Medical Device Industry Opposes Draft Bill Treating Devices as Drugs

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices, and Cosmetics Bill, 2026, which aims to regulate medical devices in the same manner as pharmaceuticals. Industry representatives argue that such regulation could stifle innovation, deter investment, and damage India's aspirations to become a global leader in medical device manufacturing.

Industry Concerns Over Regulatory Approach

Several associations, including those representing manufacturers, traders, healthcare providers, and patient safety groups, have expressed their concerns in a letter to the Union Health Minister. They argue that the draft bill's approach to treating medical devices as pharmaceuticals is fundamentally flawed due to the distinct scientific and engineering differences between the two categories.

The draft bill, currently under inter-ministerial consultation, proposes criminal penalties for regulatory lapses similar to those applied in the pharmaceutical industry. This includes potential imprisonment for issues such as labeling errors, documentation discrepancies, and licensing problems, even when these do not result in harm. Industry groups emphasize that such punitive measures are not in line with international norms, where administrative enforcement is preferred.

Call for a Risk-Based Regulatory Framework

The medical device industry advocates for a regulatory framework based on risk assessment, quality management systems, and post-market surveillance, similar to practices in regions such as the European Union, the United States, Japan, the United Kingdom, and Australia. These regions employ administrative actions rather than criminal penalties to address compliance issues.

The letter from industry groups highlights that the draft bill continues to use pharmaceutical-centric language, with terms like "adulterated," "spurious," and "misbranded," which are not applicable to engineering products. They argue that such language reflects a lack of understanding of the fundamental differences between drugs and devices.

Potential Impact on India's Medical Device Sector

Industry stakeholders warn that the draft bill could significantly impact manufacturing and investment in India's medical device sector. By imposing stringent regulations similar to those for pharmaceuticals, the bill may discourage new entrants and deter existing players from expanding their operations.

The draft bill's approach is seen as a barrier to the sector's growth and innovation, potentially hindering India's goal of becoming a global hub for medical devices. Industry representatives are calling for a regulatory framework that recognizes the unique nature of medical devices and supports the sector's development without imposing unnecessary burdens.

As the draft bill undergoes further consultations, the medical device industry continues to advocate for a more tailored regulatory approach that aligns with international best practices and supports the sector's growth and innovation potential.