Medical Device Industry Pushes Back on India's Draft Regulatory Bill

India’s medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it improperly equates medical devices with pharmaceuticals. Industry leaders warn that this approach could stifle innovation, deter investment, and hinder the country’s aspirations to become a global hub for medical device manufacturing.

Industry Concerns Over Regulatory Approach

Several associations, representing manufacturers, healthcare providers, and patient safety groups, have collectively urged the Union Health Minister to reconsider the draft legislation. The bill, currently under inter-ministerial review, proposes criminal penalties for regulatory violations, a shift that industry experts claim is unsuitable for the engineering-focused nature of medical devices.

The draft bill's language, which includes terms like "adulterated," "spurious," and "misbranded," mirrors pharmaceutical regulations. Industry representatives argue that such terminology is inappropriate for devices, which are typically governed by risk-based assessments, quality management systems, and post-market surveillance rather than criminal sanctions.

Global Standards and Local Implications

Critics of the draft point out that international standards, such as those from the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA, focus on administrative enforcement rather than criminal penalties. The proposed Indian legislation, however, suggests imprisonment of one to seven years for infractions such as labeling errors and documentation lapses, even when no harm results.

Industry stakeholders assert that these stringent measures could deter both domestic and foreign investment in India’s medical device sector. The associations' August 8 letter to the government emphasizes the need for a regulatory framework that supports growth and innovation, distinguishing medical devices from pharmaceuticals based on their scientific and engineering attributes.

Call for a Distinct Regulatory Framework

The medical device sector is advocating for regulations that reflect the unique characteristics of medical devices, which differ significantly from drugs. They argue for a regulatory approach that aligns with global norms, emphasizing risk management and quality assurance over punitive measures.

As the draft bill undergoes further consultation, the industry remains hopeful that the government will recognize the distinct nature of medical devices. By doing so, India can foster an environment conducive to innovation and manufacturing excellence, enhancing its position in the global medical device market.