Medical Device Sector Pushes Back Against Proposed Regulatory Bill

India's medical device industry is vocally opposing the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices like pharmaceuticals. Industry leaders and healthcare groups argue that this approach could stifle innovation and investment, hampering India's growth as a global hub for medical device manufacturing.

Concerns Over Regulatory Approach

The draft bill has triggered significant backlash from various stakeholders, including manufacturers, healthcare providers, and patient safety groups. Critics highlight that the bill's regulatory framework fails to acknowledge the fundamental differences between medical devices and pharmaceutical products. They argue that medical devices are engineering products, which require distinct regulatory standards from those applied to drugs.

In a letter to the Union Health Minister, industry associations warned that the bill's current provisions could deter investment and discourage manufacturing. The letter emphasized the need for a regulatory system that supports growth, innovation, and global competitiveness in the medical device sector.

Industry’s Call for Change

Industry representatives have expressed concern over the draft bill's language, which they claim is overly drug-centric, using terms like "adulterated," "spurious," and "misbranded." They argue that these terms are inappropriate for medical devices, which should be regulated through risk-based assessments, quality management systems, and post-market surveillance, rather than criminal penalties.

The draft bill proposes imprisonment of up to seven years for regulatory lapses such as labeling errors or documentation issues, even if no harm occurs. Industry leaders pointed out that major regulatory bodies in the EU, US, Japan, UK, and Australia rely on administrative enforcement rather than criminalization for such infractions.

Seeking a Balanced Regulatory Framework

The draft bill, currently under inter-ministerial review, is part of an effort to update the 86-year-old law governing India's pharmaceutical regulations. However, stakeholders argue that the bill lacks the necessary foundation to foster a thriving medical device industry. They advocate for a separate regulatory framework that recognizes the unique nature of medical devices, distinct from pharmaceuticals.

Industry groups are pushing for a balanced approach that encourages compliance and innovation without imposing harsh penalties. They hope that the ongoing consultation process will lead to revisions that support the sector's growth and align with global best practices.