Medical Device Industry Challenges Draft Bill Treating Devices as Drugs

India's medical device industry is strongly opposing the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it unfairly equates medical devices with pharmaceutical products. Industry representatives warn that this approach could stifle innovation and deter investment in the sector.

Industry Concerns Over Draft Legislation

Various associations, including those representing manufacturers, healthcare providers, and patient safety groups, have voiced concerns about the draft bill. They have urged the Union Health Ministry to reconsider the legislation, arguing that it could impede India's goal of becoming a global leader in medical device manufacturing.

The draft bill, currently under inter-ministerial consultation, suggests criminal penalties for regulatory violations. Industry insiders argue that this could discourage manufacturing by imposing harsh penalties for issues such as labeling errors or documentation lapses, even when no harm results.

Distinct Regulatory Needs for Medical Devices

Medical devices, unlike pharmaceuticals, are engineering products that require different regulatory standards. Globally, they are typically regulated through risk-based conformity assessments, quality management systems, and post-market surveillance rather than criminal penalties.

The draft bill has been criticized for using drug-centric language and applying pharmaceutical-style criminalization to engineering deviations. This approach is unlike the regulatory frameworks in the EU, US, Japan, UK, and Australia, where administrative enforcement is the norm.

Call for a Separate Regulatory Framework

The industry advocates for a distinct regulatory framework that aligns with international standards and recognizes the unique nature of medical devices. The current draft, according to stakeholders, lacks the necessary foundation for fostering growth and innovation in the sector.

In an August 8 letter to the health minister, industry groups emphasized the need for regulations that support India's burgeoning medical devices industry. They argue that the draft bill's provisions could ultimately harm the sector's development and competitiveness on the global stage.