Medical Device Industry Challenges India's Draft Regulation Bill

India's medical device industry and healthcare groups are voicing strong opposition to the proposed Drugs, Medical Devices, and Cosmetics Bill, 2026. Industry representatives argue that the bill's approach to regulating medical devices as pharmaceuticals could negatively impact manufacturing, investment, and innovation in the sector.

Concerns Over Regulatory Approach

Industry associations, including manufacturers, traders, and healthcare providers, have formally expressed their concerns to the Union Health Minister. They argue the draft bill inadequately differentiates between medical devices and pharmaceuticals, treating devices as an extension of medicines. This approach, they say, fails to recognize the distinct scientific, engineering, and regulatory frameworks that apply to medical devices.

In a letter dated August 8, stakeholders warned that the bill could undermine India's ambitions to become a global hub for medical devices. The draft legislation, currently under inter-ministerial review, retains terminology such as "adulterated," "spurious," and "misbranded," which are traditionally associated with pharmaceuticals, and imposes severe penalties for regulatory lapses.

Industry Advocates for Risk-Based Regulation

The medical device sector contends that globally, devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance, rather than criminal penalties. They cite international standards in the EU, US, Japan, UK, and Australia, where administrative enforcement is preferred over criminalization.

Under the draft bill, penalties for regulatory infractions range from one to seven years of imprisonment for issues such as labeling errors, documentation lapses, and engineering defects, even when no harm is caused. Industry leaders argue that such measures are unnecessarily harsh and do not align with global practices.

Call for Revision

The associations are calling for a revision of the draft bill to establish a regulatory foundation that supports growth, innovation, and global competitiveness in India's medical device sector. They emphasize the need for a regulatory framework that reflects the unique characteristics of medical devices, distinct from pharmaceuticals.

As the draft bill undergoes further consultation, industry stakeholders remain hopeful that their concerns will be addressed, paving the way for a more tailored and effective regulatory environment for medical devices in India.