Indian Medical Device Industry Challenges Draft Bill's Pharma Approach

India's medical device industry has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which they argue incorrectly categorizes medical devices alongside pharmaceuticals. Stakeholders claim this misclassification could stifle innovation and investment in the sector.

Industry Pushback Against Draft Legislation

The draft bill, currently under inter-ministerial review, aims to update a law that has governed India's pharmaceutical industry for 86 years. However, industry groups, including manufacturers, healthcare providers, and patient safety organizations, have raised concerns. On August 8, they submitted a letter to the Union Health Minister, arguing that the bill's approach fails to provide a suitable regulatory framework for the medical device sector.

These organizations emphasize that medical devices are fundamentally engineering products, not pharmaceuticals, and should not be regulated as such. The letter criticizes the draft for using drug-centric terminology like "adulterated," "spurious," and "misbranded," and for applying punitive measures typically reserved for pharmaceutical violations.

Concerns Over Criminal Penalties

A significant point of contention is the bill's imposition of criminal penalties, including imprisonment ranging from one to seven years, for regulatory lapses such as labeling errors, documentation issues, and other non-compliance matters in medical devices. Industry representatives argue that such measures are not in line with international standards, where administrative enforcement is preferred over criminal penalties.

Globally, medical devices are regulated through frameworks that focus on risk-based assessments, quality management, and post-market surveillance. The industry points to regions like the European Union, United States, Japan, and Australia, where regulatory bodies adopt administrative rather than criminal approaches to enforcement.

Potential Impact on India's Medical Device Industry

Industry leaders fear that the draft bill's current form could deter investment and manufacturing in India, undermining the country's aspirations to become a global hub for medical devices. They argue that without a regulatory environment tailored to the unique nature of medical devices, India may fall behind in innovation and competitiveness.

The medical device sector is urging the government to reconsider the draft bill's provisions, advocating for regulations that recognize the distinct characteristics of medical devices. The ongoing debate highlights the need for a regulatory approach that supports growth while ensuring safety and efficacy in the sector.