Medical Device Industry Pushes Back Against Draft Bill in India
India's medical device sector opposes a draft bill equating devices with drugs, citing regulatory and investment concerns.
The Indian medical device industry, along with healthcare providers and patient safety groups, has voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The central contention is that the proposed legislation treats medical devices the same as pharmaceutical products, which could stifle innovation and deter investment in the sector.
Industry Concerns Over Regulatory Approach
Associations representing manufacturers, traders, and healthcare providers have formally petitioned the Union Health Minister, arguing that the draft bill’s approach may undermine India's potential as a global hub for medical device manufacturing. The industry emphasizes that medical devices are fundamentally different from pharmaceuticals, being engineering products rather than chemical compounds, and thus require distinct regulatory standards.
The draft bill has been criticized for using pharmaceutical terminology such as "adulterated," "spurious," and "misbranded," which the industry argues are inappropriate for medical devices. The bill also proposes criminal penalties for regulatory lapses, including labeling errors and documentation mistakes, which the industry claims could hinder growth and innovation.
Global Regulatory Standards and Practices
In their response, industry representatives highlighted that international norms, such as those from the EU, US, Japan, UK, and Australia, typically employ risk-based conformity assessments and quality management systems to regulate medical devices. These regions prefer administrative enforcement over criminal penalties, focusing on post-market surveillance and product recalls rather than imprisonment for regulatory deviations.
The draft bill's current form includes potential imprisonment ranging from one to seven years for various non-compliance issues, a measure that industry insiders warn could disproportionately impact the sector without necessarily enhancing safety or quality.
Calls for Rethinking Legislation
The associations have urged the government to reconsider the draft bill, suggesting that a more tailored regulatory framework is necessary to foster growth and innovation in the medical device sector. They argue that the existing draft lacks the foundation needed to support India's ambitions in the global medical device market.
The draft, currently under inter-ministerial review, is part of a broader effort to update the 86-year-old law governing pharmaceuticals in India. However, stakeholders argue that a separate regulatory pathway is essential for medical devices, given their distinct nature and the unique challenges they present.
As discussions continue, the medical device industry remains hopeful that their concerns will be addressed, paving the way for a regulatory environment that supports both safety and innovation.