Industry Pushback: Medical Devices Not Pharmaceuticals, Firms Say

India's medical device industry and healthcare organizations have voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which aims to treat medical devices in the same regulatory framework as pharmaceuticals. Industry leaders argue that this approach could severely hinder manufacturing, investment, and innovation in the sector.

Industry Concerns Over Draft Legislation

Several associations representing manufacturers, healthcare providers, and patient safety groups have expressed their concerns in a letter to the Union Health Minister. They argue that treating medical devices as pharmaceutical products is inappropriate due to the fundamental differences in their design, purpose, and regulation. The draft bill's language, which includes terms like "adulterated" and "misbranded," is seen as overly punitive, equating engineering deviations with criminal offenses.

The letter highlights that globally, medical devices are subject to risk-based conformity assessments and quality management systems rather than criminal penalties. The current draft proposes imprisonment ranging from one to seven years for issues such as labelling errors and documentation lapses, even when there is no harm to patients. This is in stark contrast to regulatory practices in regions like the European Union, United States, and Japan, where administrative enforcement is preferred.

Call for Revised Regulatory Approach

The associations have urged the government to reconsider the draft bill, emphasizing the need for a regulatory framework that recognizes the distinct nature of medical devices. They argue that the current draft does not provide a conducive environment for the sector to grow and compete on a global scale. The industry fears that the proposed regulations could deter investment and manufacturing, undermining India's potential to become a global hub for medical devices.

The draft bill, which is currently under inter-ministerial consultation, seeks to replace the 86-year-old law governing India's pharmaceutical regulations. The medical device sector argues that without a clear distinction between pharmaceuticals and medical devices, the bill could stifle innovation and economic growth in this vital industry.

Industry leaders are calling for a risk-based regulatory approach that aligns with international standards, ensuring that regulations are supportive of technological advancements and innovation. They highlight the need for post-market surveillance and recalls as part of a comprehensive regulatory strategy, rather than punitive measures that could hinder progress.

Impact on India's Medical Device Ambitions

The opposition to the draft bill underscores the industry's concerns about India's ambitions to become a leading player in the global medical device market. By equating medical devices with pharmaceuticals, the draft bill could impose unnecessary barriers to entry for new technologies and innovations. Industry representatives warn that this could lead to a decline in investment and manufacturing, ultimately impacting the availability and affordability of medical devices in India.

The medical device sector is seeking a regulatory framework that supports growth and innovation while ensuring patient safety. As the draft bill continues to undergo consultation, stakeholders are hopeful that their concerns will be addressed, paving the way for a more balanced approach to regulation.