Medical Device Firms Oppose Bill Equating Devices with Drugs
India's medical device sector challenges a draft bill treating devices as pharmaceuticals, citing regulatory and innovation concerns.
The Indian medical device industry is raising alarms over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which they argue inappropriately classifies medical devices alongside pharmaceuticals. Industry leaders warn that this categorization could stifle innovation, deter investment, and hinder manufacturing in India.
Industry Pushback Against Regulatory Approach
Several industry associations, including those representing manufacturers, traders, and healthcare providers, have expressed their opposition through a letter addressed to the Union Health Minister. The letter, dated August 8, outlines concerns that the draft bill fails to distinguish between the engineering nature of medical devices and pharmaceuticals, potentially compromising India's goal to become a global hub for medical device production.
Medical devices, according to industry representatives, are fundamentally different from drugs and should be regulated through risk-based conformity assessments, quality management systems, and post-market surveillance rather than criminal penalties. The draft proposes imprisonment for various compliance issues, a move that experts say deviates from international practices seen in regions like the EU, the US, Japan, and Australia.
Potential Impact on Innovation and Investment
Critics of the bill argue that the current language is too drug-centric, using terms such as "adulterated" and "misbranded" more commonly associated with pharmaceuticals. These concerns are compounded by the bill's provisions for criminal penalties for issues such as labeling errors and engineering defects, even in the absence of harm. Such measures, they argue, could discourage investment and innovation, critical to the sector's growth.
The associations have urged a regulatory framework that aligns with international standards, advocating for administrative rather than criminal enforcement. This approach, they argue, would better support the sector's growth and innovation, allowing it to compete globally.
Government's Legislative Intent
The draft bill aims to replace the 86-year-old legislation governing pharmaceutical regulations in India. Currently, it is under inter-ministerial consultation as stakeholders from various sectors continue to express their concerns. The government has not yet responded to these criticisms, but the dialogue underscores the industry's need for a regulatory environment that fosters rather than hinders growth.
As discussions continue, the medical device sector remains hopeful that the government will reconsider the bill's provisions and adopt a more nuanced approach tailored to the unique characteristics of medical devices.