Medical Device Industry Resists Draft Bill Equating Devices with Drugs
India's medical device sector opposes the 2026 Draft Bill, arguing it misclassifies devices as drugs, risking innovation and investment.
The Indian medical device industry is raising concerns over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, criticizing its approach to regulate medical devices as pharmaceuticals. Industry leaders, healthcare providers, and patient safety groups argue that this misclassification could stifle innovation and deter investment in the sector.
Industry Pushback Against Regulatory Changes
Representatives from various associations, including manufacturers and traders, have expressed their disapproval of the draft bill in a letter to the Union Health Minister. They emphasized that medical devices, being engineering products, require distinct regulatory frameworks separate from those governing pharmaceuticals. The draft's current language, they argue, fails to provide the necessary foundation for the growth and global competitiveness of India's medical device sector.
The letter, dated August 8, highlighted concerns about the draft's continued use of drug-centric terms such as "adulterated," "spurious," and "misbranded." It also criticized the imposition of severe penalties, including imprisonment for regulatory lapses, which are uncommon in other major markets like the EU, US, Japan, UK, and Australia.
Potential Impact on Manufacturing and Innovation
Industry leaders warn that the draft bill's approach could discourage manufacturing by imposing criminal penalties for issues like labeling errors, documentation mistakes, and engineering defects, even in the absence of harm. Such measures, they argue, could hinder India's ambition to become a global hub for medical devices.
Globally, medical devices are typically regulated through risk-based conformity assessments and quality management systems rather than criminal enforcement. The draft bill's alignment with pharmaceutical regulations is seen as a step back from international standards, potentially affecting the sector's ability to innovate and attract investment.
Call for a Rethink
The draft bill is currently under inter-ministerial consultation as part of the government's efforts to replace the 86-year-old law governing pharmaceutical regulations. The medical device industry is urging the government to reconsider the draft's provisions to better cater to the unique needs and characteristics of medical devices.
As the consultation process continues, industry stakeholders are hopeful that their feedback will lead to a more suitable regulatory framework that supports the growth and innovation of India's medical device sector, aligning it with global best practices.