Serious adverse events from medical devices see nearly three-fold jump
The Indian Pharmacopoeia Commission disclosed 9,373 serious adverse events caused by medical devices since 2020, according to The Indian Express.
The Indian Pharmacopoeia Commission (IPC) has disclosed that 9,373 serious adverse events (SAEs) caused by medical devices have been recorded in the country since 2020. According to a report by The Indian Express, these events, which can lead to life-threatening conditions or prolonged hospitalisation, have seen a nearly three-fold increase from 808 cases to 2,176 in 2025.
The data was accessed on October 27 following a part-compliance order issued by a bench of the Central Information Commission (CIC) on September 10. The IPC is an autonomous Central body that publishes official standards for drugs and manages the Materiovigilance Programme of India (MvPI).
The IPC previously provided figures for Medical Device Adverse Events (MDAEs) in annual reports but kept SAE figures as restricted information. In the 2024-2025 financial year, the IPC logged 14,584 MDAEs, with 22 cases forwarded to the Central Drugs Standard Control Organisation (CDSCO) for action.
Information Commissioner Jaya Varma Sinha issued the 11-page order for the SAE data after an appeal by The Indian Express. The IPC had argued that disclosing the category and manufacturer of each device would violate commercial confidence and that providing such details would be too voluminous.
The order stated that brand details and descriptions of every device could not be disclosed because it is not conclusively established whether the events arose from a procedural lapse or the device itself. The IPC contended that disclosing manufacturer names could harm the competitive position of entities under the RTI Act, 2005.