Medical Device Industry Pushes Back Against New Indian Draft Bill

India's medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes regulating medical devices in the same manner as pharmaceuticals. Industry representatives argue that this approach could stifle innovation, deter investment, and impede India's goal of becoming a global hub for medical device manufacturing.

Industry Concerns Over Regulatory Approach

Numerous associations, including those representing manufacturers, traders, and healthcare providers, have formally expressed their concerns to the Union Health Minister. They argue that medical devices, which are fundamentally engineering products, should not be regulated under the same framework as pharmaceuticals. The associations emphasize that the draft bill's reliance on drug-centric language and its focus on criminal penalties for regulatory lapses are misaligned with international standards.

The industry highlights that globally, medical devices are managed through risk-based assessments, quality management systems, and administrative enforcement, rather than criminalization. The draft bill, however, proposes severe penalties ranging from one to seven years of imprisonment for issues such as labeling errors and documentation lapses, even in the absence of harm.

Potential Impact on Manufacturing and Innovation

Critics of the draft bill warn that its current form could dissuade investment in India's medical device industry, which is seen as a potential growth sector. They argue that the bill does not provide the necessary regulatory foundation to support the sector's growth and innovation. Instead, they fear it could set back India's ambitions by imposing overly stringent regulations that are not in line with practices in regions such as the European Union, United States, Japan, United Kingdom, and Australia.

The draft bill is currently under inter-ministerial consultation, and industry stakeholders are hopeful for revisions that will better support the unique characteristics of medical devices. They advocate for a regulatory framework that aligns with global standards, emphasizing the need for a system that encourages innovation and growth while ensuring patient safety.

Call for a Separate Regulatory Framework

In their communications to the government, industry groups have called for the creation of a distinct regulatory framework for medical devices. Such a framework would recognize the engineering and scientific distinctions between devices and pharmaceuticals, facilitating a more appropriate regulatory environment.

As discussions continue, the medical device industry remains committed to working with policymakers to develop regulations that foster innovation and growth while maintaining high standards of safety and quality.