India's Medical Device Industry Challenges New Draft Bill Regulations

India's medical device industry, along with healthcare groups, has voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The sector argues that the proposed legislation inappropriately treats medical devices as pharmaceutical products, potentially stifling innovation, investment, and manufacturing.

Industry Concerns Over New Regulations

The draft bill, currently under inter-ministerial review, has sparked concern among various stakeholders, including manufacturers, traders, and patient safety advocates. These groups have formally addressed their objections in a letter to the Union Health Minister, emphasizing that the bill does not establish a conducive regulatory framework for the growth and global competitiveness of India's medical device sector.

According to industry representatives, the draft legislation fails to acknowledge the fundamental differences between medical devices and pharmaceuticals. They argue that devices are engineered products, requiring distinct regulatory approaches, unlike drugs. The bill's use of pharmaceutical-centric terminology such as "adulterated," "spurious," and "misbranded" has been criticized for inappropriately applying drug-related criminal penalties to engineering deviations.

Global Standards and Local Implications

The proposed bill suggests criminal penalties, including imprisonment for one to seven years, for various infractions such as labeling errors and documentation lapses, even when no harm results. Industry leaders point out that this is not standard practice in major markets like the European Union, United States, Japan, the United Kingdom, or Australia, where administrative enforcement is preferred over criminalization.

By aligning more closely with pharmaceutical regulations, the draft bill may inadvertently hinder India’s ambition to become a global hub for medical devices. The industry is urging for a regulatory framework that mirrors global standards, focusing on risk-based conformity assessments, quality management systems, and effective post-market surveillance.

Call for Reconsideration

The medical device sector's appeal for a reconsideration of the draft bill is rooted in the need for policies that foster innovation and investment. As the draft undergoes further consultation, stakeholders remain hopeful that revisions will reflect the unique nature of medical devices, ensuring a balanced regulatory environment that supports both safety and industry growth.