Health ministry sensitises pharma cos to set up PV cells for monitoring ADRs

Health ministry sensitises pharma cos to set up PV cells for monitoring ADRs

Mumbai, September 22, 2017:


In order to equip and sensitise Indian pharma companies to set up pharmacovigilance (PV) cells for generating adverse drug reaction (ADR) data, Ghaziabad based Indian Pharmacopoeia Commission (IPC) under the Union health ministry conducted workshops in Bengaluru and Hyderabad in the first week of September 2017 to help companies collect, process and forward ADRs to licensing authorities mandated through a gazette notification.


The Union health ministry, through a gazette notification on March 8, 2016, had mandated pharma companies to set up PV cell in their companies in accordance to the Drugs and Cosmetic Rules for updates on ADRs emerging from the use of the drug manufactured or marketed by the respective market authorisation holders (MAH) in the country.


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.


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.


According to sources, 70 pharma companies have set up PV cells in their organizations  to collect, process and forward ADRs to licensing authorities. There has also been active participation from market authorisation holders (MAHs) for ADRs. 


The Pharmacovigilance Programme of India (PvPI) has so far reported around 3 lakh adverse drug reactions (ADRs), as it has added 40 more ADR monitoring centres (AMCs) in the past three months.


As of today, PvPI has under its fold 250 AMCs. Around 40 AMCs were identified at district hospitals based in the North Eastern part of India, Uttar Pradesh and Himanchal Pradesh to get 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. IPC had earlier this year received the letter of intent from 40 district hospitals to participate as AMCs under the PvPI at district level.


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.


Typical activities in PV department are ADR case processing and reporting (electronic or hard copy), Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Report (PADER), product quality complaints management, medical inquiries management, safety data exchange agreement management, signal detection for risk-benefit evaluation, risk management programs (RMP), literature monitoring for ADR case reports (including local literature monitoring, EU MLM search), training of company employees on ADR reporting, global compliance monitoring, audits and inspections.