Medical Device Industry Challenges Draft Bill Treating Devices as Drugs

The medical device industry in India has voiced strong objections to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it unjustly categorizes medical devices alongside pharmaceuticals. Industry representatives and healthcare stakeholders argue that such a classification could stifle innovation, discourage investment, and harm the sector’s growth.

Concerns Over Regulatory Approach

Stakeholders, including manufacturers, healthcare providers, and patient safety groups, have formally expressed their concerns to the Union Health Minister. They argue that the draft bill, by treating medical devices as pharmaceuticals, fails to acknowledge the engineering and scientific distinctions between the two. The bill proposes stringent penalties, including imprisonment for regulatory lapses, which the industry views as excessive and misaligned with international practices.

The draft bill is part of an initiative to replace the current 86-year-old pharmaceutical regulations in India. However, industry voices argue that the bill's drug-centric language, using terms like "adulterated" and "spurious," is inappropriate for medical devices and does not align with global regulatory standards.

Impact on Innovation and Investment

The industry fears that the imposition of criminal penalties for issues such as labeling errors or documentation lapses could deter investment and innovation. The draft bill suggests imprisonment ranging from one to seven years for various infractions, a measure not typically seen in other major markets such as the EU, the US, Japan, the UK, or Australia, where administrative enforcement is preferred.

Associations representing the sector have highlighted that globally, medical devices are regulated through risk-based assessments and quality management systems, rather than punitive measures. They argue that the current draft does not provide a conducive regulatory framework for the sector to thrive and compete on a global scale.

Call for Reassessment

In a letter dated August 8, industry associations urged the government to reconsider the draft bill. They emphasized the need for a regulatory framework that supports the growth and innovation of India's medical device sector, which aspires to become a global hub. The associations advocate for a system that is in line with international standards, focusing on post-market surveillance and quality management rather than punitive criminalization.

As the draft bill undergoes inter-ministerial consultation, the medical device industry remains hopeful for amendments that recognize the unique nature of medical devices. The ongoing debate highlights the critical need for a balanced approach that ensures patient safety while fostering innovation and investment in the sector.