Medical Device Industry Opposes Bill Treating Devices as Pharma

India's medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing it inappropriately equates medical devices with pharmaceuticals. Industry leaders warn that the proposed regulations could stifle innovation and investment in a sector critical to India's healthcare goals.

Industry Concerns Over the Draft Bill

The draft bill, currently under inter-ministerial review, proposes treating medical devices similarly to pharmaceuticals, applying stringent penalties for regulatory lapses. Industry associations representing manufacturers, healthcare providers, and patient safety groups have collectively urged the Union Health Minister to reconsider the draft. They argue that the bill's approach could hinder India's ambition to become a global hub for medical device manufacturing.

Critics of the bill emphasize that medical devices are engineering products, not drugs, and thus require different regulatory frameworks. They contend that the bill's language, which includes terms like "adulterated," "spurious," and "misbranded," is rooted in pharmaceutical regulation and inappropriate for the medical device sector.

Comparison with Global Standards

The draft bill's provisions include criminal penalties ranging from one to seven years of imprisonment for labeling errors, documentation issues, and other non-compliant activities, even if no harm results. This approach, industry experts argue, contrasts sharply with international practices. In regions like the European Union, United States, Japan, United Kingdom, and Australia, administrative measures, rather than criminal penalties, are the norm for addressing regulatory issues in the medical device sector.

Global standards typically involve risk-based conformity assessments, quality management systems, post-market surveillance, and recall procedures. These frameworks are seen as more suitable for managing the unique aspects of medical devices, which differ significantly from pharmaceuticals.

Call for a Distinct Regulatory Framework

The letter submitted by industry groups on August 8 highlights the need for a distinct regulatory approach that recognizes the scientific and engineering differences between medical devices and pharmaceuticals. The associations argue that the draft bill does not provide the necessary foundation for the sector to grow, innovate, and compete on a global scale.

The ongoing debate underscores the importance of crafting a regulatory framework that supports India's burgeoning medical device industry while ensuring patient safety and compliance with international standards. As the government reviews the draft bill, stakeholders remain hopeful for a regulatory environment that fosters growth and innovation.