IPC registers 35,979 ICSRs to maintain product specific safety data

The amendment to the Drugs and Cosmetics (D&C) Rules, 1945, has made pharmacovigilance (PV) a legal obligation for MAHs

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The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (PvPI), has registered 35,979 Individual Case Safety Reports (ICSRs) during 2019-20 through 104 Marketing Authorization Holders (MAHs) for maintaining product specific safety data in the country.  

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The amendment to the Drugs and Cosmetics (D&C) Rules, 1945, has made pharmacovigilance (PV) a legal obligation for MAHs. Therefore, MAHs have been mandated to set up pharmacovigilance cell in their companies in accordance with the D&C Rules, 1945 through a gazette notification on March 8, 2016.    

Medicine Tablet
Picture: Pixabay

This will guide them to collect, process and forward the report to the licensing authority for information on adverse drug reactions (ADRs) emerging from the use of the drug manufactured or marketed by the respective MAH in the country.

The drug exporting pharmaceutical companies can 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.

A pharmaceutical company can meet their PV obligations either by setting up in-house systems for PV or can enter into contractual arrangements with contract research organizations (CROs) specializing in PV function.

Besides monitoring at ADR monitoring centres (AMCs), NCC-PvPI, also received ADRs through several hospitals and medical colleges (non-AMCs) across India. The non-AMCs sends the suspected ADRs filled in the suspected ADR reporting form to a dedicated e-mail- [email protected]

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Further, these reports are processed for causality assessment at the nearby AMC and communicated to WHO-UMC through VigiFlow. During the Index Period of 2019-20, as many as 2508 ADRs were reported via non-AMCs.

The PvPI has reported total 63,384 ICSRs for the period 2019-20 from AMCs, pharmaceutical industry and consumers to VigiBase for effective ADR monitoring, as per the official data released by IPC.

Coherent and flawless communication channels have been key to successful functioning of PvPI programme. The dissemination of knowledge and expertise at NCC-PvPI has been successfully percolating to its target audience and across the board to the AMCs affiliated to it with use of state-of-the-art information technology.

PvPI Helpline with Toll free number 1800 180 3024 was initiated on October 11, 2013. Since then it has been serving as one of the reliable tools for reporting suspected adverse events.

Patients, consumers and healthcare professionals (HCPs) report suspected adverse events due to the use of medical products or medical devices with the continuous efforts of PV officials posted at AMCs. Through the helpline facility, calls are primarily responded to in English and Hindi on all working days between 9:00 am and 5:30 pm.

“ADR PvPI” Mobile app is also freely downloadable from Google Play Store for reporting of adverse event by the HCPs or consumers.

ADR is one of the leading causes of morbidity and mortality worldwide. The consequences of ADRs burden on the healthcare system are increased cost of therapy and prolongation of hospitalization. It is, therefore, imperative to monitor the safety of medicines.

PvPI is Government of India’s flagship drug safety monitoring programme which collates and analyses drug-related adverse events. Union health ministry recasted this programme on April 15, 2011 resulting in shifting PvPI from All India Institute of Medical Sciences (AIIMS), New Delhi to IPC, Ghaziabad. Since then, IPC has been entrusted with the responsibility as the NCC-PvPI.

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