New MDMCs set up related to medical device

New MDMCs set up in Uttarahand, Karnataka & Gujarat to report adverse events related to medical device

Medical Devices Lab

As a major boost to the Materiovigilance Programme of India (MvPI), the Ghaziabad-based Indian Pharmacopoeia Commission (IPC) has designated the following as the new Medical Device Adverse Event Monitoring Centres (MDMC) adding to the current list of 26 MDMCs in the country to report serious adverse events (SAEs) due to faulty medical devices.

  • All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand;
  • Hassan Institute of Medical Sciences, Hassan, Karnataka;
  • Parul Institute of Pharmacy, Vadodara, Gujarat

MDMCs have been set up to analyse SAEs 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.

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

To strengthen the culture of reporting SAEs, government had earlier mandated to report SAEs through the Pharmacovigilance Programme of India (PvPI) also.

Also read: Medical devices to be regulated as drugs

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.

The purpose of the programme is to study and follow MDAE and enables dangerous ones to be withdrawn from the market.

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 SAEs due to medical devices as part of the MvPI.