Medical Device Industry Challenges Draft Bill on Regulatory Grounds

India's medical device industry has voiced strong objections to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it unjustly equates medical devices with pharmaceuticals. This legislation, they claim, could stifle innovation and deter investment in the sector.

Industry Voices Concerns Over Regulatory Approach

The draft bill has sparked controversy among industry stakeholders, including manufacturers, healthcare providers, and patient safety groups. They have collectively urged the Union Health Minister to reconsider the bill's provisions, which they argue do not adequately differentiate between medical devices and pharmaceuticals. According to industry representatives, treating medical devices as pharmaceuticals ignores the engineering and scientific distinctions between the two categories.

Medical devices, unlike pharmaceuticals, are engineering products that require a distinct regulatory approach. The industry's letter to the government emphasizes that the current draft does not provide a conducive regulatory framework for the growth and global competitiveness of India's medical device sector.

Concerns Over Language and Penalties

Industry leaders have expressed dissatisfaction with the draft's use of drug-centric language, including terms like "adulterated," "spurious," and "misbranded." They argue that applying such language and pharmaceutical-style criminal penalties to engineering deviations is inappropriate. The draft imposes severe penalties, including imprisonment of one to seven years for issues such as labelling errors, documentation lapses, and engineering defects, even when no harm results.

Comparatively, international standards in regions such as the EU, US, Japan, UK, and Australia focus on risk-based conformity assessments, quality management systems, and administrative enforcement rather than criminalization. The industry contends that India's approach should align with these international practices to foster a more supportive environment for medical device innovation.

Potential Impact on India's Global Ambitions

With India's aspirations to become a global hub for medical devices, industry leaders warn that the proposed bill could undermine these goals. The associations' letter highlights the need for a tailored regulatory framework that encourages manufacturing and investment, rather than imposing restrictive measures that could drive away potential investors.

As the draft bill undergoes inter-ministerial consultation, the medical device industry remains hopeful that the government will consider their feedback and implement changes that recognize the unique nature of medical devices. The outcome of this legislative process will be crucial for the future trajectory of India's medical device industry and its role on the global stage.