Sixty pharma cos submit ADRs reports in XML format mandated by PvPI

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Around 60 companies have submitted their ADR reports in Extensible Mark- up Language format (XML -E2B) towards building the quantum of adverse drug reaction reports (ADRs) for drug safety in the country.

Pharmacovigilance programme of India (PvPI) had mandated pharmaceutical companies to submit their ADR reports in XML -E2B.

This comes at a time when various Indian headquartered global pharmaceutical companies have also established in-house PV units to remain compliant with PV regulations outside India.

Government has also notified that the companies shall have a PV system in place for collecting, processing and forwarding the report to the licensing authority for information on ADRs emerging from the use of drug manufactured or marketed by the pharmaceutical companies in India.

As of today, around 2.30 lakh adverse drug reactions  have been reported from PvPI to the Uppsala Monitoring Centre (UMC) in Sweden, which is WHO’s collaborating centre for international drug monitoring.

There are 210 ADR Monitoring Centres (AMCs) in the country registered with the Vigiflow software which is meant to report adverse drug reaction data to World Health Organization (WHO) database on a consistent basis, as a part of the PvPI.

Technical Data Associates (TDAs) working in the AMCs help in accurate reporting of ADRs with the help of Vigiflow in coordination with Indian Pharmacopoeia Commission (IPC) Ghaziabad for final analysis and reports.

TDAs are accountable to collect information from the patients, perform follow up with them, enter information in the prescribed software (Vigiflow) and sending them to IPC for further analysis and documentation. IPC has been assigned to update information on ADRs that is being reported in India from across all its centres through VigiFlow to the Uppsala Monitoring Centre  in Sweden, which is WHO’s collaborating centre for international drug monitoring.

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. Drug Controller General of India (DCGI) is the authority to identify the AMCs to further train them on using Vigiflow software and thereafter authorise password to them for linking with the data base of WHO called as Vigibase.

Pharmacovigilance as a science and specialty is slowly picking up in the country but research and reporting outcomes are limited. Letter writing, package insert warnings are some of the conventional methods used for communication of pharmacovigilance knowledge.

Source: 1

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