Medical Device Industry Pushes Back Against India's Draft Bill

The Indian medical device industry, alongside healthcare and patient safety groups, has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, which aims to update the country's regulatory framework, is being criticized for treating medical devices similarly to pharmaceuticals. Industry stakeholders argue that this approach could stifle innovation, deter investment, and impede India's progress toward becoming a global hub for medical device manufacturing.

Concerns Over Regulatory Approach

Industry representatives emphasize that medical devices are fundamentally different from pharmaceuticals, both in terms of engineering and regulatory requirements. Unlike drugs, medical devices are typically subject to risk-based conformity assessments and quality management systems rather than the stringent drug-centric regulations proposed in the draft bill. According to a letter sent to the Union Health Minister, the bill's language uses terms such as "adulterated," "spurious," and "misbranded," which are inappropriate for engineering products.

Potential Impact on Innovation and Investment

The draft bill suggests criminal penalties, including imprisonment for up to seven years, for errors related to labeling, documentation, and licensing, even if no harm results. Industry leaders warn that such measures could discourage innovation and investment in India's medical device sector. They argue that globally, regulatory bodies like the EU MDR, US FDA, and Japan PMDA focus on administrative enforcement rather than criminalization for non-compliance.

Call for a Distinct Regulatory Framework

Several industry associations have submitted a formal request to the government to reconsider the draft bill. They urge the creation of a distinct regulatory framework that recognizes the unique nature of medical devices. The associations argue that the current draft fails to provide the necessary foundation for the sector to thrive and compete on a global scale. They stress the need for regulations that support growth and innovation, rather than imposing pharmaceutical-style controls that could hinder development.

As the draft bill undergoes inter-ministerial consultation, the medical device industry remains hopeful that their concerns will be addressed. They continue to advocate for regulations that reflect international best practices, enabling India to strengthen its position in the global medical device market.