Indian medical device industry pushes for standalone regulation amid draft bill controversy

Eleven medical device industry associations have urged Union Health Minister J.P. Nadda to create a standalone law for medtech regulation, intensifying a long-running dispute over whether devices should be governed under the same framework as pharmaceuticals. The appeal comes shortly after the government circulated a draft Drugs, Medical Devices and Cosmetics Bill for industry feedback, according to Business Standard.

In its final comments, a major domestic industry group said the 2026 draft could not be endorsed in its present form. The association argued that the proposal is too heavily shaped by drug regulation, relies on punitive language that does not fit medical technology, and departs from global medtech practice. Rajiv Nath, forum coordinator for the Association of Indian Medical Device Industry, told Business Standard that the draft still uses terms such as “adulterated” and “spurious” and extends pharma-style criminal penalties to engineering and compliance lapses.

The industry’s concern is that a device is not a drug: it is designed, manufactured and assessed under a different logic, with risk varying by category, intended use and lifecycle. According to the draft bill seen by Business Standard, even technical non-conformities could trigger stop-production orders, criminal cases and prison terms of six months to seven years. Nath argued that this kind of treatment could deter manufacturing and said enforcement should instead reflect the actual risk posed by a device, whether the issue involves a labeling mistake, a documentation error or a problem with device identification.

The associations are also seeking a new committee made up of engineers, clinicians, biomedical specialists, industry representatives and patient safety advocates to design a separate medical devices law. They want that framework aligned with internationally recognized approaches, including the European Union’s medical device regime and the U.S. Food and Drug Administration’s model, both of which are more explicitly risk-based. The group also wants an autonomous national medical devices regulator, modeled loosely on the Telecom Regulatory Authority of India, to oversee state authorities and conformity assessment bodies more clearly.

The push for a separate statute is not new. Business Standard reported in 2023 that manufacturers, patient groups and hospitals had asked the government to withdraw an earlier draft and replace it with a dedicated medical devices bill. More recently, the sector has objected to proposed changes in testing fees, sterilization labeling and possible relaxations for refurbished equipment imports, reflecting broader anxiety that policy could become more burdensome at the same time the government is trying to modernize oversight. Industry groups have argued that the cumulative effect could weaken competitiveness, slow exports and expose patients to poorly tracked or lower-quality devices.

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Indian medical device industry pushes for standalone regulation amid draft bill controversy

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