India's Medical Device Industry Challenges Draft Bill's Pharma Approach

The Indian medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to treat medical devices similarly to pharmaceuticals. Industry groups argue this approach could stifle innovation, manufacturing, and investment in the sector.

Industry Pushback on Regulatory Approach

Organizations representing medical device manufacturers, healthcare providers, and patient safety groups have raised concerns about the draft bill's implications. They have communicated their stance to the Union health minister, emphasizing that the bill's treatment of medical devices as pharmaceutical products is misguided.

The industry contends that medical devices, being engineering products, require distinct regulatory frameworks separate from those applied to pharmaceuticals. The draft bill's language, which includes terms like "adulterated," "spurious," and "misbranded," is seen as inappropriate for the engineering-centric nature of medical devices.

Concerns Over Criminal Penalties

One of the most contentious aspects of the draft bill is the introduction of criminal penalties, including imprisonment ranging from one to seven years, for regulatory lapses such as labelling errors or documentation mistakes. Industry representatives argue that such measures are not in line with international norms, where administrative enforcement is preferred over criminalization.

Globally, jurisdictions like the EU, US, Japan, UK, and Australia regulate medical devices through risk-based assessments, quality management systems, and post-market surveillance. The draft bill's punitive measures are seen as a potential deterrent to growth and innovation within India's medical device sector.

Calls for a Separate Regulatory Framework

In their communications, industry associations have highlighted the need for a separate, well-defined regulatory framework tailored specifically for medical devices. They argue that the current draft does not provide the necessary foundation for the sector to thrive and compete on a global scale.

The associations have urged the government to reconsider the draft bill's provisions, warning that failing to do so could hinder India's goal of becoming a global hub for medical device manufacturing and innovation.

The draft bill is currently undergoing inter-ministerial consultations, and stakeholders are hopeful that their feedback will lead to a more favorable regulatory environment for the medical device industry.