NCC-MvPI identifies 119 new MDAEM centres in various states to report medical device adverse events
The Ghaziabad-based Indian Pharmacopoeia Commission (IPC) which is the national co-coordinating centre (NCC) for the Materiovigilance Programme of India (MvPI) has identified 119 new Medical Device Adverse Event Monitoring (MDAEM) centres in various states to report medical device adverse events.
Speaking on the sidelines of the recently concluded IPC at Nagpur, a senior IPC official said that MDAEM centres have been set up to analyse serious adverse events (SAEs) exclusively as part of MvPI.
Kerala has the maximum number of 53 centres followed by Maharashtra which has 9 centres. Other centres are located at Haryana, Jammu and Kashmir, Uttar Pradesh, Karnataka, Gujarat, Telangana, West Bengal, Andhra Pradesh, Punjab, Rajasthan, New Delhi, Jharkhand, Assam, Odisha, Tamil Nadu, Meghalaya, Haryana and Punjab.
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.
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.
“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,” according to an official associated with the development
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To strengthen the culture of reporting SAEs, the government had earlier mandated reporting of SAEs through the Pharmacovigilance Programme of India (PvPI) also. The purpose of the programme is to study and follow MDAE and enable dangerous ones to be withdrawn from the market.
IPC has also set a mandate to set up more ADR monitoring centres (AMCs) as part of PvPI with focus on North Eastern (NE) states. 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.
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