Union health ministry is in the process of setting up Adverse Drug Reaction Monitoring Centres (AMCs) in teaching hospitals and centres covered under the National Health Programmes (NHP). Corporate hospitals will also be roped in as a part of the programme, an official informed.
Ghaziabad based Indian Pharmacopoeia Commission (IPC) which is the national coordination centre (NCC) for Pharmacovigilance Programme of India (PvPI) will serve as a nodal agency for the AMCs. Currently, 150 AMCs have been established in India under PvPI.
Government's plan to establish ADR centres in all the medical colleges will help leverage resources like technical manpower required for the PvPI. Technical Data Associates (TDAs) working under PvPI will hence get support from the pharmacology division of the respective medical institutions to carry out their functions as a part of the programme.
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. Currently, 110 centres have the Swedish software Vigiflow which helps in accurate reporting of ADRs with the help of TDAs working in the ADR monitoring centres as of today. Around 40 more such centres have been identified to be registered with Vigiflow soon.
To ensure pan India presence for getting adverse event information from the patients from across the spectrum, IPC is keenly focusing on bringing the hospitals under the rural and urban areas under its fold.
With the addition, the total number of AMCs enrolled within the IPC under the pharmacovigilence programme will be 180. Currently, there are 150 registered AMCs across the country that plays very important role in timely reporting of adverse drug reaction to IPC. Once enrolled NCC will provide all kind of 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 as required followed by entering information in the Vigiflow and sending them to NCC via the same software.