A COMPARATIVE REVIEW OF HUMAN AND VETERINARY GENERIC DRUG APPROVAL SYSTEMS

KARTHIKESAVAN PONMURUGESAN; VIVEK REDDY MURTHANNAGARI; HEMALATHA DEVARAJ; JESWANTH RAJ NAGARAJAN; GANESH GNK

doi:10.22159/ajpcr.2025v18i6.54622

Authors

KARTHIKESAVAN PONMURUGESAN Department of Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Tamil Nadu, India.
VIVEK REDDY MURTHANNAGARI Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Tamil Nadu, India
HEMALATHA DEVARAJ Department of Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Tamil Nadu, India
JESWANTH RAJ NAGARAJAN Department of Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Tamil Nadu, India
GANESH GNK Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Ooty, Tamil Nadu, India.

DOI:

https://doi.org/10.22159/ajpcr.2025v18i6.54622

Keywords:

Generic drugs, regulatory framework, harmonization, veterinary medicine, bioequivalence, pharmacovigilance, antimicrobial resistance, One Health, data exclusivity, animal welfare, human medicine

Abstract

This review compares human and veterinary generics' regulatory regimes with respect to applicable similarities and differences between approval processes, dossier presentation, bioequivalence test protocols, and post-marketing control. Therapeutic equivalence is the aim of both industries, albeit under regulatory regime, there are enormous disparities in bioequivalence protocols, pharmacovigilance schemes, and ethical requirements. These differences lead to inefficiencies, cost increase in drug development, and potential negative effect on animal and human health, specifically AMR and off-labeling. Global issues of new nature, including implications on AMR, controversy of data exclusivity, and animal welfare in clinical trials, are highlighted by the review. Efforts at harmonizing endeavors, for instance, via ICH and VICH are framed as filling the regulation gap. They urge an international concerted effort to align intellectual property rights with the interests of public health and animal welfare and with prudent use of antimicrobials in addition to promoting the One Health approach.

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