Medical Device Firms Challenge Proposed Indian Regulatory Bill

India's medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices as pharmaceuticals. Industry leaders and healthcare groups argue that such measures could stifle innovation and deter investment in the sector.

Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial review, has sparked considerable concern among stakeholders. Medical devices are fundamentally different from pharmaceuticals, being primarily engineering products. Treating them under the same regulatory framework as drugs, the industry argues, is misguided.

Several associations representing device manufacturers, healthcare providers, and patient safety groups have formally addressed their concerns to the Union Health Minister. They emphasize that the bill's current form could undermine India's goal of becoming a global hub for medical device manufacturing.

Industry's Push for Distinct Regulations

In their communication dated August 8, industry representatives highlighted the need for a regulatory framework that acknowledges the unique nature of medical devices. They criticized the draft for using drug-centric language and imposing severe penalties, including imprisonment for non-compliance with labeling and documentation standards. Such penalties, they note, are not aligned with international practices.

“The draft continues to treat medical devices as an adjunct to pharmaceuticals, despite clear scientific, engineering, and regulatory distinctions between the two categories,” the letter stated. The industry is advocating for regulations that focus on risk-based assessments and quality management systems, similar to those employed by regulatory bodies in the EU, US, Japan, and Australia.

Global Regulatory Practices

Globally, agencies like the EU MDR, US FDA, and Japan PMDA regulate medical devices through risk-based conformity assessments rather than punitive measures. The draft bill’s approach, which includes potential imprisonment for technical and administrative errors, is seen as a deterrent to innovation.

The letter from industry groups underscores the importance of adopting a regulatory framework that supports growth and innovation. They warn that the proposed bill could lead to decreased investment and hinder the development of India’s medical device sector.