Medical device companies oppose draft bill treating devices as drugs

The Story in Brief

Medical device industry, patient safety groups and healthcare providers have written to the Union health minister opposing the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The August 8 letter argues that the bill treats medical devices like pharmaceuticals, using drug-centric terms such as "adulterated" and "spurious" and imposing imprisonment of 1-7 years for labelling or engineering errors even when no harm occurs.

The industry says medical devices are engineering products, not drugs, and need risk-based regulation with recalls, not criminal penalties. Global regulators like the US FDA and EU MDR rely on administrative enforcement. The draft is under inter-ministerial consultation. Associations warn it will hurt investment and set back India's ambition to become a global medical device hub.