# Medical device companies oppose draft bill treating devices as drugs 2026-08-12T06:57:49+00:00 | Governance | Indian Opinion Desk Corroboration: 1 independent outlet 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. ## Coverage - health.economictimes.indiatimes.com Tags: Drugs Medical Devices and Cosmetics Bill, health ministry, innovation, manufacturing, medical devices, regulation Canonical: https://indianopinion.org/medical-device-companies-oppose-draft-bill-treating-devices-as-drugs/ License: Summary and commentary (c) Indian Opinion, reusable with attribution. Facts belong to the linked sources. Cite: https://indianopinion.org/medical-device-companies-oppose-draft-bill-treating-devices-as-drugs/#story-in-brief Review state: restored archive article, accurate at time of publication, not offered to search indexes.