Industry Pushback: Medical Devices Oppose Indian Draft Bill

The medical device industry in India is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders argue that the proposed legislation, which treats medical devices similarly to pharmaceuticals, could have adverse effects on manufacturing, innovation, and investment in the sector.

Concerns Over Regulatory Approach

The draft bill has raised alarms among manufacturers, healthcare providers, and patient safety groups, who argue that it fails to recognize the fundamental differences between medical devices and pharmaceutical products. According to industry representatives, the bill's provisions for criminal penalties related to regulatory lapses are particularly concerning. They warn that such measures could discourage investment and hinder India's goal of becoming a global hub for medical devices.

In a letter addressed to the Union Health Minister on August 8, several associations representing stakeholders in the medical device sector called for a reevaluation of the draft bill. They emphasized that medical devices are engineering products, distinct from pharmaceuticals, and should not be regulated as drugs. The letter also criticized the use of pharma-centric language in the bill, such as terms like "adulterated," "spurious," and "misbranded," noting that these terms are inappropriate for regulating engineering products.

Global Standards in Focus

The medical device industry is advocating for regulatory frameworks that align with global standards, which typically involve risk-based assessments, quality management systems, post-market surveillance, and recalls rather than criminal penalties. Industry representatives highlighted that in regions like the EU, US, Japan, UK, and Australia, administrative enforcement is the norm, and imprisonment for regulatory lapses is not practiced.

The draft bill proposes imprisonment ranging from one to seven years for offenses such as labelling errors, documentation lapses, and licensing issues, even in cases where no harm has occurred. Industry stakeholders argue that such stringent measures could stifle innovation and deter new entrants from investing in the Indian market.

Industry Calls for Dialogue

As the draft bill undergoes inter-ministerial consultation, the medical device industry is urging the government to engage in a dialogue to develop a regulatory framework that supports growth and innovation. They argue that a balanced approach is needed to ensure patient safety while also fostering a conducive environment for the medical device sector to thrive.

The ongoing debate highlights the need for a tailored regulatory approach that acknowledges the unique characteristics of medical devices, differentiating them from pharmaceuticals. As the government considers the feedback from industry stakeholders, the outcome of this legislative process could have significant implications for the future of India's medical device industry.