Industry Pushback: Medical Devices Not Pharmaceuticals Says Draft Bill Opposition
Medical device industry opposes India's draft bill, citing concerns over misclassification with pharmaceuticals.
The medical device industry in India has voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it improperly equates medical devices with pharmaceutical products. Industry leaders, patient safety groups, and healthcare providers are urging the government to reconsider the proposed legislation, warning that it could stifle innovation and deter investment in the sector.
Concerns Over Regulatory Approach
Industry associations have expressed significant concerns over the draft bill’s approach to regulation, which they argue fails to recognize the distinct nature of medical devices compared to pharmaceuticals. In a letter to the Union Health Minister, stakeholders highlighted that the bill's language and penalties are more suited to drug regulation, including terms like "adulterated," "spurious," and "misbranded," which do not align with the engineering focus of medical devices.
The draft bill proposes criminal penalties, including imprisonment ranging from one to seven years for various regulatory lapses such as labeling errors and documentation issues, even when no harm occurs. Industry representatives argue that such measures are excessive and not in line with global practices where administrative enforcement is more common.
Impact on Innovation and Investment
Companies fear that the proposed legislation could hamper India's ambitions to become a global hub for medical device manufacturing. The industry argues that the draft bill does not provide the necessary regulatory foundation for growth and innovation. Instead, it risks discouraging investment and slowing down the sector's development.
The medical device sector, which relies on risk-based conformity assessments and quality management systems, is concerned that the draft bill's pharma-centric approach does not reflect the operational realities and regulatory needs of the industry. Globally, regions such as the EU, US, Japan, and Australia employ risk-based regulatory frameworks that focus more on quality management and post-market surveillance rather than criminal penalties.
Call for a Revised Bill
The draft bill is currently under inter-ministerial consultation, and industry stakeholders are hopeful for amendments that recognize the unique characteristics of medical devices. They advocate for a regulatory framework that supports innovation while ensuring patient safety without imposing undue burdens on the industry.
As the government considers replacing the 86-year-old law governing pharmaceuticals, industry leaders stress the importance of a balanced and appropriate regulatory approach that distinguishes between drugs and medical devices. The outcome of this legislative process will be crucial for the future of the medical device industry in India.