Medical Device Industry Opposes Draft Bill: Not Like Pharma, They Argue

India's medical device sector is raising concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which it argues inappropriately categorizes medical devices alongside pharmaceuticals. Industry leaders and healthcare associations are urging the government to reconsider the draft, which they claim could negatively impact manufacturing, innovation, and investment in the sector.

Industry Pushback Against the Draft Bill

Organizations representing manufacturers, healthcare providers, and patient safety groups have addressed their objections in a letter to the Union Health Minister. They argue that the bill's approach to regulating medical devices as if they were pharmaceuticals overlooks the fundamental differences between the two categories, both in terms of scientific and regulatory frameworks.

The draft bill proposes stringent penalties, including imprisonment for up to seven years for labeling errors and other regulatory non-compliances. Critics highlight that this approach is not aligned with international practices, where administrative measures, rather than criminal penalties, are used for managing regulatory deviations in the medical device sector.

Concerns Over Innovation and Global Competitiveness

The medical device industry fears that the draft bill could deter investment and innovation, hindering India's goal of becoming a global hub for medical device manufacturing. The industry advocates for a regulatory environment that recognizes the unique nature of medical devices, which are typically governed by engineering principles, rather than pharmacological ones.

Associations have pointed out that the draft's reliance on drug-centric language, using terms such as "adulterated" and "spurious," is inappropriate for the medical device sector. They argue that a risk-based regulatory framework, akin to those employed by the EU MDR, US FDA, and other global bodies, would be more suitable.

Call for a Revised Regulatory Framework

The industry is calling for a reconsideration of the draft bill to better accommodate the specific needs of medical devices. They emphasize the importance of a regulatory framework that supports growth and innovation while ensuring patient safety without imposing unnecessary criminal penalties.

As the draft bill undergoes inter-ministerial consultation, stakeholders hope that their concerns will prompt a revision that aligns with international standards and fosters a supportive environment for the medical device industry in India.