Nearly 3-fold jump in serious adverse events caused by medical devices: New data

Why in the News

For the first time, India’s count of Serious Adverse Events (SAEs) caused by medical devices is public, showing a nearly threefold rise from 808 in 2020 to 2,176 in 2025. The Indian Pharmacopoeia Commission (IPC) released it after an order of the Central Information Commission (CIC), the final appeal body for information requests. It still refused to name device categories or manufacturers.

What is a serious adverse event, and who tracks it?

1. What it is: An SAE is device harm that can threaten life or prolong a hospital stay. Global norms count death, longer hospitalisation, a life-threatening situation or disability as serious.
2. Who tracks it: The IPC, an autonomous Central body setting drug standards, runs the Materiovigilance Programme of India (MvPI). Launched in 2015, it works like a safety watch on devices.
3. How events are reported: Events are logged at 775 monitoring centres or on the Adverse Drug Monitoring System (ADRMS) portal. Every SAE must reach the IPC within 15 days.
4. Earlier disclosure: The IPC’s annual reports gave broad totals of Medical Device Adverse Events (MDAEs), every reported device harm. They kept SAE figures restricted.
5. The takeaway: Until now the public could not see how often devices cause grave harm.

What does the data show, and is anyone acting on it?

1. Six-year total: The IPC “received and reviewed” 9,373 SAEs over the six years.
2. Minor items flagged: Annual report lists of “suspected devices” include surgical gloves, syringes and urine bags. The 2022-23 report even listed a male condom as a “counterfeit device”.
3. Few cases escalated: In 2024-25 only 22 events went to the national regulator, the Central Drugs Standard Control Organisation (CDSCO), for “necessary action”. Most were gloves, syringes and urine bags.
4. Stents in the Implant Files: The Implant Files investigation found Abbott’s coronary stents made up over half of all MDAEs logged in 2018.

Why were device and maker details withheld?

1. Commercial confidence: The IPC argued naming manufacturers is exempt under Section 8(1)(d) of the Right to Information (RTI) Act, 2005. It protects information that would harm a firm’s competitive position.
2. Cause not established: The CIC withheld brand details. It was not conclusively established whether each event came from a procedural lapse or the device itself.
3. Too voluminous: The IPC also said details for every MDAE were too voluminous and collating them would divert its resources.
4. Long road to release: Requests to update the 2018 dataset were denied. The six-year data came only after a final CIC appeal in 2025.

How does a public device database work elsewhere?

1. MAUDE: The United States runs the Manufacturer and User Facility Device Experience (MAUDE) database, a public record of adverse events across all device categories.
2. Granular detail: It records device-related deaths and injuries. Users can see the brand, manufacturer, model and type of event.

Challenges

1. Hidden makers: Patients and doctors cannot avoid a faulty device whose brand and manufacturer stay confidential.
2. Open-ended confidentiality: Without a finished causality review, the “not established” ground can be invoked for every event.
3. Low-risk noise: Suspect lists dominated by gloves and syringes crowd out high-risk implants such as stents.

Way Forward

1. Maker-level disclosure: The IPC should publish brand, manufacturer and model for serious events once causality is assessed.
2. Time-bound causality review: Assess each SAE within a fixed period, so confidentiality cannot be claimed indefinitely.
3. Clear referral rule: CDSCO should define which events require referral for action, with high-risk implants first.

Conclusion

India now counts serious harm from medical devices but still hides which devices cause it, so patients cannot act on the data. Whether the IPC and the regulator move from counting events to naming devices and acting on them is the change to watch.

Key numbers

1. MDAEs logged, 2024-25: 14,584.
2. Stent share, 2018: Abbott coronary stents were 290 of 566 MDAEs (Implant Files).
3. Escalation, 2023-24: 16 of 10,269 MDAEs forwarded to CDSCO, including one drug-eluting stent.
4. Escalation, 2022-23: 12 of 3,868 MDAEs forwarded, including a “suspect” inhaler, an incubator and a coronary stent.

Back2Basics: Central Drugs Standard Control Organisation (CDSCO)

1. Head: It functions under the Drugs Controller General of India (DCGI).
2. Mandate: Licensing, approval and market authorisation of drugs, medical devices and cosmetics under the Drugs and Cosmetics Act, 1940.
3. Centre-State split: The DCGI licenses new drugs, vaccines and certain categories. State Drug Controllers license the manufacture and sale of most other drugs.

Matching Previous Year Question

“[2020, GS2, 10 marks] “Recent amendments to the Right to Information Act will have profound impact on the autonomy and independence of the Information Commission”. Discuss.”