Medical Device Industry Rejects Pharma-Like Regulation in Draft Bill

India's medical device sector is pushing back against the Draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices under the same framework as pharmaceuticals. Industry stakeholders argue that such an approach could stifle innovation and deter investment in the sector.

Industry Concerns Over Regulatory Framework

Several associations representing manufacturers, healthcare providers, and patient safety groups have raised concerns in a letter to the Union Health Minister. The draft bill, they argue, treats medical devices as if they are pharmaceuticals, applying stringent regulations that may not be suitable for engineering products.

The industry points out that medical devices, which are fundamentally engineering products, require a different regulatory approach than drugs. They call for a regulatory framework that recognizes the unique nature of medical devices, emphasizing that the bill's current language and penalties are more appropriate for pharmaceuticals.

Potential Impact on Innovation and Investment

The draft bill proposes criminal penalties, including imprisonment for one to seven years, for issues such as labeling errors and documentation lapses, even when no harm occurs. This approach is seen as excessive compared to international standards, such as those of the EU MDR, US FDA, and other global regulators, which focus on administrative enforcement rather than criminalization.

By treating medical devices like pharmaceuticals, the bill risks discouraging manufacturers and investors, potentially hindering India's aspirations to become a global hub for medical device production and innovation. The associations contend that the bill does not provide the necessary regulatory foundation to support the sector's growth and global competitiveness.

Calls for a Distinct Regulatory Approach

In their letter dated August 8, industry representatives stress the need for a regulatory system that incorporates risk-based conformity assessments, quality management systems, and post-market surveillance. They argue that these measures, rather than punitive actions, would better support the sector's development.

The draft bill is currently under inter-ministerial consultation, and the medical device industry is hopeful that their feedback will lead to a more tailored regulatory approach. As the government seeks to replace the 86-year-old law governing pharmaceuticals, stakeholders emphasize the importance of a distinct framework for medical devices to foster innovation and maintain patient safety.