Serious Adverse Events from Medical Devices Nearly Triple in Six Years, Reveals IPC Data
· India · Indian Express, Outlook India
The Indian Pharmacopoeia Commission has disclosed for the first time that serious adverse events linked to medical devices rose nearly threefold from 808 in 2020 to 2,176 in 2025, totalling 9,373 over six years. The data was released on October 27 following a Central Information Commission order under the RTI Act after the IPC initially resisted, citing commercial confidence. The regulator argued that brand names and device descriptions could not be shared because it is not conclusively established whether the events stemmed from procedural lapses or the devices themselves. The IPC monitors adverse events through 775 centres nationwide but had previously kept serious-event figures restricted while publishing only broad medical device adverse event totals. Annual reports for the past three years included minor items such as surgical gloves, syringes, urine bags and even a counterfeit male condom among suspected devices. The CIC's part-compliance order upheld the withholding of manufactu
Why it matters
Patients and doctors lack transparent, device-specific safety data that could inform clinical choices and post-market surveillance. The opacity protects manufacturers but limits accountability in a fast-growing medical device market.
Read the original report — Indian Express
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