, A. H., Jatoi, W. B., Maitlo, A. A., Memon, A. F., & Bhayo, M. S. (2021). Assessment of heavy metal content of commonly consumed herbal medicines in Sindh, Pakistan. Environmental Science and Pollution Research International, 4(2), 612–624. [DOI] [PubMed] [Google Scholar]
  45. Teng, L. (2022). Pharmacovigilance for herbal and traditional medicines in Japan. In Barnes J. (Ed.), Pharmacovigilance for herbal and traditional medicines (pp. 371–383). Cham: Springer International Publishing. [Google Scholar]
  46. Toklu, H. Z. (2016). Pharmacovigilance of herbal medicine: Herbavigilance. Advances in Pharmacoepidemiology & Drug Safety, 5(4), 10.4172/2167-1052.1000208 [DOI] [Google Scholar]
  47. WHO . (2021). Key technical issues of herbal medicines.
  48. World Health Organization . (2004). WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems (p. 82). World Health Organisation. [Google Scholar]
  49. World Health Organization . (2019). WHO Global report on traditional and complementary medicine 2019. [Google Scholar]
  50. Zarei, M. H. (2022). Herbal medicines pharmacovigilance in Iran. Future Natural Products, 8(1), 29. 10.34172/fnp.2022.06 [DOI] [Google Scholar]

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