Medical Device Industry Rejects Draft Bill Treating Devices as Drugs

The Indian medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders argue that the bill's approach of regulating medical devices as pharmaceutical products could stifle innovation and deter investment in the sector.

Industry Concerns Over Draft Bill

Key stakeholders, including manufacturers, healthcare providers, and patient safety groups, have collectively urged the Union Health Ministry to reconsider the draft legislation. According to industry sources, the bill's alignment of medical devices with pharmaceuticals fails to recognize the fundamental differences in design, regulation, and usage between the two categories.

Associations representing various sectors have submitted a letter dated August 8 to the health minister, emphasizing the potential negative impact on India's goal to become a global hub for medical devices. The letter describes the bill's language as drug-centric, using terms like "adulterated" and "misbranded" that are more applicable to pharmaceuticals.

Regulatory Approach Criticized

The draft bill proposes severe penalties, including imprisonment ranging from one to seven years for labeling errors, documentation lapses, and other infractions, even when no harm results. Industry representatives argue that this approach is inconsistent with international practices, where administrative actions are preferred over criminal penalties.

Globally, medical devices are typically regulated through risk-based assessments, quality management systems, and post-market surveillance. Countries like the United States, Japan, and the UK use these methods to ensure safety and compliance without resorting to criminalization.

Call for a Separate Regulatory Framework

The medical device sector is advocating for a distinct regulatory framework that considers the unique nature of medical devices. Such a framework would facilitate growth and innovation while maintaining high safety standards. The industry emphasizes that engineering products should not be subjected to the same regulations as chemical-based pharmaceuticals.

The draft bill is currently under review as part of an inter-ministerial consultation process. Stakeholders are hopeful that their concerns will be addressed, paving the way for a regulatory environment that supports the sector's expansion and contribution to the healthcare ecosystem.