IPC Discloses 9,373 Serious Medical Device Adverse Events Since 2020: Report

The Indian Pharmacopoeia Commission has disclosed for the first time that it received and reviewed 9,373 Serious Adverse Events caused by the use of medical devices in India since 2020, with the annual count rising from 808 in 2020 to 2,176 in 2025, a nearly three-fold jump across six years. Serious Adverse Events, or SAEs, are medical events that may lead to life-threatening conditions or prolonged hospitalisation.

The Indian Express in a report accessed the figures on October 27 after a September 10 part-compliance order by a bench of the Central Information Commission under the RTI Act. The data covers SAEs “received and reviewed” by the IPC, an autonomous Central body that publishes official standards for drugs.

The disclosure matters because the IPC has so far published annual totals for Medical Device Adverse Events, or MDAEs, from 775 monitoring centres across the country, while keeping the serious-event numbers restricted. The release also throws light on how India reports device-related harm and how much detail remains outside the public domain.

Secrecy And Disclosure

The IPC publishes annual MDAE totals but has not separately broken out “serious” cases in its reports for the last three years. Those reports give broad counts of medical device adverse events but do not categorise serious events on their own.

That changed after an 11-page CIC order on an appeal filed by The Indian Express. Information Commissioner Jaya Varma Sinha referred to the IPC’s plea that disclosing the category of device involved and its manufacturer would violate “commercial confidence”.

The order held that brand details and a description of every medical device for which an MDAE had been logged could not be disclosed because “it is not conclusively established whether they arose due to a procedural lapse or due to the medical device itself”. The IPC told the CIC bench: “the information sought regarding the name of the manufacturer of the medical device is exempted from disclosure under Section 8(1)(d) of the RTI Act, 2005, as it relates to commercial confidence and third-party information, the disclosure of which may harm the competitive position of the concerned entity”.

The IPC also argued that details such as the category and manufacturer of each MDAE were “too voluminous” and that sharing them “requires collection and collation which would divert the time and resources of the public authority”.

Earlier Device Data

In 2018, as part of Implant Files, The Indian Express first reported on the categorisation of MDAEs in the medical devices industry and its links with doctors and hospitals.

That reporting showed that coronary stents made by Abbott accounted for more than 50 per cent of the entries. Of the 566 MDAEs logged that year, 290 related to Abbott coronary stents.

Abbott had said then that its stents were recognised as “among the world’s most used and studied” with “an unparalleled safety record”. After that, The Indian Express filed several RTI requests seeking an updated version of the 2018 dataset, but the information was denied under provisions of the RTI Act.

The six-year dataset has now been released after a final appeal filed by the newspaper before the CIC in 2025.

Annual Device Totals

The broader annual data shows a much larger stream of reports. In 2024-2025, the IPC logged 14,584 MDAEs, but forwarded only 22 cases to the Central Drugs Standard Control Organisation for “necessary action”.

Those 22 “suspected devices” were mostly everyday items such as surgical gloves, syringes and urine bags. The list also included one mechanical ventilator and one blood transfusion set according to The Indian Express.

The pattern was similar a year earlier. In 2023-2024, the IPC listed 10,269 MDAEs and sent only 16 cases to CDSCO. That set included pregnancy test kits, catheters and BP monitors, along with one drug-eluting stent.

The 2022-2023 count stood at 3,868 MDAEs. Twelve cases were forwarded to CDSCO that year, including one suspect inhaler, one incubator and one coronary stent. The IPC committee said the 12 suspect medical devices that needed “further action” included a male condom. The 2022-2023 report also listed a male condom as a “counterfeit device”.

Monitoring System Context

The reporting system sits under the Materiovigilance Programme of India, launched in 2015. Under this programme, the IPC compiles MDAEs and runs the Adverse Drug Monitoring System (ADRMS), an online portal meant to streamline reports of adverse events related to medical devices.

The reporting timeline is short. All SAEs must be reported to the IPC within 15 days. Global norms classify an event as serious if it leads to death, extended hospitalisation, a life-threatening situation or disability, among other outcomes.

Other countries disclose more. In the US, the Manufacturer and User Facility Device Experience, or MAUDE, database is a public repository of adverse events and problems linked to all categories of medical devices. It lets users see details such as the brand, manufacturer, model and the type of adverse event reported.