Industry Pushback: Medical Devices Not Pharma Products, Say Experts

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which aims to regulate medical devices in the same manner as pharmaceuticals. Industry representatives and healthcare groups argue that such an approach could stifle innovation and deter investment, impacting India's goal of becoming a global hub for medical device manufacturing.

Concerns Over Regulatory Approach

Several key industry associations have written to the Union Health Minister, expressing concerns that the draft bill fails to recognize the fundamental differences between medical devices and pharmaceuticals. They argue that the bill's current framework could inadvertently harm the sector's growth by imposing stringent regulatory measures more suited to drug manufacturing.

The draft bill proposes criminal penalties, including imprisonment for regulatory lapses such as labelling errors and documentation mistakes. Industry experts point out that globally, medical devices are regulated through risk-based assessments and quality management systems, not through punitive measures typical in pharmaceutical regulation.

Potential Impact on Innovation and Investment

Stakeholders warn that the draft bill's approach could discourage investment and innovation in the medical device sector. The use of drug-centric language, including terms like "adulterated," "spurious," and "misbranded," further blurs the lines between the two distinct industries. This lack of clarity could lead to increased compliance costs and hinder the sector's ability to compete internationally.

The industry advocates for a regulatory framework that aligns with international practices, such as those of the EU MDR, US FDA, and other global standards, which rely on administrative enforcement rather than criminal penalties for non-harmful deviations.

Calls for Rethinking the Draft Bill

The medical device sector has called for a comprehensive reconsideration of the draft bill to ensure it supports the industry's unique needs and growth potential. By recognizing the engineering and scientific distinctions between medical devices and pharmaceuticals, the government could foster an environment that encourages innovation and attracts global investment.

The draft bill is currently undergoing inter-ministerial consultation, and industry leaders hope their concerns will lead to amendments that better serve the sector's interests. As the debate continues, stakeholders emphasize the importance of creating a supportive regulatory environment that aligns with global standards and facilitates the industry's expansion.