Taking a giant leap towards strengthening the pharmacovigilance programme of India (PvPI), around 30 to 40 adverse drug reaction (ADR) monitoring centres have been identified at district hospitals based in the North Eastern part of India, Uttar Pradesh and Himanchal Pradesh to get pan India ADR information.
This will augment government’s plan to roll out the pharmacovigilance programme of India at district level hospitals in few months time. Ghaziabad based Indian Pharmacopoeia Commission (IPC) under the Union Health Ministry has received the letter of intent from 40 such district hospitals which wish to participate as adverse drug monitoring centres (AMCs) under the PvPI at district level.
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 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.
IPC which is the national coordination centre (NCC) for PvPI serves as a nodal agency for the AMCs. Around 210 registered AMCs across the country play an important role in timely reporting of adverse drug reaction to IPC. Once enrolled NCC will provide logistic and technical support to AMCs for their smooth functioning.
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. IPC is keen on bringing the hospitals under the rural and urban areas under its fold.
To further widen the scope of PvPI and strengthen evidence based information, government had also upgraded a certain per cent of its technical data associates (TDA) last year to the cadre of senior technical data associates working in over 100 AMCs across the country under PvPI.
TDAs 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. The TDAs working under PvPI currently get support from the pharmacology division of the respective medical institutions to carry out their functions as a part of the programme.