jrnls.org logo
Submit

BROWSE ALL JOURNALS

SEE ALL 19 JOURNALS
Indian Journal of Pharmaceutical Education and ResearchNOW IN
Article

Regulatory Pathway for Genotoxic Impurities in Europe, US, Canada, India, Australia and UK

Kavyashree Kadehalli Ramegowda1, Sangita Mishra1, Venkatesh Madhugiri Prakash1,2★★ Corresponding author

  1. 1Centre of Excellence in Regulatory Sciences, Department of Pharmaceutics, JSS College of Pharmacy, JSS AHER, SS Nagara, Mysuru, Karnataka, INDIA.
  2. 2Faculty of Pharmaceutical Sciences, UCSI University, Kuala Lumpur, MALAYSIA.

CORRESPONDENCE

Venkatesh Madhugiri Prakash

Centre of Excellence in Regulatory Sciences, Department of Pharmaceutics, JSS College of Pharmacy, JSS AHER, SS Nagara, Mysuru, Karnataka, INDIA.

venkateshmpv@jssuni.edu.in

Received: 29-03-2025; Revised: 06-05-2025; Accepted: 08-07-2025.

Volume 60, Issue 1S · pp. s42–s51 · PUBLISHED · DOI: 10.5530/ijper.20260762

View on IJPER original site ↗

ABSTRACT

Genotoxic Impurities (GTIs) pose a significant risk to pharmaceutical safety due to their ability to damage DNA and cause cancer-related mutations. Regulatory agencies such as the EMA, USFDA, Heath Canada, CDSCO and TGA have established stringent frameworks to manage these risks, incorporating tools such as Structure-Activity Relationships (SAR) analysis and the Threshold of Toxicological Concern (TTC) to establish safe exposure limits. These frameworks emphasize both proactive impurity profiling and the development of sensitive analytical methods for trace-level detection. This review delves into the classification, mechanisms and control strategies for GTIs, highlighting innovations such as AI-driven predictive modeling and global efforts to improve impurity detection and management. Furthermore, it emphasizes the evolving role of risk-based approaches in addressing emerging genotoxic challenges throughout the pharmaceutical manufacturing pipeline. By combining cutting-edge science and regulatory rigor, the pharmaceutical industry continues to reduce GTI risks, ensuring the development of safer, higher-quality medicines for patients worldwide.

KEYWORDS

Open in new tab

REFERENCES

As published

Showing references and in-text citations exactly as published.

    Cite this article

    SELECT FORMAT

    Ramegowda, K. K., Mishra, S., & Prakash, V. M. (). Regulatory Pathway for Genotoxic Impurities in Europe, US, Canada, India, Australia and UK. Indian Journal of Pharmaceutical Education and Research, 60(1S), s42–s51. https://doi.org/10.5530/ijper.20260762