Medical Device Industry Pushes Back Against Indian Draft Bill

India's medical device industry and healthcare organizations are raising alarms over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it erroneously categorizes medical devices as pharmaceuticals. This move, they claim, threatens to stifle innovation and deter investment in the sector.

Industry Concerns Over Regulatory Approach

The proposed legislation has prompted a strong response from various stakeholders, including manufacturers, healthcare providers, and patient advocacy groups. These entities have collectively addressed the Union health minister, urging a reconsideration of the draft. They argue that the bill fails to establish a regulatory framework conducive to the growth and global competitiveness of India's medical device sector.

The industry's core argument is that medical devices, being engineering products, differ fundamentally from pharmaceuticals and should not be regulated under the same framework. The draft's use of drug-centric terminology such as "adulterated," "spurious," and "misbranded" is seen as inappropriate for medical devices, which are typically subject to risk-based conformity assessments, quality management systems, and post-market surveillance.

Potential Impact on Innovation and Investment

Industry leaders warn that the draft bill's inclusion of criminal penalties, ranging from one to seven years for errors in labeling, documentation, licensing, and reporting, could severely impact manufacturers. Such penalties are viewed as excessive, especially in cases where no harm occurs. In contrast, international standards, such as those from the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA, focus on administrative enforcement rather than criminalization.

The medical device sector fears that the draft bill, if enacted in its current form, will discourage investment and innovation, ultimately hindering India's aspirations to become a global hub for medical device manufacturing. Industry representatives emphasize the need for a distinct regulatory framework that acknowledges the unique nature of medical devices and supports the sector's growth.

Call for a Revised Legislative Framework

As the draft bill undergoes inter-ministerial consultation, stakeholders are advocating for revisions that reflect the distinct characteristics of medical devices. They argue for a regulatory environment that aligns with global practices and supports the sector's potential for innovation and competitiveness.

The ongoing debate highlights the critical need for a nuanced approach to regulation that distinguishes between pharmaceuticals and medical devices, ensuring that India's regulatory landscape supports both sectors' growth and development.