Medical Device Firms Resist Draft Bill Equating Devices with Pharma

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which they argue inappropriately regulates medical devices as pharmaceutical products. Industry representatives, patient safety advocates, and healthcare providers have expressed concerns that the draft legislation could stifle innovation and deter investment in the sector.

Industry Pushback Against Regulatory Approach

The draft bill, currently under inter-ministerial review, has sparked criticism for its pharmaceutical-centric language and the introduction of severe penalties for regulatory non-compliance. Associations representing manufacturers and healthcare providers have formally requested the Union Health Minister to reconsider the bill’s provisions, warning it could impede India's aspiration to become a global leader in medical device manufacturing.

In a letter dated August 8, industry groups emphasized the differences between medical devices and pharmaceuticals, noting that devices are engineering products requiring distinct regulatory frameworks. They argue the draft bill's approach fails to provide the necessary regulatory foundation for the sector's growth and competitiveness on a global scale.

Concerns Over Criminal Penalties

Critics of the bill are particularly concerned about the potential criminalization of administrative errors. The draft imposes penalties, including imprisonment of one to seven years, for issues such as labeling mistakes, documentation errors, and licensing lapses. Industry leaders argue that these measures are disproportionate, especially when no harm results from such deviations.

Globally, medical devices are typically regulated through risk-based assessments, quality management systems, and post-market surveillance rather than through criminal penalties. The current draft stands in contrast to practices in regions like the EU, US, Japan, UK, and Australia, where administrative enforcement is the norm.

Call for Sector-Specific Regulations

The medical device sector is advocating for a regulatory framework that acknowledges the unique characteristics of medical devices, separate from those applied to pharmaceuticals. They urge the government to adopt international best practices that focus on risk management and quality assurance rather than punitive measures.

The bill's current language, which includes terms like "adulterated," "spurious," and "misbranded," has been criticized for not aligning with the engineering nature of medical devices. Industry groups stress the importance of aligning India's regulations with global standards to foster innovation and attract investment.

As the draft bill undergoes further consultation, stakeholders from the medical device industry remain hopeful that their concerns will be addressed, leading to a more conducive environment for the sector's development and growth.