Medical Device Industry Opposes Draft Bill Equating Devices with Drugs

India's medical device industry has voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes regulating medical devices in the same manner as pharmaceuticals. The industry, along with healthcare providers and patient safety groups, argues that the bill could impede manufacturing growth, innovation, and investment in the sector.

Industry Concerns Over Regulatory Approach

Several associations representing manufacturers, traders, healthcare providers, and patient groups have communicated their concerns to the Union Health Minister. They argue that the bill's approach fails to recognize the distinct nature of medical devices, which are fundamentally engineering products, distinct from pharmaceuticals. These groups warn that the bill could deter investment and undermine India's goal of becoming a global leader in medical device manufacturing.

The opposition stems from the draft's use of pharmaceutical-centric terminology and regulatory measures. Terms like "adulterated," "spurious," and "misbranded" are applied to medical devices, and the bill proposes criminal penalties for regulatory infractions, even when no harm occurs. Industry representatives argue that such measures are inappropriate for the medical device sector, which globally is regulated through risk-based assessments and quality management systems rather than criminal penalties.

Global Standards and Consequences

The industry points out that leading regulatory frameworks, such as the EU's Medical Device Regulation (MDR), the US Food and Drug Administration (FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Australia's Therapeutic Goods Administration (TGA), favor administrative enforcement over criminalization for non-compliance.

The draft bill proposes imprisonment ranging from one to seven years for errors related to labeling, documentation, licensing, and more, which the industry argues is a departure from global practices. This approach, they say, could severely impact the sector's ability to innovate and compete internationally.

Call for Reconsideration

The associations have called for a reassessment of the draft bill to better align with the unique needs and characteristics of the medical device industry. They emphasize the need for a regulatory framework that supports growth, innovation, and global competitiveness, rather than one that imposes pharmaceutical-style penalties on engineering-based products.

The draft bill is currently under inter-ministerial consultation, and the medical device industry hopes that its concerns will be addressed to foster an environment conducive to the sector's development.