Medical Device Industry Challenges India's Draft Regulatory Bill

India's medical device industry, alongside healthcare providers and patient safety groups, is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, which seeks to regulate medical devices in the same manner as pharmaceuticals, has sparked concerns about its potential impact on manufacturing, innovation, and investment in the sector.

Concerns Over Regulatory Framework

Stakeholders in the medical device sector argue that the draft bill fails to recognize the fundamental differences between medical devices and pharmaceuticals. These concerns have been formally communicated to the Union Health Minister through a letter from various industry associations, dated August 8. The letter warns that the current draft could undermine India's ambitions to become a global hub for medical device manufacturing.

The industry highlights that medical devices are engineering products, distinct from pharmaceuticals, and require different regulatory considerations. The draft's approach, which includes terms such as "adulterated," "spurious," and "misbranded," traditionally associated with pharmaceuticals, is seen as inappropriate for the medical devices sector.

Potential Impact on Innovation and Investment

Industry representatives are particularly concerned about the draft bill's punitive measures, which include imprisonment for regulatory lapses such as labelling errors and documentation mistakes. These penalties could range from one to seven years, even in cases where no harm has occurred. This approach contrasts with international standards, such as those by the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA, where administrative enforcement is more commonly practiced.

Such stringent regulations, according to the industry, could deter investment and stifle innovation by imposing excessive legal risks on manufacturers. The associations argue that a more nuanced regulatory framework is necessary, one that supports growth and competitiveness while ensuring safety and quality.

Call for Re-evaluation

The draft bill, currently under inter-ministerial review, aims to replace the existing 86-year-old law governing pharmaceutical regulations in India. However, the medical device industry is urging a re-evaluation of the draft to better align with the unique characteristics and needs of the sector.

The associations emphasize the importance of adopting a risk-based approach to regulation, similar to international practices, which involves conformity assessments, quality management systems, post-market surveillance, and recalls. They argue that such a framework would better support the sector's growth and global competitiveness.

As the debate over the draft bill continues, industry stakeholders remain hopeful that their concerns will be addressed, leading to a regulatory environment that fosters innovation, ensures patient safety, and attracts investment into India's burgeoning medical device industry.