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New Delhi: The Indian Pharmacopoeia Commission (IPC) has ordered marketing rights holders to “promptly” report all adverse events due to medical devices, concerned by the underreporting of such cases linked to locally made equipment.
Serious & Non-serious Cases
The move, seeking to enhance patient safety, requires them to report events-both serious and non-serious, and known and unexpected-on the government’s Materiovigilance Programme of India (MvPI) platform.
The directive comes amid an India recall of Johnson &Johnson’s hip replacement device in the wake of global reports of metal poisoning and high failure rates. “Adverse event reporting under MvP is not merely a regulatory requirement but a cornerstone of patient safety,” said a recent letter by V Kalaiselvan, secretary-cum-scientific director, IPC.
The letter said that despite the availability of simplified reporting mechanisms, underreporting by domestic medical device manufacturers continues to be a matter of concern, limiting the completeness of national safety data and delaying detection of potential risks in the Indian market.
Many Benefits Seen
He said that timely and accurate reporting helps facilitate identification of new and emerging risks, assess the frequency and severity of known risks, and implement appropriate risk mitigation measures such as design changes, labelling updates, field safety corrective actions, and other regulatory interventions.
To facilitate seamless and user-friendly reporting, multiple reporting modalities have been developed by the government, said the letter.
Last year India’s drug regulator had also asked the manufacturers of medical devices to establish a robust system for the timely identification and reporting of adverse events.
To ensure compliance with the quality management system, the drug regulator had said that it was “imperative” that all medical device licence holders establish robust systems and processes for the timely identification, documentation, and reporting.
Patient Safety Key
The government mandates companies to carry out post-market surveillance (PMS) of medical devices to ensure safety and performance of the medical devices.
The health ministry had earlier launched the MVPI to improve Indian patient safety by monitoring, recording and analysing the root cause of adverse events or risks associated with the use of medical devices.
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