Volume : 13, Issue : 08, August – 2026
Title:
REGULATORY CHALLENGES IN CONDUCTING BIOEQUIVALENCE STUDIES IN INDIA FOR EXPORT MARKETS.
Authors :
Gurram Teja*, Dr.R.Narasimha Rao, Dr.T.Vijaya Kumari
Abstract :
Bioequivalence (BE) studies serve as the scientific foundation for establishing therapeutic equivalence between generic formulations and their innovator counterparts. In India, the conduct of BE studies has expanded rapidly owing to the country’s strong generic manufacturing base and globally accredited Contract Research Organizations (CROs). However, several regulatory challenges continue to hinder seamless operations and global acceptability of BE data. This paper critically examines these regulatory challenges faced by Indian pharmaceutical companies and CROs while conducting BE studies intended for export markets.
Keywords: Bioequivalence, Regulatory challenges, CDSCO, Export markets, Generic drugs, Clinical research, Data integrity, Harmonization
Cite This Article:
Please cite this article in press Gurram Teja et al., Regulatory challenges in conducting Bioequivalence studies in India for export markets.,, Indo Am. J. P. Sci, 2026; 13(08).
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