Medical Device Industry Challenges Draft Bill Treating Devices as Pharma

India’s medical device industry, alongside healthcare groups, is vocally opposing the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices similarly to pharmaceuticals. Stakeholders argue that this approach could stifle innovation and deter investment, potentially impacting the country’s ambitions to establish itself as a global hub for medical device manufacturing.

Concerns Over Regulatory Approach

Industry representatives, including manufacturers, traders, and healthcare providers, have formally addressed their concerns to the Union health minister. They emphasize the fundamental differences between medical devices and pharmaceuticals, noting that the draft bill does not recognize these distinctions. The letter, dated August 8, highlights that medical devices are engineering products, not drugs, and should be regulated accordingly.

Critics of the bill point out that its language remains rooted in pharmaceutical terminology, using terms such as “adulterated,” “spurious,” and “misbranded.” Moreover, it proposes criminal penalties for regulatory violations, including labelling errors and documentation lapses, which are typically handled through administrative measures in other major markets like the EU, US, Japan, and the UK.

Potential Impact on the Industry

The proposed penalties, which include imprisonment for periods ranging from one to seven years for even minor infractions, have raised alarms within the industry. Stakeholders argue that such stringent measures could drive away investment and innovation, as companies may find it increasingly risky to operate under these conditions.

“Globally, medical devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance, not imprisonment,” the letter states, urging a reconsideration of the bill’s provisions to align with international standards.

Call for a Distinct Regulatory Framework

The draft bill, currently under inter-ministerial review, aims to update the 86-year-old legislation governing pharmaceuticals in India. However, industry voices are calling for a distinct regulatory framework for medical devices that acknowledges their unique characteristics and requirements.

The opposition to the draft bill underscores the need for a nuanced approach to regulation that fosters an environment conducive to growth and innovation. By treating medical devices as an adjunct to pharmaceuticals, the bill risks undermining the sector’s potential to contribute significantly to healthcare advancements and economic growth.

As the government considers feedback from various stakeholders, the industry remains hopeful for a regulatory framework that supports its objectives while ensuring safety and efficacy in the use of medical devices.