Medical Device Industry Challenges Draft Bill's Pharma Approach

The Indian medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it unjustifiably treats medical devices as pharmaceuticals. Industry leaders and healthcare groups warn that this approach could impede manufacturing, innovation, and investment.

Industry Voices Concerns Over Regulatory Approach

In a letter dated August 8, various associations representing medical device manufacturers, traders, and healthcare providers urged the Union Health Minister to reconsider the draft bill. The letter highlights that the bill fails to recognize the fundamental differences between medical devices and pharmaceuticals, both scientifically and regulatory-wise.

The draft bill's language and proposed penalties are particularly troubling for the industry. Terms such as "adulterated," "spurious," and "misbranded," typically associated with pharmaceuticals, are applied to medical devices. Furthermore, the bill suggests imposing criminal penalties, including imprisonment for up to seven years, for regulatory lapses like labeling errors or documentation mistakes, even if no harm occurs. Industry stakeholders argue that this is not the norm in major markets such as the EU, US, Japan, UK, or Australia, where administrative enforcement prevails.

Potential Impact on India's Medical Device Ambitions

The draft bill is part of the government's efforts to update the 86-year-old law governing pharmaceuticals, but the medical device sector fears it may stifle growth and innovation. The associations' letter emphasizes that the bill does not provide a conducive regulatory framework for the industry to thrive and compete globally.

Medical devices are engineering products that require specific regulatory standards, distinct from pharmaceuticals. The industry advocates for a risk-based approach, including conformity assessments, quality management systems, and post-market surveillance, rather than a punitive, drug-centric model.

India has ambitions to become a global hub for medical device manufacturing, but stakeholders warn that the current draft bill could deter investment and hinder progress. The industry's pushback underscores the need for a regulatory framework that recognizes the unique nature of medical devices and supports innovation and growth.

Ongoing Consultations and Future Dialogue

The draft bill is currently undergoing inter-ministerial consultations. The medical device industry hopes that ongoing discussions will lead to a revised regulatory approach that aligns with international best practices and supports the sector's growth objectives.

As the debate continues, industry leaders and healthcare providers remain committed to engaging with policymakers to ensure that the final version of the bill fosters a supportive environment for India's medical device industry.