Experts at Indian Pharmacopoeia Commission (IPC) and Central Drugs Standard Control Organisation (CDSCO) recently met to outline a plan towards designing Pharmacovigilance (PV) as per the regional needs for addressing challenges in setting up PV cells in pharmaceutical companies in the country.
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In order to achieve the same, they have recommended developing a positive culture of adverse event (AE) reporting by Marketing Authorization Holders (MAH) in pharmaceutical companies through regulatory interventions.
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“There is a need to address online reporting of AEs and also understand its coordination with the VigiFlow so that PV systems can be effectively implemented by the MAHs in pharmaceutical companies.
There is an urgent need to create awareness about the PV Guidance Document with major focus on submission of E2B XML ADR related files to the Pharmacovigilance Programme of India (PvPI),” according to Dr Rajeev Singh Raghuvanshi, secretary-cum-scientific director, IPC.
VigiFlow is a web-based individual case safety report (ICSR) management system that is available for use by national pharmacovigilance centres of the World Health Organization (WHO) Programme for International Drug Monitoring. It supports the collection, processing and sharing of data of ICSRs to facilitate effective data analysis.
It also manages VigiBase which is WHO’s database of ICSRs and the world’s largest repository of adverse effects from medicines.
Rubina Bose, deputy drugs controller (DDC), Central Drugs Standard Control Organisation (CDSCO), Western Zone emphasized on the importance of PvPI towards safe medicines.
Dr Salvador Alvarado Lopez, pharmacovigilance officer, Uppsala Monitoring Centre (UMC), Sweden informed that WHO supports the national regulatory authorities of member countries by providing their stakeholders easy access to VigiFlow and Vigibase and that WHO is currently running a pilot project of online reporting of AEs by pharmaceutical companies.
Uppsala Monitoring Centre (UMC) based in Sweden is an independent centre for drug safety and scientific research working towards safe and effective use of medicines globally. It collects and analyses data from most countries around the world to make sure appropriate standards and systems are in place to prevent unnecessary harm to patients.
Dr Vivek Ahuja, vice president, medical affairs and head, global pharmacovigilance, Sun Pharma India explained that there is a need to overcome barriers in PV practices through inculcating positive behavioral changes towards AE reporting among the professionals involved in supply chain management of medicines like manufacturers, importers and distributors.
He emphasized that we need to give personal motivation, use deliberate practice and implement regulatory obligation to change the environment. There is now a growing sense of assurance from MAHs that they would effectively implement the PV system and also train their colleagues in their organization.
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