Medical Device Industry Pushes Back Against Draft Bill, Cites Regulatory Concerns

India's medical device sector is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. Industry representatives argue that the bill's approach of treating medical devices akin to pharmaceuticals could stifle manufacturing, innovation, and investment opportunities.

Industry Concerns Over Regulatory Approach

Leaders from the medical device industry, supported by patient safety groups and healthcare providers, have expressed their apprehensions about the draft bill. They emphasize that medical devices, being engineering products, possess distinct characteristics from pharmaceuticals and thus require a different regulatory framework.

In communications addressed to the Union Health Minister, various associations have highlighted the potential negative impacts of the bill. They argue that the draft, which is currently under inter-ministerial review, could undermine India's ambition to emerge as a global hub for medical devices. The bill's language, which includes terms such as "adulterated," "spurious," and "misbranded," reflects a pharmaceutical-centric mindset, according to the industry's feedback.

Potential Impact on Innovation and Investment

The draft bill proposes stringent measures, including criminal penalties ranging from one to seven years of imprisonment for lapses such as labeling errors, documentation issues, and engineering defects, even if no harm results. This approach, the industry argues, is misaligned with international standards. Globally, regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA focus on risk-based assessments, quality management systems, and administrative enforcement rather than criminalization.

Industry stakeholders fear that such punitive measures could deter investment and discourage manufacturers from innovating within India's borders. The associations have urged the government to reconsider the bill and develop a regulatory framework that supports growth and competitiveness in the medical devices sector.

Call for a Distinct Regulatory Framework

The medical device sector is calling for a regulatory foundation that recognizes the unique nature of medical devices. Industry leaders argue that a framework tailored to the specificities of medical devices, separate from pharmaceuticals, is essential for fostering innovation and ensuring patient safety.

The draft bill's current form, as per industry feedback, lacks provisions for risk-based conformity assessments and post-market surveillance, which are critical for the sector's advancement. The associations hope that ongoing consultations will lead to a more balanced regulatory environment that aligns with global practices and supports India's strategic goals in the healthcare industry.