Medical Device Firms Challenge Bill Over Pharma Comparisons

India's medical device industry is pushing back against the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that the proposed legislation erroneously equates medical devices with pharmaceutical products. Industry representatives warn that this approach could severely impact manufacturing, investment, and innovation within the sector.

Industry Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial review, has drawn criticism from various industry associations, including manufacturers, traders, healthcare providers, and patient advocacy groups. They have collectively urged the Union health minister to reconsider the bill's provisions, which they argue are not conducive to the growth of India's medical device sector.

The primary concern is the bill's treatment of medical devices as pharmaceutical products, despite the distinct scientific and regulatory differences between the two categories. Industry groups have pointed out that the bill's language continues to use drug-centric terms such as "adulterated," "spurious," and "misbranded," applying criminal penalties for compliance issues typically addressed through administrative enforcement in other countries.

Potential Consequences for Innovation and Investment

Critics of the draft bill emphasize that the proposed criminal penalties, which include imprisonment for labeling errors and documentation lapses, could deter investment and stifle innovation in the medical device sector. This stands in contrast to international standards, such as those observed by the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA, where a risk-based approach and administrative actions are the norm.

The associations have highlighted that the bill does not provide a solid regulatory foundation for the sector to flourish and compete on a global scale. They argue that the bill's current form could undermine India's potential to become a leading hub for medical device manufacturing and innovation.

Calls for a Revised Regulatory Framework

The medical device industry is advocating for a regulatory framework that recognizes the engineering nature of medical devices, distinct from pharmaceuticals. They suggest that the framework should focus on risk-based conformity assessments, quality management systems, post-market surveillance, and recalls, rather than punitive measures.

As the draft bill undergoes further consultation, industry stakeholders are hopeful that their concerns will be addressed to create a more supportive environment for the medical device sector, paving the way for growth and global competitiveness.