Medical Device Industry Pushes Back Against Indian Draft Bill

The Indian medical device industry has raised significant concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it inaccurately classifies medical devices alongside pharmaceuticals. Industry leaders warn that this approach could negatively impact manufacturing, investment, and innovation in the sector.

Industry Concerns Over Regulatory Approach

Representatives from various associations, including manufacturers, traders, and healthcare providers, have voiced their opposition to the draft bill. They argue that the bill's framework fails to recognize the fundamental differences between medical devices and pharmaceuticals. Unlike drugs, which are chemical-based, medical devices are engineering products requiring distinct regulatory standards.

In a letter addressed to the Union health minister, these groups have emphasized that the draft bill does not provide the necessary regulatory foundation for the medical device sector to thrive and compete on a global scale. The letter, dated August 8, highlights that the bill continues to treat medical devices as an extension of pharmaceuticals, ignoring their unique scientific and engineering characteristics.

Potential Impact on Innovation and Investment

The draft bill proposes stringent penalties, including imprisonment for lapses in labeling, documentation, licensing, and post-market surveillance reporting. Industry stakeholders argue that such measures, typically reserved for pharmaceutical regulations, could deter investment and innovation in the medical device sector. They point out that global regulatory bodies, such as the EU MDR, US FDA, and Japan PMDA, favor administrative enforcement over criminal penalties for non-compliance.

By maintaining a drug-centric regulatory language, the bill employs terms like "adulterated," "spurious," and "misbranded," which are not applicable to engineering products. This approach, industry leaders argue, could lead to unnecessary criminalization of engineering deviations that do not result in harm.

Calls for a Distinct Regulatory Framework

The medical device industry is urging the government to adopt a regulatory framework that aligns with international practices, focusing on risk-based assessments, quality management systems, and effective post-market surveillance. They argue that such a framework would better support the growth of India's medical device sector, attracting global investment and fostering innovation.

The draft bill is currently under inter-ministerial consultation, with industry groups hopeful that their feedback will lead to a more nuanced approach that acknowledges the distinct nature of medical devices. As India seeks to establish itself as a global hub for medical device manufacturing, stakeholders emphasize the importance of a regulatory environment that encourages, rather than hinders, growth and innovation.