Medical Device Industry Challenges Draft Bill Equating Devices with Drugs

India's medical device industry and healthcare groups are voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The bill, which aims to overhaul the regulatory framework for pharmaceuticals, extends similar regulatory measures to medical devices, a move that industry leaders argue could stifle innovation and deter investment.

Concerns Over Regulatory Approach

Industry representatives, patient safety advocates, and healthcare providers have collectively expressed their concerns in a letter to the Union Health Minister. They argue that the draft bill fails to recognize the fundamental differences between medical devices and pharmaceuticals. The letter emphasizes that medical devices are engineering products, not drugs, and should not be subjected to the same regulatory framework.

The draft legislation includes provisions for criminal penalties, including imprisonment for up to seven years, for regulatory lapses such as labeling errors and documentation mistakes. Industry stakeholders contend that such measures are excessive and could severely impact the sector's growth. They point out that major regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA do not impose criminal penalties for similar issues, opting instead for administrative enforcement.

Impact on Manufacturing and Innovation

The opposition to the draft bill is rooted in fears that it could undermine India's aspirations to become a global hub for medical devices. Industry leaders warn that equating medical devices with pharmaceuticals could discourage both domestic and foreign investment, ultimately hindering manufacturing and innovation within the sector.

Associations representing manufacturers, traders, and healthcare providers have urged the government to reconsider the draft bill's approach. They argue that a risk-based regulatory framework, akin to those used internationally, would better support the sector's growth and competitiveness on a global scale.

Call for Regulatory Distinction

The letter to the Health Minister highlights the need for a regulatory distinction between medical devices and pharmaceuticals. Industry representatives stress that the draft bill's language, which includes terms like "adulterated," "spurious," and "misbranded," is inappropriate for medical devices. They advocate for a regulatory framework that focuses on conformity assessments, quality management systems, and post-market surveillance.

As the draft bill undergoes inter-ministerial consultation, stakeholders are hopeful that their concerns will prompt a reevaluation of the proposed regulations. The medical device industry continues to push for a legislative framework that supports innovation while ensuring patient safety and maintaining global competitiveness.