Medical Device Industry Challenges Draft Bill's Pharma Classification
India's medical device sector opposes a draft bill equating devices to drugs, citing regulatory and innovation concerns.
The Indian medical device sector is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which positions medical devices under the same regulatory framework as pharmaceuticals. Industry leaders, patient safety advocates, and healthcare providers have expressed concerns that such a classification could stifle innovation and deter investment in the growing sector.
Industry Pushback Against Regulatory Changes
Key stakeholders from the medical device industry have reached out to the Union Health Minister through formal communications, urging a reconsideration of the bill's provisions. They argue that treating medical devices as pharmaceutical products ignores the fundamental differences in their engineering and functionality. The draft bill, currently under inter-ministerial review, is seen as a potential setback for India’s ambitions to become a global hub for medical devices.
The industry's letter, dated August 8, highlights that the proposed legislation lacks the necessary regulatory framework tailored for medical devices. It warns that the bill’s drug-centric approach could impose undue burdens on manufacturers, potentially driving away investment and innovation.
Concerns Over Criminal Penalties
The draft legislation includes stringent penalties, such as imprisonment ranging from one to seven years for regulatory non-compliance issues like labeling errors and documentation lapses. Industry representatives argue that such severe penalties are not aligned with global practices in regions like the European Union, the United States, Japan, the United Kingdom, and Australia, where administrative measures are the norm.
These international markets typically employ risk-based assessments, quality management systems, and post-market surveillance rather than criminal penalties. The Indian sector fears that mimicking pharmaceutical regulations could lead to a chilling effect on the engineering-focused medical device industry.
Calls for a Distinct Regulatory Framework
The letter from industry groups emphasizes the need for a distinct regulatory framework that recognizes the unique characteristics of medical devices. The current draft, they argue, continues to use language and penalties more suited to pharmaceuticals, with terms like “adulterated,” “spurious,” and “misbranded” being misapplied to engineering products.
The medical device sector is advocating for regulations that align more closely with international standards, fostering an environment conducive to innovation and growth. Without such changes, industry leaders warn that India's potential to become a leader in medical device manufacturing and innovation could be significantly compromised.