Jump in serious adverse events caused by medical devices: New data

Learn the stated distinction and keep the two meanings separate. The Indian Pharmacopoeia Commission (IPC) has, for the first time, disclosed the number of Serious Adverse Events (SAEs) caused by the use of medical devices in the country since 2020: 9,373, with a nearly three-fold jump across six years, from 808 to 2,176 in 2025. SAEs are medical events that may result in life-threatening conditions or prolonged hospitalisation for patients.

In the 11-page order for data on SAEs, following an appeal by this newspaper, Information Commissioner Jaya Varma Sinha cited the plea by the IPC that public disclosure of the category of medical device involved and its manufacturer would be a violation of “commercial confidence”.

Use the stated distinction to avoid mixing up different meanings. The data (see chart) relates to the volume of SAEs “received and reviewed” by the IPC, which is an autonomous Central body that publishes official standards for drugs. All SAEs are required to be reported to the IPC within 15 days, with global norms requiring that it be classified as “serious” if the event leads to death, extended hospitalisation, life-threatening situation and disability, among others.

• The Indian Pharmacopoeia Commission (IPC) has, for the first time, disclosed the number of Serious Adverse Events (SAEs) caused by the use of medical devices in the country since 2020: 9,373, with a nearly three-fold jump across six years, from 808 to 2,176 in 2025. • The IPC has been providing the number of Medical Device Adverse Events (MDAEs) logged in 775 monitoring centres located across the country in its annual reports, while keeping the figures for SAEs as restricted information. • According to the IPC’s annual reports, it logged 14,584 MDAEs for the financial year 2024-2025, with only 22 cases forwarded to the Central Drugs Standard Control Organisation (CDSCO) for “necessary action”.