Medical Device Industry Challenges Draft Bill Treating Devices as Drugs

The medical device industry in India is voicing strong opposition to the proposed Drugs, Medical Devices, and Cosmetics Bill, 2026, arguing that it inaccurately categorizes medical devices as pharmaceuticals. Industry leaders, healthcare providers, and patient safety advocates warn that this approach could stifle innovation, deter investment, and undermine India's aspirations to become a global hub for medical device manufacturing.

Industry Concerns Over Regulatory Approach

Organizations representing manufacturers and healthcare groups have formally expressed their concerns to the Union Health Ministry. They argue that the draft bill, by treating medical devices like drugs, fails to recognize the distinct scientific and engineering nature of these products. According to a letter seen by the Economic Times, the bill's language continues to use drug-centric terms such as "adulterated" and "misbranded," and imposes pharmaceutical-style criminal penalties for regulatory infractions.

The draft bill proposes imprisonment ranging from one to seven years for issues such as labeling errors, documentation lapses, and engineering defects, even when no harm has occurred. This approach is starkly different from international norms, where administrative measures, rather than criminal penalties, are the standard for regulatory enforcement.

Potential Impact on Innovation and Investment

Industry groups argue that the bill's stringent regulatory framework could hinder the growth of India's medical device sector. They emphasize that the draft does not provide the necessary regulatory foundation for the sector to thrive and compete on a global scale. The letter to the ministry highlights that globally, medical devices are regulated through risk-based assessments, quality management systems, and post-market surveillance rather than criminalization.

There is concern that the bill could discourage investment in the medical device industry, which is crucial for innovation and development. By equating medical devices with pharmaceuticals, the draft bill may impose excessive regulatory burdens, making it less attractive for domestic and international investors.

Call for a Rethink

The medical device industry is urging the government to reconsider the draft bill and adopt a regulatory framework that reflects the unique characteristics of medical devices. Industry leaders are advocating for regulations that support innovation and align with global best practices, such as those in the European Union, United States, Japan, United Kingdom, and Australia, which focus on administrative enforcement rather than criminal penalties.

The draft Drugs, Medical Devices, and Cosmetics Bill, 2026, is currently under inter-ministerial consultation. As the debate continues, stakeholders in the medical device sector remain hopeful for a revised bill that fosters growth and innovation while ensuring patient safety and regulatory compliance.