Medical Device Industry Opposes Draft Bill Treating Devices as Drugs

India's medical device industry has expressed strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it incorrectly categorizes medical devices alongside pharmaceuticals. Industry representatives and healthcare organizations warn that this approach could negatively impact manufacturing, investment, and innovation in the sector.

Industry Concerns Over Regulatory Approach

The draft bill has sparked concern among various stakeholders, including manufacturers, healthcare providers, and patient safety groups. These entities have collectively urged the Union Health Minister to reconsider the bill's provisions, emphasizing that medical devices should not be regulated as pharmaceuticals. They argue that the proposed legislation lacks a clear distinction between the two categories, which could undermine India's goal of becoming a global hub for medical devices.

Associations representing the sector have pointed out that medical devices are primarily engineering products, not drugs. They have highlighted that the draft bill continues to employ pharmaceutical terminology and criminal penalties for regulatory lapses, which they argue are inappropriate for the medical device industry.

Potential Impact on Innovation and Investment

The industry has voiced concerns that the draft bill's use of terms like "adulterated," "spurious," and "misbranded"—typically associated with pharmaceutical regulation—could lead to the criminalization of non-compliance in areas traditionally managed through administrative measures. For instance, the bill proposes imprisonment of 1-7 years for issues such as labeling errors, documentation lapses, and engineering defects, even when no harm has occurred. This approach, the industry argues, is not aligned with international standards.

Globally, countries like the United States, European Union, Japan, and Australia regulate medical devices through risk-based assessments and quality management systems, focusing on post-market surveillance and recalls rather than criminal penalties. The industry fears that adopting a pharmaceutical-centric model could deter investment and stifle innovation within India's medical device sector.

Calls for a Revised Regulatory Framework

In a letter dated August 8, industry associations have stressed the need for a regulatory framework that supports growth, innovation, and global competitiveness. They argue that the current draft does not provide the necessary foundation for the sector's development and urge the government to consider a more tailored approach.

The draft bill is currently under inter-ministerial consultation, and stakeholders are hopeful that their feedback will be taken into account. As discussions continue, the medical device industry remains vocal about the need for regulations that reflect the unique characteristics and challenges of the field, rather than imposing a one-size-fits-all approach.