Medical Device Industry Challenges Draft Bill Over Pharma Parallels

India's medical device industry, along with healthcare providers and patient safety groups, is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The industry argues that the bill wrongly equates medical devices with pharmaceutical products, a move they say could stifle innovation, deter investment, and impair India's manufacturing capabilities.

Concerns Over Regulatory Approach

Associations representing manufacturers, traders, and healthcare providers have formally addressed their concerns to the Union Health Minister. They warn that the proposed legislation would hinder India's potential to become a global leader in the medical device sector. The draft bill, currently under inter-ministerial review, is seen by the industry as failing to provide a suitable regulatory environment for growth and innovation.

Critics of the bill highlight that medical devices, which are fundamentally engineering products, should not be regulated under the same framework as pharmaceuticals. The draft employs drug-centric terminology such as "adulterated," "spurious," and "misbranded," and proposes criminal penalties for regulatory lapses similar to those in pharmaceuticals.

Industry's Call for a Specialized Framework

The industry advocates for a distinct regulatory framework that aligns with international standards, which focus on risk-based assessments and quality management systems rather than criminalization. The draft bill's provision for imprisonment ranging from one to seven years for issues such as labeling errors and documentation lapses has been particularly contentious. Industry representatives argue that such punitive measures are not in line with practices in regions like the EU, US, Japan, UK, and Australia, where administrative enforcement prevails.

By treating deviations in medical device engineering with the same severity as pharmaceutical violations, the bill could discourage innovation and pose a significant barrier to new entrants in the market. The associations emphasize the need for a regulatory approach that supports post-market surveillance and recalls rather than punitive actions.

Looking Forward

As discussions continue, the medical device industry remains hopeful for revisions to the draft bill that will consider the unique nature of medical devices. The sector seeks a framework that encourages growth and innovation while maintaining high standards of safety and efficacy. The outcome of these deliberations could have far-reaching implications for India's position in the global medical device market.