Last Updated on March 9, 2021 by The Health Master
The Pharmacovigilance Programme of India (PvPI) has so far reported around 4.7 lakh adverse drug reactions (ADRs) since its inception in 2010 and plans to add 30 more ADR monitoring centres (AMCs) in the current list of 311 AMCs by March 31, 2021.
As of today, PvPI has under its fold 311 AMCs. 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 311 registered AMCs today 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.
IPC is also planning to roll out PvPI at district level hospitals for its effective implementation. Ghaziabad based IPC has been receiving letter of intent from district hospitals across the country to participate as AMCs.
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.
Government, through a gazette notification March 8, 2016, has mandated pharma companies to set up PV cell in their companies in accordance to the rules for updates on ADRs emerging from the use of the drug manufactured or marketed by the respective MAH in the country.
A pharmaceutical company can meet their pharmacovigilance obligations either by setting up in-house systems for pharmacovigilance or can enter into contractual arrangements with contract research organizations (CROs) specializing in pharmacovigilance function.
The drug exporting pharmaceutical companies are supposed to set up a PV system to fulfill its legal tasks in relation to pharmacovigilance, design to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.