Medical Device Industry Opposes Draft Bill Equating Devices with Pharmaceuticals

The Indian medical device industry, along with healthcare providers and patient safety groups, has raised concerns over the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation classifies medical devices similarly to pharmaceuticals, a move stakeholders argue could have detrimental effects on manufacturing, innovation, and investment in the sector.

Industry Pushback Against Regulatory Approach

Associations representing manufacturers, traders, and healthcare professionals have formally objected to the bill in a letter to the Union health minister. They argue that the proposed regulations fail to acknowledge the fundamental differences between medical devices, which are engineering products, and pharmaceuticals. This misclassification, they warn, could hinder India's aspirations to become a global hub for medical device manufacturing.

The industry groups emphasize that medical devices should not be subject to the same regulatory framework as drugs. They highlight that globally, devices are governed by risk-based assessments, quality management systems, and post-market surveillance, rather than the punitive measures outlined in the draft bill.

Concerns Over Penal Provisions

A major point of contention is the draft bill's imposition of criminal penalties for regulatory lapses. The bill proposes imprisonment ranging from one to seven years for issues such as labeling errors, documentation mistakes, or licensing deficiencies, even if no harm results. Industry representatives argue that such severe measures are not aligned with international practices, where administrative enforcement is more common.

The draft bill's language, which includes terms like "adulterated," "spurious," and "misbranded," is seen as inappropriate for the engineering-focused nature of medical devices. Stakeholders argue that these terms are more suited to pharmaceuticals and could lead to unnecessary criminalization of technical deviations.

Call for a Distinct Regulatory Framework

The medical device industry is advocating for a separate regulatory framework that recognizes the unique characteristics of devices. They stress the need for policies that encourage growth and innovation while ensuring patient safety through appropriate oversight.

The draft bill is currently under inter-ministerial review, with industry leaders hopeful that their feedback will lead to revisions that better serve the interests of the medical device sector and, by extension, the healthcare needs of the population.