Medical Device Industry Opposes India's New Regulatory Draft Bill

India's medical device industry, along with healthcare providers and patient safety groups, is vocally opposing the draft Drugs, Medical Devices, and Cosmetics Bill, 2026. They argue that the draft, which treats medical devices as pharmaceutical products, could severely impact manufacturing, innovation, and investment in the sector.

Industry Pushback Against Regulatory Approach

Several associations representing manufacturers and healthcare providers have written to the Union Health Minister. They urge a reconsideration of the bill, warning that it may discourage manufacturing and impede India's goal of becoming a global leader in medical device production. Industry insiders emphasize that medical devices are fundamentally engineering products, not pharmaceuticals, and require a different regulatory approach.

The draft bill is currently under inter-ministerial review, aiming to replace the 86-year-old law governing India's pharmaceutical regulations. However, stakeholders argue that the proposed legislation lacks the necessary regulatory framework to support the growth and global competitiveness of India's medical devices sector.

Concerns Over Criminal Penalties

The opposition highlights that the draft bill employs drug-centric terminology such as "adulterated," "spurious," and "misbranded" and introduces criminal penalties for regulatory lapses. This includes imprisonment for labeling errors, documentation issues, and other non-harmful engineering deviations, with penalties ranging from one to seven years. Industry critics point out that such punitive measures are not common in other major markets like the EU, US, Japan, UK, or Australia, where administrative enforcement prevails.

According to the associations, the draft bill should align with global standards, which regulate medical devices through risk-based assessments, quality management systems, and post-market surveillance rather than criminalization.

Calls for a Distinct Regulatory Framework

The medical device sector has called for a distinct regulatory framework that acknowledges the scientific, engineering, and regulatory differences between medical devices and pharmaceuticals. They argue that the current draft fails to provide a conducive environment for innovation and growth, risking India's position in the global market.

As the draft bill undergoes further consultation, the industry remains hopeful that the government will consider their feedback to foster a more favorable regulatory landscape for medical devices.