Medical Device Firms Challenge New Bill, Cite Misclassification with Pharma

India's medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it unfairly equates medical devices with pharmaceuticals. According to industry representatives, this misclassification could stifle innovation, deter investment, and impede the country's goal of becoming a global hub for medical device manufacturing.

Industry Concerns Over Regulatory Approach

The draft bill proposes treating medical devices under the same regulatory framework as pharmaceuticals, which includes imposing criminal penalties for regulatory lapses. Industry groups argue that this approach fails to recognize the fundamental differences between engineering-based medical devices and chemically-based pharmaceuticals. They warn that such regulations could lead to a chilling effect on manufacturing and innovation within the sector.

In a letter to the Union Health Minister dated August 8, several associations representing manufacturers, healthcare providers, and patient safety groups urged a reconsideration of the draft bill. They emphasized that the bill's regulatory framework is inadequate for supporting the growth and global competitiveness of India's medical devices sector.

Call for Risk-Based Regulation

The letter highlights the industry's concern that the bill continues to use language and penalties more suited to the pharmaceutical sector, including terms like "adulterated," "spurious," and "misbranded." These terms, along with the imposition of pharma-style criminal penalties for engineering deviations, are seen as inappropriate for the medical device industry.

Globally, medical devices are regulated through risk-based conformity assessments, quality management systems, and post-market surveillance rather than criminal penalties. The industry argues that such an approach is consistent with international practices followed by regulatory bodies like the EU MDR, US FDA, Japan's PMDA, the UK's MHRA, and Australia's TGA.

Potential Impact on India's Global Ambitions

Industry leaders warn that the draft bill could undermine India's ambitions to become a leading player in the global medical device market. They argue that the proposed regulations could discourage foreign investment and hinder domestic manufacturers' ability to innovate and compete internationally.

The draft bill, currently under inter-ministerial consultation, seeks to replace the 86-year-old law governing India's pharmaceutical regulations. However, the medical device industry contends that a separate regulatory framework is necessary to address the unique challenges and opportunities within their sector.

As the government considers feedback from various stakeholders, the medical device industry remains hopeful that their concerns will be addressed, ensuring a regulatory environment that supports innovation and growth while maintaining patient safety.