Medical Device Sector Challenges Draft Bill's Pharma-Like Regulations

India's medical device industry is mounting a strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which it argues mistakenly categorizes medical devices as pharmaceutical products. Industry leaders, along with patient safety groups and healthcare providers, warn that the proposed regulations could stifle innovation, hinder manufacturing, and deter investment in the sector.

Industry Pushback Against Drug-Centric Regulations

Key industry associations have voiced their concerns in a letter to the Union Health Minister, highlighting the bill's potential to undermine India's ambition of becoming a global hub for medical devices. The draft bill, currently under inter-ministerial review, is seen as an attempt to replace the country's 86-year-old pharmaceutical regulations. However, critics argue it fails to establish a conducive regulatory framework for the distinct needs of the medical device sector.

The letter emphasizes the fundamental differences between medical devices and pharmaceuticals, pointing out that devices are engineering products that require a separate regulatory approach. The draft's reliance on drug-centric language and its application of criminal penalties for regulatory lapses, such as labeling errors and documentation issues, have raised alarms. These penalties, ranging from one to seven years of imprisonment, are viewed as excessive, especially in cases where no harm occurs.

Global Practices and Industry Concerns

Globally, medical devices are regulated through risk-based assessments and quality management systems rather than criminalization. The industry cites international standards, such as those from the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA, which focus on administrative enforcement for compliance issues.

Industry representatives argue that the draft bill's approach could lead to a chilling effect on innovation and discourage manufacturers from operating in India. The use of terms like "adulterated," "spurious," and "misbranded"—traditionally associated with pharmaceuticals—further complicates the regulatory landscape for medical devices.

Call for a Distinct Regulatory Framework

The medical device sector is urging the government to reconsider the draft bill and develop a regulatory framework that recognizes the unique characteristics of medical devices. By aligning more closely with global practices, India can better support its burgeoning medical device industry and foster an environment conducive to growth and innovation.

As the draft bill undergoes further consultations, the outcome will be closely watched by stakeholders who hope for a balanced approach that safeguards patient safety while promoting industry advancement.