It has come to the notice that around 3 lakh adverse drug reactions (ADRs)have been reported so far by the Pharmacovigilance Programme of India (PvPI), due to the 40 more ADR monitoring centres (AMCs) in the past three months.
Around 250 AMCs are under PvPI fold and around 40 AMCs were identified at the district hospitals that are based in the North Eastern part of India, Uttar Pradesh and Himachal Pradesh to get the PAN India ADR information. This has augmented Government’s plan to roll out the pharmacovigilance programme of India at district level hospitals in few months time.
India Pharmacopoeia Commission (IPC) based in Ghaziabad under the Union Health Ministry has received a letter of intent from 40 district hospitals to participate as AMCs under the PvPI at the district level. IPC is the national coordination centre (NCC) for PvPI.
Indian Pharmacopoeia Commission (IPC) is assigned to update information on ADRs that is being reported in India from all its ADR monitoring centres (AMCs) through a Vigiflow software to the Uppsala Monitoring Centre (UMC) in Sweden. UMC is the WHO’s collaborating centre for international drug monitoring. Vigiflow software is given free of cost to PvPI and prescribed to AMCs based on the efficiency to deliver in terms of frequency and quality of reports.
IPC serves as a nodal agency for AMC. There are around 210 registered AMCs across the country that play an important role in timely reporting of ADR to IPC. Logistic and technical support will be provided to the AMC once they are registered for smooth functioning.
The hospitals, medical colleges and institutes that are approved by the Medical Council of India (MCI) can act as AMCs. After enrollment, these organizations are required to efficiently collect the adverse event information from patients and follow up with them to check the completeness of ADR reports. IPC aims in bringing the hospitals under the rural and urban areas under its fold.
Through a gazette notification, the government has mandated the pharma companies to set up PV cell in their companies in accordance with the rules updates on ADRs emerging from the use of the drug manufactured and marketed by the respective MAH in the country.
A PV system is set up by the drug exporting pharmaceutical companies to accomplish the legal tasks in relation to the pharmacovigilance. PV system also helps in monitoring the safety of authorised medicinal products and detects any changes to their risk-benefit balance.
A pharmaceutical drug manufacturing company can meet their pharmacovigilance obligations either by setting up in-house systems for pharmacovigilance or by entering a contractual agreement with the Contract Research Organizations (CROs) specialise in pharmacovigilance function.