Veterinary Pharmacovigilance: A Review of Systems in France, USA and India
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Keywords:
Veterinary, Pharmacovigilance, EMAAbstract
Pharmacovigilance is an integral part of the healthcare system similarly; PV (Pharmacovigilance) for veterinary aspects is also a relatively new but emerging concept. It is gaining importance as animal-based food products are consumed by humans and there have been reports of adverse events in humans due to exposure to veterinary products such as hypersensitivity reactions, nausea dizziness, and adverse effect of veterinary products on the environment like decrease in vulture population due to diclofenac administered in cattle which were later consumed by vultures causing toxicity and death. In this paper, we have reviewed systems in France and USA and current scenarios in India and emphasized on the importance of having such a system in India, which is still lacking. An efficient Veterinary PV system is required in India due to ever growing of new veterinary pharmaceuticals entering the market.
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References
Ema. (2023) Pharmacovigilance (veterinary medicines). European Medicines Agency. Available from: https://www.ema.europa.eu/en/veterinary-regulatory/post-authorisation/pharmacovigilance-veterinary-medicines
Fleischer S., Sharkey M., Mealey K., Ostrander E. and Martinez M. (2008). Pharmacogenetic and metabolic differences between dog breeds: their impact on canine medicine and the use of the dog as a preclinical animal model. AAPS Journals, 10 (1), 110-9.
Keck G. and Ibrahim C. (2001). Veterinary pharmacovigilance: between regulation and science. Journal of Veterinary Pharmacology and Therapeutics, 24, 369-373.
Kumar R, Kalaiselvan V, Verma R, Kaur I, Kumar P, and Singh GN. (2017). Veterinary pharmacovigilance in India: A need of hour. Indian J Pharmacol. Jan-Feb; 49(1):2-3.
Mallem, Yassine, Rozenblum, M. and Pouliquen, Hervé. (2014). Veterinary Pharmacovigilance: User guide. 45. 24-28.
Pharmacovigilance for Veterinary Medicinal Products. Anses. (2022) Available from: https://www.anses.fr/en/content/pharmacovigilance-veterinary-medicinal-products-0
Rahman, Syed and Ruknuddin, Galib. (2022). History of Pharmacovigilance in India (1983-2022). Journal of Pharmacovigilance and drug safety 19. 6-17.
Rajesh S., (2020) Importance & need of veterinary pharmacovigilance in India. Pashudhan Prahree. Available from: https://www.pashudhanpraharee.com/importance-need-of-veterinary-pharmacovigilance-in-india
U.S.Food and Drug Administration. Available from: https://www.fda.gov/media/79095/download
Veterinary medicines regulation: Highlights - European medicines agency. Available from: https://www.ema.europa.eu/en/documents/newsletter/veterinary-medicines-regulation-highlights-issue-1_en.pdf
Woodward K. (2005a). Veterinary pharmacovigilance. The legal basis in the European Union. Journal of Veterinary Pharmacology and Therapeutics, 28: 231-285
Woodward K. (2005b). Veterinary pharmacovigilance. Adverse effects of veterinary medicinal products in animals and on the environment. Journal of Veterinary Pharmacology and Therapeutics, 28, 171–184.