Medical Device Industry Opposes India's Draft Regulatory Bill

The medical device industry in India, alongside healthcare groups and patient safety advocates, is raising significant concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation is under fire for equating medical devices with pharmaceuticals, potentially stifling innovation and investment in the sector.

Industry Pushback on Regulatory Approach

Associations representing manufacturers, traders, and healthcare providers have collectively voiced their opposition to the draft bill, urging the Union Health Ministry to reconsider its provisions. They argue that the bill could derail India's ambitions to become a global hub for medical devices by imposing stringent criminal penalties for regulatory lapses similar to those applied to drugs.

In a letter dated August 8, industry representatives highlighted the fundamental differences between medical devices and pharmaceuticals. They emphasized that medical devices, being engineering products, require distinct regulatory measures that focus on risk management and quality systems rather than the drug-centric language of the draft bill.

Concerns Over Criminal Penalties

The draft bill proposes penalties, including imprisonment ranging from one to seven years for issues such as labeling errors, documentation mistakes, and licensing infractions, even when these do not result in harm. Industry leaders argue that this approach is at odds with international practices, where administrative enforcement is the norm. Regulatory frameworks in regions like the EU, US, Japan, UK, and Australia focus on risk-based assessments and post-market surveillance rather than criminalization.

Call for a Distinct Regulatory Framework

The medical device sector is advocating for a separate regulatory foundation that recognizes the engineering-based nature of devices. Current draft provisions, they argue, fail to provide the necessary environment for growth and global competitiveness. The sector is calling for regulatory language and enforcement mechanisms that align with global standards, fostering an environment conducive to innovation and investment.

The draft bill, intended to replace the 86-year-old law governing pharmaceutical regulations in India, is currently undergoing inter-ministerial consultations. As the debate continues, industry stakeholders hope to influence a framework that supports the unique needs of medical device manufacturing and innovation.