Medical Device Industry Challenges India's Draft Bill

The Indian medical device industry has raised significant concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it unjustly categorizes medical devices as pharmaceuticals. The industry warns that such a classification could have detrimental effects on manufacturing, innovation, and investment in the sector.

Industry Pushback Against the Draft Bill

Key players in the medical device sector, along with healthcare providers and patient safety groups, have collectively voiced their opposition to the draft bill. Their primary argument is that medical devices, being engineering products, are fundamentally different from pharmaceuticals and should not be regulated as such. The opposition has been formalized in a letter to the Union Health Minister, urging a reconsideration of the bill's approach.

The draft legislation, currently under inter-ministerial review, proposes to replace the existing 86-year-old law governing pharmaceutical regulations in India. However, industry representatives argue that the bill's framework does not provide the necessary regulatory foundation to foster growth and global competitiveness in India's medical device sector.

Concerns Over Regulatory Language and Penalties

One of the industry's main concerns is the language used in the draft bill, which includes terms like "adulterated," "spurious," and "misbranded," typically associated with drug regulation. Moreover, the bill proposes severe criminal penalties for regulatory lapses, such as labelling errors or documentation mistakes, with potential imprisonment ranging from one to seven years, even if no harm results from these errors.

Industry advocates argue that such punitive measures are not aligned with international practices. In regions like the European Union, the United States, Japan, the United Kingdom, and Australia, medical devices are regulated through risk-based assessments, quality management systems, and post-market surveillance rather than through criminal sanctions.

Call for a Distinct Regulatory Framework

The medical device sector has emphasized the need for a distinct regulatory framework that recognizes the unique nature of medical devices. They argue that the current draft bill's approach could stifle innovation and deter investment, hindering India's goal of becoming a global hub for medical devices.

As the draft bill undergoes further review, the industry continues to advocate for regulations that support growth and innovation while ensuring patient safety. The outcome of these discussions will be crucial in shaping the future landscape of India's medical device industry.