Medical Device Industry Opposes Draft Bill Treating Devices as Pharma

The Indian medical device industry, alongside healthcare providers and patient safety groups, is raising strong objections to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Stakeholders argue that the bill's approach to regulating medical devices as pharmaceuticals could stifle innovation and deter investment in the sector.

Concerns Over Regulatory Approach

Leading associations representing manufacturers, traders, and healthcare providers have formally addressed their concerns to the Union Health Minister. They argue that the draft bill, which is currently under inter-ministerial review, lacks the necessary regulatory framework to support the growth and competitiveness of India's medical device sector on a global scale.

The associations emphasize that medical devices are fundamentally different from pharmaceuticals, being engineering products rather than chemical formulations. They contend that treating these devices as pharmaceuticals, with similar regulatory penalties, could be detrimental to the industry.

Potential Impact on Innovation and Investment

The draft bill proposes criminal penalties, including imprisonment ranging from one to seven years, for regulatory lapses involving labelling errors, documentation mistakes, and engineering defects, even if no harm results. Industry representatives argue that such measures are not aligned with international practices in regions like the EU, US, Japan, UK, and Australia, where administrative enforcement is preferred.

Globally, medical devices are typically regulated through risk-based assessments, quality management systems, and post-market surveillance. The Indian industry fears that the bill's punitive approach could discourage manufacturing and innovation, undermining India's ambition to become a leader in the global medical device market.

Call for a Distinct Regulatory Framework

The letter from industry associations highlights the need for a regulatory system that acknowledges the unique characteristics of medical devices. They seek a framework that fosters innovation and investment, rather than imposing pharmaceutical-style regulations that may not be suitable for engineering-based products.

The draft bill, which aims to replace the existing 86-year-old law governing pharmaceutical regulations in India, has prompted widespread debate among stakeholders. As the consultation process continues, the medical device industry remains hopeful for revisions that better align with international standards and support the sector's growth.