PvPI Reports 63,384 ICSRs To VigiBase Towards Effective ADR Monitoring

Mumbai, 22 April 2021:

The Pharmacovigilance Programme of India (PvPI) has reported 63,384 Individual Case Safety Reports (ICSRs) for the period 2019-20 from adverse drug reaction (ADR) monitoring centres (AMCs), pharmaceutical industry and consumers to VigiBase for effective ADR monitoring, as per the official data released by Indian Pharmacopoeia Commission (IPC).

IPC functions as the National Coordination Centre (NCC) for PvPI. PvPI extended its outreach to common masses by enrolling 41 new AMCs thereby enhancing the total number of AMCs from 270 to 311 so far and has also generated 4.7 lakh ADRs since its inception in 2010.

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.

The WHO Adverse Reactions Terminology (WHO-ART) is a dictionary meant to serve as a basis for rational coding of adverse reaction terms and MedDRA is a clinically-validated international medical terminology used by regulatory authorities. WHO-ICD (International Classification of Diseases) is designed to promote international comparability in the collection, processing, classification, and presentation of mortality statistics. The WHO Drug Dictionary is an international classification of medicines created by the WHO Programme for international drug monitoring and managed by the Uppsala Monitoring Centre (UMC) in Sweden, which is WHO's collaborating centre for international drug monitoring.

VigiFlow is a web-based ICSR management system that is available for use by national pharmacovigilance centres of the WHO Programme for international drug monitoring. VigiFlow supports the collection, processing and sharing of data of ICSRs to facilitate effective data analysis.

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.

IPC is also planning to roll out PvPI at district level hospitals for its effective implementation. Ghaziabad based IPC has been receiving letter of intent from district hospitals across the country to participate as AMCs.

Medical colleges, hospitals and institutes approved by the Medical Council of India (MCI) can act as AMCs. Once enrolled they are required to efficiently collect the adverse event information from the patients, do follow up with them to check the completeness of the ADR reports.

Government, through a gazette notification March 8, 2016, has mandated pharma companies to set up PV cell in their companies in accordance to the rules for updates on ADRs emerging from the use of the drug manufactured or marketed by the respective MAH in the country.

The drug exporting pharmaceutical companies are supposed to set up a PV system to fulfill its legal tasks in relation to pharmacovigilance, design to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Pharmabiz