Industry Pushback: Medical Devices Not Pharmaceuticals, Say Companies

India's medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes regulating medical devices similarly to pharmaceuticals. Stakeholders argue this approach could stifle innovation and deter investment.

Industry Concerns Over Draft Bill

The draft bill, currently under inter-ministerial review, has prompted industry associations and healthcare groups to lobby the Union Health Ministry for changes. They argue that treating medical devices like pharmaceuticals ignores the fundamental differences between the two, both in terms of engineering and regulation.

In a letter dated August 8, industry representatives expressed concerns to the health minister, emphasizing the bill's failure to provide a suitable regulatory framework for the burgeoning medical device sector. The letter, seen by ET, criticizes the bill's use of pharmaceutical-centric terminology such as "adulterated" and "misbranded," and its imposition of criminal penalties for regulatory lapses similar to those in drug regulation.

Call for a Risk-Based Regulatory Approach

Critics of the draft argue that globally, medical devices are regulated through risk-based assessments, quality management systems, and post-market surveillance, rather than the criminal penalties proposed in the bill. The draft suggests imprisonment for errors in labeling, documentation, and licensing, even in the absence of harm, a practice not followed by regulatory bodies in the EU, US, Japan, UK, or Australia.

Industry leaders warn that such stringent regulations could discourage manufacturing and innovation, hindering India's goal of becoming a global hub for medical device production. They advocate for a regulatory approach that reflects the unique nature of medical devices, distinct from pharmaceuticals.

Implications for India's Healthcare Sector

The controversy surrounding the draft bill highlights a critical juncture for India's healthcare policy. As the government seeks to update an 86-year-old law governing pharmaceuticals, the industry calls for a nuanced strategy that fosters growth and innovation in the medical device sector.

Stakeholders emphasize the need for a regulatory environment that balances patient safety with the industry's capacity for innovation and growth. The outcome of this legislative process will have significant implications for India's position in the global medical device market.