Last Updated On: 03/10/2017


Secretary Health, Government of India dedicated “ADR PvPI” Android Mobile App and Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products to the Nation on 29th September 2017.

 The Secretary, Ministry of Health and Family Welfare, Government of India launched/ dedicated the below mentioned facilities to the nation for the benefit of stakeholders including the Indian masses on 29th September 2017.

 

 

1. “ADR PvPI” Android Mobile App [developed in-house] for ADR reporting:

NCC-PvPI has developed an advanced version of the android mobile app which empowers all the healthcare professionals and consumers for Adverse Drugs Reaction (ADR) reporting. This new app has been developed to have administrative control of data with IPC, NCC-PvPI with the following features:

 

·         Supports source document and image attachment

·         Supports HCPs as well as consumer reporting

·         XML generation

·         Auto filling of report details to save time



 

2.   Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products: 

In order to ensure smooth functioning of Pharmacovigilance activities by Pharmaceutical industries, NCC-PvPI, IPC in collaboration with Central Drugs Standard Control Organization (CDSCO) developed Pharmacovigilance Guidance for Marketing Authorization Holders of Pharmaceutical Products


This Pharmacovigilance guidance document is introduced for the first time by the Government of India for Pharmaceutical industries which aim to establish and ensure an effective Pharmacovigilance system at their site as per recent amendment in Drugs & Cosmetics Rules, 1945, Schedule Y vide Gazette Notification G.S.R. 32 (E) published on 08 Mar 2016.


 

The MAHs Pv Guidance Document comprises of following modules:

MODULE 1 – Pharmacovigilance System Master File

MODULE 2 – Collection, Processing & Reporting of Individual Case Safety Reports 

MODULE 3 – Preparation & Submission of Periodic Safety Update Report 

MODULE 4 – Quality Management System at Marketing Authorization Holder Organization

MODULE 5 – Audits  & Inspections of Pharmacovigilance System at at Marketing Authorization Holder Organization

MODULE 6 – Submission of Risk Management Plan