India's Medical Device Sector Opposes Draft Bill's Pharma Approach
Indian medical device firms argue against a draft bill treating devices as pharmaceuticals, citing risks to innovation and investment.
The Indian medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it unfairly equates medical devices with pharmaceuticals. Industry leaders and healthcare groups are concerned that this approach could stifle innovation, discourage investment, and harm manufacturing efforts.
Industry Pushback Against Draft Bill
Representatives from various associations, including manufacturers, healthcare providers, and patient safety groups, have communicated their concerns to the Union Health Minister. They have urged a reconsideration of the draft, emphasizing that treating medical devices as pharmaceuticals is scientifically and regulatorily inappropriate. These stakeholders argue that such treatment could derail India's aspirations of becoming a global hub for medical device production.
In a letter dated August 8, industry leaders highlighted that the draft bill does not provide the necessary regulatory framework for the medical devices sector to thrive. The letter criticizes the draft for using pharmaceutical-centric language and imposing criminal penalties typically associated with drug regulation on engineering products.
Calls for a Distinct Regulatory Framework
The industry advocates for a regulatory system that acknowledges the unique nature of medical devices, which differ significantly from pharmaceuticals in terms of engineering and scientific principles. Globally, medical devices are subject to risk-based conformity assessments and quality management systems, rather than the criminal penalties proposed in the draft bill.
The current draft suggests imprisonment for various infractions, including labeling errors and documentation lapses, even in the absence of harm. This approach contrasts with international practices in regions like the EU, US, Japan, UK, and Australia, where administrative enforcement is the norm.
Potential Impact on Innovation and Investment
Industry leaders warn that the draft bill could deter investment and innovation by imposing stringent criminal penalties. The medical device sector, which relies heavily on engineering advancements and rapid innovation, could face significant setbacks if subjected to pharmaceutical-style regulation.
The draft bill is currently under inter-ministerial consultation, and industry stakeholders are hopeful that their feedback will prompt revisions that better align with global standards and support the sector's growth.