Medical Device Firms Oppose Draft Bill Equating Devices with Drugs

India's medical device industry, along with healthcare providers and patient safety groups, is raising concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft bill, which aims to overhaul the country's pharmaceutical regulations, is being criticized for equating medical devices with pharmaceuticals, a move that industry stakeholders argue could hinder manufacturing and innovation.

Industry Concerns Over Regulatory Approach

The draft bill has prompted a strong response from various associations representing manufacturers, traders, and healthcare providers. These groups have communicated their concerns to the Union Health Minister, urging a reconsideration of the bill's provisions. They argue that the bill's approach could deter investment and manufacturing, potentially derailing India's aspirations to become a global hub for medical devices.

The core of the industry's argument is that medical devices are fundamentally different from pharmaceutical products. Unlike drugs, which are primarily chemical in nature, medical devices are engineering products. As such, they require a distinct regulatory framework that acknowledges these differences.

Criticism of Drug-Centric Language

One of the primary criticisms of the draft bill is its use of drug-centric language, including terms like "adulterated," "spurious," and "misbranded." The bill also proposes criminal penalties for regulatory lapses, such as labelling errors and documentation mistakes, which industry stakeholders argue are more appropriately addressed through administrative measures.

"Globally, medical devices are regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls, not imprisonment," the industry groups stated in their communication. They highlighted that leading regulatory bodies such as the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA employ administrative enforcement rather than criminal penalties.

Call for a Distinct Regulatory Framework

The associations have suggested that the draft bill lacks the necessary regulatory foundation for the medical devices sector to thrive. By treating medical devices as an adjunct to pharmaceuticals, the bill overlooks the scientific, engineering, and regulatory distinctions between the two categories.

Industry stakeholders are advocating for a regulatory framework that aligns with international standards, emphasizing risk-based assessments and quality management systems tailored to the unique nature of medical devices. They argue that such an approach would not only protect patient safety but also foster innovation and competitiveness in the global market.

As the draft bill undergoes inter-ministerial consultation, the medical device industry remains hopeful that their concerns will be addressed. The outcome of this legislative process could have significant implications for the future of India's medical device sector and its role in the global market.