Medical Device Industry Challenges Draft Bill Treating Devices as Drugs

India's medical device industry is vocally opposing the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which they argue inappropriately equates medical devices with pharmaceuticals. The draft bill's approach could stifle innovation and discourage investment, industry leaders warn.

Industry Pushback Against Pharmaceutical Classification

Medical device manufacturers and healthcare groups have united in their opposition to the proposed legislation, which they claim inadequately differentiates between pharmaceuticals and medical devices. Industry representatives have sent a letter to the Union Health Minister, arguing that the bill's classification could negatively impact India's goal of becoming a global leader in medical device manufacturing.

The letter, dated August 8, highlights concerns that the bill fails to establish a regulatory framework conducive to growth and innovation in the medical device sector. It emphasizes the fundamental differences in the scientific, engineering, and regulatory aspects of medical devices compared to pharmaceuticals.

Concerns Over Regulatory Language and Penalties

Critics of the draft bill point out that it uses pharmaceutical-centric language, including terms like "adulterated," "spurious," and "misbranded." These terms, they argue, are inappropriate for the medical device sector and suggest a misunderstanding of the industry's regulatory needs.

Furthermore, the bill proposes stringent penalties, including imprisonment for labeling errors, documentation issues, and other deviations. Such criminalization is not aligned with global practices, where administrative measures are more common. Industry leaders note that major markets like the EU, US, Japan, UK, and Australia rely on risk-based conformity assessments and quality management systems rather than criminal penalties.

Potential Impact on Innovation and Global Competitiveness

The medical device sector emphasizes that the draft bill could deter investment and innovation, critical elements for India to compete internationally. By treating medical devices as pharmaceuticals, the bill imposes undue regulatory burdens that could hinder the sector's growth.

As the draft bill undergoes inter-ministerial consultation, industry stakeholders are calling for a revision that recognizes the distinct nature of medical devices. They advocate for a regulatory framework that supports innovation and aligns with international standards, enabling India to strengthen its position in the global market.