To ensure getting pan India adverse drugs event information, government is planning to upgrade 10 per cent of its technical data associates (TDA) to the cadre of senior technical data associates (STDA) working in over 100 Adverse Drug Reaction Monitoring Centres (AMCs) across the country under the Pharmacovigilance Programme of India (PvPI).
The promotion of the TDAs is subject to the respective TDA having a satisfactory work experience of two years and a satisfactory work report. Lateral entry is also ensured to enhance the career prospects of the TDAs and to also upgrade the manpower on an ongoing basis based on the requirement of the AMCs in the country.
Currently, 125 TDAs are working under PvPI. 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.
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. Ghaziabad based Indian Pharmacopoeia Commission (IPC) which is the national coordination centre (NCC) for PvPI serves as a nodal agency for the AMCs. Currently, 180 AMCs have been established in India under PvPI.
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 also keenly focusing on bringing the hospitals under the rural and urban areas under its fold.
Around 180 registered AMCs across the country play an important role in timely reporting of adverse drug reaction (ADR) to IPC. Once enrolled NCC provides logistic and technical support to AMCs for their smooth functioning.