Nearly 3-fold jump in serious adverse events caused by medical devices: New data

The Indian Pharmacopoeia Commission (IPC) has disclosed the alarming surge in serious adverse events (SAEs) caused by medical devices in India, with a nearly three-fold increase over six years. In 2025, the IPC recorded 2,176 SAEs, compared to just 808 cases reported in 2020. These SAEs encompass medical events that could result in life-threatening situations or prolonged hospitalization for patients.

The IPC, an autonomous Central body, has been overseeing the publication of official standards for drugs since its establishment. However, it had previously kept the figures for SAEs as restricted information.

Following a part-compliance order issued under the Right to Information Act (RTI) by the Central Information Commission (CIC), the IPC revealed the data, which pertains to the volume of SAEs received and reviewed by them. The IPC maintains records of Medical Device Adverse Events (MDAEs) logged in 775 monitoring centers across the country within its annual reports, but categorised the "serious" events separately until recently.

The IPC's refusal to disclose the category of medical devices involved and their manufacturers as it could potentially violate "commercial confidence" was challenged by the newspaper. The IPC argued that revealing such information might harm the competitive position of the respective entities. However, Information Commissioner Jaya Varma Sinha ruled in favor of transparency, stating that the disclosure of brand details and descriptions of medical devices is necessary for public welfare.

Earlier investigations by The Indian Express revealed that coronary stents manufactured by Abbott accounted for more than half of the entries in the MDAEs dataset in 2018. Despite this, the IPC denied the newspaper's subsequent requests for an update on the dataset, citing provisions of the RTI Act. The IPC's annual reports for 2022-2023, 2023-2024, and 2024-2025 logged 3,868, 10,269, and 14,584 MDAEs, respectively, with only a small fraction forwarded to the Central Drugs Standard Control Organisation (CDSCO) for further action.