Medical Device Industry Challenges India's Draft Bill Proposal

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which equates medical devices with pharmaceuticals. Industry representatives argue that such a classification could stifle manufacturing, investment, and innovation within the sector.

Industry Concerns Over Regulatory Approach

The draft bill has sparked significant concern from various associations representing manufacturers, traders, healthcare providers, and patient advocacy groups. These organizations have reached out to the Union health minister, urging a reassessment of the draft's provisions. They caution that treating medical devices as pharmaceutical products could deter investment and hinder India's ambition to become a global hub for medical devices.

In their communication dated August 8, the associations highlighted that the draft bill fails to establish a suitable regulatory framework tailored to the unique needs of the medical device sector. They emphasized that medical devices are fundamentally different from pharmaceuticals, being engineering products that require distinct regulatory considerations. The letter criticized the draft for continuing to use drug-centric language, such as terms like "adulterated," "spurious," and "misbranded," and for applying pharmaceutical-style criminal penalties to issues arising from engineering deviations.

Comparisons to Global Standards

The industry has pointed out that the proposed penalties, which include imprisonment for labeling errors, documentation lapses, licensing issues, and engineering defects, do not align with global practices. In contrast, regulatory bodies in Europe, the United States, Japan, the United Kingdom, and Australia focus on administrative enforcement rather than criminal penalties. These regions utilize risk-based conformity assessments, quality management systems, post-market surveillance, and product recalls to regulate medical devices.

India's medical device sector fears that the draft bill's stringent measures could lead to unnecessary criminalization and discourage innovation. The industry advocates for a regulatory framework that supports growth and competitiveness on a global scale, arguing for a model that reflects international standards and practices.

Call for Revisions

As the draft bill undergoes inter-ministerial consultation, industry stakeholders are hopeful for revisions that will address their concerns. They seek a regulatory approach that recognizes the distinct nature of medical devices and fosters an environment conducive to innovation and investment. The outcome of these discussions will be crucial in shaping the future of India's medical device industry and its role in the global market.