Medical Device Sector Challenges India's New Regulatory Bill

The draft Drugs, Medical Devices and Cosmetics Bill, 2026, has drawn significant opposition from India's medical device industry and healthcare groups. Critics argue that the proposed legislation, which treats medical devices similarly to pharmaceuticals, could stifle innovation, deter investment, and damage the nation's manufacturing potential.

Industry Concerns Over Regulatory Approach

Key industry players, including associations representing manufacturers, healthcare providers, and patient safety groups, have expressed their dissatisfaction with the draft bill. In a letter to the Union Health Minister, they warned that the bill's approach could hinder India's aspirations to become a global hub for medical devices. The letter emphasized the distinct nature of medical devices, which are engineering products, and argued that they should not be regulated as drugs.

The draft bill continues to use pharmaceutical-centric language, referring to devices with terms like "adulterated," "spurious," and "misbranded." The industry has raised concerns that this could lead to criminal penalties for what are essentially engineering deviations, an approach not seen in international markets.

Global Regulatory Practices

Globally, medical devices are typically governed by risk-based assessments, quality management systems, and post-market surveillance, rather than criminal penalties. The draft bill's provision for imprisonment ranging from one to seven years for issues such as labeling errors or documentation lapses has been particularly contentious. Such stringent measures are not practiced by regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, or Australia TGA, which prefer administrative enforcement.

The bill is currently in the phase of inter-ministerial consultation. In their communication dated August 8, industry associations highlighted that the draft fails to provide a robust regulatory framework that would support the growth and competitiveness of India's medical devices sector on a global scale.

Call for Rethink and Redesign

The medical device sector's pushback against the draft bill underscores the need for a regulatory approach that acknowledges the unique nature of medical devices. Stakeholders are urging the government to reconsider the bill's provisions to foster an environment conducive to innovation and growth.

As the Indian government seeks to update an 86-year-old law governing pharmaceuticals, the medical device industry is advocating for regulations that reflect international best practices and support the sector's development.