The Indian Pharmacopoeia Commission (IPC) which is the National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (NCC-PvPI), will be rolling out a series of induction-cum-training programmes for coordinators of newly recognized 35 Adverse Drug Reaction (ADR) Monitoring Centres (AMCs) and Pharmacovigilance Associates (PAs) under PvPI.
PvPI extended its outreach in the country by enrolling around 35 new AMCs thereby enhancing the total number of AMCs from 311 to 346 so far and has also generated 4.7 lakh ADRs since its inception in 2010.
In a recent induction meet, Dr Vijit Agrawal, Senior Pharmacovigilance Associate, sensitized stakeholders on the process of data entry through VigiFlow” and also gave a live demo for the same. As many as 28 participants attended the training programme and this training session helped the participants to enhance their understanding of data entry into the new version of VigiFlow.
A total of 54 participants including coordinators of newly recognized AMCs and newly inducted Pharmacovigilance Associates under PvPI attended the programme.
Another session on “Reporting of Adverse Drug Reactions” was delivered by Rishi Kumar, Scientific Assistant, PvPI given an insight into “Suspected Adverse Drug Reaction Notification Form and New VigiFlow”. The speakers from UMC, Sweden, Therese Lundin and Carina Akerhei detailed the participants about the ‘Updates and functioning of the New VigiFlow’ with special emphasis on the case processing of Marketing Authorisation Holders (MAHs).
PvPI has also reported 63,384 Individual Case Safety Reports (ICSRs) for the period 2019-20 from AMCs, pharmaceutical industry and consumers to VigiBase for effective ADR monitoring, as per the official data released by Indian Pharmacopoeia Commission (IPC).
NCC-PvPI receives ICSRS from various stakeholders such as physicians, pharmacists, other healthcare professionals (HCPs), consumers (Non-HCPs), etc. Spontaneous reports from physicians (51.2%) continue to be the major source of reports received, followed by pharmacists (14.8%) other healthcare professionals (17.6%) and consumers (21.5 %).
VigiBase is the unique World Health Organisation (WHO) global database of ICSRs. Alongside its data management and quality assurance tools, the VigiBase system is also linked to medical and drug classifications such as WHO-ART, MedDRA, WHO-ICD, and WHO Drug.
The Signal Review Panel (SRP) of PvPI has also recommended seven prescribing information leaflet (PIL) changes and one signal to the CDSCO for appropriate regulatory actions. After preliminary analysis of PvPI data, 19 monthly drugs safety alerts have also been issued to sensitize the healthcare professionals, patients and consumers through PvPI Newsletters, bulk SMS drug alerts, web-portal of IPC.
Based on the PvPI recommendations, CDSCO has issued orders to the concerned marketing authorization holder (MAH) and industry for necessary action and compliance.
IPC has been assigned to update information on ADRs that is being reported in India from across all its centres through Vigiflow software to the UMC in Sweden. Vigiflow is a software given to the PvPI free of cost and prescribed to AMCs based on their efficiency to deliver in terms of frequency and quality of reports.
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