Pharma MNCs have started outsourcing pharmacovigilance (PV) related services to Indian Clinical Research Organisations (CROs) mostly around case processing which includes receiving, processing and reporting the PV cases to regulators in an effective way.  A pharmaceutical company can meet their pharmacovigilance obligations either by setting up in-house systems for pharmacovigilance or can enter into contractual arrangements with CROs specializing in pharmacovigilance function.

According to sources, 100 plus MNC 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 on this front.   

Pharmaceutical companies are supposed to set up a PV system to fulfill its legal tasks in relation to PV, design to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.

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 with the Drugs and Cosmetic Rules for updates on ADRs emerging from the use of the drug manufactured or marketed by the respective MAH in the country.

This comes at a time when the new draft clinical trial rules have also underlined the importance of Periodic Safety Update Report submission and post marketing surveillance for patient safety.  

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.

These functions according to experts involves periodic reporting, writing aggregate reports, literature searches from doctors across the world and if there is a side-effect from a drug, it can be captured and reported. Pharma MNCs having captive units are today giving this job to large system integrators like IQVIA.

Pharma industry has been favourably impacted by this trend as it is able to meet compliance levels at a price point where it is able to get right expertise to simulate, analyse and produce data which involves doctors and case processing teams for better case assessment towards patient safety.

This has augmented government’s plan to roll out the  pharmacovigilance programme of India (PvPI) even at district level hospitals. As of today, PvPI has under its fold 250 AMCs.

Indian Pharmacopoeia Commission (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.