Cases of serious harm caused by medical devices in India triple

Cases of serious harm to patients due to the use of medical devices in India have nearly tripled in the last six years. Data from the Indian Pharmacopoeia Commission (IPC) shows that 808 such cases were recorded in the year 2020, which increased to 2,176 in the year 2025. A total of 9,373 serious cases have emerged from the year 2020 to date.

According to a report by Dainik Bhaskar, these figures have come to light for the first time under the Right to Information (RTI). The IPC has released this information following orders from the Central Information Commission. According to a report by The Indian Express, several RTI applications were filed to obtain this information. The definition of serious cases includes situations that pose a risk to the patient's life, require prolonged hospitalisation, or cause other serious health problems.

Previously, the IPC used to provide the total number of cases in its annual report, but did not disclose separate figures for serious cases. The IPC refused to provide the names of companies manufacturing medical devices and the categories of devices. The IPC stated that this could affect the professional confidentiality of the companies. Additionally, the institution stated that it is not clear whether any adverse event was caused by the device or due to an error in the procedure.

The IPC collects information on adverse events occurring after the use of medical devices from 775 monitoring centres across the country. According to the IPC's annual report, 14,584 adverse events related to medical devices were recorded in the financial year 2024-25. Out of these, only 22 cases were sent to the Central Drugs Standard Control Organisation (CDSCO) for further action. In the financial year 2023-24, 10,269 cases were recorded, of which 16 cases were forwarded. Meanwhile, in the year 2022-23, 3,868 cases emerged, and 12 cases were sent to the CDSCO.

The list of suspicious devices includes products such as surgical gloves, syringes, urine bags, pregnancy test kits, catheters, and blood pressure monitors. In some cases, ventilators, blood transfusion sets, and heart stents were also included in the list of suspicious devices.

The Materiovigilance Programme of India was launched in 2015 to oversee adverse events related to medical devices in India. Under this programme, the IPC receives information on such events through an online portal. According to the rules, it is mandatory to inform the IPC of serious adverse events within 15 days. As per international standards, if an event results in the death of a patient, poses a risk to life, requires prolonged hospitalisation, or results in conditions such as permanent disability, it is considered a serious event. In America, there is a public database named MAUDE for information regarding adverse events related to medical devices, which provides details of the device brand, manufacturer, model, and the event.

The Materiovigilance Programme of India was a mechanism to monitor adverse effects caused by the use of medical devices. Under this programme, data was being collected to maintain the safety and quality of the devices.