Medical Device Industry Pushes Back Against Indian Draft Bill

The medical device industry in India is raising concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it could hamper innovation and investment by treating medical devices like pharmaceuticals. Industry leaders and healthcare groups have voiced their opposition, highlighting the potential negative impact on the sector's growth.

Industry Concerns Over Regulatory Approach

Various associations representing manufacturers, healthcare providers, and patient groups have conveyed their apprehensions to the Union Health Ministry. They argue that the draft bill does not appropriately distinguish between medical devices and pharmaceuticals, thereby risking the sector's potential to develop into a global hub for medical technology.

The draft legislation, which is currently under inter-ministerial review, proposes to replace the existing 86-year-old law governing pharmaceutical regulations in India. However, the industry criticizes the bill for its drug-centric language and the imposition of stringent penalties on medical devices for regulatory lapses.

Call for Risk-Based Regulation

In a letter addressed to the health minister, industry representatives emphasized that medical devices are fundamentally engineering products, not pharmaceutical drugs. They pointed out that globally, medical devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance, rather than through criminal penalties.

The draft bill suggests imprisonment for periods ranging from one to seven years for issues such as labeling errors and documentation lapses, even when no harm occurs. Industry insiders argue that such measures are not aligned with international practices seen in regions like the EU, USA, Japan, UK, and Australia, where administrative enforcement is more common.

Potential Impact on India's Medical Device Sector

The opposition from the medical device sector comes amid India's ambition to establish itself as a leading player in the global medical devices market. Industry leaders warn that the draft bill, in its current form, could deter investment and discourage manufacturing, which are crucial for the sector's growth and innovation.

As the consultation process continues, stakeholders are advocating for a regulatory framework that recognizes the unique nature of medical devices and promotes a conducive environment for their development and marketing. The outcome of this legislative process will be critical in determining the future trajectory of India's medical device industry.