Industry Pushback: Draft Bill Equates Medical Devices to Pharma

The Indian medical device industry is voicing strong opposition against the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices under the same framework as pharmaceuticals. Industry representatives argue that this approach could stifle manufacturing growth and innovation, as well as deter investment.

Industry Concerns Over Regulatory Approach

Several associations, including those representing manufacturers, healthcare providers, and patient safety groups, have formally addressed their concerns to the Union Health Minister. They argue that the draft bill's approach fails to recognize the distinct nature of medical devices, which are fundamentally different from pharmaceuticals. The associations emphasize that medical devices are engineering products and should not be subject to the same regulatory language and penalties designed for drugs.

The draft bill, which is currently undergoing inter-ministerial consultations, proposes criminal penalties for regulatory lapses, such as labeling errors and documentation issues, with potential imprisonment ranging from one to seven years. Industry stakeholders argue that such stringent measures could hinder India's goal of becoming a global hub for medical device manufacturing.

Call for Differentiated Regulation

In their August 8 letter, industry groups highlighted that the draft bill uses drug-centric terminology like "adulterated," "spurious," and "misbranded," which are inappropriate for the medical device sector. They also noted that international standards, such as those set by the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA, focus on risk-based assessments, quality management systems, and administrative enforcement rather than criminalization.

The medical device sector is advocating for a regulatory framework that reflects global best practices, focusing on conformity assessments, post-market surveillance, and recalls. This approach, they argue, would foster a more conducive environment for innovation and investment.

Potential Impact on Investment and Manufacturing

Industry leaders warn that the draft bill, if enacted in its current form, could deter both domestic and foreign investment in the medical device sector. They stress that the bill's punitive measures could discourage manufacturers from establishing operations in India, thereby impacting the country's economic growth and its ambition to lead in medical device innovation.

The ongoing debate underscores the need for a nuanced regulatory framework that recognizes the unique characteristics of medical devices. Industry stakeholders are hopeful that their feedback will prompt a reconsideration of the draft bill, ensuring that regulations support rather than hinder the sector's growth.