The Draft Drugs, Medical Devices & Cosmetics Bill, 2026 has drawn concerns from 11 organisations representing medical device manufacturers, traders, hospitals, healthcare providers, clinicians and patient groups, who have urged the Union Health Ministry to reconsider the proposed framework. The groups argue that medical devices are fundamentally different from medicines and should not be regulated through a largely pharmaceutical-focused framework. They are calling for a separate Medical Devices Act and an independent regulator.

One of the major concerns raised is the proposed criminalisation of certain technical and compliance-related mistakes. The groups said the draft Bill could impose one to seven years of imprisonment for issues such as labelling, documentation and licensing-related lapses. They argued that technical or administrative errors should generally be addressed through…