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The Indian Pharmacopoeia Commission (IPC) has till date established a nationwide robust network of 639 Medical Device Adverse Event Monitoring Centres (MDMCs) in the country from an initial 10 MDMCs under the Materiovigilance Programme of India (MvPI) to report medical device related adverse events (MDAEs), according to official sources.
MvPI, under the aegis of the IPC, plays a vital role in identifying, assessing, and preventing adverse events or risks associated with medical products. It was launched by the Union health ministry on July 06, 2015.
IPC, an autonomous institution under the Health Ministry, publishes Indian Pharmacopoeia (IP) to set the benchmark for pharmacopoeial standards for drugs for use in humans and animals.
Today, IPC, which is also the National Coordination Centre (NCC) for the MvPI, coordinates a nationwide network of MDMCs established in hospitals, medical colleges, and other healthcare institutions. The MDMCs act as frontline units responsible for collecting and forwarding reports of MDAEs to the NCC at IPC for scientific evaluation and regulatory follow-up.
At the inception of the programme, the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, was designated as the NCC for the MvPI. However, in 2018, the IPC, Ghaziabad, was entrusted with the role of the NCC, while SCTIMST transitioned to serve as the National Collaborating Centre to offer technical and scientific expertise.
MvPI’s main purpose is to strengthen its post-market surveillance system and align national practices with global standards of medical device vigilance, as adopted by regulatory bodies such as the US FDA, European Medicines Agency (EMA), and the World Health Organization (WHO).
In order to promote a culture of safety and accountability in medical device use, the MvPI has built a national database of medical device adverse events, strengthened evidence-based decision-making in device regulation, enhance public confidence and oversight mechanisms.
According to officials, MvPI continuous its focus and efforts in training, capacity building, and sensitization of healthcare personnel regarding the importance of medical device vigilance. Through these initiatives, MvPI is currently addressing the challenges of underreporting of medical device related adverse events largely due to limited awareness, misconceptions about liability, and lack of familiarity with reporting processes among healthcare professionals.
“In order to ensure patient safety and device reliability in the rapidly evolving medical technology landscape, MvPI acts as a bridge between healthcare professionals, manufacturers, and regulators. While challenges remain, the ongoing focus on digital transformation, stakeholder awareness, and scientific evaluation is expected to further enhance the programme’s reach and impact,” according to an official.
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