IPC Identifies 17 Medical Device Monitoring Centres To Analyse SAEs Exclusively

Mumbai, 12 July 2019: To develop the culture of reporting of adverse events in healthcare institutions in the country, the Ghaziabad-based Indian Pharmacopoeia Commission (IPC) has identified 17 medical device monitoring centres pan India to analyse serious adverse events (SAEs) exclusively as part of Materiovigilance Programme of India (MvPI).

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 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. Government has also been contemplating to introduce a high risk medical device registry to track SAEs due to faulty medical devices. 

Uptil now SAEs have been reported through the Pharmacovigilance Programme of India (PvPI). Central Drugs Standard Control Organisation (CDSCO) had launched PvPI in July 2010 with Ghaziabad-based IPC as the National Co-ordinating Centre (NCC) to track adverse drug reactions (ADRs).

“Considering the fact that PvPI has filled the vacuum in reporting SAEs through its 270 ADR monitoring centres (AMCs) in the country, SAEs need to be intensively analysed in view of patient safety as devices are different from drugs which have a different shelf life. Medical device monitoring centres will do a dedicated job of reporting and analysing SAEs as envisaged in MvPI,” explains Dr V Kalaiselvan, principal scientific officer, IPC, Ghaziabad. 

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.

“Besides this, we are strengthening and evolving various tools to report SAEs like the Medical Device Adverse Event (MDAE) reporting form,” added Dr Kalaiselvan. 

The union health ministry in the past had mandated AMCs across the country to report SAEs due to medical devices as part of the MvPI.

The MvPI, being coordinated by the IPC at Ghaziabad, was launched in 2015. IPC 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