Medical Device Industry Criticizes Draft Bill: Calls for Regulatory Distinction

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that its approach of treating medical devices like pharmaceuticals could stifle growth, innovation, and investment in the sector. The draft, which is currently under inter-ministerial review, has sparked concern among manufacturers, healthcare providers, and patient safety groups.

Concerns Over Regulatory Approach

Key industry players have expressed that the draft bill's pharmaceutical-centric regulatory framework is inappropriate for medical devices, which are fundamentally engineering products. A coalition of associations has communicated these concerns to the Union Health Minister, emphasizing that the bill's provisions could deter investment and manufacturing, ultimately hampering India's ambition to emerge as a global hub for medical devices.

In their communication dated August 8, the associations highlighted that the draft continues to classify medical devices as adjuncts to pharmaceuticals, ignoring the significant scientific and engineering differences between the two. The language of the bill, which includes terms such as "adulterated," "spurious," and "misbranded," reflects a drug-centric view that does not align with the operational realities of the medical device industry.

Impact of Proposed Criminal Penalties

One of the most contentious aspects of the draft bill is the imposition of criminal penalties for regulatory lapses. The industry argues that this approach is unprecedented globally, where medical devices are typically regulated through risk-based assessments, quality management systems, and post-market surveillance. The draft proposes imprisonment ranging from one to seven years for issues such as labeling errors, documentation lapses, and licensing problems, even in cases where no harm has occurred.

Industry representatives have pointed out that similar legislative frameworks in regions like the European Union, United States, Japan, United Kingdom, and Australia focus on administrative enforcement rather than criminalization. This discrepancy raises concerns about the potential chilling effect on innovation and the willingness of international players to invest in India’s medical device sector.

Industry Calls for Revised Bill

The medical device industry is urging the government to reconsider the draft bill's provisions and develop a regulatory framework that supports growth and innovation. Stakeholders argue that a distinct regulatory approach, separate from pharmaceuticals, is necessary to accommodate the unique characteristics and needs of medical devices.

As the draft bill undergoes further consultation, the outcome will be closely watched by industry leaders and investors, who are hopeful for a legislative environment that fosters development and positions India as a leader in the medical device industry.