Industry Pushback: Draft Bill Treating Devices as Drugs Faces Opposition

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices in the same manner as pharmaceuticals. Industry stakeholders, including manufacturers and healthcare providers, argue that this approach could significantly impede manufacturing, innovation, and investment in the sector.

Concerns Over Regulatory Approach

The draft bill, currently undergoing inter-ministerial consultation, has raised alarms among various associations representing the medical device sector. In a letter dated August 8 to the Union Health Minister, these associations emphasized the need to differentiate between medical devices and pharmaceutical products. They argue that medical devices are fundamentally engineering products, distinct from drugs, and require a separate regulatory framework.

The letter criticized the draft for perpetuating a drug-centric regulatory language, using terms like "adulterated," "spurious," and "misbranded," which are typically associated with pharmaceuticals. The industry contends that applying such language and associated criminal penalties to medical devices could stifle the sector's growth and innovation.

Potential Impact on Innovation and Investment

Industry leaders warn that the proposed bill could deter investment and hinder India's ambition to become a global hub for medical devices. By treating medical devices as pharmaceuticals, the draft bill imposes stringent penalties, including imprisonment for regulatory lapses such as labeling errors and documentation issues, even in the absence of harm.

In contrast, international regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA adopt a more nuanced approach. These agencies typically employ risk-based conformity assessments, quality management systems, and administrative enforcement rather than criminal penalties for non-compliance.

Call for a Distinct Regulatory Framework

The medical device sector advocates for a regulatory framework that recognizes the unique nature of medical devices. Such a framework would prioritize risk management, post-market surveillance, and recalls over criminalization, aligning more closely with global standards. The industry's feedback underscores the necessity of a supportive regulatory environment to foster growth and innovation in this technologically advanced field.

This pushback from the medical device industry highlights the critical need for regulations that accommodate the specific characteristics of engineering products, ensuring that India's regulatory landscape supports rather than hinders its burgeoning medical device sector.