As a step towards strengthening the pharmacovigilance programme of India (PvPI), the Indian Pharmacopoeia Commission (IPC) under the Union Health Ministry has so far registered a total of 250 adverse drug reaction (ADR) monitoring centres (AMCs) to access pan -India ADR information.
PvPI has till date reported around 2.30 lakh adverse drug reactions through AMCs and registered 25% contribution from market authorisation holders (MAH). Around 75% has come from its integration with national health programmes and consumers.
MAHs collect, process and forward the report to the licensing authority for information on adverse drug reactions emerging from the use of the drug manufactured or marketed by the respective MAH in the country through a gazette notification on March 8, 2016.
Nine more AMCs were recently added at district hospitals and medical colleges in the state of Uttar Pradesh (UP) based on the letter of intent received by the Union Health Ministry.
Meanwhile, Drug Controller General of India (DCGI) has also suggested to explore possibilities of identifying district hospitals across the country to be developed as AMCs. This is followed by 31 ADR monitoring centres having been identified recently at district hospitals based in the North Eastern part of India and Himanchal Pradesh.
IPC is in the process of identifying more such district hospitals which wish to participate as AMCs under the PvPI at district level. Pan India ADR information will be taken forward with all district hospitals in the country and implemented at PHC and taluka level health centres. This will augment government’s plan to roll out the pharmacovigilance programme of India at district level hospitals in a few months time.
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.
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. The registered AMCs across the country play an important role in timely reporting of adverse drug reaction to IPC. Once enrolled, NCC provides logistic and technical support to AMCs for their smooth functioning.
Technical data associates (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 part of the programme.