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Centre may push for MAHs participation in ADR reporting in PvPI

Suja Nair Shirodkar
Thursday, October 13, 2016, 08:00 Hrs  [IST]

Keen to set new standards for patient safety through a strong PvPI, the Centre is contemplating to begin auditing of marketing authorization holders (MAHs) to ensure ADR reporting from medical representatives of MAHs as well. In a recent meeting there was a consensus among experts for the need for the MAHs to establish a well-integrated pharmacovigilance system in their respective organizations.

Through this move, the IPC hopes to expand its reach to ensure better participation and contribution from all the segments of the pharma industry including MAH in reporting of ADRs effectively to PvPI. Sources informed that taking into consideration the pivotal role that marketing authorization holders can play in further expanding the PvPI, there was strong recommendation among experts to include them actively in the ADR reporting.

To enable this, experts suggested making available updated package insert leaflet information of the respective products on their website by MAHs. This is with a view to enhance the quality of reports and focus on causality assessment while filing ADR reports. These recommendation submitted by IPC are said to be under serious consideration by the Centre.

The meeting also focused on the need for the industries to implement and develop a system to report Indian ICSRs or periodic safety update reports (PSUR) in XML ICH E2B format within 30 days. To enhance and strengthen the PvPI, experts also recommended the development of indigenous system or information technology (IT) tool to report, collate, analyse and identify new signals in pharmacovigilance is the need of hour to ensure that a robust pharmacovigilance system is in place. This is along with updating patient information leaflets (PILs) regularly and submission of updated PILs to CDSCO and NCC-PvPI.

Over the years, the IPC which acts as the national coordinating centre (NCC) has been working very hard to strengthen the PvPI across the country. Under its able leadership, 23 new AMCs were launched across the country this year, as AMCs of PvPI establishing itself from Kashmir to Kanyakumari bringing its total number of AMCs to 202. At present there are AMCs established in 29 states and four union territories (UTs) across the country.


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Prajith Pharm D Oct 13, 2016 12:02 PM
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1. Increased scrutiny of drug safety due to high visibility drug withdrawals
2. Ensuring regulatory compliance as per the requirement of different agencies
3. Need to have surveillance programs through the product’s life cycle
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5. Integration of safety data collected through partners/affiliates

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