MvPI Reports 1,213 Medical Devices Adverse Event Reports From Across Country Since 2014

Mumbai, 12 Aug 2019:

The Ghaziabad-based Indian Pharmacopoeia Commission (IPC) which is the National Coordinating Centre (NCC) for the Materiovigilance Programme of India (MvPI) has received 1,213 Medical Devices Adverse Event (MDAE) reports from across the country since 2014.

During the period, January 1 to March 15, 2019, MvPI received 252 reports.

Uptil now MDAEs used to be reported through the Pharmacovigilance Programme of India (PvPI). Central Drugs Standard Control Organisation (CDSCO) had launched PvPI in July 2010 and MvPI in 2015 to track adverse drug reactions (ADRs) and MDAE respectively.

This is a significant milestone as the Union health ministry has also been contemplating to introduce a high risk medical device registry to track MDAEs due to faulty medical devices.

MvPI is meant to enable safety data collection in a systematic manner so that regulatory decisions and recommendations on safe use of medical devices for India could be based on data generated in India. This is also envisaged to develop the culture of reporting of adverse events in healthcare institutions in the country.

IPC has recently identified 17 medical device monitoring centres pan India to analyse MDAEs exclusively as part of MvPI.

This is a welcome change for the consumers and patients who are administered high risk medical devices like stents and implants as part of therapy in cardiac and orthopaedic disorders.

MDAEs need to be intensively analysed in view of patient safety as devices are different from drugs which have a different shelf life.

IPC has also set a mandate to set up a total of 300 ADR monitoring centres (AMCs) by 2020 as part of PvPI with focus on North Eastern (NE) states. It is in the process of identifying district hospitals in NE states which wish to participate as AMCs under the PvPI at district level.

The Union health ministry in the past had mandated AMCs across the country to report MDAEs as part of the MvPI.

The MvPI is being coordinated by the IPC at Ghaziabad which functions as the NCC and Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as the collaborating centre. Technical support is being provided by the National Health Systems Resource Centre (NHSRC) in New Delhi.

The purpose of the programme is to study and follow MDAE and enables dangerous ones to be withdrawn from the market. Pharmabiz