Medical Device Sector Rejects Draft Bill Over Pharma Regulation Approach

The Indian medical device sector is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that its approach to regulate medical devices as pharmaceutical products could stifle manufacturing, innovation, and investment. Stakeholders from the industry, alongside patient safety groups and healthcare providers, have collectively urged the Union health minister to reconsider the draft legislation.

Industry Concerns Over Regulatory Approach

In a letter dated August 8, representatives from various associations highlighted that the draft bill lacks the necessary regulatory framework to support the growth and competitiveness of India's medical devices sector on a global scale. The letter criticized the draft for failing to recognize the distinct scientific and engineering differences between medical devices and pharmaceuticals. It also pointed out the inappropriate use of drug-related terminology such as "adulterated," "spurious," and "misbranded," which the industry argues are not applicable to devices.

The draft bill proposes criminal penalties, including imprisonment ranging from one to seven years for errors in labeling, documentation lapses, licensing issues, and engineering defects, regardless of whether these mistakes cause harm. Industry leaders argue that this approach is not in line with international practices where administrative enforcement is preferred. They cite examples from regulatory bodies such as the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA, which favor risk-based assessments and quality management systems.

Impact on Manufacturing and Global Competitiveness

Manufacturers and traders fear that the stringent regulations could deter investment and manufacturing in India, undermining the country’s ambition to become a global hub for medical devices. The draft bill is seen as a potential obstacle to innovation due to its pharma-centric language and punitive measures. The industry is advocating for a regulatory framework that aligns more closely with engineering standards rather than pharmaceutical regulations.

The draft bill is currently under inter-ministerial consultation. Previously, the government announced plans to overhaul the 86-year-old law governing pharmaceutical regulations in India, indicating a broader move to update and streamline regulatory practices across the health sector.

As the debate continues, stakeholders are calling for a balanced approach that supports both patient safety and the growth of the medical device sector. They emphasize the need for a regulatory environment that fosters innovation while maintaining high standards of safety and effectiveness.