India's Medical Device Industry Opposes New Regulatory Draft Bill

India's medical device industry, alongside healthcare and patient safety groups, has voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The draft proposes regulations treating medical devices akin to pharmaceuticals, which industry leaders argue could stifle manufacturing, innovation, and investment in the sector.

Industry Concerns Over Regulatory Approach

The draft bill has been met with criticism for its approach to regulating medical devices as if they were pharmaceutical products. Industry representatives emphasize that medical devices are fundamentally different, being engineering products rather than chemical compounds. They argue that the bill's language, which includes terms like "adulterated" and "misbranded," is more suited to drug regulation and inappropriate for medical devices.

Associations representing manufacturers and healthcare providers have collectively written to the Union health minister, urging a reconsideration of the bill. They warn that the proposed regulations could deter investment and undermine India's potential to become a leading global hub for medical device manufacturing.

Potential Impact on Global Competitiveness

The draft bill's punitive measures, including imprisonment for regulatory lapses such as labeling errors and documentation mistakes, have been particularly contentious. Industry experts note that such measures do not align with international practices in regions like the EU, US, Japan, UK, or Australia, where administrative enforcement is the norm.

The letter from industry associations, dated August 8, argues that the current draft fails to provide a robust regulatory framework necessary for the sector's growth and global competitiveness. It highlights the need for a risk-based approach to regulation, focusing on conformity assessments, quality management, and post-market surveillance, rather than criminal penalties.

Call for a Distinct Regulatory Framework

Medical device leaders are advocating for a regulatory framework that acknowledges the distinct nature of medical devices. They stress the importance of fostering an environment conducive to innovation and investment, crucial for the industry's expansion and for meeting healthcare needs effectively.

The draft bill is currently undergoing inter-ministerial consultations, and stakeholders hope for revisions that will better accommodate the unique characteristics of medical devices. The industry remains hopeful that their concerns will be addressed, ensuring that the regulatory landscape supports rather than hinders their growth ambitions.