Medical Device Industry Challenges Draft Bill on Regulatory Grounds

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders and healthcare groups argue that the draft legislation improperly classifies medical devices in the same category as pharmaceuticals, potentially stifling innovation and deterring investment.

Industry Concerns Over Regulatory Approach

The draft bill, which aims to update the 86-year-old regulations governing pharmaceuticals in India, has raised alarm within the medical device sector. Stakeholders, including manufacturers and patient safety groups, have expressed concerns that the bill's approach fails to recognize the fundamental differences between engineering-based medical devices and chemical-based pharmaceuticals.

In a letter sent to the Union Health Minister on August 8, several associations highlighted that the draft continues to use pharmaceutical-centric language, such as terms like "adulterated" and "misbranded," which are ill-suited for the medical device industry. The letter, viewed by The Economic Times, argues that the bill lacks the necessary regulatory framework to support the growth and global competitiveness of India's medical device sector.

Potential Impacts on Manufacturing and Innovation

The medical device industry fears that the bill's stringent penalties, which include imprisonment for various regulatory lapses, could severely impact manufacturing and innovation. The draft proposes criminal penalties for issues ranging from labeling errors to engineering defects, even when no harm is caused. Such measures, the industry argues, are not aligned with international practices where administrative enforcement is the norm.

Globally, countries like the US, EU, Japan, and Australia regulate medical devices through risk-based conformity assessments, quality management systems, and post-market surveillance, rather than punitive measures. The Indian industry warns that adopting a pharmaceutical-style regulatory framework could undermine India's ambitions of becoming a global hub for medical device manufacturing.

Call for a Rethink on Regulation

The medical device sector is urging the government to reconsider the draft bill, advocating for regulations that reflect the unique nature of medical devices. The industry emphasizes the importance of a regulatory environment that fosters innovation, supports manufacturing growth, and aligns with international standards.

The draft bill is currently under inter-ministerial consultation, and the industry hopes that its feedback will be considered to ensure a balanced approach that encourages development while maintaining safety and quality standards.