Medical Device Firms Challenge Draft Bill's Pharma-Like Regulations

India's medical device industry is pushing back against the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which they argue improperly categorizes medical devices alongside pharmaceuticals. Industry stakeholders, including manufacturers, healthcare providers, and patient advocacy groups, have expressed concerns that the draft legislation could stifle innovation and deter investment in the sector.

Industry Concerns Over Regulatory Approach

Representatives from various associations have voiced their objections in a letter to the Union Health Minister, dated August 8. They argue that the draft bill fails to recognize the distinct nature of medical devices, which are engineering products, not pharmaceuticals. The industry fears that treating these devices as drugs could lead to inappropriate regulatory measures, including criminal penalties for regulatory non-compliance, which are not typically applied to devices in other major markets like the US and EU.

The letter emphasizes that the draft bill's use of pharmaceutical-centric language, such as terms like "adulterated," "spurious," and "misbranded," is not suitable for medical devices. It also criticizes the imposition of severe penalties, including imprisonment for documentation errors and labeling issues, which could occur even if no actual harm is caused.

Global Regulatory Standards Highlighted

The opposition points out that globally, medical devices are regulated through risk-based assessments, quality management systems, and post-market surveillance, rather than through punitive measures. The industry insists that adopting such a drug-centric regulatory framework could undermine India's potential to become a leading hub for medical device manufacturing and innovation.

Currently, the draft bill is undergoing inter-ministerial consultations as the government seeks to update the 86-year-old law governing India's pharmaceutical regulations. The medical device sector is advocating for a more tailored regulatory approach that aligns with international standards and supports the unique characteristics of medical devices.

As the debate continues, stakeholders are hopeful that their concerns will be addressed to foster a regulatory environment conducive to growth and technological advancement in India's medical device industry.