Indian Medical Device Sector Opposes Draft Bill on Regulatory Grounds

India's medical device industry and healthcare organizations are strongly opposing the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The proposed legislation, which treats medical devices similarly to pharmaceutical products, has raised concerns about its potential impact on manufacturing, investment, and innovation within the sector.

Concerns Over Treatment as Pharmaceuticals

The draft bill, currently under inter-ministerial consultation, has prompted industry stakeholders to express their apprehensions. Associations representing manufacturers, healthcare providers, and patient safety groups have communicated their concerns in a letter to the Union Health Minister. They argue that the bill's approach could deter investment and hinder India's ambitions to become a global leader in medical devices.

The industry's primary contention is that medical devices, which are engineering products, should not be regulated as pharmaceuticals. The letter highlighted the scientific, engineering, and regulatory distinctions between medical devices and drugs, urging a regulatory framework that acknowledges these differences.

Regulatory Language and Penalties

Industry representatives have criticized the draft bill for continuing to use drug-centric terminology such as "adulterated," "spurious," and "misbranded." Furthermore, the bill proposes criminal penalties for regulatory lapses, including imprisonment for labeling errors and documentation issues, even when no harm occurs. Such measures, the industry argues, are inconsistent with global practices where administrative enforcement is the norm.

The draft bill suggests imprisonment ranging from one to seven years for various infractions, a stark contrast to regulatory approaches in regions like the European Union, United States, Japan, United Kingdom, and Australia. These jurisdictions typically employ risk-based conformity assessments, quality management systems, and post-market surveillance without resorting to criminal penalties.

Industry's Call for a Revised Approach

In their August 8 letter, industry associations emphasized the need for a regulatory framework that supports growth and innovation. They warned that the current draft does not provide the necessary foundation for the sector to flourish on a global scale. The letter also pointed out that the draft's regulatory approach could undermine India's position as a potential hub for medical device manufacturing.

The industry is advocating for a revised bill that differentiates medical devices from pharmaceuticals, aligning with international standards and practices. By doing so, stakeholders hope to foster an environment conducive to innovation and investment, ensuring that India's medical device sector remains competitive on the world stage.