India's Medical Device Sector Pushes Back Against Draft Bill

India's medical device industry is raising alarms over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices in the same manner as pharmaceuticals. Industry leaders argue this approach could stifle innovation and deter investment, hindering the sector's growth.

Industry Concerns Over Regulatory Approach

Several influential associations, representing manufacturers, healthcare providers, and patient safety groups, have communicated their concerns to the Union Health Minister. They argue that the bill's current framework fails to recognize the fundamental differences between medical devices and pharmaceuticals. The bill, they claim, could negatively impact India's ambition to become a global hub for medical device manufacturing.

The industry's primary contention is that medical devices are engineering products, not drugs, and thus should not be subject to the same regulatory framework. The draft bill, however, continues to use pharmaceutical-centric language, including terms like "adulterated" and "spurious," and proposes criminal penalties for regulatory lapses typically handled through administrative measures in other countries.

Potential Impact on Innovation and Investment

The draft bill proposes severe penalties, including imprisonment ranging from one to seven years for labeling errors, documentation oversights, and other regulatory deviations, even in the absence of harm. Industry representatives point out that such stringent measures are not seen in established regulatory environments like the EU, US, Japan, UK, or Australia, where administrative enforcement is preferred.

According to industry insiders, this regulatory approach could deter investment and innovation in India's medical device sector, which is crucial for the country's economic growth and its goal to become a leader in medical device production.

Call for a Distinct Regulatory Framework

The associations have urged the government to reconsider the draft bill and develop a regulatory framework that recognizes the unique nature of medical devices. They advocate for a system based on risk assessment, quality management, and post-market surveillance, similar to international standards.

The current draft is under inter-ministerial consultation, and the industry is hopeful that their concerns will be addressed to ensure a conducive environment for growth and innovation in the sector.