Medical Device Industry Challenges Draft Bill Over Pharma-like Regulations

India's medical device industry has raised significant concerns regarding the draft Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders argue the bill improperly categorizes medical devices alongside pharmaceuticals, potentially stifling innovation and investment. The opposition comes from a coalition of manufacturers, healthcare providers, and patient safety groups.

Industry's Response to the Draft Bill

The draft bill proposes treating medical devices similarly to pharmaceuticals, introducing criminal penalties for regulatory infractions. This approach has drawn criticism from several industry associations, which have directly appealed to the Union health minister. They warn that such measures could undermine India's goal of becoming a global hub for medical device manufacturing.

In a letter dated August 8, industry representatives outlined their concerns, emphasizing the distinct nature of medical devices as engineering products. The letter criticizes the bill for using drug-centric language, such as 'adulterated' and 'spurious', and for applying pharmaceutical-style criminal penalties to deviations in engineering standards.

Concerns Over Regulatory Approach

The bill's proposed penalties include imprisonment of one to seven years for minor infractions, such as labeling errors or documentation lapses. Critics argue that this punitive approach is inconsistent with international norms. Globally, countries like the United States, European Union, Japan, and Australia use risk-based assessments and administrative enforcement rather than criminal penalties.

The medical device industry is concerned that such stringent measures could deter investment and innovation. The letter to the health ministry argues that the bill's current form lacks the regulatory framework necessary for the sector to thrive and compete on a global stage.

Calls for Revision and Separate Regulations

Industry stakeholders are advocating for a regulatory framework that recognizes the unique characteristics of medical devices, separate from pharmaceuticals. They emphasize the need for regulations that focus on quality management, post-market surveillance, and recalls rather than punitive measures.

The draft bill is currently under inter-ministerial consultation, and the industry hopes for amendments that align with international best practices. The pushback from the medical device sector highlights the critical need for tailored regulations that support growth and innovation while ensuring patient safety.