Medical Device Firms Oppose Draft Bill Treating Devices as Drugs

India's medical device industry is pushing back against the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices under the same framework as pharmaceuticals. Industry representatives argue that this approach could stifle innovation and investment, potentially derailing India's ambitions to become a global hub for medical technology.

Industry Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial review, has encountered significant opposition from medical device manufacturers, patient safety groups, and healthcare providers. These stakeholders have communicated their concerns to the Union health minister, emphasizing that medical devices, which are fundamentally engineering products, differ significantly from pharmaceuticals and should not be managed as such.

In a letter dated August 8, industry associations highlighted that the bill fails to provide a conducive regulatory environment necessary for the sector's growth and competitiveness on the world stage. The letter criticized the draft for using pharmaceutical-centric language and imposing criminal penalties for regulatory lapses, a move they argue could deter investment and halt manufacturing progress.

Comparisons with International Standards

The draft bill's provisions include potential imprisonment of one to seven years for minor infractions such as labeling errors or documentation mistakes, even when no harm occurs. Industry leaders point out that this is not the norm in other major markets such as the European Union, United States, Japan, UK, or Australia, where administrative measures are typically employed for similar issues.

Globally, medical devices are overseen through risk-based conformity assessments and quality management systems, with an emphasis on post-market surveillance and recalls rather than criminalization. The industry argues that adopting such international best practices would better serve the sector's needs.

Call for Rethink and Collaboration

As the draft bill undergoes scrutiny, stakeholders are urging the government to reconsider its approach by collaborating with industry experts to develop a regulatory framework tailored to the unique characteristics of medical devices. This, they suggest, would foster an environment of innovation and ensure the sector can thrive both domestically and internationally.

The outcome of this legislative process is seen as pivotal for the future of India's medical device industry, which seeks to align itself with global standards and expand its footprint in the international market.