An overview of the worldwide master key for pharmacovigilance and its role in India

Review Article

  • Janmejay Pant University Institute of Pharma Sciences (UIPS), Chandigarh University, Punjab, India. https://orcid.org/0000-0002-8498-5251
  • Harneet Marwah University Institute of Pharma Sciences, Chandigarh University, Mohali Punjab, India
  • Ripudaman M Singh University Institute of Pharma Sciences (UIPS), Chandigarh University, Gharuan, Mohali 140413, India.
  • Subhajit Hazra University Institute of Pharma Sciences, Chandigarh University, Mohali Punjab, India
Keywords: ADR, HCP, India, Pharmacovigilance, PvPI, WHO

Abstract

Pharmacovigilance (PV) is defined as the science and activities related to the detection, assessment, understanding, and prevention of Adverse Drug Reactions (ADRs) and related conditions. In the 1970s, several significant cases of ADR aided the advancement of the discipline. Between 1989 and 2004, several attempts were made to implement such a program in India, but the scheme was eventually launched in 2010 and is now operating successfully and producing positive results. The pharmacovigilance Program of India (PvPI) contributed different data to the World Health Organization (WHO) Uppsala Monitoring Center (UMC) based on the data gathered from this process. Indian regulatory have sent several alerts to stakeholders and provided the Central Drugs Standard Control Organization (CDSCO) with several recommendations. CDSCO has since advised Marketing Authorisation Holders (MAHs) to follow the same guidelines and has amended the Drugs and Cosmetics Act and Regulations to reflect this. The time has come for Indian regulatory authorities to take the required action based on data generated in our country rather than data generated in several other countries.

Author Biographies

Janmejay Pant, University Institute of Pharma Sciences (UIPS), Chandigarh University, Punjab, India.

Research Scholar

Harneet Marwah, University Institute of Pharma Sciences, Chandigarh University, Mohali Punjab, India

Research Scholar

Ripudaman M Singh, University Institute of Pharma Sciences (UIPS), Chandigarh University, Gharuan, Mohali 140413, India.

Associate Professor

Subhajit Hazra, University Institute of Pharma Sciences, Chandigarh University, Mohali Punjab, India

Research scholar

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Published
2021-06-01
How to Cite
1.
Pant J, Marwah H, Singh RM, Hazra S. An overview of the worldwide master key for pharmacovigilance and its role in India. jpadr [Internet]. 2021Jun.1 [cited 2021Jun.13];2(2):16-2. Available from: https://jpadr.com/index.php/jpadr/article/view/2