Medical Device Industry Opposes Indian Draft Bill on Drug Regulation
Industry groups argue that the 2026 draft bill unfairly equates medical devices with pharmaceuticals, risking innovation and investment.
India's medical device industry and healthcare organizations are voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. They argue that equating medical devices with pharmaceuticals and imposing criminal penalties for regulatory issues could stifle innovation and discourage investment in the sector.
Industry Concerns Over Regulatory Approach
Leading associations representing manufacturers, healthcare providers, and patient safety groups have formally requested the Union Health Ministry to reconsider the draft bill. Their primary concern is that the bill does not acknowledge the fundamental differences between medical devices and pharmaceuticals. The draft continues to use pharmaceutical-centric terminology such as "adulterated," "spurious," and "misbranded," which the industry argues are not suitable for engineering products like medical devices.
These groups emphasize that globally, medical devices are regulated using risk-based assessments, quality management systems, and post-market surveillance, rather than through criminal penalties. The bill proposes imprisonment ranging from one to seven years for various regulatory lapses, even in cases where no harm has occurred, which contrasts sharply with practices in other regions such as the EU, US, and Japan.
Potential Impact on India's Medical Device Sector
The industry fears that the draft bill could hinder India's ambitions to become a global hub for medical device manufacturing. Associations have argued that the bill's approach threatens to undermine the sector's growth by discouraging both domestic and foreign investment. The use of drug-centric language and punitive measures could lead to a chilling effect on innovation and development within the industry.
Medical devices, being engineering products, require a different regulatory framework than pharmaceuticals. The industry advocates for a system that focuses on engineering standards and quality control rather than criminal penalties. They argue that adopting such a framework would better support the sector's growth and align with global standards.
Next Steps and Government Response
The draft bill is currently under inter-ministerial consultation, and it remains to be seen how the government will respond to the industry's concerns. The medical device sector is urging the government to create a regulatory environment that fosters growth and innovation, which they believe is essential for the industry's future success.
As the consultation process continues, stakeholders await further developments and hope for amendments that will address their concerns while supporting the advancement of India's medical device industry.