Environmental Pharmacovigilance (EPV): An emerging branch of Science- A review

  • K Vyas Research Officer (Ayu), RARIND, CCRAS, Jaral Pandoh, District Mandi, H.P.
  • V Sharma HOD of QA, Torque Pharma, Baddi, District Mandi, H.P.
Keywords: Environmental Risk Assessment, Pharmaceuticals, Adverse Environmental Impact, Regulatory approval process.


Introduction: Environmental Pharmacovigilance (EPV) is a developing branch of science relating to the detection, assessment, understanding and prevention of Adverse Environmental Impacts (AEI) of Pharmaceutical products. It identifies risk levels of pharmaceutical residues mainly in water & soil for Environmental Risk Assessment (ERA) and its effective management. These spotting activities are necessary not only after launch of a new pharmaceutical product but also through its whole Life cycle.

Aims & Objectives: The branch is aimed to find out significant environmental issues related to Pharmaceuticals in Environment (PIE).

Review & Discussion: The main components of Environmental Pharmacovigilance (EPV) are- Environment, Pharmaceutical Product, Product user (Human/ animal)/ dealer and Victims of the risks developed. The victims may be non-targeted human population, wild life species or aquatic inhabitants etc. The documentation of this vigilance search is completely limited as it is quite difficult to differentiate the relative impact of pharmaceuticals and other Environmental stimuli. Moreover, management plans require deep knowledge of Physico-chemistry, pharmacokinetics, toxicology and other sciences, which make it very specific. Though Environmental Risk Assessment is already included in regulatory approval process for new drugs, its implementation is poor in Developing countries.

Conclusion:  there is great need to focus on this branch of vigilance in order to save the world from fatal hazards.