Data released under the Right to Information Act show that serious adverse events linked to medical devices in India rose from 808 in 2020 to 2,176 in 2025. In 2024–25, only 22 of 14,584 device-related reports were forwarded to the national drug regulator. The figures, obtained by The Indian Express, do not show that devices have become more dangerous; rising numbers may partly reflect better reporting. They do expose a monitoring system that collects signals but rarely acts on them in public.
India’s system for tracking harm from medical devices has, for the first time, disclosed how often things go wrong. According to The Indian Express, which obtained the data under the Right to Information (RTI) Act, the Indian Pharmacopoeia Commission (IPC) recorded 9,373 serious adverse events (SAEs) involving medical devices between 2020 and 2025. The annual count rose from 808 in 2020 to 2,176 in 2025, an increase of about 2.7 times. The story was published on 6 November and has been reported by Outlook and other outlets.
What counts as a serious event
Under India’s Materiovigilance Programme (MvPI), which the IPC has run since 2015, a serious adverse event is one that is life-threatening or causes prolonged hospitalisation. Reports are meant to reach the IPC within 15 days. They come from a network of 775 monitoring centres, mostly hospitals and medical colleges, as well as from manufacturers and healthcare professionals.
Reports up, referrals flat
The more striking figures concern what happened to the reports. The IPC logs all device-related adverse events, serious or not, and forwards some to the Central Drugs Standard Control Organisation (CDSCO), which licenses devices and can order recalls:
Year Events logged Forwarded to CDSCO
| Year | Events logged | Forwarded to CDSCO |
| 2022–23 | 3,868 | 12 (0.31%) |
| 2023–24 | 10,269 | 16 (0.16%) |
| 2024–25 | 14,584 | 22 (0.15%) |
So in three years, reports rose almost fourfold while referrals to the regulator stayed in the low double digits. The data do not explain the referral criteria. It may be that most reports involve user error, known risks or insufficient information, and do not justify regulatory action. But without published criteria or outcomes, the public cannot tell whether the low referral rate reflects careful triage or a bottleneck.
Which devices
Brand names and device descriptions were withheld, but the cases forwarded to CDSCO give some idea of the range:
- 2024–25: mostly surgical gloves, syringes and urine bags, as well as a mechanical ventilator and a blood-transfusion set.
- 2023–24: pregnancy-test kits, catheters, blood-pressure monitors and a drug-eluting stent.
- 2022–23: an inhaler, an infant incubator, a coronary stent, and a condom flagged as counterfeit.
The list mixes high-risk implants with everyday consumables. That is a reminder that device safety concerns not only sophisticated technology but also the quality of mass-produced products used millions of times a day in Indian hospitals.
Secrecy over brands
The disclosure came after a long appeal. According to the reports, the IPC initially refused to name manufacturers, citing “commercial confidence” under Section 8(1)(d) of the RTI Act, and said collating the information would be “too voluminous”. In a 10 September order, Information Commissioner Jaya Varma Sinha directed partial disclosure. The order noted it was “not conclusively established” whether events “arose due to a procedural lapse or due to the medical device itself”, and it allowed brand and device details to be withheld. The data were released on 27 October.
That reasoning has some basis. An adverse-event report is a signal, not proof that a device is faulty. A patient may be harmed by incorrect use, an underlying illness or a combination of factors. But other regulators manage the same uncertainty while publishing more. The US Food and Drug Administration’s MAUDE database makes individual device reports publicly searchable at brand level, with a disclaimer that a report does not establish causation. Doctors, hospitals and researchers can use those reports to spot patterns early.
Why the numbers may be rising
The increase needs careful interpretation. India has expanded both regulation and monitoring of devices in recent years. Since 2023, all classes of medical device have required licences under the Medical Devices Rules, 2017, and the monitoring network has grown. A larger network, greater awareness and better reporting would all raise counts even if devices were no safer or more dangerous than before. Health systems with strong safety cultures often record more incidents, not fewer, because they look harder.
The data released do not allow NSH to separate these explanations. Answering that question would require reports per device type, per unit sold and per reporting centre over time, which the IPC has not published.
The context
Device safety has a troubled recent history in India. In 2018, the “Implant Files”, an international investigation in which The Indian Express took part, found that more than half of 566 device-related events reported in India up to that point involved coronary stents from a single manufacturer, Abbott, which said its stents had “an unparalleled safety record”. Faulty hip implants from another company led to a long compensation process. The new data suggest that the reporting system built since then is collecting far more information, but they leave open whether that information is being turned into regulatory action.
Separately, the Directorate General of Health Services is reported to have issued an order on 23 October barring hospitals from reusing devices intended for single use, a sign that device safety is already on the ministry’s agenda.
