Aimed at ushering in good pharmacovigilance (PV) practices in the country for drug safety, around 100 pharma companies have joined hands with Central Drugs Standard Control Organisation (CDSCO) and Pharmaco-vigilance Programme of India (PvPI) to come up a set of exhaustive guidelines on par with the existing global guidelines.
The guidelines will feature pertinent areas like signal detection for risk-benefit evaluation and risk management programmes. Signal management is not compulsory in the present set of guidelines. Risk benefit of the product can be measured properly through signal detection.
“Apart from the overwhelming response in the form of participation, pharma companies have also responded in a big way by submitting their ADR reports in Extensible Mark- up Language format (XML-E2B),” said a senior official associated with the development.
Pharmaco-vigilance programme of India (PvPI) had mandated pharmaceutical companies to submit their ADR reports in XML -E2B towards building the quantum of adverse drug reaction reports (ADRs) for drug safety in the country.
As of today, around one lakh adverse drug reactions (ADRs) have been reported from PvPI to the Uppsala Monitoring Centre (UMC) in Sweden, which is WHO's collaborating centre for international drug monitoring. Various Indian headquartered global pharmaceutical companies have also established in-house PV units to remain compliant with PV regulations outside India.
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.
Government has also notified that the companies shall have a pharmacovigilance (PV) system in place for collecting, processing and forwarding the report to the licensing authority for information on ADRs emerging from the use of drug manufactured or marketed by the pharmaceutical companies in India.
There are 210 ADR Monitoring Centres (AMCs) in the country registered with the Vigiflow software which is meant to report adverse drug reaction (ADR) data to World Health Organization (WHO) database on a consistent basis, as a part of the PvPI.
Technical Data Associates (TDAs) working in the AMCs help in accurate reporting of ADRs with the help of Vigiflow in coordination with Indian Pharmacopoeia Commission (IPC) Ghaziabad for final analysis and reports.
The drug exporting pharmaceutical companies can 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.
List of SOPs for PV Dept involves procedures for collecting the adverse event reports, validating the adverse reaction reports, evaluating the cases for their seriousness, follow up of cases for missing information, expedited reporting, electronic reporting, periodic reports, signal management and risk benefit assessment and response to request for information from regulatory authorities, Interaction between safety issues and product defects, handling of urgent safety restrictions and safety variations, management and use of databases, training, internal audit of the pharmacovigilance system and archiving.
Sources of collection of adverse event reports are health care professionals, consumers, clinical trials, post marketing surveillance studies, regulatory authorities, literature publications, social media, product quality complaints, medical inquiries, pre-clinical research and business partners.