In order to implement pharmacovigilance regulations effectively across the country, the Indian Pharmacopoeia Commission (IPC) has recently trained 40 drug inspectors on pharmacovigilance (PV) audit and inspections and is in the process of drafting PV audit check list for the drug regulators to implement it effectively.
A meeting with Central Drugs Standard Control Organisation (CDSCO) officials and state drug controllers concluded recently in which state drug controllers were sensitised on PV and also were apprised about the recent developments on IPC being nominated as 8th WHO collaborative centre to support World Health Organization (WHO) member countries in establishing pharmacovigilance programme in their health systems.
IPC-PV division has been assigned the status of WHO collaborating centre to promote medicine safety not only in India and but globally too. It will also provide guidelines and support in policy decision making process of WHO.
“This will help state drug controllers and other stakeholders to share IPC and WHO responsibility on implementing PV for Indian and global population towards drug safety through effective PV practices,” said Dr.V Kalaiselvan, principal scientific officer at the IPC.
IPC has also 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.
This step is very much relevant as many of the medicines employed by these public health programmes are new and/or have safety concerns associated with them.
There are 7 WHO collaborative centres globally in pharmacovigilance and WHO collaborative centre for PV in public health and regulatory services from India will serve as the 8th centre. CDSCO under the Union health ministry had initiated a nation-wide Pharmacovigilance Programme of India (PvPI) in July 2010. CDSCO and the PvPI have also come out with a set of exhaustive guidelines on par with existing global guidelines and features pertinent areas like signal detection for risk-benefit evaluation and risk management programmes towards drug safety.
Within a span of seven years, PvPI has become a formidable force at international level for the best pharmacovigilance practices including ADR reporting and providing skill development. The Individual Case Safety Reports (ICSRs) are collected in a scientific way and analysed to facilitate appropriate decisions at CDSCO.