Medical Device Industry Rejects Pharma-Like Regulation in Draft Bill

India's medical device industry, alongside healthcare providers and patient safety groups, is pushing back against the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The groups argue that the proposed regulations, which treat medical devices similarly to pharmaceutical products, could stifle manufacturing, investment, and innovation in the sector.

Industry Concerns Over Regulatory Approach

The draft bill has drawn criticism for utilizing pharmaceutical-centric language and imposing severe penalties, including imprisonment for regulatory lapses such as labeling errors and documentation mistakes. Industry representatives emphasize that medical devices are fundamentally different from pharmaceuticals, being engineering products that require distinct regulatory frameworks.

In a letter dated August 8 to the Union Health Minister, associations representing manufacturers, traders, and healthcare providers urged a reassessment of the draft bill. They warned that the current approach could deter investment and undermine India's goal to become a global hub for medical devices. The letter highlighted that the bill fails to establish the necessary regulatory foundation for the sector to thrive and compete internationally.

Global Practices in Medical Device Regulation

The industry points out that international standards, such as those set by the European Union Medical Device Regulation (EU MDR), the U.S. Food and Drug Administration (FDA), and other regulatory bodies in Japan, the UK, and Australia, do not involve criminal penalties for engineering deviations. Instead, these systems focus on risk-based conformity assessments, quality management systems, post-market surveillance, and recalls as primary regulatory tools.

The draft bill's approach, according to the industry, could lead to a chilling effect on innovation and growth. The use of terms like "adulterated," "spurious," and "misbranded"—common in pharmaceutical regulation—are seen as inappropriate for medical devices, which operate under different scientific and engineering principles.

Call for Revised Legislative Framework

As the draft bill undergoes inter-ministerial consultation, stakeholders are advocating for a revised framework that aligns with global best practices and recognizes the unique nature of medical devices. The call for change is rooted in the belief that a balanced and suitable regulatory environment is essential for fostering innovation and ensuring patient safety without imposing undue burdens on manufacturers.

India's medical device sector has been growing rapidly, with aspirations to expand its footprint globally. However, industry leaders caution that progress could be hampered by regulations that do not adequately differentiate between medical devices and pharmaceuticals. The outcome of these discussions will be crucial in shaping the future landscape of India’s medical device industry.