New Delhi/Alive News: The number of serious health problems linked to medical devices in India has nearly tripled in six years, rising from 808 cases in 2020 to 2,176 in 2025. A total of 9,373 serious cases have been reported since 2020, according to data released by the Indian Pharmacopoeia Commission (IPC) following a Right to Information (RTI) request.
According to The Indian Express, the figures were disclosed after an order from the Central Information Commission. Serious cases include incidents where a patient’s life is at risk, prolonged hospitalisation is required or major health complications develop.
The IPC collects information on medical device-related problems through 775 surveillance centres across the country. However, its annual reports previously did not provide separate figures for serious incidents.
The IPC also declined to disclose manufacturers’ names and device categories, citing commercial confidentiality. It is not always clear whether an incident was caused by a faulty device or a mistake during a medical procedure.
Very few cases referred for investigation
During 2024-25, a total of 14,584 adverse events involving medical devices were reported, but only 22 cases were referred to the Central Drugs Standard Control Organisation (CDSCO) for further action.
In 2023-24, 10,269 cases were recorded, with 16 referred to the CDSCO. In 2022-23, 3,868 incidents were reported, of which 12 were referred.
The suspected devices included surgical gloves, syringes, urine bags, catheters, pregnancy test kits, blood pressure monitors, ventilators and heart stents.
Serious incidents must be reported within 15 days
India launched the Materiovigilance Programme in 2015 to monitor medical device safety. Under its rules, serious adverse events must be reported to the IPC within 15 days.
The United States, meanwhile, maintains a public database called MAUDE, which provides information about medical device manufacturers, brands and reported incidents.
