Medical Device Firms Oppose Draft Bill Treating Them as Pharma

India's medical device industry has expressed strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it unjustly equates medical devices with pharmaceuticals. Industry leaders, patient safety groups, and healthcare providers have communicated their concerns to the Union Health Minister, stating that such regulatory treatment could stifle innovation, deter investment, and hinder India's ambition to become a global leader in medical devices.

Industry Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial review, has sparked criticism for its pharmaceutical-centric language and proposed punitive measures. Industry representatives argue that medical devices, fundamentally distinct from pharmaceuticals, should not be subject to the same regulatory framework. They emphasize that devices are engineering products, requiring a different approach to regulation than drugs.

Associations representing manufacturers and traders have highlighted that the draft bill's language includes terms such as "adulterated," "spurious," and "misbranded," typically associated with pharmaceuticals. These terms, coupled with proposed criminal penalties for regulatory non-compliance, are seen as inappropriate for the medical device sector.

Potential Impact on Innovation and Manufacturing

The industry is particularly concerned about the bill's potential to discourage manufacturing and innovation. The associations argue that the proposed criminal penalties, which range from one to seven years of imprisonment for issues like labeling errors and documentation lapses, are excessive. Such measures, they note, are not standard practice in regions with advanced regulatory frameworks like the EU, US, Japan, UK, or Australia, where administrative enforcement is more common.

Industry stakeholders argue that the bill fails to provide a regulatory foundation conducive to growth and global competitiveness. They call for a risk-based conformity assessment and quality management system, akin to international standards, to govern the sector effectively.

Calls for Rethinking the Draft Bill

In a letter dated August 8, industry associations urged the government to reconsider the draft's approach. They argue that aligning medical device regulations too closely with pharmaceuticals could inadvertently harm the sector's growth prospects. By treating devices as an adjunct to pharmaceuticals, the draft overlooks the distinct scientific, engineering, and regulatory differences between the two categories.

The medical device industry is hopeful for a regulatory framework that recognizes its unique nature and supports its development as a key component of India's healthcare system. Stakeholders continue to advocate for a bill that facilitates innovation and investment, enabling India to strengthen its position as a leader in the global medical device market.