Medical Device Industry Rejects Draft Bill Equating Devices with Drugs

India's medical device industry, along with healthcare groups, is strongly opposing the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. This draft legislation aims to regulate medical devices under the same framework as pharmaceuticals, a move industry leaders argue could stifle innovation and deter investment.

Industry Pushback Against Regulatory Changes

Associations representing manufacturers, traders, and healthcare providers have addressed a letter to the Union health minister, urging a reconsideration of the draft bill. They warn that equating medical devices with pharmaceuticals could undermine India's goal of becoming a global hub for medical device manufacturing.

The industry's primary contention is that medical devices, fundamentally engineering products, should not be subjected to drug-style regulations. The draft bill's language, which includes terms like "adulterated," "spurious," and "misbranded," reflects a pharmaceutical-centric approach that is seen as inappropriate for the medical device sector.

Concerns Over Penal Provisions

A significant point of contention is the draft bill's provision for criminal penalties, including imprisonment for labeling errors and other regulatory lapses. Industry representatives argue that such measures are not aligned with international practices, where administrative enforcement is preferred over criminal penalties.

Globally, regions like the European Union, United States, Japan, and Australia manage medical device regulation through risk-based assessments, quality management systems, and post-market surveillance. These regions typically do not impose imprisonment for regulatory infractions unless harm occurs.

Call for a Distinct Regulatory Framework

In their August 8 letter, industry associations emphasized the need for a regulatory framework that recognizes the unique characteristics of medical devices. They argue that the current draft bill fails to provide the necessary foundation for the sector to thrive and compete on a global scale.

The bill, which is under inter-ministerial review, seeks to replace the existing 86-year-old law governing pharmaceutical regulations in India. However, industry leaders insist that a separate regulatory approach is essential for fostering growth and innovation in the medical device sector.

As the government considers feedback on the draft bill, the medical device industry remains hopeful that their concerns will lead to a more tailored and supportive regulatory environment.