The Pharmacovigilance Programme of India (PvPI) and Central Drugs Standard Control Organisation (CDSCO) will be drafting this guidance document for good pharmacovigilance (PV) in India for drug safety. The main intention behind this guideline is to give the industry with best practices in pharmacovigilance that can help them in preventing Adverse Drug Reactions (ADRs). The guidelines will feature relevant areas like signal observation for risk-benefit evaluation and management. A pharmaceutical company can meet their PV obligations either by setting up in-house systems for PV or can enter into contractual plans with Contract Research Organizations specializing in PV function.
Typical activities in PV department are Adverse Drug Reactions case processing and reporting, Periodic Safety Update Report, Periodic Benefit Risk Evaluation Report, Periodic Adverse Drug Experience Report , product quality complaints management, medical inquiries management, safety data exchange agreement management, signal detection for risk-benefit evaluation, risk management programs, literature monitoring for Adverse Drug Reaction case reports, training of company employees on ADR reporting, global compliance monitoring, audits and inspections.
The number of SOPs related to PV may vary from few in number to many, depending upon the length and complexity of the processes involved. The SOPs are expected to cover all PV functions and should be structured comprehensively detailing the necessary steps. Since PV involves global operations, clearly written SOPs ensures consistency, compliance, and quality, clear roles and responsibilities, uniform performance over multiple users to avoid errors of oral communication.
Health care professionals, consumers, clinical trials, PMS studies, regulatory authorities, literature publications, social media, product quality complaints, medical enquiries, pre-clinical research and business partners are the sources of collection of adverse event reports.
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