New Delhi, November 6, 2026: Serious adverse events reported in connection with medical devices in India have increased nearly threefold over six years, according to previously undisclosed government data obtained by The Indian Express under the Right to Information (RTI) Act.
Figures released by the Indian Pharmacopoeia Commission (IPC) show that reported serious adverse events rose from 808 in 2020 to 2,176 in 2025, while a total of 9,373 cases were recorded over the six-year period.
The disclosure has raised questions about medical device safety, transparency and regulatory oversight, particularly because detailed information about the manufacturers and products involved has not been made public.
Importantly, these reports do not automatically establish that a medical device was defective or directly caused the reported harm.
9,373 Serious Adverse Events Reported Since 2020
According to the data disclosed by the IPC, serious adverse event reports associated with medical devices have increased substantially.
The figures show:
| Indicator | Reported Figure |
|---|---|
| Serious adverse events in 2020 | 808 |
| Serious adverse events in 2025 | 2,176 |
| Total reported during 2020–2025 | 9,373 |
| Increase between 2020 and 2025 | Approximately 169% |
| Medical device monitoring centres | 775 |
The number of annual reports in 2025 was approximately 2.7 times the figure recorded in 2020.
However, the data alone cannot determine whether the increase reflects more medical complications, greater use of medical devices, improved reporting or a combination of these factors.
What Are Serious Adverse Events?
A Serious Adverse Event (SAE) is a medical incident associated with treatment or healthcare that may result in severe consequences for a patient.
Such incidents can include life-threatening conditions, prolonged hospitalisation, significant disability or death.
In the context of medical devices, adverse events may involve equipment used for diagnosis, treatment, monitoring or patient care.
Examples of medical devices include cardiac stents, catheters, ventilators, syringes, implants, diagnostic equipment and blood pressure monitors.
A reported adverse event is a signal requiring assessment. It does not necessarily prove that the equipment malfunctioned or was responsible for the patient’s condition.
Data Disclosed After Central Information Commission Order
The information became public following a prolonged RTI process initiated by The Indian Express.
The newspaper had sought detailed information about serious adverse events associated with medical devices.
After earlier requests were denied, the matter reached the Central Information Commission (CIC).
On September 10, 2026, Information Commissioner Jaya Varma Sinha issued an order addressing the disclosure request.
The newspaper subsequently obtained the six-year dataset on October 27.
The figures were published on November 6, bringing previously restricted information into the public domain.
Why Were Manufacturer and Brand Names Withheld?
Although the IPC disclosed the number of serious adverse event reports, it did not release detailed information about the manufacturers and medical device brands involved.
The Commission argued that disclosure could affect commercial confidentiality and third-party business interests.
It cited Section 8(1)(d) of the RTI Act, 2005, which provides exemptions for certain commercially sensitive information.
The IPC also maintained that a reported adverse event does not conclusively establish whether harm resulted from a defect in the medical device or from a procedural lapse during its use.
The distinction is important because identifying a device in a report does not establish manufacturer responsibility.
Only 22 Cases Forwarded to CDSCO in 2024–25
The IPC’s annual reports reveal a significant difference between the number of medical device adverse event reports received and the number of cases forwarded to the national drug regulator.
During FY2024–25, the Commission recorded 14,584 Medical Device Adverse Events (MDAEs).
However, only 22 cases were forwarded to the Central Drugs Standard Control Organisation (CDSCO) for necessary action.
The devices mentioned in these referrals included surgical gloves, syringes, urine bags, a mechanical ventilator and a blood transfusion set.
The numbers raise questions about the screening and referral process, although they do not establish that all other reported events required regulatory action.
Previous Years Also Show Limited Regulatory Referrals
The IPC’s earlier annual reports show a similar pattern.
| Financial Year | Medical Device Adverse Events | Cases Forwarded to CDSCO |
|---|---|---|
| 2022–23 | 3,868 | 12 |
| 2023–24 | 10,269 | 16 |
| 2024–25 | 14,584 | 22 |
The figures cover all reported medical device adverse events, not only serious cases.
The 9,373 serious adverse events reported for 2020–2025 represent a separate dataset and should not be directly compared with the financial-year totals as though they measure the same category.
The relatively small number of regulatory referrals highlights the importance of understanding how reports are assessed and which cases require further action.
What Is the Materiovigilance Programme of India?
India established the Materiovigilance Programme of India (MvPI) in 2015 to monitor problems associated with medical devices.
The initiative aims to systematically collect, assess and analyse adverse event reports from healthcare institutions.
The Indian Pharmacopoeia Commission serves as the programme’s national coordination centre.
According to the latest reporting, the programme has 775 monitoring centres across India.
These centres help identify potential safety concerns involving medical devices used in hospitals, clinics and other healthcare facilities.
The information collected may support regulatory decisions, safety recommendations and corrective measures.
Serious Incidents Must Be Reported Within 15 Days
Under India’s medical device vigilance reporting arrangements, serious adverse events are expected to be reported to the IPC within 15 days.
Timely reporting enables authorities to identify potentially serious problems and investigate whether similar incidents are occurring elsewhere.
The IPC has also developed an online reporting platform known as the Adverse Drug Monitoring System (ADRMS) to streamline the submission of adverse event information.
Effective reporting depends on hospitals, medical professionals, manufacturers and other stakeholders recognising and documenting potential safety incidents.
Earlier Investigation Highlighted Coronary Stent Reports
The latest disclosure follows earlier investigations into India’s medical device safety monitoring system.
In 2018, The Indian Express reported findings from the international Implant Files investigation.
The reporting identified 566 medical device adverse event entries, including 290 associated with coronary stents manufactured by Abbott.
At the time, Abbott defended the safety record of its products, describing its stents as extensively used and studied.
Those reports did not establish that all the recorded incidents were caused by defective stents.
The latest RTI disclosure provides additional information about subsequent years but does not publicly identify the manufacturers associated with the newly reported serious events.
How Other Countries Report Medical Device Problems
Medical device surveillance systems operate in several countries.
In the United States, the Food and Drug Administration (FDA) maintains the Manufacturer and User Facility Device Experience (MAUDE) database.
The database provides public access to reports involving medical device malfunctions, injuries and deaths.
Entries can include information about the device category, manufacturer, model and reported incident.
However, the FDA also cautions that adverse event reports do not establish causation or provide a reliable measure of how frequently a device causes harm.
The comparison highlights differences in the level of publicly accessible information available through national reporting systems.
Why the Increase Matters for Patient Safety
Medical devices play an essential role in modern healthcare, from routine diagnostic tests to complex surgical procedures.
Monitoring their safety after they enter the market is important because some problems may only become apparent during widespread clinical use.
An effective surveillance system can help identify recurring complications, potential manufacturing issues, incorrect usage and weaknesses in clinical procedures.
The rise in reported serious adverse events underlines the need for detailed investigation and transparent communication.
However, patients should not interpret the increase as evidence that medical devices in general have become unsafe.
Many devices provide substantial medical benefits, and the appropriate response to a safety concern depends on the specific product, clinical circumstances and evidence available.
Calls for Greater Transparency in Medical Device Monitoring
The release of the six-year dataset is an important development in public access to medical device safety information.
It provides a clearer picture of the number of serious adverse events reported to Indian authorities.
At the same time, the absence of product-level and manufacturer-level details limits the public’s ability to understand which categories of equipment account for the reported incidents.
Greater clarity about investigation outcomes, reporting practices and regulatory actions could help strengthen confidence in the monitoring system.
The central challenge is to improve patient safety while ensuring that manufacturers are not incorrectly blamed for incidents whose causes have not been established.
Government Data Highlights Need for Stronger Surveillance
The latest IPC figures show that serious adverse event reports associated with medical devices increased from 808 in 2020 to 2,176 in 2025.
With 9,373 reports recorded across six years, the disclosure represents a significant new source of information about medical device surveillance in India.
The findings highlight the importance of timely reporting, careful investigation and effective regulatory follow-up.
As medical technology becomes more widely used across Indian healthcare, the quality and transparency of post-market surveillance will remain essential to protecting patients.
Source: The Indian Express, November 6, 2026; Indian Pharmacopoeia Commission; Central Information Commission; Ministry of Health and Family Welfare
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