Draft Bill Sparks Backlash: Medical Devices Not Pharmaceuticals, Say Industry Leaders

The medical device industry in India is raising alarms over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it could stifle innovation and deter investment by treating medical devices similarly to pharmaceuticals. Industry representatives, patient safety groups, and healthcare providers have collectively voiced their concerns, urging the Union health minister to reconsider the bill's implications.

Concerns Over Regulatory Approach

Key industry players argue that the draft legislation fails to recognize the fundamental differences between medical devices and pharmaceutical products. A letter submitted to the Union health minister highlights the industry's stance that medical devices are fundamentally engineering products, not drugs, and should not be subjected to the same regulatory framework. The bill's current language, which includes terms like "adulterated" and "misbranded," traditionally associated with drugs, has been criticized for not reflecting the unique nature of medical devices.

The draft bill proposes stringent penalties, including imprisonment ranging from one to seven years for various regulatory lapses such as labeling errors and documentation issues. Industry stakeholders argue that such measures are not aligned with international practices, where administrative enforcement is preferred over criminalization. They point out that regions like the EU, US, Japan, UK, and Australia utilize risk-based conformity assessments and quality management systems rather than severe criminal penalties.

Impact on Manufacturing and Innovation

Industry associations warn that the proposed legislation could have adverse effects on India's aspirations to become a global hub for medical device manufacturing. They argue that the bill's approach may deter both domestic and international investment, citing concerns that stringent regulations could lead to a decline in manufacturing activities and hinder innovation in the sector.

Moreover, the draft bill's failure to provide a robust regulatory foundation specific to medical devices could impede the sector's growth and its ability to compete on a global scale. The industry is advocating for a regulatory framework that acknowledges the scientific and engineering advancements unique to medical devices, rather than applying a one-size-fits-all approach that mirrors pharmaceutical regulations.

Call for a Revised Legislative Framework

The opposition to the draft bill is part of a broader call for a revised legislative framework that better aligns with international standards and practices. Industry leaders emphasize the need for regulations that support innovation while ensuring patient safety through appropriate risk management strategies.

As the draft bill undergoes inter-ministerial consultation, industry representatives remain hopeful that their feedback will lead to significant changes that separate the regulatory pathways for pharmaceuticals and medical devices. They argue that a more nuanced approach would not only protect the interests of manufacturers and investors but also enhance India's position in the global medical device market.