Global Pharmacovigilance, challenges, and future considerations: West globe and East globe

Review Article

  • Jyoti Sushma Gadhade BJGMC, and SGH, Agarkar Nagar, Opp. Pune railway station Pune, Maharashtra, India 411001 https://orcid.org/0000-0001-6203-4503
  • Rajesh Sudhakar Hiray BJGMC, and SGH, Agarkar Nagar, Opp. Pune railway station Pune, Maharashtra, India 411001
Keywords: Pharmacovigilance, safety, west globe, east globe

Abstract

Pharmacovigilance (PV) plays a consequential role in the drug regulatory system and is a constantly evolving multifaceted field. In the process of carrying out its effective management, the PV system does undergo a lot of challenges on a global pitch. PV system is well developed in the western globe (United States,  United Kingdom,  Germany) while the east globe (e.g.: India) is still in the evolving stage. Major discrepancies include different regulatory authorities for each nation with different forms for ADR reporting and also different timelines. To mention a few; there is a regulatory gap because of the continuously evolving regulations and business processes, it is difficult to comply with the diverse regulations effectively; gross underreporting in the east as compared to the west; increased concern about the safety and potential toxicity of traditional Chinese herbs in the east; self-medication; linguistic barrier, etc. Steps like harmonization of regulation by drafting guidelines that are uniform globally; leveraging digital technologies to optimize ADR reporting; meticulous and timely reporting; inclusion of PV in the curriculum etc. can be employed. While PV has witnessed substantial development over the years, areas of discrepancies need to be identified to build a seamless PV system. Need for an effective revolutionary roadmap to tackle all the hindrances to fortify its harmonious functioning.

Author Biographies

Jyoti Sushma Gadhade, BJGMC, and SGH, Agarkar Nagar, Opp. Pune railway station Pune, Maharashtra, India 411001

Assistant Professor, Department of Pharmacology

Rajesh Sudhakar Hiray, BJGMC, and SGH, Agarkar Nagar, Opp. Pune railway station Pune, Maharashtra, India 411001

Professor & HOD, Department of Pharmacology

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Published
2021-06-01
How to Cite
1.
Gadhade JS, Hiray RS. Global Pharmacovigilance, challenges, and future considerations: West globe and East globe. jpadr [Internet]. 2021Jun.1 [cited 2021Sep.18];2(2):2-. Available from: http://jpadr.com/index.php/jpadr/article/view/28