Industry Pushback: Draft Bill Misclassifies Medical Devices as Pharma

The Indian medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, claiming it mistakenly categorizes medical devices alongside pharmaceuticals. This classification, they argue, could severely impact manufacturing and innovation within the sector.

Industry Concerns Over Regulatory Approach

Several associations representing manufacturers, healthcare providers, and patient safety groups have expressed their concerns to the Union Health Ministry. In a letter dated August 8, these groups warned that the draft bill, if enacted, would undermine investment and hinder India's aspirations to become a global hub for medical devices.

The industry argues that medical devices are fundamentally engineering products, distinct from pharmaceuticals, and should not be regulated as drugs. The draft bill's language, which includes terms like "adulterated" and "spurious," reflects a pharmaceutical-centric approach that the industry finds inappropriate for medical devices.

Potential Impact on Innovation and Investment

The draft bill proposes criminal penalties, including imprisonment of one to seven years, for regulatory lapses such as labeling errors and documentation issues. Industry leaders argue that this stringent approach could discourage innovation and investment. They point out that other major regulatory bodies, such as the EU MDR, US FDA, Japan's PMDA, UK's MHRA, and Australia's TGA, favor administrative enforcement over criminal penalties for similar issues.

"Globally, medical devices are regulated through risk-based conformity assessments and quality management systems," the letter states. "The draft bill's approach does not align with international best practices."

Call for a Revised Regulatory Framework

The draft bill is currently undergoing inter-ministerial consultation. Industry stakeholders are urging the government to reconsider the regulatory framework to better suit the unique characteristics of medical devices. They advocate for a regulatory foundation that promotes growth, innovation, and global competitiveness in the sector.

As the debate continues, the medical device industry remains hopeful for a regulatory approach that recognizes the distinct nature of medical devices and supports India's ambition to lead in this field.