Indian Medical Device Industry Rejects New Draft Bill
The Indian medical device sector opposes a draft bill treating devices like drugs, fearing it may stifle innovation.
India's medical device industry is raising concerns over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices similarly to pharmaceuticals. Industry leaders argue that this approach could negatively impact manufacturing, investment, and innovation within the sector.
Industry Leaders Voice Concerns
Several associations representing manufacturers, traders, and healthcare providers have formally expressed their opposition to the draft bill. They have addressed a letter to the Union Health Minister, highlighting that equating medical devices with pharmaceuticals is not scientifically or practically viable. This stance, they argue, could hinder India's goal of becoming a global hub for medical devices.
The industry emphasizes that medical devices are fundamentally engineering products, distinct from pharmaceutical drugs, and should be regulated accordingly. The draft bill's language, which includes terms like "adulterated," "spurious," and "misbranded," mirrors drug regulation frameworks and introduces criminal penalties for regulatory non-compliance. Industry representatives warn this could deter foreign investment and stifle domestic innovation.
Potential Impact on the Sector
The draft bill, currently under inter-ministerial review, proposes imprisonment for periods ranging from 1 to 7 years for labeling errors, documentation issues, and other administrative lapses, regardless of whether any harm has occurred. Critics argue that this approach is inconsistent with international standards, where administrative solutions rather than criminal penalties are typically employed.
Globally, regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA focus on risk-based assessments, quality management systems, and post-market surveillance rather than punitive measures. The Indian medical device sector advocates for a similar framework, emphasizing the need for a regulatory environment that supports growth and innovation.
Calls for Regulatory Rethink
The letter submitted on August 8 outlines the industry's demand for a regulatory framework that recognizes the unique nature of medical devices. The associations argue that the draft bill fails to provide the necessary foundation for the sector to thrive and compete on a global scale.
Industry leaders are calling for a clear distinction between the regulation of pharmaceuticals and medical devices, seeking a framework that aligns with international best practices. They stress the importance of fostering an environment conducive to innovation and investment, crucial for the sector's growth and India's positioning as a leader in the global medical device market.