Medical Device Industry Challenges Draft Bill Treating Devices as Drugs

The medical device industry in India has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that equating medical devices with pharmaceuticals could impede manufacturing and innovation. Industry leaders and healthcare groups have expressed concerns that the draft bill's approach could deter investment and hinder India's aspirations to become a global hub for medical device manufacturing.

Industry Concerns Over Regulatory Approach

The draft legislation, currently under inter-ministerial review, has drawn criticism for applying pharmaceutical-style regulations to medical devices. Key industry associations have reached out to the Union Health Minister, urging a reconsideration of the draft's provisions. These groups argue that the bill fails to recognize the fundamental differences between medical devices and pharmaceuticals, both in terms of engineering and regulatory requirements.

In a letter dated August 8, industry representatives highlighted that the draft bill does not establish a suitable regulatory framework for the growth and global competitiveness of India's medical device sector. They emphasized that medical devices should not be treated as an extension of pharmaceuticals, citing distinct scientific and engineering principles that govern their development and use.

Concerns Over Criminal Penalties

A significant point of contention is the draft bill's imposition of criminal penalties, including imprisonment for one to seven years for errors related to labeling, documentation, licensing, and post-market surveillance. Industry leaders argue that such punitive measures are not aligned with international practices. They point out that regions like the European Union, the United States, Japan, the United Kingdom, and Australia rely on administrative enforcement rather than criminal penalties for regulatory deviations in the medical device sector.

The industry is particularly concerned about the use of drug-centric language in the bill, with terms such as "adulterated," "spurious," and "misbranded" being applied to medical devices. These terms, typically associated with pharmaceuticals, do not accurately reflect the nature of engineering products like medical devices, which are subject to different types of compliance and safety assessments.

Call for a Distinct Regulatory Framework

Industry stakeholders are advocating for a regulatory framework that reflects the unique characteristics of medical devices. They argue for the adoption of risk-based conformity assessments, quality management systems, and post-market surveillance practices tailored to the medical device industry, rather than a one-size-fits-all approach derived from pharmaceutical regulations.

The pushback from the medical device industry underscores the need for a nuanced approach to regulation that supports innovation while ensuring patient safety. As the draft bill undergoes further review, industry leaders are hopeful that their concerns will be addressed, paving the way for a regulatory environment that fosters growth and investment in India's burgeoning medical device sector.