Indian Medical Device Industry Opposes Draft Regulation Bill

India's medical device industry, alongside healthcare providers and patient safety groups, is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, which aims to replace the existing 86-year-old pharmaceuticals regulation law, has raised concerns for potentially stifling growth and innovation in the medical device sector by treating these devices as pharmaceutical products.

Concerns Over Regulatory Approach

The primary contention from industry stakeholders is the draft bill's approach to regulate medical devices in a manner akin to pharmaceuticals. Associations representing manufacturers and healthcare providers have reached out to the Union Health Minister, urging a reevaluation of the draft. They argue that the bill's pharmaceutical-centric language and its provision for criminal penalties could deter investment and manufacturing, hindering India's aspirations to become a global hub for medical devices.

In a letter dated August 8, these associations highlighted that medical devices are fundamentally different from pharmaceuticals, being engineering products rather than drugs. They emphasized that the regulatory framework should reflect these distinctions, allowing the sector to innovate and compete on a global scale. The draft bill is currently undergoing inter-ministerial consultations.

Call for Risk-Based Regulatory Framework

The medical device industry has pointed out that globally, medical devices are governed through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls, rather than through criminal penalties. The draft bill's provision for imprisonment of 1-7 years for issues like labeling errors and documentation lapses, even in the absence of harm, is a significant departure from international practices followed by regulatory bodies such as the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA, where administrative enforcement is more common.

The industry stakeholders have expressed their concerns about the bill's use of terms like "adulterated," "spurious," and "misbranded," which are traditionally associated with pharmaceuticals. They argue that such language could lead to undue criminalization of engineering deviations, further discouraging innovation and development within the sector.

Industry's Push for Sector-Specific Regulations

Stakeholders are advocating for a regulatory framework that distinctly addresses the unique characteristics of medical devices, as opposed to bundling them with pharmaceuticals. They believe that the current draft lacks the necessary regulatory foundation to support the sector's growth and its ability to innovate and compete globally. The industry is hopeful that the government will consider the feedback and revise the draft to align with international best practices, fostering an environment conducive to growth and innovation.

As the draft bill undergoes further scrutiny, the medical device industry continues to push for changes that would ensure a more appropriate regulatory environment, promoting both safety and innovation. The outcome of this legislative process will likely have significant implications for the future of India's medical device sector.