Medical Device Industry Pushes Back Against India's Draft Bill

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

Industry Concerns Over Regulatory Approach

Associations representing manufacturers, traders, healthcare providers, and patient groups have collectively addressed a letter to the Union Health Minister. They argue that the draft bill's approach to regulate medical devices as pharmaceuticals fails to recognize the fundamental differences between the two categories. The letter, dated August 8, points out that medical devices are engineering products, not drugs, and should not be subject to drug-centric regulations.

The industry argues that the draft's language, which includes terms such as "adulterated," "spurious," and "misbranded," is inappropriate for medical devices. These terms, along with the threat of criminal penalties for regulatory lapses, are seen as detrimental to the growth and competitiveness of India's medical device sector.

Global Regulatory Practices Highlighted

The letter also highlights how global practices differ significantly from the proposed draft. In regions like the European Union, United States, Japan, United Kingdom, and Australia, medical devices are regulated through risk-based conformity assessments and quality management systems, rather than punitive measures. The draft bill's provision for imprisonment ranging from one to seven years for issues such as labeling errors, documentation lapses, and engineering defects, even when no harm occurs, is seen as a stark contrast to international norms.

Industry representatives emphasize that the draft bill does not provide the necessary regulatory framework for the sector to thrive in a competitive global market. They warn that stringent regulations could discourage investment and manufacturing, undermining India's ambition to become a leading hub for medical devices.

Call for a Revised Regulatory Framework

The draft bill is currently undergoing inter-ministerial consultation, and the industry is advocating for a revised approach that recognizes the unique nature of medical devices. The associations urge the government to adopt a regulatory framework that aligns with international standards and supports innovation and growth in the sector.

As the government considers updating the 86-year-old law governing pharmaceutical regulations, the medical device industry seeks a balanced and informed approach that fosters development while ensuring patient safety. The outcome of these consultations could have significant implications for the future of India's medical device industry.