Medical Device Industry Challenges India’s New Regulatory Bill

India's medical device industry is voicing strong objections to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices similarly to pharmaceuticals. Industry leaders, healthcare providers, and patient safety groups argue that this approach could stifle innovation, manufacturing, and investment in the sector.

Industry Concerns Over Regulatory Approach

Representatives from various associations have communicated their concerns to the Union Health Minister, emphasizing the distinct nature of medical devices compared to pharmaceuticals. They argue that medical devices are fundamentally engineering products, not drugs, and require a different regulatory framework. The draft bill's language, which includes terms like 'adulterated', 'spurious', and 'misbranded', is seen as inappropriate for devices and could lead to unnecessary criminal penalties for regulatory lapses.

The bill proposes imprisonment for offenses such as labeling errors, documentation issues, and other deviations, even when no harm is caused. Industry insiders point out that such measures are not aligned with global practices, where administrative enforcement is the norm. In markets like the EU, US, Japan, UK, and Australia, regulatory frameworks focus on risk-based assessments and quality management systems rather than criminal penalties.

Global Comparison and Strategic Implications

The draft bill is part of the government's effort to update the 86-year-old law governing pharmaceutical regulations in India. However, industry stakeholders warn that without a clear and distinct regulatory framework for medical devices, the bill could hinder India's ambition to become a global hub for medical device manufacturing and innovation. They advocate for a system that recognizes the unique characteristics of medical devices and supports growth and competition on the global stage.

In their correspondence dated August 8, the associations have highlighted the need for a regulatory foundation that fosters innovation and competitiveness. The draft bill is currently under inter-ministerial review, and industry leaders are hopeful for revisions that address their concerns.

The debate over the draft bill highlights the complex regulatory landscape faced by the medical device industry in India. As the government seeks to modernize its regulations, balancing patient safety with industry growth remains a critical challenge.