Industry Pushback: Medical Devices Not Pharmaceuticals, Firms Argue

India's medical device industry is rallying against the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes treating medical devices similarly to pharmaceuticals. Industry representatives, patient safety advocates, and healthcare providers have voiced concerns to the Union health minister, warning that the bill could stifle manufacturing, deter investment, and impede innovation in the sector.

Industry Concerns Over Regulatory Approach

The draft legislation aims to replace the country's 86-year-old pharmaceutical regulation framework. However, stakeholders argue that the proposed bill fails to recognize the fundamental differences between medical devices and pharmaceuticals. They highlight that medical devices are engineering products and should not be regulated under the same criteria as drugs.

In a letter dated August 8, several associations urged the government to reconsider the draft, emphasizing that it lacks the necessary regulatory foundation to support the growth and global competitiveness of India's medical devices sector. The letter points out that the draft continues to use drug-centric terms such as "adulterated," "spurious," and "misbranded," applying pharmaceutical-style criminal penalties to deviations in engineering standards.

Global Regulatory Practices

The medical device industry stresses that globally, devices are regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls. Imprisonment for labeling errors, documentation lapses, and other non-harmful issues, as proposed in the draft, is not standard practice in regions like the EU, US, UK, Japan, or Australia, where administrative enforcement is preferred.

The draft bill suggests imprisonment ranging from one to seven years for various infractions, which industry experts argue could severely impact India's ambition to become a global hub for medical device manufacturing. The industry is advocating for a regulatory framework that aligns with international norms, focusing on administrative penalties rather than criminalization.

Call for Rethink

As the draft bill undergoes inter-ministerial consultation, industry leaders are calling for a framework that fosters innovation and investment, rather than imposing stringent regulations that could drive manufacturers away. The current draft's approach, they argue, risks setting back India's progress in the medical device sector, which is seen as a key area for economic growth and technological advancement.