Indian Medical Device Industry Rejects Draft Bill Equating Devices with Drugs

India's medical device industry and healthcare groups are voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. They argue that the bill's approach to regulating medical devices as pharmaceuticals could stifle manufacturing and innovation in the sector.

Industry Concerns Over Regulatory Approach

Several associations representing manufacturers, traders, healthcare providers, and patient safety groups have reached out to the Union Health Minister. In their letter dated August 8, these groups warned that the draft bill could deter investment and undermine India's goal of becoming a global hub for medical device manufacturing.

The industry leaders emphasize that medical devices are fundamentally engineering products, distinct from pharmaceuticals. They argue that the bill's drug-centric language, which includes terms like "adulterated," "spurious," and "misbranded," alongside the imposition of pharma-style criminal penalties, is inappropriate for the regulation of medical devices.

Global Regulatory Practices

The draft bill proposes imprisonment terms ranging from one to seven years for various infractions, including labeling errors and documentation lapses, even when these do not result in harm. This approach contrasts sharply with international standards, where administrative measures such as risk-based conformity assessments and quality management systems are preferred.

In markets like the European Union, the United States, Japan, the United Kingdom, and Australia, regulatory bodies focus on administrative enforcement rather than criminal penalties for non-compliance in the medical device sector. The Indian industry stakeholders argue that adopting a similar approach would be more conducive to growth and innovation.

Call for Policy Reassessment

The draft bill is currently under inter-ministerial review, and its final version is yet to be seen. Industry representatives are urging the government to reconsider the bill's provisions to better align with the unique characteristics of medical devices.

By treating medical devices as an adjunct to pharmaceuticals, the bill fails to provide the necessary regulatory framework for the sector's growth and global competitiveness, stakeholders argue. They are advocating for a distinct regulatory pathway that recognizes the scientific and engineering differences between medical devices and drugs.

As the debate continues, the medical device industry remains hopeful that the government will take into account the diverse needs of the sector and craft regulations that foster innovation while ensuring patient safety.