Industry Rejects Draft Bill Equating Medical Devices with Pharma

India's medical device industry, along with healthcare and patient safety groups, has raised significant concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, which aims to replace an 86-year-old law, has been criticized for equating medical devices with pharmaceuticals, a move industry leaders argue could severely impact manufacturing, investment, and innovation.

In a coordinated response, various associations representing manufacturers, traders, healthcare providers, and patient groups have written to the Union Health Minister. They urge a reconsideration of the bill, highlighting that its current form could derail India's ambitions of becoming a global hub for medical device manufacturing. The draft bill remains under inter-ministerial consultation.

Concerns Over Regulatory Approach

The industry's primary contention is the draft bill's treatment of medical devices as an extension of pharmaceuticals. This perspective, they argue, fails to acknowledge the distinct scientific, engineering, and regulatory differences between the two sectors. The associations emphasize that globally, medical devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance rather than the punitive measures typical in pharmaceutical regulation.

The draft bill proposes criminal penalties, including imprisonment ranging from one to seven years, for regulatory lapses such as labeling errors, documentation issues, and engineering defects. Industry representatives argue that such measures are not aligned with international practices, which favor administrative enforcement over criminalization.

Potential Impact on Innovation and Investment

Industry leaders warn that the draft bill's stringent regulatory framework could discourage investment in the sector and stifle innovation. They point out that the proposed penalties could deter new entrants and existing manufacturers from expanding operations in India. The associations express concern that the bill's drug-centric language, using terms like "adulterated," "spurious," and "misbranded," is inappropriate for a sector driven by engineering and technological advancements.

The opposition to the draft bill underscores the need for a regulatory framework that fosters growth and competitiveness in India's medical device industry. The sector is advocating for a distinct regulatory approach that aligns with international standards, allowing it to compete effectively on the global stage.

The draft bill's development comes at a time when India is striving to enhance its reputation as a leader in medical device manufacturing. The industry hopes that a revised approach will better support this goal, facilitating increased innovation and investment while ensuring patient safety.