Medical Device Adverse Events in India: What It Means

India’s drug and device regulator has revealed, for the first time, how many medical device adverse events in India have been serious enough to cause real harm. The number is rising fast. The Indian Pharmacopoeia Commission (IPC) told the Indian Express, in response to a Right to Information request, that it reviewed 9,373 serious adverse events since 2020. The yearly count has nearly tripled in that time. It climbed from 808 cases in 2020 to 2,176 in 2025.

Medical device adverse events in India: what the new data shows

The figures were shared under the Materiovigilance Programme of India, also called MvPI. This is the system the IPC runs alongside its better known drug safety arm. A serious adverse event, in this context, is one that can cause death, a life threatening situation, prolonged hospitalisation or permanent disability. The IPC had never before disclosed these serious case numbers. So this six year trend is the first public look at how often a device in India causes genuine harm, not just a minor glitch.

The devices flagged over the years include cardiac stents, inhalers, incubators, pregnancy test kits, catheters and blood pressure monitors. Everyday items such as syringes and surgical gloves show up too. However, only a small fraction of these cases get escalated for action. In 2024 and 2025 alone, just 22 of 14,584 logged complaints were forwarded to the CDSCO, India’s central drugs authority, for further scrutiny.

How device safety reporting actually works

The MvPI runs through 775 monitoring centres across hospitals and institutions in India. Each centre is a point where a doctor, nurse or administrator can log a problem with a device. Once a centre gets a report, it must reach the IPC within 15 days. The case is then reviewed, and investigated further if needed. The IPC, based in Ghaziabad, coordinates this entire network, much like it also coordinates drug safety reports through the older Pharmacovigilance Programme.

So the system itself is not short of structure. What it has lacked, until this RTI response, is transparency about how many reports actually turn out to be serious.

Why brand and manufacturer names stay hidden

When asked to name the brands behind these serious events, the IPC declined. It cited Section 8(1)(d) of the RTI Act, which protects information that could harm a company’s competitive position. It also argued that compiling full details for every case would be too voluminous a task. A Central Information Commission order partly upheld the Indian Express’s appeal. However, it still agreed that brand details could not be released, since it is not conclusively established whether an event happened because of a procedural lapse or because of the device itself.

That stands in contrast to the United States. There, the FDA’s public MAUDE database lists the brand, manufacturer and model behind a reported event. So patients and doctors can look up a product’s safety history before a purchase. In India, a patient has no such way to check a specific stent or monitor.

How to report a problem with a medical device

Reporting a device problem in India does not need a lawyer or a court first. The IPC publishes a Medical Device Adverse Event Reporting Form just for consumers and users, separate from the one meant for hospitals. It sits on the IPC’s website. Say a family member has had a bad experience with a device, from a hearing aid to an implant. They can fill in the device name, when the problem happened and what went wrong. It then goes to the nearest Materiovigilance Monitoring Centre, usually the hospital where the device was used, or straight to the IPC.

This is a separate track from reporting a bad reaction to a medicine, which instead goes through the Pharmacovigilance Programme’s helpline at 1800 180 3024. Devices and drugs sit under related but distinct systems. So it helps to know which one applies before you report.

FAQ

What counts as a serious adverse event for a medical device?

It is an event that causes death, a life threatening condition, prolonged hospitalisation or permanent disability. A minor fault with no lasting harm does not count as serious.

Can I find out if my device brand has a history of problems?

Not directly. The IPC has not made brand names public for these cases. So there is no searchable database for consumers here, unlike in the United States.

Who should I contact if a medical device fails?

First, report it to the hospital or clinic where it was used. They can route it to the nearest Materiovigilance Monitoring Centre. You can also fill in the IPC’s consumer form directly.

This disclosure is a first step, not a finished picture. Manufacturer level data is still not public. So the safest approach, for now, is simple: keep records of the product, and report anything that goes wrong. After all, each report is what eventually builds the pattern regulators act on.