Serious medical device incidents rise threefold in India, IPC data shows

The Indian Pharmacopoeia Commission reported that serious adverse events linked to medical devices surged to 2,176 in 2025, up from 808 in 2020, bringing the six‑year total to 9,373 cases. These events are defined as incidents that can cause death, long hospital stays or lasting disability. The figures were obtained after a Central Information Commission order compelled the IPC to share data that had previously been kept confidential. The commission, which sets official drug standards, had only published overall numbers of device‑related adverse events from its network of 775 monitoring centres, without separating the serious cases. Earlier reports listed minor items such as disposable gloves, injection needles and urine collection bags, and even a male condom in the 2022‑23 list, as suspected faulty devices. The IPC argued that revealing manufacturers’ names would breach commercial confidentiality, citing Section 8(1)(d) of the RTI Act, and the CIC order agreed that brand details could not be released without clear proof of device fault. In 2018, an investigative series showed that more than half of the recorded device problems involved coronary stents made by Abbott, with 290 of the 566 incidents that year linked to those stents. The IPC’s annual data show 14,584 device adverse events logged for 2024‑25, but only 22 were sent to the Central Drugs Standard Control Organisation for action, the majority being items like gloves, needles and urine bags. Similar patterns appear for the previous two years, with only a few dozen cases forwarded for regulatory review. The IPC gathers these reports under the Materiovigilance Programme of India and runs the ADRMS online portal, requiring reporting of serious events within 15 days.

Context

India’s device safety system mirrors international schemes such as the U.S. MAUDE database, but limited public disclosure makes it harder for patients and watchdogs to assess risks.