Medical Device Firms Challenge India's Draft Regulatory Bill

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it inappropriately categorizes medical devices alongside pharmaceuticals. Industry stakeholders believe this could stifle innovation and deter investment in the sector, according to sources familiar with the matter.

Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial consultation, seeks to overhaul the 86-year-old legislation governing pharmaceutical regulations in India. However, medical device manufacturers and healthcare providers argue that the bill fails to recognize the fundamental differences between medical devices and pharmaceutical products. They assert that the draft imposes pharmaceutical-style criminal penalties on medical device companies for regulatory lapses, which could hinder the sector’s growth and innovation.

In a letter dated August 8, industry associations urged the Union Health Minister to reconsider the bill, emphasizing the need for a regulatory framework that supports the distinct nature of medical devices. They highlighted that the bill's language continues to use terms like "adulterated," "spurious," and "misbranded," which are traditionally associated with pharmaceuticals, not engineering products.

Global Standards and Risk-Based Regulation

The medical device sector argues that globally, devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance—not through criminal penalties. The draft bill's provision for imprisonment ranging from one to seven years for issues like labeling errors or documentation lapses is seen as excessive. The industry points out that such punitive measures are not standard practice in other major markets, including the EU, US, Japan, UK, and Australia, where administrative enforcement is preferred.

Representatives from the industry stress that aligning with global regulatory practices is crucial if India is to achieve its ambition of becoming a global hub for medical device manufacturing. They argue that the current draft does not lay down a suitable regulatory foundation for the sector's growth and competitiveness on the international stage.

Industry Pushback and Future Implications

The opposition to the draft bill is not just about regulatory language but also about the potential impact on India's economic and innovation landscape. By equating medical devices with drugs, the bill could impose unnecessary barriers on a sector that operates on different scientific and engineering principles.

Industry leaders are urging the government to engage in further dialogue to craft a regulatory framework that recognizes these distinctions and fosters an environment conducive to innovation and investment. The outcome of this legislative process could have significant implications for the future of India's medical device industry and its role in the global market.