Medical Device Industry Challenges Indian Draft Bill on Regulation
India's medical device sector opposes a draft bill equating devices with drugs, citing possible harm to innovation and investment.
The medical device industry in India is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders argue that the bill's approach of regulating medical devices in the same manner as pharmaceuticals could stifle innovation and deter investment. This stance was articulated in a letter to the Union Health Minister, underscoring the potential negative impact on India's goal of becoming a global hub for medical devices.
Industry Concerns Over Regulatory Approach
The draft bill proposes criminal penalties for regulatory infractions, such as labeling errors and documentation lapses, which are common in engineering products. Industry representatives argue that this approach is more suited to pharmaceuticals and not to medical devices, which are fundamentally different. The letter points out that globally, medical devices are regulated through risk-based assessments and quality management frameworks, not through criminalization.
Associations representing manufacturers, traders, and patient safety groups have expressed that the draft continues to use drug-centric terminology, applying terms like "adulterated" and "misbranded" to devices. This, they argue, is inappropriate for engineering products, which should be subject to different regulatory standards.
Comparisons with International Standards
Critics of the draft bill highlight that the proposed penalties, which include imprisonment for up to seven years for certain infractions, are not in line with international practices. In regions like the European Union, the United States, Japan, the UK, and Australia, administrative measures rather than criminal penalties are the norm for regulating medical devices.
The draft bill is currently under inter-ministerial consultation, and the medical device industry is seeking a revision that acknowledges the unique nature of devices compared to pharmaceuticals. Industry stakeholders are advocating for a regulatory framework that supports growth and innovation, without the punitive measures currently proposed.
Call for Policy Rethink
The opposition to the draft bill is rooted in concerns that its current form does not provide the necessary foundation for the medical devices sector to flourish. The industry stresses the importance of a regulatory environment that encourages innovation and competitiveness on a global scale. They urge policymakers to consider a framework that aligns with international standards and practices, fostering a conducive environment for the sector's growth.
As the draft bill undergoes further scrutiny, the medical device industry remains hopeful for amendments that recognize the distinct nature of medical devices and address their concerns about the proposed regulatory framework.