Medical Device Industry Challenges Proposed Regulatory Bill

The medical device industry in India has raised strong objections to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it inappropriately categorizes medical devices as pharmaceutical products. This, industry leaders claim, could stifle manufacturing, innovation, and investment in the sector.

Concerns Over Regulatory Approach

Industry representatives, alongside patient safety groups and healthcare providers, have expressed significant concerns regarding the draft bill, which is currently under inter-ministerial review. They argue that the bill lacks the necessary regulatory framework to support the growth and global competitiveness of India's medical devices sector. In a letter to the Union health minister dated August 8, several associations warned that the bill's approach could hinder India's ambition to become a global hub for medical devices.

The letter criticizes the draft's failure to recognize the distinct scientific, engineering, and regulatory differences between medical devices and pharmaceuticals. The industry's opposition highlights the bill's use of pharmaceutical-centric language and penalties, which include criminalization for regulatory lapses such as labeling errors and documentation issues.

Global Standards and Local Implications

Critics of the draft bill point out that the proposed penalties, which include imprisonment for up to seven years for various infractions, do not align with international regulatory practices. They note that regions such as the European Union, the United States, Japan, the United Kingdom, and Australia employ administrative enforcement measures rather than criminal penalties for regulatory non-compliance in the medical device sector.

Industry leaders argue that the bill's approach could deter investment and innovation, as the risk of severe penalties for engineering deviations might discourage manufacturers. They emphasize that globally, medical devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance, rather than through punitive measures.

Call for Revised Legislation

The opposition to the draft bill reflects broader concerns within the medical device industry about India's regulatory environment. The current legislative framework is seen as ill-suited to the unique requirements of the medical device sector, which demands distinct regulatory considerations separate from those applied to pharmaceuticals.

Industry stakeholders are urging the government to reconsider the draft bill and develop a regulatory framework that aligns with international best practices, ensuring that India's medical device industry can thrive and compete on a global scale.