India's Medical Device Industry Challenges Draft Bill's Pharma Approach

India's medical device industry is raising strong objections to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes treating medical devices similarly to pharmaceuticals. Industry experts argue that such a classification could stifle innovation and deter investment in the sector.

Concerns Over Regulatory Approach

Industry associations and healthcare groups have expressed their concerns to the Union Health Ministry, highlighting that the draft bill's approach could hinder India's ambitions to become a global hub for medical devices. They argue that the bill’s framework fails to recognize the fundamental differences between medical devices and pharmaceuticals, which are engineering products that require distinct regulatory standards.

The draft bill proposes criminal penalties for regulatory lapses, including labelling errors and documentation mistakes, which the industry believes are excessive. The associations have pointed out that in other major markets, such as the EU, US, Japan, UK, and Australia, administrative enforcement is preferred over criminalization for such issues.

Pushback from Industry Stakeholders

In a letter dated August 8, industry representatives urged the government to reconsider the bill's provisions, arguing that the current draft uses drug-centric language and applies pharmaceutical-style penalties to engineering deviations. Terms like “adulterated,” “spurious,” and “misbranded” are cited as inappropriate for the medical device sector.

The letter emphasizes that globally, medical devices are regulated through risk-based conformity assessments and quality management systems rather than punitive measures. The industry fears that the proposed bill could lead to unnecessary imprisonment for minor infractions, which could drive away potential investors and manufacturers.

Call for a Distinct Regulatory Framework

The draft bill, which is under inter-ministerial consultation, aims to replace the 86-year-old law governing India's pharmaceutical regulations. However, stakeholders argue that it fails to establish a solid regulatory foundation for the medical device sector to thrive. The industry is calling for a regulatory framework that supports growth, innovation, and global competitiveness without imposing undue burdens.

As the debate continues, industry leaders hope for a revised bill that acknowledges the unique nature of medical devices and aligns with international best practices to ensure the sector's sustainable development.