Medical Device Industry Challenges Draft Bill's Pharma-Like Regulations

India's medical device industry is voicing strong opposition to the draft Drugs, Medical Devices, and Cosmetics Bill, 2026. Industry leaders argue that the bill's attempt to regulate medical devices as pharmaceuticals could stifle innovation and deter investment. The draft, currently under inter-ministerial review, seeks to update the 86-year-old law governing pharmaceutical regulations in India.

Concerns Over Regulatory Approach

Associations representing manufacturers, traders, healthcare providers, and patient safety groups have formally requested the Union Health Minister to reconsider the draft. Critics emphasize that equating medical devices with drugs fails to account for the fundamental differences in their design, function, and regulatory needs. The draft's language, which includes terms like "adulterated" and "misbranded," reflects a pharmaceutical-centric approach that many believe is inappropriate for medical devices.

Moreover, the bill proposes criminal penalties for various regulatory lapses, including labelling errors and documentation issues, with potential imprisonment ranging from one to seven years. Industry representatives argue that such stringent measures are not aligned with international practices, where regulatory frameworks focus on risk-based assessments and quality management rather than criminalization.

Impact on Innovation and Investment

The medical device sector warns that the draft bill could hinder India's ambitions to become a global hub for medical device manufacturing. The associations contend that the proposed regulations do not provide a conducive environment for growth and innovation. They argue that the bill, as it stands, could deter investment by introducing unnecessary legal risks for manufacturers.

Globally, medical devices are typically regulated through administrative enforcement rather than criminal penalties. This approach is prevalent in regions such as the European Union, the United States, Japan, the United Kingdom, and Australia, where regulatory bodies focus on post-market surveillance and quality assurance rather than punitive measures.

Calls for a Revised Framework

Industry stakeholders are advocating for a regulatory framework that recognizes the distinct nature of medical devices. They propose the adoption of risk-based conformity assessments and quality management systems tailored to the engineering and scientific nuances of medical devices. This would align India's regulations with international standards and support the sector's growth and competitiveness on a global scale.

The ongoing discussions highlight the need for a balanced approach that ensures patient safety without compromising the industry's potential for innovation and economic contribution. As the draft bill undergoes further consultation, stakeholders remain hopeful for a resolution that addresses their concerns while advancing India's healthcare objectives.