Draft Bill Faces Backlash: Medical Devices Not Pharmaceuticals, Say Industry Leaders

The draft Drugs, Medical Devices and Cosmetics Bill, 2026, has ignited strong opposition from India's medical device industry and healthcare groups. Stakeholders argue that the proposed legislation, which treats medical devices similarly to pharmaceuticals and introduces criminal penalties for regulatory non-compliance, could significantly hinder manufacturing, investment, and innovation within the sector.

Industry Pushback Against Regulatory Changes

Industry associations representing manufacturers, traders, healthcare providers, and patient safety groups have collectively urged the Union health minister to reconsider the draft bill. They warn that its current form could derail India's aspirations of becoming a global hub for medical devices. The associations emphasize that medical devices, fundamentally different from pharmaceuticals, should not be subjected to the same regulatory framework.

In a letter dated August 8, the industry groups highlighted that the draft bill fails to establish a suitable regulatory foundation for the growth and global competitiveness of India's medical device sector. The letter, seen by ET, criticizes the draft for persisting with a pharmaceutical-centric approach, despite clear scientific and engineering distinctions between medical devices and drugs.

Concerns Over Criminal Penalties

One of the most contentious aspects of the draft bill is the imposition of severe penalties, including imprisonment ranging from one to seven years for infractions such as labelling errors, documentation lapses, licensing issues, and other deviations. Industry leaders argue that these penalties are disproportionate, especially when no harm occurs, and are not aligned with global regulatory practices.

Globally, medical devices are typically regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls. The draft bill's approach, which mirrors drug regulations with terms like "adulterated," "spurious," and "misbranded," could stifle the engineering-driven nature of medical device innovation.

Global Standards and India's Position

Industry representatives point out that leading regulatory bodies such as the EU MDR, US FDA, Japan's PMDA, UK's MHRA, and Australia's TGA do not employ criminal penalties as a primary enforcement tool. Instead, administrative measures are commonly used to address compliance issues, allowing for a more balanced regulatory environment that supports innovation while ensuring safety.

The draft bill is currently under inter-ministerial consultation as the government seeks to update the 86-year-old law governing pharmaceuticals in India. However, the medical device industry remains steadfast in its opposition, advocating for a regulatory framework that recognizes the unique characteristics of medical devices and fosters a conducive environment for growth and innovation.