Industry Pushback: Medical Devices Oppose New Draft Bill Regulations

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it inaccurately categorizes medical devices as pharmaceuticals. Industry leaders warn that this could stifle innovation and investment, hindering India's goal of becoming a global hub for medical device manufacturing.

Concerns Over Regulatory Approach

Key industry associations, representing manufacturers and healthcare providers, have written to the Union Health Minister urging a revision of the draft. The bill, they argue, lacks a distinct regulatory framework necessary for the diverse nature of medical devices. The current approach, which aligns device regulations with those of drugs, does not acknowledge the scientific and engineering differences between the two.

The associations highlighted that medical devices require risk-based regulatory assessments, quality management systems, and post-market surveillance, unlike pharmaceuticals. They emphasized the need for a regulatory model that reflects international standards, such as those in the European Union and the United States, where administrative enforcement is predominant.

Impact on Manufacturing and Innovation

Industry representatives fear that the draft's stringent regulations, including potential imprisonment for compliance failures, could deter investment and innovation. The bill proposes penalties ranging from one to seven years for issues such as labeling errors and documentation mistakes, even if no harm occurs. This punitive approach contrasts with global norms, where administrative actions are favored over criminal penalties.

The draft bill's language, using terms like "adulterated" and "misbranded," further underscores the industry's concerns about its drug-centric focus. These terms, they argue, are inappropriate for engineering products like medical devices and could lead to unnecessary legal burdens.

Call for a Distinct Regulatory Framework

The medical device sector is advocating for a regulatory framework that distinctly separates the treatment of medical devices from pharmaceuticals. The current draft, they argue, fails to provide the necessary foundation for growth and global competitiveness. In their letter dated August 8, industry leaders highlighted the urgent need for policies that encourage innovation and investment, rather than imposing restrictive measures.

As the draft bill undergoes inter-ministerial consultation, the medical device industry hopes for a reconsideration of its provisions. With India's aspirations to play a significant role in the global medical device market, stakeholders stress that supportive regulations are crucial for fostering a thriving and innovative industry.