Industry Pushback: Medical Devices Not Pharmaceuticals, Say Companies

The Indian medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Companies and healthcare groups argue that categorizing medical devices alongside pharmaceuticals could stifle manufacturing and innovation, potentially impacting India's aspirations to become a global hub for medical devices.

Concerns Over Regulatory Approach

Industry leaders have submitted a letter to the Union health minister, expressing concerns that the draft bill fails to provide the necessary regulatory framework for the growth of the medical devices sector. They argue that medical devices, fundamentally different from pharmaceuticals in terms of engineering and scientific principles, should not be regulated as drugs.

The draft bill proposes penalties including imprisonment for regulatory lapses such as labelling errors, documentation mistakes, and licensing issues. This approach, industry representatives say, mirrors drug regulations and is not aligned with global practices. They point out that regions like the European Union, United States, Japan, and Australia rely on administrative enforcement rather than criminal penalties for similar issues.

Impact on Innovation and Investment

Medical device manufacturers and healthcare providers warn that the proposed regulatory changes could deter investment and innovation. The draft bill's language, which includes terms like "adulterated" and "spurious," is traditionally associated with pharmaceuticals and not suited for engineering products. Stakeholders fear this could lead to a chilling effect on the industry, discouraging new entrants and stalling advancements.

The bill is currently under inter-ministerial review as the government seeks to replace the 86-year-old law governing pharmaceutical regulations. Meanwhile, industry associations continue to advocate for a regulatory framework that recognizes the distinct nature of medical devices, emphasizing the need for risk-based assessments, quality management systems, and post-market surveillance over punitive measures.

Global Regulatory Standards

Industry representatives are urging the Indian government to adopt regulatory practices more aligned with international standards. They highlight that countries with advanced medical device sectors employ risk-based conformity assessments and focus on quality management rather than imposing criminal penalties for non-compliance.

The medical device sector's call for a reconsideration of the draft bill underscores their commitment to ensuring that regulatory changes do not hinder India's potential to compete on a global scale. As discussions continue, stakeholders remain hopeful that their concerns will be addressed to foster a conducive environment for growth and innovation in the industry.