Medical Device Industry Opposes Draft Bill Treating Devices as Drugs

India's medical device industry and healthcare groups are voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. They argue that the bill's approach of categorizing medical devices similarly to pharmaceuticals could stifle innovation and deter investment in the sector.

Industry Concerns Over Draft Bill

Several associations representing manufacturers, healthcare providers, and patient safety groups have formally expressed their concerns to the Union Health Minister. They contend that the draft bill, which aims to replace an 86-year-old law governing pharmaceutical regulations, fails to recognize the distinct nature of medical devices compared to pharmaceuticals.

The industry emphasizes that medical devices are engineering products, not drugs, and should not be subjected to the same regulatory framework. The draft bill's language, which includes terms like "adulterated," "spurious," and "misbranded," reflects a pharmaceutical-centric approach, applying criminal penalties for regulatory lapses that are typically administrative in nature globally.

Global Regulatory Practices

Industry representatives argue that internationally, medical devices are regulated through risk-based assessments, quality management systems, and post-market surveillance rather than criminal penalties. They point out that countries such as the United States, the European Union, Japan, the United Kingdom, and Australia focus on administrative enforcement rather than imprisonment for regulatory deviations.

The draft bill proposes imprisonment ranging from one to seven years for issues such as labeling errors, documentation lapses, and engineering defects, even when these do not result in harm. This approach contrasts sharply with international norms, which prioritize corrective actions and recalls over punitive measures.

Calls for Regulatory Revisions

The associations have urged the government to reconsider the draft bill and develop a regulatory framework that supports the growth and innovation of India's medical device sector. They warn that the current form of the bill could undermine India's ambitions to become a global hub for medical device manufacturing.

The draft bill is currently undergoing inter-ministerial consultation, and stakeholders hope that their feedback will lead to significant revisions. The industry's pushback underscores the need for a regulatory environment that acknowledges the unique characteristics of medical devices and fosters a conducive atmosphere for investment and advancement.