Generic placeholder image

Current Drug Safety


ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

Review Article

Issues and Challenges in Pharmacovigilance of Herbal Formulations

Author(s): Vasudev Pai, Chandrashekar Kodangala Subraya*, Aswatha Ram Holavana Halli Nanjundaiah, Venkatesh Kamath and Vijayanarayana Kunhikatta

Volume 19, Issue 1, 2024

Published on: 09 March, 2023

Page: [19 - 23] Pages: 5

DOI: 10.2174/1574886318666230209110922

Price: $65


Pharmacovigilance is important for generating accurate safety of herbal medications information. The present methods were designed for synthetic medications and will need to be modified to account for the unique characteristics of medicinal plants. The objective of pharmacovigilance is to identify, measure, and explain adverse effects or other potential drug-related issues associated with herbal, traditional, and complementary therapies, as well as to avoid them. Required data for pharmcovigilance of herbal drugs and formulation were obtained from electronic sources (google scholar, PubMed, Scopus, Web of Science), several textbooks. The keywords used to search for various journal publishers such as Willey Online Library, Springer, Wolters Kluwer and Elsevier were closely monitored. This review article covers all the relevant information on issues and challenges in pharmacovigilance of formulation covering Herbal drugs.

Keywords: Pharmacovigilance, adverse drug reaction, herbal medicine, drug safety, herbal medicinal products, fungal contamination.

Graphical Abstract
Rahul D, Rajeev G, Vinay K, Vivek V, Vikas T. Detection, assessment, understanding and prevention of adverse effects:pharmacovigilance: A review. Int J Pharm Sci Rev Res 2013; 20(1): 71-86.
WHO. Pharmacovigilance: Ensuring the safe use of medicines. World Health Organization: Geneva, 2004. Available from:
Alomar M, Tawfiq AM, Hassan N, Palaian S. Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future. Ther Adv Drug Saf 2020; 11: 2042098620938595.
[] [PMID: 32843958]
Muriithi DN, Mokaya D, Muturi SK. Adverse drug reaction occurrence,reporting and associated factors among patients in selected hospitals in Kirinyaga County, Kenya. J Pharm Kenya 2020; 24(3): 53-8.
Sandeep S, Dinesh KC, Neeraj KS, Sharma IP. Pharmacovigilance of herbal medicines: Current state and future directions. 2011; 7(25): 69-73.
Barnes J, Mills SY, Abbot NC, Willoughby M, Ernst E. Different standards for reporting ADRs to herbal remedies and conventional OTC medicines: face-to-face interviews with 515 users of herbal remedies. Br J Clin Pharmacol 1998; 45(5): 496-500.
[] [PMID: 9643624]
Thürmann PA. Methods and systems to detect adverse drug reactions in hospitals. Drug Saf 2001; 24(13): 961-8.
[] [PMID: 11735652]
Kalaiselvan V, Kumar P, Mishra P, Singh G. System of adverse drug reactions reporting: What, where, how, and whom to report? Indian J Crit Care Med 2015; 19(9): 564-6.
[] [PMID: 26430348]
Jordan SA, Cunningham DG, Marles RJ. Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment. Toxicol Appl Pharmacol 2010; 243(2): 198-216.
[] [PMID: 20018204]
Shaw D, Ladds G, Duez P, Williamson E, Chan K. Pharmacovigilance of herbal medicine. J Ethnopharmacol 2012; 40(3): 513-8.
Barnes J. Pharmacovigilance of herbal medicines: A UK perspective. Drug Saf 2003; 26(12): 829-51.
[] [PMID: 12959628]
Gasser U, Klier B, Kühn AV, Steinhoff B. Current findings on the heavy metal content in herbal drugs. Pharmeur Sci Notes 2009; 2009(1): 37-50.
[PMID: 19275871]
Street RA, Kulkarni MG, Stirk WA, Southway C, Van Staden J. Variation in heavy metals and microelements in South African medicinal plants obtained from street markets. Food Addit Contam Part A Chem Anal Control Expo Risk Assess 2008; 25(8): 953-60.
[] [PMID: 18608487]
Gair R. Heavy metal poisoning from Ayurvedic medicines. B C Med J 2008; 50(2): 105.
Health Canada. Ayurvedic medicines: lead contamination 2005. Available from:
Sagoo S, Little C, Greenwood M, et al. Assessment of the microbiological safety of dried spices and herbs from production and retail premises in the United Kingdom. Food Microbiol 2009; 26(1): 39-43.
[] [PMID: 19028303]
Guédon D, Brum M, Bizet D, et al. Impurities in herbal substances, herbal preparations and herbal medicinal products, I. Microbial contamination. STP Pharma Prat 2007; 17: 183-208.
Haripriya S, Syamala M, Mujeebuddin CS. Pharmacovigilance System in India. Int J Pharm Sci Rev Res 2020; 63(1): 73-80.
Roy AK, Sinha KK, Chourasia HK. Aflatoxin contamination of some common drug plants. Appl Environ Microbiol 1988; 54(3): 842-3.
[] [PMID: 3132102]
Koren G, Randor S, Martin S, Danneman D. Maternal ginseng use associated with neonatal androgenization. JAMA 1990; 264(22): 2866.
[] [PMID: 2232076]
Palaian S. Pharmacovigilance practices and activities: Issues, challenges, and future direction. Academic Press London 2017; pp. 145-62.
Gomase V, Changbhale S, Patil S, Kale K. Metabolomics. Curr Drug Metab 2008; 9(1): 89-98.
[] [PMID: 18220576]
Kang YJ. Herbogenomics: from traditional Chinese medicine to novel therapeutics. Exp Biol Med 2008; 233(9): 1059-65.
[] [PMID: 18535158]
National Archives. US Department of Health and Human Services Food and Drug Administration. Current good manufacturing practice in manufacturing, packaging, labelling, or holding operations for dietary supplements; final rule. Fed Regist 2007; 72: 34752-958.
Ajanal M. Adverse drug reaction and concepts of drug safety in Ayurveda: An overview. J Young Pharma 2013; 5(4): 116-20.
Therapeutic Goods Administration. 2006. Available from:
Wal A, Wal P, Gupta S, Sharma G, Rai AK. Pharmacovigilance of herbal products in India. J Young Pharm 2011; 3(3): 256-8.
[] [PMID: 21897669]
Mann RD, Andrews EF. Pharmacovigilance. John Wiley & Sons, Ltd. New Jersey 2007; pp. 1-3.

Rights & Permissions Print Export Cite as
© 2024 Bentham Science Publishers | Privacy Policy