Mumbai: The Materiovigilance Programme of India (MvPI), under the aegis of the Indian Pharmacopoeia Commission (IPC), has received and reviewed 47,614 medical device associated adverse event cases until September 2025 since its inception in 2015.
It has forwarded 59 recommendations to the Central Drugs Standard Control Organisation (CDSCO) for regulatory consideration and issued 37 medical device safety alerts. These safety alerts were further disseminated to all the Medical Device Adverse Event Monitoring Centres (MDMCs) and relevant stakeholders for prompt action.
The IPC has till date established a nationwide robust network of 639 MDMCs in the country from an initial 10 MDMCs under the MvPI to report medical device related adverse events (MDAEs). 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.
The MvPI is a flagship public health initiative launched by the ministry of health and family welfare (MoHFW), Government of India, on July 06, 2015. The programme was established to ensure patient safety, quality, and performance of medical devices used in the country by systematically monitoring, collecting, and analysing MDAEs.
The MvPI officials have urged its stakeholders i.e. healthcare professionals, biomedical engineers, manufacturers, importers, distributors, and patients to voluntarily report any incident of device malfunction, performance failure, or labelling error that may compromise patient safety.
To facilitate efficient and user-friendly reporting, the programme has introduced multiple reporting platforms, including Medical Device Adverse Event Reporting Form (for institutional or individual reporting), available in Hindi and English along with instructions for use at www.ipc.gov.in).
The MvPI has introduced Adverse Drug Reaction Monitoring System (ADRMS) platform, which was officially launched by the Union minister of health & family welfare and minister of chemicals and fertilizers, J P Nadda, during the 1st Policy Makers’ Forum held on August 19, 2024. This digital advancement marks a critical step toward integrated pharmacovigilance and materiovigilance reporting within a unified platform.
It has also launched MvPI Mobile Application (available on Google play store), and Toll-Free Helpline (1800-180-3024) for effective reporting of MDAEs.
Each report received under MvPI undergoes a systematic evaluation by MvPI team followed by domain experts to determine the cause, severity, and preventability of the reported event. Based on these analyses, the NCC at IPC provides evidence-based recommendations to the CDSCO for appropriate regulatory actions. Such actions may include issuance of safety alerts, revisions in labelling or instructions for use, and mandating additional testing or clinical evaluations.
