Draft Bill Faces Pushback for Treating Medical Devices as Drugs

India's medical device industry, along with healthcare providers and patient safety groups, has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, which seeks to regulate medical devices in a manner akin to pharmaceuticals, has raised significant concerns about its potential impact on manufacturing, investment, and innovation within the sector.

Industry Stance Against Proposed Regulations

Several associations representing manufacturers, healthcare providers, and patient advocacy groups have formally addressed their concerns to the Union Health Ministry. They argue that the draft bill fails to recognize the fundamental differences between medical devices and pharmaceuticals, which could hinder India's aspirations to become a global leader in medical device manufacturing.

The industry argues that medical devices, being engineering products, should not be subjected to the same regulatory framework as drugs. The draft bill's language, which includes terms like "adulterated," "spurious," and "misbranded," typically associated with pharmaceuticals, has been criticized for applying pharma-style criminal penalties to the medical device sector.

Concerns Over Criminal Penalties and Global Practices

The draft bill proposes imposing criminal penalties, including imprisonment of up to seven years, for regulatory lapses such as labeling errors, documentation issues, and licensing violations. Industry stakeholders assert that such punitive measures are not in line with international norms. For instance, regions like the European Union, the United States, Japan, the United Kingdom, and Australia primarily use administrative enforcement for medical device regulation.

In their letter dated August 8, the associations emphasize that the draft bill does not provide the necessary regulatory foundation for the growth and innovation of the medical device sector. They argue that the draft continues to treat medical devices as an adjunct to pharmaceuticals, despite the clear scientific and engineering distinctions between the two categories.

Call for a Risk-Based Regulatory Approach

The medical device industry advocates for a regulatory framework based on risk-based conformity assessments, quality management systems, and post-market surveillance, rather than criminal penalties. They highlight that the current approach could discourage investment and stifle innovation, ultimately affecting patient safety and access to cutting-edge medical technologies.

As the draft bill undergoes inter-ministerial consultation, industry stakeholders hope for a revised approach that recognizes the unique nature of medical devices and fosters an environment conducive to innovation and global competitiveness.