Out of the 150 ADR Monitoring Centres (AMCs), 40 AMCs have been identified for registration with the Vigiflow software which is meant to report adverse drug reaction (ADR) data to World Health Organisation (WHO) database on a consistent basis, as a part of the Pharmacovigilance Programme of India (PvPI), informed an official associated with the development.
Currently 110 centres have the Swedish software Vigiflow which helps in accurate reporting of ADRs with the help of Technical Data Associates (TDAs) working in the ADR monitoring centres as of today. They are working 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 (UMC) 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 speciality is slowly picking up in the country but research and reporting outcomes are limited. Effective communication of the safety data to the general public is a key challenge which need to be addressed on a war footing. Letter writing, package insert warnings are some of the conventional methods used for communication of pharmacovigilance knowledge.
It has also been given to understand that there has also been lack of methodological approach and the specialty of pharmacovigilance has been more hospital focused than community focused.