Medical Device Industry Challenges Draft Bill's Pharma-Like Regulations

India's medical device industry, along with healthcare groups, is raising concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation has been criticized for treating medical devices similarly to pharmaceuticals, a move that industry stakeholders argue could impede manufacturing, innovation, and investment in the sector.

Industry Reactions to the Draft Bill

Several associations representing manufacturers, traders, and healthcare providers have voiced their opposition to the draft bill in a letter to the Union Health Minister. They argue that the bill, which aims to replace the longstanding pharmaceutical regulations in India, fails to consider the unique nature of medical devices. The letter emphasizes that medical devices are fundamentally engineering products, distinct from pharmaceuticals, and should not be subject to the same regulatory framework.

The industry is particularly concerned about the bill's introduction of criminal penalties for regulatory lapses. Under the proposed legislation, deviations such as labeling errors, documentation issues, and licensing failures could result in imprisonment for up to seven years, even if no harm has occurred. This approach, the industry argues, is not in line with international standards where administrative enforcement is preferred.

Calls for Regulatory Distinction

The draft bill's language has also drawn criticism for its drug-centric terminology, using words like "adulterated," "spurious," and "misbranded," which are more applicable to pharmaceuticals. Industry representatives have highlighted that globally, medical devices are regulated through risk-based assessments, quality management systems, and post-market surveillance rather than criminal penalties.

In their communication to the Health Minister, associations stressed that the draft bill does not provide the necessary regulatory foundation for India's medical device sector to thrive. They warn that the current approach could discourage investment and hinder India's ambitions to establish itself as a global hub for medical devices.

Current Status and Next Steps

The draft bill is currently undergoing inter-ministerial consultation, with various stakeholders continuing to push for changes that would better align the legislation with international practices. Industry groups are advocating for a more nuanced regulatory framework that recognizes the distinct characteristics of medical devices and supports their growth and innovation potential.

The evolving discourse around the draft bill underscores the critical need for a regulatory approach that balances safety with industry development. As consultations continue, the medical device sector remains hopeful for revisions that will foster a conducive environment for innovation and investment.