A continuous increase has been recorded in cases of severe harm caused by the use of medical devices. According to new data revealed through an RTI, where there were 808 such cases recorded in the year 2020, the number increased to 2,176 in the year 2025.

Total 9,373 cases since 2020

A total of 9,373 cases of severe harm related to medical devices have come to light in the country since 2020. This information was made available by the Indian Pharmacopoeia Commission following an order by the Central Information Commission.

The Indian Pharmacopoeia Commission works to gather information on adverse events through 775 surveillance centers established across the country.

Adverse events and regulatory referral

During the financial year 2024-25, a total of 14,584 adverse events related to medical devices were recorded, out of which 22 cases were forwarded to the Central Drugs Standard Control Organization, known as CDSCO.

However, it has not yet been clarified whether these adverse events occurred due to a defect in the device or because of an error during the medical procedure. Additionally, the Indian Pharmacopoeia Commission has refused to disclose the names of the medical device manufacturing companies and the categories of the devices.