Now Reading: Medical device companies oppose draft bill treating devices as drugs
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Medical device companies oppose draft bill treating devices as drugs
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 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.
The Indian Opinion
The government has rightly sought to replace an 86-year-old law, but lumping medical devices with drugs is a category error. The narrative that a single umbrella law simplifies regulation ignores the fundamental difference between a pill and a pacemaker. Curing a software bug by threatening jail time will scare away innovation, not foster it. The test is whether the health ministry will carve out a separate chapter for devices before the bill reaches Parliament.
Source: health.economictimes.indiatimes.com
This story was synthesised by AI from the source linked above.
