Medical Device Industry Opposes India's 2026 Draft Bill
Medical device firms argue the 2026 draft bill equates devices with drugs, risking innovation.
The Indian medical device industry, along with healthcare and patient safety groups, is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation is under scrutiny for treating medical devices in the same regulatory framework as pharmaceuticals, a move that industry insiders warn could stifle innovation and deter investment.
Industry Concerns Over Regulatory Approach
In a letter dated August 8 to the Union Health Minister, several associations representing manufacturers, traders, and healthcare providers have expressed their concerns. They argue that the draft bill's approach to regulation fails to recognize the fundamental differences between medical devices and pharmaceutical products. The letter highlights the need for a regulatory foundation that supports the growth and competitiveness of India's medical device sector globally.
The draft bill proposes penalties, including imprisonment of one to seven years, for issues such as labeling errors, documentation lapses, and licensing problems, even when these do not result in harm. This approach has been criticized for applying pharmaceutical-style criminalization to engineering deviations, which is not aligned with global practices.
Global Standards and Practices
Industry leaders point out that in regions like the European Union (EU), United States (US), Japan, United Kingdom (UK), and Australia, medical devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance. These regions prioritize administrative enforcement over criminal penalties for non-compliance.
The draft bill's language, using terms such as "adulterated," "spurious," and "misbranded," has also drawn criticism for its pharma-centric focus. Stakeholders argue that such language is inappropriate for engineering products like medical devices, which require a distinct regulatory approach.
A Call for Rethink
The pushback from the medical device industry comes as the government seeks to update the 86-year-old law governing India's pharmaceutical regulations. The draft bill is currently undergoing inter-ministerial consultations. Meanwhile, industry representatives are urging the government to reconsider the bill's provisions to foster an environment conducive to innovation and investment in the medical device sector.
The industry's response underscores the need for a nuanced regulatory framework that recognizes the unique characteristics of medical devices, ensuring that India's ambition to become a global hub for medical device manufacturing is not undermined.