Medical Device Firms Challenge India's Draft Bill on Regulatory Grounds

India's medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes treating medical devices as pharmaceutical products. Industry leaders argue that this approach could stifle growth, innovation, and investment in the sector.

Industry Concerns Over Regulatory Approach

Associations representing manufacturers, traders, and healthcare providers have formally appealed to the Union health minister, urging a reassessment of the proposed legislation. They warn that the draft bill's current form could deter investment and impede India's goal of becoming a global hub for medical device manufacturing.

The draft legislation, which is under inter-ministerial review, aims to replace the existing 86-year-old pharmaceutical regulations. However, industry stakeholders argue that the bill does not lay down a suitable regulatory framework for medical devices, which they emphasize are fundamentally different from pharmaceuticals in terms of engineering and regulatory needs.

Criticism of Drug-Centric Language

The draft bill has been criticized for its use of pharmaceutical-centric terminology such as "adulterated," "spurious," and "misbranded," which it applies to medical devices. Industry representatives argue that these terms, along with the proposed criminal penalties for regulatory lapses, are inappropriate for the medical device sector.

"Globally, medical devices are regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls, not imprisonment," the industry letter states. The bill suggests imprisonment terms ranging from one to seven years for issues such as labeling errors, documentation mistakes, and licensing problems, even in cases where no harm has occurred.

Global Regulatory Standards

The industry points out that in regions such as the European Union, United States, Japan, United Kingdom, and Australia, administrative enforcement is the norm for handling regulatory issues in the medical device sector. They argue that adopting a similar approach in India would be more conducive to fostering innovation and growth.

As the draft bill undergoes further consultation, the medical device industry continues to advocate for a regulatory framework that recognizes the unique nature of medical devices and aligns with international standards.